五个月短程化疗及六个月全程间歇方案治疗菌阳肺结核的临床对照研究

Controlled clinical trial on efficacy of 5 month regimens and whole course intermittent 6 month regimens in treating bacillary pulmonary tuberculosis

目的考核利福喷丁（Ｌ）的疗效；缩短疗程或全程间歇以减少用药次数；观察全程应用吡嗪酰胺（Ｚ）对疗效及毒副反应的影响。方法以利福平（Ｒ）为对照，采用５个月疗程方案（Ⅰ组２ＳＨＲＺ／３Ｒ２Ｈ２Ｚ２，Ⅱ组２ＳＨＲＺ／３Ｌ１Ｈ２Ｚ２）、６个月全间歇方案（Ⅲ组２Ｓ３Ｈ３Ｒ３Ｚ３／４Ｌ１Ｈ２Ｚ２，Ⅳ组２Ｓ３Ｈ３Ｒ３Ｚ３／４Ｌ１Ｈ２Ｅ２），观察Ｚ的全程应用结果，巩固期以乙胺丁醇（Ｅ）为对照。３６６例初治菌阳肺结核随机分入以上４组。结果（１）３３９例完成疗程者中３２９例治疗成功，满疗程时痰菌阴转率Ⅰ～Ⅳ组分别为９７０％、９４１％、１０００％、９７２％。Ｘ线病灶有效率依序为９６０％、９７６％、１０００％和９４４％。５个月组与６个月组空洞关闭率分别为７７％及７６％。各组相互比较均无显著性差异（Ｐ＞０．０５），未见严重副作用。（２）３０５例完成３年随访，Ⅰ、Ⅱ、Ⅲ、Ⅳ组细菌学加Ｘ线复发分别为２、３、６和３例。结论本研究结果进一步证明Ｌ是长效、高效、安全、便于督导的新药；巩固期用Ｚ无必要；现有基本药物合理联用有可能缩短疗程为５个月，值得进一步研究。

Objective To assess the therapeutic efficacy of rifapentine (L), to reduce the duration of treatment and the frequency of drug administration, and to observe the influence on efficacy and adverse reactions of using pyrazinamide (Z) through whole course. Method Two 5 month regimens respectively including rifampin (R) and L and two whole course intermittent regimens were designed as following: Ⅰ: 2SHRZ/3R 2H 2Z 2; Ⅱ: 2SHRZ/3L 1H 2Z 2; Ⅲ: 2S 3H 3R 3Z 3/4L 1H 2Z 2; Ⅳ: 2S 3H 3R 3Z 3/4L 1H 2E 2. A total of 366 newly diagnosed bacillary pulmonary tuberculosis patients were admitted and randomly allocated. Result 339 cases completed the prescribed short course chemotherapy. The sputum conversion rates at the end of the treatment of groups Ⅰ、Ⅱ、Ⅲ and Ⅳ were 97.0%、94.1%、100.0% and 97.2% respectively. X ray resolution rates were 96.0%、97.6%、100.0% and 94.4% respectively. Cavity close rates of the 5 month regimens and the 6 month regimens were 77% and 76%. Comparing the results among groups, there were no statistically significant differences ( P > 0.05), and no obvious side effect was found. 305 patients have been followed up for 3 years since completion of the chemotherapy. The bacteriological relapse and bacteriological relapse with deterioration on chest X ray in groups Ⅰ、Ⅱ、Ⅲand Ⅳ were seen in 2,3,6 and 3 cases respectively. Conclusion Domestic made rifapentine is a long acting, highly effective antituberculosis drug. It is unnecessary to use Z in continuation phase, and it is possible to shorten the duration to 5 months with the appropriate combination of essential drugs, which is worthwhile for further study.