依卡倍特钠治疗胃溃疡及胃炎的疗效和安全性  

A randomized, double blind, multi-centers and comparative control clinical trial of ecabet sodium for gastric ulcer and gastritis

作　　者：王惠吉[1] 于中麟[1] 林三仁[2] 周丽雅[2] 钱家鸣[3] 刘晓红[3] 程留芳[4] 孙国辉[4] 黄乃侠[5] 吕宗舜[5] 

机构地区：[1]首都医科大学附属北京友谊医院,北京100050 [2]北京大学第三医院,北京100083 [3]北京协和医院,北京100730 [4]解放军总医院,北京100853 [5]天津医科大学总医院,天津300052

出　　处：《中国新药杂志》2005年第8期1045-1048,共4页Chinese Journal of New Drugs

摘　　要：目的:研究依卡倍特钠治疗胃炎、胃溃疡的有效性与安全性。方法:采用多中心随机双盲对照方法。入选患者225例,其中胃溃疡90例,糜烂性胃炎135例。胃溃疡研究:试验组(n=46)口服依卡倍特钠1gbid及雷尼替丁150mgbid,对照组(n=44)口服雷尼替丁150mgbid,疗程均为4周。糜烂性胃炎研究:试验组(n=69)口服依卡倍特钠1gbid,对照组(n=66)口服替普瑞酮50mgtid,疗程均为4周。内镜下观察胃溃疡和胃炎的愈合率,检测治疗前后胃黏膜组织的前列腺素(PG)含量,并观察两组的不良反应。结果:试验组胃溃疡有效率(S1+S2)为65.22%(30/46),对照组为63.64%(28/44),组间比较无显著性差异(P>0.05),但痊愈率(S2)试验组显著高于对照组(39.13%vs15.91%,P<0.05);治疗1周试验组疼痛缓解迅速,与对照组比较有显著性差异(P<0.05)。试验组内镜下糜烂性胃炎的糜烂灶愈合率为68.12%(47/69),对照组为65.15%(43/66),组间比较差异无显著性(P>0.05);试验组胃黏膜PG水平治疗后显著增加[与用药前差值为(8397±14978)pg·mL-1,P<0.01],对照组无明显变化。两组不良反应均轻微。结论:依卡倍特钠治疗胃溃疡、胃炎安全有效。Objective：To evaluate the safety and efficacy of ecabet sodium in the treatment of gastric ulcer and gastritis. Methods：Of 225 patients with gastric ulcer or gastritis recruited in a multicenter, randomized, double blind and comparative control clinical trial, 90 patients with gastric ulcer orally received ecabet sodium （ 1 g, bid, n = 46） plus ranitidine （ 150 mg, bid） or ranitidine alone （ 150 mg,bid, n = 44） for 4 weeks; 135 patients with erosive gastritis were orally treated with ecabet sodium （ 1 g, bid, n = 69 ） or teprenone （50 mg bid, n = 66） for 4 weeks. The cure rate of gastric ulcer or gastritis were examined by an enteroscopy. The prostaglandin （PG） level in gastric mucosa was measured pre-and post-treatment. Results： The effect rate of both regimens showed no significant difference in the treatment of gastric ulcer （65.22 % vs. 63.64%）. The cure rate of the gastric ulcer in the bi-therapeutic group was higher than that in the mono- therapeutic group （39.13% vs. 15.91%, P 〈 0.05）. The adjunctive therapy of ecabet with ranitidine relieved the gastric pain more rapid than the ranitidine alone therapy（ P 〈 0.05）. No significant difference in the healing rate of the erosive gastritis was found in both therapeutic groups （68.12% of ecabet vs. 65.15% of teprenone, P 〉 0.05）. The PG level in the gastric mucosa post-treatment significantly escalated in the ecabet group, and no significant difference in the teprenone group, compared with the ones pre-treatment. The patients had good tolerance and experienced mild adverse events in the both therapeutic groups. Conclusion： Ecabet sodium is effective and safe in the treatment of gastric ulcer and gastritis.

关 键 词：依卡倍特钠 胃溃疡 胃炎 雷尼替丁 替普瑞酮 

分 类 号：R969.4[医药卫生—药理学] R975.6[医药卫生—药学]