"Shuganning Injection Post-marketing Clinical Safety Hospital Centralized Monitoring Research Launch Meeting" Held in Zhengzhou

On May 14, the kick-off meeting of Guizhou Ruihe Pharmaceutical Co., Ltd. "centralized monitoring and research on 30,000 cases of clinical safety hospital of Shuganning injection after listing" was held in Zhengzhou. The First Affiliated Hospital of Henan University of traditional Chinese medicine and Shanghai yizheng pharmaceutical technology, as the project lead unit and the third party CRO company, are jointly committed to further improving the safety of clinical medication of Shuganning injection.

The meeting was presided over by Professor Li Xuelin and Director Tang Jinfa of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine. Responsible persons from different centers across the country and relevant clinical pharmacists from five monitoring hospitals in Henan sub-center attended the meeting. At the kick-off meeting, Zhu Mingjun, President of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, and Zhao Yun, General Manager of Guizhou Ruihe Pharmaceutical, delivered welcome speeches.

At the kick-off meeting, the speech video of Academician Zhang Boli of the Chinese Academy of Engineering on this meeting was first played. Academician Zhang first affirmed the significance of the company's post-market clinical safety monitoring research, and put forward three suggestions for this project: First, the key to project implementation It lies in scheme design, second, the core of project development lies in quality control, and third, the establishment of an expert committee to objectively evaluate adverse reactions.

President Zhu Mingjun and Professor Zhao Wenxia of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine gave a thematic report entitled "Research Progress of Clinical Safety Re-evaluation of Chinese Medicine after Marketing" and "Current Situation of TCM Treatment of Liver Cirrhosis, professor Liu Shuang of Youan Hospital affiliated to Capital Medical University introduced in detail the protective effect of Shuganning injection on tissue-engineered fatty liver cells, anti-cholestasis effect on drug-induced tissue-engineered liver cholestatic injury (DIC), inhibition of stellate cell activation in DMN rat liver, and the key mechanism of anti-liver fibrosis.

At the meeting, the project team members Professor Li Chunxiao, Dr. Xu Tao, Dr. Ling Xiao and Dr. Zhang Bo of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine trained the centralized monitoring research plan, research methods, quality control methods and EDC data management of Shuganning Injection Hospital respectively. The project manager of Shanghai Yonzheng Technology CRO Company, Jia Shenke, introduced the third-party CRO parallel quality control plan.

In this project, the First Affiliated Hospital of Henan College of Traditional Chinese Medicine, as the monitoring unit, with the cooperation of the participating monitoring hospitals, carried out a post-marketing safety hospital centralized monitoring study on Shuganning Injection, with a total of 30,000 inpatients. Six sub-centers will be set up in the east, west, north and south of the country, with more than 40 2. tertiary hospitals under its jurisdiction. This study mainly adopts the real world research method. Through the multi-center, large sample and centralized monitoring in hospital, the usage and dosage of Shuganning injection and the incidence of common, occasional and rare adverse reactions in the disease population are determined. The manifestations, types and population distribution of adverse reactions are found, the severity and influencing factors are analyzed, and the clinical medication schemes such as solvent selection, incompatibility and combined medication are explored, to provide more basis for clinical correct use.

In recent years, Ruihe Pharmaceutical attaches great importance to research and development, especially the re-evaluation of the safety of Shuganning injection, and has invested a lot of money to carry out related research. The launch of the centralized monitoring research project of clinical safety hospital after the listing of Shuganning injection is a concrete embodiment of the joint professional hospital's duty and responsibility under the new normal to ensure the safety of drug use by the public and promote the healthy development of products.