2名患者使用临床研究抗癌药，官方通报！

Core Viewpoint - The investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing highlights issues related to medical recommendations, drug procurement, and regulatory compliance in the healthcare sector [1][2][3]. Group 1: Patient Cases - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital, where she was recommended to use the drug Cadonilimab starting April 17, 2024 [2]. - Patient Tang was diagnosed with cervical cancer in June 2017 and was also recommended to use Cadonilimab after a recurrence in January 2024, starting her treatment on January 30, 2024 [2][4]. Group 2: Medical Professional Conduct - The investigation revealed that the doctor, referred to as Li, recommended Cadonilimab to both patients, despite the initial recommendation for a different drug, Pembrolizumab, citing cost and effectiveness [4][5]. - Doctor Li admitted to discussing potential risks associated with Cadonilimab, which has a reported incidence of immune-related pneumonia at 1.7% [3][4]. Group 3: Drug Procurement and Usage - Cadonilimab was approved for sale on June 28, 2022, with a market price of 13,220 yuan per unit, and patients could obtain it through various means, including self-purchase and charity programs [6][7]. - Both patients acquired a total of 70 and 90 units of Cadonilimab, respectively, through a combination of self-purchase, charity donations, and clinical research supplies [6][7]. Group 4: Regulatory and Compliance Issues - The investigation found that the clinical research drugs obtained by the patients were improperly sourced, with evidence of forged documents used to acquire these drugs from pharmacies [8][9]. - The pharmacies involved were penalized for non-compliance with drug management regulations, highlighting systemic issues in the oversight of drug distribution [9]. Group 5: Quality and Safety of the Drug - The investigation confirmed that the Cadonilimab used by the patients was produced according to national standards and did not exhibit quality issues, despite being labeled for clinical research use [10][11]. Group 6: Institutional Response - Following the investigation, health authorities initiated a comprehensive review of medical practices and regulatory compliance to prevent similar incidents in the future, emphasizing the need for improved oversight in clinical research and drug management [12].