初始耐药结核治疗的系统评价与Meta分析

The systematic evaluation of the initial resistance pulmonary tuberculosis treatment:a Meta-analysis

目的系统评价药物治疗初始耐药较非耐药肺结核的有效性。方法计算机检索Cochrane图书馆、MEDLINE、EMbase、VIP、CNKI和CBMdisc电子资料库,查找药物治疗初始耐药与非耐药肺结核的队列研究,然后由两位研究者独立进行资料提取和质量评价,采用RevMan 5.1软件进行Meta分析,并采用GRADEpro 3.6系统对证据质量和等级推荐进行分级。结果共将10个研究纳入Meta分析,初始耐药与非耐药肺结核病人相比,6个月末痰菌阴转率为91%[RR=0.91,95%CI(0.86,0.96),P<0.001],肺空洞闭合率为70%[RR=0.7,95%CI(0.60,0.82),P<0.001],2年后细菌学复发率为4.98倍[RR=4.98,95%CI(3.07,8.07),P<0.001]。GRADE系统评价结果显示,2年后细菌学复发率和肺空洞闭合率证据质量为中等,6个月末痰菌阴转率与肺部病灶吸收有效率证据质量为极低。结论初始耐药与非耐药肺结核相比,在6个月末痰菌阴转率、肺空洞闭合率等方面均低,2年后细菌学复发率较高。初始耐药是化疗失败的一个重要原因。鉴于系统评价为二次研究,受纳入分析的原始文献质量影响较大,且评价过程可能存在偏倚等局限性,上述结论尚需进一步通过开展大规模、高质量的基础和临床研究来验证。

Objective To systematically evaluate the tuberculosis versus that of non-drug-resistance. Methods efficacy of drug for initial drug resistant pulmonary Published literature were searched from Coehrane Library, MEDLINE, EMbase, VIP, CNKI, CBMdisc and other electronic databases until April, 2011. We included cohort studies that compared the efficacy of the treatment of initial drug resistant pulmonary tuberculosis with that of non-drug-resistant tuberculosis. After making data extraction and quality assessment, we use RevMan 5. 1 software for Meta-analysis and GRADEpro 3. 6 system for classifying the quality of evidence and grade of recommendation. Results There are ten studies included in the Meta-analysis. The results shows that, compared to patients with non-drug-resistant tuberculosis,those of initial drug resistance have a sputum negative conversion rate of 91% at the end of 6 months[RR=0.91,95%CI（0.86,0.96） ,P〈0. 001],lung cavity closure rate of 70%[RR= 0.7,95 %CI（ 0. 60,0. 82} , P〈0. 0017 ,and a 2-year bacterial recurrence rate of 4.98 times[RR= 4.98,95 M CI（ 3.07, 8. 071 ,P〈0. 001]. The classification of GRADE shows that bacterial relapse rate after 2 years and the lung cavity closure rate are the moderate quality of evidence,sputum negative conversion rate is a very low quality of evidence. Conclusions Compared the treatment of initial drug resistant tuberculosis with that of non-drug-resistance,there are lower rates in lung cavity closure and sputum negative conversion at the end of 6 months, while higher rates in bacterial relapse after 2 years. Initial drug resistance is one of the major reasons of the failure of TB chemotherapy. As systematic evaluation is a second study which impacted largely by the quality of the original documents which might have bias in the process of evaluation, these findings need further large-scale, high-quality basic and clinical research.