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Results for “Randomized Response Technic”

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PubMed1994

Adolescent contraceptive counseling and gynecology: a deficiency in pediatric office-based care.

With the large and increasing numbers of sexually active adolescents, pediatricians must learn to deal with the issues of adolescent pregnancy and sexually transmitted diseases (STD). This is particularly true at a time when health care reform will encourage primary care physicians to assume a greater role in general medical management of their patients. One hundred Connecticut general practice pediatricians were randomly selected to examine the frequency, level of comfort, and rationale for involvement regarding sexual history taking, contraceptive counseling, and performance of pelvic examinations. This represents 9% of all Connecticut pediatricians. The response rate was 54%. The results were as follows: Seventy-nine percent of responding pediatricians counseled on STDs, 39% counseled on family planning, and only 62% almost always took a sexual history from the their adolescent patients, ages 10 and up. Thirty-one percent of respondents stated they would refer a male inquiring about contraception to a family planning clinic. Thirty-eight percent never do pelvic examinations on their sexually active adolescent patients. Connecticut pediatricians are providing adolescents with counseling on other high-risk behaviors such as drug and alcohol use, but provide inadequate care related to adolescent sexual activity.

Adolescent↗

PubMed1989

Microvascular free-tissue transfers to the hand and upper extremity.

Hundreds of authors world-wide are responsible for the development of the present state of microvascular free-tissue transplantation. The applied technique represents a true developmental landmark in the field of surgery, now applicable to the broad spectrum of surgical subspecialties. In hand surgery, the revolutionary use of free-tissue transplantation has saved innumerable limbs, and improved the quality of life for tens of thousands of patients. In spite of our comfort level using these techniques and incorporating them into our armamentarium of patient care, we stand only on the threshold of microsurgical clinical applicability. The field has expanded substantially during the last 15 years. First, as a substitute for more conventional solutions to wound coverage problems, substituting for often cumbersome attached random or axial pattern pedicle flaps; then, incorporating neurosurgical techniques to provide sensibility to viable but otherwise anesthetic flaps, and kinetic function to transplanted muscle; and subsequently, with the incorporation of muscle, bone, and total joints. An ever-increasing knowledge of the metabolic consequences of ischemia and hypoxia on different types of tissue has allowed us to be even more aggressive in assessing indications for composite tissue transplantation. In the future we should anticipate continued advances in optics and magnification in the surgical microscope, with particular emphasis on three-dimensional perspective and enhanced video capabilities. Technologic development of instruments and suture material should continue helping to raise the capability of what is presently the most limiting factor--the surgeon--to a higher level of potential for his or her patients. Even with improved links to video equipment, stereoscopic imaging, or even more sophisticated visual images, the lowest common denominator is the skill of the microsurgeon; more rigorous technical development will be necessary during the surgeon's training period. Besides a fundamental knowledge of vascular clotting mechanisms and the effects of anticoagulation, we have only an elementary understanding of chemically induced vasospasm, and a developing appreciation of the physiologic impact of microsurgical trauma on small blood vessels, even with the most sophisticated and delicate techniques. As the field enlarges, our ability to deal with irreversible vessel spasm, inexplicable arterial or venous clotting, or the enormity of other complications associated with microvascular free-tissue transplantation, will only grow. A richer understanding of tissue biology will not only improve our technical capabilities, but will promote consideration of a

Adult↗

PubMed1999

Knowledge and perception of professionals towards school injuries.

As injuries remain a threat to children everywhere including school, this study was undertaken to reveal the knowledge and perceptions of school physicians, nurses, teachers and social workers regarding school injuries. To accomplish this aim, all school-based clinics operated by a physician were identified. All physicians and nurses were included in this survey. In addition, a teacher or a social worker was randomly selected from the same school. They were requested to fill in a questionnaire to collect relevant information. Findings indicate that school injury is not perceived as a priority problem by all social workers and 68.5% of teachers. Moreover, its economic burden was not perceived by one third of physicians and nurses. Regarding associated risk factors, more than 80% of the surveyed professionals recognized nine out of the 16 stated factors as a risk for school injuries. However, less than 80% viewed that the risk of school injury is higher in technical schools, schools which include more than one educational stage as well as in the evening shift. Moreover, less than 80% of nurses recognized that a higher risk is associated with poorly kept school building, primary schools and methods of transportation. Furthermore, less than 80% of teachers recognized that boys are at a much higher risk of injuries. Surveyed professionals ranked increase supervision, continuous maintenance of school building as well as health education activities as priority preventive strategies. Mass media was the method of health education that received the highest priority while the least were pupils' activities and the organization of an injury prevention day. It can be concluded that, school professionals, exceptionally teachers and social workers need to be aware of the extent of school injuries and the risks associated with their occurrence. Such awareness is the key issue in ensuring the safety of children while they are at school. Moreover, it is indispensable for the planning and implementation of effective preventive strategies. They should also recognize that pupils' involvement is a highly effective mean of creating awareness about safety and to encourage them to take the responsibility of their safety as well as that of other pupils. Organized training programs directed to all personnel in the area of school injuries are deemed essential.

