四联抗结核固剂量复合剂的临床疗效研究.doc

四联抗结核固定剂量复合剂的临床疗效研究 钟球1，高翠南2，陈瑜晖1，黄桂清1，李建伟1，莫卓鼎3 （1.广东省结核病防治研究所 广州 510623 ，2.广州市胸科医院 广州 510095； 3.湛江市结核病防治所 湛江 524008） 摘要: 目的 研究四联抗结核固定剂量复合剂的近期临床疗效及安全性。方法 将广东省湛江市六个县区登记的540例初治涂阳肺结核病人分为研究组和对照组,用对照研究方法对两组病例的临床症状、治疗效果和不良反应等情况进行对比研究。结果 (1)研究组治愈率为94.4%，对照组为92.2%，两组的治愈率无显著性差异（χ2= 1.071, P=0.301）；(2)两组患者相关临床症状（如咳嗽、胸痛、乏力、盗汗、低热、咯血）逐渐得到改善，两组无显著性差异( P0.05) ；(3)2、3月末研究组痰菌阴转率分别为90.7%、94.1%，对照组分别为89.6%，91.9%，差异无显著性（P0.05）；胸片显示空洞愈合方面，研究组的空洞闭合率为78.2%，对照组为61.2%，研究组比对照组高。(4)研究组与对照组的不良反应发生率分别为21.5%和20.0%，无显著性差异（P0.05）；强化期对照组的消化道不良反应发生率明显大于研究组（P0.05）；两组血常规、肝功能异常率接近；研究组因不良反应停药率高于对照组（P0.05）。结论 四联FDC与板式组合药具有同等的抗结核疗效，不良反应发生率相近，并且在治疗管理方面显示出较大的优势，建议推荐在我国结核病防治规划中应用。 关键词：固定剂量复合剂；肺结核；临床疗效；研究 A study on clinic efficacy of fixed-dose combinations with four drugs in treating tuberculosis patients Zhong Qiu 1，Gao Cuinan 2, Cheng Yuhui1, Huang Guiqing1, Li Jianwei1,Mo Zhuoding （１. Anti-tuberculosis research institute of Guangdong province，Guangzhou，510630 ２.Ｇuangzhou chest hospital, Guangzhou, 510095 3.Zhangjiang City Dispensary for Tuberculosis Treatment and Prevention, Zhangjiang, 524008） Abstract: Objective To research the effects and safety of fixed-dose combinations (FDC) with four drugs in treatment of tuberculosis. Methods 540cases of the diagnosis of smear positive pulmonary tuberculosis in six counties of Zhanjiang Municipality in Guangdong province, with the case group using FDC and control group using the blister pack. The clinical manifestation, treatment outcome and adverse reaction were compared by the method of control study. Results (1) The cure rates in the FDC group and in the control group were 94.4% and 92.2% respectively,. There was no significant difference between the two groups（χ2= 1.071, P=0.301）. (2) The incidence of clinic symptoms such as cough, 广东省医学科学技术研究基金项目,编号：WSTJJ20061227440803195912292422 chest pain, fatigue, night sweating, fever and emptysis gradually declined in both groups after treatment, and there was no significant difference betwee