Borovskaya T G
E.D. Goldberg Research Institute of Pharmacology and Regenerative Medicine, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia.
Ter Arkh. 2017;89(11):93-99. doi: 10.17116/terarkh2017891193-99.
The review gives summarized information on the preclinical data and clinical trials evaluating the safety of the antiviral drug Kagocel. It notes that the manufacturer of the drug pay special attention to the control of its impurity content. There is information on the development and validation of highly sensitive and specific high-performance liquid chromatography procedures, the application of which can guarantee that free gossypol impurities are absent in the drug. The results of preclinical toxicity study of Kagocel in experiments on laboratory animals are briefly reviewed; particular attention is paid to the investigation of the drug's safety for the reproductive system of immature animals. It is noted that evaluation of the total toxic properties of Kagocel has revealed no signs of intoxication. Investigations of the reproductive toxicity of Kagocel have showed no effect on spermatogenesis. A set of experimental studies of the long-term effects of the use of Kagocel in different regimens has confirmed that the drug has no negative effect on the reproductive organs in the offspring of experimental rats and on its development. Many clinical trials, including those with participation of children aged 2 years or older, have provided important data on drug safety. The results given in the review lead to the conclusion that the use of the antiviral drug Kagocel in both general and pediatric practice is proven safe.
这篇综述给出了评估抗病毒药物卡古缩宫素安全性的临床前数据和临床试验的总结信息。文中指出该药物制造商特别关注其杂质含量的控制。有关于高灵敏度和特异性高效液相色谱法程序的开发与验证的信息，应用该方法可确保药物中不存在游离棉酚杂质。简要回顾了卡古缩宫素在实验动物身上进行的临床前毒性研究结果；特别关注了该药物对未成熟动物生殖系统安全性的研究。文中指出，对卡古缩宫素总体毒性特性的评估未发现中毒迹象。卡古缩宫素生殖毒性的研究表明对精子发生没有影响。一组关于以不同方案使用卡古缩宫素的长期影响的实验研究证实，该药物对实验大鼠后代的生殖器官及其发育没有负面影响。许多临床试验，包括有2岁及以上儿童参与的试验，都提供了有关药物安全性的重要数据。综述中给出的结果得出结论，抗病毒药物卡古缩宫素在普通医疗和儿科实践中的使用已被证明是安全的。
