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PubMed1989

Biosynthetic human growth hormone in burned patients: a pilot study.

A 15-day, open trial was conducted in 12 adult burned patients of whom six were randomly allocated to form a control group and six to receive biosynthetic human growth hormone (somatropin). All were fed enterally and treated according to a standard burn protocol. The mean age, burn size, energy and nitrogen intakes were well matched in each group. The resting energy expenditures (REE) were comparable in each group and the REEs exceeded the calculated basal energy expenditures by a mean of 36.8 +/- 4.1 per cent for both groups. Blood urea values were significantly lower in somatropin-treated patients but there was no significant difference in nitrogen balance, protein oxidation or the rate of plasma protein recovery between the two groups. The basal plasma insulin concentration and basal insulinogenic index were significantly higher in somatropin-treated patients but insulin release, in response to injected glucose, was comparable in both groups. All patients had impaired glucose disposal due to insulin resistance but the area under the glucose curve increased significantly during somatropin treatment. It is concluded that somatropin administration did not significantly improve nutrition in burned patients but has been shown to exacerbate the existing insulin resistance.

Adult↗

PubMed1983

[Clinical evaluation of schizophyllan (SPG) in advanced gastric cancer--a randomized comparative study by an envelope method].

To clarify the clinical efficacy of SPG, a beta-1, 3 glucan extracted from cultured Schizophyllum commune Fries, a randomized comparative study was performed in combination with mitomycin C+5-fluorouracil (MF protocol) or tegafur (F protocol). A total of 514 cases with inoperable or recurrent gastric cancer were randomly allocated to either the SPG group or the control group, 367 of which were finally assessed for clinical efficacy. SPG was intramuscularly given at a dose of 20 mg twice a week or 40 mg once a week. Significant prolongation of life span was confirmed in the SPG group (MF protocol: p less than 0.01, F protocol: p less than 0.05), although the combination of SPG did not demonstrate a remarkable antitumor effect in both MF and F protocols. Among immune response parameters tested, the positive reactions in the PHA skin test were maintained in the SPG group and decreases in lymphocyte counts were inhibited by SPG in the MF protocol. Side effects associated with SPG therapy were noted in 6 of 258 cases treated with SPG. From these results, it is indicated that the combination of SPG and the chemotherapeutic agents may be useful in treating patients with inoperable or recurrent gastric cancer.

Adjuvants, Immunologic↗

PubMed1985

Prospective randomized trial in advanced malignant melanoma with cis-platinum, vindesine, and etoposide vs. cis-platinum, vindesine, and lomustine.

Thirty-seven consecutive patients with disseminated malignant melanoma and previously untreated with chemotherapy were randomly allocated to receive vindesine, cis-platinum, and etoposide (Regimen A) or vindesine, cis-platinum, and lomustine (Regimen B). In 31 evaluable patients, Regimen A induced an overall response rate of 31% and a complete response rate of 6%; with Regimen B the corresponding findings were 20% and 20%, respectively. The median duration of complete response was 12 months with both regimens and the comparative median total survivals were 8 and 6 months, respectively. In no case was toxicity so severe to require treatment discontinuation, and the major dose-limiting side effect was myelosuppression, especially in the patients treated with Regimen B. Present results confirm once more the limited activity of drugs and regimens presently utilized in the treatment of advanced malignant melanoma.

Adult↗

PubMed1990

A single-blind pilot study comparing standard and half bedtime doses of ranitidine in the short-term healing of duodenal ulcer.

In this two-center, pilot trial we assessed the efficacy of single bedtime does of 150 mg ranitidine (half dose) and 300 mg ranitidine (full dose) in promoting duodenal ulcer healing by comparing the proportions of healed ulcers after 4 and 8 weeks of treatment. One hundred thirty-nine patients (106 men) were randomly allocated according to a prearranged treatment schedule to either dose and were treated single-blind (endoscopist). One hundred twenty-six patients (63 given 150 mg ranitidine and 63 given 300 mg) completed the trial. In the per-protocol analysis, 55 patients given full doses (81%) and 47 given half doses (70%) of ranitidine had healed ulcers at 4 weeks. Sixty full-dose and 55 half-dose patients (95% and 87%, respectively), had healed ulcers at 8 weeks. The difference was not significant using the chi 2 test (two-tailed), but the 95% confidence limits were in favor of the 300-mg dose. This study had a 75% power to detect a 25% difference in healing rates between the two groups.

