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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 study the efficacy and safety of icarubital in the treatment of gastritis and gastric ulcer. Methods: A multicenter, randomized, double-blind, controlled trial was performed. 225 patients were enrolled, including 90 cases of gastric ulcer and 135 cases of erosive gastritis. Gastric ulcer study: In the test group (n = 46), 1 g of idarubicin and 150 mg of ranitidine were given orally, while ranitidine 150 mg of idardine was given to the control group (n = 44) for 4 weeks. Erosive gastritis: The experimental group (n = 69) received 1 g of idarubicin orally, while the control group (n = 66) received teprenone 50 mg of tid for 4 weeks. Endoscopic observation of gastric ulcer and gastritis healing rate, detection of gastric mucosa before and after treatment of prostaglandin (PG) content, and to observe the two groups of adverse reactions. Results: The effective rate of gastric ulcer (S1 + S2) was 65.22% (30/46) in the experimental group and 63.64% (28/44) in the control group. There was no significant difference between the two groups (P> 0.05) S2) in the experimental group was significantly higher than that in the control group (39.13% vs15.91%, P <0.05). The pain relief rate in the experimental group at 1 week after treatment was significantly lower than that in the control group (P <0.05). The healing rate of erosive gastritis was 68.12% (47/69) in the experimental group and 65.15% (43/66) in the control group, there was no significant difference between the two groups (P> 0.05) PG level after treatment significantly increased [before and medication difference (8397 ± 14978 pg · mL-1, P <0.01], no significant change in the control group. Adverse reactions were mild in both groups. Conclusion: Econetine sodium is safe and effective in the treatment of gastric ulcer.