5-HT1受体抑制剂(曲坦类)治疗妊娠期偏头痛:医疗使用说明书分析

Я. О. Гриньків
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引用次数: 0

摘要

考虑到育龄妇女偏头痛的高患病率,这种病理对母亲和胎儿健康状况的影响,选择适当的药物治疗是一个极其重要的过程。目标-分析使用在乌克兰药品市场上注册的曲坦类药物治疗怀孕期间妇女偏头痛发作的可能性,根据说明书、科学文献等数据。材料-数据来自信息参考和科学文献,乌克兰国家药品注册,UTIS。研究方法。网络测量、比较分析;数据的系统化。截至2022年9月,ele曲坦、zolmitriptan、rizatriptan、sumatriptan、frovatriptan在乌克兰注册。关于舒马匹坦使用的最完整信息在«Sumamigren»,«Antimigraine-Zdorovya»的说明中。从所有说明书中总结出的信息:“只有在对母亲的预期益处超过对胎儿的可能风险的情况下,才可以使用舒马曲坦”。利扎曲坦说明书上的信息与利扎美格伦和利佐普坦几乎相同,而利扎曲坦-法玛坦说明书上的信息要简洁得多:“在怀孕期间,仅在紧急情况下使用”。佐米曲坦的说明书“佐米曲坦喷雾”指出:“只有当预期的治疗效果超过对胎儿/儿童的潜在风险时,孕妇才可以使用该药”。国内外片剂生产商也给出了类似的信息。1种药物frovatriptan已注册,其中指出:“孕妇使用的安全性尚未确定”,1种药物ele曲坦:“没有孕妇临床使用的经验”。截至2022年9月,以下药物在乌克兰注册:舒马曲坦、利扎曲坦、佐米曲坦、frovatriptan、ele曲坦。释放形式:片剂、包壳片剂或膜壳片剂、口腔分散片剂、胶囊、给药鼻喷雾剂。每一种曲坦类药物的医疗使用说明中的信息内容相似,但不完全相同。舒马曲坦被认为是治疗孕妇偏头痛发作的唯一相对安全的曲坦类药物。曲坦类药物新剂型和原料药(阿莫曲坦、拉西米坦、纳曲普利坦)的注册是曲坦类药物开发和扩大国内医药市场的一个前景方向。
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5-HT1 receptor inhibitors (triptans) for the treatment of migraine during pregnancy: an analysis of the instructions for medical use
Considering the high prevalence of migraine among women of reproductive age, the impact of this pathology on the state of health of the mother and the fetus, the selection of adequate pharmacotherapy is an extremely important process. Goal ‒ to analyze the possibility of using triptans registered on the pharmaceutical market of Ukraine for the treatment of migraine paroxysms in women during pregnancy on the basis of instructions, data from scientific literature, etc. Materials ‒ data from informational reference and scientific literature, State Register of Medicinal Products of Ukraine, UTIS. Research methods – webometric, comparative analyses; systematization of data. As of September 2022, eletriptan, zolmitriptan, rizatriptan, sumatriptan, frovatriptan are registered in Ukraine. The most complete information on the use of sumatriptan is presented in the instructions for «Sumamigren», «Antimigraine-Zdorovya». Summarized information from all the instructions: «The use of sumatriptan is possible only in cases where the expected benefit for the mother exceeds possible risks for the fetus». The information in the instructions for rizatriptan is practically identical for Rizamigren and Rizoptan, and for Rizatriptan-Pharmaten it is presented significantly more succinctly: «During pregnancy, should be used only in case of urgent need». The instructions for zolmitriptan «Zolmigren Spray» indicate: «use of the drug by pregnant women is possible only when the expected therapeutic effect for the woman exceeds the potential risk for the fetus/child». Domestic and foreign manufacturers of tablets indicate similar information. 1 medicine of frovatriptan is registered, where it is indicated: «The safety of the use of in pregnant women has not been established» and 1 medicine of eletriptan: «There is no experience of clinical use of in pregnant women». As of September 2022, the following medicines are registered in Ukraine: sumatriptan, rizatriptan, zolmitriptan, frovatriptan, eletriptan. Forms of release: tablets, tablets covered with a shell or a film shell, tablets dispersible in the oral cavity, capsules, dosed nasal spray. The content of the information in the instructions for the medical use of each triptan medicine taken separately for the analysis of the INN is similar, but not identical. Sumatriptan is considered the only relatively safe triptan for treatment of migraine paroxysms in pregnant women. A prospective direction for the development and expansion of the domestic pharmaceutical market of triptans is the registration of new release forms (and active substances (almotriptan, lasmiditan, naratriptan).
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