Acute Disease↗

PubMed1982

Duration of chemotherapy in childhood acute lymphoblastic leukaemia. The Medical Research Council's Working Party on Leukaemia in Childhood.

In three childhood acute lymphoblastic leukaemia (ALL) therapeutic trials a total of 493 patients still in first remission 18 months or 2 years after starting treatment were randomly allocated to stop treatment or continue to 3 years. Periods of 18 months or 2 years were as effective as 3 years for girls, but for boys 18 months was inferior to 3 years, although there was little difference between 2 and 3 years. These conclusions refer only to the treatment regimens employed in these trials, however, and in view of the rather different results for girls in a later trial and the high testicular and marrow relapse rates in boys, the results must be interpreted cautiously. Disease-free survival 5 years after randomisation to stop or continue treatment was 76% for girls, but only 40% for boys.

Antineoplastic Agents↗

PubMed1987

Ranitidine 150 mg at night in the prevention of gastric ulcer relapse.

After healing of a gastric ulcer, 53 patients were randomly allocated to either 12 months maintenance treatment with ranitidine 150 mg at night or an identical placebo. Fifty patients completed the trial. The patients were interviewed every third month. If symptoms indicated a relapse, endoscopy was done; and if an ulcer was found the maintenance trial was terminated. All remaining patients were endoscoped after one year. The accumulated relapse rate in the ranitidine group (36%) was significantly lower (p less than 0.01) than in the placebo group (76%), as also was the antacid consumption (p less than 0.01). Four of the six ulcers found at the final one year endoscopy were asymptomatic. In all but two of the 26 patients with relapse of symptoms an ulcer was found at endoscopy. The patients that suffered a recurrence had significantly (p less than 0.05) higher maximal acid output than those without ulcer recurrence. The time needed for healing of the relapse ulcers (four or eight weeks) corresponded to that needed for healing of the preinclusion ulcers. It is concluded that ranitidine 150 mg at night significantly reduces the gastric ulcer recurrence rate, and that relapsing ulcers are similar to the initial ones in healing response.

Adult↗

PubMed1987

Prospective trial of operative versus non-operative treatment of severe vesicoureteric reflux in children: five years' observation. Birmingham Reflux Study Group.

Children with severe vesicoureteric reflux were allocated randomly to either operative or non-operative treatment and followed up. Altogether 161 children were observed for two years, of whom 104 were followed up for five years. Reflux was abolished in 98% of ureters reimplanted, but more than half of the patients treated non-operatively continued to show severe reflux at five years. Two patients progressed to end stage renal failure, and a further four with extensive bilateral renal scarring became hypertensive. There were no significant differences between treatment groups in the incidence of breakthrough urinary infection, renal excretory function and concentrating ability, renal growth, progression of existing renal scars, or new scar formation. Progressive scarring occurred at all ages but was significantly more common during the first two years' observation. Furthermore, new scars developed exclusively during the first two years' observation, affecting 10 children aged 2-7 at allocation. Neither treatment can claim superiority or fully protect the kidneys from further damage, and efforts must continue to be directed towards identifying those at risk before scarring develops.

Adolescent↗

PubMed1985

Comparison of tri-potassium di-citrato bismuthate tablets with ranitidine in healing and relapse of duodenal ulcers.

120 patients were randomly allocated to receive ranitidine 150 mg twice daily or a tri-potassium di-citrato bismuthate (TDB) tablet four times a day in a trial comparing the effects of these drugs in the short-term healing and post-healing relapse rates of duodenal ulceration. At 4 weeks 81% of those on ranitidine and 90% of those on TDB had healed ulcer craters. At 8 weeks 97% of those on ranitidine and 97% of those on TDB had healed. These differences are not significant. After ulcer healing, the cumulative rates of relapse, as determined endoscopically, for symptomatic and symptomless ulcers were 74% for ranitidine and 41% for TDB at 4 months (p less than 0.001), 87% for ranitidine and 55% for TDB at 8 months (p less than 0.001), and 89% for ranitidine and 62% for TDB at 12 months (p less than 0.001). Females had significantly lower relapse rates than males. In the ranitidine group smokers had a higher rate of early relapse and failure to remain healed at 12 months than did non-smokers; no such difference occurred in the TDB-treated group.

