耐利福平肺结核病人的治疗观察

Clinical observation of therapy for pulmonary tuberculosis patient with rifampicin resistance

目的探讨含二线药物治疗方案的有效性和安全性。方法采用多中心、随机分组方法,将耐药结核病监测中发现的耐药肺结核(至少耐利福平)患者154例,随机分入观察组和对照组,采取不同化疗方案治疗。观察组以二线抗结核药物为主;对照组则为国家结核病控制规划制订的复治方案,均为一线抗结核药物。以细菌学和影像学改变作为疗效评价标准。结果(1)114例完成全程治疗,40例患者退出研究,其中对照组26例,观察组14例(P>0.05);(2)细菌学改变:观察组痰菌转阴率为81.7%,对照组为70.0%(P>0.05)。在病变范围较小者中,观察组和对照组痰菌转阴率分别为90.3%、90.0%(P>0.05),在病变范围较大者中,观察组和对照组痰菌转阴率分别为77.5%、52.2%(P<0.05)。(3)影像学改变:2组X线胸片病灶吸收差异无统计学意义。(4)安全性:观察组和对照组中发生不良反应的分别有17例、8例(P>0.05)。结论对于初治的耐药肺结核患者,以及病变较广泛的耐药肺结核患者,采用含二线药物的治疗方案同样安全,但疗效可能更好。

Objective To investigate the effiacy and safety of the treatment regimen containing the second-line anti-tuberculosis drugs. Methods 154 patients with drug resistant pulmonary tu- berculosis （PTB） （at least resistant to rifampicin） from different centers were assigned randomly to a study group which were treated by a regimen containing the second line antituberculosis drugs, and a control group which received a regimen recommended by NTP. Sputum smear conversion and X-ray changes were evaluated. Results 154 PTB patients with rifampicin-resistance were en- rolled, and 114 patients completed, 40 patients were dropped out（26 from the control group and 14 from the study group） without statistically significant difference（P〉0.05）. The rates of sputum smear negative conversion in the study group and in the control were 81.7% and 70.0% without statistically significant difference（P〉0. 05）. 90.3 % and 90.0% respectively in the study The rates of sputum smear negative conversion were group and the control group for patients with limited focus on chest X-ray（P〉0. 05）, However, we found that the rates of sputum negative conversion were significantly higher in the study group（77.5%） compared with the control （52.2%） for pa- tients with extensive loci on chest X-ray（P〈0.05）. The absorption of loci on chest X-ray cannot be seen significant difference between two groups. 17 patients were seen side effects in the study group, and 8 in the control group wihout significant difference （P〉0. 05）. Conclusion The regi- men which included the second-line anti-tuberculosis drugs had the same safety as which recommen- ded by NTP, and perhaps it is more effective for untreated patients with drug resistance, and those with extensive foci on chest X-ray.