大承气汤治疗阳明腑实证慢性功能性便秘临床疗效及安全性研究

Study on Clinical Effect and Safety of Dachengqi Decoction for Chronic Functional Constipation with Yangming and Bowel Excess Syndrome

目的:观察大承气汤治疗阳明腑实证慢性功能性便秘(CFC)的临床疗效。方法:选择CFC患者150例,采用随机数字表法分为观察组和对照组各75例。对照组采用枸橼酸莫沙必利分散片治疗,观察组在对照组基础上联合大承气汤治疗。治疗4周后,比较2组临床疗效和不良反应发生率,以及治疗前后症状评分、血清学指标[P物质(SP)、胃动素(MTL)、一氧化氮(NO)]水平及便秘患者生活质量量表(PACQOL)评分变化。结果:观察组总有效率为96.00%,对照组为85.33%,2组比较,差异有统计学意义(P<0.05)。治疗后,观察组大便间隔时间、每次排便时间、粪便性状、腹胀、排便费力、排便不尽感等症状评分及总分均较治疗前降低(P<0.05),且观察组上述各项评分均低于对照组(P<0.05)。治疗后,2组血清SP、MTL水平均较治疗前升高(P<0.05),NO水平较治疗前降低(P<0.05);且观察组SP、MTL水平高于对照组(P<0.05),NO水平低于对照组(P<0.05)。治疗后,2组PAC-QOL量表中生理、社会心理、担忧、满意度评分及总分均较治疗前降低(P<0.05),且观察组上述各项评分均低于对照组(P<0.05)。观察组不良反应发生率为6.67%,对照组为20.00%,2组比较,差异有统计学意义(P<0.05)。结论:大承气汤治疗阳明腑实证CFC疗效显著,可有效缓解便秘症状,改善消化道激素水平,增强肠运动能力,提高生活质量,且安全性较高。

Objective:To observe the clinical effect of Dachengqi Decoction for chronic functional constipation(CFC)with yangming and bowel excess syndrome.Methods:A total of 150 cases of CFC patients were selected and divided into the observation group and the control group according to the random number table method,with 75 cases in each group.The control group was treated with Mosapride Citrate Dispersible Tablets,and the observation group was additionally treated with Dachengqi Decoction based on the treatment of the control group.After four weeks of treatment,the changes in symptom scores,levels of serological indexes[substance P(SP),motilin(MTL),nitric oxide(NO)],and Patient Assessment of Constipation Quality of Life(PAC-QOL)scores before and after treatment as well as the clinical effects and the incidence of adverse reactions were compared between the two groups.Results:The total effective rate was 96.00%in the observation group and 85.33%in the control group,the difference being significant(P<0.05).After treatment,the scores of interval time of defecation,each defecation time,stool trait,symptoms such as abdominal distension,difficulty in defecation,and incomplete defecation,and the total scores in the observation group were all decreased when compared with those before treatment(P<0.05),and the above scores in the observation group were lower than those in the control group(P<0.05).After treatment,the levels of SP and MTL in serum in the two groups were increased when compared with those before treatment(P<0.05),and NO levels were decreased when compared with those before treatment(P<0.05);the levels of SP and MTL in the observation group were higher than those in the control group(P<0.05),and the NO level was lower than that in the control group(P<0.05).After treatment,the scores of physiological,psychosocial,worry,and satisfaction of PAC-QOL scale,and the total scores in the two groups were decreased when compared with those before treatment(P<0.05),and the above scores in the observation group were lower than those in the control group(P<0.05).The incidence of adverse reactions was 6.67%in the observation group and 20.00%in the control group,the difference being significant(P<0.05).Conclusion:Dachengqi Decoction has an ideal curative effect in the treatment of CFC with yangming and bowel excess syndrome,which can effectively relieve constipation symptoms,improve the levels of gastrointestinal hormone,and enhance intestinal motility and the quality of life,with high safety.