Gabriel S E, Jaakkimainen L, Bombardier C
Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905.
Ann Intern Med. 1991 Nov 15;115(10):787-96. doi: 10.7326/0003-4819-115-10-787.
To describe the relative risk for serious gastrointestinal complications due to non-aspirin nonsteroidal anti-inflammatory drug (NSAID) exposure among NSAID users as well as in selected subgroups.
Overview and meta-analysis.
A literature search of English-language studies examining the association between NSAIDs and adverse gastrointestinal events for the period 1975 to 1990 identified using MEDLINE and communicating with three internationally recognized experts.
A qualitative summary of study characteristics and a critical appraisal of study quality were done. The results of 16 primary studies were selected and combined statistically. Summary estimates were weighted by sample size and quality score.
The overall odds ratio of the risk for adverse gastrointestinal events related to NSAID use, summarized from 16 studies (9 case-control and 7 cohort) was 2.74 (95% Cl, 2.54 to 2.97). The summary odds ratios were as follows: elderly patients, (aged greater than or equal to 60 years), 5.52 (Cl, 4.63 to 6.60); patients under 65 years of age, 1.65 (Cl, 1.08 to 2.53); women, 2.32 (Cl, 1.91 to 2.82); and men, 2.40 (Cl, 1.85 to 3.11). The summary odds ratio for NSAID users receiving concomitant corticosteroids compared with NSAID users not receiving corticosteroids was 1.83 (Cl, 1.20 to 2.78). The summary odds ratio for the first gastrointestinal event was 2.39 (Cl, 2.16 to 2.65). The relative risk for a subsequent or unspecified gastrointestinal event was 4.76 (Cl, 4.05 to 5.59). The summary odds ratio for less than 1 month of NSAID exposure was 8.00 (Cl, 6.37 to 10.06); for more than 1 month but less than 3 months of exposure, the summary odds ratio was 3.31 (Cl, 2.27 to 4.82); and for more than 3 months of exposure, the summary odds ratio was 1.92 (Cl, 1.19 to 3.13).
Users of NSAIDs are at approximately three times greater relative risk for developing serious adverse gastrointestinal events than are nonusers. Additional risk factors include age greater than 60 years, previous history of gastrointestinal events, and concomitant corticosteroid use. Another possible risk factor is the first 3 months of NSAID therapy. The risk for serious gastrointestinal events appears to be equal among men and women. These data represent summary statistics from 16 studies and cannot be considered generalizable to all NSAID users.
描述非阿司匹林非甾体抗炎药（NSAID）使用者以及特定亚组中因接触NSAID而发生严重胃肠道并发症的相对风险。
综述与荟萃分析。
通过医学文献数据库（MEDLINE）检索1975年至1990年期间研究NSAIDs与不良胃肠道事件之间关联的英文研究，并与三位国际知名专家交流。
对研究特征进行定性总结并对研究质量进行严格评估。选择16项主要研究的结果并进行统计学合并。汇总估计值按样本量和质量得分加权。
16项研究（9项病例对照研究和7项队列研究）汇总得出，与使用NSAID相关的不良胃肠道事件风险的总体比值比为2.74（95%可信区间，2.54至2.97）。汇总比值比如下：老年患者（年龄大于或等于60岁）为5.52（可信区间，4.63至6.60）；65岁以下患者为1.65（可信区间，1.08至2.53）；女性为2.32（可信区间，1.91至2.82）；男性为2.40（可信区间，1.85至3.11）。与未接受皮质类固醇的NSAID使用者相比，接受皮质类固醇的NSAID使用者的汇总比值比为1.83（可信区间，1.20至2.78）。首次胃肠道事件的汇总比值比为2.39（可信区间，2.16至2.65）。后续或未明确的胃肠道事件的相对风险为4.76（可信区间，4.05至5.59）。接触NSAID少于1个月的汇总比值比为8.00（可信区间，6.37至10.06）；接触超过1个月但少于3个月的汇总比值比为3.31（可信区间，2.27至4.82）；接触超过3个月的汇总比值比为1.92（可信区间，1.19至3.13）。
NSAID使用者发生严重不良胃肠道事件的相对风险比未使用者高约三倍。其他风险因素包括年龄大于60岁、既往胃肠道事件史以及同时使用皮质类固醇。另一个可能的风险因素是NSAID治疗的前3个月。严重胃肠道事件的风险在男性和女性中似乎相等。这些数据代表了16项研究的汇总统计结果，不能认为适用于所有NSAID使用者。
