莪连颗粒治疗脾虚瘀热型慢性萎缩性胃炎伴肠化生临床随机对照研究

“Elian Granules” for the treatment of chronic atrophic gastritis of spleen deficiency and heat stagnation pattern accompanied with intestinal metaplasia: a randomized controlled clinical trial

目的观察莪连颗粒治疗脾虚瘀热型慢性萎缩性胃炎伴肠化生的临床疗效。方法将90例脾虚瘀热型慢性萎缩性胃炎伴肠化生患者随机分为治疗A组(A组)、治疗B组(B组)、对照C组(C组),每组30例。A组予高剂量莪连颗粒,B组予普通剂量莪连颗粒,C组予胃复春片。三组疗程均为12周,观察萎缩性胃炎及肠化生疗效,比较中医证候积分,并评价用药安全性。结果 1最终完成试验者80例,A组28例,B组26例,C组26例。2全分析集(FAS)中,各组临床疗效分别为96.67%、93.33%和66.67%;组间临床疗效比较,差异有统计学意义(P<0.05),A组、B组分别与C组比较,差异均有统计学意义(P<0.05)。符合方案分析集(PPS)中,各组临床疗效分别为96.43%、96.15%和66.67%;组间临床疗效比较,差异有统计学意义(P<0.05),A组、B组分别与C组比较,差异均有统计学意义(P<0.05)。3治疗前后组内比较,各组萎缩及肠化生级度变化情况差异均有统计学意义(P<0.05);A组、B组分别与C组组间治疗后比较,萎缩及肠化生级度变化情况差异均有统计学意义(P<0.05)。4治疗前后组内比较,各组中医证候积分差异均有统计学意义(P<0.05);A组、B组分别与C组组间治疗后比较,中医证候积分差异有统计学意义(P<0.05)。5各组间不良反应发生率比较,差异无统计学意义(P>0.05)。结论莪连颗粒治疗脾虚瘀热型慢性萎缩性胃炎伴肠化生,可明显改善患者临床症状,逆转胃黏膜的萎缩及肠化生,且安全性较好。

Objective To observe the clinical efficacy of＂Elian Granules＂in treating chronic atrophic gastritis（ CAG） of spleen deficiency and heat stagnation pattern accompanied with intestinal metaplasia. Methods Ninety cases with CAG of spleen deficiency and heat stagnation pattern accompanied with intestinal metaplasia were randomized into three groups： treatment A group（ group A）,treatment B group（ group B） and control group（ group C）,with 30 cases in each group. Group C was treated with＂Wei Fuchun Tablets＂,group B was treated with＂Elian Granules＂at the common dosage and group A was treated with＂Elian Granules＂at the high dosage,with the course of 12 weeks. The safety was evaluated. Results 1 Eighty cases finished the trail,with 28 cases in group A,26 cases in group B and 26 cases in group C. 2 For full analysis set（ FAS）,the clinical efficacy was 96. 67%,93. 33% and 66. 67% respectively,with significant difference among these groups（ P 〈 0. 05）,and there were also significant difference between group A and C as well as between group B and C（ P 〈 0. 05）. 3 In each group,there was significant differences in grade of atrophy and intestinal metaplasia between before and after treatment（ P 〈 0. 05）; after treatment,significant difference was found in grade of atrophy and intestinal metaplasia between group A and C as well as group B and C（ P 〈 0. 05）. 4 In each group,there was significant difference in TCM symptoms after treatment（ P 〈 0. 05）. 5 No significant difference was found in occurrence rate of adverse reaction among the groups（ P 〉 0. 05）. Conclusion ＂Elian Granules＂can effectively improve the clinical symptoms and safely reverse the gastric mucosa pathology in patients with CAG accompanied with intestinal metaplasia.