Accident Prevention↗

PubMed1998

[Regulating function of enzymization and deenzymization of the lactate dehydrogenase isozymes in the mouse tissues during hypoxia].

OBJECTIVE: Study the characteristics of changes of LDH enzyme map of mouse under slight hypoxia. METHODS: Treated mouse with artificial hypoxia, various tissue biopsies were made for the test of LDH enzymatic activity by specific staining technical LDH(1-5)relative percent enzymatic activity were measured with CS-910 dual-wavelength thin-layer chromatography scanner. RESULTS: The relative percent enzymatic activity of LDH isozymes of various tissues after slight hypoxia shift to the isozymes LDH1 and LDH2, whose principal subunits are H subunits, and the relative percent enzymatic activity of LDH1 (H4), LDH2-(H3M) increased (the relative percent enzymatic activity of LDH2 increased markedly, P < 0.05), while LDH (M4) in various tissues decreased prominently except the cardiac muscle, and that of LDH4 (HM3) decreased as well. After the PAGE of the hypoxia treated cardiac muscle specimen was made, activity subbands originated regularly in the isozyme pattern of LDH, with the regularity of LDH1 (0 subband), LDH2 (0-1 subbands), LDH3 (0-2 subbands), LDH4 (1-3 subbands), LDH5 (2-4 subbands). After adding appropriate amount of NAD+ to mouse cardiac muscle specimen with hypoxia, PAGE showed the numbers of subbands of four kinds of isozymes (LDH2-LDH5) decreased even totally disappeared in the isozyme pattern. CONCLUSIONS: The negative feedback regulation of enzymization and deenzymization of LDH isozymes is one of mouse stress responses to slight hypoxia.

Animals↗

PubMed1994

Epidural anaesthesia prolonged into the postoperative period prevents stress response and platelet hyperaggregability after peripheral vascular surgery.

The occlusion rate of peripheral vascular grafts depends on technical as well as endogenous factors. Platelets play an integral part in graft failure and it has been suggested that anaesthesia may influence platelet function. In order to evaluate the influence of anaesthesia on stress response and platelet function in peripheral vascular surgery, patients (n = 18) were allocated to either general anaesthesia (GA; n = 9) followed by alleviation of postoperative pain with intramuscular analgesics or to lumbar epidural anaesthesia (EPI; n = 9) which was continued for 24 hours postoperatively. Before, during, as well as after vascular surgery of the lower extremity plasma levels of cortisol, glucose, serotonin (p-5HT), and urinary 5-hydroxyindole-3-acetic acid (5-HIAA) were analysed and platelet aggregability was determined. In the GA group surgery was accompanied by a significant stress response while in the EPI group this stress response was almost completely abolished. Platelet aggregability was reduced intraoperatively in both groups but in the postoperative period there was a marked hyperaggregability only in the GA group. P-5HT was increased preoperatively in both groups but was not affected by surgery. It is concluded that epidural anaesthesia, due to its effects on platelet aggregability, may be advantageous for peripheral vascular surgery.

Aged↗

PubMed2004

Endothelin and pulmonary arterial hypertension.

