基于真实世界理论的加味逍遥胶囊治疗中枢性性早熟疗效研究

A Study on the Therapeutic Effect of Modified XiaoYao Capsules Based on Real World Theory for Central Precocious Puberty

目的 基于真实世界理论对加味逍遥胶囊治疗中枢性性早熟的疗效进行研究。方法 选择符合中枢性性早熟和肝郁化火证诊断标准的4~10岁女性患儿79例,由医生依据患儿病情、临床指南以及患儿家属的治疗意愿决定使用加味逍遥胶囊或注射用醋酸曲普瑞林进行治疗,6个月后进行疗效评估。结果 使用加味逍遥胶囊治疗的患儿病情较轻。加味逍遥胶囊治疗的有效率为71.43%,与曲普瑞林治疗的有效率(90.00%)比较,差异无统计学意义(P>0.05)。经多因素logistic回归分析,Tanner乳房分期级别越高,疗效越差(P<0.01);患儿使用的药物组别、患儿的年龄以及治疗前的骨龄、骨龄超前值、身高、Tanner外阴分期、是否有阴道出血、FSH、LH、E2水平对疗效没有影响(P>0.05)。结论 加味逍遥胶囊用于治疗病情较轻的中枢性性早熟可以取得较好的疗效。曲普瑞林治疗中枢性性早熟疗效佳。Tanner乳房分期级别越高,疗效越差。

OBJECTIVE To study on the therapeutic effect of modified XiaoYao capsules for central precocious puberty based on real world theory.METHODS 79 female patients aged 4 to 10 years old were selected based on the diagnostic criteria for central precocious puberty and liver depression transforming into fire syndrome.The physicians decided to use modified XiaoYao capsules or injection of Triptorelin acetate based on the condition of the patients,clinical guidelines,and the treatment preferences of the patients′families.The therapeutic effect was evaluated after 6 months.RESULTS Patients treated with modified XiaoYao capsules had milder symptoms.The effective rate of modified XiaoYao capsules was 71.43%and there was no statistically significant difference(P>0.05)compared to the effective rate of Triptorelin acetate treatment(90%).After a multiple logistic regression analysis,it was found that the higher the Tanner breast staging level,the worse the therapeutic effect(P<0.01).The drug group used by the children,the age of the child and the bone age,bone age before treatment,height,Tanner vulva stage,vaginal bleeding,FSH,LH,E 2 levels did not affect the efficacy(P>0.05).CONCLUSION Modified Xiaoyao capsules could achieve good therapeutic effects when used to treat central precocious puberty with milder symptoms.Triptorelin was effective in treating central precocious puberty.The higher the Tanner breast staging level,the worse the therapeutic effect.