摘要
目的 评价肝门部恶性胆道梗阻单、双侧引流的有效性与安全性。方法 联合检索PubMed、Embase、Cochrane Library数据库,检索年限均从1975年至2013年8月,纳入单、双侧引流的随机对照和非随机对照试验。用RevMan5.0软件进行荟萃分析,用相对危险度（RR）值及95％可信区间（CI）对单、双侧引流进行比较.在荟萃分析中用RR及其95％CI比较两组差异。混合性的数据资料采用固定效应模型和随机效应模型,当研究间出现显著异质性时,荟萃分析采用随机效应模型。研究之间的异质性检验采用卡方检验（P＜ 0.10为异质性有统计学意义）和I2分析（I2＞ 50％为异质性有统计学意义）。对于异质性的来源采用亚组分析和敏感性分析,潜在的发表偏倚采用漏斗图分析。结果 经过筛选共纳入3个随机对照试验和7个观察性研究,合计894例患者。荟萃分析结果显示主要观察重点：单、双侧引流的支架通畅率优于单侧（RR=2.03,95％CI：1.16 ～ 3.56,P=0.01）;而引流的有效性（RR=1.07,95％CI：0.97～1.18,P=0.20）和患者的生存率（RR=-0.16,95％CI：-0.40 ～ 0.08,P=0.20）差异无统计学意义。次要观察重点：单双侧引流的技术成功率（RR=1.05,95％CI：0.98 ～ 1.17,P=0.34）、早期并发症（RR=1.15,95％CI：0.75 ～ 1.76,P=0.52）、晚期并发症（RR=1.09,95％CI：0.75 ～ 1.60,P=0.65）、30 d病死率（RR=0.68,95％CI：0.38 ～ 1.23,P=0.20）同样差异没有统计学意义。结论 虽然双侧引流支架通畅率较单侧好,现存循证医学证据还不足够支持双侧引流,期待更多严格设计前瞻性随机对照研究出现来验证。
Objective To assess the efficacy and safety of bilateral versus unilateral biliary drainage in malignant hilar obstruction.Methods Topically relevant studies,regardless of randomized or observational design,were searched for in PubMed,EmBase and the Cochrane Library database.Risk ratios （RRs） with 95% confidence intervals （CIs） were calculated to compare the effect of the two treatments.Results Three randomized trials and 7 observational studies were included,involving 894 patients with malignant hilar obstruction.The meta-analysis assessment of primary outcomes showed that the stent patency rate was better in bilateral drainage than in unilateral drainage （RR =2.03,95% CI [1.16-3.56],P =0.01）,but there were no significant differences in successful drainage rate （RR =1.07,95% CI [0.97-1.18],P =0.20） and patient survival rate （RR =-0.16,95% CI [-0.40-0.08],P =0.20）.In the analysis of secondary outcomes,there were also no significant differences in the technical success rate （RR =1.05,95% CI [0.98-1.17],P =0.34）,the early complication rate （RR =1.15,95% CI [0.75-1.76],P =0.52）,late complication rate （RR =1.09,95% CI [0.75-1.60],P =0.60） and 30-day mortality rate （RR =0.68,95% CI [0.38-1.23],P =0.20）.Conclusion Although the cumulative stent patency was better for the bilateral than the unilateral drainage approach,based on the available data,there is not enough data to support bilateral drainage for malignant hilar obstruction.Well-designed randomized controlled trials are necessary to confirm it.
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2015年第2期118-123,共6页
Chinese Journal of Hepatology
关键词
胆道
引流术
荟萃分析
Biliary tract
Drainage
Meta-analysis
