Clinical Observation Of Bushen Huoxue Recipe In The Treatment Of Premature Ovarian Insufficiency With Kidney Deficiency And Blood Stasis Syndrome

Objective:This study aims to observe the clinical efficacy and safety of Bushen Huoxue Recipe in patients with Premature Ovarian Insufficiency and kidney deficiency and blood stasis syndrome.At the same time,observe the difference of serum exosomes in patients with Premature Ovarian Insufficiency and normal ovarian function group.To increase the conception rate for more female patients,delay the decline of ovarian function,and improve the quality of life brings more possibilities.Methods:1.Collect 60 patients with Premature Ovarian Insufficiency of kidney deficiency and blood stasis type from the Second Affiliated Hospital and the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,and use random number table method to divide 60 patients with Premature Ovarian Insufficiency into observation group（Artificial cycle therapy plus Bushen Huoxue prescription）and control group（artificial cycle therapy）,30 cases each.Test group:Give hormone therapy combined with Bushen Huoxue Decoction,and give estradiol valerate tablets（Bayer Vital Gmb H,approval number:National Medicine Zhunzi J20171038）orally,1 mg/time,1 time/day,for 21 days;in service Estradiol valerate tablets plus progesterone capsules（Zhejiang Xianli Pharmaceutical Co.Ltd.,approval number:H20041902）,2 capsules/time,2 times a day;patients with normal menstrual cycle are on the fifth menstrual period Start taking the medicine on the same day,if there are no menstrual cramps,start taking the medicine after excluding pregnancy,enter the next cycle of treatment,and continue treatment for 3 menstrual cycles.Control group:only given hormone therapy,given oral estradiol valerate tablets,1 mg/time,once a day,for21 days;in the last 5 days of taking estradiol valerate tablets,plus progesterone capsules,2 capsules/Times,2 times/d;after continuous treatment for 3 menstrual cycles,compare the treatment effects of the two groups and the scores of TCM syndromes before and after treatment,serum follicle-stimulating hormone（FSH）,estradiol（E₂）,luteinizing hormone（LH）,anti-Müllerian hormone（AMH）levels.2.Collect 30 patients with normal ovarian function in the Second Affiliated Hospital and the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,and collect blood from patients with POI before treatment and30 cases from the normal ovarian function group respectively,after centrifugation Serum exosomes were extracted,and the morphological differences of exosomes were observed under electron microscope.Western-Blot was used to detect Flotillin,CD9,and TSG101,which are specific protein molecules on the surface of exosomes.Results:1.Comparison of overall effective rate:The treatment group has a cure rate of16.67%,a significant effective rate of 50.00%,an effective rate of 26.67%,and an overall effective rate of 93.33%.In the control group,the cure rate was 6.67%,the significant effective rate was 33.33%,the effective rate was 30.00%,and the overall effective rate was 70.00%.The curative effect comparison between the two groups after treatment（P<0.05）was statistically significant.2.Comparison of TCM syndrome scores:There was no statistically significant difference in TCM syndrome scores between the two groups of patients before treatment（P>0.05）.After treatment,the TCM syndrome scores of the two groups of patients were lower than before treatment,and the treatment group was lower than the control group（P<0.05）.3.Comparison of related indicators:After treatment,the serum FSH and LH of the two groups were significantly decreased,and the serum E2,AMH levels and AFC were significantly increased.Compared with this group before treatment,the differences were statistically significant（all P<0.05）,and The improvement effect of the treatment group on the indicators of patients with Premature Ovarian Insufficiency was more significant,and the differences were statistically significant compared with the control group after treatment（all P<0.05）.4.The serum exosomes were extracted and tested by Western-Blot,and it was confirmed that the exosomes-related proteins CD9,Flotillin,and TSG101 were positively expressed in the two groups of serum.It was confirmed that the extracts were exosomes,and then the normal ovarian function group was observed under a transmission electron microscope.The exosomes in the POI group are all round or oval membranous vesicles.There are low-density electrons in the vesicles,and the particle diameter is about 50-100nm,but early-onset ovaries The number of exosomes in the dysfunctional patient group was relatively less than that in the normal ovarian function group.Conclusion:1.Bushen Huoxue Decoction has a good clinical effect in treating Premature Ovarian Insufficiency of kidney deficiency and blood stasis.It can lower the patient’s FSH level,increase the AMH level,and increase the E₂ level.2.The number of exosomes in patients with POI is less than that in the normal group,which confirms that exosomes and related proteins may be related to ovarian function damage.