BACKGROUND AND OBJECTIVES: Pulmonary arterial hypertension (PHT) is a potentially fatal disease. The purpose of this article is to review the current knowledge of the role played by endothelin (ET) in PHT and the relevant drug regimens used in the treatment of this condition. METHODS: A detailed search via MEDLINE (PubMed) was performed by using PHT and ET as the key terms. RESULTS: PHT could be a primary or a secondary diagnosis associated with various heart and lung diseases. PHT appears during the late stage of systemic sclerosis and may complicate other systemic diseases such as systemic lupus erythematosus. The vascular endothelium and activation of various mediators and growth factors such as the ET system are thought to play a crucial role in the development of this condition. The pathologic process progresses very rapidly from vasoconstriction to widespread pulmonary vascular obstruction. The use of high doses of calcium channel blockers is of limited value. Life-long anticoagulant therapy is recommended for the treatment of PHT. Currently, the drug being used in PHT therapy is continuous central-venous prostacyclin infusion. Prostacyclin is a strong vasodilator with antiaggregate and antifibrotic properties and has the potential to reduce endothelial injury and to induce vasculature remodeling. This treatment results in improved functional status and increased life span. Unfortunately, its use is accompanied by various side effects, technical difficulties, and high cost. The role of other therapeutic modalities (inhaled prostacyclin, subcutaneous treprostinil, oral beraprost, sildenafil) in vascular remodeling, and the improvement in functional capacity and survival of patients with PHT, are currently under investigation. Bosentan, administered orally, is a recently developed active ET receptor antagonist. It is a promising new therapeutic tool in the treatment of PHT because of its potent vasodilator, antiproliferative, and vascular remodeling activity. CONCLUSIONS: The revolutionary conceptual shift in understanding the pathogenesis of PHT from a vasoconstrictive process to a vasoproliferative one, has led to a modification in the treatment of this disease from the use of vasodilators to the use of drugs with antiproliferative and vascular remodeling activity. Until now, prostacyclin was the only drug of this type available for the treatment of PHT. ET blockade seems to be a reasonable and potential therapeutic option.

Antihypertensive Agents↗

PubMed1999

Prevalence of nonreporting behavior of sharps injuries in Taiwanese health care workers.

BACKGROUND: Health care workers (HCWs) were surveyed to identify factors associated with nonreporting behavior of sharps injuries (SIs) in Taiwan. METHODS: We surveyed 10,469 full-time medical, nursing, technical, and supporting personnel employed at 16 randomly selected hospitals from 132 available accredited teaching hospitals in Taiwan. Information about the most recent injury and reporting behavior after an SI were collected from July 1996 to June 1997 by using a pretested structured questionnaire. Eleven categories, including an open-ended option, were provided for participants to explain their nonreporting behavior. RESULTS: Questionnaires were completed by 82.6% (8645) of our sample, of whom 87.3% reported to have experienced a recent SI. A used item was the most commonly (P <. 001) involved item in an SI, and SIs with a used item were significantly more likely (odds ratio 3.6; CI 95%, 3.03-4.26; P <. 001) to be reported compared with an SI that involved unused items. A total of 81.8% of injuries were not reported, with job category significantly affecting reporting behavior (P <.001). Medical staff had the highest nonreporting rate (85.2%). Although attendees of a prevention program were statistically more likely (P <.001) to report an injury compared with nonattendees, the level of reporting in both groups was not encouraging (21.3% and 17.2%, respectively). All reasons given for nonreporting were disconcerting, but none more so than the use of subjective assessment of risk by 21.7% of HCWs who did not report their injuries. Other reasons for not reporting SIs included that the item was unused (34%) and that the HCW was too busy to report the SI (14.9%), unaware of reporting requirements (14. 4%), or immune to hepatitis B virus (12.4%). CONCLUSIONS: With 82% of SIs in Taiwanese HCWs going unreported, the expected national incidence will be seriously underestimated and impact the appropriateness of prevention programs. The very low rate of reporting suggests that the current reporting system requires simplification. Because most injuries involved used items, the reporting systems also should include a more responsive management component. The results also suggest that the current prevention programs, currently provided by the general nursing department, require expert content knowledge in infection control if nonreporting and SIs are to be reduced.

Humans↗

PubMed2004

Pharmacologic enhancement of rat skin flap survival with topical oleic acid.

