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Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases

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收录情况： ◇ SCIE ◇ CSCD-C

作者：
Cao Shan[1] * ; Zhang Wenhao[2] ; Zhao Ziwei[3] ; Heng Mingli[4] ; Bu Huaien[4] ; Wang Hongwu[4,*1] ; Liu Xinghui[5,*2] ; Wang Zhong[6] ; Cai Yan[7] ; Ma Yuyan[8] ; Cui Shihong[9] ; Deng Jihong[10] ; Ding Guifeng[11] ; Ding Yajuan[12] ; Dong Linhong[13] ; Duan Zhentao[14] ; Fan Ling[15] ; Fan Yang[16] ; Fu Fen[17] ; He Jing[18] ; Ji Shuying[19] ; Jin Lin[20] ; Li Hong[21] ; Li Hongying[22] ; Liao Tao[22] ; Lu Wei[23] ; Luo Xiucui[24] ; Lv Zhihui[25] ; Ma Fengchun[26] ; Ma Dafeng[27] ; Shi Tianyun[28] ; Sun Juying[29] ; Sun Xiaotong[30] ; Teng Hong[31] ; Wang Jinhua[32] ; Wang Ruihua[33] ; Wang Ying[34] ; Wang Zhengling[35] ; Xi Jie[36] ; Xu Minjuan[37] ; Xu Zhihong[38] ; Yan Qian[39] ; Yang Cuirong[40] ; Yang Yimei[10] ; Yin Jie[41] ; Yu Jinhua[42] ; Yuan Wenjun[43] ; Zhang Guanli[39] ; Zhang Meihua[44] ; Zhao Renfeng[45] ; Zhong Yonghong[46] ; Zhou Jian[47] ;
机构： [1]Department of Synopsis of Godden Chamber, Hubei University of Chinese Medicine, Wuhan 430060, China [2]Chinese Internal Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China [3]Chinese Preventive Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China [4]Department of Public Health, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China [5]Department of Obstetrics, West China Second University Hospital, Chengdu 610041, China [6]Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences, Beijing 100700, China [7]Department of Obstetrics, The Fourth Hospital of Harbin Medical University, Harbin 150001, China [8]Department of Obstetrics, Qilu Hospital of Shandong University, Jinan 264001, China [9]Department of Obstetrics, Maternal and Child Health Hospital of Henan Province, Zhengzhou 450052, China [10]Department of Gynecology, Kunming City Maternal and Child Health Hospital, Kunming 650021, China [11]Department of obstetrics, Maternal and Child Health Hospital of Xinjiang, Wulumuqi 830001, China. [12]Department of Obstetrics, Changchun Obstetrics- Gynecology Hospital, Changchun 130042, China [13]Department of Obstetrics, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning 530023, China [14]Department of Obstetrics and Gynecology, Dali Bai Autonomous Prefecture Maternal and Child Health Hospital, Dali 671099, China [15]Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100123, China [16]Department of Obstetrics and Gynecology, Ningxia People's Hospital, Yinchuan 750021, China [17]Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Nan Chang University, Nanchang 330006, China [18]Department of Obstetrics, Women's Hospital School of Medicine Zhejiang University, Hangzhou 310006, China [19]Department of Obstetrics, Tang Shan City Maternal and Child Health Hospital of Tangshan 0633000, China [20]Department of Obstetrics, Shiyan Maternal and Child Health Hospital, Shiyan 442000, China [21]Department of Gynecology, Qujing No.1 Hospital, Qujing 655000, China [22]Department of Obstetrics, Maternal and Child Health Hospital of Liuzhou, Liuzhou 545001, China [23]Department of Obstetrics, The First People's Hospital Of Lianyungang, Lianyungang 222002, China [24]Department of obstetrics, Lianyungang Maternal and Child Health Hospital, Lianyungang 222006, China [25]Department of Obstetrics, Qinghai University Affiliated Hospital, Xining 810001, China [26]Department of Obstetrics and Gynecology, Mentougou Maternal and Child Health Care Hospital, Beijing 102300, China [27]Department of Obstetrics and Gynecology, Chengdu Jinniu District Traditional Chinese Medicine Hospital, Chengdu 610083, China [28]Department of Obstetrics, Nan Yang The First People's Hospital, Nanyang 473002, China [29]Department of Obstetrics and Gynecology, Maternal and Child Health Hospital of Pingdingshan City, Pingdingshan 467200, China [30]Department of Obstetrics, Gansu Provincial Hospital, Lanzhou 730000, China [31]Department of Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China [32]Department of Obstetrics, The People's Hospital of Xiangyun, Daili 672100, China [33]Department of Obstetrics, Maternal and Child Health Hospital of Qinhuangdao City, Qinhuangdao 066000, China [34]Department of Obstetrics and Gynecology, East Ward of Sichuan Provincial People's Hospital, Chengdu 610101, China [35]Department of Obstetrics and Gynecology, Chenghua people's Hospital, Chengdu 610051, China [36]Department of Birth Control, Shanghai Jiading Maternal and Child Health Hospital, Shanghai 201821, China [37]Department of Obstetrics, Ganzhou People's Hospital, Ganzhou 341000, China [38]Department of Obstetrics, People's Hospital of Deyang City, Deyang 618000, China [39]Department of Obstetrics, Yantaishan Hospital, Yantai, Yantai 264001, China [40]Department of Obstetrics and Gynecology, Maternal and Child Health Hospital of Xiangyang, Xiangyang 441021, China [41]Department of Obstetrics and Gynecology, Fourth Hospital of Hebei Medical University , Shijiazhuang 050019, China [42]Department of Obstetrics and Gynecology, Nanchang People's Hospital, Nanchang 330200, China [43]Department of Obstetrics and Gynecology, Shanghai Changning Central Hospital, Shanghai 200336, China [44]Department of Obstetrics, Maternal and Child Health Hospital of Taiyuan, Taiyuan 030012, China [45]Department of Obstetrics and Gynecology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, China [46]Department of Obstetrics, Yue Bei People's Hospital, Shaoguan 512026, China [47]Department of Obstetrics, Shanghai First Maternity and Infant Hospital, Shanghai 200040, China
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ISSN：

