2名患者使用临床研究抗癌药，官方通报调查结果

Core Viewpoint The article discusses the investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing, highlighting the actions of medical professionals and the procurement of the drugs, as well as the regulatory implications. Group 1: Basic Situation - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital. In August 2023, her condition recurred, leading to the recommendation of the drug Cadonilimab by her doctor [2] - Patient Tang was diagnosed with cervical cancer in June 2017 and also underwent surgery. In January 2024, her condition recurred, and she was recommended to use Cadonilimab as a more affordable option compared to another drug [2] Group 2: Investigation and Handling - The investigation revealed that Doctor Li recommended Cadonilimab to both patients, which was confirmed through patient interviews and communication records [3][4] - Doctor Li acknowledged the recommendation of Cadonilimab and admitted to providing patients with information about the drug's effects and risks [5][6] Group 3: Drug Procurement - Cadonilimab was approved for sale in June 2022 at a price of 13,220 yuan per unit. Patients could obtain it through self-purchase, charity programs, or clinical research projects [7] - Patient Li obtained a total of 70 units of the drug through various means, while Patient Tang obtained 90 units, with both patients having purchased some units at the market price [8] Group 4: Clinical Research Drug Sources - The investigation found that the clinical research drugs obtained by the patients were improperly sourced, with evidence of forgery by sales personnel from the drug company [9] - The pharmacies involved were found to have violated regulations by distributing clinical research drugs without proper authorization [10] Group 5: Drug Quality Verification - Cadonilimab was confirmed to meet quality standards as it was approved by the National Medical Products Administration, and the drugs used by the patients were produced according to regulatory requirements [11][12] Group 6: Investigation of Clinics - The clinic where the patients received infusions was found to have legitimate qualifications but was involved in irregularities, including the use of forged prescriptions [13]