目的 系統(tǒng)評(píng)價(jià)知柏地黃丸輔助治療女童中樞性性早熟（CPP）的臨床療效及安全性。方法 使用計(jì)算機(jī)對(duì)中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)（CNKI）、維普中文科技期刊數(shù)據(jù)庫(kù)（VIP）、萬(wàn)方數(shù)據(jù)庫(kù)（Wanfang Date）、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)（CBM）、Cochrane Library、PubMed和Web of Science等數(shù)據(jù)庫(kù)進(jìn)行文獻(xiàn)檢索，收集自建庫(kù)起至2023年10月25日知柏地黃丸聯(lián)合促性腺激素釋放激素類似物（GnRHa）治療女童CPP的臨床隨機(jī)對(duì)照試驗(yàn)（RCT），使用RevMan 5.4軟件進(jìn)行Meta分析。結(jié)果 共納入14項(xiàng)RCTs、包括1 101例患兒。Meta分析結(jié)果顯示：試驗(yàn)組臨床有效率高于對(duì)照組［RR＝1.19，95% CI（1.13，1.25），P＜0.000 01］；試驗(yàn)組治療后子宮容積［MD＝-0.75，95% CI（-0.93，-0.58）］、卵巢容積［MD＝-0.26，95% CI（-0.34，-0.17）］、卵泡直徑［MD＝-0.68，95% CI（-0.85，-0.50）］等第二性征回縮優(yōu)于對(duì)照組（均P＜0.000 01）；試驗(yàn)組治療后血清促黃體生成素（LH）水平［MD＝-0.75，95% CI（-0.95，-0.54）］、血清卵泡刺激素（FSH）水平［MD＝-1.23，95% CI（-1.53，-0.94）］、血清雌二醇（E2）水平［SMD＝-1.07，95% CI（-1.54，-0.59）］均明顯低于對(duì)照組（均P＜0.000 01）；治療后骨齡指數(shù)（BAI）［MD＝-0.12，95% CI（-0.16，-0.08），P＜0.000 01］的改善優(yōu)于對(duì)照組；試驗(yàn)組的不良反應(yīng)率低于對(duì)照組［RR＝0.64，95% CI（0.40，1.03），P＝0.07］。結(jié)論 知柏地黃丸聯(lián)合GnRHa治療女童CPP臨床療效明顯優(yōu)于單用GnRHa組，且能夠更有效的使患兒第二性征回縮，降低性激素水平，抑制下丘腦-垂體-性腺軸的發(fā)育，有效延緩生長(zhǎng)發(fā)育，且安全性良好，不會(huì)增加不良反應(yīng)發(fā)生。

Objective To analyze and evaluate the clinical efficacy and safety of Zhibai Dihuang Pills in the adjuvant treatment of central precocious puberty (CPP) in girls. Methods Databases such as CNKI, VIP, Wanfang Date, CBM, Cochrane Library, PubMed and Web of Science were searched by computer for randomized controlled trials (RCT) of Zhibai Dihuang Pills combined with gonadotropin-releasing hormone agonist (GnRHa) in the treatment of CPP in girls. Data collection from database establishment to October 25, 2023. Meta-analysis was performed using RevMan 5.4 software. Results A total of 14 RCTs were included, including 1 101 children. The results of Meta-analysis showed that the clinical response rate of the experimental group was higher than that of the control group [RR = 1.19, 95%CI (1.13, 1.25), P < 0.000 01]. Treatment group after treatment of uterine volume [MD = ?0.75, 95%CI (?0.93, ?0.58), P < 0.000 01], after treatment ovarian volume [MD = ?0.26, 95%CI (?0.34, ?0.17)], follicle diameter [MD = ?0.68, 95%CI (?0.85, ?0.50)] and other secondary sex characteristics were better than the control group (P < 0.000 01). After the treatment,the levels of serum luteinizing hormone (LH) [MD = ?0.75, 95%CI (?0.95, ?0.54)], serum follicle-stimulating hormone (FSH) [MD = ?1.23, 95%CI (?1.53, ?0.94)] and serum estradiol (E2) [SMD = ?1.07, 95%CI (?1.54, ?0.59)] in experimental groups were significantly lower than those of the control groups (P < 0.000 01). After the treatment of bone age index (BAI) [MD = ?0.12, 95%CI (?0.16, ?0.08), P < 0.000 01] improved better than that of control group; the adverse reaction rate in the experimental group was lower than that in the control group [RR = 0.64, 95%CI (0.40, 1.03), P= 0.07]. Conclusion The clinical efficacy of Zhibai Dihuang Pills combined with GnRHa in the treatment of CPP in girls is obviously better than that of GnRHa group alone, and it can more effectively retract the secondary sexual characteristics of children, reduce the level of sex hormones, inhibit the development of hypothalamic-pituitary-gonad axis, effectively delay growth and development, and has good safety without increasing the occurrence of adverse reactions.

R287.5

國(guó)家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃（2018YFC1704100，2018YFC1704101）