RÉSUMÉ
Objective:To investigate the efficacy and safety of polatuzumab vedotin (pola) in treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).Methods:The clinical data of 1 DLBCL patient receiving multiple treatments in Jiangsu Cancer Hospital in May 2016 were retrospectively analyzed, and the related literature was reviewed.Results:The patient, a 57-year-old male, was diagnosed with DLBCL in May 2016. Since June 2016, he had received treatments with four lines including anti-CD20 monoclonal antibody combined with chemotherapy, chemotherapy only and chimeric antigen receptor T cell (CAR-T). However, the disease relapsed or progressed after all treatments. Therefore, the patient had received 6 cycles of pola combined with rituximab since December 2019. Unexpected adverse events were not found during the treatment. The evaluation of clinical efficacy was complete remission after the end of treatment. The progression-free survival time was more than 13 months with follow-up until January 2021.Conclusion:Pola initially shows good efficacy and safety in treatment of patients with relapsed/refractory DLBCL.
RÉSUMÉ
OBJECTIVE：To pr ovide reference for improving extended clinical trial system in China. METHODS ：The implementation experience of the international extended clinical trial system was introduced from three aspects ： system development，application scope and principles ，application and approval ；the evolution and challenges of the system in China were further analyzed ，and relative suggestions were put forward. RESULTS & CONCLUSIONS ：The development of international extended clinical trial system in the United States ，the United Kingdom ，Australia and the European Union had been relatively mature. The specific system had not formally been established in China ，and the implementation of the system faced many challenges，such as the ethical problems caused by drug use risk ，the sponsor dilemma caused by the difficult balance between the resistance of initiating application and the benefits ，the difficulty of review caused by the unknown responsible party of risk assessment and the urgent time of approval. It can be dealt with by the following measures ：improving the existing laws and regulations，strengthen information disclosure and risk prevention work ，make clear the division of responsibilities in the process of system operation. Meanwhile ，based on the existing international model ，the management system of the expanded clinical trials in China is established. Corresponding application paths are set up for different application types such as “single patient emergency ”， “single patient non emergency ”and“two or more patients group ”，and all parties should be mobilized to supervise so as to promote the improvement and implementation of the extended clinical trial system.
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At present, there are no specific targeted drugs for the treatment of pneumonia (COVID-19) caused by the novel coronavirus (SARS-CoV-2). Interferon, lopinavir/ritonavir, ribavirin, chloroquine phosphate were chosen as off-label use, and remdesivir was chosen as compassionate use. This paper reviewed the behavior of the two medication response to the new major infectious disease.