Considerations When Offering Minimally Proven Investigational Treatments

https://doi.org/10.1016/j.ophtha.2022.11.008
ISSN 0161-6420/22

中文摘要

這篇文章討論了醫生在提供未經嚴格評估的治療時應考慮的因素。許多常見的醫療干預從未進行嚴格評估，以確保其風險不超過其效益。在美國，多達73%的門診藥物處方off label use並沒有得到充分的科學支持。文章說明了醫生提供未經證實的治療時應平衡為沒有其他選擇的患者提供潛在的挽救生命的治療與遵守希波克拉底誓言，即doing no harm。作者強調，在提供未經證實的治療之前，醫生必須考慮個別的臨床情況，並警告患者缺乏充分的和有良好控制的臨床試驗數據，FDA用於確定是否有足夠的證據支持其有效性的數據。在提供未經證實的治療之前，應該滿足某些標準，例如，治療應提供比現有治療更大的益處，醫生必須具備相關的技能和知識。此外，治療的結果必須得到監控，包括副作用和併發症。文章還提到了應遵循的一些準則，例如美國眼科學會的道德準則和美國食品藥品監督管理局提供的指南，以確保患者福利和權利是在考慮使用未經證實的療法時的首要考慮因素。最後，作者還提醒醫生在決定使用未經證實的治療時，應考慮有限的醫療資源的社會成本和成本效益。

English Abstract

The article “Considerations When Offering Minimally Proven Investigational Treatments” discusses the challenges and ethical considerations that physicians face when providing unproven treatments to patients with life-threatening conditions. The article explains that many medical interventions lack rigorous evaluation to ensure their risks do not outweigh their benefits, and as a result, investigational treatments may be the only option for patients with severe, life-shortening conditions. Physicians must balance the need to provide access to potentially life-saving therapies against the Hippocratic oath of “first doing no harm.” The article provides examples of minimally proven investigational treatments, including surgical techniques, laser procedures, and off-label use of medications, that have been adopted by ophthalmologists before being substantiated. The authors argue that physicians must assess each individual clinical situation to determine whether an investigational treatment would be appropriate, and they must alert patients to the absence of adequate and well-controlled clinical trial data. The article emphasizes the importance of informed consent and the need for appropriate review mechanisms, including prospective institutional review board approval and the disclosure of financial and non-financial conflicts of interest. Ultimately, the article stresses that any decision on the use of unproven investigational therapies must involve a serious and thoughtful discussion of the risks and benefits with the patient, and treatment should be recommended only after careful consideration of the patient’s social, emotional, occupational, and physical needs, acknowledging the protection of potentially vulnerable patients.