| ObjectiveDecreased ovarian reserved, owing to the declining of reproductive and endocrine of ovarian function, is the complicated ascites diseases of the gynecology. Meantime it is also a research focus in Gynecologic endocrinology and Reproductive yield. Once did you catch this disease, the success rate of the natural conception and artificial impregnation reduced. Declining of ovarian endocrine function can lead to abnormal menstruation, take on climacteric symptoms, such as memory abilities declining; depression, anxiety; hot flashes, night sweats, vaginal dryness malaise et. c. Modern medicine Hormone replacement therapy (HRT) is used to improve the clinical syndrome at present. Such as Dehydroepiandrosterone(DHEA). Although DHEA can improve the ovarian function, its use is limited at home for potential carcinogenicity, people’s conception, unobvious curative effect, and unofficially listed in domestic. Using the complementary and alternative medicine to treat the gynecological diseases has a long-standing history, and some studies has showed that TCM has improved the ovary function, and regulated menstruation. Well the studies on the POF of kindy yin deficiency and liver yang hyperactivity is less. The capsule of nourishing yin to soothe the liver is proprietary Chinese medicine based on the30years of clinical experiences of professor Wang XY, famous physicians of CAM of Guangdong province. The capsule has been observed and used for many years. Many clinical studies has indicated it can be effective in the emotion disease. The study based on the basic theory of TCM and syndrome differentiation, aimed to whether the capsule improve the ovarian function of women in menopausal transition and its safety. The study adopted the parallel randomized controlled trails. The research object came from60women, included in the standard, of gynecology clini c of department of Guangdong province of TCM hospital from March2012to March2013. Then experient groups were Were divided into the capsule of nourishing yin to soothe the liver and the sham groups is the kuntai caps ule.12weeks later, we would compared the efficiency treatment and its safety before and after. We observed the change of menstrual cycle,1peri od and the volume；and determined the FSH (follicle-stimulating hormone), estradiol (E2), serum inhibin B (INH-B), seedling resistance tube hormone (AMH), ovarian hemodynamics by transvaginal sonography and evaluated the effect of capsule of nourishing yin to soothe the liver on the function o varian by Chinese medicine symptom complex scoreat the Early follicular p hase (also3～5days of menstrual cycle. For those Amenorrhea, should no dominant follicle or the thickness endometrium≦5mm, or in the3～5days of MPA (medroxyprogesterone) withdraw bleeding, do we collected blood s ampling from the venous). Safety indexes including blood, urine, stool ro utine, liver and kidney function, electrocardiogram. In this studies we s hould timely observe and record adverse effective. When analysis data we would use PASW Statistic18.0. multiple comparisons in independent sample s with t test, non-normal distribution or heterogeneity of variance adopt ed the Rank Sum Test. Comparing the group used paired sample t test or ma tching symbols of rank sum test. When the range of baseline data is shift, make the baseline as covariate by covariance analysis.Results(1) The treatment group and control group in age, height, weight, menstrual disorders, motherhood, syndrome score, serum FSH, E2, AMH, INH-B, bilateral ovarian volume and ovarian stromal artery peak flow velocity (PSV), right ovary, resistance index (RI) had no statistical significance of differences before treatment. Baseline data were comparable. The serum LH, FSH/LH, left ovarian RI had differences has been between two groups, made the baseline as covariate by covariance analysis. Correlation between two variables analysis showed that in serological indexes part of patients had affinity connection, such as:FSH showed negative correlation relationship between E2and INH-B. INH-B showed negative correlation relationship with the FSH/LH, the right ovarian volume showed positive correlation relationship with INH-B in Gynecological B ultrasonic, the left ovarian PSV showed positive correlation relationship with AMH. The right ovarian PSV showed positive correlation relationship with AMH.The right ovarian PSV showed positive correlation relationship with INH-B. Those results showed the ovarian endocrine indexes and ultrasound ovarian hemodynamics index has certain relevance, which can reflect to some extent the ovarian function.(2) The total score after treatment of menstrual disorders, main syndrome and all the syndrome was more decreased than before the treatment in treatment groups, so the difference has statistical significance. The total score after treatment of main syndrome and all the syndrome more decreased than before the treatment in control groups. the difference has statistical significance. Although the score of menstrual disorders has been declined, the difference has no statistical significance (P>0.05). The compare between the treatment and control showed treatment group in improving the menstrual disorder was better than the control group. The treatment group improving the main syndrome、 all clinical syndrome and menstrual disorders was better than than controls in the patients of Less than or equal to40, the difference has statistical significance.(3)The serological indexes and ultrasound parameters change of two groups treatment before and after has no statistical significance. But for those Less than or equal to40, in improving the level of INH-B, the treatment is better than control. The difference has statistical significance.(4) Before and after treatment No obvious abnormal case of Two groups of patients was found in all safety index, such as blood, urine, stool routine, liver and kidney function, electrocardiogram. Adverse reaction,3cases in treatment group for the loose stools;2cases in control group for Breast distending pain, has no clinical significance through statistic analysis. So the groups of medicine were safe.Conclusion(1) the capsule of nourishing yin to soothe the liver can effectively improve the menstrual disorders:regulating the the menstrual cycle, increasing the menstrual volume of hypomenorrhea patients, Shorten the menstrual extension period; effectively relieving symptoms of kindy Yin deficiency and liver yang hyperactive, for example irritability, xerostomia to drink, overexertion and fatigue, soreness and weakness of waist and knees, baking hot and sweating, eye dryness et.c.(2)Although the two groups can’t restore the abnormal serology indexes to normal levels, the capsule of nourishing yin to soothe the liver is better han controls in raising the level of serum INH-B.(3) In study, neither taken on the safety indexes of two groups the clinical difference, nor adverse drug reaction, which demonstrated it was very safe with TCM in decline of ovarian reverse.(4) The capsule of of nourishing yin to soothe the liver can improve the condition of the menstrual disorders, effectively relive the syndrome of kindy Yin deficiency and liver yang hyperactive, and improve the ovarian function. Meantime it is a kind of worthy to extending proprietary Chinese medicine for qualify of safeness、convenience and cheapness. |
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