我院静注人免疫球蛋白_PH4_临床应用的合理性研究_兰杨

·药物与临床·

我院静注人免疫球蛋白(PH4)临床应用的合理性研究

兰杨，冯雷*，梅丹（中国医学科学院北京协和医学院北京协和医院，北京100730）

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20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。

关键词：静脉注射人免疫球蛋白;药品短缺;合理用药

doi:10.11669/cpj.2014.14.021中图分类号：Ｒ288文献标志码：A文章编号：1001－2494（2014）14－1262－06

Ｒesearch of Clinical ApplicationＲationality for Intravenous Human Immunoglobulin（PH4）in Our Hospital

LAN Yang，FENG Lei*，MEI Dan（Peking Union Medical College Hospital Chinese Academy of Medical Sciences Peking Union Medical College，Beijing100730，China）

ABSTＲACT：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 from2011to2012.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 of650patients using IVIg in our hospital from2011to2012were analyzed retrospectively.According to the drug instructions，Chinese Pharmacopoeia Clinical Medication Notice2010and relative domestic and foreign clinical treatment guidelines，we evaluated the rationality of medication and the conformance of clinical diagnoses and instruction indications.ＲESULTS In our750valid cases，there were351male patients（46.8%）and400female patients（53.2%）.Average age of these patients was30.5years old（0－101years）.The use of IVIg was distributed in20clinical departments of our hospital.Total dosage was 45842.5g.Per capita dosage was61.1g（2.5－572.5g）.Total cost was8.396million 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 was13.3g.Per capita course of treatment was4.5d（1－32d）.CONCLUSION Among the hospitalized patients using IVIG from2011to2012，616cases meet the indications of instruction，accounting for82.1%；134cases were beyond the indications，accounting for17.9%.According to the latest domestic and international guidelines，580cases corre-sponded with the recommendations of guidelines，accounting for77.3%；18cases were not recommended by guidelines，accounting for 2.4%；152cases were not mentioned in guidelines，accounting for20.3%.Since the IVIG is rare and the market supply is once lac-king，the effective management measures made by our hospital play an important role in ensuring the rational administrations.

KEY WOＲDS：intravenous immunoglobulin；drug shortage；rational administration

作者简介：兰杨，女，主管药师研究方向：医院药学*通讯作者：冯雷，女，副主任药师研究方向：临床药学Tel/Fax：（010）69158226E-mail：fengl@