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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 explore the efficacy and safety of second-line drug treatment. Methods A total of 154 patients with drug-resistant pulmonary tuberculosis (at least rifampin-resistant) found in the surveillance of drug-resistant TB were randomly divided into observation group and control group by multi-center and randomized grouping, and were treated with different chemotherapy regimens. The observation group was dominated by second-line anti-tuberculosis drugs. The control group was the first-line anti-tuberculosis drug developed by the national TB control program. To bacteriological and imaging changes as the evaluation criteria. Results (1) 114 cases completed the whole treatment, 40 patients withdrew from the study, of which 26 cases in the control group and 14 cases in the observation group (P> 0.05); (2) Bacteriological changes: The sputum negative rate in the observation group was 81.7% The control group was 70.0% (P> 0.05). In the lesser range, the negative rate of sputum in observation group and control group were 90.3% and 90.0% respectively (P> 0.05). In the larger range of disease, the negative rate of sputum in observation group and control group were respectively 77.5%, 52.2% (P <0.05). (3) Imaging changes: 2 groups of chest X-ray absorption difference was not statistically significant. (4) Safety: There were 17 cases in the observation group and 8 cases in the control group (P> 0.05). Conclusions For patients with newly-diagnosed drug-resistant TB, as well as those with more extensive resistance to TB, it is equally safe to adopt a second-line drug-containing regimen, but the response may be better.