CAJ | 학술논문

目的：系统评价耐多药结核（multidrug-resistanttuberculosis，MDR-TB）患者在使用二线抗结核药物治疗过程中肝损害的发生率情况。方法：以“tuberculosis”、“multidrug-resistant”、“MDR-TB”、“sideeffect”、“adverse”、“safe-ty”、“tolerability”和“耐多药结核”、“副反应”、“不良反应”为关键词在Medline（1966年1月1日至2014年3月1日）、Embase（1974年1月1日至2014年3月1日）和TheCochraneLibrary（1993年1月1日至2014年3月1日）3个英文数据库及中国期刊全文专题数据库（1994年1月1日至2014年3月1日）、万方数据库（1998年1月1日至2014年3月1日）、中国生物医学文献数据库（1978年1月1日至2014年3月1日）和中国科技期刊数据库（1989年1月1日至2014年3月1日）4个中文数据库中系统检索MDR-TB患者在使用二线抗结核药物治疗过程中发生肝损害的随访研究，摘录有关信息，用随机效应模型进行Meta分析，并按照诊断标准、研究人群、研究类型、既往抗结核治疗史和治疗疗程进行亚组分析和敏感性分析。结果：根据入选及排除标准，共纳入26篇文献，3875名MDR-TB患者，其中373名发生了肝损害，各研究之间存在一定的异质性，采用随机效应模型加权合并的肝损害发生率为7．7％（95％CI：5．5％～10．8％）。亚组分析显示，肝损害在治疗疗程≥18个月及非亚洲人群中发生率较高，但各亚组结果之间差异无统计学意义（P＞0．05）。26篇文献中，只有9篇文献报告了肝损害的诊断标准，但标准不统一。结论：MDR-TB患者在使用二线抗结核药物治疗过程中肝损害不良反应的发生率较高，且诊断标准不统一，应重视对肝损害的防治，并制定统一的诊断标准。
목적：계통평개내다약결핵（multidrug-resistanttuberculosis，MDR-TB）환자재사용이선항결핵약물치료과정중간손해적발생솔정황。방법：이“tuberculosis”、“multidrug-resistant”、“MDR-TB”、“sideeffect”、“adverse”、“safe-ty”、“tolerability”화“내다약결핵”、“부반응”、“불량반응”위관건사재Medline（1966년1월1일지2014년3월1일）、Embase（1974년1월1일지2014년3월1일）화TheCochraneLibrary（1993년1월1일지2014년3월1일）3개영문수거고급중국기간전문전제수거고（1994년1월1일지2014년3월1일）、만방수거고（1998년1월1일지2014년3월1일）、중국생물의학문헌수거고（1978년1월1일지2014년3월1일）화중국과기기간수거고（1989년1월1일지2014년3월1일）4개중문수거고중계통검색MDR-TB환자재사용이선항결핵약물치료과정중발생간손해적수방연구，적록유관신식，용수궤효응모형진행Meta분석，병안조진단표준、연구인군、연구류형、기왕항결핵치료사화치료료정진행아조분석화민감성분석。결과：근거입선급배제표준，공납입26편문헌，3875명MDR-TB환자，기중373명발생료간손해，각연구지간존재일정적이질성，채용수궤효응모형가권합병적간손해발생솔위7．7％（95％CI：5．5％～10．8％）。아조분석현시，간손해재치료료정≥18개월급비아주인군중발생솔교고，단각아조결과지간차이무통계학의의（P＞0．05）。26편문헌중，지유9편문헌보고료간손해적진단표준，단표준불통일。결론：MDR-TB환자재사용이선항결핵약물치료과정중간손해불량반응적발생솔교고，차진단표준불통일，응중시대간손해적방치，병제정통일적진단표준。
Objective:To systematically evaluate the incidence of liver injury in multi-drug resistant tu-berculosis ( MDR-TB ) patients with the treatment of second-line anti-TB drugs.Methods: Medline (January 1, 1966 to March 1, 2014), Embase (January 1, 1974 to March 1, 2014) and the Cochrane library (January 1, 1993 to March 1, 2014) with four Chinese databases including VIP ( January 1, 1989 to March 1, 2014), CBMDisc (January 1, 1978 to March 1, 2014), CNKI (January 1, 1994 to March 1, 2014)and Wanfang (January 1, 1998 to March 1, 2014), were systematically searched with the keywords including “Tuberculosis”,“multidrug-resistant”,“MDR-TB”,“side effect”,“adverse”,“safety” and “tolerability” for the follow-up studies of MDR-TB patients with liver injury during the treatment of second-line anti-TB drugs.The relevant information was extracted and the data were analyzed using the random-effects model .Subgroup and sensitivity analyses were performed based on the diagnostic criteria, study population , study design , history of anti-TB treatment and treatment length .Results: A total of 26 articles with 3 875 MDR-TB patients were included , of which 373 patients developed liver in-jury, and the weighed combined incidence of liver injury was 7.7%(95%CI:5.5%-10.8%).There was some heterogeneity among the studies .Subgroup analyses showed that the incidence of liver injury was higher in groups with treatment length≥18 months and non-Asian populations , but there was no sig-nificant difference between the groups (P>0.05).Among the 26 articles, only nine of them reported the diagnostic criteria of liver injury , while the criteria were not uniform .Conclusion:The incidence of liver injury during the treatment of second-line anti-TB drug in MDR-TB patients was high , and the diag-nostic criteria were not uniform .We should pay attention to the prevention and treatment of liver injury , and develop standard diagnostic criteria for it .