OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Syst...OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol(E2) or blood follicle stimulating hormone(FSH) levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio(OR): 1.05, 95% confidence intervals(CI): 0.71 to1.55] and changes in FSH level [mean difference(MD): 2.14, 95% CI:-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores(MD:-1.14, 95% CI:-2.03 to-0.25)and changes in E2level(MD:-16.41, 95% CI:-18.83to-13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group(OR: = 0.35, 95% CI: 0.25 to0.48, P < 0.01).CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.展开更多
OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world a...OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications.This study was based on a very large population after the injection was approved and marketed in China.All patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse events.RESULTS:The post-marketing surveillance was performed in 10 094 female patients from April to December,2015.The incidence of adverse drug reactions(ADRs) was 0.79‰(8/10 094).Among the 8 patients,the reported adverse events mainly included systemic abnormalities,such as fever,chills and eyelid edema;skin and appendages disorders,such as pruritus and rash;gastrointestinal disorders,such as nausea,abdominal distension and pain;heart rate and rhythm disorders,such as palpitation and increased heart rate.All of these ADRs were mild in severity.CONCLUSION:In this study the ADRs incidence rate of MI is very low,which supports that it is generally safe for use in obstetric and gynecological diseases.However,the total number of 8 ADRs recorded over a relatively short time span seems limited,and the low number of reports could not represent an absolute guarantee of safety.展开更多
文摘OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol(E2) or blood follicle stimulating hormone(FSH) levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio(OR): 1.05, 95% confidence intervals(CI): 0.71 to1.55] and changes in FSH level [mean difference(MD): 2.14, 95% CI:-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores(MD:-1.14, 95% CI:-2.03 to-0.25)and changes in E2level(MD:-16.41, 95% CI:-18.83to-13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group(OR: = 0.35, 95% CI: 0.25 to0.48, P < 0.01).CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.
基金Sichuan Science and Technology Support Project:the Nested Case-control Study on Adverse Reaction Centralized Monitoring and Risk Factors of Leonurus Japonicus Injection(No.2014ZS0139)the Major State Basic Research Grant(973-program+2 种基金2011CB505406)Ph.D.Programs Foundation of Ministry of Education of China(No.2013-1210110001)State Administration of Traditional Chinese Medicine "Twelve-Five" Focus on Cultivating Subjects of Chinese Preventive Medicine[(2012)170]
文摘OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications.This study was based on a very large population after the injection was approved and marketed in China.All patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse events.RESULTS:The post-marketing surveillance was performed in 10 094 female patients from April to December,2015.The incidence of adverse drug reactions(ADRs) was 0.79‰(8/10 094).Among the 8 patients,the reported adverse events mainly included systemic abnormalities,such as fever,chills and eyelid edema;skin and appendages disorders,such as pruritus and rash;gastrointestinal disorders,such as nausea,abdominal distension and pain;heart rate and rhythm disorders,such as palpitation and increased heart rate.All of these ADRs were mild in severity.CONCLUSION:In this study the ADRs incidence rate of MI is very low,which supports that it is generally safe for use in obstetric and gynecological diseases.However,the total number of 8 ADRs recorded over a relatively short time span seems limited,and the low number of reports could not represent an absolute guarantee of safety.
