[On the etiologic significance of exogenic and endogenic maternal damage for the origin of congenital heart defects].
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Drug-Related Side Effects and Adverse Reactions↗
Biomedical subjects
T Simon
Publications and source records attributed to T Simon.
Chrysotherapy. Suppression of immunoglobulin synthesis.
Forty-four subjects with classic or definite rheumatoid arthritis who were on individualized chrysotherapy were observed for changes in serum protein electrophoresis, immunoglobulins, and circulating lymphocyte counts. By paired variate analysis, significant declines from pretreatment values were recorded for the following--electrophoretic protein fractions: gamma, alpha-1, alpha-2, (P less than 0.05); immunoglobulins: IgM--53% (P less than 0.001), IgG--37% (P less than 0.01), IgA--34% (P less than 0.001). Rheumatoid factor decreased in 29 of 39 subjects, 15 becoming seronegative (P less than 0.001); circulating lymphocytes decreased by 27% (P less than 0.001). The maximal suppressive effect on IgG and IgM was not achieved until the third and fourth years of therapy by sustained weekly administration of gold sodium thiomalate (one year cumulative dosage, mean 2106 mg, range 1065-2,885; greater than or equal to 4 year cumulative dosage, mean 8747 mg, range 5,385-15,160 mg). An immunosuppressive effect is suggested by these results.
Adult↗
Advances in pre- and posttransplant immunologic testing in kidney transplantation.
Pre- and posttransplant risk estimation in kidney transplantation is important for the selection of appropriate treatment strategies. Recently, using new immunologic tests, we made observations within the framework of the Collaborative Transplant Study that may influence clinical practice. Complement-dependent lymphocytotoxic panel reactivity as a measure of anti-HLA sensitization, although criticized for its low sensitivity, is a useful indicator of an increased risk of rejection. Using the more sensitive complement-independent ELISA methodology, which utilizes solubilized HLA molecules instead of lymphocytes, we found that recipients with preformed complement-dependent anti-HLA antibodies showed a decreased graft survival only if their antibodies were directed against both HLA class I and class II, whereas isolated reactivity only against HLA class I or class II was of no clinical consequence. Pretransplant serum-soluble CD30 (sCD30) was found to be an independent and highly predictive factor of immunologic risk. The effects of sCD30 and anti-HLA antibodies were additive. Importantly, even patients without anti-HLA antibodies showed a strong HLA matching effect if their pretransplant serum contained high levels of sCD30. Although the role of anti-HLA antibody formation after transplantation remains uncertain, ELISA-detected sCD30 was shown to indicate impending graft rejection as early as on posttransplant days 3 to 5. Another very sensitive indicator of impending rejection is provided by posttransplant monitoring of the cytotoxic T-lymphocyte effector genes, perforin and granzyme B, in peripheral blood using real-time PCR.
Antigens, CD↗
Average national payments.
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Arthritis, Rheumatoid↗
Recommended methods for conducting radiolabeled platelet survival studies.
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Blood Platelets↗
Uneventful administration of plasma products in a recipient with T-activated red cells.
A patient with T-polyagglutinable red cells and a severe coagulopathy provided an opportunity to observe the results of plasma transfusion in the face of T-activation. The patient was a 52-year-old Navajo Indian with a perforated gall bladder and related sepsis due to Clostridium perfringens. The gall bladder was removed surgically. Postoperatively, he had severe thrombocytopenia, and prolonged partial thromboplastin and prothrombin times. The patient's red cells were agglutinated by Arachis hypogaea and Glycine soja lectins but were unagglutinated by extracts of Salvia horminum, Salvia sclarea, and Bandeiraea simplicifolia. No untoward reactions or any evidence of hemolysis were observed when the patient was given platelet concentrates and 4 units of single-donor plasma. Serial plasma hemoglobin and haptoglobin levels documented that there was no hemolysis. His coagulopathy responded, and he had a successful surgical re-exploration and recovery. This case documents that serious adverse consequences do not necessarily follow transfusion of plasma in a recipient with T-activated red cells. T-activation is a relative but not absolute contraindication to plasma transfusion.
