留言板

尊敬的读者、作者、审稿人, 关于本刊的投稿、审稿、编辑和出版的任何问题, 您可以本页添加留言。我们将尽快给您答复。谢谢您的支持!

姓名
邮箱
手机号码
标题
留言内容
验证码

质子泵抑制剂导致的急性泛发性发疹性脓疱病:基于真实世界的药物警戒研究

赵喆 王涛 唐彦 陈晓光 赵彬

赵喆, 王涛, 唐彦, 陈晓光, 赵彬. 质子泵抑制剂导致的急性泛发性发疹性脓疱病:基于真实世界的药物警戒研究[J]. 协和医学杂志.
引用本文: 赵喆, 王涛, 唐彦, 陈晓光, 赵彬. 质子泵抑制剂导致的急性泛发性发疹性脓疱病:基于真实世界的药物警戒研究[J]. 协和医学杂志.
ZHAO Zhe, WANG Tao, TANG Yan, CHEN Xiaoguang, ZHAO Bin. Acute Generalized Exanthematous Pustulosis Caused by Proton Pump Inhibitors: A Real-World Pharmacovigilance Study[J]. Medical Journal of Peking Union Medical College Hospital.
Citation: ZHAO Zhe, WANG Tao, TANG Yan, CHEN Xiaoguang, ZHAO Bin. Acute Generalized Exanthematous Pustulosis Caused by Proton Pump Inhibitors: A Real-World Pharmacovigilance Study[J]. Medical Journal of Peking Union Medical College Hospital.

质子泵抑制剂导致的急性泛发性发疹性脓疱病:基于真实世界的药物警戒研究

详细信息
    通讯作者:

    赵彬 电话:010-69156513, E-mail:zhaobin@pumch.cn

  • 中图分类号: R753.1

Acute Generalized Exanthematous Pustulosis Caused by Proton Pump Inhibitors: A Real-World Pharmacovigilance Study

  • 摘要:

      目的   探讨不同质子泵抑制剂(proton pump inhibitors,PPIs)与急性泛发性发疹性脓疱病(acute generalized exanthematous pustulosis,AGEP)的关联性及特点。   方法   检索2004年1月至2020年6月美国食品药品监督管理局(Food and Drug Administration,FDA)不良事件报告系统(FDA adverse events reporting system,FAERS)数据库中PPIs/AGEP相关报告,采用比例失衡测量法及贝叶斯法对不同PPIs导致的AGEP进行关联性分析,并比较其发病时间及预后。   结果   共检索到此期间PPIs导致的AGEP病例报告162例。其应用的PPIs药物主要为奥美拉唑(33.95%,55/162),其次为埃索美拉唑(29.63%,48/162)、泮托拉唑(26.54%,43/162)。以泮托拉唑与AGEP的关联性最强,其次为奥美拉唑和兰索拉唑,埃索美拉唑与AGEP的关联性较弱。PPIs导致AGEP发病时间的中位数为6(2,12)d,60.00%~83.33%的患者于用药后10 d内发病(除雷贝拉唑外)。3例(1.86%) AGEP患者死亡,128例(79.50%)需住院治疗。以埃索美拉唑导致的AGEP患者住院比率最高(91.49%,43/47),其次为泮托拉唑(88.37%,38/43)、兰索拉唑(85.71%,12/44),奥美拉唑(61.82%,34/55)最低。   结论   基于对FAERS数据库的药物警戒研究,揭示了不同PPIs导致AGEP的风险及特点,可为临床合理用药提供依据。

