The clinical effect of dextranomer paste (Debrisan) in post-operative wounds (20 patients) was compared with the standard treatment in our department (polyvinylpyrrolidone, 20 patients) in a randomized study. All variables dealing with cleansing, inflammation-reducing effect and signs of ongoing healing were studied. Dextranomer paste appeared to be significantly better than polyvinylpyrrolidone in wounds with a high degree of pus and debris. No side-effects were observed in the dextranomer paste group. One patient in the control group showed an allergic reaction (oedema and erythema) and was withdrawn from the study.
Sixty infants (age: 6-12 months; weight: 6.5-12 kg) with upper airways inflammation and fever during an epidemic influenza were selected to compare, in a double-blind study, the therapeutic activity of nimesulide and paracetamol.Both treatment groups received four suppositories per day for two days and three for the next three days. Antipyretic activity was checked by scheduled measurement of rectal temperature. General and respiratory symptoms were evaluated on entry and at the end of treatment by the physician and daily by the parents. Mean body temperature at baseline was 39.17.C (SD +/- 0.35) in the nimesulide group and 39.2.C (SD +/- 0.38) with paracetamol.Two hours after the first drug intake, fever decreased significantly in both groups (-0.99.C in nimesulide and -0.90.C in paracetamol group). Temperature normalization was attained in most cases by Day 3. ANOVA for repeated measurements did not show significant differences between treatments. Respiratory symptoms improved significantly in both groups.Recovery rate was significantly different in favour of nimesulide only for nasal discharge. Efficacy was judged as good or excellent in 27 out of 30 patients treated with nimesulide and 24 out of 30 in the paracetamol group. In the remaining patients, the efficacy was poor.There were no reported side-effects.
Increased biosynthesis of prostaglandins following acute ureteral obstruction is well recognised. Its inhibition by the use of prostaglandin synthetase inhibitors produces relief from pain in renal colic. Diclofenac has been available in the United States and Europe since 1974, but was introduced much more recently in India, so this study is very useful in view of the differences between the Indian and Caucasian populations. Evaluation was made of the efficacy and safety of diclofenac sodium, a potent prostaglandin synthetase inhibitor, administered orally and compared wih a spasmolytic agent (Baralgan(R)) * and a narcotic (pethidine).In a prospective randomized study, a total of 94 patients with acute renal colic were randomized to three groups. Diclofenac sodium relieved pain in 30 out of 33 patients (90.9%) at the end of one hour which lasted up to 3 hours.Nineteen patients out of 30 (63.3%) receiving Baralgan orally experienced pain relief which lasted up to three hours in 13 patients. Intramuscular pethidine relieved pain in 29 out of 31 patients (93.5%) at the end of 1 hour which lasted in 23 patients up to 3 hours. Chi-squared tests revealed significant differences in pain-relief between the three groups both at 1 hour (chi-squared = 12.15; d.f.: 2; p < 0.01) and at 3 hours (chi-squared = 17.42; d.f.: 2; p < 0.01).Side-effects occurred in two patients receiving diclofenac sodium and six patients receiving Baralgan. There were no side-effects in patients receiving pethidine (chi-squared = 8.23; d.f.:2; p < 0.05). It is concluded that diclofenac sodium 150 mg orally is effective and safe in the emergency treatment of acute renal colic.
Forty-nine patients with endoscopically proven duodenal ulcer were evaluated for six weeks in a randomized, double-blind trial comparing two regimens of sucralfate. Twenty-six patients were treated with sucralfate 4 g a day (Group 1) and another 23 with sucralfate 2 g per day (Group 2). Endoscopy was repeated after six weeks to assess ulcer healing.Ulcer healing was observed in 24 out of 26 patients in Group 1 (92.3%) and in 18 out of 23 patients in Group 2 (78.2%).There was no statistical difference between groups.
Nicardipine is a novel dihydrophyridine calcium channel blocking agent, and as such a potent arterial vasodilator. Two hundred and seventy-three patients with essential hypertension with supine diastolic blood pressure of 95-114 mm Hg were enrolled into this multicentre, double-blind, randomized, placebo-controlled, parallel dose-response study. Of these patients, 251 were analyzed for efficacy, and the remaining 22 were excluded, either because of non-qualifying blood pressure or premature discontinuation.The patients were randomized to receive either one of the four nicardipine dosages, 10, 20, 30 or 40 mg t.l.d. or a matching placebo. Supine diastolic and systolic blood pressure as well as heart rate were measured eight hours after the last dose - trough - and one hour after a clinic dose peak. Plasma samples of nicardipine were collected during the last visit, at the trough time, to assess its duration of action. The median age was 51 years, 57% were males, and all other baseline demographics were comparable among treatment groups.The mean change in supine diastolic blood pressure with nicardipine after six weeks of treatment was statistically significant from baseline at both trough and peak. At peak, all nicardipine doses were superior to placebo (p < 0.0015), and nicardipine 20-40 mg were significantly (p < 0.001) better than nicardipine 10 mg. At trough, all doses were superior to placebo (p < 0.0001) except nicardipine 10 mg where p < 0.05. Nicardipine 30 and 40 mg was superior to nicardipine 10 mg (p < 0.04).In supine systolic blood pressure at trough, nicardipine 40 mg was superior to nicardipine 20 mg by a margin of 4.61 mm Hg. Both the mean reduction in supine systolic and supine diastolic blood pressure occurred in a dose-response related fashion; 53% of the patients became normotensive with nicardipine 30 mg t.i.d., while the corresponding number for nicardipine 40 mg t.i.d. was 62%. The correlation between the reduction in supine diastolic blood pressure and nicardipine plasma levels at trough after six weeks of therapy was significant (p = 0.002).The majority of the adverse reactions were vasodilatory in nature, but were not related to peak antihypertensive response. The side-effects did not increase in a dose-related fashion, except for pedal oedema. Only a few patients had a small increase in heart rate.Nicardipine can be used safely in hypertension, and is an effective new addition to the antihypertension armamentarium.
Zinc acexamate (ZAC) is an anti-ulcer drug, antisecretory and stimulator of mucosal defensive mechanisms, which has proved its efficacy in many controlled clinical trials. To determine the incidence of adverse reactions and to verify its clinical efficacy, a post-marketing surveillance study in the treatment of acute peptic ulcer was performed.Included in the study were 1 697 patients, 373 with gastric ulcer and 1 324 with duodenal ulcer. ZAC was prescribed at a dose of 600 mg/day in 263 patients and 900 mg/day in 1 434 during an average period of 5.2 weeks. Sixty-five patients (3.8%) did not attend the final control visit, the reasons remaining unknown.Adverse reactions were present in 85 patients (5.2%), only three of these requiring interruption of treatment. Eleven patients (0.7%) showed oral intolerance to the drug.The efficacy of the treatment was no different from that observed in previous clinical trials, a global healing rate of 75.5% (70.8% in gastric and 76.8% in duodenal ulcer) being obtained. In those patients who had antecedents of recent intake of non-steroidal anti-inflammatory drugs (191 patients), the healing rate was 78.5% (79.2% in gastric and 78.1% in duodenal ulcers). No differences were found between the two doses of ZAC studied.The study confirmed the high therapeutic safety of ZAC and its anti-ulcer efficacy in both gastric and duodenal ulcer. A favourable trend to the 600 mg/day dose and a slightly greater effect in NSAID-related ulcers were also observed.
