“董氏针药”治疗小儿厌食症的大样本随机对照临床研究

Randomized controlled clinical study with large sample on Dong's acupuncture and medicine in treating infantile anorexia

目的观察"董氏针药"治疗小儿厌食症的临床疗效。方法将4 050例厌食症患儿随机分为苏脾饮组、山麦组及董氏针药组,每组1 350例。苏脾饮组予董氏苏脾饮,山麦组予山麦健脾口服液,董氏针药组予董氏苏脾饮加针刺四缝穴综合治疗。观察临床疗效,比较起效时间、中医证候积分、身高、体质量及血红蛋白水平的变化情况。结果 (1)试验期间共脱落489例,最终完成试验者共3 561例,其中苏脾饮组1 121例、山麦组1 117例、董氏针药组1 323例。(2)苏脾饮组、山麦组、董氏针药组临床总有效率分别为72.26%、70.01%和90.02%;组间临床疗效比较,董氏针药组明显优于苏脾饮组、山麦组(P<0.05),而苏脾饮组与山麦组差异无统计学意义(P>0.05)。(3)组间起效时间比较差异有统计学意义,董氏针药组起效时间明显快于其余两组(P<0.05),苏脾饮组与山麦组差异无统计学意义(P>0.05)。(4)治疗前后组内比较,各组中医证候积分差异均有统计学意义(P<0.05);组间治疗前后中医证候积分差值比较,董氏针药组明显高于其余两组(P<0.05),而苏脾饮组与山麦组差异无统计学意义(P>0.05)。(5)组间治疗后身高、体质量及血红蛋白水平比较,差异无统计学意义(P>0.05)。结论 "董氏针药"治疗小儿厌食症,可显著改善患儿的食欲、增加食量,而见效较快是优势。

Objective To observe the clinical efficacy of Dong＇ s acupuncture and medicine in treating infantile anorexia. Methods 4 050 children patients with anorexia were randomly divided into the Supi Liquid group, Shanmai group and Dong＇ s acupuncture and medicine group, 1 350 cases in each group. The Supi Liquid group was treated with Dang＇ s Supi Liquid, the Shanmai group was treated with Shanmai Jianpi oral liquid, the Dang＇ s acupuncture and medicine group was treated with Dong＇ s Supi Liquid combined with acupuncture on Sifeng point （ EX-UE 10 ）. The clinical efficacy was observed, and the changes of onset time, TC M syndrome scores, body height, body weight and hemoglobin level were compared. Results （1） 489 cases fell off during the trial, and 3 561 eases completed the whole test, among which I 121 cases in the Supi Liquid group,l 117 cases in the Shanmai group and 1 323 cases in the Dong＇ s acupuncture and medicine group. （2） The clinical total effective rate of Supi Liquid group, Shanmai group and Dang＇ s acupuncture and medicine group were 72.26%, 70.01% and 90.02% respectively . The clinical efficacy of Dong＇ s acupuncture and medicine group was significantly better than that of the Supi Liquid and Shanmai group（ P 〈0.05 ）, there was no statistically significant difference on the clinical efficacy between the Supi Liquid group and Shanmai group（ P 〉0.05 ）. （3） In the onset time, there were statistically significant differences among the three groups ,the onset time in the Dong＇ s acupuncture and medicine group was significantly earlier than that in the other two groups（ P 〈0.05 ） , there was no statistically significant difference on the onset time between the Supi Liquid group and Shanmai group（ P 〉0.05 ）. （4） Comparison of treatment before and after within group, the difference of TCM syndrome scores in all groups were statistically significant （ P 〈0.05 ） ; comparison among groups,the difference of TCM syndrome scores between treatment before and after in the Dong＇ s acupuncture and medicine group was obviously higher than that in the other two groups（ P 〈0.05 ）, there was no statistically significant difference between the Supi Liquid group and Shanmai group （P 〉0.05 ）. （5） There were no statistically significant differences on the body height, body weight and hemoglobin level among the three groups after treatment （P 〉 0.05 ）. Conclusion Dong＇ s acupuncture and medicine shuw good effect on infantile anorexia, which can significantly improve the appetite of children patients and increase the tood intake. Rapid onset is its advantage.