含氟喹诺酮类药物方案治疗耐利福平肺结核患者的近期效果和安全性评价  

Study on the efficacy and safety of short-term treatment including fluoroquinolones anti- tuberculosis drugs for rifampicin resistant pulmonary tuberculosis

作　　者：康万里[1] 谢艳光 谭卫国[3] 初乃惠[1] 李亮[1] 游永红[1] 杨应周[3] 王晓萌[4] 闫兴录 缪梓萍[4] 端木宏谨[1] 

机构地区：[1]北京市结核病胸部肿瘤研究所,北京101149 [2]黑龙江省结核病防治研究所 [3]深圳市慢性病防治院 [4]浙江省疾病预防控制中心结核病防治所

出　　处：《中华流行病学杂志》2009年第2期179-183,共5页Chinese Journal of Epidemiology

摘　　要：目的评价中国结核病控制项目地区以含氟喹诺酮类药物方案治疗耐利福平肺结核患者的近期治疗效果和安全性。方法对2004-2006年黑龙汀、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耐利福平肺结核患者随机分为试验组（含氟喹诺酮类药物方案组，采用3RFT AM Ofx Pro PAS-INH／5RFT Ofx Pto PAS-INH方案治疗）和对照组（复治方案组，采用3H1R3Z3E3S3／5H3R3E3方案治疗），采用遵循研究方案分析和意向性分析，比较两组的近期治疗效果并观察不良反应。结果（1）共入选154例耐利福平肺结核患者，其中单耐利福平25例（16.2％），耐多药（耐利福平＋异烟肼、耐利福平＋异烟肼＋链霉素、耐利福平＋异烟肼＋乙胺丁醇和耐利福平＋异烟肼＋乙胺丁醇＋链霉素）114例（74.0％），其他（耐利福平＋链霉素、耐利福平＋乙胺丁醇和耐利福平＋乙胺丁醇＋链霉素）15例（9.8％）。114例耐利福平肺结核患者完成疗程，其中试验组71例，对照组43例。（2）经遵循研究方案分析试验组和对照组阴转率分别为78.9％和65.1％（X^2CMH=4.558，P=0.011）；意向性分析试验组和对照组阴转率分别为65.9％和40.6％（X^2CMH=0.272，P=0.001），试验组阴转率高于对照组；治疗耐多药的效果试验组阴转率高于对照组。（3）两组各有3例因严重不良反应退组；完成疗程的试验组不良反应发生率为23.9％（17／71），对照组不良反应发生率为18.6％（8／43），两组不良反应发生率差异无统计学意义（X^2=0.446，P=0.504）：结论含氟喹诺酮类药物治疗方案和复治方案治疗耐利福平／耐多药肺结核都可取得一定疗效，而且含氟喹诺酮类药物治疗方案组的疗效优于复治方案组。Objective To evaluate the efficacy and safety of short-term treatment including fluoroquinolones anti-tuberculosis drugs for rifampicin resistant pulmonary tuberculosis （TB） in those areas carrying out the‘TB control project＇. Methods TB cases involved in this study were from TB drug resistance surveillance in Heilongjiang province, Zhejiang province and Shenzhen city from 2004 to 2006. TB cases with rifampicin resistant were randomly divided into the treatment group （including fluoroquinolones anti-tuberculosis drugs group） and the control group （re-treatment regimen group）. The treatment group was treated with 3RFT AM Ofx Pto PAS-INH/5RFT Ofx Pto PAS-INH while the control group was treated with 3 H3R3Z3E3S3/5 H3R3E3. Efficacy of short-term treatment was analyzed by per-protocol analysis （PP analysis） and intention-to- treat analysis （ITT analysis） while drug adverse reactions was also observed. Results （1）154 patients with rifampicin resistant pulmonary tuberculosis were recruited among them, 25 （16.2%） were only resistant to rifampicin, 114 （74.0%） to MDR-TB and 15 （9.8%） to others （resistant R＋S, resistant R＋E and resistant R＋E＋S ）.114 TB cases completed the full course of treatment, with 71 in the treatment group and 43 in the control group. （2）Sputum negative conversion rate of the treatment group and the control group were 78.9% and 65.1% （ X^2CMH=4.558, P=0.011 ） respectively, by per-protocol analysis. Sputum negative conversion rate of the treatment group and the control group were 65.9% and 40.6% （X^2CMH=0.272, P=0.001 ） respectively, by intention-to-treat analysis. The sputum negative conversion rate of the treatment group was higher than in the control group when treating rifampicin resistant pulmonary tuberculosis and MDR-TB patients. （3）Three patients withdrew in each of the two groups because of adverse effects to the drugs. Rates of adverse reaction to drugs appeared to be 23.9% （17/71） and 18.6% （8/43） in the treatment an

关 键 词：结核病 耐多药 耐药 安全性 

分 类 号：R521[医药卫生—内科学]