益胃化裁方治疗胃阴不足型慢性萎缩性胃炎随机对照双盲研究

Randomized Controlled Double-blind Study of Yiwei Huacai Fang( 益胃化裁方) for Chronic Atrophic Gastritis with Stomach-Yin Deficiency Syndrome

目的评价益胃化裁方治疗胃阴不足型慢性萎缩性胃炎的临床疗效。方法胃阴不足型慢性萎缩性胃炎患者44例,采用随机区组、双盲双模拟、平行对照的多中心临床研究设计方法,分为试验组20例与对照组24例。试验组予益胃化裁方免煎颗粒,每日1剂;同时服用维酶素模拟片剂,每次0.8 g,每日3次。对照组予维酶素口服,每次0.8 g,每日3次;同时服用益胃化裁方免煎颗粒粒模拟剂,每日1剂。两组均治疗12周。于治疗前及治疗1、2、4、8、12周及停药4周观察两组患者中医证候积分变化;治疗前后观察两组患者胃镜和病理黏膜萎缩分级的变化,并评价临床疗效。结果试验组临床疗效总有效率为85.0%,显著优于对照组的66.7%(P<0.05)。治疗8、12周及停药4周时试验组中医证候积分中主症积分与总积分均显著低于对照组(P<0.01)。两组治疗前后胃镜黏膜萎缩分级与病理学黏膜萎缩分级均有改善趋势,但差异均无统计学意义(P>0.05)。结论益胃化裁方治疗胃阴不足型慢性萎缩性胃炎疗效确切,可显著改善患者临床症状。

Objective To evaluate clinical efficacy of Yiwei Huacai Fang for chronic atrophic gastritis with stomach-Yin deficiency. Methods Multi-center clinical study design methods including randomized block, double- blind and double-dummy and parallel control were adopt. Forty-four cases of chronic atrophic gastritis with stomach- Yin deficiency syndrome were randomly divided into an experimental group （20 cases） and a control group （24 cases）. The experimental group was given boil-free granule with Yiwei Huacai Fang, one dose daily, and simulative vatacoenayme tablets, 1 g each time, three times a day. The control group was given vatacoenayme 0. 8 g each time, three times a day, and boil-free granule with simulative Yiwei Huacai Fang, one dose daily. Both groups were treated for 12 weeks. Scores of Chinese medicine syndrome in two groups were observed before treatment, 1, 2, 4, 8, and 12 weeks after starting treatment, and 4 weeks after stopping medication. Classification of gastroscope and pathological mucosa atrophy were observed in two groups before and after treatment, and clinical efficacy was evaluated. Results The total effective rate in the experimental group was 85.0%, which was significantly better than 66.7% in the control group （ P 〈 0. 05 ）. Eight and 12 weeks after starting primary symptom score and the total score of Chinese medicine group than those in the control group （P 〈 0.01 ）. mucosa atrophy showed improving trend in both two treatment and 4 weeks after stopping medication, the syndrome score were much lower in the experimental After treatment, classification of gastroscope and pathological groups, but there was no significant differences in changes of classification between before and after treatment in both groups （P 〉 0. 05）. Conclusion There is definite curative effect of Yiwei Huacai Fang in the treatment of chronic atrophic gastritis with stomach-Yin deficiency syndrome, and it may significantly improve patients＇ clinical symptoms.