Adult↗

PubMed1985

Does mass closure of midline laparotomies stand the test of time? A random control clinical trial.

We compared the incidence of wound failure (burst abdomen and incisional herniation up to 4 years after operation) in a consecutive series of 282 major laparotomies closed with continuous monofilament nylon, and randomly allocated to mass (all layers except skin) or layered (anterior and posterior aponeuroses separately sutured) techniques. Surgeons were free to choose the site and direction of incision which resulted in a preponderance of midline incisions in the mass, and of paramedian incisions in the layered, group. One patient in the former, and two in the latter, burst their abdomens during early convalescence, and 17 incisional hernias were discovered within four years in the mass group compared with four in the layered group (log rank X2 7.16, P less than 0.01). Seven hernias in the former, and one in the latter, group were not detected within eight months of operation. We conclude that layered closure of a paramedian incision results in a lower incidence of incisional hernias than mass closure of a midline incision and that many hernias are not discovered until years after operation.

Abdomen↗

PubMedDate not supplied

Impact of management change and an intervention program on health care personnel.

BACKGROUND: There has been a major shift in the organization and responsibility for the provision of geriatric care in Sweden. This was believed to be stressful. We therefore decided to launch a controlled intervention program on health care personnel aimed at enhancing their adaptation and ability to cope. The purpose of this study was to assess the impact of management change on psychosocial parameters of health care personnel and the effects, if any, of a structured intervention program. METHODS: Two separate wards were randomly allocated to be either intervention (I) or control (C) ward. The I-ward personnel were subjected to a psychologist's structured 10-session intervention program for 20 weeks. The program consisted of an initial educational part followed by a practical problem-solving discussion part. A structured questionnaire on psychosocial issues was answered by the participants before (0 weeks), immediately after (20 weeks), and 10 weeks after the intervention (30 weeks). RESULTS: There were no significant changes in the psychosocial parameters of the C-ward personnel. In the I-ward, however, there was a significant increase in work demand as well as in positive feelings about work, as compared to the C-ward at the 30-week follow-up. There was also significantly better work comfort in the I-ward. CONCLUSIONS: We did not find any anticipated negative psychosocial effects on health care personnel undergoing an organizational change. However, by offering a structured intervention program to one group of health care personnel, we found some positive psychosocial effects. Future research is needed to pinpoint which factor or factors in the intervention program were the most crucial for the effects to occur.

Adult↗

PubMed1989

Comparison of nizatidine and cimetidine as once-nightly treatment of acute duodenal ulcer. Nizatidine Multicenter Duodenal Ulcer Study Group.

Nizatidine, a new H2-receptor antagonist for the treatment of duodenal ulcer disease, was compared with cimetidine in an 8-wk, randomized, double-blind, multicenter clinical trial. Patients were randomly allocated to receive either nizatidine 300 mg h.s. or cimetidine 800 mg h.s. Patients were treated for 8 wk, regardless of the healing status of their ulcers. An endoscopy was performed at Wk 2, 4, and 8. Healing rates with nizatidine 300 mg h.s. were numerically, but not statistically significantly, superior to those with cimetidine 800 mg h.s. at each treatment period. Ulcer healing rates at Wk 2, 4, and 8 were 41% (78/191), 73% (130/179), and 81% (145/179) for nizatidine and 33% (60/184), 67% (116/174), and 75% (126/168) for cimetidine, respectively. Symptoms of peptic ulcer disease were similarly reduced at each treatment period by nizatidine and cimetidine. Patients with healed ulcers at either Wk 2 or Wk 4 were continued on therapy and an endoscopy was performed at Wk 8. Ulcer recurrence occurred in 10% of nizatidine-treated and 19% of cimetidine-treated patients at Wk 8 (p = 0.085). The observation of recurrence of duodenal ulcer while patients were receiving full-dose H2-receptor antagonist therapy has not been reported previously.

Acute Disease↗

PubMed1986

Absence of benefit of incentive spirometry in low-risk patients undergoing elective cholecystectomy. A controlled randomized study.

