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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 evaluate the anti-TB efficacy and side effects of 4 doses of HRZE fixed-dose combination (FDC) and 2 drugs (HR) under DOTS management. Methods Totally 225 patients with smear-positive pulmonary tuberculosis were randomly divided into treatment group (4 FDC for 4 months and 2 FDC for 4 months) and control group (2HRZE / 4HR). The sputum negative conversion rate, Lesions change and adverse reactions. Results The sputum negative conversion rates of the treatment group and the control group for 2 months were 94.6% and 93.8% respectively. The sputum negative conversion rates were 99.1% and 96.5% for the full course of treatment, respectively. The chest X ray was significantly improved, and the lesions in the treatment group and the control group were absorbed The rates were 98.2% and 97.4% respectively. The void closure rates of the two groups were 72.2% and 56.4% respectively. The treatment group and the control group had 4 cases and 3 cases of abnormal liver function. Conclusion Domestic 4-drug fixed-dose combination is a safe, effective and easily accepted by patients. And has good compliance, suitable for wide application in the country.