This study was instituted to investigate in a rat model the effect of topical coadministration of the penetration enhancer oleic acid (10% by volume) and RIMSO-50 (medical grade dimethyl sulfoxide, 50% by volume) on rat skin flap survival. A rectangular abdominal skin flap (2.5 x 3 cm) was surgically elevated over the left abdomen in 40 nude rats. The vein of the flap's neurovascular pedicle was occluded by placement of a microvascular clip, and the flap was resutured with 4-0 Prolene to its adjacent skin. At the end of 8 hours, the distal edge of the flap was reincised to gain access to the clips and the clips were removed. After resuturing of the flap's distal edge to its adjacent skin, the 40 flaps were randomly divided into four groups. Group 1 (control) flaps were treated with 5 g of saline, group 2 (dimethyl sulfoxide) flaps were treated with 2.7 g of dimethyl sulfoxide (50% by volume), group 3 flaps (oleic acid) were topically treated with 0.45 g of oleic acid (10% by volume), and group 4 (dimethyl sulfoxide plus oleic acid) flaps were treated with a mixture of 0.45 g of oleic acid (10% by volume) and 2.7 g of dimethyl sulfoxide (50% by volume) diluted in saline. Each flap was topically treated with 5 ml of drug-soaked gauze for 1 hour immediately after clip removal to attenuate reperfusion injury. Thereafter, drug was applied topically once daily for 4 more days. Digital photographs of each flap were then taken on day 6 and the flaps were then harvested. The percentage of skin survival in each flap was determined by computerized morphometry and planimetry. The mean surviving area of group 3 (oleic acid-treated flaps) was 23.60 +/- 4.19 percent and was statistically higher than that in group 1 (control, saline-treated flaps) at 7.20 +/- 2.56 percent. The mean surviving area of group 2 (dimethyl sulfoxide-treated flaps) at 18.00 +/- 5.23 percent and group 4 (oleic acid- and dimethyl sulfoxide-treated flaps) at 9.90 +/- 3.44 percent did not achieve statistically higher mean surviving areas than controls. A topical solution of oleic acid (10% by volume) caused a statistically significant increase in the survival of rat abdominal skin flaps relative to controls. Dimethyl sulfoxide and the two experimental drugs together did not increase the percentage of flap survival when given as a single 5-ml dose released from a surgical sponge at reperfusion for 1 hour and then daily for a total of 5 days. The reasons for the lack of response are unknown but may have included the technical difficulty of delivering an adequate dose of dimethyl sulfoxide topically and immiscibility between dimethyl sulfoxide and oleic acid. Further studies may be warranted.

Abdomen↗

PubMed1995

Low molecular weight heparin started before surgery as prophylaxis against deep vein thrombosis: 2500 versus 5000 XaI units in 2070 patients.

The optimal administration regimens of low molecular weight heparins (LMWHs) have not yet been established. The aim of this study was to compare the efficacy and safety of 2500 and 5000 XaI units of the LMWH dalteparin in patients undergoing elective general surgery for malignant and benign abdominal disease. Prophylaxis was started in the evening before surgery and given once-daily every evening thereafter. The study was designed as a prospective, randomized, double-blind, multicentre trial. Some 66.4 per cent of patients were operated on for a malignant disorder. The primary endpoint was deep vein thrombosis (DVT) detected with the fibrinogen uptake test. Bleeding complications were recorded and classified. Analysis was made both on an intention to treat basis and in patients given correct prophylaxis (86.3 per cent). A total of 2097 patients were randomized and 27 excluded after randomization. A technically correct fibrinogen uptake test was obtained in 1957 patients. The incidence of DVT was significantly lower in patients given 5000 XaI units, this being true for both correct prophylaxis (6.8 versus 13.1 per cent, P < 0.001), on an intention to treat basis (6.6 versus 12.7 per cent, P < 0.001), and in patients with malignant disease (8.5 versus 14.9 per cent, P < 0.001). Sixty-seven patients (3.2 per cent) died within 30 days with no difference between the groups. There were two cases of fatal pulmonary embolism. The frequency of bleeding complications in the whole series was higher in patients randomized to 5000 XaI units (4.7 versus 2.7 per cent, P = 0.02), although this was not the case in those operated on for malignant disease (4.6 versus 3.6 per cent, P not significant). Dalteparin in the dose of 5000 XaI units started in the evening before surgery has a good thromboprophylactic effect in high-risk general surgery at the cost of a small bleeding risk. In patients with malignant disease there was no increased risk of bleeding. The overall frequency of fatal pulmonary embolism with dalteparin is extremely low, even in this high-risk group of patients.

Adult↗

PubMed2005

The development of quality assurance programs for radiotherapy within the German Hodgkin Study Group (GHSG). Introduction, continuing work, and results of the radiotherapy reference panel.