To determine the potential benefit of incentive spirometry, which has been advocated to prevent pulmonary complications after upper-abdominal surgery, we compared a group of patients receiving incentive spirometry to another group receiving no specialized postoperative respiratory care. Forty patients in the American Society of Anesthesiologists' class 1 and 2 who were undergoing cholecystectomy (through right subcostal incision) were included in the study and were randomly allocated to one of the two groups. Patients receiving incentive spirometry were encouraged by a specialized respiratory physiotherapist to breathe deeply for five minutes hourly, 12 times daily, for three postoperative days. No statistically significant difference between the two groups was found in the radiologic evidence of postoperative pulmonary complications, arterial oxygen pressure, spirometric measurement, and clinical evaluation at the second or fourth postoperative day (or both). In particular, deterioration on the chest x-ray film at the fourth postoperative day was observed in eight of 20 patients in the group receiving incentive spirometry and in six of 20 in the control group. Our study confirms the postoperative deterioration of respiratory function after upper-abdominal surgery and demonstrates the lack of therapeutic values of incentive spirometry in these patients at low risk for pulmonary complications.

Adult↗

PubMed1986

A single nighttime dose of ranitidine 300 mg versus ranitidine 150 mg twice daily in the acute treatment of duodenal ulcer: a European multicenter trial.

Six hundred and five patients with endoscopically diagnosed duodenal ulcer were randomly allocated to treatment with ranitidine 300 mg at night or ranitidine 150 mg twice daily in a prospective double-blind multicenter trial conducted in nine European countries. Endoscopy at 4 weeks showed complete ulcer healing in 246 of 301 patients (82%) treated with ranitidine 150 mg b.i.d. and 230 of 304 patients (76%) treated with ranitidine 300 mg at night. Cumulative healing rates at 8 weeks were 95 and 94% respectively. Both treatment regimens were equally effective at rapidly reducing the incidence of ulcer-related symptoms. Adverse events were few and consistent with those reported in previous studies with ranitidine 150 mg twice daily. The results of this trial indicate that a single nighttime dose of ranitidine is an effective and safe alternative to the twice daily regimen in the acute treatment of duodenal ulcer.

Adult↗

PubMed1978

Very long-term treatment of peptic ulcer with cimetidine.

In an open trial, 96 patients with endoscopically proven peptic ulcers were randomly allocated to treatment with cimetidine (1 g/day) for periods of 3, 6, 9, or 12 months. After their courses of treatment, the patients were followed up for at least 6 months. In 92% the ulcers had healed after treatment for 1 month, and in a further 5% the ulcers healed during the next 2 months. Ulcers recurred during treatment in 24% of patients and within 6 months of withdrawal of treatment in a further 43%. In nearly a third of patients the recurrences were asymptomatic and were discovered only through routine endoscopic studies. Continuous treatment with full doses of cimetidine for a year seems to prevent relapse of the majority of ulcers which have healed during treatment; but it does not cure the ulcer disease, since relapse generally occurs quite rapidly when treatment is discontinued.

Cimetidine↗

PubMed1986

Randomized comparative trial of three monospecific antivenoms for bites by the Malayan pit viper (Calloselasma rhodostoma) in southern Thailand: clinical and laboratory correlations.

Three monospecific antivenoms for Malayan pit viper (MPV) (Calloselasma rhodostoma) were compared in Southern Thailand, where this species is the most common cause of snake bite morbidity. Forty-six patients with proved MPV bites and incoagulable blood, indicating systemic envenoming, were randomly allocated for treatment with Thai Red Cross (TRC), Thai Government Pharmaceutical Organization (GPO), or Twyford Pharmaceutical monospecific antivenoms. Both GPO and Twyford antivenoms produced rapid and permanent restoration of blood coagulability, but TRC antivenom failed in 2/15 cases. Patients in the GPO group showed the greatest increase in plasma fibrinogen concentration during the first 24 hr and had fewer early anaphylactic reactions (6/15) compared with Twyford 8/16 and with TRC 13/15. Pyrogenic reactions occurred more frequently after TRC antivenom (8/15) than GPO (1/15) or Twyford (0/16). Patients requiring more than one dose of antivenom were identifiably more severely envenomed on admission. In an accompanying laboratory study the antivenoms were assessed in rodents using five WHO standard tests of neutralizing activity. Compared with the other two antivenoms TRC was significantly inferior in anti-lethal potency, GPO was superior in anti-hemorrhagic and anti-necrotic potency and Twyford was superior in anti-procoagulant and anti-defibrinogenating potency. The clinical efficacy of these antivenoms against local necrosis remains equivocal. GPO and Twyford antivenoms are recommended for the treatment of systemic envenoming by MPV in an initial dose of 5 ampoules.

