Efficacy and safety of pancreatic enzyme replacement therapy on exocrine pancreatic insufficiency: a meta-analysis.
Efficacy and safety of pancreatic enzyme replacement therapy on exocrine pancreatic insufficiency: a meta-analysis.
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胰酶替代疗法治疗外分泌胰腺功能不全的有效性和安全性：荟萃分析
DOI：
10.18632/oncotarget.21659
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发表时间：
2017-11-07
期刊：
影响因子：
--
通讯作者：
Liu R
中科院分区：
文献类型：
--
作者：
Gan C;Chen YH;Liu L;Gao JH;Tong H;Tang CW;Liu R
胰酶替代疗法（PERT）广泛应用于外分泌性胰腺功能不全（EPI）患者，但其疗效和安全性尚未量化。因此，我们进行了荟萃分析，以确定PERT对EPI患者的疗效和耐受性。材料与方法由两位独立审稿人检索PubMed、Medline、Cochrane图书馆数据库、2016年12月前发表的循证医学/临床试验，以确定前瞻性随机对照试验（RCTs）。结果筛选7项随机对照试验，共282例患者，进行定性评价（Jadad评分）。与基线相比，PERT增加了CFA (WMD: 26.56, 20.35至32.76,I2 = 79.6%, P < 0.001)，与安慰剂相比，CFA （WMD: 17.97, 12.61至23.34,I2 = 76.7%, P < 0.001）。同时，与基线和安慰剂相比，PERT的CNA、SFE、SNE和SW均有显著改善，不良事件无统计学差异。亚组分析表明，标准形式的PERT更有效，异质性显著降低，大样本量也在一定程度上降低了异质性。结论PERT在EPI患者中是有效且可耐受的，特别是在标准给药的情况下。标准PERT治疗的长期效果需要更大规模、更高质量的EPI研究。
Background Pancreatic enzyme replacement therapy (PERT) is widely applied to patients with exocrine pancreatic insufficiency (EPI), but its effect and safety has not been quantified. Therefore we performed a meta-analysis to determine the efficacy and tolerance of PERT on patients with EPI. Materials and Methods PubMed, Medline, Cochrane library database, Evidence-based medicine/clinical trials published before December 2016 were searched by two independent reviewers to identify prospective randomized controlled trials (RCTs). Results Seven RCTs, randomizing a total of 282 patients, were filtrated and assessed qualitatively (Jadad score). PERT increased CFA (WMD: 26.56, 20.35 to 32.76, I2 = 79.6%, P < 0.001) compared with baseline, and CFA (WMD: 17.97, 12.61 to 23.34, I2 = 76.7%, P < 0.001) vs. placebo. Meanwhile, CNA, SFE, SNE and SW were significantly improved in PERT compared with baseline and placebo, with no statistical differences in adverse events. Subgroup analysis indicated that standard forms of PERT displayed more effectiveness with significantly decreased heterogeneity, and large sample size also reduced the heterogeneity to some degree. Conclusions PERT is demonstrated to be effective and tolerable in patients with EPI, especially using standard administration of PERT. Larger and higher quality studies on EPI are demanded to long-term effect of standard PERT treatment.
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