BACKGROUND AND PURPOSE: The German Hodgkin Study Group (GHSG), including more than 500 participating centers, established a central radiotherapy (RT) reference center to improve quality of treatment, starting with the first study generation in 1978. More than 11,000 patients with Hodgkin's lymphoma (HL) have been enrolled into these trials. Extensive continuing quality assurance programs (QAPs) during the study generations have been performed. The purpose of the present article is to summarize the experiences and results of the performed and ongoing QAPs. MATERIAL AND METHODS: A panel of expert radiation oncologists (second study generation HD4-6, 1988-1994, and third study generation HD7-9, 1993-1998) retrospectively evaluated the adequacy of treatment fields, applied radiation doses, treatment time, and technical parameters. Furthermore, a detailed analysis of relapses in correlation with the performed RT was conducted. For the fourth study generation (HD10-12, 1998-2002), the RT reference center changed from Munich to Cologne. New RT QAPs were initiated according to the demands of the new trials and former programs were enhanced: (1) central prospective radiation oncologic review of cross-sectional imaging (HD10, HD11) to create the individual radiation treatment plan; (2) retrospective analysis of the adequacy of the performed involved-field (IF) RT (HD10, HD11); (3) the multidisciplinary HD12 panel (radiation oncologists, medical oncologists, diagnostic radiologists); (4) initiation and integration of a teleradiotherapy network into the GHSG trials. RESULTS: A strong achievement of these activities in the era of extended-field RT was to show that major deviations of radiation treatment portals and radiation dose from prospective treatment prescriptions revealed to be unfavorable prognostic factors for patients with early-stage HL (HD4). The central prospective radiation oncological review of all diagnostic imaging (HD10, HD11) showed that corrections of disease involvement in 49% of patients (593/1,214) with early stages (HD10) and in 67% of patients (936/1,397) with intermediate stages (HD11) were necessary. These procedures had a significant impact on the correctness of stage definition, allocation to treatment groups and on the extension of the IF treatment volume. Until now, 1,080 patients in HD10 and HD11 have been evaluated retrospectively with regard to the adequacy of the performed IF-RT. Although the participating institutions got a precise RT prescription, interim results reveal deviations in a significant number of cases. In the HD12 trial (advanced stages), a multidisciplinary panel of radiation oncologists, radiologists and medical oncologists reviewed all the diagnostic imaging from diagnosis throughout the treatment in comparison to the documentation forms. For patients with poor response to chemotherapy, the panel recommended RT independent of the randomization. This procedure ensured that patients with a poor response to chemotherapy received additional RT. 1,080 of 1,594 randomized patients (68%) could be analyzed. After chemotherapy, 599 patients (56%) showed residual disease (> 1.5 cm), and in 145/1,080 patients (13.5%) the panel recommended additional RT independent of the randomization arm. The introduction of electronic image transfer optimized and simplified the workflow of the QAPs. Rapid online consultation and real-time teleconferences regarding disease involvement, patient management and communication of the RT prescription with connected hospitals proved to be extremely helpful. CONCLUSION: Today, radiation oncologists in the GHSG perform a continuous and efficient QAP to improve treatment quality of study patients. For early favorable and unfavorable HL a central prospective review of all diagnostic imaging is performed by expert radiation oncologists to control the disease extension and to define the IF treatment volume. Retrospective analysis of RT portals by an expert panel detects faults in the applied irradiation. Participants are trained on the definition of IF-RT by workshops on the occasion of annual GHSG meetings and on the annual meetings of the German Society of Therapeutic Radiation Oncology (DEGRO). For the advanced stages a multidisciplinary panel evaluates the treatment response to chemotherapy. Patients with a poor response receive additional RT due to the panel's recommendation. The introduction of teleradiotherapy into the GHSG trials improves the dialogue between the central RT reference center and study participants and thus contributes to high RT quality for study patients.

Disease-Free Survival↗

PubMed2006

Iliac anastomotic stenting with a sirolimus-eluting biodegradable poly-L-lactide stent: a preliminary study after 6 weeks.

