双环醇片预防抗结核药物所致肝损害的疗效分析

目的观察双环醇片预防抗结核药物所致肝损害的临床疗效。方法将435例初治肺结核病人随机分为两组,均应用"2HRZS(E)/4HR"方案抗结核化疗,试验组218例,抗结核治疗同时每日口服双环醇片75mg治疗,对照组217例,抗结核治疗同时每日口服甘草酸二铵胶囊450mg治疗。结果试验组药物性肝损害发生率(4.1%)及HBsAg阳性病人肝损害发生率(8.0%)均较对照组(12.4%,33.3%)低(P<0.01,P<0.05)。试验组抗结核化疗中断率为2.3%,调整化疗方案率为1.4%;与对照组(6.9%,4.6%)比较,均有显著性差异(P<0.05)。两组均未发生与研究药物相关的其他不良事件。结论双环醇片75mg?d-1可显著降低初治肺结核患者抗结核药物所致肝损害的发生率,并可减少因抗结核药所致肝损害而造成的不规则化疗发生率。

Analysis on treatment outcome of Bicyclol in preventing antituberculosis drug-induced liver injury

Objective To investigate the therapeutic efficacy of Bicyclol on prevention of liver injury induced by antituberculosis drugs. Methods 435 pulmonary tuberculosis（TB） patients with initial chemotherapy of 2HRZS（E）/4HR were randomly divided into two groups. The trial group including 218 cases received Bicyclol orally 75mg·d-1 and the control group including 217 cases administrated with Diammonium Glycyrrhizinate 450mg·d-1. Results The incidence of drug-induced liver injury in the trial group（4.1%） was significantly lower than that（12.4%） in the control group（P〈0.01）. The incidence of drug-induced liver injury among HBsAg positive patients in the trial group（8.0%） was significantly lower than that（33.3%） among HBsAg positive patients in the control group（P〈0.05） .The interruption rate and adjusting rate of chemotherapy regimen in the trial group were all lower as compared with those in the control group（all P〈0.05）. There were no adverse events related to the investigating drugs in this study. Conclusion Bicyclol can obviously reduce the incidence of anti-TB drug-induced liver injury and therefore decrease the frequency of irregular chemotherapy.