| Research objective:In the first part of this study,we evaluated the clinical efficacy and safety of Guchong decoction in the treatment of dysfunctional uterine bleeding by meta analysis of related literature.In the second part,Guchong granule was given to the patients of menorrhagia(ovulatory dysfunctional uterine bleeding)with Spleen-qi deficiency.Through the observation of menstrual bleeding score,TCM syndrome score,recurrence rate,safety and other indicators,to evaluate the clinical efficacy of Guchong granule in the treatment of menorrhagia with Spleen-qi deficiency,and provide objective basis for the research of new Chinese patent medicine.Methods:1、Meta analysis:We searched three international electronic databases(Pub Med,MEDLINE and Web of science)and three Chinese electronic databases(.CNKI,VIP and Wan Fang).According to the inclusion criteria and exclusion criteria to select literature,extract data,and evaluate the risk of literature bias.We used Revman 5.3 software for meta analyze.2、Clinical research:From August 2017 to November 2019,32 patients with menorrhagia who met the inclusion criteria were selected.32 patients were randomly divided into two groups by SAS statistical software.The observation group was given Guchong granules orally,and the control group was given placebo.Usage: taking one bag per time,three times a day,starting treatment on the third day of menstruation,7 days per menstrual cycle,a total of 3 menstrual cycles.Before and after treatment,the total clinical efficacy,menstrual bleeding score,TCM syndrome efficacy score and single TCM syndrome score were observed.The recurrence rate,safety evaluation and clinical efficacy were compared between the two groups after treatment.Result:1、Meta analysis:11 articles were included,a total of 1070 patients were analyzed.The ther apeutic effect of Guchong decoction alone or combined with western medicine on dysfunctional uterine bleeding was better than that of Western medicine alone or Chinese patent medicine,the difference was statistically significant(P<0.05).Guchong decoction or Guchong decoction combined with western medicine was superior to western medicine alone in hemoglobin change,hemostasis time and menstrual bleeding score(P<0.05).Guchong decoction was better than Chinese patent medicine in improving menstrual bleeding score.Guchong decoction alone or combined with western medicine was significantly lower than western medicine alone in the incidence of adverse reactions and recurrence rate(P<0.05).2、Clinical research results(1)Reducing menstrual volume: The effective rate of the experimental group to improve the amount of menstrual bleeding was 83% and 16% in the control group,There was significant difference between the two groups in three months after treatment(P<0.05).The effective rate of the experimental group was 54% in one month and 70% in two months;The effective rate of the control group was 33% in one month and 33% in two months.There was no significant difference in the effective rate between the two groups(P>0.05).(2)Changes of menstrual bleeding score:Intra group comparison:There was statistical significance before and after treatment in the experimental group(P <0.05);there was no statistical significance before and after treatment in the control group(P>0.05).Comparison among groups:There was no significant difference between the two groups in one month and two months(P>0.05).There was significant difference between the two groups in three months after treatment(P<0.05).(3)Changes of TCM syndrome score:Intra group comparison:There was statistical significance before and after treatment in the experimental group(P<0.05);there was no statistical significance before and after treatment in the control group(P>0.05).Comparison among groups:There was no significant difference between the two groups after treatment for one month and two months(P>0.05);there was significant difference between the two groups after treatment for three months(P<0.05).(4)Effective rate of TCM syndrome treatment:One month after treatment,the effective rate of the experimental group was 20%,5 cases were effective,and the control group was effective in 0 case,the difference was not statistically significant(P>0.05);after 2 months of treatment,the total effective rate of the experimental group was 79%,3 cases were effective,16 cases were effective,the total effective rate of the control group was 66%,1 case was effective,3 cases were effective,the difference was not statistically significant(P>0.05);after 3 months of treatment,the effective rate of the experimental group was 87%,including 1 case of recovery,8 cases of significant effect,12 cases of effective,and 33% of the control group,including 1 case of significant effect,1 case of effective,the difference was statistically significant(P<0.05).(5)Changes of single TCM syndrome score:There was statistical significance before and after treatment in improving the symptoms of menstrual bleeding,mental fatigue,menstrual color and quality,shortness of breath and laziness,interview with Shaohua,loose stool and empty stomach(P<0.05);in terms of improving the symptoms of narcolepsy,there was no significant difference before and after treatment in the treatment group(P>0.05);in terms of improving symptoms of color and quality of menstruation and fatigue,the control group had statistical significance before and after treatment(p<0.05);in terms of improving menstrual bleeding,shortness of breath,lack of expression,poor complexion,stupidity,loose stools and empty stomach,there was no significant difference between the control group and the control group before and after treatment(P>0.05);the difference between the two groups before and after treatment was compared.The effect of the experimental group was better than that of the control group in the amount of menstrual bleeding,the difference was statistically significant(P<0.05);in terms of improving menstrual bleeding,shortness of breath,l ack of expression,poor complexion,stupidity,loose stools and empty stomach,there was no significant difference between the experimental group and the control group(P>0.05).(6)Recurrence rate:After 1 month follow-up,the recurrence rate of the experimental group was 35%,and that of the control group was 100%.There was no significant difference between the two groups(P>0.05).(7)Safety evaluation:After treatment,the vital signs of the two groups were compared.There was no significant difference between the two groups(P>0.05).The incidence of adverse events was 37% in the experimental group and 50% in the control group.There was no significant difference between the two groups(P>0.05).No adverse reactions occurred in both groups.Conclusion:(1)Through Meta analysis,compared with western medicine or Chinese patent medicine,Guchong decoction or Guchong decoction combined with western medicine can effectively improve menstrual volume,control complete hemostasis time,reduce menstrual bleeding score,improve hemoglobin change,and have low adverse reactions and recurrence rate.(2)Through clinical research,we found that Guchong granule can effectively treat menorrhagia(ovulatory dysfunctional uterine bleeding)with Spleen-qi deficiency,significantly reduce menstrual volume,effectively improve the TCM syndrome of spleen-qi deficiency.It’s safe and low in the recurrence rate.The be st treatment course is 3 months. |
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