【作者】 闫丽萍； 吴哲渊； 张祖荣； 沙巍； 陈静； 潘启超； 沈鑫； 袁政安； 张青； 肖和平；

【Author】 YAN Li-ping;WU Zhe-yuan;ZHANG Zu-rong;SHA Wei;CHEN Jing;PAN Qi-chao;SHEN Xin;YUAN Zheng-an;ZHANG Qing;XIAO He-ping;Clinic and Research Center of Tuberculosis,Shanghai Key Lab of Tuberculosis,Shanghai Pulmonary Hospital;Tongji University School of Medicine;

【机构】 同济大学附属上海市肺科医院结核科； 上海市疾病预防控制中心结核病防治科；

【摘要】 目的探讨一线抗结核药物在初治耐多药肺结核(MDR-PTB)的治疗中是否仍有应用的空间,为正确处理初治耐多药肺结核提供依据。方法对2011年1月至2013年12月上海市所有登记的肺结核患者(共19 042例)采用"全面筛查"方式,共发现168例初治MDR-PTB患者,将具有上海市户籍或工作居住证并签订了知情同意书的114例患者纳入本次研究。经上海市耐多药肺结核防治专家组分析讨论后对所有研究对象进行初治标准方案治疗。以患者强化期治疗不同效果进行分组,显效者继续观察再进行给予12H-R-Z-E方案治疗(简称"标准组")12个月,无效者则给予耐多药方案治疗(简称"耐多药组")24个月,标准组治疗成功的患者每2个月随访1次,至信息采集截止时平均随访了16个月。观察2组治疗成功率、患者失访率、死亡率、药物不良反应发生率。对2组数据"率"的比较采用卡方检验,当理论频数<1时,采用Fisher确切概率法检验。以P <0.05为差异有统计学意义。结果 58例强化期显效者继续给予12H-R-Z-E方案治疗,56例无效者给予耐多药方案治疗,基本方案为6Cm-Lfx-Pto-PAS-Z/18LfxPto-PAS-Z。标准组和耐多药组获得治疗成功率、患者失访率分别为69.0%(40/58)和67.9%(38/56)、5.2%(3/58)和7.1%(4/56),差异均无统计学意义(χ~2=0.66,P=0.192;χ~2=0.93,P=0.336));标准组和耐多药组的死亡率、药物不良反应发生率分别为0.0%和10.7%(6/56)、13.8%(8/58)和53.6%(30/56),差异均有统计学意义(χ~2=6.56,P=0.010;χ~2=20.29,P=0.000)。其中标准组中15例治疗失败者转入耐多药组治疗,获得治疗成功率为73.3%(11/15)、死亡率6.7%(1/15);标准组40例治愈者有2例在疗程结束6个月后复发,经药物敏感性试验再次确诊为MDR-PTB。结论初治耐多药肺结核采用12H-R-Z-E标准化疗方案治疗在治疗成功率、患者失访率方面与"延迟"耐多药治疗(初始未采用耐多药治疗方案,无效后使用)的患者差异无统计学意义,说明一线抗结核药物治疗初治耐多药肺结核仍有一定的空间,延迟进行耐多药方案治疗不影响治疗效果,且分类治疗有助于患者减少药物不良反应和死亡率。更多还原

【Abstract】 Objective To discuss whether first-line antituberculosis drugs could be used to treat newlydiagnosed multi-drug resistant pulmonary tuberculosis(MDR-PTB) and to provide evidence for correct treatment of newly-diagnosed MDR-PTB.Methods From January 2011 to December 2013,all 21402 registered pulmonary tuberculosis(PTB) patients in Shanghai were screened.168 newly diagnosed MDR-PTB patients were detected,among whom 114 patients whose household registration is Shanghai or who have temporary residential permit of Shanghai were patients were enrolled in the study.The expert panel designed chemotherapy regimen for each MDR-PTB patient.58 new patients were treated with original regimen due to favorable treatment reaction at the end of the intensive phase.56 patients were treated with MDR-PTB regimen due to unfavorable treatment reaction at the end of the intensive phase.The MDR-PTB regimen in the study was 6 Cm-Lfx-Pto-PAS-Z/18 Lfx-PtoPAS-Z.Patients cured with 12 HRZE regimen were followed up every two months.At the end of the information collection,patients were followed up with an average of 16 months after treatment completion.Results Out of 58 patients who were treated with original regimen,40(69.0%) were cured,15(25.9%) were transferred to MDR-PTB regimen because of continuous positive sputum culture with DST result of MDR-TB again.Out of15 patients,9(73.3%) were successfully treated with MDR-PTB regimen.The cure rate of 56 patients in MDRPTB regimen group was 67.9%.6 patients(10.7%) received MDR-PTB regimen died and none received 12 HRZE regimen died.The difference was statistically significant(χ~2=6.5595,P=0.01).The lost to follow-up rate in MDRPTB regimen group and 12 HRZE regimen groupwas 7.1% and 5.17%,respectively.The difference was not statistically significant(χ~2=0.6613,P=0.1919).Patients received MDR-PTB regimen have higher adverse drug reaction rate than Patients received 12 HRZEregimen(49.6% and 20%).Conclusion First-line drugs can still be used in the treatment of some newly diagnosed MDR-PTB patients.The classification treatment of newly diagnosed MDRPTB patients make patients get reasonable treatment,reduce unnecessary adverse drug reactions and improve patient compliance.Delayed treatment of newly diagnosed MDR-PTB patients does not affect the treatment efFect.Diagnostic accuracy of multi-drug resistant TB remains to be further improved.更多还原