Waljee A K, Dimagno M J, Wu B U, Schoenfeld P S, Conwell D L
Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.
Aliment Pharmacol Ther. 2009 Feb 1;29(3):235-46. doi: 10.1111/j.1365-2036.2008.03885.x. Epub 2008 Nov 8.
Pancreatic enzyme supplementation is standard treatment for malabsorption caused by chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications to continue to market these agents because published data demonstrated variation in formulation, bioavailability and shelf-life while providing limited data about efficacy and safety.
To review systematically the design and results of randomized, parallel-design trials of pancreatic enzyme supplements in chronic pancreatitis patients with steatorrhea.
A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Two authors performed duplicate data extraction on study design, improvement in coefficient of fat absorption (CFA), diarrhoea and adverse events using pre-specified forms. Agreement between investigators for data extraction was greater than 95%.
Of 619 articles found through literature searching, 20 potentially relevant articles were identified and four manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared with placebo, but fat malabsorption remained abnormal. Important differences in patient population, study endpoint, study design, pancreatic enzyme dosage and measurement of CFA were present across trials, which precluded comparison of different agents.
Enzyme supplementation improves CFA compared to placebo, but may not abolish steatorrhoea.
补充胰酶是治疗慢性胰腺炎所致吸收不良的标准疗法。美国食品药品监督管理局（FDA）最近要求所有制造商提交新药申请，以便这些药物能继续上市销售，因为已发表的数据表明，这些药物在剂型、生物利用度和保质期方面存在差异，而关于疗效和安全性的数据有限。
系统回顾针对慢性胰腺炎脂肪泻患者的胰酶补充剂随机平行设计试验的设计与结果。
通过计算机辅助检索MEDLINE和EMBASE以识别相关研究。两名作者使用预先指定的表格，对研究设计、脂肪吸收系数（CFA）改善情况、腹泻及不良事件进行重复数据提取。研究者之间在数据提取方面的一致性超过95%。
通过文献检索找到619篇文章，确定了20篇可能相关的文章，4篇手稿符合纳入标准。没有研究对不同补充剂进行直接比较。与安慰剂相比，补充酶更有可能改善CFA，但脂肪吸收不良仍未恢复正常。各试验在患者群体、研究终点、研究设计、胰酶剂量和CFA测量方面存在重要差异，这使得不同药物之间无法进行比较。
与安慰剂相比，补充酶可改善CFA，但可能无法消除脂肪泻。
