| 康万里,谢艳光,谭卫国,初乃惠,李亮,游永红,杨应周,王晓萌,闫兴录,缪梓萍,端木宏谨.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[J].Chinese journal of Epidemiology,2009,30(2):179-183 |
| 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 |
| Received:September 11, 2008 |
| DOI： |
| KeyWord: 结核病，耐多药 耐药 安全性 |
| English Key Word: Multidrug-resistant tuberculosis Drug resistance Safety |
| FundProject:国家自然科学基金资助项目(30671752) |
| Author Name | Affiliation | E-mail | | KANG Wan-li | Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing 101149, China | | | XIE Yan-guang | 黑龙江省结核病防治研究所 | | | TAN Wei-guo | 深圳市慢性病防治院 | | | CHU Nai-hui | Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing 101149, China | | | LI Liang | Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing 101149, China | | | YOU Yong-hong | Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing 101149, China | | | YANG Ying-zhou | 深圳市慢性病防治院 | | | WANG Xiao-meng | 浙江省疾病预防控制中心结核病防治所 | | | YAN Xing-lu | 黑龙江省结核病防治研究所 | | | MIAO Zi-ping | 浙江省疾病预防控制中心结核病防治所 | | | DUANMU Hong-jin | Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing 101149, China | Email:dmhj@tb123.com |
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| Abstract: |
| 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年黑龙江、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3对照组，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。 |
| English Abstract: |
| 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 Heilongiiang 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 wim 3RFT AM ofx Pto PAS-INH/5RFT ofx Pto PAS.INH while the control group was treated with 3 H3R323E3S3/5 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 fuIl 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%(X2CMH=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%(X2CMH=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 rifampicm resistant pulmonary tuberculosis and MDR-TB patients.(3)Three patients withdrew in each of the two groups because ofadverse 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 and in the control groups,with no statistically significant difference between the two groups.Conclusion The efficacy of treatment including fluoroquinolones anti-tuberculosis drugs group seemed beaer than the re-treatment regimen group in treating patients with rifampicin resistant pulmonary tuberculosis and those MDR-TB patients. |
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