文章摘要

自拟柴郁寄生汤治疗高泌乳素血症伴不孕症的前瞻性随机对照研究

作者: 1崔丽敏, 2岳峰, 1张鑫, 1赵东敏
1 廊坊市妇幼保健院产前诊断中心,河北 廊坊 065000
2 廊坊市人民医院风湿科,河北 廊坊 065000
通讯: 崔丽敏 Email: lsofigh@126.com
DOI: 10.3978/j.issn.2095-6959.2021.06.019

摘要

目的:探讨自拟柴郁寄生汤治疗高泌乳素血症伴不孕症的效果。方法:采用多中心、随机、双盲、双模拟与平行对照前瞻性方式对2016年10月至2019年9月廊坊市妇幼保健院收治的106例高泌乳素血症伴不孕症的患者进行研究。以随机数字表法将106例患者分为对照组与研究组各53例。对照组服用甲磺酸溴隐亭片治疗,研究组在此基础上加用自拟柴郁寄生汤治疗。对比两组治疗的总有效率、治疗前后血清内分泌激素指标[血清催乳素(prolactin,PRL)、促卵泡激素(follicle-stimulating hormone,FSH)与孕酮(progesterone,P)]的变化、优势卵泡数、排卵数、随访6个月的妊娠率、妊娠时间,以及不良反应的发生率。结果:研究组治疗的总有效率为94.34%,高于对照组(79.25%),差异有统计学意义(P<0.05)。治疗后,研究组PRL值低于对照组(P<0.01),FSH与P值高于对照组,差异有统计学意义(P<0.01)。研究组患者优势卵泡、排卵率均高于对照组,差异有统计学意义(P<0.01或P<0.05)。随访6个月,研究组妊娠率(35.85%)高于对照组(16.98%),差异有统计学意义(P<0.05)。生存曲线数据分析表明:与对照组相比,研究组患者妊娠时间更短,差异具有统计学意义(P<0.01)。研究组不良反应发生率为3.77%,与对照组(5.66%)比较差异无统计学意义(P>0.05)。结论:自拟柴郁寄生汤治疗高泌乳素血症伴不孕症疗效确切,可以有效改善患者的内分泌激素水平,提高妊娠率,且安全可靠,值得临床推广。
关键词: 自拟柴郁寄生汤;中医;高泌乳素血症;不孕症

A prospective randomized control study of self-made Chaiyujisheng Decoction in the treatment of hyperprolactinemia with infertility

Authors: 1CUI Limin, 2YUE Feng, 1ZHANG Xin, 1ZHAO Dongmin
1 Department of Obstetrics and Gynecology, Maternal and Child Health Hospital of Langfang City, Langfang 065000, Hebei, China
2 Department of Rheumatology, Langfang People’s Hospital, Langfang 065000, Hebei, China

CorrespondingAuthor: CUI Limin Email: lsofigh@126.com

DOI: 10.3978/j.issn.2095-6959.2021.06.019

Abstract

Objective: To investigate the effect of self-simulated Chaiyujisheng Decoction on the treatment of hyperprolactinemia with infertility. Methods: A total of 106 cases of hyperprolactinemia with infertility in our hospital from October 2016 to September 2019 were studied and the prospective methods used in the research were multicenter, randomized, double-blind in addition to double simulation and parallel control. Totally 106 patients were randomly divided into a control group and a study group, with the table of random number 53 cases in each group. The control group was treated with bromocryptine mesilate tablets, and the study group was treated with Chaiyujisheng Decoction. The total effective rates of treatment, the changes of serum endocrine hormone indexes [serum prolactin (PRL), follicle-stimulating hormone (FSH), and progesterone (P)], predominance of follicles, ovulation, pregnancy rates, of follow-up for 6 months, pregnancy time, and the incidence of adverse reactions were compared between the 2 groups before and after the treatment. Results: The total effective rate of treatment in the study group was 94.34% higher than that in the control group 79.25%, and the difference was statistically significant (P<0.05). After the treatment, the PRL of the study group was lower than those of the control group (all P<0.01), and its FSH and P were higher than those of the control group with the statistically significant differences (P<0.01). The dominant follicles and ovulation rate of the study group were higher than those of the control group, and the differences were statistically significant (P<0.01 or P<0.05). After follow-up for 6 months, the pregnancy rate in the study group was 35.85% higher than that in the control group (16.98%) (P<0.05). Survival curve showed that compared with the control group, the pregnancy time of the study group was shorter, and the difference was statistically significant (P<0.01). The incidence of adverse reactions in the study group was 3.77% and the control group was 5.66%, but there was no significant difference between them (P>0.05). Conclusion: The self-designed Chaiyujisheng Decoction is effective, safe and reliable on the treatment of hyperprolactinemia with infertility, which can effectively improve the endocrine hormone levels of patients, and improve the pregnancy rate, so it is worthy of clinical promotion.
Keywords: self-imitating Chaiyujisheng Decoction; traditional Chinese medicine; hyperprolactinemia; infertility