目的 探討六味地黃丸聯(lián)合醋酸亮丙瑞林治療女童中樞性性早熟的臨床療效。方法 選取2021年3月—2022年5月北京市通州區(qū)婦幼保健院收治的120例中樞性性早熟女童，按隨機(jī)數(shù)字表法將所有患者分為對照組和治療組，每組各60例。對照組給予注射用醋酸亮丙瑞林微球，3.75 mg/次，1次/4周，以附帶的注射液溶劑將藥物充分混懸后皮下注射。治療組在對照組治療基礎(chǔ)上口服六味地黃丸，體質(zhì)量15～20 kg者，3 g/次；體質(zhì)量21～25 kg者，4 g/次；體質(zhì)量＞25 kg者，6 g/次；均為2次/d。兩組療程均為6個月。觀察兩組的臨床療效，比較治療前后兩組生長發(fā)育指標(biāo)[骨齡差值（ΔBA）/年齡差值（ΔCA）、生長速率（GV）]，超聲檢查相關(guān)參數(shù)，兒少心理健康量表（MHS-CA）、兒少主觀生活質(zhì)量問卷（ISLQ）評分，以及血清促黃體生成素（LH）、卵泡刺激素（FSH）、胰島素樣生長因子1（IGF-1）、Ｉ型原膠原Ｎ-端前肽（P1NP）水平。統(tǒng)計兩組不良反應(yīng)情況。結(jié)果 治療后，治療組總有效率是88.33%，顯著高于對照組的73.33%（P＜0.05）。治療后，兩組ΔBA/ΔCA、GV均較治療前顯著降低（P＜0.05），且以治療組降低更明顯（P＜0.05）。治療后，兩組乳房直徑、子宮容積、卵巢容積、最大卵泡直徑均較治療前顯著減?。?i>P＜0.05），以治療組減小更顯著（P＜0.05）。治療后，兩組MHS-CA、ISLQ評分均較治療前顯著增加（P＜0.05），且治療后，治療組MHS-CA、ISLQ評分均顯著高于對照組（P＜0.05）。治療后，兩組血清LH、FSH、IGF-1、P1NP水平均顯著降低（P＜0.05）；治療后，治療組LH、FSH、IGF-1、P1NP水平顯著低于對照組（P＜0.05）。治療后，治療組和對照組不良反應(yīng)發(fā)生率分別是6.67%、5.00%，兩組比較差異無統(tǒng)計學(xué)意義。結(jié)論 六味地黃丸聯(lián)合醋酸亮丙瑞林治療女童中樞性性早熟安全性較好，療效確切，能有效減慢患兒骨齡成熟和生長速度，抑制生殖系統(tǒng)過早發(fā)育，改善心理健康和生活質(zhì)量，進(jìn)一步調(diào)節(jié)機(jī)體性激素水平和骨代謝。

Objective To explore the clinical effect of Liuwei Dihuang Pills combined with leuprorelin acetate in treatment of central precocious puberty in girls. Methods A total of 120 girls with central precocious puberty admitted to Tongzhou District Maternal and Child Health Hospital of Beijing from March 2021 to May 2022 were selected and divided into control group and treatment group by random number table method, with 60 cases in each group. Patients in the control group were given Leuprorelin Acetate Microspheres for injection, 3.75 mg/time, once/4 weeks, the drug was fully suspended and injected subcutaneously with the included injection solvent. Patients in the treatment group were po administered with Liuwei Dihuang Pills, body weight of 15 — 20 kg, 3 g/time, body weight of 21 — 25 kg, 4 g/time, body weight > 25 kg, 6 g/time, twice daily. The treatment course of both groups was 6 months. The clinical efficacy of the two groups was observed, and the growth and development indicators [ΔBA/Age difference (ΔCA), growth rate (GV)], ultrasonic-related parameters, adolescent Mental Health Scale (MHS-CA) and Subjective Quality of Life Questionnaire (ISLQ) scores, and serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), insulin-like growth factor 1 (IGF-1), and type I procollagen N-terminal propeptide (P1NP) in the two groups were compared before and after treatment. The adverse reactions of the two groups were analyzed. Results After treatment, the total effective rate of the treatment group was 88.33%, which was significantly higher than that of the control group (73.33%, P < 0.05). After treatment, ΔBA/ΔCA and GV in two groups were significantly decreased compared with before treatment (P < 0.05), and the decrease was more obvious in the treatment group (P < 0.05). After treatment, breast diameter, uterine volume, ovarian volume and maximum follicle diameter in two groups were significantly decreased compared with before treatment (P < 0.05), and the decrease was more significant in the treatment group (P < 0.05). After treatment, the MHS-CA and ISLQ scores of the two groups were significantly increased compared with before treatment (P < 0.05), and after treatment, the MHS-CA and ISLQ scores of the two groups were significantly higher than those of the control group (P < 0.05). After treatment, serum levels of LH, FSH, IGF-1 and P1NP in two groups were significantly decreased (P < 0.05). After treatment, the levels of LH, FSH, IGF-1 and P1NP in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, the incidence of adverse reactions in the treatment group and the control group was 6.67% and 5.00%, respectively, and there was no statistical significance between the two groups. Conclusion Liuwei Dihuang Pills combined with leuprorelin acetate is safe and effective in the treatment of central precocious puberty in girls, and can effectively slow down the bone age maturity and growth rate of children, inhibit the premature development of reproductive system, improve mental health and quality of life, which can further regulate the level of sex hormone and bone metabolism.

R985

北京市通州區(qū)科技計劃項目（KJ2022CX051）