PURPOSE: To assess technical feasibility and biocompatibility of a new biodegradable sirolimus-eluting poly-L-lactide (PLLA) vascular anastomotic stent. METHODS: A polytetrafluoroethylene bifurcated graft was implanted in 9 pigs through a midline abdominal incision. After transverse graft limb incision, 6 unloaded PLLAs, 6 sirolimus-loaded PLLAs, and 6 unloaded stainless steel (316L) stents were randomly implanted at both iliac anastomotic sites. Stents were deployed with a 6-mm balloon under direct vision without the use of angiography. Prior to sacrifice after 6 weeks, contrast-enhanced computed tomography (CT) was performed to determine patency of the target vessels. Stented segments were surgically explanted and processed for histology to measure the mean luminal diameter and intimal thickness and to assign vascular injury and inflammation scores. RESULTS: No animals were lost during the study period. All stented graft limbs were patent on CT and histology. At the anastomotic sites and iliac arteries, the mean luminal diameter of SIR-PLLA stents (4.11+/-0.15 and 4.08+/-0.13 mm, respectively) were comparable to metal stents (4.23+/-0.35 and 4.21+/-0.26 mm, respectively), but significantly higher compared to unloaded PLLA stents [3.32+/-0.56 mm (p<0.001) and 3.29+/-0.39 mm (p=0.013), respectively]. At the iliac arteries, the mean intimal thickness was significantly lower with SIR-PLLA stents (0.09+/-0.02 mm) compared to unloaded PLLA stents (0.31+/-0.15 mm, p<0.001) and metal stents (0.19+/-0.04 mm, p=0.004). Vascular injury scores demonstrated only mild vascular trauma for all stents (SIR-PLLA: 0.42+/-0.63, PLLA: 0.51+/-0.62, metal: 0.50+/-0.62). Only mild inflammatory reaction was noted around SIR-PLLA stent struts (1.14+/-0.46), which was comparable to metal stents (1.27+/-0.45) but significantly lower than PLLA stents (1.79+/-0.56, p<0.001). CONCLUSION: SIR-PLLA stents showed comparable luminal diameter compared to metal stents, so incorporating sirolimus could reduce the inflammatory and neointimal response to PLLA stents. These findings need to be assessed with longer follow-up to confirm maintenance of efficacy.

Absorbable Implants↗

PubMed1983

Adaptive plasticity in primate spinal stretch reflex: initial development.

Description of the neuronal and synaptic bases of memory in the vertebrate central nervous system (CNS) requires a CNS stimulus-response pathway that is defined and accessible, has the capacity for adaptive change, and clearly contains the responsible substrates. This study was an attempt to determine whether the spinal stretch reflex (SSR), the initial, purely spinal, portion of the muscle stretch response, which satisfies the first requirement, also satisfies the second, capacity for adaptive change. Monkeys prepared with chronic fine-wire biceps electromyographic (EMG) electrodes were trained to maintain elbow position and a given level of biceps background EMG activity against constant extension torque. At random times, a brief additional extension torque pulse extended the elbow and elicited the biceps SSR. Under the control mode, reward always followed. Under the SSR increases or SSR decreases mode, reward followed only if the absolute value of biceps EMG from 14 to 24 ms after stretch onset (the SSR interval) was above or below a set value. Animals performed 3,000-6,000 trials/day over data-collection periods of up to 15 mo. Background EMG and the initial 30 ms of pulse-induced extension remained stable throughout data collection. Under the SSR increases or SSR decreases mode, SSR amplitude (EMG amplitude in the SSR interval minus background EMG amplitude) changed appropriately. Change was evident in 5-10 days and progressed over at least 4 wk. The SSR increased (SSR increases) to 140-190% control amplitude or decreased (SSR decreases) to 22-79%. SSR change did not regress over 12-day gaps in task performance. A second pair of biceps electrodes, monitored simultaneously, supplied comparable data, indicating that SSR amplitude change occurred throughout the muscle. Beyond 40 ms after pulse onset, elbow extension was inversely correlated with SSR amplitude. The delay between the SSR and its apparent effect on movement is consistent with expected motor-unit contraction time. The data demonstrate that the SSR is capable of adaptive change. At present the most likely site(s) of the mechanism of SSR amplitude change are the Ia synapse and/or the muscle spindle. Available related evidence suggests persistent segmental change may in fact come to mediate SSR amplitude change. If so, such segmental change would constitute a technically accessible fragment of a memory.

Adaptation, Physiological↗

PubMed2002

Radiotherapy or chemotherapy followed by radiotherapy with or without amifostine in locally advanced lung cancer.

