辛开苦降法治疗慢性萎缩性胃炎的随机双盲对照临床试验

Randomized double-blind controlled clinical trial of Xinkai Kujiang method in the treatment of chronic atrophic gastritis

[目的]基于黏膜定标活检观察辛开苦降法治疗慢性萎缩性胃炎的临床疗效。[方法]采用随机、双盲、阳性药物对照临床试验研究设计,纳入130例就诊于我院门诊的慢性萎缩性胃炎患者,随机分为试验组及对照组。试验组予辛开苦降方免煎颗粒剂及胃复春模拟药治疗,对照组予胃复春片及辛开苦降方免煎颗粒剂模拟药治疗,疗程12周,治疗结束后随访1个月。比较2组患者临床症状、病理积分、中医证候有效率及临床有效率。[结果](1)试验组中医证候有效率为88.33%,临床有效率为38.33%;对照组中医证候有效率为70.00%,临床有效率21.67%,组间比较差异有统计学意义(P<0.05)。(2)治疗后2组患者胃脘胀满、胃脘疼痛积分较治疗前均有明显下降,2组之间差异无统计学意义;试验组随访时胃脘胀满、胃脘疼痛积分较治疗结束时有明显降低,对照组积分差异无统计学意义,随访时2组比较差异有统计学意义(P<0.05)。(3)治疗后2组患者慢性炎、活动性炎、异性增生病理积分较治疗前无明显下降,2组之间比较差异无统计学意义;试验组治疗后萎缩、肠化、病理总分较治疗前明显下降,且明显低于对照组(P<0.05);对照组治疗前后萎缩、肠化、病理总分差异无统计学意义(P>0.05)。[结论]辛开苦降法在改善萎缩性胃炎患者的临床症状方面与胃复春片疗效无异,但其对萎缩、肠化的改善作用明显优于胃复春片,疗效持续时间也优于胃复春片。

[Objective] To observe the clinical effect of Xinkai Kujiang method in the treatment of chronic atrophic gastritis.[Methods]A randomized, double-blind, positive-controlled clinical trial was performed. One hundred and thirty patients of chronic atrophic gastritis who were treated in our outpatient clinic were randomized into the control group and the experimental group. The experimental group was given Xinkai Kujiang Fang granules and the simulated drug of Weifuchun. The control group was given the treatment of Weifuchun Tablets and the simulated drug of Xinkai Kujiang Fang granules. The course of treatment was 12 weeks, and the patients were followed up for 1 month after the end of treatment. After the treatment, we compared the clinical symptoms, pathological scores, TCM syndrome effectiveness and clinical effectiveness in two groups.[Results](1) The effective rate of the TCM syndromes in the experimental groupwas 88.33%,and the clinical effective rate was 38.33%.In the control group,the effective rate of the TCM syndromes was 70%,and the clinical effective rate was 21.67%.The difference of the TCM syndromes and the clinical effective rate were statistically significant between the two groups(P<0.05).(2)After treatment,the scores of stomach cramps and aches in the two groups were significantly lower than those before treatment.There was no significant difference between the two groups. At the follow-up, the scores of stomach cramps and aches were significantly lower in the experimental group compared with those at the end of treatment and also lower than the control group(P<0.05).There was no significant difference in the scores of stomach cramps and aches in the control group at the follow-up and the end of treatment.(3)After treatment, the pathological scores of chronic inflammation, active inflammation and atypical hyperplasia in the two groups were not significantly lower than those before treatment(P>0.05).In the experimental group, the atrophy, intestinal metaplasia and pathological total score were significantly lower than those before treatment, and significantly lower than the control group(P<0.05).There was no significant difference in atrophy, intestinal metaplasia and pathological total score before and after treatment in the control group(P>0.05). [Conclusion]Xinkai Kujiang method is not superior to Wei Fuchun in improving the clinical symptoms of patients with atrophic gastritis, but it has significantly better efficacy in treating atrophy and intestinal amelioration, and the duration of effect is better than Wei Fuchun.