替普瑞酮对预防非甾体抗炎药相关性溃疡复发的临床研究

中国临床药理学与治疗学 ›› 2012, Vol. 17 ›› Issue (7): 806-811.

替普瑞酮对预防非甾体抗炎药相关性溃疡复发的临床研究

郭淦华¹, 王芳芳¹, 宋丰前², 沈建冲¹, 陆备军¹, 周春飞¹, 叶淑云¹

¹浙江省慈溪市第三人民医院消化内科,慈溪 315324,浙江;
²湖南省娄底市中心医院消化内科,娄底 417000,湖南

收稿日期:2012-01-13 修回日期:2012-04-03 发布日期:2012-07-17
作者简介:郭淦华,男,硕士,主治医师,研究方向:胃肠病学。E-mail: guoganhua1@163.com
基金资助:
慈溪市2010年科技计划项目(CN2010012)

Clinical research of teprenone to prevent recurrence of NSAIDs-related ulcer

GUO Gan-hua¹,WANG Fang-fang¹,SONG feng-qian²,SHEN Jian-chong¹,LU Bei-jun¹,ZHOU Chun-fei¹,YE Shu-yun¹

¹Department of Digestion, Third People's Hospital of Cixi,Cixi 315324,Zhejiang, China;
²Department of Digestion,Loudi Central Hospital of Hunan, Loudi 417000, Hunan, China

Received:2012-01-13 Revised:2012-04-03 Published:2012-07-17

摘要/Abstract

摘要： 目的: 比较长期单独使用替普瑞酮、米索前列醇与奥美拉唑预防非甾体抗炎药(NSAIDs)相关性溃疡复发的疗效和安全性。 方法: 选取107例长期应用NSAIDs所致消化性溃疡的患者,经6～8周的治疗溃疡愈合后,随机分为:替普瑞酮组(38例),长期服用替普瑞酮50 mg/次,3次/d;奥美拉唑组(35例),长期服用奥美拉唑 20 mg/次,2次/d;米索前列醇组(34例),长期服用米索前列醇 200 μg/次,2次/d;疗程共52周,分别观察和比较3组患者第0～26、27～52周期间溃疡的复发率和不良反应的发生率。 结果: 第0～26周期间替普瑞酮组、米索前列醇组与奥美拉唑组患者溃疡复发人数分别为5(13.2%)、5(14.3%)、4(11.8%)例,经比较各组间差异无统计学意义(P＞0.05);第27～52周期间3组患者溃疡复发人数分别为6(18.2%)、3(10.0%)、4(13.3%)例,经比较各组间差异无统计学意义(P＞0.05)。第0～26周期间3组患者发生不良反应的人数分别为5(13.2%)、4(11.4%)、12(35.3%)例,经比较替普瑞酮与奥美拉唑组组间差异无统计学意义(P＞0.05),米索前列醇组显著高于其它两组 (P＜0.05);第27～52周期间3组发生不良反应的人数分别为3(9.1%)、9(30.0%)、10(33.3%)例,经比较奥美拉唑与米索前列醇组显著高于替普瑞酮组(P＜0.05)。 结论: 应用替普瑞酮可显著降低NSAIDs相关性溃疡复发,与长期使用米索前列醇和质子泵抑制剂(PPI)类药物的疗效相同,但相关药物并发症的发生显著减少。

关键词: 非甾体抗炎药, 替普瑞酮, 奥美拉唑, 米索前列醇, 消化性溃疡, 复发

Abstract: AIM: To compare the therapeutic efficacy and safety of use of exclusive long-term Teprenone, Misoprostol and Omeprazole to prevent recurrence of NSAIDs-related ulcer. METHODS: 107 cases of patients with NSAIDs-related ulcer were enrolled and randomly divided into three groups after cured by 6-8 weeks treatment: The therapeutic Teprenone group(38 cases)was followed by the treatment with long-term use Teprenone (50 mg,tid). the Omeprazole group (34 cases) by the exclusive long-term use of Omeprazole (20 mg,bid);and the Misoprostol group (35 cases) by the exclusive long-term use of misoprostol (200 μg,bid). During the treatment course of 52 weeks,incidence rates of ulcer recurrence and adverse reactions of the three groups were measured at the 26^th and 52^th week. RESULTS: During the period of the first 26 weeks,recurrence cases of the three groups were 5(13.2%),5(14.3%) and 4(11.8%),respectively;there was no statistically significant difference among the three groups(P＞0.05);and the cases during the period of the 27^th and 52^th weeks were 6(18.2%), 3(10.0%) and 4(13.3%),respectively,with no statistically difference among the three groups(P＞0.05). Incidence rates of adverse reactions were 5(13.2%),4(11.4%)and 12(35.3%)in the three groups respectively during the period of the first 26 weeks,with no statistically significant between Omeprazole and Teprenone groups(P＞0.05);but the rate in the Misoprotol group was significantly higher than the other two groups(P＜0.05). From the 27^th week to the 52^th week,adverse reaction rates were 3(9.1%),9(30.0%) and 10(33.3%),respectively, with the rate in Teprenone group was significantly lower than the other two groups(P＜0.05). CONCLUSION: Long-term Teprenone is equivalent to PPI or Misoprotol in preventing the recurrence of NSAIDs-related ulcer,and adverse reaction is reduced.

Key words: NSAIDs, Teprenone, Omeprazole, Misoprostol, Peptic ulcer, Recurrence

中图分类号:

郭淦华, 王芳芳, 宋丰前, 沈建冲, 陆备军, 周春飞, 叶淑云. 替普瑞酮对预防非甾体抗炎药相关性溃疡复发的临床研究[J]. 中国临床药理学与治疗学, 2012, 17(7): 806-811.

GUO Gan-hua,WANG Fang-fang,SONG feng-qian,SHEN Jian-chong,LU Bei-jun,ZHOU Chun-fei,YE Shu-yun. Clinical research of teprenone to prevent recurrence of NSAIDs-related ulcer[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(7): 806-811.

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