Radiotherapy (RT) or radiochemotherapy is the treatment of choice for patients with medically or technically inoperable non-small cell lung cancer (NSCLC) localized to the primary site and regional lymph nodes. Radiation-induced damage has been recognized as a major complication in thoracic RT. The use of concurrent chemoradiation has been associated with an increase in acute and late toxicity. Amifostine (Ethyol) is an effective cytoprotective agent and also may have a role in protecting healthy lung tissue during radiation treatment. The purpose of these 2 clinical trials was to investigate whether daily pretreatment with amifostine could reduce the incidence of esophagitis, and acute and late lung toxicity without affecting the antitumor efficacy of the treatment. The first was a phase III randomized trial of 146 patients with locally advanced lung cancer. All patients received conventional RT to a total of 55 to 60 Gy, and they were assigned randomly to pretreatment with 340 mg/m(2) of amifostine (A). Acute and late toxicities were graded according to the Radiation Therapy Oncology Group (RTOG) grading system from grades 0 to 4. Ninety-seven patients were evaluated 2 months post-RT for the incidence of pneumonitis; 43% (23 of 53) of patients in the RT arm and 9% (9 of 44) in the A plus RT arm experienced grade > or = 2 pneumonitis (P <.001). Forty-nine percent (26 of 53) of patients in the RT arm and 16% (7/44) in the A plus RT arm showed changes that were representative of grade > or = 2 lung damage in the computed tomography (CT) scan. Fibrosis was present in 53% (19 of 36) of patients receiving RT versus 28% (9 of 32) in the A plus RT arm at 6 months (P < 0.05). The incidence of esophagitis grade > or = 2 during week 4 was 42% (31 of 73) in the RT arm versus 4% (3 of 73) in the A plus RT arm (P <.001). Among 97 patients evaluable for response 2 months after RT, complete or partial responses were present in 76% (40 of 53) of patients in the RT arm and 75% (33 of 44) in the A plus RT arm (P = 1.0). The second trial was a phase II randomized study of 45 patients with NSCLC. All patients had received platinum-based induction chemotherapy before being referred for conventional radiation treatment with or without A; a total dose of 55 to 60 Gy was administered at the primary site. Acute and late toxicities were evaluated and graded according the RTOG criteria from grades 0 to 4. Forty-five patients were evaluable for response 2 months after RT. Complete or partial responses were achieved in 78% (18 of 23) of patients in the RT arm and 82% (18 of 22) in the A plus RT arm (P =.278). By week 5, 74% (17 of 23) of patients in the RT group versus 36% (8 of 22) in the A plus RT group experienced grade > or = 2 esophagitis. (During the follow-up period, pulmonary toxicity was evaluated by CT scan.) Three months after RT, 65% (15/23) of patients in the RT group and 32% (7 of 22) in the A plus RT group presented with grade > or = 2 pneumonitis (P =.038). Amifostine reduces the incidence of acute and late radiation-induced toxicities.

Acute Disease↗

PubMed1997

Laser soldering technique for sutureless urethral surgery.

Investigators have attempted sutureless surgery to decrease operative time, lessen the inflammatory response, maintain luminal continuity, and increase the ease of performing technically difficult surgery. Only recently has laser-tissue welding (LTW) been used for urologic reconstruction in humans. Herein, we present our technique of laser soldering with the half-watt diode laser and wavelength matched albumin-based solder. Our methodology of LTW relies on bonding between the outer surface of the wound edges and the solder. The 808-nm diode wavelength does not penetrate deep tissue, and thus relies on indocyanine green dye to localize photon absorption. Since 1994, we have performed LTW, as an adjunct to suturing (N = 25) and as a primary means of tissue closure (N = 11). Preoperative diagnoses included hypospadias, urethral stricture, urethral diverticulum, and urethral fistulae. Follow-up ranged between 3 months and 3 years to identify complications of wound healing, stricture, and fistula formation. In the 37 patients undergoing urethral surgery, no strictures or diverticula have resulted. None of the patients have had wound infections or poor wound healing. Overall, five patients have developed fistulas between 2 weeks and 6 months postoperatively. The location of the hypospadiac meatus was scrotal or penoscrotal in four of these patients. Two fistulas developed following sutureless urethroplasty (reoperative) after traumatic catheterization for urinary retention (one case for inadvertent catheter removal). In our initial experience, the overall complication rate using laser soldering was 19% compared to 24% in an historical control group. Half of the complications occurred in a reoperative situation. More recently, the overall fistula rate was 14%; however, for primary cases, the current fistula rate is only 6%. LTW is safe and easy to perform. The application of protein solders (+/-chromophores) have permitted far greater tensile strengths to be achieved than laser alone. Temperature-control and chromophore-control have permitted safety and efficacy to be achieved. Solder application site and technique are equally important in the success of the LTW process. A randomized, prospective study comparing LTW to suturing is ongoing.

Adolescent↗

PubMed1989

Reduction of blood transfusion requirement in open heart surgery by administration of high doses of aprotinin--preliminary results.

Reduction of homologous blood requirement in cardiac surgery is of increasing interest and may be achieved by various technical and pharmacological means. High-dose aprotinin (about 840 mg, equivalent to 6 million Kallikrein inactivator units), a serine proteinase inhibitor, was administered during open heart surgery to 60 patients refusing homologous blood transfusions or suspected to have an increased risk of bleeding. As a significant decrease in donor blood requirement could be observed, a prospective, randomised double blind study in 80 male patients undergoing primary coronary surgery with high-dose aprotinin administration was performed. Mean blood loss was reduced by 45.9% (652 ml in the treated vs 1204 ml in the untreated group, p less than 0.01) and the mean amount transfused was decreased by 74.2% (242 ml vs 937 ml, p less than 0.01). No homologous blood was needed in 57.9% of the aprotinin-treated patients and in 31.6% of patients not treated with aprotinin.

