国产固定复合制剂肺宁／肺安治疗肺结核近期临床分析

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>0.05);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5.8%(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。

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

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.87.1%(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.