中国临床药学杂志

目的 分析静注人免疫球蛋白在神经内科超说明书的用药情况并制定管理措施，为临床合理用药提供参考。方法 回顾性分析2016-2021年某医院神经内科使用静注人免疫球蛋白的58例住院患者超说明书用药情况并给予循证证据评价，同时引入PDCA管理法规范其在神经内科的超说明书用药。结果 纳入研究的58例使用静注人免疫球蛋白患者均为超适应证用药，其中超适应证用药排名前三的为吉兰-巴雷综合征（18例）、自身免疫性脑炎（12例）和视神经脊髓炎谱系疾病（10例），给药剂量为(23.37±2.66) g，疗程为(4.64±0.77) d。经过循证医学评价后发现49例超说明书使用静注人免疫球蛋白是合理的，9例是不合理的，用药的合理率为84.48%。同时建立了静注人免疫球蛋白在神经内科规范化使用的临床路径。结论 静注人免疫球蛋白在神经内科超说明书使用大多数都有循证医学证据支持，但也存在少数不合理的现象。规范静注人免疫球蛋白在神经内科的超说明书使用，可促进临床用药合理化。

AIM To analyze the off-label drug use of human immunoglobulin for intravenous injection in neurology department and to provide reference for clinical rational drug use. METHODS Retrospective analysis and evidence-based evaluation of off-label drug use in 58 inpatients using human immunoglobulin for intravenous injection were conducted in the neurology department of a hospital from 2016 to 2021. The PDCA(plan-do-check-action) management law was introduced to regulate off-label drug use in neurology department. RESULTS The 58 patients who received human immunoglobulin for intravenous injection were all treated with off-indication medication. The top 3 drugs for overindication were Guillain-Barre syndrome(18 patients), autoimmune encephalitis(12 patients), and neuromyelitis optica(10 patients). The average dosage was(23.37±2.66) g, and the average course of treatment was(4.64±0.77) days. After evidence-based evaluation, it was found that 49 patients were reasonable, 9 patients were unreasonable, and the reasonable rate of drug use was 84.48%.At the same time, the clinical pathway of human immunoglobulin for intravenous injection used in neurology department was established. CONCLUSION Most of the off-label use of human immunoglobulin for intravenous injection in neurology department is supported by evidence-based evaluation. A few irrationalities also exist. Standardizing the off-label use of human immunoglobulin for intravenous injection in neurology department can promote the rationalization of clinical medication.