Blood Coagulation Disorders↗
The incidence of hearing impairment after successful treatment of neuroblastoma.
BACKGROUND: Platinum compound based chemotherapy has contributed to improved survival rates in neuroblastoma patients. We studied the association of hearing loss with the use of platinum based drugs. METHODS: Data of children from the two German neuroblastoma study cohorts, NB90 and NB97, were analyzed for the incidence of hearing impairments greater than WHO grade 2. Data from patients surviving more than 1 year after diagnosis without progression or recurrence were used. RESULTS: Of these 1,170 patients, 146 (12.5 %) had persisting hearing impairments. The incidence was low after localized neuroblastoma INSS stage 1 - 3 with 35/650 (5 %) and stage 4S with 2/113 (2 %), but high in stage 4 disease with 109/405 (27 %). Ototoxicity depended on the cumulative cisplatin dose. For doses of 1 - 200 mg/m (2), 201 - 400 mg/m (2), 401 - 600 mg/m (2) and 601 - 800 mg/m (2) we found hearing impairments in 5/39 (12 %), 28/221 (13 %), 61/230 (26 %) and 50/225 (22 %) patients, respectively. The incidence of hearing impairment was not age dependent. In stage 4 patients, there was an additional effect of high dosed carboplatin. 65/188 (40 %) patients developed hearing impairments after carboplatin containing (1,500 mg/m (2)) high dose chemotherapy with autologous stem cell reinfusion compared to only 33/217 (15 %) in patients receiving platinum free maintenance chemotherapy. Substitution of cisplatin (40 mg/m (2) x d, d 1 - 4, 96 h infusion) with carboplatin (100 mg/m (2) x d, d 1 - 4, 1 - 2 h infusion) due to otoxicity during induction chemotherapy did not reduce event free survival. CONCLUSION: One fourth of high risk neuroblastoma survivors suffer from treatment induced hearing impairments. The substitution of cisplatin with carboplatin was not associated with an increased rate of tumor recurrences.
Antineoplastic Combined Chemotherapy Protocols↗
Neuroblastoma preoperatively treated as nephroblastoma: does inadequate therapy worsen the prognosis?
BACKGROUND: The current standard in the treatment of nephroblastoma is preoperative chemotherapy based on radiological appearance. After subsequent surgical removal few tumours proved histologically to be neuroblastoma. We asked whether initial chemotherapy according to nephroblastoma trials would change the prognosis for those neuroblastoma patients. RESULTS: Out of 1603 patients registered in the German neuroblastoma trials, 29 patients (1.8 %) have preoperatively been treated according nephroblastoma protocols. Advanced stages (11 stage 3, 12 stage 4) were dominant. Diagnostic work up of those patients revealed elevation of catecholamine metabolites in only 39 % (compared to 80 % of the control patients) and mIBG uptake in only 71 % (compared to 89 % of the control patients). Elevation of NSE was observed in 92 % of patients (control group 72 %). Patients with preoperative nephroblastoma treatment were older than the patients of the control group. Risk factors like MYCN amplification or elevation of LDH were more often detected. The outcome of the patients with preoperative chemotherapy according nephroblastoma trials was worse than that of the control group, but risk group adapted survival analysis revealed no disadvantage. CONCLUSION: The prognosis of children with neuroblastoma tumours, which have been radiologically classified as nephroblastoma, is inferior compared to the prognosis of patients without preoperative nephroblastoma therapy. The difference appears to be associated rather with more unfavourable biology than with the element "preoperative chemotherapy".
Adolescent↗
[Efficiency and side effects of antiretroviral treatment of HIV infected pregnant women].
