Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis.
Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis.
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DOI：
10.1111/j.1365-2036.2008.03885.x
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发表时间：
2009-02-01
影响因子：
7.6
通讯作者：
Conwell DL
中科院分区：
文献类型：
--
作者：
Waljee AK;Dimagno MJ;Wu BU;Schoenfeld PS;Conwell DL
胰酶补充剂是慢性胰腺炎引起的吸收不良的标准治疗方法。FDA最近要求所有制造商提交新药申请（NDA），以继续销售这些药物，因为已公布的数据表明配方，生物利用度和保质期的变化，同时提供有关疗效和安全性的有限数据。系统地回顾了在慢性胰腺炎伴脂肪肝患者中补充胰酶的随机、平行设计试验的设计和结果。对MEDLINE和EMBASE进行计算机辅助检索，以识别相关研究。两位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、腹泻和不良事件进行了重复数据提取。研究者之间数据提取的一致性大于95%。在通过文献检索发现的619篇文章中，确定了20篇潜在相关文章，4篇手稿符合纳入标准。没有研究对不同的补充剂进行头对头比较。与安慰剂相比，酶补充剂更有可能改善CFA，但脂肪流产仍然异常。在患者人群、研究终点、研究设计、胰酶剂量和CFA测量方面存在重要差异，这排除了不同药物的比较。与安慰剂相比，补充酶可改善CFA，但可能无法消除脂肪酸。
Pancreatic enzyme supplementation is standard treatment for malabsorption due to chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications (NDAs) 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 systematically review 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), diarrhea, 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 4 manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared to placebo, but fat malaborption 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 steatorrhea.
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影响因子：
2.9
作者：
Safdi, Michael;Bekal, Pradeep K.;Toskes, Phillip P.
通讯作者：
Toskes, Phillip P.
影响因子：
5.1
作者：
Borowitz, Drucy;Goss, Christopher H.;Murray, Frederick T.
通讯作者：
Murray, Frederick T.
影响因子：
5.1
作者：
Rosenstein, BJ;Cutting, GR
通讯作者：
Cutting, GR
DOI：
10.1097/00005176-200207000-00017
发表时间：
2002-07-01
影响因子：
2.9
作者：
Francisco, MP;Wagner, MH;Novak, DA
通讯作者：
Novak, DA
影响因子：
24.5
作者：
AXON, ATR;CLASSEN, M;LEES, WR
通讯作者：
LEES, WR