Clinical trial: irsogladine maleate, a mucosal protective drug, accelerates gastric ulcer healing after treatment for eradication of Helicobacter pylori infection - the results of a multicentre, double-blind, randomized clinical trial (IMPACT study)
Clinical trial: irsogladine maleate, a mucosal protective drug, accelerates gastric ulcer healing after treatment for eradication of Helicobacter pylori infection - the results of a multicentre, double-blind, randomized clinical trial (IMPACT study)
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DOI：
10.1111/j.1365-2036.2010.04250.x
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发表时间：
2010-04-15
影响因子：
7.6
通讯作者：
Goto, H.
中科院分区：
文献类型：
--
作者：
Hiraishi, H.;Haruma, K.;Goto, H.
P>背景单纯幽门螺杆菌根除治疗不足以治愈所有胃溃疡。目的通过双盲研究验证马来酸伊索拉定治疗终止和评估根除幽门螺杆菌治疗之间的疗效。方法对322例单发幽门螺杆菌阳性胃溃疡患者进行根除治疗，然后随机分配到治疗组[给予4毫克/天伊索拉定]马来酸盐（n = 150）]或对照组[给予安慰剂（n = 161）]。治疗7周后比较胃溃疡愈合率。结果马来酸伊索拉定组愈合率（83.0%）显着高于安慰剂组（72.2%；χ 2 检验，P = 0.0276）。在根除失败病例的亚组分析中，马来酸伊索拉定组的胃溃疡愈合率（57.9%）显着高于安慰剂组（26.1%；χ 2 检验，P = 0.0366）。 结论 马来酸伊索拉定对根除 H. pylori 后的胃溃疡有效。在成功根除或未成功根除的患者中观察到的高治愈率证明了马来酸伊索拉定治疗的有效性，无论根除结果如何。
P>BackgroundHelicobacter pylori eradication therapy alone is not sufficient to heal all gastric ulcers.AimTo verify the efficacy of treatment with irsogladine maleate between the termination and assessment of treatment for eradicating H. pylori in a double-blind study.MethodsThree hundred and twenty-two patients with a single H. pylori-positive gastric ulcer were given eradication treatment, then assigned randomly to a treatment group [given 4 mg/day irsogladine maleate (n = 150)] or a control group [given a placebo (n = 161)]. The gastric ulcer healing rates were compared after 7 weeks of treatment.ResultsThe healing rate was significantly higher in the irsogladine maleate group (83.0%) than in the placebo group (72.2%; chi 2 test, P = 0.0276). In the subgroup analysis of cases of eradication failure, the gastric ulcer healing rate was significantly higher in the irsogladine maleate group (57.9%) than in the placebo group (26.1%; chi 2 test, P = 0.0366).ConclusionsIrsogladine maleate was effective for treating gastric ulcer after H. pylori eradication. The high healing rates observed in patients with or without successful eradication demonstrate the usefulness of irsogladine maleate treatment regardless of the outcome of eradication.