关键词： Safty Product surveillance postmarketing Drug-related side effects and adverse reactions Motherwort injection

摘要：
OBJECTIVE: To investigate the safety profiles of Motherwort injection (MI). METHODS: A multi-center, prospective and drug derived 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 parts per thousand (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. (C) 2018 JTCM. All rights reserved.

基金：
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) and State Administration of Traditional Chinese Medicine "Twelve-Five" Focus on Cultivating Subjects of Chinese Preventive Medicine [ (2012) 170]

基金编号： (2012) 170

语种：
外文
被引次数：
WOS：
PubmedID：
中科院分区：
出版当年[2018]版：
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
最新[2025]版：
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
JCR分区：
出版当年[2018]版：
Q4 INTEGRATIVE & COMPLEMENTARY MEDICINE
最新[2023]版：
Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

影响因子： 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

第一作者：
第一作者机构： [1]Department of Synopsis of Godden Chamber, Hubei University of Chinese Medicine, Wuhan 430060, China
通讯作者：
通讯机构： [4]Department of Public Health, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China [5]Department of Obstetrics, West China Second University Hospital, Chengdu 610041, China [*1]Department of Public Health, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. [*2]Department of Obstetrics, West China Second University Hospital, Chengdu 610041, China.
推荐引用方式(GB/T 7714)：
Cao Shan,Zhang Wenhao,Zhao Ziwei,et al.Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases[J].JOURNAL OF TRADITIONAL CHINESE MEDICINE.2018,38(4):625-635.
APA：
Cao Shan,Zhang Wenhao,Zhao Ziwei,Heng Mingli,Bu Huaien...&Zhou Jian.(2018).Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases.JOURNAL OF TRADITIONAL CHINESE MEDICINE,38,(4)
MLA：
Cao Shan,et al."Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases".JOURNAL OF TRADITIONAL CHINESE MEDICINE 38..4(2018):625-635

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