Aprotinin↗

PubMed2004

Protein biomarkers and drug design for cancer treatments.

The development of new cancer treatments is quickly evolving away from traditional practices of the last 25 years. This change is occurring not only at the technical level, but also conceptually as the human genome is unravelled and decades of research contribute to our understanding of the molecular complexity of this disease. It is anticipated that disease initiation and progression is dictated by an understandable set of acquired capabilities. Knowledge of the molecular events associated with these acquired capabilities will allow the development of targeted agents coupled with new biomarkers for the prevention of cancer progression. This will have a profound influence on how drugs are developed, approved, and used by the medical community. The Food and Drug Administration (FDA) has over 400 Investigational New Drug (IND) applications for cancer in its portfolio, which increasingly involve molecular targets and genomic applications. However, only one-fifth of IND agents succeed in New Drug Application (NDA) and there is more expense and uncertainty around successful drug development than ever before. Biomarkers should help the success rate of INDs by enhancing the link between target and disease as well as in improving patient selection and monitoring response. In this review, we discuss how biomarkers can be used for target validation and pharmacodynamic modeling in preclinical drug discovery. We then explore the use of biomarkers in clinical development from proof of mechanism to proof of concept studies, as well as their use in the prevention setting.

Animals↗

PubMed1989

[The sympatho-adrenergic stress reaction in ear surgery using various anesthesia technics].

The aim of the present study was to investigate the effects of various anaesthetic procedures on the endocrine stress responses during ear microsurgical operations. Simple mastoidectomies, radical mastoidectomies and tympano plastics were carried out in 49 patients under the following randomised anaesthetic procedures: Group 1 halothane anaesthesia and retroauricular infiltration anaesthesia with lidocaine and ornipressin (n = 14), Group 2 fentanyl anaesthesia and retroauricular anaesthesia with lidocaine and ornipressin (n = 10), Group 3 fentanyl anaesthesia and retroauricular infiltration anaesthesia with lidocaine and epinephrine (n = 14), and Group 4 retroauricular infiltration anaesthesia with prilocaine and epinephrine (n = 14). The plasma levels of epinephrine, norepinephrine, glucose, lactate and free glycerol were measured in addition to mean arterial pressure (MAP) and heart rate (HR) immediately before anaesthesia, 10 minutes after skin incision, 10 minutes after having started bone drilling, at the end of the operation and 3 hours after operation. All data were subjected to covariance analysis including the age factor. Plasma catecholamine concentrations remained within the normal range during the investigation in patients subjected to general anaesthesia (Groups 1-3). Plasma catecholamines (epinephrine and norepinephrine) increased significantly in Group 4 (retroauricular infiltration anaesthesia). There were no group variabilities with regard to MAP and HR. The plasma levels of epinephrine and norepinephrine demonstrate a direct response to stress followed by a secondary change in glucose, lactate and free glycerol. The beneficial effect of general anaesthesia is documented by normal plasma levels of epinephrine and norepinephrine throughout the operation.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2007

Chemomechanical caries removal in children: an operator's and pediatric patients' responses.

BACKGROUND: This study investigated an operator's and pediatric patients' responses to chemo-mechanical caries removal (CMCR) versus the traditional method (TM) of caries removal using a handpiece and a round bur when treating dentinal-depth occlusal lesions with minimal enamel access in primary molars. METHODS: Data were collected from 50 children at baseline and before, during and after caries removal using CMCR or TM. The subjects in the CMCR group were on average younger than the subjects in the TM group and had more deep lesions. RESULTS: The operator rated CMCR as needing more clinical and technical effort and more total effort than TM. He was less satisfied with CMCR than with TM. Subjects in the CMCR group perceived the time needed for treatment as significantly longer than did the subjects in the TM group. Fear of the dentist decreased in subjects in the TM group from before to after the operative appointment, while it increased in subjects in the CMCR group. CONCLUSIONS: The authors found no direct advantage in using CMCR over using TM. CLINICAL IMPLICATIONS: CMCR cannot be recommended as an alternative to TM when treating dentinal depth occlusal lesions with minimal access in primary molars.

Age Factors↗