三仁汤加减治疗湿热内蕴型功能性消化不良临床研究

Clinical Study of Modified Sanren Decoction in the Treatment of Internal Retention of Damp-Heat Type of Functional Dyspepsia

目的:观察三仁汤加减治疗湿热内蕴型功能性消化不良(functional dyspepsia,FD)的临床疗效。方法:104例湿热内蕴型FD患者按照随机数字表法分为观察组和对照组,每组52例。对照组患者给予口服奥美拉唑肠溶胶囊联合乌灵胶囊,观察组患者给予三仁汤,两组疗程均为1个月。治疗结束后观察患者的临床疗效,比较两组患者治疗前后中医主要证候积分,同时应用放射免疫法测定治疗前后血浆中胃动素和促胃液素的水平变化,并对比两组患者的复发率及用药安全性。结果:观察组有效率为90.38%(47/52)明显高于对照组的71.15%(37/52)(P<0.05);两组患者治疗后中医主要证候(脘腹痞满、饮食减少、口干口苦、舌红苔黄腻、困倦及恶心呕吐)积分明显低于治疗前,且与对照组比较,观察组中医主要证候积分显著下降(P<0.05);与治疗前比较,两组患者治疗后胃动素和促胃液素水平均明显升高,且观察组患者胃动素和促胃液素水平高于对照组(P<0.05);随访6个月内,观察组复发率为4.26%(2/47)明显低于对照组的18.92%(7/37)(P<0.05);两组患者均未见明显不良反应。结论:三仁汤加减治疗湿热内蕴型FD具有良好的临床疗效,可明显改善患者的主要证候,同时提高胃动素和促胃液素的水平,降低FD的复发率,用药安全性高。

Objective：To explore the clinical study modified Sanren Tang in the treatment of internal retention of damp-heat type of functional dyspepsia（ FD）. Methods：104 cases of patients with internal retention of damp-heat type of FD were randomly divided into the observation group and the control group,52 cases in each group. Patients in the control group were treated with Omeprazole Enteric-coated capsules combined with capsule of Wuling,while patients in the observation group were treated with Sanren Tang.Two groups were treated for a month. The effective rate was observed,and traditional Chinese medicine main symptoms integral of two groups were compared and analyzed before and after treatment. Motilin（ MTL） and gastrin（ GAS） levels in the two groups were detected by radioimmunity method before and after treatment,and the recurrence rate and drug safety were compared. Results：The effective rate of observation group was 90. 38%（ 47/52）,which was significantly higher than the control group[71. 15%（ 37/52）]（ P〈0. 05）. Two groups of patients after treatment of traditional Chinese medicine syndrome（ abdominal fullness,eating less,dry mouth,red tongue,drowsiness,nausea and vomiting） score was significantly lower than before treatment,and it was decreased more obvious of the observation group than of the control group（ P〈0. 05）. Compared with before treatment,the levels of MTL and GAS in both groups after treatment were significantly increased. In addition,compared with the control group,the observation group of patients increased more significantly（ P〈0. 05）. The recurrence rate of observation group was 4. 26%（2/47） during follow-up of 6 months,which was obviously lower than the control group[18. 92%（7/37）]（ P〈0. 05）. No adverse reactions were found in the two groups of patients. Conclusion：There is good clinical curative effect of modified Sanren Tang in the treatment of internal retention of damp-heat type of functional dyspepsia,and it can significantly improve the main symptoms of patients and the level of MTL and GAS,reduce the recurrence rate of FD and high safety in administration.