加味五子衍宗丸治疗肾虚精亏证黄体功能不全所致的女性不孕

Modified Wuzi Yanzongwan for Female Infertility Kidney Essence Deficiency Syndrome Caused by Luteal Phase Defect

摘要:

目的：探讨加味五子衍宗丸对黄体功能不全（LPD）所致女性不孕妊娠率的疗效及对激素水平和子宫内膜容受性的影响。方法：将130例患者随机按数字法分为对照组和观察组各65例。对照组采用地屈孕酮片，在阴道B超监测到排卵后当日服用，20 mg·d^-1，连续服用10 d；未孕者，下个月经周期继续服用；若已怀孕，怀孕初期可以继续服用，根据孕酮水平调节用量。观察组内服加味五子衍宗丸，1剂/d。两组受孕者均给予维生素E胶囊，0.1 g/次，3次/d。两组疗程均连续观察3个月经周期，疗程结束后随访3个月经周期。记录6个月周期（治疗+随访）内的妊娠情况，并随访观察活胎率；测量基础体温（BBT），并进行黄体功能基础体温髙温相评分（HPS）；检测促卵泡刺激素（FSH），黄体生成素（LH），雌二醇（E₂）和孕酮（P）水平；采用彩色B超记录优势卵泡情况，并记录子宫内膜螺旋动脉搏动指数（PI）和阻力指数（RI），测量子宫内膜厚度，并进行Salle评分；进行肾虚精亏证评分；以上指标治疗前后各评价1次。结果：对照组临床疗效总有效率为77.42%，观察组为93.65%，观察组高于对照组（χ²=6.678，P<0.01）；对照组临床妊娠率为32.26%，观察组为52.38%，观察组临床妊娠率高于对照组（χ²=5.181，P<0.05），两组活胎率比较差异无统计学意义；治疗后观察组FSH，LH，E₂和P水平高于对照组（P<0.01）；治疗后观察组HPS评分高于对照组，优势卵泡直径大于对照组，肾虚精亏证评分低于对照组（P<0.01）；治疗后观察组Salle评分高于对照组，子宫内膜增厚于对照组，PI和RI均低于对照组，A型子宫内膜比例多于对照组（P<0.01）；两组治疗期间均无不良反应及严重不良事件的发生。结论：加味五子衍宗丸治疗LPD所致不孕肾虚精亏证患者，能调节HPOA轴，提高了黄体功能，改善激素水平，减轻肾虚精亏证评分，改善了子宫内膜容受性，从而提高妊娠率，临床疗效优于西医治疗。

Abstract:

Objective: To discuss the efficacy of modified Wuzi Yanzongwan for female infertility caused by luteal phase defect (LPD) and investigate its effect on hormone levels and endometrial receptivity. Method: One hundred and thirty patients were randomly divided into control group (65 cases) and observation group (65 cases) by random number table. Patients in control group took Dydrogesterone tablets from the day of ovulation detected by vaginal B-ultrasound, 20 mg/day for continuous 10 days. If not pregnant, Dydrogesterone tablets were taken continuously at the next menstrual cycle. If pregnant, Dydrogesterone tablets can be taken at the early pregnancy stage and their dose shall be adjusted according to progesterone levels. Patients in observation group added modified Wuzi Yanzongwan, 1 dose/day. Pregnant women in both groups took vitamin E capsules, 0.1 g/time, 3 times/day. The treatment course was 3 menstrual cycles for both groups, and the follow-up period was also 3 menstrual cycles after treatment. The pregnancy was recorded for a total of 6 months (treatment and follow-up), and the live fetus rate was observed in follow-up. Basal body temperature (BBT) was detected, and the scores of high-temperature phase (HPS) of luteal basal body temperature were graded. Levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E₂) and progesterone were detected. Dominant follicle conditions, and endometrial thickness were recorded by colorful B-ultrasound. Endometrial spiral arteries pulsatility index (PI), resistance index (RI) and endometrial thickness were measured and recorded. Scores of Salle and kidney essence deficiency syndrome were graded. The above indexes were evaluated both before and after treatment. Result: The total effective rate for the disease was 93.65% in observation group, higher than 77.42% in control group (χ²=6.678, P<0.01). Clinical pregnancy rate was 52.38% in observation group, higher than 32.26% in control group (χ²=5.181, P<0.05) after treatment, but there was no statistically significant difference in live fetus rate between two groups. After treatment, levels of FSH, LH, E₂ and P and scores of HPS and Salle were higher than those in control group (P<0.01). Diameter of dominant follicle was shorter than that in control group (P<0.01). And score of kidney essence deficiency syndrome was lower than that in control group (P<0.01). Endometrial thickening was less than that in control group (P<0.01). PI and RI were lower than those in control group (P<0.01). Ratio of type A endometrium was larger than that in control group (P<0.01). There were no adverse reactions and serious adverse events during treatment. Conclusion: Modified Wuzi Yanzongwan can regulate HPOA axis, improve luteal function, ameliorate hormone and endometrial receptivity, reduce scores of kidney essence deficiency to improve pregnancy rate. Its clinical efficacy is superior to that of western medicine.