半夏泻心汤加味治疗儿童单纯性肥胖胃强脾滞证的临床随机对照观察

Modified Banxia Xiexintang for Treatment of Simple Obesity in Children with Syndrome of Stomach Hyperactivity and Spleen Stagnation:A Randomized Controlled Study

目的:观察半夏泻心汤加味治疗胃强脾滞证儿童单纯性肥胖症的临床疗效及安全性。方法:采用随机、双盲、安慰剂对照的研究方法,将78例单纯性肥胖症胃强脾滞证患儿随机分为观察组和对照组(每组39例),在饮食运动干预的基础上,观察组给予半夏泻心汤加味,对照组给予安慰剂。两组均治疗2月后比较中医证候疗效、体质量指数(BMI)、腰围、臀围、肥胖度和可视化食欲量表指标改善情况,并观察其安全性。结果:治疗后,观察组有效率为88.89%(32/36),对照组有效率为77.14%(27/35),观察组总有效率明显高于对照组(Z=-2.301,P<0.05)。与本组治疗前比较,治疗2个月后,两组患儿体质量、BMI、腰围、臀围、肥胖度均明显降低(P<0.05,P<0.01)。观察组患儿中医证候积分、可视化食欲量表各指标均明显降低(P<0.05);对照组患儿除贪食多食外,其余中医证候积分均明显降低(P<0.05),进食欲望、饥饿感、意愿进食数量积分均明显降低(P<0.05),而饱胀感积分治疗前后差异无统计学意义。与对照组治疗后比较,观察组中医证候总积分、主证及次证各项积分、体质量、BMI、腰围、臀围、肥胖度、进食欲望、饥饿感、意愿进食数量均明显降低(P<0.05,P<0.01),但饱胀感积分差异无统计学意义。治疗前后未发现与试验药物有关的不良反应。结论:半夏泻心汤加味能有效降低胃强脾滞证单纯性肥胖症患儿的体质量、BMI、腰围、臀围和肥胖度,改善肥胖患儿体型及临床症状,并提高其治疗疗效及依从性,临床应用安全。

Objective:To observe the clinical efficacy and safety of modified Banxia Xiexintang in treating simple obesity in children with the syndrome of stomach hyperactivity and spleen stagnation.Method:A randomized,double-blind,placebo-controlled study was conducted,in which 78 children with simple obesity due to stomach hyperactivity and spleen stagnation were randomized into an observation group(39 cases)and a control group(39 cases).On the basis of diet and exercise intervention,the observation group received modified Banxia Xiexintang and the control group received placebo.The two groups were compared in terms of the therapeutic effect regarding TCM symptoms,body mass index(BMI),waist circumference,hip circumference,obesity,and visual analogue scale of appetite after 2 months of treatment,and the treatment safety was observed.Result:After treatment,the response rate in the observation group was 88.89%(32/36),which was higher than that(77.14%,27/35)in the control group(Z=-2.301,P<0.05).After 2 months of treatment,the body weight,BMI,waist circumference,hip circumference,and obesity decreased in both groups(P<0.05,P<0.01).The TCM symptom scores and visual analogue scale scores of appetite in the observation group declined(P<0.05).The control group showed decreased scores of TCM symptoms except gluttony and overeating(P<0.05),declined scores of desire to eat,hunger,and willingness to eat declined(P<0.05),and no significant change in the score of fullness before and after treatment.Compared with the control group,the observation group showed decreased total score of TCM symptoms,scores of primary and secondary TCM symptoms,body weight,BMI,waist circumference,hip circumference,obesity,and scores of desire to eat,hunger,and willingness to eat(P<0.05)and no significant difference in the score of fullness after treatment.No adverse reaction related to the drug application was observed during the treatment period.Conclusion:Modified Banxia Xiexintang can reduce the body weight,BMI,waist circumference,hip circumference,and obesity,improve the body shape,alleviate the symptoms,and enhance the therapeutic effect and compliance of children with simple obesity,being safe in clinical application.