含冰片中成药临床合理使用与药学评价的专家共识(2022,北京)

Expert consensus on rational clinical use and drug evaluation of Chinese patent medicines containingborneol(2022,Beijing)

冰片具有开窍醒神、清热止痛的功效,含冰片中成药品种多、临床应用广泛,且不合理用药(不对证使用、重复用药、超长疗程服用等)情形常见。同时,历代本草曾多次记载冰片不当使用的安全风险,现代药理学实验也有相关提示,所以,含冰片中成药应成为医疗机构合理用药的关注点。为了规范此类中成药的合理使用,特制定本共识。本共识采用“共识报告”的形式,由来自全国多地三级医疗机构的28名药学专家经Delphi法形成。共识形成前进行了充分调研,共识形成中开展了相关问题的文献学统计分析和循证评价,并采用认可度和推荐度评分进行了专家意见的综合,最终形成了含冰片中成药的“合理使用基本原则”和“药学评价与用药指导的关键原则”两部分共21条陈述及其说明性文字。旨在为医疗机构药师、医师和医保管理者提供含冰片中成药合理使用与药学评价的参考意见。

Borneol has the effects of awakening the mind,clearing away heat and relieving pain.There are many varieties of Chinese patent medicines containing borneol,which are widely used in clinical practice,butthe unreasonable use of these drugs is prominent,such as the use on incorrect syndrome,the repeated medication,and the long-term use.At the same time,the improper use of borneol recorded in many ancient Chinese medicine books has a high safety risk,and modern toxicology experiments have also been reported,which make this kind of drugs be the focus of rational drug use in hospitals.This consensus is aim to regulate the rational use of Chinese patent medicines containing borneol.This consensus is in the form of"consensus report",which is formed by 28 pharmaceutical experts from three-level medical institutions in many places across the country through Delphi method.The relevant Questionnaire was carried out before the formation of the consensus.The literature statistical analysis and evidence-based evaluations of relevant issues were also carried out during the formation of the consensus,and the expert opinions were synthesized by using the recognition and recommendation scores.Finally,21 statements and explanatory texts were formed in two parts of"basic principles for rational use"and"key principles for pharmaceutical evaluation and drug use guidance"of Chinese patent medicines containing borneol.The purpose of this work is to provide reference opinions on rational use and pharmaceutical evaluation of Chinese patent medicines containing borneol for pharmacists,doctors and medical insurance administrators in medical institutions.