Grazioli I, Avossa M, Bogliolo A, Broggini M, Carcassi A, Carcassi U, Cecconami L, Ligniere G C, Colombo B, Consoli G
Medical Department, Schiapparelli Searle, Turin, Italy.
Clin Exp Rheumatol. 1993 May-Jun;11(3):289-94.
Gastrointestinal symptoms and lesions are often associated with the clinical use of non-steroidal antiinflammatory drugs (NSAIDs). An open-label, single arm multicenter Italian study evaluated if misoprostol, a prostaglandin E1 analogue with gastroduodenal mucosal protective activity, was effective in the prevention and treatment of NSAID-induced gastroduodenal lesions. Patients affected by rheumatoid arthritis (RA) or osteoarthritis (OA), in treatment with NSAIDs and suffering from gastric symptoms or gastroduodenal lesions related to NSAID use, were admitted to the study. Gastrointestinal and arthritic symptoms were assessed before and after 4 weeks co-administration of an NSAID (the most frequent was diclofenac, used in 35% of the RA and in 22% of the OA patients, followed by piroxicam and tenoxicam respectively) + misoprostol (200 mcg two times daily in 58% of the cases, 200 mcg three times daily in 39%, 200 mcg four times daily in 3%). On admission and after 4 weeks of therapy a gastrointestinal endoscopy was performed to evaluate the condition of the gastroduodenal mucosa. Final results showed that: (i) NSAID-related gastric lesions were more frequent than duodenal lesions; (ii) when patients were given misoprostol and NSAIDs, 96% of them did not develop gastric lesions and 97% did not develop duodenal lesions; (iii) even when NSAID therapy was continued, gastric or duodenal lesions induced by NSAIDs healed or in any case did not worsen in 92% and 91% respectively of the cases; (iv) during the period of coadministration of NSAIDs+misoprostol, NSAID-related UGI symptoms disappeared or improved in 77% of the cases.(ABSTRACT TRUNCATED AT 250 WORDS)
胃肠道症状和病变常与非甾体抗炎药（NSAIDs）的临床使用相关。一项开放标签、单臂多中心意大利研究评估了米索前列醇（一种具有胃十二指肠黏膜保护活性的前列腺素E1类似物）在预防和治疗NSAIDs引起的胃十二指肠病变方面是否有效。患有类风湿性关节炎（RA）或骨关节炎（OA）、正在接受NSAIDs治疗且患有与NSAIDs使用相关的胃部症状或胃十二指肠病变的患者被纳入该研究。在联合使用一种NSAID（最常用的是双氯芬酸，35%的RA患者和22%的OA患者使用，其次分别是吡罗昔康和替诺昔康）+米索前列醇（58%的病例每日两次服用200微克，39%每日三次服用200微克，3%每日四次服用200微克）4周前后，对胃肠道和关节炎症状进行评估。在入院时和治疗4周后进行胃肠道内镜检查以评估胃十二指肠黏膜状况。最终结果显示：（i）NSAIDs相关的胃部病变比十二指肠病变更常见；（ii）当患者服用米索前列醇和NSAIDs时，96%的患者未出现胃部病变，97%未出现十二指肠病变；（iii）即使继续进行NSAIDs治疗，NSAIDs引起的胃部或十二指肠病变分别在92%和91%的病例中愈合或无论如何都未恶化；（iv）在NSAIDs+米索前列醇联合给药期间，77%的病例中与NSAIDs相关的上消化道症状消失或改善。（摘要截断于250字）
