Shafiq Nusrat, Rana Surinder, Bhasin Deepak, Pandhi Promila, Srivastava Puja, Sehmby Surjit S, Kumar Raj, Malhotra Samir
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 160012.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD006302. doi: 10.1002/14651858.CD006302.pub2.
The efficacy of pancreatic enzymes in reducing pain and improving steatorrhoea is debatable and the evidence base for their utility needs to be determined.
To evaluate the efficacy of pancreatic enzymes in patients with chronic pancreatitis. The specific objectives were to compare the following: 1) pancreatic enzyme versus placebo; 2) different pancreatic enzyme preparations and 3) different dosage schedules of the enzyme preparations. We evaluated the following outcomes: change in frequency of abdominal pain, duration of pain episodes, intensity of pain, weight loss, steatorrhoea, faecal fat and quality of life.
We devised a search strategy to detect all published and unpublished literature and the search included CENTRAL (The Cochrane Library 2009, issue 1), MEDLINE (1965 to February 2009) and EMBASE (1974 to Feburary 2009). We handsearched reference lists and published abstracts from conference proceedings to identify further relevant trials. The date of the last search was April 2009.
Randomised controlled trials with or without blinding. We included abstracts or unpublished data if sufficient information was available.
Two authors independently extracted and pooled the data pertinent to study outcomes. We combined continuous data using standardised mean difference (SMD) with 95% confidence interval (CI) and calculated the odds ratio (OR) for dichotomous data (95% CI).
Ten trials, involving 361 participants, satisfied the inclusion criteria. All the trials were randomised; two had a parallel design while the remainder had a cross-over design. Although some individual studies reported a beneficial effect of pancreatic enzyme over placebo in improving pain, incidence of steatorrhoea and analgesic consumption, the results of the studies could not be pooled for these outcomes. With the use of pancreatic enzymes, we observed a non-significant benefit for weight loss (kg) (SMD 0.06; 95% CI -0.23 to 0.34); a significant reduction in faecal fat (g/day) (SMD -1.03; 95% CI -1.60 to -0.46) and non-significant difference in subjects' Clinical Global Impression of Disease Symptom Scale (SMD -0.63; 95% CI -1.41 to 0.14). We found no significant benefit in reducing faecal fat with any particular schedule of enzyme preparation or type of enzyme.Another small study did not show any significant benefit of timing the administration of enzyme preparations in relation to meals on faecal fat.
AUTHORS' CONCLUSIONS: The role of pancreatic enzymes for abdominal pain, weight loss, steatorrhoea, analgesic use and quality of life in patients with chronic pancreatitis remains equivocal. Good quality, adequately powered studies are much warranted.
胰酶在减轻疼痛和改善脂肪泻方面的疗效存在争议，其应用的证据基础有待确定。
评估胰酶对慢性胰腺炎患者的疗效。具体目标是比较以下各项：1）胰酶与安慰剂；2）不同的胰酶制剂；3）酶制剂的不同给药方案。我们评估了以下结果：腹痛频率的变化、疼痛发作的持续时间、疼痛强度、体重减轻、脂肪泻、粪便脂肪及生活质量。
我们制定了一项检索策略，以检索所有已发表和未发表的文献，检索范围包括CENTRAL（《 Cochr ane图书馆2009年第1期》）、MEDLINE（1965年至2009年2月）和EMBASE（1974年至2009年2月）。我们手工检索了参考文献列表以及会议论文集发表的摘要，以识别更多相关试验。最后一次检索日期为2009年4月。
有或无盲法的随机对照试验。如果有足够的信息，我们纳入摘要或未发表的数据。
两位作者独立提取并汇总与研究结果相关的数据。我们使用标准化均数差（SMD）及95%置信区间（CI）合并连续数据，并计算二分数据的比值比（OR）（95%CI）。
10项试验，涉及361名参与者，符合纳入标准。所有试验均为随机试验；2项采用平行设计，其余采用交叉设计。尽管一些个体研究报告胰酶在改善疼痛、脂肪泻发生率和镇痛药使用方面优于安慰剂，但这些结果无法汇总用于这些结局。使用胰酶时，我们观察到体重减轻（千克）有非显著益处（SMD 0.06；95%CI -0.23至0.34）；粪便脂肪（克/天）显著降低（SMD -1.03；95%CI -1.60至-0.46），且受试者疾病症状临床总体印象量表无显著差异（SMD -0.63；95%CI -1.41至0.14）。我们发现，任何特定的酶制剂给药方案或酶类型在降低粪便脂肪方面均无显著益处。另一项小型研究未显示酶制剂与进餐时间相关的给药对粪便脂肪有任何显著益处。
胰酶在慢性胰腺炎患者的腹痛、体重减轻、脂肪泻、镇痛药使用及生活质量方面的作用仍不明确。高质量、有足够效力的研究非常必要。