Adult↗

PubMedDate not supplied

[Vaccination against hepatitis B: 3 years' experience at the Latium Operative Unit].

A campaign against hepatitis B was launched in 1985 in Latium Region, Italy, aimed at hospital workers, newborns of HBsAg positive mothers, hemodialysis patients, thalassemics and hemophiliacs. Subsequently, since the beginning of 1987 other at risk categories were included, namely households of HBsAg positive carriers, subjects with accidental exposure to Hepatitis B virus (HBV) (i.e exposure to street syringes), health care personnel working outside the hospital setting such as dentists, private clinics and laboratory workers, etc. A protocol was defined by the Regional Epidemiologic Unit (Osservatorio Epidemiologico Regionale) in order to evaluate the immunogenicity and safety af the two plasma-derived (pd) vaccines registered in Italy, MSD and Pasteur, in field conditions. Subjects belonging to these at risk categories were distributed among 21 hospital based vaccination units, to which the two vaccines were randomly allocated. Subjects were considered eligible for vaccination if they were HBsAg negative and Anti-HBs negative or Anti-HBs positive at low titer i.e. less than 20 milli-International units per milliliter. Subjects with insulin dependent diabetes, chronic liver disease or known hypersensitivity to vaccine components were also excluded. Antibody response was checked at six months since the beginning of the vaccination, i.e. after two doses of the MSD and three doses of Pasteur vaccine and expressed in miU/ml by use of Hollinger formula. Pre-vaccination screening, vaccination and post-vaccination anti-HBs testing were offered free of charge.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1986

[Clinical and instrumental evaluation by multiple colonic manometry of tiropramide, trimebutine and octylonium bromide in the irritable colon: I. Administration by single i.v].

Sixty out-patients with acute or sub-acute irritable colon were randomly allocated to receive a single intravenous dose of 50 mg tiropramide, 50 mg trimebutine maleate or 10 mg octilonium bromide. Before and after injection, multiple colonic manometry was performed, monitoring tonus, intensity and frequency of sinusoid contraction waves, transitories and vibrations, as well as the voluntary contraction capacity. Significant variations in tonus were not observed with any drug, but, while tiropramide left unmodified the voluntary contractile ability, a significant inhibition was observed with trimebutine and octilonium. The overall power of spontaneous colonic contractions did not vary significantly with tiropramide, whereas some decrease was observed with trimebutine, and a substantial one with octilonium. Moreover, while with tiropramide and, to a lesser extent, with trimebutine there was a significant redistribution of muscular power so as to increase phasic propulsion waves and to decrease the ineffective transitory and vibrational contractions, with octilonium only a decreased wave amplitude was recorded without alteration of the frequency of transient spasms. Based on these observations, tiropramide was evaluated as being at least as effective an antispasmodic as octilonium and at least as effective a synchronizer as trimebutine, while setting itself aside from both reference drugs as it was the only one to act contemporarily as both an antispasmodic and a synchronizer.

Adult↗

PubMed1999

An experimental study of influences on the perceived likelihood of seeking genetic testing: "nondirectiveness" may be misleading.

It has been suggested that decision making involves the implicit weighing up of those advantages and disadvantages of possible options considered relevant at the time the decision is made. If this is so, the information that people have most readily available at the time of the decision would influence the decision outcome. The study reported here experimentally evaluates the effect of manipulating the issues on which individuals focus as a way of investigating subtle directive influences. Participants (n = 104) were interviewed about their anticipated likelihood of opting for testing for hereditary hemochromatosis. All participants were given standard information about hemochromatosis, including a description of the disorder as causing progressive damage over many years and an explanation that treatment is most effective if begun before the age of 30 years. Individuals were randomly allocated to groups according to age group (30 years and under, or over 30 years) and gender. Those allocated to the positive group were then encouraged to focus on positive aspects of the previously given information by considering the extent to which statements applied to them, whereas the negative group focused on negative aspects. The control group focused on an unrelated disease. Analyses of variance indicated that the focusing manipulation affected the likelihood of opting for testing. This effect interacted with age of respondent: in participants over 30, the positive group ratings of likelihood of testing increased, whereas in the negative group they decreased; in participants 30 and under, both the positive and negative groups showed an increased desire to be tested. The control group did not alter significantly. The relevance of these findings to "nondirective" approaches to genetic counseling is considered.

Adult↗