| ObjectivesThis clinical Study aims to observe the effectiveness and safety of Bushen Culuan Formula in the treatment of infertility caused by premature ovarian insufficiency(poi),and explore its effect mechanism to provide reliable evidence-based medicine for the diseaseMethodsAccording to the inclusion and exclusion criteria,56 cases of patients with Infertility caused by POI were included.Patients with infertility were collected from Xiyuan Hospital,Acupuncture Hospital and TCM Clinic of China Academy of Chinese Medical Sciences,due to premature ovarian insufficiency of kidney deficiency and blood stasis.They were divided into the treatment group and the control group with a random number table.The treatment group(30 cases)was treated with Bushen Culuan Formula,and the control group(26 cases)was given Elimen and Clomiphene.Results1.Comparison of total effective rate:the total effective rate in the treatment group was 93.33%,and that in the control group was 88.46%.The difference between the two groups was statistically significant(P<0.05),which indicated that Bushen Culuan Formula was effective in treating patients with POI,and was better than that of the control group.2.Comparison of ovulation rate:The ovulation rate in the treatment group was 56.7%and that in the control group was 73.08%.The difference between the two groups was statistically significant(P<0.05),indicating that the treatment of Elimen and clomiphene was better than that of Bushen Culuan Formula3.Comparison of pregnancy rates:the pregnancy rate in the treatment group was 16.67%,and that in the control group was 11.54%.The difference between the two groups was not statistically significant(P>0.05),indicating that the two groups had comparable efficacy in increasing the pregnancy rate due to the small sample size and short observation period.4.Related indicators comparison:Before and after treatment,the differences in serum hormones FSH,AMH,INHB,and FSH/LH in the treatment group were statistically significant(P<0.05),indicating that Bushen Culuan Formula can significantly improve serum hormone levels and reduce FSH/LH Value,increase AMH,INHB levels.Before and after treatment of the control group,the combination of Eleme and Clomiphene increased the AMH value,increased the number of sinusoidal follicles(AFC)(P<0.05),reduced the FSH and LH values,and increased the E2 and INHB levels in the two groups(P>0.05).After a three-month treatment cycle,there was no significant difference in the improvement of LH,E2,FSH/LH,and AMH between the two groups(P>0.05),indicating that the two group had similar effects in improving E2,FSH/LH,AMH,without significant differences.In addition,there were statistically significant differences in improving FSH,INHB levels,and increasing the number of sinusoidal follicles(P<0.05),indicating that the Bushen Culuan Formula can significantly reduce FSH,increase INHB,and increase the number of sinusoidal follicles(AFC)than the control group.5.Comparison of TCM Symptom Points:Comparing within the group after treatment,the individual TCM syndrome scores and total symptom scores of the POI patients decreased in the treatment group,and the differences were statistically significant(P<0.05),indicating that Bushen Culuan Formula can effectively improve the clinical POI symptoms caused by kidney deficiency and blood stasis and estrogen deficiency.The menstrual color and general symptom improvement showed significant differences in the control group of patients with POI(P<0.05),and the other symptoms did not improve significantly(P>0.05)among the TCM syndromes.This shows that the combination of Elimen and Clomiphene can improve the TCM syndromes to a certain extent.In addition,after treatment,the treatment group had statistically significant differences in improving menstrual darkness and total symptom scores(P<0.05),indicating that the treatment group was superior the control group in improving menstrual darkness and total symptom scores;and they both showed equally effects on improving individual symptoms such as softness in waist and legs,insomnia,low abdominal pain,menstrual period,volume,quality,chills,cold limbs,loss of libido,hot flushes and night sweats(P>0.05).Conclusions:1.This study shows that Bushen Culuan Formula and rejuvenating recipe has a definite clinical effect in treating infertility,with a total effective rate of 93.33%,which is significantly better than the combination in reducing FSH,increasing INHB levels,and increasing the number.2.Bushen Culuan Formula can effectively improve the clinical symptoms of infertility caused by POI,which belongs to the type of kidney deficiency and blood stasis.After treatment for three menstrual cycles,the patient's symptoms were effectively improved,including kidney deficiency and blood stasis syndrome,menstrual period,amount,Color,quality and estrogen deficiency.3.Bushen Culuan Formula can effectively improve the ovarian reserve function of patients with POI,and has high safety and no toxic side effects;it can be treated clinically as an empirical method.In addition,the animal experiments will be needed to further explore its mechanism of action. |
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