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活血补肾配方颗粒对多囊卵巢综合征不孕症患者促排卵周期子宫内膜容受性的影响

Effects of Huoxue Bushen Formula Granules on endometrial receptivity during ovulation induction in infertility patients with polycystic ovary syndrome

摘要:

目的:探讨活血补肾配方颗粒对PCOS不孕症患者促排卵周期子宫内膜容受性(ER)的影响。方法:随机对照试验研究。选择2019年1月-2023年1月中国中医科学院西苑医院50例PCOS不孕症患者作为观察对象,采用随机数字表法分为观察组29例、对照组21例。2组均于月经周期或黄体酮撤退出血第5天起口服枸橼酸氯米芬。在此基础上,于月经第5天起观察组服用活血补肾配方颗粒,对照组服用戊酸雌二醇片。服药至注射hCG后7 d,自月经第10天起监测排卵并指导同房。2组均治疗3个月经周期,随访3个月。于排卵后6~8 d行B超检测并获取子宫动脉搏动指数(PI)、血流阻力指数(RI)。分别于治疗前后进行中医证候评分,采用子宫内膜容受性评分(Salle评分)评估ER水平,记录2组妊娠情况及治疗期间的不良反应。结果:治疗后,观察组中医证候评分[14.0(13.0,15.0)分比16.0(14.5,19.5)分, Z=-3.23]低于对照组( P<0.001)。观察组治疗后Salle评分[12.0(9.5.0,13.5)分比10.0(9.0,11.0)]分, Z=-3.84]高于同组治疗前( P<0.001)。观察组治疗后PI[(0.68±0.52)比(0.81±0.06), t=18.25]、RI[(1.65±0.36)比(2.24±0.45), t=22.78]及对照组治疗后PI[(0.68±0.61)比(0.82±0.07), t=18.89]、RI[(1.80±0.41)比(2.23±0.44), t=21.82]低于同组治疗前( P<0.001),但2组治疗后比较差异无统计学意义( t值分别为-0.39、-1.37, P>0.05)。观察组总有效率为75.86%(22/29)、对照组为71.43%(15/21),2组比较差异无统计学意义( χ2=0.12, P=0.724)。观察组妊娠率为82.76%(24/29)、对照组为57.14%(12/21),2组比较差异有统计学意义( χ2=3.96, P=0.046)。观察组不良反应发生率为3.45%(1/29)、对照组为9.52%(2/21),2组比较差异无统计学意义( χ2=0.80, P=0.372)。 结论:活血补肾配方颗粒可改善PCOS不孕症肾虚血瘀证患者ER,提高妊娠率,降低中医证候评分,提高患者生活质量,且安全性较好。

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abstracts:

Objective:To evaluate the effects of Huoxue Bushen Formula Granules on endometrial receptivity (ER) in patients with polycystic ovary syndrome (PCOS) in ovulation induction cycle.Methods:A randomized controlled trial was conducted. Totally 50 patients with PCOS infertility in Xiyuan Hospital of China Academy of Chinese Medical Sciences from January 2019 to January 2023 were selected as the observation objects, and were divided into observation group (29 cases) and control group (21 cases) according to the random number table method. Both groups were given oral clomiphene citrate on the 5th day of menstrual cycle or progesterone withdrawal. On this basis, the observation group was given Huoxue Bushen Formula Granules on the 5th day of menstruation, while the control group was given estradiol valerate tablets. 7 days after taking medication and injecting hCG from the 10th day of menstruation, ovulation was monitored and sexual intercourse was guided. Both groups were treated for 3 menstrual cycles and followed up for 3 months. B-ultrasound was performed on 6-8 days after ovulation to obtain uterine artery pulsatility index (PI) and blood flow resistance index (RI). TCM syndrome scores were evaluated before and after treatment, and the endometrial receptivity score (Salle score) was used to evaluate the level of ER. The pregnancy and adverse reactions during treatment were recorded in the two groups.Results:After treatment, TCM syndrome score in the observation group [14.0 (13.0, 15.0) vs. 16.0 (14.5, 19.5), Z=-3.23] was lower than that of the control group ( P<0.001). The Salle score of the observation group after treatment [12.0 (9.5.0, 13.5) vs. 10.0 (9.0, 11.0), Z=-3.84] was higher than that before treatment ( P<0.001). The PI (0.68±0.52 vs. 0.81±0.06, t=18.25), RI (1.65±0.36 vs. 2.24±0.45, t=22.78) after treatment in the observation group and the control group were lower than those before treatment ( P<0.001), without statistical significance ( t values were -0.39, -1.37, respectively, P>0.05). The total effective rate of the observation group was 75.86% (22/29), and that of the control group was 71.43% (15/21), without statistical significance ( χ2=0.12, P=0.724). The pregnancy rate of the observation group was 82.76% (24/29), and that of the control group was 57.14% (12/21), with statistical significance ( χ2=3.96, P=0.046). The incidence of adverse reactions of the observation group was 3.45% (1/29) and that of the control group was 9.52% (2/21), without statistical significance ( χ2=0.80, P=0.372). Conclusion:Huoxue Bushen Formula Granules can improve the ER of PCOS infertility patients with kidney deficiency and blood stasis syndrome, improve the pregnancy rate, reduce the TCM syndrome score, improve the quality of life of patients with high safety.

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作者: 朱雪莹 [1] 张路 [2] 黄欲晓 [3] 沈建武 [4] 李军茹 [5] 罗然 [3]
期刊: 《国际中医中药杂志》2024年46卷9期 1128-1133页 ISTIC
栏目名称: 临床研究
DOI: 10.3760/cma.j.cn115398-20231125-00294
发布时间: 2024-09-17
基金项目:
中国中医科学院科技创新工程项目 中国中医科学院西苑医院苗圃课题 Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences Nursery Project of Xiyuan Hospital, China Academy of Chinese Medical Sciences
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