Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomiz...Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.展开更多
Objective:To observe the clinical efcacy and safety of external application of Rupi Sanjie Xiaotong Plaster(乳癖散结消痛膏,RPSJXTP)in treating breast hyperplasia of liver stagnation and phlegm coagulation pattern.Meth...Objective:To observe the clinical efcacy and safety of external application of Rupi Sanjie Xiaotong Plaster(乳癖散结消痛膏,RPSJXTP)in treating breast hyperplasia of liver stagnation and phlegm coagulation pattern.Methods:Totally 72 female patients with breast hyperplasia of liver stagnation and phlegm coagulation pattern admitted to the First Hospital Affiliated to Henan University of Chinese Medicine were enrolled by ran-domized,single-blind,placebo-controlled research method,and were divided into the treatment group(36 ca-ses)and the control group(36 cases)according to computer random number method.The treatment group were given RPSJXTP,while the control group were gi ven placebo plaster.The course of treatment in both groups was 8 weeks.The breast pain score,breast color ultrasound score,lump score,depression score,and Chinese medicine syndrome score were compared between the two groups at different times.The levels of estra-diol(E_(2)),progesterone(P)and pituitary prolactin(PRL)were detected and the adverse reactions of two groups were observed during the treatment of both groups.Results:Before treatment,there was no significant difference in total breast pain score,breast color ultrasound score,lump score,depression score and levels of serum P,E_(2)and PRL between the two groups(P>0.05);compared with previous treatment,the total breast pain score,breast color ultrasound score,lump score,and depression score significantly decreased in the treat-ment group(P<0.05),and the total breast pain score and depression score of the control group significantly declined(P<0.05);compared with control group,the total breast pain score,breast color ultrasound score,lump score,and depression score significantly decreased after treatment in the treatment group(P<0.05).The improvement rate of Chinese medicine syndromes and the clinical efective rate in the treatment group were higher than those in the control group(P<0.05).There were no serious systemie adverse reactions during the treatment in both groups.Local pruritus occurred in 3 cases in the treatment group and 1 case in the control group.Conclusion:RPSJXTP is effective in treating breast hyperplasia of liver stagnation and phlegm coagula-tion pattern.It can effectively relieve the breast pain which will not recur after stopping of drug use,which can reduce the color ultrasound score,lump score,and depression score of the patients and improve Chinese medi-cine syndromes without serious adverse reactions.展开更多
基金Standardization Project of Clinical Application Guide for Chinese Patent Medicine in the Treatment of Dominant Diseases(No.SATCM-2015-BZ402)。
文摘Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.
文摘Objective:To observe the clinical efcacy and safety of external application of Rupi Sanjie Xiaotong Plaster(乳癖散结消痛膏,RPSJXTP)in treating breast hyperplasia of liver stagnation and phlegm coagulation pattern.Methods:Totally 72 female patients with breast hyperplasia of liver stagnation and phlegm coagulation pattern admitted to the First Hospital Affiliated to Henan University of Chinese Medicine were enrolled by ran-domized,single-blind,placebo-controlled research method,and were divided into the treatment group(36 ca-ses)and the control group(36 cases)according to computer random number method.The treatment group were given RPSJXTP,while the control group were gi ven placebo plaster.The course of treatment in both groups was 8 weeks.The breast pain score,breast color ultrasound score,lump score,depression score,and Chinese medicine syndrome score were compared between the two groups at different times.The levels of estra-diol(E_(2)),progesterone(P)and pituitary prolactin(PRL)were detected and the adverse reactions of two groups were observed during the treatment of both groups.Results:Before treatment,there was no significant difference in total breast pain score,breast color ultrasound score,lump score,depression score and levels of serum P,E_(2)and PRL between the two groups(P>0.05);compared with previous treatment,the total breast pain score,breast color ultrasound score,lump score,and depression score significantly decreased in the treat-ment group(P<0.05),and the total breast pain score and depression score of the control group significantly declined(P<0.05);compared with control group,the total breast pain score,breast color ultrasound score,lump score,and depression score significantly decreased after treatment in the treatment group(P<0.05).The improvement rate of Chinese medicine syndromes and the clinical efective rate in the treatment group were higher than those in the control group(P<0.05).There were no serious systemie adverse reactions during the treatment in both groups.Local pruritus occurred in 3 cases in the treatment group and 1 case in the control group.Conclusion:RPSJXTP is effective in treating breast hyperplasia of liver stagnation and phlegm coagula-tion pattern.It can effectively relieve the breast pain which will not recur after stopping of drug use,which can reduce the color ultrasound score,lump score,and depression score of the patients and improve Chinese medi-cine syndromes without serious adverse reactions.
