摘要
目的评价我院2011-2012年静注人免疫球蛋白（PH4）[intravenous immunoglobulin（PH4），IVIg]应用概况、临床诊断与说明书适应证以及相关临床治疗指南相符性；以及在市场供应短缺情况下保证临床使用的管理措施。方法回顾2011-2012年我院750例住院患者使用静注人免疫球蛋白（PH4）的概况，对患者年龄、性别、疾病诊断、使用数量、用药疗程进行统计汇总；以药品说明书、2010年版《中国药典临床用药须知》、国内外相关临床治疗指南为依据，根据临床诊断，评价用药的合理性以及与说明书适应证的相符性。结果2011-2012年我院住院750例有效病例资料中，男性351例（占46．8％）、女性399例（占53．2％）；平均年龄30．5岁（0-101岁）；静注人免疫球蛋白（PH4）的使用分布于全院加个临床科室，总用药量为45842．5g，人均用量61．1g（2．5-572．5g）．总金额839．6万余元；用量最多的疾病依次为系统性红斑狼疮、重症肌无力、格林巴利综合征、免疫性血小板减少症、多肌炎／皮肌炎、抗N-甲基-D-天冬氨酸受体脑炎、淋巴瘤、系统性血管炎、慢性炎症性脱髓鞘多发性神经病、药疹等；人均日用量13．3g，人均用药天数4．5d（1-32d）。结论我院2011-2012年住院患者使用静注人免疫球蛋白（PH4）符合药品说明书适应证为616例，占82．1％；超说明书适应证为134例，占17．9％。按照最新国内外指南衡量，符合指南推荐使用的为580例，占77．3％；不推荐使用为18例，占2．4％；指南中未提及的为152例，占20．3％。由于静注人免疫球蛋白（PH4）来源有限，市场一度出现供货短缺现象，我院及时制定有效的管理措施对于保证合理用药发挥了重要作用。
OBJECTIVE To evaluate the application profiles and the conformance of clinical diagnostics and instructions indica- tions, relative clinical treatment guidelines of intravenous immunoglobulin（PH4） in our hospital from 2011 to 2012. In addition, the management measures for clinical use in the case of market supply shortage were discussed. METHODS Age, gender, diagnosis, dose, and treatment duration of 650 patients using IVIg in our hospital from 2011 to 2012 were analyzed retrospectively. According to the drug instructions, Chinese Pharmacopoeia Clinical Medication Notice 2010 and relative domestic and foreign clinical treatment guidelines, we evaluated the rationality of medication and the conformance of clinical diagnoses and instruction indications. RESULTS In our 750 valid cases, there were 351 male patients （46. 8% ） and 400 female patients （53.2%）. Average age of these patients was 30. 5 years old （0 - 101 years）. The use of IVIg was distributed in 20 clinical departments of our hospital. Total dosage was 45 842.5 g. Per capita dosage was 61.1 g（2. 5 -572. 5 g）. Total cost was 8. 396 million yuan. Diseases sorting by sum dosage were systemic lupus erythematosus, myasthenia gravis, Guillain-Barre syndrome, immune thrombocytopenia, polymyositis/dermatomyositis, anti-N-methyl-D-aspartate receptor encephalitis, lymphoma, systemic vasculitis, chronic inflammatory demyelinating polyneuropathy, drug rash, etc. Per capita daily dose was 13.3 g. Per capita course of treatment was 4.5 d （ 1 - 32 d）. CONCLUSION Among the hospitalized patients using IVIG from 2011 to 2012, 616 cases meet the indications of instruction, accounting for 82. 1% ; 134 cases were beyond the indications, accounting for 17.9%. According to the latest domestic and international guidelines, 580 cases corresponded with the recommendations of guidelines, accounting for 77.3% ; 18 cases were not recommended by guidelines, accounting for 2.4% ; 152 cases were not mentioned in guidelines, accounting for 20. 3%. Since the IVIG
出处
《中国药学杂志》
CAS
CSCD
北大核心
2014年第14期1262-1267,共6页
Chinese Pharmaceutical Journal
