Xiaoyue Jiang, Yinyin Diing, Xinyuan Liu, Fang Ruan, Yeting Zou, Yanli Hong, Huifang Zhou
the First School of Clinical Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China.
Department of Gynecology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
J Tradit Chin Med. 2025 Oct;45(5):1098-1105. doi: 10.19852/j.cnki.jtcm.2025.05.016.
To evaluate the effectiveness and safety of the sequential therapy in treating infertility with polycystic ovary syndrome (PCOS) and luteal phase defects (LPD) by Yangxin Dianji decoction (, YXDJ-D) and Nuangong Tiaojing decoction (, NGTJ-D).
This study was undertaken in the Jiangsu Province Hospital of Chinese Medicine. Altogether 90 eligible patients with PCOS and LPD were assigned to exposed group A (Chinese Medicine therapy, YXDJ-D and NGTJ-D), exposed group B (Chinese Medicine plus Western Medicine therapy), control group (Western Medicine therapy). The exposed group A adopted the sequential therapy that YXDJ-D is taken in the postmenstrual period (follicular phase) and NGTJ-D is taken in premenstrual period (luteal phase). Control group took letrozole, dydrogesterone and was given intramuscular injection of human menopausal gonadotropin, human chorionic gonadotropin. The exposed group B was treated with the above-mentioned therapy project of integrated Chinese Medicine and Western Medicine. This study lasted for 2 courses for 6 months. The primary outcomes were pregnancy rate and early abortion rate. The secondary outcomes were the Traditional Chinese Medicine (TCM) syndrome scores, estrogen (E) and progesterone (P), endometrial volume (EV), vascularity index (VI), flow index (FI) and vascularization flow index (VFI). These outcomes will be assessed at baseline and post-intervention.
The pregnancy rates of the exposed group A and B were higher than the control group (60.00% 60.00% 53.33%), while early abortion rates of exposed groups A and B were lower than the control group (33.33% 16.67% 43.75%, 0.05). Total efficacy rates in exposed group A and B were better than the control group (93.30% 93.30% 53.30%, 0.01). TCM symptom scores and endometrial receptivity indexes (EV, FI, VFI) were significantly lower in exposed groups compared to the control group ( 0.05). P increase in exposed group B was superior to the other two groups ( 0.01). No noticeable abnormalities in safety indicators in the three groups.
The sequential therapy of YXDJ-D and NGTJ-D can effectively increase pregnancy rate, reduce the early abortion rate and alleviate the clinical symptoms of infertility in patients with PCOS and LPD by improving luteal function and promoting the endometrial receptivity.
评价养心调经汤（YXDJ-D）与暖宫调经汤（NGTJ-D）序贯疗法治疗多囊卵巢综合征（PCOS）合并不孕症及黄体期缺陷（LPD）的有效性和安全性。
本研究在江苏省中医院进行。共90例符合条件的PCOS合并LPD患者被分为暴露组A（中医治疗，YXDJ-D和NGTJ-D）、暴露组B（中西医结合治疗）、对照组（西医治疗）。暴露组A采用序贯疗法，经后期（卵泡期）服用YXDJ-D，经前期（黄体期）服用NGTJ-D。对照组服用来曲唑、地屈孕酮，并给予肌肉注射人绝经期促性腺激素、人绒毛膜促性腺激素。暴露组B采用上述中西医结合治疗方案。本研究持续2个疗程，共6个月。主要结局指标为妊娠率和早期流产率。次要结局指标为中医证候评分、雌激素（E）和孕激素（P）、子宫内膜容积（EV）、血管化指数（VI）、血流指数（FI）和血管化血流指数（VFI）。这些结局指标将在基线和干预后进行评估。
暴露组A和B的妊娠率高于对照组（60.00%、60.00%、53.33%），而暴露组A和B的早期流产率低于对照组（33.33%、16.67%、43.75%，P<0.05）。暴露组A和B的总有效率优于对照组（93.30%、93.30%、53.30%，P<0.01）。与对照组相比，暴露组的中医症状评分和子宫内膜容受性指标（EV、FI、VFI）显著降低（P<0.05）。暴露组B的P升高优于其他两组（P<0.01）。三组安全性指标均无明显异常。
YXDJ-D与NGTJ-D序贯疗法可通过改善黄体功能、促进子宫内膜容受性，有效提高PCOS合并LPD患者的妊娠率，降低早期流产率，缓解不孕临床症状。
