国产固定复合制剂肺宁/肺安治疗肺结核近期临床分析  

Study on Efficacy of Domestic-made Fixed-dose Combination(FDC) in Anti-tuberculosis Therapy Clinical Trial

作　　者：赵梅桂[1] 赵安贵[1] 龙卫军[1] 钟云辉[1] 潘海宏[1] 文善适[1] 

机构地区：[1]深圳市宝安区慢性病防治院,广东深圳518133

出　　处：《实用预防医学》2006年第4期874-875,1100,共3页Practical Preventive Medicine

摘　　要：目的 评价国产固定剂量复合制剂临床效果和安全性。方法 选取2003年6～12月登记的深圳市新发涂阳肺结核病人474例，其中试验组232例（使用FDC），对照组243例（使用板式组合药），对照两组的临床效果。结果 FDC制剂组和对照组2月末痰菌阴转率分别达91．4％和92．9％（P〉0．05）；治愈率分别为97．7％与92．0％，二者之间差异具有统计学意义（P〈0．01）；胸部X线改变，FDC制剂组有效率92．3％，组合药组为87．1％（P〉005）；两组分别有62.3％和45.7％的空洞闭合（P〉0．05）；两组因药物不良反应停药率分别为9．3％与58％（P〉0．05）。结论 国产FDC制剂是一种疗效高、毒副反应小的抗结核药物。Objective To evaluate anti- tuberculosis efficacy and safety of domestic - made fixed- dose combination （FDC）. Methods Newly diagnosed 474 sputum smear positive patients in Shenzhen City were randomized to receive FDC （n = 232） or plate combined drugs （n = 243） and the clinical efficacy and adverse effects were compared between them. Results The sputum negative conversion rates at the 2nd month in the FDC group and control group were 91.4 % vs. 92.9 % respectively （P 〉0.05） ; and the ultimate cured rates were 97.7 % and 92.0 % （P〈 0.01）. According to the chest radiography, the improvements of pulmonary lesion were 92.3 % vs. 87. t % （P 〉0.05）, the cavity closure rates were 62.3 % vs. 45.7% （P〉0.05）, and withdrawal due to adverse reactions were 9.3% vs. 5.8% （P〉0.05）. Conclusions The domestic- made fixed- dose combination （FDC） shows the satisfying therapeutic efficacy and safety.

关 键 词：抗结核治疗 FDC 社区对照 临床试验 

分 类 号：R52[医药卫生—内科学]