OBJECTIVE: Antiretroviral treatment (ART) of pregnant women and newborn reduces the vertical HIV transmission below 2 % but long term effects are still not clear. METHOD: We analyzed the data of 59 children born to HIV infected women. RESULTS: The median observation time was 404 (14-740) days. There was no vertical HIV transmission (95 %-confidence interval [CI] 0-5.1 %). Among 6 children without prenatal ART one child with congenital diaphragmatic hernia was born. In 53 infants with prenatal ART we observed 19 congenital malformations (35.8 %, 95 %-CI 23.2-50.6 %). Three were severe malformations (5.7 %, 95 %-CI 1.2-15.5 %): one supraorbital hemangioma (after zidovudine), one athetoid cerebral palsy without evidence of mitochondrial dysfunction (after zidovudine), and one unilateral femoral hypoplasia (after short term zidovudine, lamivudine, and efavirenz in late pregnancy). Sixteen minor malformations were found (30.1 %, 95 %-CI 21.2-43.8 %): ventricular septal defect (closed spontaneously after 6 months), atrial septal defect, transient and persistent pulmonary stenoses, hexadactylies, unilateral hearing impairment, dystopic kidney, subependymal bleeding cysts, and mild dilation of ventricles. CONCLUSIONS: ART prevents vertical HIV transmission. All women should be advised ART during pregnancy and delivery. The prevalence of malformations after prenatal/perinatal ART appears considerably high. Therefore, detailed information for the parents and long term follow-up of all children exposed to antiretroviral drugs are crucial.
Anti-HIV Agents↗
Infants with stage 4 neuroblastoma: the impact of the chimeric anti-GD2-antibody ch14.18 consolidation therapy.
BACKGROUND: Antibody treatment is considered tolerable and potentially effective in the therapy of neuroblastoma. We have analyzed the clinical data of infants < 1 year with stage 4 neuroblastoma with regard to the consolidation treatment. PATIENTS AND METHODS: Infants < 1 year with stage 4 neuroblastoma who completed initial treatment (6-8 chemotherapy cycles followed either by 4 cycles low dose oral chemotherapy or high dose chemotherapy with stem cell transplantation) without event were eligible for this trial. Consolidation therapy consisted of 6 cycles of antibody ch14.18 (20 mg/m(2) x d ch14.18 for 5 days every 2 months) or 12 months oral maintenance chemotherapy (MT). RESULTS: Of 59 evaluable patients, 31 received a total of 159 ch14.18 cycles, 16 received MT instead, and 12 had no further treatment. Fever (47 % of cycles), abnormal CRP without infection (25 %), rash (23 %), cough (16 %), and pain (8 %) were the main side effects. Univariate analysis found no difference in event free survival (3-year-EFS 80.5 +/- 7.1 %, 87.5 +/- 8.3 %, and 75.0 +/- 12.5 % for patients treated with antibody ch14.18, MT, and no further therapy, p = 0.433) and overall survival (3-year-OS 90.1 +/- 5.4 %, 93.8 +/- 6.0 %, and 91.7 +/- 8.0 % for patients treated with antibody ch14.18, MT, and no further therapy, p = 0.931). Multivariate analysis failed to demonstrate an advantage of antibody treatment. CONCLUSION: The outcome of infants with stage 4 neuroblastoma is good. Consolidation treatment with ch14.18 was tolerable but associated with fever, elevated CRP, rash, cough, and pain as side effects. Compared to oral maintenance chemotherapy and no consolidation treatment, ch14.18 treatment had no impact on the patients' outcome which confirms the results found in children > 1 year.
Administration, Oral↗
[Structure, use, and risks of biomaterial repositories of embryonal tumors].
