| ObjectiveIn this study,randomized,controlled,double-blind clinical trials,comparison and evaluation of Zishen Tiaogan method for the treatment of traditional Chinese medicine Yangyin Shugan capsule and placebo control program for the treatment of kidney deficiency and depression of menopausal transitional period of early decline in ovarian function in patients The effectiveness and safety of clinical treatment of ovarian function to provide evidence-based basis.MethodsIn this study,randomized,controlled,and double-blind clinical trials were conducted.From April 2016 to January 2017,84 patients with kidney deficiency and liver depression were selected to meet the diagnostic criteria and criteria for inclusion in the gynecological outpatient department of Guangdong Provincial Hospital.Early stage of ovarian dysfunction in patients with the study.Were randomly divided into treatment group(Yangyin Shugan capsule group)and control group(placebo group)according to the selection criteria.The treatment group was given Yangyin Shugan capsule,the control group of placebo capsules,the two groups were treated for 12 weeks.The main efficacy indicators included menstrual score and TCM syndrome score;serum basic hormone levels,AMH,INHB;vaginal color B-ultrasound monitoring of the number of basal ganglia and ovarian hemodynamics;safety indicators include blood,urine,Liver function(alanine aminotransferase,aspartate aminotransferase),renal function(urea,creatinine),electrocardiogram.At the time of observation,the efficacy index was measured at the 12th week,and the safety index was measured before and after treatment.During the study period,adverse events and adverse drug reactions were observed and recorded closely.The data were calculated using PASW statistics 18.0.Results1.Efficacy analysis(1)menstrual score and TCM syndrome score analysis? Comparison of the results showed that:Yangyin Shugan group after treatment of menstrual flow,menstrual color,irritability,swollen,Ya.oxisuanruan,nocturia,depression,chest tightness sigh,loss of libido,insomnia were lower than before treatment,that Yangyin Shugan capsule(P<0.05);placebo treatment after irritability,Ya.oxisuanruo,nocturia,depression,loss of libido(P<0.05);placebo treatment after treatment irritability,Yaoxisuanruan,nocturia,depression,loss of libido(P<0.05).The scores of insomnia were lower than those before treatment,and the difference was statistically significant(P<0.05).The scores of qi deficiency syndrome,deficiency of kidney deficiency syndrome,syndrome of liver depression syndrome and total score of syndrome were significantly lower than those before treatment,and the difference was statistically significant(P<0.05).The scores of the menstrual disorders,the scores of the deficiency of the kidney,the points of the syndrome and the total score of the syndrome were significantly lower than those before treatment.The difference was statistically significant(P<0.05).? Comparison between groups showed:The scores of the two groups were lower than those in the placebo group,and there was significant difference between the two groups(P<0.05).The difference was statistically significant(P<0.05).Comparison between the two groups after treatment of menstrual disorders score and TCM syndrome score difference between the group found that Yangyin Shugan capsule than the placebo group difference is higher,which in the swelling,nocturia,chest tightness sigh,insomnia(P<0.05).The difference between the two groups was statistically significant(P<0.05),and the difference was statistically significant(P<0.05).Conclusion:Yangyin Shugan capsule can alleviate the symptoms of kidney deficiency and liver depression.The scores of the two groups were compared between the two groups after treatment.It was found that the scores of Yangyin Shugan capsule were lower than those of the placebo group,but the improvement effect was not obvious.The difference was statistically significant(P>0.05).Compared with the difference between the two groups after treatment,it was found that there was a difference between the scores of syndrome and syndromes of liver depression syndrome,and it was suggested that Yuyin Shugan capsule could alleviate better than placebo Ovarian function in patients with liver depression symptoms,the independent sample rank and test,the difference was statistically significant(P<0.05).?Compared with the placebo group,the difference was statistically significant(P<0.05).Conclusion:Yangyin Shugan capsule is superior to the placebo group in the improvement of menstrual disorders and the total score.(2)bFSH,bLH,bE2,bFSH/bLH level analysis?The results showed that there was no significant difference in bFSH,bLH,bE2 and bFSH/bLH levels between the two groups before and after treatment,and there was no significant difference between the two groups(P>0.05)There were no significant differences in bFSH,bLH,bE2 and bFSH/bLH levels between the two groups before and after treatment,and there was no significant difference between the two groups(P>0.05).? Comparison between groups showed:There was no significant difference in bFSH,bLH,bEH,bFSH/bLH between the two groups before and after treatment,and there was no significant difference between the two groups(P>0.05).The levels of bFSH,bLH,bE2,bFSH/bLH(P>0.05).The difference between the two groups was not significant,and the differences were not statistically significant(P>0.05).(3)Analysis of serum AMH and INHB levels? Comparison of the results showed that:The levels of serum AMH in the placebo group were significantly higher than those in the control group(P<0.05),and the serum levels of AMH were significantly higher than those in the control group(P<0.05)(P<0.05).The level of serum AMH in the placebo group was lower than that in the control group(P<0.05),and the difference was statistically significant(P<0.05).? Comparison between groups showed:The two groups after treatment found Yangyin Shugan capsule than in the placebo group the level of INHB increased significantly,the independent sample rank sum test,the difference was statistically significant(P<0.05);the difference of serum AMH and INHB levels in the two groups after treatment were compared between the two groups,found Yangyin Shugan capsule and the placebo group is higher than the poor,by the independent samples t test and the Wilcoxon rank sum test,the difference between groups was significant(P<0.05).(4)the number of basal antral follicles and bilateral ovarian blood flow analysis? Comparison of the results showed that:After treatment,the AFC and the left ovarian PSV of the ovariectomized group were higher than those before treatment,suggesting that the effect of Yangyin Shugan Capsule on the improvement of sinus follicle and ovarian blood flow was analyzed by the matched rank test.The difference was statistically significant(P<0.05).There was no improvement in the number of basal ganglia and bilateral ovarian blood flow after treatment in the placebo group.There was no significant difference between the two groups(P>0.05).? Comparison between groups showed:Compared with the placebo group,the effect of Yinyin Shugan group was not obvious,and the difference between the two groups was statistically significant,and the difference between the two groups was statistically significant(P>0.05).Compared with the placebo group,the difference between the two groups was higher than that of the placebo group(P>0.05).There was no significant difference between the two groups(P>0.05).2.Security analysisBefore and after treatment,both groups of patients were blood,urine,liver function,renal function,ECG safety indicators,the results showed that the two groups of patients with no significant abnormalities in the detection of safety indicators.And no adverse reactions,suggesting that yin Shu Shu capsule is safe.Conclusion(1)Yangyin Shugan capsule can improve the menopausal transitional period of early decline in ovarian function in patients with irregular menstruation and kidney deficiency type of clinical symptoms,it is worth promoting the application.(2)Yangyin Shugan capsule to improve the basis of FSH,LH,E2,FSH/LH levels were not obvious,maybe through the hormone outside the regulatory pathway,the mechanism of the need for futher study in the future.(3)Yangyin Shugan capsule can effectively improve the serum AHM and INHB levels,the effect is significant.(4)Yangyin Shugan capsule to a certain extent,increase the number of basal sinus follicles and improve ovarian blood supply.(5)Yangyin Shuga.n capsule did not find adverse drug reactions,indicating that the health of yin Shu capsule is safe. |
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