基于“脾肾为本”以滋肾育胎丸论治多囊卵巢综合征不孕症临床效果与安全性观察

Clinical Effect and Safety Observation of Zishen Yutai Pill(滋肾育胎丸)Treating PCOS Infertility Based on“Spleen and Kidney As The Foundation”

目的观察基于“脾肾为本”以滋肾育胎丸论治多囊卵巢综合征(PCOS)不孕症临床效果与安全性。方法纳入97例PCOS不孕症患者(2019年4月—2021年1月),将其以随机数字表法分成对照组(48例)及观察组(49例),予以对照组患者来曲唑、地屈孕酮治疗,予以观察组来曲唑、地屈孕酮+滋肾育胎丸治疗。数据观察:疗效、1年妊娠率、治疗前后中医证候积分(月经稀发、闭经、头晕耳鸣、食少纳呆)变化、子宫内膜容受性指标变化、不良反应。结果观察组治疗总有效率(95.92%,47/49)比对照组(83.33%,40/48)更高,且观察组患者1年妊娠率高(P<0.05);治疗前,两组患者中医证候积分(月经稀发、闭经、、头晕耳鸣、食少纳呆)、黄体生成素(LH)、子宫动脉阻力指数(RI)及子宫动脉搏动指数(PI)等子宫内膜容受性指标比较无统计学意义(P>0.05),治疗后各组患者中医证候积分(月经稀发、闭经、、头晕耳鸣、食少纳呆)、RI、PI等指标均改善,观察组患者治疗后中医证候积分(月经稀发、闭经、、头晕耳鸣、食少纳呆)、RI、PI等指标优于对照组,(P<0.05);两组均未见严重胃肠道反应及肝肾功能等不良反应。结论基于“脾肾为本”以滋肾育胎丸论治PCOS不孕症临床效果显著,可提升患者妊娠率,改善患者病情,且安全可靠,值得应用。

Objective To observe the clinical effect and safety of Zishen Yutai Pill(滋肾育胎丸)treating polycystic ovary syndrome(PCOS)infertility based on“spleen and kidney as the foundation”.Methods In this study,97 PCOS infertile patients from April 2019 to January 2021 were included and divided into control group(48 cases)and observation group(49 cases)by random number table method.Patients in the control group were treated with letrozole and didrogesterone,and those in the observation group were treated with letrozole and didrogesterone combined with Zishen Yutai Pill.The curative effect,1-year pregnancy rate,TCM syndrome score before and after treatment(oligomenorrhea,amenorrhea,dizziness,tinnitus,reduced eating and and loss of appetite),endometrial receptivity index changes and adverse reactions of two groups were compared.Results The total effective rate in the observation group(95.92%)was higher than that in the control group(83.33%),and the 1-year pregnancy rate in the observation group was higher(P<0.05).Before treatment,the comparison of endometrial receptivity indexes,such as TCM syndrome scores(oligomenorrhea,amenorrhea,dizziness,tinnitus,reduced eating and and loss of appetite),luteinizing hormone(LH),uterine artery resistance index(RI)and uterine artery pulsatility index(PI)between two groups had no significance(P>0.05).After treatment,TCM syndrome scores(oligomenorrhea,amenorrhea,dizziness,tinnitus,reduced eating and and loss of appetite),RI,PI and other indicators were improved in each group,while those were better in the observation group than those in the control group(P<0.05).No serious gastrointestinal reaction and liver and kidney function were observed in both groups.Conclusion Based on“spleen and kidney as the foundation”,Zishen Yutai Pill has significant clinical effect in the treatment of PCOS infertility and can improve the pregnancy rate of patients and improve the condition of patients.It is safe and reliable,worthy of application.