补肾调周法在辅助生殖技术中的作用及临床干预研究
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摘要
目的:研究补肾调周法对拟行辅助生殖技术周期患者治疗的可行性和有效性。通过研究补肾调周法对于拟行体外受精-胚胎移植(IVF-ET)或单精子卵泡浆注射(ICSI)与冻胚移植(FET)患者干预的疗效分析,评价补肾调周法对于拟行IVF/ICSI-ET或FET的患者临床干预的价值。探讨补肾调周法在辅助生殖各个环节的作用机理,并研究中药保胎的可能机制。从中医角度为拟行IVF/ICSI-ET或FET患者提供可行性建议,增加IVF/ICSI-ET或FET的成功率,给本病的诊治提供新的方法,为临床治疗本病提供帮助。
     方法:将拟行辅助生殖技术的患者,根据其选择辅助生殖技术的方式分为两个大组,一大组为拟行鲜胚移植周期的患者,另一大组为拟行冻胚移植周期的患者。
     鲜胚移植周期组:将160例拟行IVF/ICSI-ET的患者随机分为干预组(80例)和对照组(80例),对照组采用江苏省人民医院生殖中心常规的进IVF/ICSI-ET周期方案,干预组在对照组的治疗基础上运用补肾调周法对其进行中药治疗,观察两组患者子宫内膜厚度、计算取卵数、观察受精率、计算优质胚胎率、生化妊娠率和临床妊娠率。
     冻胚移植周期组:将160例拟行冻胚移植周期(FET)的患者随机分为干预组(80例)和对照组(80例),对照组采用江苏省人民医院生殖中心常规进FET周期方案,干预组在对照组的治疗基础上运用补肾调周法对其进行中药治疗,观察两组患者子宫内膜厚度,统计生化妊娠率和临床妊娠率。
     结果:干预组患者在子宫内膜厚度、取卵数、受精率、优质胚胎率、生化妊娠率和临床妊娠率均有显著性统计学差异,其中
     鲜胚移植周期组:干预组可以极显著提高患者子宫内膜的厚度(P<0.01);而且在提高取卵数、受精率、优质胚胎率及最终提高临床妊娠率方面均优于对照组(P<0.05)。
     冻胚移植周期组:治疗组可以极显著提高患者子宫内膜的厚度(P<0.01);而且在提高患者生化妊娠率及最终提高临床妊娠率方面均优于对照组(P<0.05)。
     结论:补肾调周法可以促进患者排卵数、增加子宫内膜内膜厚度、提高受精率及优质胚胎率、辅助胚胎着床,进行安胎,提高其临床妊娠率。因此补肾调周法配合辅助生殖技术进周期方案,可明显提高患者的辅助生殖妊娠率,具有良好的经济和社会价值。
Objective:To observe the curative effect of kidney-reinforcing and menstrual cycle-regulating therapy with in assisted reproductive techniques (ART). Research the feasibility and effectiveness of the patients with kidney-reinforcing and menstrual cycle-regulating therapy with in ART. Through the study kidney-reinforcing and menstrual cycle-regulating therapy with in vitro fertilization-embryonic or single sperm injection (IVF /ICSI-ET) and frozen embryos transplantation (FET) patients, evaluation of value of kidney-reinforcing and menstrual cycle-regulating therapy with in ART. Discusses in kidney-reinforcing and menstrual cycle-regulating therapy with in ART each link mechanism, clinical treatment for help.
     Methods:ET group:The 160cases receiving IVF/ICSI-ET were randomly divided into two groups:the treatment group (n=80) treated with the routine schedule of hospital of JianSu province people combined with kidney-reinforcing and menstrual cycle-regulating therapy in different periods of IVF-ET, and the control group (n=80) with the routine schedule of hospital of JianSu province pepole alone. The, endometrium thickness, follicular oocyte number, fertilization rate, high-quality embryo rate and pregnancy rate of both groups were observed
     FET group:The 160cases receiving FET were randomly divided into two groups:the treatment group (n=80) treated with the routine schedule of hospital of JianSu province people combined with kidney-reinforcing and menstrual cycle-regulating therapy in different periods of IVF-ET, and the control group (n=80) with the routine schedule of hospital of JianSu province pepole alone. The, endometrium thickness,and pregnancy rate of both groups were observed
     Results:ET group:In the treatment group, endometrium thickness and ertilization rate increased (P<0.01), and the effect on increasing high-quality embryorate, biochemical pregnancy rate and clinical pregnancy rate was better than that in the control group (P<0.05)
     FET group:In the treatment group, endometrium thickness increased (P<0.01), and the effect on increasing biochemical pregnancy rate and clinical pregnancy rate was better than that in the control group (P<0.05)
     Conclusions:The therapy of kidney-reinforcing and menstrual cycle-regulating is effective in promoting ovulation, increasing endometrium thickness, and helping embryo implantation. In combination with assisted reproductive techniques, it increases the pregnancy rate, serving as an effective treatment for infertile women.
引文
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    综上所述,中医药在辅助生殖的多个环节可起重要或积极作用,但是仍然存在一些问题。生殖过程是极其复杂的,不孕症的治疗也是相当棘手的。体外授精-胚胎移植技术的开展不过30年的时间,文献记载中医药应用于这一技术之中也短短几年的历史,这是一项新的事业,而且有较好的苗头,是一件值得研究的课题。尽管已经取得了一定的疗效,但经验还很有限,而且相关机理的研究也很不明确。更成熟的方法还有待于更多的经验积累,对已经有的成功案例要深入地研究,在加大临床观察例数的同时要加强实验研究,在实验和临床设计上要更好地体现两者结合的优势。
    面对机遇与挑战,中医药在辅助生殖的工作仍很多,正如Stener-Victorin所说:缺少证据并不等于缺少疗效,今后研究和工作的重点可能是,在一些重要的中医药有特色的方面加强研究和开发,如1)在卵巢功能反应低下的患者中,用补肾活血的方法可以增强激素的敏感性,可能的机制是改善了下丘脑-垂体-卵巢轴的调节功能还是改善了微循环,抑或是两者联合作用,都需要进一步研究,有可能加强实验研究,在实验和临床设计上要更好地体现两者结合的优势;2)对由于月经周期紊乱,子宫内膜接受功能差而引起的着床率低下的患者,以及为了提高胚胎质量,可运用中药周期疗法,在月经期治以疏肝理气和营调经为主,卵泡期治以养血滋肾疏肝和络为主,排卵期治以滋肾助阳活血和络为主,黄体期治以养血补阳疏肝和络为主,在不同的时间给予不同的治疗方法,整个治疗过程体现补肾调经,祛瘀生新的治疗观念,顺势女性的内分泌周期,配合辅助生殖技术,迎接新的治疗周期,提高孕育成功率。这些治疗方法是采用辨证施治的方法,还是采用专方专药的方法更合理还有大量的工作要做;3)中医药对于提高超排周期的卵细胞成熟度,进而改善移植胚胎的质量有重要作用,这其中的机制的阐述还有很多要做的工作。4)降低体外授精-胚胎移植妊娠流产率中医保胎有很明显的优势,保胎的方药很多,如何筛选对保胎最有利的中药仍有很多工作要做;5)在多次IVF失败者中的运用,显示出了中医药的魅力,接下来是提高病例数,积累经验。
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