| 495 | 16 | 204 |
| 下载次数 | 被引频次 | 阅读次数 |
目的系统评价来曲唑(LE)与克罗米芬(CC)对多囊卵巢综合征(PCOS)患者的疗效,为临床用药提供依据。方法全面检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中医生物医学文献数据库(CBM)、PubMed、Embase、Cochrane Library、Web of Science数据库,检索时间为建库至2020年2月,检索内容为LE与CC治疗PCOS的临床随机对照试验(RCT),根据纳入及排除标准进行筛选,并由2名评价员独立对纳入研究进行资料提取及方法学质量评估,采用Cochrane系统评价软件RevMan5.3进行Meta分析,采用GRADEprofiler软件对证据质量等级进行分级。结果本研究纳入22篇RCT研究,共计PCOS患者3 506例。Meta分析结果显示,LE能显著提高PCOS患者的排卵率[RR=1.14,95%CI(1.05,1.24),P=0.003]、妊娠率[RR=1.37,95%CI(1.24,1.51),P<0.000 01]和活产率[RR=1.55,95%CI(1.31,1.84),P<0.000 01],增加HCG日子宫内膜厚度[MD=1.75,95%CI(0.46,3.05),P=0.008],降低OHSS发生率[RR=0.18,95%CI(0.06,0.56),P=0.003];LE组的成熟卵泡数[MD=-0.55,95%CI(-0.79,-0.31),P<0.000 01]及HCG日E2水平[MD=-185.84,95%CI(-233.60,-138.08),P<0.000 01]相较于CC组更低,差异均有统计学意义(P<0.05);两组在流产率、多胎妊娠率及子宫动脉血流指数方面差异无统计学意义(P>0.05)。根据GRADE标准,活产率、OHSS发生率为中等质量证据,妊娠率、多胎妊娠率、流产率、成熟卵泡数为低质量证据,排卵率、HCG日子宫内膜厚度、HCG日E2水平、子宫动脉阻力指数(RI)、子宫动脉搏动指数(PI)为极低质量证据。结论 LE的促排卵疗效总体优于CC,但需要大规模,设计更严谨的多中心临床试验加以验证。
Abstract：Objective:To systematically evaluate the efficacy of letrozole(LE) and clomiphene citrate(CC) in the treatment of polycystic ovary syndrome(PCOS) for providing a basis for clinical medication.Methods:A comprehensive retrieval of CNKI,Wanfang, VIP,CBM,PubMed, EMBASE,Cochrane Library and Web of Science database was conducted from the establishment of database to February 30 2020. The clinical randomized controlled trials(RCT) of LE or CC in the treatment of PCOS were screened according to the inclusion and exclusion criteria. Two evaluators independently extracted the data and evaluated the methodological quality of the included studies. The Cochrane system evaluation software RevMan5.3 was used for meta-analysis. GRADEprofiler software was used to classify for the quality of evidence.Results:This study included 22 RCTs with 3 506 PCOS patients. Meta-analysis results showed that LE significantly increase the ovulation rate of PCOS patients[RR=1.14,95%CI(1.05,1.24),P=0.003],pregnancy rate[RR=1.37,95%CI(1.24,1.51),P<0.000 01],live birth rate[RR=1.55,95%CI(1.31,1.84),P<0.000 01],endometrial thickness on HCG day[MD=1.75,95%CI(0.46,3.05),P=0.008],and reduced the incidence of OHSS[RR=0.18,95%CI(0.06,0.56),P=0.003]. The number of mature follicles in the LE group[MD=-0.55,95%CI(-0.79,-0.31),P<0.000 01] and E2 level on HCG day[MD=-185.84,95%CI(-233.60,-138.08),P<0.000 01] were significantly less than those in the CC group(P<0.05).There were no significant differences in abortion rate, multi-pregnancy rate and uterine artery blood flow index between the two groups(P>0.05). According to the GRADE standard, the live birth rate and the OHSS incidence were medium quality evidence; the pregnancy rate, multi-pregnancy rate, abortion rate and the number of mature follicles were low quality evidence; the ovulation rate, endometrial thickness on HCG days, E2 level on HCG day, uterine artery resistance index(RI) and uterine artery pulsatility index(PI) were extremely low quality evidence.Conclusions:The ovulation induction effect of LE is generally better than that of CC,but it needs to be verified by large-scale and more rigorous multicenter clinical trials.
