生脉散辨证加减治疗小儿心肌炎随机对照研究

Randomized Controlled Trial of Modified Decoction of Sheng-Mai-San in Pediatric Patients with Myocarditis

目的观察生脉散辨证加减治疗小儿心肌炎临床疗效。方法将51例心肌炎患儿随机分配进入生脉散组(26例)及对照组(25例),在营养心肌治疗基础上分别给予生脉散辨证加减和西医常规治疗,14 d后统计2组显效及有效人数,比较2组治疗前后的心酶指标及心肌蛋白指标。结果生脉散组治疗小儿心肌炎总有效24例,对照组17例,2组比较,差异具有统计学意义(P<0.05);2组治疗后多项心酶指标及心肌蛋白指标下降,对于心肌特异性较强的肌酸激酶同工酶、羟基丁酸脱氢酶及超敏心肌肌钙蛋白,生脉散组治疗后其水平显著低于对照组(P<0.05)。结论无论是临床疗效还是心肌损伤指标方面,生脉散辨证加减配合静滴磷酸肌酸钠均明显优于西医常规治疗。

Objective To explore the effect of modified decoction of Sheng-Mai-San based on syndrome differentiation in pediatric patients with myocarditis.Methods Fifty-one pediatric patients with myocarditis were randomly assigned to Sheng-Mai-San group（26 patients） or control group（25 patients）,treated with modified Sheng-Mai-San or western routine therapy respectively,based on myocardium nutrition treatment.The cases of good respond or moderate respond in 2 groups were calculated after 14 days course of treatment.And the measurements of myocardial enzymes and myocardial proteins were assessed at baseline and 14 days.Results The cases of good respond and moderate respond in Sheng-Mai-San group were 24,and those in control group were 17.The difference between 2 groups was significant（P0.05）.All of the measurements of myocardial enzymes and myocardial proteins were declined after treatment in 2 groups.The values of CK-MB,HBDH and cTnT-HS,which are specific to myocardial damage especially,were lower significantly in Sheng-Mai-San group compared with those in control group after 14 days of treatment（P0.05）.Conclusion The therapy using modified decoction of Sheng-Mai-San based on syndrome differentiation with creatine phosphate sodium was more effective than routine therapy of modern medicine in the respect of clinical effect and measurements of myocardial damage.