PREVENTION OF GASTRODUODENAL DAMAGE INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS - CONTROLLED TRIAL OF RANITIDINE
PREVENTION OF GASTRODUODENAL DAMAGE INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS - CONTROLLED TRIAL OF RANITIDINE
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DOI：
10.1136/bmj.297.6655.1017
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发表时间：
1988-10-22
影响因子：
105.7
通讯作者：
WOOD, JR
中科院分区：
文献类型：
--
作者：
EHSANULLAH, RSB;PAGE, MC;WOOD, JR
目的：评价雷尼替丁150 mg每日2次对需要萘普生、吡罗西康、双氯芬酸和吲哚美辛等非甾体类抗炎药的患者的预防作用。此外，还研究了危险因素，以帮助针对特定患者群体进行此类治疗。设计：双盲、安慰剂对照、随机、平行组，在0、4和8周进行内窥镜评估。环境——在五个欧洲国家的二级转诊中心进行多中心门诊研究。患者：297例18岁以上的类风湿性关节炎或骨关节炎患者，基线内镜检查无胃和十二指肠病变（一周后未服用非甾体类抗炎药）。排除在过去30天内服用其他抗风湿药、合并溃疡药物或消化性溃疡治疗的患者。年龄、性别、关节炎疾病和使用的非甾体抗炎药类型在两个治疗组中具有可比性。总共有263名患者完成了试验。干预措施-雷尼替丁150毫克，每日两次或安慰剂（加上选定的非甾体抗炎药）在基线内窥镜检查后五天内开处方，连续两周。研究期间允许使用扑热息痛，但不允许使用抗酸剂。如果在四周内窥镜检查中发现最严重的损伤（包括溃疡），或在研究者的判断中发现较轻的损伤，则患者退出。终点：胃和十二指肠溃疡或病变发生频率，或两者兼有。测量结果及主要结果：8周消化性溃疡的累计发生率为10.3% (27/263)；雷尼替丁组135例患者中有2例（1.5%）发生十二指肠溃疡，而安慰剂组126例患者中有10例（8%）发生十二指肠溃疡。8周时，两组胃溃疡发生率相同（6%）。虽然雷尼替丁组在4周内发生的胃病变明显减少，但这种差异在8周时并不明显。两组在任何时间点的十二指肠非溃疡性病变发生率均无显著差异。75例服用吡罗昔康的患者中有12例（16%）发生消化性溃疡，其中三分之二发生十二指肠溃疡。有消化性溃疡病史的患者特别容易发生复发性溃疡，雷尼替丁对复发性溃疡有一定保护作用。结论：雷尼替丁150 mg每日2次可显著降低十二指肠溃疡的发生率，但与四种常用非甾体类抗炎药中的一种合用可显著降低胃溃疡的发生率。
Objective-To evaluate the prophylactic effect of ranitidine 150 mg twice daily in patients requiring one of the following non-steroidal anti-inflammatory drugs: naproxen, piroxicam, diclofenac, and indomethacin. In addition, risk factors were studied in order to help in targeting of such treatment to specific groups of patients. Design-Double blind, placebo controlled, randomised, parallel group with endoscopic assessments at 0, 4, and 8 weeks. Setting-Multicentre outpatient study at secondary referral centres in five European countries. Patients-297 patients with rheumatoid arthritis or osteoarthritis over the age of 18 without lesions in stomach and duodenum at baseline endoscopy (after one week without taking non-steroidal antiinflammatory drugs). Those taking other antirheumatic agents, concomitant ulcerogenic drugs, or treatment for peptic ulcers within the previous 30 days were excluded. Age, sex, arthritic disease, and type of non-steroidal anti-inflammatory drug used were comparable in the two treatment groups. In all, 263 patients completed the trial. Interventions-Ranitidine 150 mg twice daily or placebo (plus the selected non-steroidal antiinflammatory drug) was prescribed within five days after the baseline endoscopy for two consecutive periods of four weeks. Paracetamol was permitted during the study, but not antacids. Patients were withdrawn if the most severe grade of damage (including ulceration) was found at the four week endoscopy or when indicated, or with lesser damage at the investigator''s discretion. End point-Frequency of gastric and duodenal ulceration or lesions, or both. Measurements and main results-The cumulative incidence of peptic ulceration by eight weeks was 10.3% (27/263); 2 out of 135 (1.5%) developed duodenal ulceration in the ranitidine group, compared with 10 out of 126 (8%) taking placebo. The frequency of gastric ulceration was the same (6%) for the two groups at eight weeks. Though significantly fewer gastric lesions developed in the ranitidine group by four weeks, this difference was not evident by eight weeks. The frequency of non-ulcerative lesions in the duodenum did not differ greatly for the two groups at either time point. Twelve out of 75 (16%) patients taking piroxicam developed peptic ulceration, of whom two thirds had duodenal ulceration. Patients with a history of peptic ulcer were particularly susceptible to recurrent ulceration, against which ranitidine offered some protection. Conclusions-Ranitidine 150 mg twice daily significantly reduced the incidence of duodenal ulceration but not gastric ulceration when prescribed concomitantly with one of four commonly used non-steroidal anti-inflammatory drugs.