[1] Balen AH,Morley LC,Misso M,et al.The management of anovulatory infertility in women with polycystic ovary syndrome:an analysis of the evidence to support the development of global WHO guidance[J].Hum Reprod Update,2016,22:687-708.
[2] Amer SA,Smith J,Mahran A,et al.Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome[J].Hum Reprod,2017,32:1631-1638.
[3] Homburg R.Clomiphene citrate-end of an era?A mini-review[J].Hum Reprod,2005,20:2043-2051.
[4] Mitwally MF,Casper RF.Use of an aromatase inhibitor for induction of ovulation in patients with an inadequate response to clomiphene citrate[J].Fertil Steril,2001,75:305-309.
[5] Legro RS,Brzyski RG,Diamond MP,et al.Letrozole versus clomiphene for infertility in the polycystic ovary syndrome[J].N Engl J Med,2014,371:119-129.
[6] Atay V,Cam C,Muhcu M,et al.Comparison of letrozole and clomiphene citrate in women with polycystic ovaries undergoing ovarian stimulation[J].J Int Med Res,2006,34:73-76.
[7] 王沛丽，王芳，丁楠.来曲唑和克罗米芬分别联合HMG治疗多囊卵巢综合征疗效的系统评价[J].生殖医学杂志，2015,24:626-633.
[8] 丁楠，王芳，简启亮，等.不同剂量来曲唑对多囊卵巢综合征患者疗效的Meta分析[J].生殖与避孕，2015,35:626-634.
[9] 刘真，唐惠林，翟所迪.来曲唑治疗多囊卵巢综合征的系统评价[J].中国药学杂志，2011,46:1762-1767.
[10] Hu S,Yu Q,Wang Y,et al.Letrozole versus clomiphene citrate in polycystic ovary syndrome:a meta-analysis of randomized controlled trials[J].Arch Gynecol Obstet,2018,297:1081-1088.
[11] The Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome[J].Fertil Steril,2004,81:19-25.
[12] Al-Obaidi MT,Ali ZH,Al-Saadi WI,et al.Impact of letrozole versus clomiphene citrate on endometrial receptivity in Iraqi women with polycystic ovarian syndrome[J].J Clin Pharm Ther,2019,44:618-622.
[13] Wang L,Wen XQ,Lv SL,et al.Comparison of endometrial receptivity of clomiphene citrate versus letrozole in women with polycystic ovary syndrome:a randomized controlled study[J].Gynecol Endocrinol,2019,35:862-865.
[14] Ghahiri A,Mogharehabed N,Mamourian M.Letrozole as the first-line treatment of infertile women with poly cystic ovarian syndrome(PCOS) compared with clomiphene citrate:a clinical trial[J].Adv Biomed Res,2016,5:6.
[15] Roy KK,Baruah J,Singla S,et al.A prospective randomized trial comparing the efficacy of letrozole and clomiphene citrate in induction of ovulation in polycystic ovarian syndrome[J].J Hum Reprod Sci,2012,5:20-25.
[16] Selim M,Borg T.Letrozole and clomiphene citrate effect on endometrial and subendometrial vascularity in treating infertility in women with polycystic ovary syndrome[J].J Gynecol Oncol,2012,28:405-410.
[17] Ray PB,Ray A,Chakraborti PS.Comparison of efficacy of letrozole and clomiphene citrate in ovulation induction in Indian women with polycystic ovarian syndrome[J].Arch Gynecol Obstet,2012,285:873-877.
[18] Badawy A,Abdel Aal I,Abulatta M.Clomiphene citrate or letrozole for ovulation induction in women with polycystic ovarian syndrome:a prospective randomized trial[J].Fertil Steril,2009,92:849-852.
