Department Of Synopsis Of Godden Chamber Cao Shan, Wenhao Zhang1, Ziwei Zhao2, Mingli Heng3, Huaien Bu3, Hongwu Wang3, Xinghui Liu4, Zhong Wang5, Yan Cai6, Yuyan Ma7, Department Of Obstetrics Cui Shihong, Jihong Deng8, Yimei Yang9, Guifeng Ding10, Yajuan Ding11, Linhong Dong12, Zhentao Duan13, Ling Fan14, Yang Fan15, Fen Fu16, Jing He17, Shuying Ji18, Lin Jin19, Hong Li20, Hongying Li21, Tao Liao21, Wei Lu22, Xiucui Luo23, Zhihui Lü24, Fengchun Ma25, Dafeng Ma26, Tianyun Shi27, Juying Sun28, Hong Teng29, Jinhua Wang30, Ruihua Wang31, Ying Wang32, Zhengling Wang33, Jie Xi34, Minjuan Xu35, Zhihong Xu36, Qian Yan37, Guanli Zhang37, Cuirong Yang38, Jie Yin39, Jinhua Yu40, Wenjun Yuan41, Meihua Zhang42, Renfeng Zhao43, Yonghong Zhong44, Jian Zhou45. 1. Chinese Internal Medicine, Tianjin Universi?ty of Traditional Chinese Medicine, Tianjin 300193, China. 2. Chinese Preventive Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 3. Department of Public Health, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 4. Department of Obstetrics, West China Second University Hospital, Chengdu 610041, China. 5. Institute of Basic Research in Clinical Medi?cine China Academy of Chinese Medical Sciences, Beijing 100700, China. 6. Department of Obstetrics, The Fourth Hospital of Harbin Medical University, Harbin 150001, China. 7. Department of Obstetrics, Qilu Hospital of Shandong University, Jinan 264001, China. 8. Department of Gynecology, Kunming City Maternal and Child Health Hospital, Kunming 650021, China. 9. Department of Gynecology, Kun?ming City Maternal and Child Health Hospital, Kunming 650021, China. 10. Department of obstetrics, Maternal and Child Health Hospital of Xinjiang, Wulumuqi 830001, China. 11. Department of Obstetrics, Changchun Obstetrics-Gynecology Hospital, Changchun 130042, China. 12. Department of Obstetrics, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning 530023, China. 13. Department of Obstetrics and Gynecology, Dali Bai Autonomous Prefecture Maternal and Child Health Hospital, Dali 671099, China. 14. Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100123, China. 15. Department of Obstetrics and Gynecology, Ningxia People's Hospital, Yinchuan 750021, China. 16. Department of Obstetrics and Gynecology, The Sec?ond Affiliated Hospital of Nan Chang University, Nanchang 330006, China. 17. Department of Obstetrics, Women's Hospital School of Medicine Zhejiang University, Hangzhou 310006, China. 18. Department of Obstetrics, Tang Shan City Maternal and Child Health Hospital of Tangshan 0633000, China. 19. Department of Obstetrics, Shiyan Maternal and Child Health Hospital, Shiyan 442000, China. 20. Department of Gynecology, Qujing No.1 Hospital, Qujing 655000, China. 21. Department of Obstetrics, Maternal and Child Health Hospital of Liuzhou, Liuzhou 545001, China. 22. Department of Obstetrics, The First People's Hospi?tal Of Lianyungang, Lianyungang 222002, China. 23. Department of obstetrics, Lianyungang Ma?ternal and Child Health Hospital, Lianyungang 222006, China. 24. Department of Obstetrics, Qinghai University Affiliated Hospital, Xining 810001, China. 25. Department of Obstetrics and Gynecology, Mentougou Maternal and Child Health Care Hospital, Beijing 102300, China. 26. Department of Obstetrics and Gynecology, Chengdu Jinniu District Traditional Chinese Medicine Hospi?tal, Chengdu 610083, China. 27. Department of Obstetrics, Nan Yang The First People's Hospital, Nanyang 473002, China. 28. Department of Obstetrics and Gynecology, Ma?ternal and Child Health Hospital of Pingdingshan City, Ping?dingshan 467200, China. 29. Department of Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China. 30. Department of Obstetrics, The People's Hospital of Xiangyun, Daili 672100, China. 31. Department of Obstetrics, Maternal and Child Health Hospital of Qinhuangdao City, Qinhuangdao 066000, China. 32. Department of Obstetrics and Gynecology, East Ward of Sichuan Provincial People's Hospital, Chengdu 610101, China. 33. Department of Obstetrics and Gynecology, Chenghua people's Hospital, Chengdu 610051, China. 34. Department of Birth Control, Shanghai Jiading Maternal and Child Health Hospital, Shanghai 201821, China. 35. Department of Obstetrics, Ganzhou People's Hospital, Ganzhou 341000, China. 36. Department of Obstetrics, People's Hospital of Deyang City, Deyang 618000, China. 37. Department of Obstetrics, Yantaishan Hospital, Yantai, Yantai 264001, China. 38. Department of Obstetrics and Gynecology, Maternal and Child Health Hospital of Xiangyang, Xiangyang 441021, China. 39. Department of Obstetrics and Gynecology, Fourth Hospital of Hebei Medical University , Shijiazhuang 050019, China. 40. Department of Obstetrics and Gynecology, Nanchang People's Hospital, Nanchang 330200, China. 41. Department of Obstetrics and Gynecology, Shanghai Changning Central Hospital, Shanghai 200336, China. 42. Department of Obstetrics, Maternal and Child Health Hospital of Taiyuan, Taiyuan 030012, China. 43. Department of Obstetrics and Gynecology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, China. 44. Department of Obstetrics, Yue Bei People's Hospital, Shaoguan 512026, China. 45. Department of Obstetrics, Shanghai First Maternity and Infant Hospital, Shanghai 200040, China.
Abstract
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¡ë(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.
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¡ë(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.
Entities:
Keywords:
Drug-related side effects and adverse reactions; Motherwort injection; Product surveillance, postmarketing; Safty