非甾体抗炎药所致胃肠道黏膜损伤的预防。随机对照临床试验的荟萃分析。

Prevention of nonsteroidal anti-inflammatory drug-induced gastrointestinal mucosal injury. A meta-analysis of randomized controlled clinical trials.

作者信息

Koch M, Dezi A, Ferrario F, Capurso I

机构信息

Department of Digestive Diseases and Nutrition, General Hospital San Filippo Neri, Rome, Italy.

出版信息

Arch Intern Med. 1996 Nov 11;156(20):2321-32.

PMID:8911239

Abstract

BACKGROUND

The policy of prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal mucosal injury is still a matter of discussion. Indeed, no consensus exists as to whether cotherapy with histamine type 2 (H2) blockers or misoprostol is cost-effective.

METHODS

Placebo-controlled randomized clinical trials on the use of H2 blockers or misoprostol, as preventive agents (published between) January 1970 and December 1994), were identified through MEDLINE and reference lists from literature reviews. Crude rates of endoscopic lesions with short-term (< 2 weeks) and long-term (> 4 weeks) NSAID treatment were systematically assessed by 3 independent observers based on the intention-to-treat principle. The method of DerSimonian and Laird was used for pooling data. Heterogeneity was evaluated by using the Q statistic and the plots described by L'Abbe and colleagues.

RESULTS

Twenty-four trials met the criteria for entry into the study. Gastric ulcer was found to be significantly reduced by misoprostol-both in short-term (pooled rate difference [RD], -13%, 95% confidence interval [CI], -26% to -1%) and long-term (RD, -8%; 95% CI, -18% to -1%) NSAID treatment-but not by H2 blockers. The risk for duodenal ulcer was significantly reduced by H2 blockers (RD, -2%; 95% CI, -5% to -0.2%) and by misoprostol (RD, -3%; 95% CI, -6% to -0.1%) in long-term but not in short-term administration.

CONCLUSIONS

The use of misoprostol, but no that of H2 blockers, was beneficial in the prevention of NSAID-induced gastric ulcers. The number of patients to be treated to prevent 1 gastric ulcer with short- and long-term NSAID treatment is 11 and 15, respectively, for an intermediate baseline risk of 10%. Misoprostol and H2 blockers were beneficial in the long-term prevention of duodenal ulcers; misoprostol or H2 blockers in the short-term prevention of duodenal ulcers remains to be confirmed.

摘要

背景

非甾体抗炎药（NSAID）所致胃肠道黏膜损伤的预防策略仍存在争议。事实上，对于联合使用组胺2型（H2）受体阻滞剂或米索前列醇是否具有成本效益，目前尚无共识。

方法

通过医学文献数据库（MEDLINE）及文献综述中的参考文献列表，检索1970年1月至1994年12月期间发表的关于使用H2受体阻滞剂或米索前列醇作为预防药物的安慰剂对照随机临床试验。3名独立观察者根据意向性分析原则，系统评估了短期（<2周）和长期（>4周）NSAID治疗后内镜下病变的粗发病率。采用DerSimonian和Laird方法合并数据。使用Q统计量及L'Abbe及其同事描述的图表评估异质性。

结果

24项试验符合纳入本研究的标准。结果发现，米索前列醇可显著降低NSAID短期（合并率差[RD]，-13%，95%置信区间[CI]，-26%至-1%）和长期（RD，-8%；95%CI，-18%至-1%）治疗引起的胃溃疡发生率，但H2受体阻滞剂无此作用。H2受体阻滞剂（RD，-2%；95%CI，-5%至-0.2%）和米索前列醇（RD，-3%；95%CI，-6%至-0.1%）在长期使用而非短期使用时可显著降低十二指肠溃疡风险。