应用抗结核固定剂量复合剂治疗初治肺结核效果分析

[目的]比较国产抗结核固定剂量复合剂FDC(费宁/费安)和国家肺结核标准治疗方案的组合包装板式药(2H3R3Z3E3/4H3R3)治疗初治肺结核病人的疗效,探讨固定剂量复合剂FDC在DOTS下应用的可行性。[方法]将270例初治活动性肺结核病例随机分配到观察组(136例)和对照组(134例),观察组在强化期(服药的前2月)服用费宁+乙胺丁醇(E),巩固期(服药的后4月)服用费安,均每日用药;对照组服用国家肺结核标准治疗方案的组合包装板式药(2H3R3Z3E3/4H3R3),隔日用药。[结果]观察组和对照组治疗2月末和6月末痰菌转阴率分别为95.2%、97.6%和97.5%、98.7%,两组比较差异无显著性(P值分别为0.7617和0.1836)。疗程结束时,观察组和对照组胸部X线有效率分别为94.3%和95%,差异无统计学意义(P=0.8451);观察组和对照组空洞闭合率分别为63.6%和45.8%,差异无统计学意义(P=0.2310)。总不良反应发生率:观察组15%,对照组25.3%,两组比较差异无统计学意义(P=0.0764)。胃肠道反应发生率观察组低于对照组(P=0.0404)。[结论]国产抗结核复合制剂FDC治疗初治肺结核病与国家肺结核标准治疗方案的组合包装板式药疗效相当,具有一定推广应用价值。

ANALYSIS ON THE EFFECT OF FIXED-DOSE COMBINATION FOR THE INITIAL TREATMENT OF TUBERCULOSIS IN CHINA

[Objective] To evaluate the treatment outcome of domestic fixed-dose combination as anti-tuberculosis therapy and explore the feasibility of DOTS. [Methods] A randomized control trial was conducted and 191 pulmonary tuberculosis patients were randomly distributed into 2 groups. The trial group was treated daily with Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol tablets for the first 2 months and treated with Rifanpicin and Isoniazid tablets for the subsequent 4 months. The control group was treated wi...