仁术健胃颗粒治疗气虚血瘀热郁证慢性萎缩性胃炎

Treatment of chronic atrophic gastritis with deficiency of vital energy blood stasis pyretic stagnation by Renzhujianwei granula:a randomized single blinded controlled study

[目的]评价仁术健胃颗粒治疗慢性萎缩性胃炎(CGA)气虚血瘀热郁证的有效性和安全性。[方法]采用随机、单盲、阳性药对照方法。72例CAG气虚血瘀热郁证患者分为试验组和对照组,各36例,分别给予仁术健胃颗粒1袋(12 g)/次,3次/d及胃复春片4片/次,3次/d治疗,疗程12周。以胃黏膜病理及胃镜下炎症变化为主要疗效指标,中医证候记分、幽门螺杆菌(Hp)为次要疗效指标进行评价。以血、尿、粪便常规加潜血、肝肾功能和心电图检查作为安全性评价的依据。[结果]病理疗效:试验组总有效率为72.2%,对照组50.0%;胃镜疗效:试验组总有效率为86.1%,对照组67.7%;中医证候疗效:试验组总有效率为83.3%,对照组63.9%;综合疗效:试验组总有效率为66.7%,对照组47.2%;2组比较差异均有统计学意义(均P<0.05)。2组间Hp阴转率的比较P>0.05。[结论]仁术健胃颗粒能有效治疗CAG气虚血瘀热郁证,并具有良好的安全性。

[Objective]To evaluate the efficacy and safety of Renzhujianwei Granula（RG）on chronic atrophic gastritis（CAG）patients with the deficiency of vital energy,blood stasis and pyretic stagnation.[Methods]Randomized,single blind,positive medicine parallel controlled method was adopted.72 cases of patients according to inclusive criteria were randomly allocated into test group that include 36 cases treated with RG and control group that of 36 cases treated with Weifuchun tablet.After 12 weeks,we assessed the effectiveness of RG with the pathological change of gastromucosa,the endoscopic changes of inflammation,the score of traditional Chinese medicine symptom-complex and helicobacter pylori,assessed the security of RG with the laboratory data and the records of adverse events.[Results]After 12 weeks,the curative effect of pathology,the curative effect of endoscopy,the score of traditional Chinese medicine symptom-complex and the therapeutic effect of synthetic was found different with statistical significance respectively between two groups（P〈0.05）.There was no stastical significance between two groups on the rate of the Hp positive result.During the test,there was no statistical significance between two groups on the side effect and adverse events.[Conclusion]RG was an effective medicine for CAG of the type of deficiency of vital energy,blood stasis and pyretic stagnation and had favorable security.