含利福喷汀每周或二周1次短化方案治疗涂阳肺结核临床对照研究——三年随访结果

Controlled clinical trial of rifapentine given once weekly or fortnightly in 6month regimens for the treatment of bacillary tuberculosis——Results at 3year follow-up

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/5H2L1/2; Ⅱ (Experiment Group Ⅱ) 1SHRZ/5H2L1; Ⅲ (Control Group) 1SHRZ/5H2R2. 277 cases have completed the prescribed short course. The results at the end of treatment were as follows:(1) The 2month 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 cavityclosure rate in all three groups. (4) The sideeffects of both rifapentine and refampin were rather low. Among them, 261 patients were followedup for 3 years since the stopping of chemotherapy. The bacteriological relapse and bacteriological relapse with deterioration on chest Xray in Groups Ⅰ, Ⅱ and Ⅲ were 4 cases, 3 caese and 2 cases respectively. During followupperiod, 81.1% of further resoluiton of residual lung lesions and 65.9% of cavityclosure in these cases have been observed. Based on these data, it could be confirmed that domestic made rifapentine is a longacting, highly effective antituberculosis drug which has very low sideeffect and is conducive to implementing supervised chemotherapy. Hence it is recommended that RFT is a suitable drug in 6month regimens which can be widely used in DOTS.