Availability of statistically sufficient numbers of tumor samples and other biomaterials in high quality together with corresponding clinical data is crucial for biomedical research. Tumor repositories from individual scientists are mostly not sufficient to satisfy these criteria, especially since pediatric tumors are rare. In 2000 three centralized tumor repositories (neuroblastoma in Cologne, nephroblastoma in Würzburg, hepatoblastoma, brain tumors in Bonn) have been established by the "German Competence Net Pediatric Oncology und Hematology". The aim was to collect biomaterial including tumor samples, normal tissue, and blood in high quality for research and diagnostic purposes at a central institution. Informed consent of the parents or patients is a prerequisite for scientific use of the samples and is requested by the therapy trial. The samples are collected according to accepted standards and shipped in the specially designed Tumorbox. The tumor repository organizes the distribution of the samples to the cooperating diagnostic laboratories. The number of collected tumor samples has increased over the years. In 2000, samples from 200 patients were collected while the patient number increased to 321 in 2005. Over the years the tumor repositories collected more than 7,150 samples (fresh frozen tumor, fresh frozen normal tissue, and blood). Through links with clinical trial databases the samples can be connected with clinical data. 12 of 14 applications for tumor material to be used in specific scientific projects have been approved by an independent supervisory board. The establishment of central tumor repositories represents a major step for biomedical research activities and quality control in pediatric oncology.
Biocompatible Materials↗
Stressful events, pessimism, natural killer cell cytotoxicity, and cytotoxic/suppressor T cells in HIV+ black women at risk for cervical cancer.
OBJECTIVE: This study examines whether stressful negative life events and pessimism were associated with lower natural killer cell cytotoxicity (NKCC) and T cytotoxic/suppressor cell (CD8+CD3+) percentage in black women co-infected with human immunodeficiency virus Type 1 (HIV-1) and human papillomavirus (HPV), a viral initiator of cervical cancer. METHOD: Psychosocial interviews, immunological evaluations, and cervical swabs for HPV detection and subtyping were conducted on 36 HIV+ African-American, Haitian, and Caribbean women. RESULTS: Greater pessimism was related to lower NKCC and cytotoxic/suppressor cells after controlling for presence/absence of HPV Types 16 or 18, behavioral/lifestyle factors, and subjective impact of negative life events. CONCLUSIONS: A pessimistic attitude may be associated with immune decrements, and possibly poorer control over HPV infection and increased risk for future promotion of cervical dysplasia to invasive cervical cancer in HIV+ minority women co-infected with HPV.
AIDS-Related Opportunistic Infections↗
Comparison of omeprazole, metronidazole and clarithromycin with omeprazole/amoxicillin dual-therapy for the cure of Helicobacter pylori infection.
In this randomized, multicenter trial, we evaluated the effectiveness and side effect profile of a modified omeprazole-based triple therapy to cure Helicobacter pylori infection. The control group consisted of patients treated with standard dual therapy comprising omeprazole and amoxicillin. One hundred and fifty-seven H. pylori infected patients with duodenal ulcers were randomly assigned to receive either a combination of omeprazole 10 mg, clarithromycin 250 mg and metronidazole 400 mg (OCM) given three times daily for 10 days (n = 81), or a combination of omeprazole 20 mg and amoxicillin 1 g (OA) given twice daily for 14 days (n = 76). Prior to treatment and after 2 and 6 weeks, gastric biopsies from the antrum and corpus were obtained for histology and H. pylori culture. H. pylori infection was cured in 97.4% after OCM and in 65.8% after OA in the per-protocol analysis (p < 0.001) (intention-to-treat analysis: 93.4% and 63.2%, respectively). H. pylori was successfully cultured in 122 patients (77%). The overall rate of metronidazole resistance was 19.7% (24/122), no primary resistance to clarithromycin or amoxicillin was found. In the OCM group, all patients infected with metronidazole-sensitive H. pylori strains (n = 51) and those infected with strains of unknown susceptibility to metronidazole (n = 14) were cured (100%), while 77% (10/13) of those harboring metronidazole-resistant strains were cured of the infection (p = 0.36). Side effects leading to premature termination of treatment occurred in 2.5% of the patients in the OCM group and in 1.4% of the OA group. We conclude that combined treatment with omeprazole, clarithromycin and a higher dose of metronidazole is highly effective in curing H. pylori infection, and that this regimen remains very effective in the presence of metronidazole-resistant strains.
Adolescent↗
Quantitation of gold lymphocyte binding during chrysotherapy.
