Kar H K, Balakrishnan S, Vasantha Kumar G, Sirumban P, Roy R G
Indian J Lepr. 1985 Jan-Mar;57(1):78-89.
Hepatotoxicity in two drug regimens was studied at Central Leprosy Teaching and Research Institute, Chengalpattu (Tamil Nadu) during 1983-84. In 'P' regimen-prothionamide 350 mg daily, dapsone 100 mg daily and rifampicin 600 mg at monthly intervals were given. In' C' regimen-dapsone 100 mg daily, rifampicin 600 mg once a month and clofazimine 300 mg once a month and 100 mg alternate day were given. Trial was started with fifty multibacillary adult leprosy patients in each group. Enzymatic hepatic dysfunction was noted in 52-58 per cent of the cases even before the therapy was started. In 'P' regimen, four cases of clinical jaundice and six cases of high bilirubinaemia was noticed during the trial as against two cases each of clinical jaundice and high bilirubinaemia in 'C regimen. Of the two cases of clinical jaundice in 'C' regimen, one turned out to be a case of HBV infection. The study which is in progress, indicated higher hepatotoxicity in 'P' regimen which is probably explained by the simultaneous use of two hepatotoxic drugs. Viral hepatitis is endemic in this area and might have aggravated the hepatotoxicity observed.
1983年至1984年期间,在坦米尔纳德邦坦贾武尔中央麻风病教学与研究所对两种药物治疗方案的肝毒性进行了研究。在“P”方案中,每天给予350毫克丙硫异烟胺、100毫克氨苯砜,每月间隔给予600毫克利福平。在“C”方案中,每天给予100毫克氨苯砜,每月一次给予600毫克利福平,每月一次给予300毫克氯法齐明,隔日给予100毫克。每组从50名多菌型成年麻风病患者开始试验。甚至在治疗开始前,就有52%至58%的病例出现酶性肝功能障碍。在“P”方案中,试验期间发现4例临床黄疸和6例高胆红素血症,而“C”方案中临床黄疸和高胆红素血症各有2例。在“C”方案的2例临床黄疸病例中,有1例被证明是乙肝病毒感染病例。正在进行的研究表明,“P”方案的肝毒性更高,这可能是由于同时使用了两种肝毒性药物所致。该地区病毒性肝炎流行,可能加重了所观察到的肝毒性。