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目的监测固定剂量复合制剂(FDC)在治疗初治活动性肺结核病人中的应用效果,为推广使用提供依据。方法应用FDC制剂治疗3个试点县(市)2008年4月1日～9月30日期间发现的符合要求的初治活动性肺结核病人,使用统一的调查表进行治疗效果和不良反应等的观察和记录。结果监测入选病例235例,其中初治涂阳128例(54.5%),初治涂阴107例(45.5%)。涂阳病例2个月末涂片阴转率为89.3%,治愈率为85.2%,初治失败率为2.5%(3/118);涂阴病例完成疗程率为81.7%,疗程中均未发生痰菌阳转。不良反应的总体发生率为19.1%,以肝功能损害、胃肠道反应和神经系统症状为主。因不良反应而需散装药替代率为46.7%。不良反应发生时间主要集中在开始服药后的2个月内(占78.3%)。药物性肝功能损害发生率为14.0%,最早在疗程第21天,最晚在疗程第147天。结论 FDC制剂具有与现用板式组合药相似的药物特性,但全人群适用性更好。
Objective To monitor the effect of fixed-dose combination (FDC) in the treatment of patients with newly diagnosed active pulmonary tuberculosis and provide the basis for the promotion of its use. Methods FDC was used to treat patients with newly diagnosed active pulmonary tuberculosis (TB) who met the requirements from April 1, 2008 to September 30, 2008 in three pilot counties (cities), and the treatment effect and adverse reactions were observed using a unified questionnaire And record. Results A total of 235 patients were selected for surveillance. Among them, 128 (54.5%) were smear-positive and 107 (45.5%) were smear-negative. At the end of 2 months, smear negative conversion rate was 89.3%, cure rate was 85.2%, initial treatment failure rate was 2.5% (3/118); smear negative cases completed the treatment rate was 81.7%, no sputum Yang positive bacteria. The overall incidence of adverse reactions was 19.1%, with liver damage, gastrointestinal reactions and neurological symptoms. Due to adverse reactions and bulk drug substitution rate was 46.7%. Adverse reactions occurred mainly within 2 months after starting medication (78.3%). The incidence of drug-induced liver dysfunction was 14.0%, the earliest in the treatment of the first 21 days, the latest 147 days of treatment. Conclusions FDC preparations have similar pharmacological properties as current plate-type combinations, but the general population is more amenable to use.