Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: randomized controlled double blind clinical trial.

Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. AIM: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n = 23) received normal saline infusion, group 2 (test; n = 23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients had complete response, five (22%) partial/no response, two (9%) died, one (4%) lost to follow up. In the control, five (22%) patients had complete response, 16 (70%) partial/no response, one (4%) died, one (4%) lost to follow up. Short-term loco-regional response was better in the test (DF = 3, 95% Confidence Interval 0.418, 0.452, P = 0.0048). In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

Study of clinical profile and antibiotic response in typhoid fever.

The objective of the present study is to evaluate the clinical profile and pattern of various drugs used in the treatment of typhoid fever. A retrospective analysis of adult patients suffering from typhoid fever was done at Kasturba Medical College hospital, Attavar during the year 1999-2001. Diagnosis of patients was based on clinical features, widal test and blood culture. The sensitivity pattern of isolates from blood culture was recorded. The mode of presentation, clinical course, treatment history, laboratory investigations reports, antibiotic administered, response to therapy and the complications were recorded. Total number of 44 cases of typhoid fever were studied. Out of these 21(47.7%) were males and 23(52.3%) were females. Average age of presentation was 23.9 years. Average duration of hospital stay was 10.8 days. Fever was present in all patients. Resistance of S. typhi to amoxicillin, chloramphenicol, ampicillin and co-trimoxazole were significantly high. Ciprofloxacin also showed resistance in 18.1% of cases. Sensitivity to cephalosporin was 100% in our study. Ciprofloxacin was the most commonly used antibiotic in our study (23 patients). Chloramphenicol alone was used in 2 patients and in 3 patients it was given after 6 days of ciprofloxacin treatment. Third generation cephalosporins (ceftriaxone) alone were used in 16 patients. Indiscriminate use of drugs in typhoid fever should be discouraged. Appropriate antibiotic as indicated by sensitivity tests should be employed to prevent the development of resistant strains of S. typhi.

An open comparative clinical trial to assess the efficacy and safety of losartan versus enalapril in mild to moderate hypertension.

OBJECTIVES: To compare the efficacy and safety of losartan with enalapril, in mild to moderate hypertension. METHODS: An open, enalapril controlled study was conducted in 30 patients with mild to moderate hypertension. Losartan 50 mg was administered to patients for eights weeks. Throughout the study blood pressure was measured every two weeks. Routine laboratory investigations were performed before entering the trial, fourth week and at the end of the study. Adverse effects were recorded. After eight weeks losartan was stopped and enalapril 10 mg daily was administered to the same patients after two weeks washout period. The same methodology that was followed for losartan trial was repeated for enalapril trial also. RESULTS: Losartan treatment resulted in a highly significant reduction in the mean sitting diastolic blood pressure. Comparison with enalapril showed that both drugs are equally efficacious in reducing blood pressure in mild to moderate hypertension. The percentage of responders was slightly more with losartan than enalapril (86.7% vs 76.7%). Adverse events reported with losartan were mild. Enalapril also was well tolerated like losartan but there was high incidence of dry cough, which was reported in nine patients (30%). CONCLUSIONS: Losartan is an effective antihypertensive drug with an excellent safety and tolerability profile. It shows similar blood pressure lowering efficacy to that of enalapril. In contrast to enalapril, losartan does not cause dry cough.