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 Patients with Smear Positive Pulmonary Tuberculosis

目的评价在DOTS管理下应用4药（HRZE）N定剂量复合N（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（2HRZF／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 （2 yinuonikang/4 yifu capsule） and a control group （2 HRZE/4 HR） 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.