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Journal of Traditional Chinese Medicine ›› 2018, Vol. 38 ›› Issue (04): 625-635.

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

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, Lv 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   

  1. Department of Synopsis of Godden Chamber,Hubei University of Chinese Medicine;Chinese Internal Medicine,Tianjin University of Traditional Chinese Medicine;Chinese Preventive Medicine,Tianjin University of Traditional Chinese Medicine;Department of Public Health,Tianjin University of Traditional Chinese Medicine;Department of Obstetrics,West China Second University Hospital;Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences;Department of Obstetrics,The Fourth Hospital of Harbin Medical University;Department of Obstetrics,Qilu Hospital of Shandong University;Department of Obstetrics,Maternal and Child Health Hospital of Henan Province;Department of Gynecology,Kunming City Maternal and Child Health Hospital;Department of obstetrics,Maternal and Child Health Hospital of Xinjiang;Department of Obstetrics,Changchun Obstetrics-Gynecology Hospital;Department of Obstetrics,The First Affiliated Hospital of Guangxi University of Chinese Medicine;Department of Obstetrics and Gynecology,Dali Bai Autonomous Prefecture Maternal and Child Health Hospital;Department of Obstetrics,Beijing Obstetrics and Gynecology Hospital,Capital Medical University;Department of Obstetrics and Gynecology,Ningxia People's Hospital;Department of Obstetrics and Gynecology,The Second Affiliated Hospital of Nan Chang University;Department of Obstetrics,Women's Hospital School of Medicine Zhejiang University;Department of Obstetrics,Tang Shan City Maternal and Child Health Hospital;Department of Obstetrics,Shiyan Maternal and Child Health Hospital;Department of Gynecology,Qujing No.1 Hospital;Department of Obstetrics,Maternal and Child Health Hospital of Liuzhou;Department of Obstetrics,The First People's Hospital Of Lianyungang;Department of obstetrics,Lianyungang Maternal and Child Health Hospital;Department of Obstetrics,Qinghai University Affiliated Hospital;Department of Obstetrics and Gynecology,Mentougou Maternal and Child Health Care Hospital;Department of Obstetrics and Gynecology,Chengdu Jinniu District Traditional Chinese Medicine Hospital;Department of Obstetrics,Nan Yang The First People's Hospital;Department of Obstetrics and Gynecology,Maternal and Child Health Hospital of Pingdingshan City;Department of Obstetrics,Gansu Provincial Hospital;Department of Obstetrics,The Second Hospital of Jilin University;Department of Obstetrics,The People's Hospital of Xiangyun;Department of Obstetrics,Maternal and Child Health Hospital of Qinhuangdao City;Department of Obstetrics and Gynecology,East Ward of Sichuan Provincial People's Hospital;Department of Obstetrics and Gynecology,Chenghua people's Hospital;Department of Birth Control,Shanghai Jiading Maternal and Child Health Hospital;Department of Obstetrics,Ganzhou People's Hospital;Department of Obstetrics,People's Hospital of Deyang City;Department of Obstetrics,Yantaishan Hospital;Department of Obstetrics and Gynecology,Maternal and Child Health Hospital of Xiangyang;Department of Obstetrics and Gynecology,Fourth Hospital of Hebei Medical University;Department of Obstetrics and Gynecology,Nanchang People's Hospital;Department of Obstetrics and Gynecology,Shanghai Changning Central Hospital;Department of Obstetrics,Maternal and Child Health Hospital of Taiyuan;Department of Obstetrics and Gynecology,The People's Hospital of Guangxi Zhuang Autonomous Region;Department of Obstetrics,Yue Bei People's Hospital;Department of Obstetrics,Shanghai First Maternity and Infant Hospital;
  • Online:2018-08-15 Published:2018-08-15
  • Supported by:
    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]

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Abstract: 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.

Key words: Safty, Product surveillance,postmarketing, Drug-related side effects and adverse reactions, Motherwort injection

Cite this article

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, Lv 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. Post-marketing safety surveillance and reevaluation of Motherwort injection:A clinical study of 10094 cases[J]. Journal of Traditional Chinese Medicine, 2018, 38(04): 625-635.