[19] Dehbashi S,Kazerooni T,Robati M,et al.Comparison of the effects of letrozole and clomiphene citrate on ovulation and pregnancy rate in patients with polycystic ovary syndrome[J].Iran J Basic Med Sci,2009,34:23-28.
[20] Bayar U,Basaran M,Kiran S,et al.Use of an aromatase inhibitor in patients with polycystic ovary syndrome:a prospective randomized trial[J].Fertil Steril,2006,86:1447-1451.
[21] 焦艳，闫洪超.来曲唑与克罗米芬治疗多囊卵巢综合征疗效[J].中国计划生育学杂志，2019,27:1019-1021.
[22] 李伏福，黄维瑜.来曲唑与克罗米芬对排卵效果及患者性激素水平的影响观察[J].中国处方药，2019,17:90-91.
[23] 李砚，姚念玲，王运萍，等.来曲唑与克罗米芬治疗多囊卵巢综合征的疗效及对促排卵的效果比较[J].海南医学，2019,30:1965-1968.
[24] 白烨.克罗米芬与来曲唑对多囊卵巢综合征患者促排卵效果及其妊娠的影响[J].临床合理用药杂志，2016,9:38-39,51.
[25] 陈利云.来曲唑与氯米芬促排卵治疗多囊卵巢综合征的疗效比较[J].泰山医学院学报，2016,37:549-551.
[26] 李朔.比较来曲唑与克罗米芬治疗多囊卵巢综合征的疗效[J].中国实用医刊，2016,43:123-124.
[27] 孙立兰，叶青，陈艳娥.来曲唑改善多囊卵巢综合征不孕患者激素水平和排卵情况的疗效分析[J].中国性科学，2016,25:121-123.
[28] 梁英凤.比较来曲唑与氯米芬促排卵治疗多囊卵巢综合征临床疗效[J].中国实用医刊，2014,41:23-24.
[29] 沈桂红.克罗米芬和来曲唑促排卵治疗效果与妊娠结局的比较[J].中国医药指南，2012,10:598-599.
[30] 梁卓，苏云超，钟柏茹.来曲唑和氯米芬对多囊卵巢综合征患者促排卵的比较研究[J].广西医科大学学报，2011,28:567-569.
[31] He D,Jiang F.Meta-analysis of letrozole versus clomiphene citrate in polycystic ovary syndrome[J/OL].Reprod Biomed Online,2011,23:91-96.
[32] Nozdrin M.Letrozole-a controversial drug for OHSS prevention?[J].J Gynecol Obstet Hum Reprod,2020,49:101659.
[33] Zhao J,Xu B,Huang X,et al.Whether Letrozole could reduce the incidence of early ovary hyperstimulation syndrome after assisted reproductive technology?A systematic review and meta-analysis[J].Reprod Health,2020,17:181.
[34] He Q,Liang L,Zhang C,et al.Effects of different doses of letrozole on the incidence of early-onset ovarian hyperstimulation syndrome after oocyte retrieval[J].Syst Biol Reprod Med,2014,60:355-360.
[35] Biljan MM,Hemmings R,Brassard N.The outcome of 150 babies following the treatment with letrozole or letrozole and gonadotropins[J].Fertil Steril,2005,84:S95.
[36] Akbari Sene A,Ghorbani S,Ashrafi M.Comparison of the pregnancy outcomes and the incidence of fetal congenital abnormalities in infertile women treated with letrozole and clomiphene citrate[J].J Obstet Gynaecol Res,2018,44:1036-1041.
[37] Guyatt G,Oxman AD,Akl E,等.GRADE指南：Ⅰ.导论——GRADE证据概要表和结果总结表[J].中国循证医学杂志，2011,11:437-445.
基本信息:
中图分类号:R711.75
引用信息:
[1]吕霄,唐海,张建伟.来曲唑与克罗米芬治疗多囊卵巢综合征的Meta分析及GRADE评价[J].生殖医学杂志,2021,30(09):1222-1231.
基金信息:
山东省自然科学基金面上项目(ZR2020MH363)
2021-09-15
2021-09-15