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硬化剂临床应用研究进展

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目的 为临床合理使用硬化剂提供参考。方法 检索PubMed、中国生物医学文献数据库及国家药品监督管理局、美国食品和药物管理局、日本医药品医疗器械综合机构、欧洲药物管理局的官方网站自建库起至 2023 年 3 月的相关文献资料,总结国内外已上市的硬化剂及具有硬化治疗适应证药物的相关信息。检索UpToDate数据库及中国知网查询自建库起至 2023 年 3 月涉及硬化疗法和硬化剂的相关指南及文献,汇总其临床应用,并对硬化疗法进行循证评价。通过中国、欧盟及美国的临床试验登记网站查询硬化剂临床试验注册及硬化疗法相关内容(截至 2023 年 3 月),并分析其发展趋势。结果 硬化剂根据作用机理可分为清洁剂类、渗透型、化学性硬化剂,批准的适应证主要为静脉曲张、血管扩张等。相关指南中硬化疗法的临床应用多为高质量或中等质量证据;硬化疗法性价比高、操作简单,可作为主要治疗方案或术中的辅助手段;无水乙醇联用聚桂醇在静脉畸形等方面疗效及安全性较好。共获得临床试验 107项,包括硬化剂辅助手术治疗安全性的评估(39项、36。45%),新型硬化剂的探索及原有硬化剂的安全性、有效性评估(61项、57。01%),硬化剂联用效果评估(7项、6。54%);硬化剂联用比单用的疗效更好,泡沫硬化疗法的疗效、安全性均较好。结论 硬化剂种类多样,建议国内临床医师和药师全面、系统总结硬化剂的种类及使用方法,推出规范指南,从而更好地指导临床实践。
Research Progress on Clinical Application of Sclerosants
Objective To provide a reference for the rational use of sclerosants in clinical practice.Methods The relevant literature and data in the PubMed,the China Biology Medicine disc,the official websites of National Medical Products Administration,Food and Drug Administration,Pharmaceuticals and Medical Devices Agency and European Medicines Agency from the inception of each database to March 2023 were searched to summarize the relevant information on the sclerosants and drugs with indication for sclerotherapy that had been launched at home and abroad.The guidelines and studies involving sclerosants and sclerotherapy in the UpToDate database and CNKI from the inception of each database to March 2023 were searched to summarize their clinical application,and the evidence-based evaluation was conducted.The relevant information on clinical trial registration of sclerosants and sclerotherapy up to March 2023 was obtained by the clinical trial registration websites of China,the European Union and the United States,and the development trend of sclerosants was analyzed.Results Sclerosants could be classified into cleaning agents,penetrating agents and chemical agents based on their mechanism.The approved indications were mainly varicose veins,vasodilation and so on.The clinical application of sclerotherapy in relevant guidelines was mostly based on the high-or moderate-quality evidence.Sclerotherapy was cost-effective and simple to operate,which was a main treatment plan or an auxiliary method during surgery.Absolute ethanol combined with lauromacrogol was effective and safe in the treatment of venous malformations and others.A total of 107 clinical trials were obtained,including the safety evaluation of sclerotherapy assisting surgery(39 cases,36.45%),the exploration of new sclerosants and safety and efficacy evaluation of existing sclerosants(61 cases,57.01%),the effect evaluation of the combination of sclerosants(seven cases,6.54%).The combined use of sclerosants was more effective than their single use,and foam sclerotherapy was effective and safe.Conclusion There are many kinds of sclerosants.It is suggested that domestic clinical physicians and pharmacists should comprehensively and systematically summarize the types and usage of sclerosants,and formulate standardized guidelines to better guide the clinical practice.

sclerosantsclerotherapyclinical applicationresearch progress

洪峻、赵志刚

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首都医科大学附属北京天坛医院,北京 100070

首都医科大学药学院,北京 100069

硬化剂 硬化疗法 临床应用 研究进展

北京市医院管理局重点医学专业发展计划

ZYLX201827

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(2)
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