在DOTS管理下应用国产4药固定剂量复合剂治疗初治菌阳肺结核的可行性研究  

Feasibility study of domestic four-drug fixed-dose combination under DOTS as initial treatment in ptients with smear positive pulmonary tuberculosis

作　　者：马丽萍[1] 吴晓光[1] 初乃慧[1] 朱莉贞[1] 陕斌 王敏[3] 王燕 张文书 李会军 候栋 

机构地区：[1]北京胸科医院,北京101149 [2]四川省都江堰市疾病预防控制中心,都江堰611800 [3]四川省彭州市疾病预防控制中心,彭州611930 [4]四川省龙泉驿区疾病预防控制中心,龙泉驿610100 [5]山东省苍山县结防所,苍山277700 [6]山东省临邑结防所,临邑251500 [7]山东省郓城县结防所,郓城274700

出　　处：《中国防痨杂志》2010年第5期254-258,共5页Chinese Journal of Antituberculosis

摘　　要：目的评价在DOTS管理下应用4药(HRZE)固定剂量复合剂(FDC),和2药(HR)的抗结核疗效及不良反应。方法将225例初治涂阳肺结核患者,随机分为治疗组(2个月4药FDC/4个月2药FDC)和对照组(2HRZE/4HR),观察近期痰菌阴转率、X线病变改变情况及不良反应。结果治疗组和对照组2个月痰菌阴转率分别为94.6%、93.8%;满疗程痰菌阴转率分别为99.1%、96.5%;胸部X线明显改善,治疗组和对照组病灶吸收率分别为98.2%和97.4%;2组空洞闭合率分别为72.2%和56.4%;治疗组和对照组各有4例和3例肝功异常。结论国产4药固定剂量复合剂是一种安全、高效、易被患者接受的抗结核药物制剂。且有很好的依从性,适于在国内广泛推广应用。Objective To assess antituberculosis efficacy and adverse events of domestic four-drug fixed-dose combination in smear positive pulmonary tuberculosis under the management of directly observed treatment short-course（DOTS）. Method Two hundreds and twenty-five new patients with smear positive pulmonary tuberculosis were randomly divided into a treatment group（2yinuonikang/4yifu capsule） and a control group（2HRZE/4HR） to observe rates of sputum negative conversion in short time,chest X-ray improvement and advert events. Result The sputum negative conversion rates in the treatment group and the control were 94.6% and 93.8% at the 2nd month,and 99.1% and 96.5% at the end of treatment.Chest radiography showed remarkable improvement of lesions.The foci absorption rate in the treatment group and the controls were 98.2% and 97.4%,respectively,and the cavity closure rates were 72.2% in the treatment group and 56.4% in the controls.Hepatic dysfunction was seen among 4 cases in the treatment group and 3 cases in the controls. Conclusion Domestic four-drug fixed-dose combination shows an excellent therapeutic efficacy,safety and good compliance in antituberculous chemotherapy which could be recommended widely in tuberculosis control in China.

关 键 词：结核 肺/药物疗法 抗结核药 固定剂量复合剂 

分 类 号：R521[医药卫生—内科学]