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符合选例条件的321例初治涂阳肺结核随机分入2个含国产利福喷汀(L)试验组和利福平(R)对照组:Ⅰ组1SHRZ/5H2L1/2;Ⅱ组1SHRZ/5H2L1;Ⅲ组1SHRZ/5H2R2。277例完成治疗,治后2月痰培养阴性率三组均>96.0%,满疗程痰菌阴转率分别为100.0%、100.0%及98.9%。各组X线病灶有效率及空洞关闭率相仿(P>0.05),未见严重副反应。276例中261例完成3年随访。Ⅰ、Ⅰ、Ⅲ组中细菌学复发及细菌学加X线复发分别为4、3及2例;随访期间治疗末残留的病灶吸收率及空洞关闭率各达81.1%及65.9%。本研究结果验证国产利福喷汀适用于简化的6个月短程方案,具有高效、长效(1或2周用药1次)、低毒、经济、便于督导等特点,建议作为一线药推广应用于直视下短化(DOTS)。
A total of 321 newly diagnosed smear-positive pulmonary tuberculosis patients were selected and randomly divided into two groups including domestic rifapentine (R) test group and rifampicin (R) control group: Group Ⅰ 1SHRZ / 5H2L1 / 2; Group Ⅱ 1SHRZ / 5H2L1; Group Ⅲ 1SHRZ / 5H2R2.277 cases completed treatment, sputum culture negative rate in February after three groups were> 96.0%, full course sputum negative conversion rates were 100.0%, 100.0% and 98 .9%. X-ray lesion efficiency and void closure rate in each group were similar (P> 0.05), no serious side effects. 261 of 276 patients completed the 3-year follow-up. Bacteriological relapse, bacteriological and X-ray recurrent rates in groups Ⅰ, Ⅰ and Ⅲ were 4, 3 and 2 respectively. Absorption rate and void closure rate at the end of follow-up were 81.1% and 65.9% . The results of this study verify that domestic rifapentine is suitable for simplified 6-month short-range program, with high efficiency, long-acting (1 or 2 weeks of medication 1), low toxicity, economical, easy to supervise and so on, Shorten (DOTS) under direct vision.