  • [1] Shin JM, Cho YM, Sachs G. Chemistry of covalent inhibition of the gastric (H+, K+)-ATPase by proton pump inhibitors[J]. J Am Chem Soc, 2004, 126:7800-7811.
    [2] Yu LY, Sun LN, Zhang XH, et al. A Review of the Novel Application and Potential Adverse Effects of Proton Pump Inhibitors[J]. Adv Ther, 2017, 34:1070-1086.
    [3] Sidoroff A. Acute generalized exanthematous pustulosis[J]. Chem Immunol Allergy, 2012, 97:139-148.
    [4] Dewerdt S, Vaillant L, Machet L, et al. Acute generalized exanthematous pustulosis induced by lansoprazole[J]. Acta Derm Venereol, 1997, 77:250.
    [5] Nantes Castillejo O, Zozaya Urmeneta JM, Valcayo Peñalba A, et al. Acute generalized exanthematous pustulosis induced by omeprazole[J]. Gastroenterol Hepatol, 2008, 31:295-298.
    [6] Schmitz B, Sorrells T, Glass JS. Acute generalized exanthematous pustulosis caused by pantoprazole[J]. Cutis, 2018, 101:E22-e23.
    [7] Academic Committee of Chinese Practice Algorithm on Real World Study of Clinical Medicine. Chinese practice algorithm on real world study of clinical medicine[J]. Zhonghua Shi Yan He Lin Chuang Gan Ran Bing Za Zhi (Electronic Version), 2017, 11:521-525.
    [8] 中国临床医学真实世界研究施行规范专家委员会. 中国临床医学真实世界研究施行规范[J]. 中华实验和临床感染病杂志(电子版), 2017, 11:521-525.
    [9] Gargoloff PD, Corral R, Herbst L, et al. Effectiveness of agomelatine on anhedonia in depressed patients:an outpatient, open-label, real-world study[J]. Hum Psychopharmacol, 2016, 31:412-418.
    [10] Quackenbush D, Allen JG, Fowler JC. Comparison of Attachments in Real-World and Virtual-World Relationships[J]. Psychiatry, 2015, 78:317-327.
    [11] Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports[J]. Pharmacoepidemiol Drug Saf, 2001, 10:483-486.
    [12] Sakaeda T, Tamon A, Kadoyama K, et al. Data mining of the public version of the FDA Adverse Event Reporting System[J]. Int J Med Sci, 2013, 10:796-803.
    [13] Van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions[J]. Pharmacoepidemiol Drug Saf, 2002, 11:3-10.
    [14] Natsch S, Vinks MH, Voogt AK, et al. Anaphylactic reactions to proton-pump inhibitors[J]. Ann Pharmacother, 2000, 34:474-476.
    [15] Bose S, Guyer A, Long A, et al. Evaluation and management of hypersensitivity to proton pump inhibitors[J]. Ann Allergy Asthma Immunol, 2013, 111:452-457.
    [16] Lin CY, Wang CW, Hui CR, et al. Delayed-type hypersensitivity reactions induced by proton pump inhibitors:A clinical and in vitro T-cell reactivity study[J]. Allergy, 2018, 73:221-229.
    [17] Britschgi M, Steiner UC, Schmid S, et al. T-cell involvement in drug-induced acute generalized exanthematous pustulosis[J]. J Clin Invest, 2001, 107:1433-1441.
    [18] Sidoroff A, Dunant A, Viboud C, et al. Risk factors for acute generalized exanthematous pustulosis (AGEP)-results of a multinational case-control study (EuroSCAR)[J]. Br J Dermatol, 2007, 157:989-996.
    [19] Schaerli P, Britschgi M, Keller M, et al. Characterization of human T cells that regulate neutrophilic skin inflammation[J]. J Immunol, 2004, 173:2151-2158.
    [20] Kakeda M, Schlapbach C, Danelon G, et al. Innate immune cells express IL-17A/F in acute generalized exanthematous pustulosis and generalized pustular psoriasis[J]. Arch Dermatol Res, 2014, 306:933-938.
    [21] Kabashima R, Sugita K, Sawada Y, et al. Increased circulating Th17 frequencies and serum IL-22 levels in patients with acute generalized exanthematous pustulosis[J]. J Eur Acad Dermatol Venereol, 2011, 25:485-488.
    [22] Sidoroff A, Halevy S, Bavinck JN, et al. Acute generalized exanthematous pustulosis (AGEP)——a clinical reaction pattern[J]. J Cutan Pathol, 2001, 28:113-119.
    [23] Ahrens D, Chenot JF, Behrens G, et al. Appropriateness of treatment recommendations for PPI in hospital discharge letters[J]. Eur J Clin Pharmacol, 2010, 66:1265-1271.
    [24] Ying J, Li LC, Wu CY, et al. The status of proton pump inhibitor use:a prescription survey of 45 hospitals in China[J]. Rev Esp Enferm Dig, 2019, 111:738-743.
    [25] Thienvibul C, Vachiramon V, Chanprapaph K. Five-Year Retrospective Review of Acute Generalized Exanthematous Pustulosis[J]. Dermatol Res Pract, 2015, 2015:260928.
    [26] Li XQ, Andersson TB, Ahlström M, et al. Comparison of inhibitory effects of the proton pump-inhibiting drugs omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole on human cytochrome P450 activities[J]. Drug Metab Dispos, 2004, 32:821-827.
    [27] Roujeau JC, Bioulac-Sage P, Bourseau C, et al. Acute generalized exanthematous pustulosis. Analysis of 63 cases[J]. Arch Dermatol, 1991, 127:1333-1338.
    [28] Patek TM, Teng C, Kennedy KE, et al. Comparing Acute Kidney Injury Reports Among Antibiotics:A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)[J]. Drug Saf, 2020, 43:17-22.
  • 加载中
计量
  • 文章访问数:  44
  • HTML全文浏览量:  7
  • PDF下载量:  10
  • 被引次数: 0
出版历程
  • 收稿日期:  2020-10-15
  • 网络出版日期:  2021-07-05

目录

    /

    返回文章
    返回