助孕汤治疗肾阳虚型PCOS致不孕症的临床观察

发布时间：2018-05-14 07:44

本文选题：肾阳虚型 + PCOS　；参考：《河南中医药大学》2016年硕士论文

【摘要】：目的:观察助孕汤对肾阳虚型PCOS所致不孕症患者临床症状改善、中医证候积分、体重指数(BMI)、基础体温(BBT)、妊娠率、流产率、卵泡最大直径、排卵当天子宫内膜厚度、性激素水平及安全性指标的影响,分析并评价其疗效及安全性,为中医药辨证治疗本病提供思路及方法。方法:选择2014年1月至2016年1月期间,于河南省中医院妇科门诊就诊,且符合纳入及排除标准的患者60例,按照就诊时间顺序纳入本课题。采用随机数字表法分组,试验组与对照组各30例。用双盲法研究观察,试验组给予助孕汤治疗,对照组给予龙鹿胶囊治疗,均于月经来潮第5日服至下一次月经来潮,助孕汤日一剂,水煎取汁400ml,早、晚各200ml温服,龙鹿胶囊每次5粒,每日3次,口服。治疗3个月为一个疗程,共计9个月。若患者治疗期间妊娠,则停止服药;若患者发生不良事件,及时治疗并评估是否继续治疗;若发生严重不良事件,则退出试验。采用统一指标,观察两组患者治疗前及治疗后的临床症状改善、中医证候积分、体重指数(BMI)、基础体温(BBT)、妊娠率、流产率、主卵泡最大直径、排卵当天子宫内膜厚度、性激素水平情况及安全性指标情况,对观察结果进行统计学分析,评价其疗效及安全性,得出相关结论。结果:1临床疗效对比:治疗结束后,治疗组痊愈有8例,显效14例,无效2例,有效6例,治愈率为26.67%,有效率为93.33%。对照组痊愈3例,显效8例,有效14例,无效5例,治愈率为10%,总有效率为83.33%。两组患者的临床疗效分布对比经χ~2检验,χ~2=8.395,P0.05,有统计学差异。2中医证候积分及妊娠率、流产率比较:治疗后两组患者中医症候积分均较治疗前有所降低,差异有统计学意义(P0.05)。且治疗组患者中医症候积分降低较对照组多,具有统计学差异(P0.05)。治疗组总妊娠8例,流产0例,妊娠率26.67%,流产率0%,对照组妊娠2例,流产1例,妊娠率6.67%,流产率50%。治疗组的妊娠率高于对照组,流产率低于对照组,均有P0.05,差异有统计学意义。3临床检查指标比较:试验结束后,两组患者卵巢主卵泡最大直径、BBT双相例数均较治疗前有所增加,且治疗组较对照组增加较多,差异有统计学意义(P0.05)。治疗后,试验组排卵当天内膜较治疗前有所增厚,有统计学差异(P0.05),两组患者排卵当天内膜增厚对比,无明显统计学差异(P0.05)。治疗后两组患者LH、P、T、PRL对比均有统计学差异(P0.05),E_2、FSH对比无明显差异(P0.05)。试验组治疗前后对比,LH、P、T、PRL对比均有P0.01,有显著统计学差异,E_2、FSH与治疗前相比无明显差异;对照组FSH、LH、T、PRL对比,有统计学差异(P0.05),而P、E_2与治疗前相比无明显差异。4安全性指标:治疗组及对照组血、尿、粪便常规及心电图、肝肾功能均未见明显异常,未见患者有不良反应。两组药物安全性较好。结论:通过对助孕汤治疗肾阳虚型PCOS不孕症的临床观察,研究材料表明助孕汤能有效治疗肾阳虚型PCOS不孕症,促进卵巢主卵泡最大直径增加,增加排卵当天子宫内膜厚度,改变BBT单相性,改善患者生殖内分泌水平,提高妊娠率,降低流产率,显著改善患者的临床症状和体征。治疗期间未发现患者有不良反应,且安全性监测指标示该药无明显毒副作用。本研究表明助孕汤临床疗效显著,无明显毒副作用,值得进一步研究及推行。
[Abstract]:Objective: To observe the improvement of clinical symptoms of infertility caused by kidney yang deficiency type PCOS, TCM syndrome score, body mass index (BMI), basic body temperature (BBT), pregnancy rate, abortion rate, maximum follicle diameter, endometrial thickness, sex hormone level and safety index in the day of ovulation, analysis and evaluation of its efficacy and safety, for traditional Chinese medicine. Methods: to provide ideas and methods for the treatment of this disease. Methods: from January 2014 to January 2016, 60 patients in the Department of gynaecologic clinic in Henan Traditional Chinese Medicine Hospital were treated in the Department of gynecologic clinic in Henan Traditional Chinese Medicine Hospital, and the patients were in accordance with the inclusion and exclusion criteria. The randomized digital table was used to group the patients. The test group and the control group were divided into 30 cases. The group was given the decoction of help pregnant soup, and the control group was given the long Lu Lu capsule treatment, all of which were taken to the next menstrual tide on fifth days of menstruation, one dose of soup day, 400ml, early and late 200ml, 3 times a day, 3 times a day for 3 months, for a total of 9 months. If an adverse event occurred, the patient was treated and evaluated in time to continue the treatment; if a serious adverse event occurred, the trial was withdrawn. A unified index was used to observe the improvement of the clinical symptoms before and after the treatment of the two groups, the TCM syndrome score, the body mass index (BMI), the basal body temperature (BBT), the pregnancy rate, the abortion rate, the largest diameter of the main follicle, ovulation. On the day of endometrium thickness, sex hormone level and safety index, the observation results were statistically analyzed, and the efficacy and safety were evaluated. Results: 1 clinical curative effects were compared: after the treatment, 8 cases were cured, 14 cases were markedly effective, 2 cases were not effective, 6 cases were effective, the cure rate was 26.67%, the effective rate was 93.33%. control