结核病控制项目地区耐药结核病两种治疗方案的对比研究

目的 探讨符合我国国情的耐药结核病治疗方案.方法 将2004至2006年间黑龙江、浙江、深圳三省(市)结核病控制项目地区结核病耐药监测中发现的对利福平耐药肺结核患者随机分为耐药方案组和复治方案组,耐药方案组采用利福喷汀/丁胺卡那霉素/氧氟沙星/丙硫异烟胺/对氨基水杨酸异烟肼(3个月)+利福喷汀/氧氟沙星/丙硫异烟胺/对氨基水杨酸异烟肼(5个月)方案治疗,复治方案组采用异烟肼/利福平/吡嗪酰胺/乙胺丁醇/链霉素(3个月)+异烟肼/利福平/乙胺丁醇(5个月)方案治疗,分别于治疗第3、6、8个月末时进行痰涂片检查,以第8个月末痰涂片阴转为治疗有效的评价标准.结果 共纳入对利福平耐药的肺结核患者154例,其中至少对异烟肼和利福平同时耐药的耐多药结核病(MDR-TB)114例,其他类型耐药40例.耐药方案组85例,复治方案组69例.114例患者完成8个月疗程,8个月末痰涂片阴转率耐药方案组为65.9%(56/85),复治方案组为40.6%(28/69),组间差异有统计学意义(X2=9.834,P=0.002).114例MDR-TB患者中85例完成8个月治疗,8个月末痰涂片阴转率耐药方案组为61.8%(42/68),复治方案组为39.1%(18/46),组间差异有统计学意义(x2=5.638,P=0.018).治疗8个月未痰涂片阴转率与患者年龄、病程、治疗方案以及耐药类型有关(均P＜0.05).完成疗程患者的不良反应发生率耐药方案组为23.9%(17/71),复治方案组为18.6%(8/43),组间差异无统计学意义(x2=0.446,P=0.504).结论 耐药方案对耐药结核病患者的疗效优于复治方案.对没有条件按照世界卫生组织原则制定的方案治疗的耐药患者,或者没有条件开展耐药性检测地区而高度怀疑为耐药结核病的患者,可以使用耐药方案治疗,以后根据药物敏感试验或治疗效果调整方案.

Effects of two treatment regimens for drug-resistant tuberculosis in tuberculosis control project areas: a comparative study

Objectives To search for an ideal therapeutic regimen for muhidrug resistant tuberculosis conforming to the situation of China. Methods One hundred and fifty-four patients with rifampin-resistant tuberculosis, 114 multi-drug resistant (MDR-TB) and 40 resistant to other drugs, in Heilongjiang, Zhejiang, and Sbenzhen, 107 males and 47 females, aged 39 (19-77), were randomly divided into 2 groups:85 patients in the group of drug-resistant regimen, 3RFT AM Ofx Pto PAS-INH/SRFT Ofx Pro PAS-INH regimen, including rifapentine (RFT), amikacin (Am), ofloxacin(Ofx), protionamide (Pto), para-aminosalicylic acid-isoniazid (PAS-INH) for 3 months and then RFT, Ofx, Pto, and PAS-INH for 5 months, and 69 in the retreatment regimen group undergoing 3 H3R3Z3E3S3/5 H3R3E3, including isoniazid (H), rifampin (R), pyrazinamide (Z) , ethambutol (E), and streptomycin (S) for 3 months and then H, R, and E for 5 months. Sputum smear was checked and the sputum smear conversion rate was calculated as an effective treatment indicator 3, 6, and 8 months later. Results One hundred and fourteen of the 154 patients were treated for a good 8 months. The sputum smear conversion rate 8 months after treatment of the drug-resistant regimen group was 65.9% (56/85), significantly higher than that of the retreatment regimen group [40.6% (28/69), X2 = 9.834, P = 0.002]. Eighty-five of the 114 MDR-TB patients had been treated for a good 8 months with a sputum smear conversion rate of 61.8% (42/68), significantly higher than that of the retreatment regimen group [39.1% (18/46), X2=5.638,P =0.018]. Sputum smear conversion at the end of the 8th month was related to age, course of disease, therapeutic regimen, and the type of drug-resistance (all P < 0.05). The side-effect rate of the drug-resistant regimen group was 23.9% (17/71), higher than that of the retreatment regimen group [18.6% (8/43)], but not significantly (X2 = 0.446, P = 0.504). Conclusion The drug-resistant regimen recommended above is more effective than the retreatment regimen and should be considered in the areas where the WHO guideline fails to be followed or drug sensitivity Lest (DST) cannot be conducted and adjusted according to the results of DST and treatment.