基于析因设计观察夜啼灵散外敷治疗食积内热型小儿夜啼的临床疗效

Clinical effect of external application of Yetiling powder in treatment of nocturnal fretfulness in infants due to dyspepsia and internal heat: A study based on factorial design

目的:观察夜啼灵散外敷治疗食积内热型小儿夜啼的临床疗效,探讨夜啼灵散中各类药物的主次作用,评估最佳药物配伍方案。方法:将54例食积内热型夜啼患儿采用随机数字表法分为27组,每组2例,再依据3×3×3析因设计表,以消食化积类药(A)、镇静安神类药(B)、行气止痛醒脾类药(C)为考察因素,各设3水平,对27组均采用中药穴位贴敷治疗,观察治疗5 d后患儿夜啼疗效及中医证候疗效。结果:夜啼疗效比较,A、C因素的3水平比较,差异均无统计学意义(P>0.05);B因素的3水平比较,差异有统计学意义(P<0.05);A与B因素的交互作用比较,差异有统计学意义(P<0.05);B因素的2水平优于1、3水平,差异均有统计学意义(P<0.05)。中医证候疗效比较,A、B、C因素的3水平比较,差异均无统计学意义(P>0.05);B与C因素的交互作用比较,差异有统计学意义(P<0.05)。结论:夜啼灵散中的因素B发挥主要作用,夜啼灵散的最佳组方是蝉蜕、炒麦芽、建曲、木香和香附。

Objective: To investigate the clinical effect of external application of Yetiling powder in the treatment of nocturnal fretfulness in infants due to dyspepsia and internal heat, as well as the role of each drug in Yetiling powder and the optimal regimen for drug compatibility.Methods: A total of 54 children with nocturnal fretfulness due to dyspepsia and internal heat were divided into 27 groups using a random number table, with 2 children in each group.Based on a 3×3×3 factorial design table, three levels were established with digestion-promoting and food retention-removing drugs(A),sedative and tranquilizing drugs(B),and Qi-moving, pain-relieving, and spleen-enlivening drugs(C) as observation factors.All 27 groups were given acupoint application, and the treatment outcomes of nocturnal fretfulness and traditional Chinese medicine(TCM) syndrome were observed after 5 days of treatment.Results: As for the comparison of the treatment outcome of nocturnal fretfulness, there were no significant differences in the three levels of the factors A and C(P>0.05),while there were significant differences in the three levels of the factor B(P<0.05);there was a statistical significance for the interaction between the factors A and B(P<0.05);as for the factor B,level 2 was significantly better than levels 1 and 3(P<0.05).As for the comparison of the treatment outcome of TCM syndrome, there were no significant differences in the three levels of the factors A,B,and C(P>0.05),and there was a statistical significance for the interaction between the factors B and C(P<0.05).Conclusion: The factor B plays a main role in Yetiling powder, and the optimal prescription of Yetiling powder is cicada slough, coloured malt, Jianqu, Saussurea costus, and Rhizoma Cyperi.