Watson D J, Harper S E, Zhao P L, Bolognese J A, Simon T J
Merck Research Laboratories, West Point, PA, USA.
MedGenMed. 2001 Nov 16;3(4):6.
Patients treated with nonselective cyclooxygenase inhibitors (nonsteroidal anti-inflammatory drugs [NSAIDs]) often experience dyspepsia and upper gastrointestinal (GI) adverse effects, and frequently require GI comedications and diagnostic procedures.
This study combined existing data to test the hypothesis that GI comedications and GI diagnostic procedures occur less frequently in osteoarthritis (OA) patients treated with rofecoxib compared with nonselective NSAIDs.
Combined analysis of 8 randomized controlled clinical trials.
Rheumatology and general practice clinics.
Men and women aged 40 years and older with OA.
Random assignment to placebo (n = 514), rofecoxib (n = 3357; 12.5, 25, or 50 mg daily combined; average 24.7 mg), or NSAIDs (n = 1564; ibuprofen 800 mg thrice daily, diclofenac 50 mg thrice daily, or nabumetone 1500 mg daily, combined).
The cumulative incidence of patients using GI comedications (antacids, antispasmodics, antiflatulents, antiregurgitants, H2 antagonists, proton pump inhibitors, sucralfate, prostaglandins, other antiulcer therapy) and needing GI procedures (upper GI barium studies, upper or lower GI endoscopies) over 12 months.
Compared with those treated with NSAIDs, patients treated with rofecoxib had a significantly lower incidence of GI comedication use (17.5% vs 27.0%, P <.001) and GI procedures (3.3% vs 5.3%, P =.02) over 12 months. Similar results were seen in analyses of protocols with placebo; in these studies, rates of GI comedications and procedures were highest with NSAIDs, while those with rofecoxib and placebo were similar to each other.
OA patients treated with rofecoxib for up to 12 months required significantly less GI comedication and significantly fewer GI procedures than those treated with NSAIDs.
使用非选择性环氧化酶抑制剂（非甾体抗炎药[NSAIDs]）治疗的患者常出现消化不良和上消化道（GI）不良反应，且经常需要使用胃肠道辅助药物和进行诊断程序。
本研究合并现有数据，以检验与非选择性NSAIDs相比，使用罗非昔布治疗的骨关节炎（OA）患者胃肠道辅助药物和胃肠道诊断程序的使用频率更低这一假设。
对8项随机对照临床试验进行合并分析。
风湿病科和全科诊所。
年龄40岁及以上的OA男性和女性。
随机分配至安慰剂组（n = 514）、罗非昔布组（n = 3357；每日联合使用12.5、25或50 mg；平均24.7 mg）或NSAIDs组（n = 1564；布洛芬800 mg每日三次、双氯芬酸50 mg每日三次或萘丁美酮1500 mg每日一次，联合使用）。
12个月内使用胃肠道辅助药物（抗酸剂、解痉药、消胀药、抗反流药、H2拮抗剂、质子泵抑制剂、硫糖铝、前列腺素、其他抗溃疡治疗）和需要进行胃肠道程序（上消化道钡餐检查、上消化道或下消化道内镜检查）的患者累积发生率。
与使用NSAIDs治疗的患者相比，使用罗非昔布治疗的患者在12个月内使用胃肠道辅助药物的发生率显著更低（17.5%对27.0%，P <.001），进行胃肠道程序的发生率也显著更低（3.3%对5.3%，P =.02）。在安慰剂对照方案分析中也观察到类似结果；在这些研究中，NSAIDs组胃肠道辅助药物和程序的发生率最高，而罗非昔布组和安慰剂组彼此相似。
与使用NSAIDs治疗的患者相比，使用罗非昔布治疗长达12个月的OA患者所需的胃肠道辅助药物显著更少，进行的胃肠道程序也显著更少。
