[关键词]
[摘要]
目的 综合评价4种钙离子通道调节剂(加巴喷丁、普瑞巴林、克利加巴林、美洛加巴林)治疗糖尿病性周围神经病理性疼痛(DPNP)的综合性能,为医疗机构遴选药品提供依据。方法 依据《中国医疗机构药品评价与遴选快速指南(第二版)》,从药学特性、有效性、安全性、经济性及其他属性5大维度,对4种钙离子通道调节剂治疗DPNP进行综合评分。结果 普瑞巴林的综合总分最高,其次是克利加巴林和加巴喷丁,美洛加巴林最低。4种药物各有特点,普瑞巴林作为国家基本药物,起效快、亲和力高且无显著肝代谢影响,但仍具滥用与致畸风险,澳大利亚药品管理局(TGA)已发布黑框警告;克利加巴林与美洛加巴林镇痛效果持久稳定,对α2δ-1亚基亲和力高,对α2δ-2亚基亲和力低,中枢不良反应较小;克利加巴林安全性最佳,不良反应少且多为自限性,但长期安全性尚待观察;加巴喷丁经济性突出,但存在肝肾毒性、呼吸抑制及致畸致癌风险,也具有TGA黑框警告。结论 提出强推荐普瑞巴林、克利加巴林、加巴喷丁,美洛加巴林因经济性差及戒断风险等,仅建议无替代药物时弱推荐。临床决策需综合权衡药物安全性、经济性及患者个体耐受性。
[Key word]
[Abstract]
Objective To comprehensively evaluate the overall profile of four calcium channel modulators(gabapentin, pregabalin, crisugabalin, and mirogabalin) in the treatment of diabetic peripheral neuropathic pain(DPNP) to provide evidence for drug selection in healthcare institutions. Methods Following the Quick Guide for Drug Evaluation and Selection in Chinese Healthcare Institutions(Second Edition), this study conducted a comprehensive scoring of the four calcium channel modulators for DPNP across five dimensions: pharmaceutical properties, efficacy, safety, economic attributes, and other relevant factors. Results Pregabalin achieved the highest total score, followed by crisugabalin and gabapentin, with mirogabalin scoring the lowest. Each drug exhibited distinct characteristics, pregabalin, a national essential medicine, acts rapidly, has high affinity, and lacks significant hepatic metabolism influence. However, it carries risks of abuse and teratogenicity, for which the Theraputic Goods Administration(TGA) has issued a black box warning. Crisugabalin and mirogabalin provide sustained and stable analgesic effects. They exhibit high affinity for the α2δ-1 subunit and lower affinity for the α2δ-2 subunit, resulting in reduced central nervous system side effects. Crisugabalin demonstrated the best safety profile, with fewer and mostly self-limiting adverse reactions, although its long-term safety requires further observation. Gabapentin showed superior cost-effectiveness. Nevertheless, it presents risks of hepatorenal toxicity, respiratory depression, teratogenicity, and carcinogenicity, also warranting a TGA black box warning. Conclusion Strong recommendations are proposed for pregabalin, crisugabalin, and gabapentin. Mirogabalin is suggested for weak recommendation only when no alternatives are available, due to its poor cost-effectiveness and withdrawal risk. Clinical decision-making must involve a comprehensive balance of drug safety, economic considerations, and individual patient tolerability.
[中图分类号]
R97
[基金项目]