Carbon rod atomic absorption analysis (CRA) was applied to the quantiation of gold lymphocyte content (GLC) during chrysotherapy. Sensitivity and accuracy of CRA compared favorably with 195Au isotopic scintillation counting, circumventing the limitations and hazards of the latter in clinical applications. Picogram gold quantification of limited sample volume, less than 10 ml blood, e.g., 10(4)-10(5) lymphocytes (5 microliters) containing 5-10 pg was achieved. GLC after IM administration increased significantly in 60% of patients; for the remainder, GLC was observed to be independent of plasma gold content or cumulative dosage. GLC during auranofin administration (6 mg/day p.o.) approached values for IM gold despite significantly lower plasma levels. Unique sensitivity of CRA enables analysis of GLC under therapeutic conditions that could elucidate whether gold alters functional determinants.
Arthritis, Rheumatoid↗
[Ventricular pro-arrhythmic effects of anti-arrhythmia drugs].
Ventricular pro-arrhythmic effects of antiarrhythmic drugs correspond either to an aggravation of a pre-existing arrhythmia or to the development of a new arrhythmia not yet observed for a patient. More easily inducible ventricular tachycardias (VT) take part in this latter category. The incidence of ventricular pro-arrhythmias is difficult to evaluate but should be close to 3 to 10% during antiarrhythmic treatments. Two main mechanisms can be involved in pro-arrhythmia: 1) reentry can cause sustained VT complicating a pre-existing cardiopathy when a sodium channel blocker is prescribed, 2) early post depolarizations can result in the occurrence of torsades de pointes complicating an antiarrhythmic treatment which prolongs ventricular repolarization and QT interval. The main risk factors of pro-arrhythmia are in the first case the existence of antecedents of VT or V fibrillation with an altered ventricular function and in the second case an important prolongation of QT with bradycardia and hypokalemia. The incidence of pro-arrhythmia should decrease when these risk factors are taken into consideration. However the diagnosis of pro-arrhythmia should be systematically evoked by clinicians since these unwanted side-effects can occur with any class Ia, Ic and III antiarrhythmic drug and any drug which prolongs QT. If this diagnosis is confirmed, the need for an antiarrhythmic treatment should then be systematically evaluated in any patient taking into consideration the benefit/risk ratio of the treatment.
Anti-Arrhythmia Agents↗
Factors associated with complications of open versus laparoscopic sigmoid resection for diverticulitis.
BACKGROUND: This study critically reviews sigmoid colon resection for diverticulitis comparing open and laparoscopic techniques. METHODS: We conducted a retrospective review of all open and laparoscopic cases of diverticulitis between 1992 and 2001. Data analyzed included the following: indications for operation, postoperative complications, and incidence of laparoscopic conversion to laparotomy. Major and minor complications were analyzed in relation to patients' preoperative diagnosis, age, presence or absence of splenic flexure mobilization, length of stay, and laparoscopic sigmoid resection versus open sigmoid resection. RESULTS: Over a 10-year period, 166 resections for diverticulitis were performed including 126 open cases and 40 laparoscopic cases. No significant differences existed in patient characteristics between the groups. Major complications occurred in 14% of patients, and the laparoscopic conversion rate was 20%. The presence of abscess, fistula, or stricture preoperatively was associated with a higher complication rate only in patients > or =50 years old undergoing open sigmoid resection. The length of stay between patients undergoing laparoscopic resection was significantly less than in patients having open resection. CONCLUSION: Advanced laparoscopic sigmoid resection is an alternative to open sigmoid resection in patients with diverticulitis and its complications. Open sigmoid resection in patients >50 years may have a higher complication rate in complicated diverticulitis when compared with laparoscopic sigmoid resection (all patient ages) and open sigmoid resection (patients <50 years old). Regarding complications, no difference existed between the length of stay in patients with open vs. laparoscopic resection.
Adult↗
Condom use on campus.
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Acquired Immunodeficiency Syndrome↗