胃逆康胶囊治疗反流性食管炎临床观察

目的 :客观评价胃逆康胶囊治疗反流性食管炎的临床疗效及安全性。方法 :选取经内镜检查符合反流性食管炎诊断标准的患者 185例 ,分 2个阶段观察 ,第一阶段为 1∶ 1随机双盲对照试验 ,胃逆康组 32例 ,吗丁啉组 33例 ;第二阶段为 3∶ 1的扩大随机对照试验 ,采用双模拟法 ,胃逆康组 90例 ,吗丁啉组 30例。治疗组予胃逆康胶囊 4粒 ,安慰剂片 1片 ;吗丁啉组予吗丁啉片 10 mg,安慰剂胶囊 4粒。均为饭前 30 m in口服 ,每日 3次 ,8周为 1疗程。结果 :胃逆康组近期痊愈 5 6例 ,显效 2 5例 ,有效 34例 ,无效 7例 ,总有效率为 94 .3% ;对照组近期痊愈 11例 ,显效 15例 ,有效 33例 ,无效 4例 ,总有效率为 93.7%。胃逆康组总疗效明显优于吗丁啉组 ( u=3.6 7,P=0 .0 0 0 2 3) ;对烧心、胸痛、反酸、打嗝等症状的消除率依次为 6 5 .4 %、72 .2 %、6 6 .7%和 78.0 % ,明显优于吗丁啉组的症状消除率 ,依次为 4 4 .1%、5 0 .0 %、4 9.1%和 4 7.4 % ( P<0 .0 5 ) ;胃逆康组内镜检查复常率为 5 2 .4 6 % ,优于吗丁啉组 33.33% (χ2 =6 .12 ,P=0 .0 13)。胃逆康组治疗前后血尿便常规、肝肾功能和心电图检查均无异常 ,有 3例出现轻度腹泻 ,2～ 5日自行消失。结论 :胃逆康胶囊治疗反流性食管炎功效明显优于吗丁啉 ,且使用安全

Clinical Study of Weinikang Capsule(胃逆康胶囊)in the Treatment of Reflux Esophagitis

Objective:To investigate the effect and safety of Weinikang Capsule on reflux esophagitis.Methods:185 cases patients with endoscopically proven reflux esophagitis were qualified for the study.The first stage was a randomized controlled and double blinded trial with 32 cases in Weinikang group and 33 in motilium group;The later was a enlarged randomized controlled trial.90 cases in Weinikang group and 30 in motilium group.Administrition:The patients in Weinikang group received 4 Weinikang Capsules tid,and 1 placebo tablet tid;patients in motilium group received 4 placebo capsules tid and 1 motilium tid, for 8 weeks.Clinical symptoms as heartburn,chestpain,acidreflux,belching and endoscopic findings were taken as criteria for comparison.Results:In the Weinikang gruop,56 cases were cured,25 cases were markedly effective,34 cases were effective,7 cases ineffective,the total effective rate was 94.3%,in the motilium group 11 cases were cured,15 cases were karkedly effective 33 cases were effective, 4 cases ineffective,the total effective, rate was 93.7%.The total effect of Weinikang group was better than motilium group(P=0 00023, rank sum test) and the disappearing rates of clinical symptoms in Weinikang group as heartburn,chestpain,acidreflux,belching were 65.4%,72.2%,66.7% and 78.0%.While they were 44 1%,50.0%,49.1% and 47.4% in motilium group,respectively compared with motilium group(P=0 013).Meanwhile the endoscopic healing rate in Weinikang group was 52.46% better than 33.33% in motilium group(P<0 05) and no any side effect was found during the treatment in Weinikang group.Conclusion:It indicated that Weinikang was effective and safe in the treatment of reflux esophagitis