蒲元胃康胶囊治疗消化性溃疡(气滞证型)的随机双盲多中心研究  

Puyuanweikang capsule for treatment of peptic ulcer with syndrome of stagnation of QI:a multicenter,randomized and double-blind clinical study

作　　者：宫尚君[1] 金毅[2] 宫丽莉[1] 刘健[3] 苗志敏[1] 马建[4] 邱根全[5] 刘学兰[6] 王启国[7] 杨浚宪[8] 宫安静[1] 刘吉华[1] 刘希双[1] 

机构地区：[1]青岛大学医学院附属医院,山东青岛266003 [2]青岛大学医学院生理教研室,山东青岛266071 [3]中国人民解放军第401医院,山东青岛266071 [4]黑龙江中医药大学附属第一医院,黑龙江哈尔滨150040 [5]西安交通大学医学院第一附属医院,陕西西安710061 [6]云南中医学院附属医院,云南昆明650021 [7]福建省中医药研究院,福建福州350003 [8]青岛海慈医疗集团,山东青岛266033

出　　处：《中国新药与临床杂志》2007年第5期363-367,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:评价蒲元胃康胶囊(Puyuanweikang capsule)治疗消化性溃疡(气滞证型)的有效性和安全性。方法:采用随机、双盲、阳性对照、多中心研究方法,进行蒲元胃康胶囊的Ⅲ期临床试验。受试者共448例,分蒲元胃康胶囊试验组336例(胃溃疡和十二指肠溃疡各168例),溃疡灵胶囊阳性对照组112例(胃溃疡和十二指肠溃疡各56例)。分别口服蒲元胃康胶囊和溃疡灵胶囊,疗程为6 wk。结果:胃溃疡试验组治疗后胃镜检查总有效率为93．3%,对照组为81%,2组疗效比较有非常显著差异(P＜0．01);十二指肠溃疡胃镜检查,试验组总有效率为95．1%,对照组76%,2组比较有非常显著差异(P＜0．01)。试验组的胃溃疡和十二指肠溃疡治疗后中医症状疗效高于对照组(P＜0．05,P＜0．01);幽门螺杆菌(Hp)根除率,胃溃疡试验组高于对照组(P＜0．01)。2组未出现明显不良反应。结论:蒲元胃康胶囊可用于治疗消化性溃疡(气滞证型),临床应用安全有效。AIM： To evaluate the clinical efficacy and safety of Puyuanweikang capsule for the treatment of peptic ulcer with syndrome of stagnation of QI. METHODS： A randonmized double-blind mutlicenter of stage Ⅲ clinical trial with positive control and 2 paralled test was carried out in 448 patients. The patients were divided into two groups： the Puyuanweikang capsule group （experimental group, n = 336） and Kuiyangling capsule group （control group, n = 112）, with a course of 6 wk for observing clinical efficacy and safety of the medicine. RESULTS： The total gastric ulcer efficacy rates were 93.3 % in experimental group and 81% in control group （P 〈 0.01 ） ; and those for duodenal ulcer efficacy rates were 95.1% in experimental group and 76 % in control group （P 〈 0.01 ） under gastroscopy. The effect on traditional Chinese medical syndrome for gastric ulcer and duodenal ulcer in experimental group were higher than those in control group （P 〈 0.05, P 〈 0.01 ） . The eradication rate of Hp in the experimental group of gastric ulcer was higher than that in the control group （P 〈 0.01 ）, but no markedly difference between the two groups in duodenal ulcer. The results of safety evaluation showed no abnormities in routine blood and urine examinations, including liver and kidney functions, and no serious adverse reactions occured. CONCLUTION ： Puyuanweikang capsule is effective and safe for the treatment of peptic ulcer with syndrome of stagnation of QI.

关 键 词：消化性溃疡 临床试验 Ⅲ期 多中心研究 随机对照试验 双盲法 蒲元胃康胶囊 气滞 证型 

分 类 号：R286.56[医药卫生—中药学] R573.1[医药卫生—中医学]