固定剂量复合剂治疗肺结核不良反应对照研究

目的 研究抗结核药物固定剂量复合剂治疗肺结核不良反应发生情况，为全国结核病防治规划推广应用提供依据。方法 在全国4省17县结核病防治规划实施中，对登记的初治涂阳肺结核患者，以县为单位采用简单随机分组方法，使用固定剂量符合剂与抗结核病组合药进行对照研究，观察患者治疗过程中不良反应的发生情况。结果 在发生不良反应的病例中，37例因重症药物不良反应停药，其中研究组10例，占研究组观察例数的2．1％，对照组27例，占对照组观察例数的5．5％。重症药物不良反应停药率对照组高于研究组（P〈0．01）。研究组某些不良反应的开始时间晚于对照组，结束时间早于对照组，持续时间短于对照组，累积时间少于对照组。65岁一组不良反应总发生率高于其他年龄组，女性某些不良反应发生率高于男性。对照组体重40〈公斤患者关节痛的发生率高于其他体重患者。结论 固定剂量复合剂重症药物不良反应导致患者停药率低于抗结核板式组合药，减少了患者中断治疗率，对提高患者规律服药率和治愈率，降低耐药率具有十分重要的意义。

Adverse effects of randomized clinical trial of fixed-dose combination on TB treatment

Objective To study the adverse effects of fixed-dose combination,and put forward to proof for drug supply system in National TB Control Programme(NTP).Methods Primary smear positive pulmonary tuberculosis cases registered in TB institutions of 17 counties from 4 provinces were simple randomization divided into experimental and control group respectively.Adverse effects of two different treatment methods were recorded and compared with uniform questionnaires throughout the treatment.Results Totally 37 cases stopped treatment due to adverse effect,10 cases in the experimental group and 27 cases in the other group respectively.The default rate in the experimental group was 2.1% and 5.5% in the control group respectively.There was significant difference between the two groups(P<0.01).Some kinds of adverse effect occurred later and ended previous in the experimental group,and it also shared a short duration and cumulating time of adverse effect.The rates of adverse effect occurring were higher in the female aged over 65 years.Occurring rate of arthralgia was higher in lower weight in control group.Conclusion Fewer adverse effects occurred especially fewer cases exited in experimental group.Fixed-dose combination might play an important role in enhancing regular treatment rate and cured rate and reduced the MDR-TB.