1Onkoderma - Clinic for Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria; 2Department of Dermatology and Venereology, Medical Institute of Ministry of Interior, Sofia, Bulgaria.
2Department of Dermatology and Venereology, Medical Institute of Ministry of Interior, Sofia, Bulgaria.
Georgian Med News. 2023 Sep(342):26-29.
Two steps are able to lead to a significant decrease in the incidence of skin cancer overall and/or to its parallel and successful surgical treatment. The first step concerns its non-occurrence or less frequent clinical manifestation and is largely related to the modern concept known as prevention, but not the one mainly related to solar radiation, but: 1) informing patients about the possible contamination of certain drugs with carcinogens/nitrosamines/NDSRIs and 2) making clinicians aware of the modern concept of limited to completely eliminated intake of nitrosamines/NDSRIs in medications. The ineffectiveness of either of these entities could in all likelihood be seen as one of the major causes of the headline growth in the incidence of skin cancer and keratinocytic cancer in particular. It is also because of this fact that the sun protection so recommended and advertised has been shown to be ineffective, yet it remains universally advertised. Polycontamination with Nitrosamines/NDSRIs within multimedication in polymorbid patients is the most serious obstacle (at the moment) for the current concept of skin cancer prevention to become a reality. The announced official "hypothetical contamination" of more than 250 drugs worldwide by the FDA in April 2023, and the establishment of permissive concentrations for 5 classes of carcinogenic activity of the nitrosamines/NDSRIs - effectively make any preventive step more than impossible or meaningless. The open question remains, how were the 5 subgroups for hypothetical carcinogenic potency of the carcinogens contained in the drugs created? On the basis of what data? What tumors occurred when these concentrations were exceeded? Data that remains hidden from the public and end users, but also data that guarantees the development of real (not hypothetical) skin tumours. The new FDA regulations also do not comment on the issues concerning the use of "hypothetical carcinogens" in the context of polycontamination and polymedication in polymorbid patients. Because of this fact, the follow-up of actual carcinomas after the intake of multiple "hypothetical carcinogens" would also seem to be not unimportant. And it turns out to be quite real and sobering to say the least. The second step, which concerns the successful treatment of skin cancer, is its early surgical treatment. This is the most promising approach, regardless of whether patients are exposed to permanent intake of carcinogens/nitrosamines/NDSRIs in the drugs. We report an 86-year-old patient, who, as part of his polymedication and polymorbidity, takes 3 drugs that, according to the official FDA list of 2023, have strictly defined reference limits for potentially available "hypothetical carcinogens": bisoprolol/carcinogenic potency class 4, olanzapine/ carcinogenic potency class 5 and venlafaxine/ carcinogenic potency class 1. The described patient developed "real carcinoma" after combined long-term intake of the "hypothetical carcinogens" announced in the official FDA lists from April 2023. Proceeding from common sense, regulators in the face of the FDA should have already long observed the development of a heterogeneous type of tumors to be able to determine 1) the potency of the 5 subclasses of carcinogens in the drugs and 2) their reference values. Moreover- they should also have the exact information why which carcinogen in which drug causes which type of tumor. Otherwise, the FDA should not announce its detailed recommendations to drug manufacturers. The present patient was successfully treated surgically by a transposition adjacent flap. The optimal dermatosurgical and reconstructive methodologies for the treatment of tumors in the ala nasi area are discussed.
两步可以显著降低皮肤癌的总体发病率和/或实现其平行且成功的手术治疗。第一步涉及到其不发生或较少发生临床症状,这在很大程度上与现代预防概念有关,但与主要与太阳辐射有关的概念无关,而是:1)告知患者某些药物可能含有致癌物质/亚硝胺/NDSRIs,以及 2)让临床医生意识到现代概念是限制在药物中完全消除亚硝胺/NDSRIs 的摄入。这两个实体中的任何一个都不能有效实施,很可能被视为皮肤癌发病率,特别是角质细胞癌发病率增长的主要原因之一。正是由于这个事实,所推荐和宣传的防晒措施被证明是无效的,但它仍然被普遍宣传。多药治疗中多药物中的亚硝胺/NDSRIs 污染是当前皮肤癌预防概念实现的最严重障碍(目前)。2023 年 4 月,FDA 宣布全球超过 250 种药物“假设污染”,并为亚硝胺/NDSRIs 的 5 类致癌活性建立允许浓度-实际上使任何预防措施变得不可能或毫无意义。目前仍存在一个悬而未决的问题,即如何为药物中致癌物质的 5 个亚类创建假设致癌潜力?基于什么数据?超过这些浓度时会发生哪些肿瘤?这些数据仍然对公众和终端用户保密,但也保证了真正(而非假设)皮肤肿瘤的发展。新的 FDA 法规也没有就多药治疗中多药治疗和多药治疗中“假设致癌物质”使用问题发表评论。由于这一事实,在摄入多种“假设致癌物质”后对实际癌的随访似乎也并非不重要。而且,至少可以说,这是相当真实和清醒的。第二步涉及皮肤癌的成功治疗,即早期手术治疗。无论患者是否因药物中持续摄入致癌物质/亚硝胺/NDSRIs 而受到影响,这都是最有前途的方法。我们报告了一位 86 岁的患者,他在多药治疗和多药治疗中同时服用了 3 种药物,根据 2023 年 FDA 的官方清单,这些药物严格规定了潜在可用“假设致癌物质”的参考限值:比索洛尔/致癌潜能等级 4、奥氮平/致癌潜能等级 5 和文拉法辛/致癌潜能等级 1。描述的患者在联合长期摄入 2023 年 4 月 FDA 官方清单中宣布的“假设致癌物质”后发展为“真正的癌”。基于常识,面对 FDA,监管机构应该已经观察到异质肿瘤的发展,以便能够确定 1)药物中 5 个亚类致癌物质的效力,以及 2)它们的参考值。此外,他们还应该有确切的信息,说明为什么哪种致癌物质在哪种药物中会导致哪种类型的肿瘤。否则,FDA 不应该向制药商公布其详细建议。目前的患者通过相邻皮瓣移位成功接受了手术治疗。讨论了鼻翼区域肿瘤的最佳皮肤外科和重建方法。