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基于德尔菲法的药源性低纤维蛋白原血症的高风险药品目录构建及防治策略
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| 篇名： | 基于德尔菲法的药源性低纤维蛋白原血症的高风险药品目录构建及防治策略 |
| TITLE： | Establishment of a high-risk medication list and preventive and therapeutic measures for drug-induced hypofi-brinogenemia based on the Delphi method |
| 摘要： | 目的 建立药源性低纤维蛋白原血症高风险药品目录及防治策略，为该疾病的防治提供参考。方法整合国内外病例报道、回顾性病例对照研究、药品不良反应自发报告数据库，筛选出19种在国内上市的药源性低纤维蛋白原血症高风险药品；围绕上述药品的临床特征与作用机制，系统梳理相关风险因素，并总结现有治疗方案，据此初步拟定防治策略建议。以指标重要性评分均值≥3.5分及变异系数＜0.3为筛选指标，通过两轮德尔菲法函询，对拟定条目进行论证、修订并最终达成共识。结果两轮专家咨询的权威程度均为0.904，第一轮函询中药源性低纤维蛋白原血症高风险药品目录、防治策略的Kendall协调系数（Kendall’W）分别为0.390和0.223，P均小于0.05；第二轮函询中上述2个条目的Kendall’W分别为0.227和0.200，P均小于0.05。经两轮专家咨询论证，最终确定了以血凝酶、部分抗感染药物为代表的11种药源性低纤维蛋白原血症高风险药品，以及贯穿“用药前评估-用药中监测-出血事件处理”全过程的5条防治策略。结论本研究建立了科学、可靠的药源性低纤维蛋白原血症高风险药品目录及防治策略，可为该疾病的早期识别、分层管理与精准干预提供理论依据与实践支撑。 |
| ABSTRACT： | OBJECTIVE To establish a high-risk medication list and preventive and therapeutic measures for drug-induced hypofibrinogenemia， and to provide a reference for the prevention and treatment of this condition. METHODS By integrating domestic and international case reports， retrospective case-control studies， and spontaneous adverse drug reaction reporting databases， 19 domestically marketed high-risk drugs for drug-induced hypofibrinogenemia were identified. Based on the clinical characteristics and mechanisms of these drugs， relevant risk factors were systematically reviewed， and existing treatment options were summarized， leading to the preliminary development of recommended preventive and therapeutic measures. A two-round Delphi consultation was conducted to evaluate， revise， and ultimately reach consensus on the preliminary findings， using a mean importance score of ≥3.5 points for indicators and a coefficient of variation ＜0.3 as screening criteria. RESULTS The coefficient of expert authority for both rounds of expert consultation was 0.904. In the first round， the Kendall coordination coefficients （Kendall’s W ） for the high-risk medication list and the proposed preventive and therapeutic measures were 0.390 and 0.223 （ P ＜0.05）， respectively. In the second round， the Kendall’s W were 0.227 and 0.200 （ P ＜0.05）， respectively. After two rounds of expert consultation and discussion， 11 high-risk drugs for drug-induced hypofibrinogenemia， represented by hemocoagulase and certain anti-infective agents， were ultimately identified， along with 5 preventive and therapeutic measures spanning the entire process of “pre-medication assessment， intra-medication monitoring， and bleeding event management”. CONCLUSIONS This study has established a scientific and reliable high-risk medication list， and corresponding preventive and therapeutic measures for drug-induced hypofibrinogenemia， providing a theoretical basis and practical support for the early identification， stratified management， and precise intervention of this condition. |
| 期刊： | 2026年第37卷第07期 |
| 作者： | 文笑；蔡乐；刘宁；高奥；朱曼 |
| AUTHORS： | WEN Xiao，CAI Le，LIU Ning，GAO Ao，ZHU Man |
| 关键字： | 低纤维蛋白原血症；药源性；药品不良反应；高风险药品；防治策略；德尔菲法 |
| KEYWORDS： | hypofibrinogenemia； drug-induced； adverse |
| 阅读数： | 4 次 |
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