抗性早熟汤剂治疗中枢性性早熟女童的疗效与安全性

The Efficacy and Safety of Anti-precocious Traditional Chinese Medicine Decoction in the Treatment of Girls with Central Precocious Puberty

目的探讨抗性早熟中药汤剂对中枢性性早熟女童的疗效及安全性。方法搜集2021—2023年于江西省儿童医院内分泌遗传代谢科就诊的中枢性性早熟女童共127例为研究对象,根据是否接受抗性早熟中药汤剂治疗分为治疗组73例与对照组54例。对照组予健康宣教及饮食调整;治疗组在对照组治疗基础上加用抗性早熟中药汤剂(1袋·次^(-1),2次·d^(-1)),根据服药后情况,随证另加炒薏苡仁(5 g)口服。治疗6个月后,比较2组治疗有效率及治疗前后骨龄、骨龄/年龄、身高、体重指数(BMI)、子宫长径、卵巢容积、促黄体生成素(LH)基础值、LH峰值、LH/促卵泡刺激素(FSH)峰值、乳房Tanner分期,并监测观察组不良反应以评估其安全性。结果治疗组治疗有效率(84.9%)明显高于对照组(11.1%)(P<0.05)。治疗前,2组各观察指标水平比较差异均无统计学意义(P<0.05);治疗后2组乳房Tanner分期分布差异有统计学意义(P<0.05),治疗组的骨龄、骨龄/年龄、卵巢容积、基础LH值、LH峰值、LH/FSH峰值均低于对照组(P<0.05)。治疗组治疗后BMI低于治疗前(P<0.05),治疗前后骨龄/年龄、子宫长径比较差异无统计学意义(P>0.05);对照组治疗后骨龄/年龄、子宫长径较治疗前升高(P<0.05)。2组治疗前后身高比较差异均无统计学意义(P>0.05)。治疗组治疗过程中有13例患儿腹泻,另加炒薏苡仁口服后症状缓解,无其他不良反应事件发生。结论抗性早熟中药汤剂治疗中枢性性早熟女童疗效肯定,安全性良好,且不会影响患儿的生长速度和增加体重。

Objective To investigate therapeutic efficacy and safety of anti-precocious traditional Chinese medicine decoction in the treatment of girls with central precocious puberty.Methods A total of 127 girls with central precocious puberty who visited the Department of Endocrine Genetics and Metabolism at Jiangxi Children’s Hospital from 2021 to 2023 were collected as the research subjects.Based on whether they received traditional Chinese medicine decoction for anti-precocious puberty,they were divided into an treatment group of 73 cases and a control group of 54 cases.The control group received health education and dietary adjustments,while the treatment group was additionally treated with anti-precocious traditional Chinese medicine decoction puberty(1 bag per time,twice a day).Based on the condition after medication,fried coix seed(5 g)was orally administered as needed.After 6 months of treatment,treatment efficiency,bone age,bone age/chronological age ratio,height,body mass index(BMI),uterine length,ovarian volume,basal luteinizing hormone(LH)level,LH peak value,LH/follicle-stimulating hormone(FSH)peak ratio,and breast Tanner staging were compared between the 2 groups before and after treatment.Additionally,adverse reactions in the observation group were monitored to evaluate its safety.Results The treatment efficiency in the treatment group(84.9%)was significantly higher than that in the control group(11.1%)(P<0.05).Before treatment,there were no statistically significant differences in the levels of the observed indicators between the 2 groups(P<0.05).However,after treatment,there was a statistically significant difference in the distribution of breast Tanner staging between the 2 groups(P<0.05).The treatment group had lower levels of bone age,bone age/chronological age ratio,ovarian volume,basal LH level,LH peak value,and LH/FSH peak ratio,compared to the control group(P<0.05).In the observation group,BMI was lower after treatment compared to before treatment(P<0.05),while there were no statistically significant differences in bone age/chronological age ratio and uterine length before and after treatment(P>0.05).In the control group,both bone age/chronological age ratio and uterine length increased after treatment compared to before treatment(P<0.05).There were no statistically significant differences in height before and after treatment in both groups(P>0.05).In the treatment group,13 children had diarrhea during the treatment,and the symptom was relieved after oral administration of fried coix seed,and no other adverse events occurred.Conclusion The traditional Chinese medicine decoction for anti-precocious puberty can have positive therapeutic efficacy and good safety in the treatment of girls with central precocious puberty,and it does not affect the growth rate or increase body weight of the patients.