Gurusamy Kurinchi Selvan, Junnarkar Sameer, Farouk Marwan, Davidson Brian R
University Department of Surgery, Royal Free Hospital and University College School of Medicine, 9th Floor, Royal Free Hospital, Pond Street, London, UK, NW3 2QG.
Cochrane Database Syst Rev. 2009 Jan 21(1):CD007086. doi: 10.1002/14651858.CD007086.pub2.
The optimal treatment for patients with suspected biliary dyskinesia is controversial. Some studies found that cholecystectomy produced symptomatic improvement in patients with gallbladder dyskinesia (diagnosed by low gallbladder ejection fraction) while others found no significant benefit. Some studies have shown that gallbladder ejection fraction can discriminate patients who would benefit from cholecystectomy. Other studies have not confirmed this.
The aim of this review was to compare the benefits and harms of cholecystectomy for patients with suspected gallbladder dyskinesia.
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2008.
We considered for inclusion all randomised clinical trials comparing cholecystectomy versus no cholecystectomy on patients with gallbladder dyskinesia.
We collected the data on the characteristics, methodological quality, mortality, number of patients in whom symptoms were improved or cured from the one identified trial. We planned to analyse the data using the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we planned to calculate the risk ratio (RR) with 95% confidence intervals based on intention-to-treat analysis.
We included one trial with 21 patients randomised: 11 to cholecystectomy and 10 to control (no cholecystectomy). This trial was considered to be of high risk of bias as patients were not blinded and the procedure-related morbidity was not reported. There was no mortality in either group. All patients in the cholecystectomy group and only one patient in the control group had improvement in symptoms (P = 0.0001) after a mean follow-up period of 33.6 months.
AUTHORS' CONCLUSIONS: The evidence for the benefits and harms of cholecystectomy in gallbladder dyskinesia from randomised clinical trials is based on a single small trial at risk of bias. Further randomised clinical trials with improved bias control are necessary to confirm or reject the promising results.
疑似胆囊运动障碍患者的最佳治疗方法存在争议。一些研究发现,胆囊切除术可使胆囊运动障碍患者(通过低胆囊排空分数诊断)的症状得到改善,而另一些研究则未发现显著益处。一些研究表明,胆囊排空分数可区分能从胆囊切除术中获益的患者。其他研究并未证实这一点。
本综述的目的是比较胆囊切除术对疑似胆囊运动障碍患者的益处和危害。
我们检索了Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版,检索截至2008年3月。
我们纳入了所有比较胆囊切除术与非胆囊切除术对胆囊运动障碍患者影响的随机临床试验。
我们从一项纳入的试验中收集了关于特征、方法学质量、死亡率、症状改善或治愈患者数量的数据。我们计划使用RevMan分析软件,采用固定效应模型和随机效应模型对数据进行分析。对于每个结局,我们计划基于意向性分析计算风险比(RR)及95%置信区间。
我们纳入了一项随机分配21例患者的试验:11例接受胆囊切除术,10例作为对照(未接受胆囊切除术)。由于患者未设盲且未报告与手术相关的发病率,该试验被认为存在高偏倚风险。两组均无死亡病例。平均随访33.6个月后,胆囊切除术组的所有患者以及对照组中仅1例患者的症状得到改善(P = 0.0001)。
随机临床试验中关于胆囊切除术对胆囊运动障碍患者益处和危害的证据仅基于一项存在偏倚风险的小型试验。需要进一步开展偏倚控制更好的随机临床试验来证实或否定这些有前景的结果。