Craig A G, Toouli J
Digestive Surgery, Flinders Medical Centre, Adelaide, South Australia, Australia, 5042.
Cochrane Database Syst Rev. 2001(3):CD001509. doi: 10.1002/14651858.CD001509.
The sphincter of Oddi regulates both bile and pancreatic juice flow into the duodenum. When dysfunction occurs it leads to problems relating to either the bile or pancreatic ducts. On the biliary side, the most common problem is recurrent biliary type pain following cholecystectomy.
Is sphincterotomy effective treatment for biliary sphincter of Oddi dysfunction patients?
Electronic data bases, including the Collaborative Review Group trial registers, MEDLINE, and EMBASE, as well as checking reference lists in as many languages as possible that had the titles: sphincter of Oddi dysfunction, biliary dyskinesia, papillary stenosis, biliary dyssynergia, odditis, papillitis, post-cholecystectomy pain, right upper quadrant pain, or unexplained right upper quadrant pain were included. These titles were matched with sphincterotomy.
Randomised placebo-controlled trials performing sphincterotomy in patients with suspected biliary sphincter of Oddi dysfunction using manometry as part of the patient evaluation. A basal pressure > 40 mmHg was defined as abnormal. The primary outcome measure were symptomatic response (defined either as cure/improvement or not improved) to sphincterotomy.
Electronic data bases were used to search for the studies. Studies were attempted to be stratified as randomised clinical trials, controlled clinical trials (i.e., quasi-randomised clinical trials), well designed observational studies using a well matched control group, or other. These groupings were then entered into a meta-analysis.
Only two randomised clinical trials met the inclusion criteria. In 49 patients studied, sphincterotomy was more effective than placebo in treating patients with an elevated basal pressure (Peto odds ratio 9.08, 95% confidence interval 2.97-277.77). In 77 patients studied, sphincterotomy was no better than placebo in treating patients with a normal normal basal pressure (Peto odds ratio 1.28, 95% confidence interval 0.52-3.13). There was no data on quality of life or health economics.
REVIEWER'S CONCLUSIONS: These results suggest that sphincterotomy for biliary sphincter of Oddi dysfunction appears effective in those patients with an elevated sphincter of Oddi basal pressure (>40 mmHg), but is no better than placebo in those patients with a normal basal pressure. The results reported in this review must be interpreted with caution as there are only two studies and one of the reviewers (Toouli) has been an author in both studies. Further trials by independent groups are recommended.
Oddi括约肌调节胆汁和胰液流入十二指肠。当功能障碍发生时，会导致与胆管或胰管相关的问题。在胆道方面，最常见的问题是胆囊切除术后反复出现胆源性疼痛。
括约肌切开术对Oddi括约肌功能障碍患者是否为有效治疗方法？
电子数据库，包括协作综述组试验注册库、MEDLINE和EMBASE，同时尽可能多地查阅多种语言的参考文献列表，这些文献标题包括：Oddi括约肌功能障碍、胆道运动障碍、乳头狭窄、胆道协同失调、胆管炎、乳头炎、胆囊切除术后疼痛、右上腹疼痛或不明原因的右上腹疼痛。将这些标题与括约肌切开术进行匹配。
对疑似Oddi括约肌功能障碍患者进行括约肌切开术的随机安慰剂对照试验，使用测压作为患者评估的一部分。基础压力>40 mmHg被定义为异常。主要结局指标是括约肌切开术后的症状反应（定义为治愈/改善或未改善）。
使用电子数据库检索研究。研究试图分为随机临床试验、对照临床试验（即准随机临床试验）、使用匹配良好的对照组的设计良好的观察性研究或其他类型。然后将这些分组纳入荟萃分析。
仅有两项随机临床试验符合纳入标准。在研究的49例患者中，括约肌切开术在治疗基础压力升高的患者方面比安慰剂更有效（Peto比值比9.08，95%置信区间2.97 - 277.77）。在研究的77例患者中，括约肌切开术在治疗基础压力正常患者方面并不比安慰剂更好（Peto比值比1.28，95%置信区间0.52 - 3.13）。没有关于生活质量或卫生经济学的数据。
这些结果表明，Oddi括约肌功能障碍的括约肌切开术在Oddi括约肌基础压力升高（>40 mmHg）的患者中似乎有效，但在基础压力正常的患者中并不比安慰剂更好。由于仅有两项研究且其中一位综述作者（Toouli）是这两项研究的作者之一，本综述中报告的结果必须谨慎解读。建议独立研究组进行进一步试验。
