摘要
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 bacillary pulmonary tuberculosis patients were admitted and randomly allocated to the following 3 groups with different chemotherapy regimens: Ⅰ (Experiment Group Ⅰ) 1SHRZ/5H2L1/2; Ⅱ (Experiment Group Ⅱ) 1SHRZ/5H2L1; Ⅲ (Control Group) 1SHRZ/5H2R2. 277 cases have completed the prescribed short course. The results at the end of treatment were as follows:(1) The 2month sputum culture negative in three regimens was ≥96%, without statistical difference (P>0.05). (2) After completing the planned chemotherapy, the sputum conversion rates (S-C-) of groups Ⅰ, Ⅱ and Ⅲ were 100%, 100% and 98.9%, respectively. (3) There were remarkable resolution and high cavityclosure rate in all three groups. (4) The sideeffects of both rifapentine and refampin were rather low. Among them, 261 patients were followedup for 3 years since the stopping of chemotherapy. The bacteriological relapse and bacteriological relapse with deterioration on chest Xray in Groups Ⅰ, Ⅱ and Ⅲ were 4 cases, 3 caese and 2 cases respectively. During followupperiod, 81.1% of further resoluiton of residual lung lesions and 65.9% of cavityclosure in these cases have been observed. Based on these data, it could be confirmed that domestic made rifapentine is a longacting, highly effective antituberculosis drug which has very low sideeffect and is conducive to implementing supervised chemotherapy. Hence it is recommended that RFT is a suitable drug in 6month regimens which can be widely used in DOTS.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
1997年第6期423-430,共8页
Chinese Journal of Antibiotics
关键词
利福喷汀
肺结核
药物疗法
利福平
Rifapentine
Rifampicin
Pulmonary tuberculosis
Clinical trial
Chemotherapy regimens