Group healed 3 cases, effective 8 cases, effective 14 cases, invalid 5 cases, the cure rate was 10%, the total effective rate was 83.33%. two group, the clinical curative effect distribution compared through the X ~2 test, X ~2=8.395, P0.05, there were statistically different.2 TCM syndrome integral and pregnancy rate, abortion rate comparison: after treatment two groups of TCM syndrome scores were lower than before treatment, the difference was Statistical significance (P0.05). And in the treatment group, the score of TCM syndrome decreased more than the control group (P0.05). There were 8 cases of total pregnancy, 0 cases of abortion, 26.67% pregnancy rate, 0% abortion rate, 2 pregnant women in the control group, 1 abortion, 6.67% pregnancy rate, the rate of abortion rate 50%. was higher than that of the control group, the abortion rate was lower than the control group, all abortion rates were lower than the control group, all the abortion rates were lower than the control group, all the abortion rates were lower than the control group, all the abortion rates were lower than the control group, all the abortions were lower than the control group, all the abortion rates were lower than the control group, all the abortion rates were lower than the control group, all the abortion rates were lower than the control group, all the abortion rates were lower than the control group, all the abortion rates were lower than the control group, all P0.05, the difference was statistically significant.3 clinical examination index: after the test, the maximum diameter of the ovarian main follicle in the two groups, the number of BBT biphasic cases increased more than before the treatment, and the treatment group increased more than the control group, the difference was statistically significant (P0.05). After the treatment, the endometrium in the test group was thicker than before the treatment, statistically significant. Difference (P0.05), there was no significant difference between the two groups of patients on the day of ovulation, and there was no significant difference (P0.05). There were statistically significant differences (P0.05), E_2, FSH contrast between the two groups after treatment (P0.05), E_2, and FSH (P0.05). There was no significant difference in the comparison of FSH, LH, T and PRL in the control group (P0.05), while P, E_2 had no significant difference in.4 safety indexes compared with before treatment: the blood, urine, stool routine and electrocardiogram were not found in the treatment group and the control group, the liver and kidney function were not obvious abnormality, no adverse reaction was found in the patients. The two groups of drugs were safe. Clinical observation on the treatment of kidney yang deficiency type PCOS infertility, the research material shows that the decoction can effectively treat the kidney yang deficiency type PCOS infertility, promote the increase of the maximum diameter of the ovarian main follicle, increase the thickness of the endometrium on the day of ovulation, change the BBT single phase, improve the level of the reproductive endocrine, improve the pregnancy rate, reduce the abortion rate and significantly improve the patient. Clinical symptoms and signs. No adverse reaction was found during the treatment, and safety monitoring indicated that the drug had no obvious toxic and side effects. This study showed that the decoction has significant clinical effect and no obvious side effects. It is worth further study and implementation.

【学位授予单位】：河南中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R271.14

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