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Rifampicin Capsules (Ⅱ) Multi-center Clinical Evaluation Officially Launched
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Add time:2017-04-12 14:20
Summary:After nearly half a year of careful preparation, on February 24, 2017, the "Anti-tuberculosis Drug Rifampicin Capsules (Ⅱ) Multi-center Clinical Evaluation for Treatment of Tuberculosis" project kick-off training meeting was held in Xuzhou, Jiangsu Province on February 24, 2017.
After nearly half a year of careful preparation, on February 24, 2017, the "Anti-tuberculosis Drug Rifampicin Capsules (Ⅱ) Multi-center Clinical Evaluation for Treatment of Tuberculosis" project kick-off training meeting was held in Xuzhou, Jiangsu Province on February 24, 2017. More than 30 people from the China National Tuberculosis Association, China Centers for Disease Control and Prevention Tuberculosis Prevention and Control Center, Jiangsu and other 10 provinces (cities) disease control centers, tuberculosis designated medical institutions leaders, tuberculosis prevention and treatment, clinical and laboratory experts, etc., attended the meeting. Start the training meeting. The launch of the project marked the official entry into the implementation phase of the multi-center clinical research evaluation of Rifampicin Capsule (Ⅱ) independently developed by Shenyang Hongqi.
Figure 1 Project kick-off training meeting
Rifampicin capsules (Ⅱ) have been used clinically for more than 20 years. Compared with rifampicin capsules, it has certain advantages in the treatment efficacy, safety, compliance and dosage of tuberculosis. This multi-center clinical evaluation is to further scientifically evaluate the clinical efficacy, compliance and drug safety of rifampicin capsules (Ⅱ) in the treatment of newly-treated tuberculosis, and provide new options for the use of anti-tuberculosis drugs in my country. The multi-center evaluation was led by the China National Tuberculosis Association, Shandong Provincial Chest Hospital, Shenyang Chest Hospital, Xi'an Chest Hospital, Xuzhou Infectious Disease Hospital, Yangzhou Third People's Hospital, Hengyang Third Hospital, Binzhou Central Hospital, etc. Eight medical institutions were the first to participate in the clinical evaluation, and the project site selection and evaluation work for one year. This kick-off training meeting not only participated in the evaluation of leaders and experts of medical institutions, but also specially invited some experts from other provinces as consultants.
The kick-off meeting was chaired by researcher Zhao Yanlin, chairman of the Basic Professional Branch of the China National Tuberculosis Association and deputy director of the Tuberculosis Prevention and Control Center of the Chinese Center for Disease Control and Prevention. Professor Cheng Shiming, secretary-general of the China Antituberculosis Association, introduced the background, purpose and significance of the project on the premise of introducing the good situation of national science and technology innovation and entrepreneurship. Yang Bo, the general manager of Shenyang Hongqi Pharmaceutical Co., Ltd., delivered a speech and proposed that as the country's tuberculosis drug R&D and production company with the longest time and the largest scale, it is the responsibility and obligation of the company to actively carry out the research and application of anti-tuberculosis drugs. He said that the company will invest more The funds for drug consistency evaluation and PQ demonstration will not only provide high-quality drugs for the treatment of tuberculosis patients in my country, but also promote my country's self-developed anti-tuberculosis drugs to the international market. Director Lu Wei of the Jiangsu Provincial Center for Disease Control and Prevention introduced the experience of tuberculosis prevention and treatment in Jiangsu Province, the basis for carrying out tuberculosis research and evaluation, and the management mechanism of anti-tuberculosis drugs in Jiangsu.
Figure 2 Cheng Shiming, secretary-general of China Tuberculosis Association, introduced the project
At the training meeting, Secretary-General Cheng Shiming introduced the overall framework of the project, researcher Zhao Yanlin introduced tuberculosis etiology laboratory diagnostic methods and quality control, and Director Zhou Lin of the Patient Care Department of the Tuberculosis Prevention and Control Center of the Chinese Center for Disease Control and Prevention introduced the inclusion of the project cases , CRF form filling and other requirements, Associate Researcher Liu Eryong introduced the signing, supervision, quality control, data collection report, etc. of the enrolled patients. Chief Physician Zhang Ruimei of Xuzhou Infectious Disease Hospital introduced the diagnosis, curative effect evaluation, adverse reaction observation and treatment of pulmonary tuberculosis patients. Du Caihong, the academic manager of the Marketing Department of Shenyang Hongqi Pharmaceutical Co., Ltd., introduced the preliminary research basis of rifampicin capsules (Ⅱ), drug supply, storage and precautions, and proposed to provide first-line anti-tuberculosis drugs for scientific evaluation. The participating experts fully discussed the contents of the research plan, unified standards and reached consensus.
Figure 3 Expert leadership report
Secretary-General Cheng Shiming finally stated that the drugs evaluated by the project are from Shenyang Red Flag, and the anti-tuberculosis drug treatment service is for tuberculosis patients across the country. The China National Tuberculosis Association has the responsibility and obligation to organize everyone to work with the enterprise to complete the project for the country. Tuberculosis prevention and treatment planning services.
Figure 4 Group photo of expert leaders
