Post-marketing safety surveillance and reevaluation of Motherwort injection：A clinical study of 10094 cases

作     者：Cao Shan Zhang Wenhao Zhao Ziwei Heng Mingli Bu Huaien Wang Hongwu Liu Xinghui Wang Zhong Cai Yan Ma Yuyan Cui Shihong Deng Jihong Ding Guifeng Ding Yajuan Dong Linhong Duan Zhentao Fan Ling Fan Yang Fu Fen He Jing Ji Shuying Jin Lin Li Hong Li Hongying Liao Tao Lu Wei Luo Xiucui Lü Zhihui Ma Fengchun Ma Dafeng Shi Tianyun Sun Juying Sun Xiaotong Teng Hong Wang Jinhua Wang Ruihua Wang Ying Wang Zhengling Xi Jie Xu Minjuan Xu Zhihong Yan Qian Yang Cuirong Yang Yimei Yin Jie Yu Jinhua Yuan Wenjun Zhang Guanli Zhang Meihua Zhao Renfeng Zhong Yonghong Zhou Jian 

作者机构：Department of Synopsis of Godden ChamberHubei University of Chinese MedicineWuhan 430060China Chinese Internal MedicineTianjin University of Traditional Chinese MedicineTianjin 300193China Chinese Preventive MedicineTianjin University of Traditional Chinese MedicineTianjin 300193China Department of Public HealthTianjin University of Traditional Chinese MedicineTianjin 300193China Department of ObstetricsWest China Second University HospitalChengdu 610041China Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesBeijing 100700China Department of ObstetricsThe Fourth Hospital of Harbin Medical UniversityHarbin 150001China Department of ObstetricsQilu Hospital of Shandong UniversityJinan 264001China Department of ObstetricsMaternal and Child Health Hospital of Henan ProvinceZhengzhou 450052China Department of GynecologyKunming City Maternal and Child Health HospitalKunming 650021China Department of ObstetricsThe First Affiliated Hospital of Guangxi University of Chinese MedicineNanning 530023China Department of Obstetrics and GynecologyDali Bai Autonomous Prefecture Maternal and Child HealthHospitalDali 671099China Department of ObstetricsBeijing Obstetrics andGynecology HospitalCapital Medical UniversityBeijing 100123China Department of Obstetrics and GynecologyNingxia People's HospitalYinchuan 750021China Department of Obstetrics and GynecologyThe Second Affiliated Hospital of Nan Chang UniversityNanchang 330006China Department of ObstetricsWomen's HospitalSchool of Medicine Zhejiang UniversityHangzhou 310006China Department of ObstetricsTang Shan City Mater-nal and Child Health Hospital of Tangshan 0633000China Department of ObstetricsShiyan Maternal and Child Health HospitalShiyan 442000China Department of GynecologyQujing No.1 HospitalQujing 655000China Department of ObstetricsMaternal and Child Health Hospital of LiuzhouLiuzhou 545001China Department of ObstetricsThe First People's Hospital Of LianyungangLianyungang 222002China Department of obstetricsLianyungang Maternal and Child Health HospitalLianyungang 222006China Department of ObstetricsQinghai University Affiliated HospitalXining 810001China Department of Obstetrics and GynecologyMentougou Maternal and Child Health Care HospitalBeijing 102300China Department of Obstetrics and GynecologyChengdu Jinniu District Traditional Chinese Medicine HospitalChengdu 610083China Department of ObstetricsNan Yang The First People's HospitalNanyang 473002China Department of Obstetrics and GynecologyMaternal and Child Health Hospital of Pingdingshan CityPingdingshan 467200China Department of ObstetricsGansu Provincial HospitalLanzhou 730000China Department of ObstetricsThe Second Hospital of Jilin UniversityChangchun 130041China Department of ObstetricsThe People's Hospital of XiangyunDaili 672100China Department of ObstetricsMaternal and Child Health Hospital of Qinhuangdao CityQinhuangdao 066000China Department of Obstetrics and GynecologyEast Ward of Sichuan Provincial People's HospitalChengdu 610101China Department of Obstetrics and GynecologyChenghua people's HospitalChengdu 610051China Department of Birth ControlShanghai Jiading Maternal and Child Health HospitalShanghai 201821China Department of ObstetricsGanzhou People's HospitalGanzhou 341000China Department of ObstetricsPeople's Hospital of Deyang CityDeyang 618000China Department of ObstetricsYantaishan HospitalYantaiYantai 264001China Department of Obstetrics and GynecologyMaternal and Child Health Hospital of XiangyangXiangyang 441021China Department of Obstetrics and GynecologyFourth Hospital of Hebei Medical UniversityShijiazhuang 050019China Department of Obstetrics and GynecologyNanchang People's HospitalNanchang 330200China Department of Obstetrics and GynecologyShanghai Changning Central HospitalShanghai 200336China Department of Obstetrics and GynecologyThe People's Hospital of Guangxi Zhuang Autonomous RegionNanning 530021China Department of ObstetricsYue Bei People's HospitalShaoguan 512026China Department of ObstetricsShanghai First Maternity and Infant HospitalShanghai 200040China Department of obstetricsMaternal and Child Health Hospital of XinjiangWulumuqi 830001China Department of ObstetricsChangchun Obstetrics—Gynecology HospitalChangchun 130042China 

出 版 物：《Journal of Traditional Chinese Medicine》 (中医杂志（英文版）)

年 卷 期：2018年第38卷第4期

页      面：625-635页

核心收录：

学科分类：1008[医学-中药学(可授医学、理学学位)] 1006[医学-中西医结合] 100602[医学-中西医结合临床] 10[医学] 

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 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] 

主　　题：Safty Product surveillance postmarket-ing Drug-related side effects and adverse reac-tions Motherwort injection 

摘      要：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 *** study was based on a very large population after the injection was approved and marketed in *** patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse ***:The post-marketing surveillance was performed in 10 094 female patients from April to December,*** 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 *** of these ADRs were mild in ***: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 ***,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.