脱氢表雄酮补充治疗卵巢功能低下患者的临床研究

发布时间：2018-05-05 23:32

本文选题：脱氢表雄酮 + 卵巢功能低下　；参考：《山东大学》2014年硕士论文

【摘要】：背景和目的脱氢表雄酮(Dehydro-epiandrosterone, DHEA)应用于卵巢功能低下患者的治疗已有10余年时间,其在改善卵巢功能、调节免疫、改善代谢及保护心血管等方面的作用明显,使得DHEA成为近年来妇科内分泌的研究热点。国内外多数关于DHEA的研究提示其有效性,故其在改善生育功能和围绝经期症状方面得到广泛应用,但尚缺乏关于DHEA的作用机制及安全性,及DHEA对中国人有效性和耐受性的研究资料,需要开展更多大样本量、随机对照的基础、临床试验。本研究通过分析卵巢功能低下患者服用DHEA前后卵巢功能指标及肝功能变化,观察DHEA是否能改善卵巢功能,是否对肝功能产生影响,为卵巢功能低下患者应用DHEA治疗提供有效性及安全性的证据。方法本研究以诊断为卵巢功能低下的患者为研究对象,共54名符合入选标准,根据就诊顺序编号,随机分为治疗组和对照组,治疗组(n=32)口服DHEA胶囊(每日3次,每次25mg),连续服用3个月；对照组(n=22)口服维生素E(每日1次,每次100mg),连续服用3个月。记录所有患者服药前和服药3个月后的促卵泡激素(follicle-stimulating hormone,FSH)、黄体生成激素(luteotrophic hormone, LH)、雌二醇(estradiol, E2)、睾酮(testosteroneT)、硫酸脱氢表雄酮(dehydroepiandrosterone sulphate, DHEAS)及胰岛素样生长因子-1(insulin-like growth factor-1, IGF-1),门冬氨酸氨基转移酶(alanine aminotransferase, AST)、丙氨酸氨基转移酶(alanine aminotransferase, ALT),基础窦卵泡数(antral follicle count, AFC),记录身高和体重并计算体重指数(body mass index, BMI)。运用SPSS20.0中文版软件包对所统计数据进行分析。结果本研究共收集54例患者,服药前治疗组、对照组患者一般资料、内分泌水平、AFC和肝功能对比,两组没有统计学差异(P0.05)。治疗组应用DHEA后,FSH水平和FSH/LH较治疗前显著降低(P0.05)：血清LH、E2无明显变化；AFC数目较治疗前有所增加,但不具备统计学差异(P0.05)；治疗组用药后血清T、DHEAS及IGF-1水平较前均有所升高,其中IGF-1升高不具备统计学差异(P0.05),血清T及DHEAS水平治疗后均明显升高(P0.05)；AST、ALT及BMI的变化均无统计学差异(P0.05)；不良反应：1例患者因卵巢多囊样改变而停药；完成试验者中2例出现面部痤疮,4例诉面部油腻感。治疗后与对照组比较,治疗组血清FSH水平、FSH/LH比值显著降低(P0.05),血清DHEAS、T水平显著升高(P0.05)；两组间其他观察项目(AFC、血清LH、E2、IGF-1水平、AST、ALT及BMI)无明显变化(P0.05)；对照组未发现不良反应。结论 1.DHEA可降低血清FSH水平、FSH/LH比值,说明其能改善卵巢功能。 2.DHEA可提高血清DHEAS、T水平,同时可能因雄激素的增高引起不良反应。 3.本研究不支持DHEA可提高窦卵泡数、血清IGF-1水平。 4.本研究DHEA应用方案并未导致肝功能及体重指数变化。
[Abstract]:Background and purpose Dehydroepiandrosterone (DHEA) has been used in the treatment of patients with ovarian dysfunction for more than 10 years. It plays an important role in improving ovarian function, regulating immunity, improving metabolism and protecting cardiovascular system. DHEA has become the focus of gynecological endocrine research in recent years. Most studies on DHEA at home and abroad suggest that it is effective, so it is widely used in improving reproductive function and peri-menopausal symptoms, but it lacks the mechanism and safety of DHEA. And DHEA for Chinese effectiveness and tolerance research data, need to carry out more large sample size, randomized controlled basis, clinical trials. In this study, we analyzed the changes of ovarian function and liver function in patients with hypofunctional ovary before and after taking DHEA, and observed whether DHEA could improve ovarian function and influence liver function. To provide evidence of efficacy and safety for patients with ovarian dysfunction treated with DHEA. Method In this study, 54 patients with ovarian dysfunction were randomly divided into treatment group (n = 54) and control group (n = 32) by oral administration of DHEA capsule (3 times a day). The control group was given vitamin E once a day, 100 mg / time for 3 months. The follicle-stimulating hormone follicle stimulating hormone FSHS, luteotrophic hormone, LHN, estradiol, E2, testosterone, dehydroepiandrosterone sulphate (DHEAS-1), insulin-like growth factor-1 (IGF-1), aspartate aminotroponin were recorded in all patients before and 3 months after administration. Alanine aminotransferase, alt, basic antral follicle count, AFCU, body height and weight were recorded and body mass index (BMI) was calculated. Using the Chinese version of SPSS20.0 software package to analyze the statistical data. Result In this study, 54 patients, before treatment group and control group, general data, endocrine level of AFC and liver function were compared. There was no statistical difference between the two groups (P 0.05). The levels of DHEA and FSH/LH in the treatment group were significantly lower than those before the treatment. The number of serum DHEA E2 was not significantly changed, but there was no statistical difference between the two groups, and the serum levels of THEAS and IGF-1 in the treatment group were higher than those before treatment, and the levels of THEAS and IGF-1 in the treatment group were higher than those before the treatment. The level of serum T and DHEAS were significantly increased after treatment. There was no significant difference in the changes of alt and BMI between the two groups. Of the 2 patients who completed the trial, 4 had facial acne and complained of facial greasy feeling. After treatment, compared with the control group, the serum FSH level and FSH / LH ratio in the treatment group were significantly lower than those in the control group (P 0.05), and the serum DHEASA T level was significantly higher than that in the control group (P 0.05), while other observation items such as AFC, serum LHH E2IGF-1 level, alt and BMIs were not significantly changed in the two groups, while no adverse reactions were found in the control group. Conclusion 1.DHEA can decrease serum FSH level and FSH / LH ratio, indicating that 1.DHEA can improve ovarian function. 2.DHEA can increase the serum DHEAST level and may cause adverse reactions due to the increase of androgen. 3. This study does not support that DHEA can increase the number of antral follicles and the level of serum IGF-1. 4. The application of DHEA in this study did not result in changes in liver function and body mass index (BMI).
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R711.75

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