| Objective:To explore the clinical effect of Zhuxiandan plus/down combined with Daying-35 on irregular menstruation of polycystic ovary syndrome(PCOS)with spleen-kidney deficiency and phlegm dampness,and to observe its influence on ovarian function.Methods:IA total of 78 patients who met the inclusion criteria were randomly divided into experimental group(n=39)and control group(n=39).The experimental group was treated with Zhuxiandan plus/minus combined with Daying-35,and the control group was treated with Daying-35,with a course of 3 months.Body mass index(BMI)before and after treatment.luteinizing hormone(LH),LH/FSH ratio,androgen(T),bilateral mean ovarian volume,menstrual score and TCM syndrome score were observed before,after treatment and 3 months after withdrawal.The clinical efficacy of the two groups was evaluated according to TCM syndrome score and menstrual scoring standard.Results:(1)Sex hormone levels:①After treatment and withdrawal,LH values in the experimental group were lower than those in the control group,with a significant difference(P<0.05).Compared with before treatment,the LH value of the experimental group decreased after treatment and after drug withdrawal,with statistical significance(P<0.05).Compared with before treatment,the LH value of the control group decreased after treatment with a significant difference(P<0.05),while the LH value of the control group increased after the withdrawal of the drug,with no significant difference compared with before treatment(P>0.05).②There was no significant difference in T value between the two groups after treatment(P>0.05).After drug withdrawal,T value of the experimental group was lower than that of the control group,the difference was statistically significant(P<0.05).T value of the experimental group after treatment and after drug withdrawal was lower than that before treatment,the difference was statistically significant(P<0.05).The T value of the control group after treatment and after drug withdrawal was lower than that before treatment,the difference was statistically significant(P<0.05).③After treatment,the ratio of LH/FSH in the experimental group was lower than that in the control group,and the difference was significant(P<0.05).After drug withdrawal,the ratio of LH/FSH in the experimental group was lower than that in the control group,and the difference was statistically significant(P<0.05).The ratio of LH/FSH in the experimental group after treatment and withdrawal was lower than that before treatment,the difference was statistically significant(P<0.05).The ratio of LH/FSH in the control group after treatment was lower than that before treatment,and the difference was statistically significant(P<0.05).There was no significant difference between the ratio of LH/FSH after withdrawal and that before treatment(P>0.05).(2)TCM syndrome score:after treatment and withdrawal,the TCM syndrome score of the experimental group was lower than that of the control group,with a significant difference(P<0.05).Compared with before treatment,the TCM syndrome score of the experimental group decreased significantly after treatment,the difference was statistically significant(P<0.05).The TCM syndrome score of the experimental group increased after drug withdrawal.and the difference was statistically significant(P<0.05).The TCM syndrome score in the control group after treatment was lower than that before treatment,the difference was statistically significant(P<0.05),but there was no significant difference between TCM syndrome score after withdrawal and that before treatment(P>0.05).(3)Menstrual score:After treatment and withdrawal,the menstrual score of the experimental group was lower than that of the control group,with statistical significance(P<0.05).Compared with before treatment,the menstrual scores of the experimental group decreased significantly after treatment and withdrawal,with statistical significance(P<0.05).Menstrual scores in the control group after treatment were low before treatment,the difference was statistically significant(P<0.01),and there was no significant difference between menstrual scores after withdrawal and before treatment(P>0.05).(4)Changes in body mass index:there was no significant difference in body mass index between the two groups before and after treatment(P>0.05).(5)Ovarian volume:There was no significant difference in the mean ovarian volume between the two groups after treatment and after withdrawal of the drug(P>0.05).The average ovarian volume in the experimental group after treatment was smaller than that before treatment,and the difference was statistically significant(P<0.05).There was no significant difference between the average ovarian volume after withdrawal and that before treatment(P>0.05).In the control group,the average ovarian volume after treatment was reduced compared with that before treatment,and the difference was statistically significant(P<0.05).There was no significant difference between the average ovarian volume after withdrawal and that before treatment(P>0.05).(6)The therapeutic effect was evaluated by the percentage reduction of TCM syndrome score:in the experimental group,6 cases were cured,12 cases were significantly effective,16 cases were effective,and 5 cases were ineffective.In the control group,0 cases were cured,0 cases showed obvious effect,20 cases were effective and 19 cases were ineffective.The total effective rate of the treatment group was 87.2%,and the total effective rate of the control group was 51.3%,and the difference was statistically significant(P<0.05).(7)The therapeutic effect was evaluated according to the standard of regulating menstruation:in the experimental group,10 cases were cured,12 cases were significantly effective,9 cases were effective,and 4 cases were ineffective.In the control group,1 case was cured,13 cases showed obvious effect,10 cases were effective and 15 cases were ineffective.The total effective rate of the treatment group was 89.7%,and the total effective rate of the control group was 61.5%,and the difference was statistically significant(P<0.05).Conclusion:The experimental group was more effective than the control group in improving menstrual irregularity and TCM syndrome score,and effectively reduced luteinizing hormone(LH),LH/FSH ratio and androgen(T).There were no significant differences in menstrual score,TCM syndrome score,LH,LH/FSH ratio in the control group after discontinuance from treatment.However,there were significant differences in menstrual scores,TCM syndrome scores and sex hormone levels between the experimental group and those before treatment.In terms of improving ovarian volume,the experimental group and the control group had the same effect.There was no significant improvement in body mass index in the two groups. |