针刺联合来曲唑对排卵障碍性不孕症的临床疗效

Clinical efficacy of acupuncture plus letrozole for ovulatory disorder infertility

目的探讨针刺联合来曲唑治疗排卵障碍性不孕症的临床疗效。方法选择2014年1月至2016年1月,在上海交通大学医学院附属第九人民医院南院中医针灸科门诊就诊,符合排卵障碍性不孕症诊断标准的60例患者为研究对象。以计算机产生的随机数字表,将其随机分为研究组与对照组,各为30例。研究组患者接受针刺联合口服来曲唑治疗,对照组患者接受单纯口服来曲唑治疗。观察2组患者排卵征象、子宫内膜厚度、基础体温(BBT),以及治疗后排卵率、3个月内妊娠率、成功妊娠率、自然流产率,并进行统计学分析。本研究遵循的程序符合上海交通大学医学院附属第九人民医院人体试验委员会制定的伦理学标准,得到该委员会批准。本研究征得受试者知情同意,并与之签署知情同意书。2组患者的年龄、不育年限、治疗前卵泡发育情况及子宫内膜厚度等一般临床资料比较,差异均无统计学意义(P>0.05)。结果 1研究组患者肌内注射人绒毛膜促性腺激素(hCG)日子宫内膜厚度、成熟卵泡数及BBT双相率,均优于对照组,并且差异均有统计学意义(t=2.330,P=0.018;t=2.035,P=0.032;χ~2=6.240,P=0.012)。2研究组患者接受治疗后的排卵率为83.3%(25/30),显著高于对照组的53.3%(16/30),并且差异有统计学意义(χ~2=6.240,P=0.012)。2组患者治疗时,均未发生卵巢过度刺激综合征(OHSS)。3研究组患者接受治疗后的3个月内妊娠率、成功妊娠率比较,差异均无统计学意义(χ~2=0.271,P=0.603;χ~2=0.142,P=0.708)。2组患者妊娠时,均未发生自然流产。结论针刺联合来曲唑治疗排卵障碍性不孕症,有利于促进患者卵泡生长,提高卵泡质量。由于本研究纳入样本量较小,此治疗方案是否值得临床推广、应用,尚需多中心、大样本的随机对照试验进一步研究证实。

Objective To study clinical efficacy of acupuncture plus letrozole tor treatment of ovulatory disorder infertility. Methods From January 2014 to January 2016, a total of 60 cases of ovulatory disorder infertility patients who received treatment in Shanghai Ninth People＇s Hospital （South Division）, Shanghai Jiao Tong University School of Medicine were recruited as research subjects. They were divided into study group （n=30） and control group （n= 30） by random number table of computer. In study group, patients were treated by acupuncture plus letrozole, and patients in control group were treated only by letrozole. Statistical analysis were given between two groups of ovulation condition, endometrial thickness, basal body temperature （BBT） bidirectional rate, and ovulation rate, pregnancy rate within 3 months after treatment, successful pregnancy rate, andspontaneous, abortion rate after treatment. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shanghai Ninth People＇s Hospital （South Division）, Shanghai Jiao Tong University School of Medicine. Informed consent was obtained from all participants. There were no significance differences between two groups among general clinical data of age, duration of infertility, development of follicles and endometrial thickness before treatment （P〉 0.05）. Results ①In study group, endometrial thickness, mature follicle number at the day of human chorionic gonadotrophin （hCG） intramuscular injection and BBT bidirectional rate were all better than those of control group, and all the differences were statistically significant （t= 2. 330, P= 0. 018; t= 2. 035, P=0.032;χ2=6.240, P=0.012）. ②Ovulation rate of patients in study group was 83.3% （25/30） which was higher than 53.3%（16/30） in control group, and the difference was statistically significant （χ2= 6. 240, P= 0. 012）. No ovarian hyper stimulation syndrome （OHSS） occurred in two groups during treatment. ③here were no significant differences between two groups in pregnancy rate within 3 months after treatment and successful pregnancy rate （χ2 = 0. 271, P = 0. 603; χ2 = 0. 142, P = 0. 708 ）. No spontaneous abortion occurred in two groups during pregnancy. Conclusions Acupuncture plus letrozole may promote the ovulatory disorder infertility patient＇s follicular growth and improve the quality of follicles. Because of the sample size in this study is relatively small, whether the treatment method is worthy of clinical application or not still need large multi-center randomized controlled trials to confirm by further studies.