标准复治化疗方案治疗多耐药与敏感复治肺结核患者的对比研究

Comparative study on the treatment effect of standard retreatment regimen in patients with poly-drug resistant- and drug sensitive pulmonary tuberculosis

目的通过分析复治化疗方案治疗多耐药复治肺结核患者的疗效，为多耐药复治肺结核合理治疗方案的制定提供参考依据。方法采用国内多中心回顾性研究，选取2010年10月至2011年12月期间我国不同省、自治区、直辖市的21家结核病诊疗机构诊治1～2次的复治涂阳、培阳肺结核患者为研究对象。根据药物敏感性试验（简称“药敏试验”）结果除外单耐药、耐多药及广泛耐药患者，共入选符合标准的患者319例；其中，多耐药组（PI）R组）57例，对一线抗结核药物均敏感（敏感组）262例。两组患者中男239例，女80例，平均年龄（42．1±5．66）岁；均采用2SHR（L）EZ／6HR（L）E为核心的复治方案进行治疗，对两组不同时期痰菌阴转率、影像学好转率及治愈率、治疗成功率等进行比较分析。采用SPSS16．0软件对数据进行统计学分析，计数资料间比较采用卡方检验，以P〈0．05为差异有统计学意义。结果治疗2个月，PDR组、敏感组痰菌阴转率分别为63．2％（36／57）、83．2％（218／262），治疗5个月痰菌阴转率分别为75．4％（43／57）、89．7％（235／262），两组比较差异均有统计学意义（x^2值分别为11．598，5．336，P值均〈0．05）。PDR组、敏感组满疗程后胸片复查的好转率分别为64．9％（37／57）、82．4％（216／262）；空洞闭合率分别为20．0％（4／20）、43．9％（47／107）。治愈率分别43．9％（25／57）、68．7％（180／262）；治疗成功率分别为70．2％（40／57）、94．3％（247／262），两组比较差异均有统计学意义（x^2值分别为8．768、4．014、12．581、30．126，P值均〈0．05）。结论标准复治化疗方案治疗敏感复治肺结核患者的疗效优于多耐药患者。应根据药敏试验结果选择敏感药物组成有效化疗方案治疗多耐药肺结核患者，以提高治愈率。

Objective To analyze the efficacy of standard retreatment regimen in patients with polydrug re sistant tuberculosis in order to provide reference data for designing standard regimen. Methods In this multicentre retrospective study, all retreatment patients with smear- or culture positive were recruited from 21 hospitals distri buted in different province in China's Mainland during Oct. 2010 and Dec. 2011. Three hundred and nineteen cases excluding monodrug-, multidrug- and extensively drug resistant tuberculosis were enrolled according to drug suscep tible testing （DST）. Fifty-seven cases belonged to polydrug resistant group and 262 cases belonged to drug sensitive group. The average age was （42.1±5.66） years old in this study including 239 males and 80 females. The standard regimen was 2SHR（L）EZ/6HR（L）E. The two groups were compared in the rate of sputum negative conversion, the image improvement, cure and treatment success. Count data were analyzed using Chi square test with SPSS 16.0 software and P〈0. 05 was statistical significant difference. Results The rate of sputum negative conversion in polydrug resistant group and drug sensitive group were 63.3% （36/57） and 83.2% （218/262） at the end of two month, and 75.4% （43/57） and 89.7% （235/262） at the end of five month. The differences were significant statis- tically. The improvement rate of chest X-ray were 64.9% （37/57） and 82.4% （216/262） when the treatment fi- nished in two groups. The rate of cavities closure were 20.0% （4/20） and 43.9% （47/107）. The cure rate was43.9% （25/57） and 68.7% （180/262）, and the rate of treatment success were 70.2% （40/57） and 94.3% （247/262）. The differences were significant statistically. Conclusion The efficacy of standard retreatment regi- men in drug sensitive pulmonary tuberculosis patients is better than that of polydrug resistant patients. To improve cure rate, effective chemotherapeutic regimen including sensitive drugs should be adopted based on DST.