安神滋阴泻火方治疗女童特发性中枢性性早熟的临床疗效及安全性观察

Clinical Efficacy and Safety of Anshen Ziyin Xiehuo Decoction in Treating Girls with Idiopathic Central Precocious Puberty

目的 探究安神滋阴泻火方治疗女童特发性中枢性性早熟(Idiopathic central precocious puberty, ICPP)的临床疗效及安全性。方法 选取荆州市中心医院2021年1月—2022年1月期间收治的88例ICPP女童,采用随机数字表法分组,设为促性腺激素释放激素类似物(Gonadotropin releasing hormone analogue, GnRHa)组与中药方剂组,每组各44例。GnRHa组给予注射用醋酸亮丙瑞林微球治疗,首剂量3.75 mg,皮下注射,之后每4周用药1次,剂量为90μg/kg,但最大剂量不超过3.75 mg。中药方剂组给予安神滋阴泻火方治疗,1剂/d。治疗24周后,观察比较两组患儿临床疗效、治疗前、治疗12周及治疗24周后的乳房发育情况(Tanner乳房分期评分)、盆腔发育情况(卵巢容积、子宫体积、卵泡直径)及骨龄(BA/CA)变化、血清激素[雌激素(Estrogen, E2)、促黄体生成素(Luteinizing hormone, LH)、促卵泡成熟激素(Follicle stimulating hormone, FSH)]水平变化,记录并比较两组患儿安全性及成本-效果分析。结果 (1)临床疗效:中药方剂组临床总有效率67.44%(29/43)与GnRHa组83.72%(36/43)比较,差异无统计学意义(P>0.05)。(2)乳房发育情况、盆腔发育情况、骨龄变化、血清激素水平变化:治疗12周、24周后,两组患儿Tanner乳房分期评分、卵巢容积、子宫容积及卵泡直径、BA/CA值、E2、LH、FSH水平均较治疗前降低,差异有统计学意义(P<0.05);治疗24周后,两组患儿Tanner乳房分期评分、卵巢容积、子宫容积及卵泡直径、BA/CA值、E2、LH、FSH水平较治疗12周后降低,差异有统计学意义(P<0.05)。治疗12周、24周后,GnRHa组Tanner乳房分期评分、卵巢容积、子宫容积及卵泡直径、BA/CA值、E2、LH、FSH水平与中药方剂组比较,差异均无统计学意义(P>0.05)。(3)安全性:中药方剂组未发生不良反应,GnRHa组不良反应发生率为13.95%,差异有统计学意义(P<0.05)。(4)成本-效果分析:中药方剂组治疗费用及成本-效果比低于GnRHa组,两组比较,差异有统计学意义(P<0.05)。结论 安神滋阴泻火方治疗女童ICPP与GnRHa效果相当,有利于改善女童性早熟体征,且安全性较GnRHa高,成本-效果分析良好。

Objective To observethe clinical efficacy and safety of AnshenZiyinXiehuo Decoction in treating girls with idiopathic central precocious puberty(ICPP).Methods A total of 88 girls with ICPP treated in Jingzhou Central Hospital from January 2021 to January 2022 were assignedinto a gonadotropin-releasing hormone analogue(GnRHa)group(n=44)and a Chinese medicine decoction group(n=44)according to therandom number table method.The GnRHa group was treated by subcutaneous injection with leuprolide acetate microspheres(first dose of 3.75 mg and then a dose of 90μg/kgwith the maximum not exceeding 3.75 mgevery 4 weeks),and the Chinese medicine decoction group was treated with Anshen Ziyin Xiehuo Decoctionat one baga day.Both groups were treated for 24 weeks.The Tanner staging of breast development,pelvic development indicators(ovarian volume,uterine volume,and follicle diameter),bone age-to-chronological age(BA/CA)ratio,and serum levels of sex hormones[estrogen(E2),luteinizing hormone(LH),and follicle-stimulating hormone(FSH)]were measured before treatment and after treatment for 12 and 24 weeks.The clinical efficacy,safety,and cost-effectiveness ratiowere compared between the two groups.Results(1)Clinical efficacy:The total responserate in the Chinese medicine decoction group was 67.44%(29/43),which was not different from that(83.72%,36/43)in the GnRHa group(P>0.05).(2)Breast development,pelvic development,BA/CA ratio,serum levels of sex hormones:After treatment for 12 and 24 weeks,the Tanner staging scores,ovarian volume,uterine volume,follicle diameter,BA/CA ratio,and serum levels of E2,LH,and FSH decreased compared with those before treatment(P<0.05).Moreover,the decreases in the indicators above were more significant after treatment for 24 weeks than after treatment for 12 weeks(P<0.05).However,the decreases showed no significant differences between the two groups(P>0.05).(3)Safety:The incidence of adverse reactions in the Chinese medicine decoction group and the GnRHa group was 0 and 13.95%,respectively,with a significant difference(P<0.05).(4)Cost-effectiveness analysis:The Chinese medicine decoction group hadlowertreatment cost and cost-effectivenessratio than the GnRHa group(P<0.05).Conclusion Anshen Ziyin Xiehuo Decoctionis comparableto GnRHa in treating girls with ICPP.The decoction can mitigate the signs of precocious puberty and has higher safety andlower cost-effectiveness ratio than GnRHa.