非甾体抗炎药的胃肠道损伤__培训课件.ppt

Conclusions: This study provides both biochemical and direct evidence of macroscopic injury to the small intestine in 68%–75% of volunteers resulting from 2 weeks’ ingestion of slow-release diclofenac ARAMIS —关节炎、风湿病及衰老医学信息系统。 3项随机试验的安全性综合分析结果表明西乐葆的上消化道耐受性明显优于双氯芬酸。 2项OA患者试验的综合结果表明，西乐葆治疗第6周的上消化道症状累积性证据（如腹痛、恶心和消化不良）较双氯芬酸少37%（ P=0.002 ）。西乐葆的上消化道症状累积性证据与安慰剂无显著区别。RA患者的分析报告结果也相似：RA患者服用西乐葆的总体上消化道耐受性明显优于双氯芬酸（ P=0.013 ）。 Reference: 1. McKenna F, Arguelles L, Burke T, Lefkowith J, Geis GS. Upper gastrointestinal tolerability of celecoxib compared with diclofenac in the treatment of osteoarthritis and rheumatoid arthritis. Clin Exp Rheumatol. 2002;20:35-43. 其他的安全性指标也表明塞来昔布的耐受性较好。双氯芬酸治疗患者因胃肠道不良事件而退出的人数明显多于塞来昔布。OA试验中，4.3%的双氯芬酸治疗患者退出，而塞来昔布治疗组为1.7%（P.05 ）。塞来昔布组和安慰剂组（2.0%）停药情况相似。RA试验中，塞来昔布组退出者占3.1%，而双氯芬酸组为10.0%（ P.001 ）。 Reference: 1. McKenna F, Arguelles L, Burke T, Lefkowith J, Geis GS. Upper gastrointestinal tolerability of celecoxib compared with diclofenac in the treatment of osteoarthritis and rheumatoid arthritis. Clin Exp Rheumatol. 2002;20:35-43. 在一项随机双盲、对象为128名内镜下证实上消化道粘膜正常的健康志愿者的研究中，比较了西乐葆 、萘普生和安慰剂治疗6.5天对上消化道粘膜的影响。患者被随机分配到西乐葆 100 mg BID组（n=32）、西乐葆 200 mg BID组（n=32）、萘普生500 mg BID组（n=32）或安慰剂组（n=32）。第7天再复查一次上消化道内镜检查。萘普生组患者治疗6.5天发生内镜确诊溃疡的人数明显多于安慰剂组。6名患者（19%）至少有一处溃疡（直径0.4-1.5cm）。而西乐葆 100mg到200mg BID组及安慰剂组均未有人确诊为溃疡。 Reference: 1. Simon LS, Lanza FL, Lipsky PE, et al. Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor: efficacy and safety in two placebo-controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects. Arthritis Rheum. 1998;41:1591-1602. CELEBREX was associated with a 7-fold decrease in the percentage of patients with endoscopic upper GI ulcers compared with ibuprofen (2.6% vs 17.9%, respectively; P=.056). The difference in incidences of erosions was similar. Naproxen resulted in a significantly increased incidence of ulcers compared with placebo (25% vs 2.5%; P.01). T