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张逸,杨丽萍,陈萍,孙建华.补肾养血调经方治疗肾虚血瘀型PCOS的真实世界研究[J].湖南中医药大学学报英文版,2024,44(1):70-76.[Click to copy
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| 补肾养血调经方治疗肾虚血瘀型PCOS的真实世界研究 |
| 张逸,杨丽萍,陈萍,孙建华 |
| (河南中医药大学第一临床医学院, 河南 郑州 450046;河南中医药大学第一附属医院妇产科, 河南 郑州 450099) |
| 摘要: |
| 目的 观察补肾养血调经方治疗多囊卵巢综合征（polycystic ovary syndrome， PCOS）的真实世界临床疗效。方法 收集2019年9月至2021年9月在河南中医药大学第一附属医院，142例经补肾养血调经方治疗的PCOS患者临床资料，根据有无生育需求及不孕情况，将142例PCOS患者分为3组。A组：无生育需求的PCOS患者；B组：有生育需求非不孕症的PCOS患者；C组：合并不孕症的PCOS患者。对3组患者治疗前后月经、妊娠、分娩及新生儿体质量等情况进行随访。结果 116例PCOS患者月经情况得到不同程度的改善，临床有效率达81.69%。A组无生育需求的94例PCOS患者中，生化妊娠5例（5.32%），临床妊娠5例（5.32%），持续妊娠5例（5.32%），活产4例，妊娠状态1例；B组有生育需求的29例非不孕症患者中，生化妊娠8例（27.59%），临床妊娠7例（24.14%），持续妊娠6例（20.69%），活产6例（20.69%）；C组PCOS合并不孕症者19例，平均不孕病程为（2.36±1.47）年，经治疗，生化妊娠7例（36.84%），异位妊娠1例（14.29%），临床妊娠6例（31.58%），早期流产1例（16.67%），持续妊娠5例（26.32%），晚期流产1例（16.67%），活产2例，妊娠状态2例。3组患者生化妊娠率、临床妊娠率、持续妊娠率进行组间比较，差异具有统计学意义（P<0.05）。所有妊娠患者中妊娠期糖尿病者3例（15.00%），妊娠期高血压者1例（5.00%），妊娠期亚临床甲状腺功能减退者2例（10.00%）。患者均为足月产，新生儿中巨大儿1例，余体质量均在正常范围，随访子代身体状况均良好。治疗期间患者均未出现严重不良反应。结论 补肾养血调经方可明显改善PCOS患者月经情况及生殖结局，安全性好。 |
| 关键词: 多囊卵巢综合征 补肾养血调经方 月经失调 不孕 真实世界 临床观察 |
| DOI：10.3969/j.issn.1674-070X.2024.01.011 |
| Received:July 26, 2023 |
| 基金项目:国家自然科学基金青年基金项目（82004412）；河南中医药大学博士科研启动基金项目（RSBSJJ2019-29）；河南省中医药传承与创新人才工程（仲景工程）中医药青苗人才培养项目（豫卫中医函〔2021〕16号）；河南中医药大学重点学科建设项目（15102044-2020）。 |
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| Real-world study of Bushen Yangxue Tiaojing Formula in treating PCOS of kidney deficiency and blood stasis pattern |
| ZHANG Yi,YANG Liping,CHEN Ping,SUN Jianhua |
| (The First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan 450046, China;Department of Gynecology and Obstetrics, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan 450099, China) |
| Abstract: |
| Objective To observe the clinical efficacy of Bushen Yangxue Tiaojing Formula (BSYXTJF) in treating polycystic ovary syndrome (PCOS) in real world. Methods The clinical data of 142 PCOS patients who were treated with BSYXTJF in the First Hospital of Henan University of Chinese Medicine from September 2019 to September 2021 were collected. Based on their fertility needs and infertility status, 142 PCOS patients were divided into 3 groups. Group A:PCOS patients without fertility needs; Group B:Non infertile PCOS patients with fertility needs; Group C:PCOS patients with concurrent infertility. Their menstruation, pregnancy, delivery, and neonatal weight before and after treatment were also followed up. Results The menstruation of 116 PCOS patients were improved to different degrees and the clinical effective rate was 81.69%. Among the 94 PCOS patients with no need for fertility in Group A, there were five cases of biochemical pregnancy (5.32%), five cases of clinical pregnancy (5.32%), five cases of continuous pregnancy (5.32%), four cases of live birth, and one case of pregnancy. Among the 29 non-infertility patients with need for fertility in Group B, there were eight cases of biochemical pregnancy (27.59%), seven cases of clinical pregnancy (24.14%), six cases of continuous pregnancy (20.69%), and six cases of live birth (20.69%). There were 19 PCOS patients complicated with infertility in Group C and their mean duration of infertility was (2.36±1.47) years. After treatment, there were seven cases of biochemical pregnancy (36.84%), one case of ectopic pregnancy (14.29%), six cases of clinical pregnancy (31.58%), one case of early miscarriage (16.67%), five cases of continuous pregnancy (26.32%), one case of late miscarriage (16.67%), two cases of live birth, and two cases of pregnancy. The biochemical pregnancy rate, clinical pregnancy rate, and continuous pregnancy rate were compared among the three groups of patients, and the differences were statistically significant (P<0.05). Among all the pregnant patients, there were three cases of gestational diabetes (15.00%), one case of gestational hypertension (5.00%), and two cases of subclinical hypothyroidism (10.00%). All the deliveries were full-term. Among the newborns, there was one case of macrosomia, and the body weight of remaining newborns was in the normal range. Furthermore, all the infants were in good physical condition during follow-up. None of the patients had serious adverse reactions during treatment. Conclusion BSYXTJF can obviously improve the menstruation and reproductive outcome of PCOS patients with good safety. |
| Key words: polycystic ovary syndrome Bushen Yangxue Tiaojing Formula menstrual disorders infertility real word clinical observation |
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