摘要
目的系统评价知柏地黄丸辅助治疗女童中枢性性早熟(CPP)的临床疗效及安全性。方法使用计算机对中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库(Wanfang Date)、中国生物医学文献数据库(CBM)、Cochrane Library、PubMed和Web of Science等数据库进行文献检索,收集自建库起至2023年10月25日知柏地黄丸联合促性腺激素释放激素类似物(GnRHa)治疗女童CPP的临床随机对照试验(RCT),使用RevMan 5.4软件进行Meta分析。结果共纳入14项RCTs、包括1101例患儿。Meta分析结果显示:试验组临床有效率高于对照组[RR=1.19,95%CI(1.13,1.25),P<0.00001];试验组治疗后子宫容积[MD=−0.75,95%CI(−0.93,−0.58)]、卵巢容积[MD=−0.26,95%CI(−0.34,−0.17)]、卵泡直径[MD=−0.68,95%CI(−0.85,−0.50)]等第二性征回缩优于对照组(均P<0.00001);试验组治疗后血清促黄体生成素(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)]均明显低于对照组(均P<0.00001);治疗后骨龄指数(BAI)[MD=−0.12,95%CI(−0.16,−0.08),P<0.00001]的改善优于对照组;试验组的不良反应率低于对照组[RR=0.64,95%CI(0.40,1.03),P=0.07]。结论知柏地黄丸联合GnRHa治疗女童CPP临床疗效明显优于单用GnRHa组,且能够更有效的使患儿第二性征回缩,降低性激素水平,抑制下丘脑-垂体性腺轴的发育,有效延缓生长发育,且安全性良好,不会增加不良反应发生。
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 1101 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<0.00001].Treatment group after treatment of uterine volume[MD=−0.75,95%CI(−0.93,−0.58),P<0.00001],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<0.00001).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<0.00001).After the treatment of bone age index(BAI)[MD=−0.12,95%CI(−0.16,−0.08),P<0.00001]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,
作者
陈思月
王素梅
林绿萍
戴秋雨
郝宏文
CHEN Siyue;WANG Sumei;LIN Lvping;DAI Qiuyu;HAO Hongwen(Beijing University of Chinese Medicine,Beijing 100029,China;The Second Clinical School of Beijing University of Chinese Medicine,Beijing 100078,China)
出处
《药物评价研究》
CAS
北大核心
2024年第4期836-849,共14页
Drug Evaluation Research
基金
国家重点基础研究发展计划(2018YFC1704100,2018YFC1704101)。
