Objective: By observing and comparing the clinical treatment effect of oral self-made ShenHuang Yishen Granule and proprietary Chinese patent medicine Nujin tablet in the treatment of late menstruation(kidney deficiency and phlegm stasis syndrome),to verify the clinical efficacy and safety of self-made Shenhuang Yishen Granule,and then to study the mechanism of ShenHuang yishen granule,to provide a new method and basis for clinical treatment of this disease.Methods: From December 2018 to September 2019,patients who met the diagnostic criteria of TCM syndrome of late menstruation(kidney deficiency and phlegm stasis syndrome)in the gynecological clinic of Affiliated hospital of changchun university of Chinese medicine were selected.72 patients were randomly divided into treatment group and control group according to the time of treatment,each group was 36 patients.Because the individual patient midway stopped the medicine without permission,the treatment group fall off 1 case the control group fall off 3 cases.The treatment group(35cases)was given the self-made Shenhuang Yishen Granule,the control group(33 cases)was given the traditional Chinese medicine preparation Nujin tablet,and the two groups were given medicine for 3courses continuously.By observing and comparing the symptom scores and clinical treatment effect of the two groups of the patients before and after treatment,the efficacy and safety of self-made Shenhuang Yishen Granule in the treatment of late menstruation(kidney deficiency and phlegm stasis syndrome)were finally verified.Results: In this clinical observation study,a total of 68 cases were observed,including35 cases in the treatment group(Shenhuang Yishen Granule)and 33 cases in the control group(traditional Chinese medicine preparation Nujin tablet).(1)In the treatment group,7cases(20.00%)were cured,18 cases(51.43%)were significantly effective,6 cases(17.14%)were effective,and 4 cases(11.43%)were ineffective,The total effective rates were88.57%.In the control group,4 cases(12.12%)were cured,10 cases(30.30%)were significantly effective,14 cases(42.42%)were effective,5 cases(15.15%)were ineffective,and the total effective rate was 84.85%.After treatment,the total efficacy of the two groups was compared with P=0.047(P<0.05),which was statistically significant.(2)In the total score of TCM syndrome,the average score of the treatment group was(24.14 ± 7.94)before treatment and(7.37 ± 6.96)after treatment,the average score of the control group was(25.09 ±7.42)before treatment and(11.12± 7.90)after treatment,the scores of the two groups decreased after treatment,and P<0.05 in both groups,The statistical analysis between the two groups showed that P=0.023(P<0.05)was significantly different.(3)The symptoms in the treatment group were compared before and after treatment,and the scores of menstrual cycle,menstrual volume,menstrual color and menstrual quality in the main symptoms were significantly reduced,and P<0.05 was statistically significant.The scores of lumbosacral soreness,hyposexuality,dizziness and tinnitus,chest abdominal fullness,fatigue,obesity and pain of lower or lesser abdomen were all decreased in the secondary symptoms,and P<0.05 was statistically significant before and after treatment.(4)After treatment,the symptoms of the two groups were statistically analyzed,In the main symptoms,the menstrual cycle(P=0.013),menstrual volume(P=0.036),menstrual color(P=0.014)and menstrual quality(P=0.044)were all P<0.05,showing significant differences.In the secondary symptoms,except for the hyposexuality(P=0.078),dizziness and tinnitus(P=0.091),obesity(P=0.124)P>0.05,there was no significant difference.In the other symptoms,lumbosacral soreness P=0.044(P<0.05),chest abdominal fullness P=0.046(P<0.05),fatigue P=0.043(P<0.05),and pain of lower or lesser abdomen P=0.038(P<0.05),which showed that the treatment group had better effect than the control group.Conclusion: By observing 68 cases of the late menstruation of the syndrome of kidney deficiency and phlegm stasis,it is found that the treatment of the late menstruation(kidney deficiency and phlegm stasis syndrome)with self-made Shenhuang Yishen Granule has significant clinical effect and safety,which can be further popularized in the clinical treatment process. |