Efficacy of stimuliv, an indigenous compound formulation, against hepatotoxicity of antitubercular drugs--a double blind study.

Anti-tubercular drugs are known to cause hepatotoxicity, which may lead to noncompliance to drug therapy. Stimuliv, an indigenous compound formulation, is reported to be useful in liver disorders. Efficacy of prophylactic administration of stimuliv against anti-tubercular drugs-induced hepatotoxicity was studied in this double blind randomized clinical trial. One hundred and forty-five newly diagnosed patients of tuberculosis were included in the study. Out of these, sixty three patients were treated with stimuliv (2 tablets thrice daily), sixty received the placebo, while twenty-two dropped out of the study. The patients were assessed clinically and biochemically at two-week intervals over a period of two months. In stimuliv-treated group, the incidence and severity of hepatotoxicity was significantly less (p < 0.05) as compared to placebo-treated group. In addition, patients treated with stimuliv had better appetite and weight gain. Stimuliv treatment may be recommended in newly diagnosed adult patients of tuberculosis.

Effect of inhibition of lens membrane Na+-K+ ATPase by ouabain pre-treatment--an in vitro study.

The precise factors responsible for the cataract formation are not known. The role of Na+-K+-ATPase in maintaining ionic concentration of lens and lens membrane permeability and its involvement in the formation of cataracts has been of recent interest. Thus the present study was undertaken to study the effect of pre-treatment with Ouabain, a known Na-K-ATPase inhibitor, on the intra-lenticular ionic concentration and the rule of lens membrane permeability in cataractogenesis. Fresh goat lenses were used for the experimental work. Isolated lens culture technique was used. The electrolytes were estimated before and 24 hours after Ouabain pre-treatment. The electrolyte pattern showed significant changes after pre-treatment with Ouabain. Lens sodium ion concentration increased significantly with a concommitant decrease in potassium ion concentration. Intra-lenticular chloride concentration also showed a significant increase as compared to control. Calcium and magnesium ion concentrations also showed slight increase after the inhibition of Na+-K+-ATPase system by Ouabain.

Correlation between serum choline esterase and serum albumin in leprosy.

The clinical material included 255 cases of leprosy consisting of Tuberculoid leprosy (74), Lepromatous leprosy (116), Lepromatous leprosy with lepra reaction. Liver biopsy could be performed on 50 cases of Lepromatous leprosy. Specific granulomatous changes and parenchymal cell damage were the significant findings. Serum choline esterase and serum albumin are synthesized in liver. Serum Choline esterase levels in the present study decreased abruptly with exacerbation of the disease but the serum albumin levels declined gradually and slowly. Possible hypothesis to explain the correlation and uneven fall in activity is discussed at the cellular level.

L.D.H. isoenzymes sub-unit ratio in leprosy and the effect of clofazimine treatment on L.D.H. isoenzymes sub-unit.

The clinical material for our studies of serum total LDH activity and LDH isoenzymes in leprosy included 255 patients consisting of Tuberculoid (74), Lepromatous leprosy (116), and Lepromatous leprosy with lepra reaction (65). 20 patients with suspected DDS resistance and repeated attacks of lepra reactions were selected for Clofazimine studies. All leprosy patients exhibited higher total LDH activity as compared to normals. M/H ratio was significantly increased in patients of Lepromatous leprosy and correlated closely with the clinical severity and advancement of disease. Tuberculoid leprosy patients showed values close to normals. Hence M/H ratio could demarcate two polar types of leprosy i.e. Tuberculoid and Lepromatous leprosy. Clofazimine treatment over a period of one year in patients with suspected DDS resistance and repeated attacks of lepra reaction decreased total LDH activity and M/H ratio considerably. Fall in M/H ratio during Clofazimine treatment could be attributed to the clearance of 'M' subunits by the drug due to removal of blockade of R.E.S. system produced by lepra bacilli.

Thalidomide in lepra reaction (ENL) in lepromatous leprosy patients.

Six male bacteriologically highly positive patients of lepromatous leprosy with ENL reaction not adequately controlled by conventional antireaction drugs were put on thalidomide 400 mg per day in four divided doses. Reaction was controlled between 13th to 18th day of therapy. There was no change in the bacteriological status. Liver functions, renal functions and hemogram were normal before therapy and remained unaltered at the end of treatment. Apart from fatigue, drowsiness and occassional constipation, thalidomide had no adverse effect. Control of ENL reaction by thalidomide in these patients is probably due to its immunosuppressive effect, more likely by its stablising action on lysosomes.

Once monthly rifampicin (1200 mg) plus daily dapsone (100 mg) and clofazimine (100 mg) in the initial treatment of lepromatous leprosy.

The therapeutic effect of rifampicin 1200 mg once monthly and 100 mg clofazimine daily for the first six months of treatment was evaluated in 30 patients of bacteriologically positive lepromatous leprosy patients. Moderate to marked clinical improvement was seen in all the patients and a very rapid bacteriological regression as indicated by the decrease in bacteriological and morphological indices of the skin within one week. Seven patients become MI negative at one month and three months and 13 at the end of nine months. Two patients became MI and BI negative at the end of six months and six at the end of nine months. These observations clearly establish the high therapeutic efficacy and practicability of the three drug regimen. Once monthly rifampicin is highly effective and well tolerated, and has many advantages like low cost, better patient compliance and reliability of the treatment. Addition of clofazimine to rifampicin and dapsone prevents the emergence of E.N.L. reactions which were seen during treatment with once monthly rifampicin and daily dapsone. This regimen is thus ideal for initial, intensive treatment of lepromatous leprosy and may help in preventing the spread of the disease and development of dapsone resistance.