Email Alert RSS
Volume 12 Issue 6
Nov.  2021
Turn off MathJax
Article Contents
Abstract
References
Related Articles
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, 2021, 12(6): 965-971. DOI: 10.12290/xhyxzz.20200262
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, 2021, 12(6): 965-971. DOI: 10.12290/xhyxzz.20200262
shu

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

  • 1.

    Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 2.

    Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100050, China

  • 3.

    Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

More Information
  • Corresponding author:

    ZHAO Bin  Tel: 86-10-69156513, E-mail: zhaobin@pumch.cn

  • Received Date: October 14, 2020
  • Accepted Date: November 29, 2020
  • Available Online: June 27, 2021
  • Issue Publish Date: November 29, 2021
    Graphical Abstract
    • Abstract
  •   Objective  To explore and compare the associations of different proton pump inhibitors (PPIs) with acute generalized exanthematous pustulosis (AGEP).
      Methods  Data were obtained from the database of Food and Drug Administration's adverse event reporting system (FAERS) from January 2004 to June 2020. Non-proportional analysis and Bayesian analysis were utilized to analyze the signs of AGEP caused by different PPIs. The onset time and prognosis of PPIs-related AGEP were also analyzed.
      Results  A total of 162 cases of AGEP caused by PPIs were reported. The most frequently used PPI was omeprazole (33.95%, 55/162), followed by esomeprazole (29.63%, 48/162) and pantoprazole (26.54%, 43/162). Pantoprazole showed the strongest correlation with AGEP, followed by omeprazole and lansoprazole, while esomeprazole appeared to have a weaker association with AGEP than other PPIs. The median time to the onset of AGEP was 6 (2, 12) days after PPI treatment, and 60.00%-83.33% of patients developed symptoms within 10 days after the medication (except rabeprazole). PPI-associated AGEP generally led to a fatality of 1.86% (3 cases) and a hospitalization rate of 79.50% (128 cases). The hospitalization rate of AGEP patients caused by omeprazole was the highest (91.49%, 43/47), followed by that of pantoprazole (88.37%, 38/43), lansoprazole (85.71%, 12/44), and omeprazole (61.82%, 34/55).
      Conclusions  Our pharmacovigilance study based on the FAERS database demonstrated in detail the risks and characteristics of AGEP caused by different PPIs, which could provide a theoretical basis for rational clinical drug use.
    • FullText(HTML)
    • References (27)
  • [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. DOI: 10.1021/ja049607w
    [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. DOI: 10.1007/s12325-017-0532-9
    [3]
    Sidoroff A. Acute generalized exanthematous pustulosis[J]. Chem Immunol Allergy, 2012, 97: 139-148. DOI: 10.1159/000335625
    [4]
    Dewerdt S, Vaillant L, Machet L, et al. Acute generalized exanthematous pustulosis induced by lansoprazole[J]. Acta Derm Venereol, 1997, 77: 250. http://europepmc.org/abstract/MED/9188895
    [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. DOI: 10.1157/13119883
    [6]
    Schmitz B, Sorrells T, Glass JS. Acute generalized exanthematous pustulosis caused by pantoprazole[J]. Cutis, 2018, 101: E22-E23. http://www.onacademic.com/detail/journal_1000040410316010_32f7.html
    [7]
    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.

    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 Shiyan He Linchuang Ganranbing Zazhi (Dianziban), 2017, 11: 521-525.
    [8]
    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. DOI: 10.1002/hup.2557
    [9]
    Quackenbush D, Allen JG, Fowler JC. Comparison of Attachments in Real-World and Virtual-World Relationships[J]. Psychiatry, 2015, 78: 317-327. DOI: 10.1080/00332747.2015.1092854
    [10]
    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. DOI: 10.1002/pds.677
    [11]
    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. DOI: 10.7150/ijms.6048
    [12]
    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. DOI: 10.1002/pds.668
    [13]
    Natsch S, Vinks MH, Voogt AK, et al. Anaphylactic reactions to proton-pump inhibitors[J]. Ann Pharmacother, 2000, 34: 474-476. DOI: 10.1345/aph.19235
    [14]
    Bose S, Guyer A, Long A, et al. Evaluation and manage-ment of hypersensitivity to proton pump inhibitors[J]. Ann Allergy Asthma Immunol, 2013, 111: 452-457. DOI: 10.1016/j.anai.2013.08.022
    [15]
    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. DOI: 10.1111/all.13235
    [16]
    Britschgi M, Steiner UC, Schmid S, et al. T-cell involve-ment in drug-induced acute generalized exanthematous pustulosis[J]. J Clin Invest, 2001, 107: 1433-1441. DOI: 10.1172/JCI12118
    [17]
    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. DOI: 10.1111/j.1365-2133.2007.08156.x
    [18]
    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. DOI: 10.4049/jimmunol.173.3.2151
    [19]
    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. DOI: 10.1007/s00403-014-1488-0
    [20]
    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. DOI: 10.1111/j.1468-3083.2010.03771.x
    [21]
    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. DOI: 10.1034/j.1600-0560.2001.028003113.x
    [22]
    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. DOI: 10.1007/s00228-010-0871-9
    [23]
    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. http://www.ncbi.nlm.nih.gov/pubmed/31373505
    [24]
    Thienvibul C, Vachiramon V, Chanprapaph K. Five-Year Retrospective Review of Acute Generalized Exanthematous Pustulosis[J]. Dermatol Res Pract, 2015, 2015: 260928. http://www.onacademic.com/detail/journal_1000040466855610_13cb.html
    [25]
    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. DOI: 10.1124/dmd.32.8.821
    [26]
    Roujeau JC, Bioulac-Sage P, Bourseau C, et al. Acute generalized exanthematous pustulosis. Analysis of 63 cases[J]. Arch Dermatol, 1991, 127: 1333-1338. DOI: 10.1001/archderm.1991.01680080069004
    [27]
    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. DOI: 10.1007/s40264-019-00873-8
    • Related Articles

  • Related Articles

    [1]JIA Chunyu, WANG Gangan, WANG Jiahui, CHEN Gang, ZHENG Ke, LI Xuemei. Correlation Between Neutrophil to Lymphocyte Ratio and eGFR in Diabetic Patients: A Cross-sectional Analysis Based on NHANES Data[J]. Medical Journal of Peking Union Medical College Hospital, 2025, 16(2): 379-385. DOI: 10.12290/xhyxzz.2024-0908
    [2]YAN Xinchun, HUO Li. Evaluation of Von Hippel-Lindau Syndrome Through Novel Small Molecular Tracer 68Ga-NY104 PET/CT Imaging[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(4): 911-915. DOI: 10.12290/xhyxzz.2024-0216
    [3]WEN Bei, ZHU He, XU Li, HUANG Yuguang. Association Between Coffee Consumption and Pain: A Cross-sectional Study Based on American National Health and Nutrition Examination Survey[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(2): 351-358. DOI: 10.12290/xhyxzz.2023-0553
    [4]WANG Na, HAN Xiaohong. Research Progress on the Correlation Between Microbiota and the Efficacy and Adverse Reactions of Antitumor Drug[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(5): 932-938. DOI: 10.12290/xhyxzz.2023-0212
    [5]HUANG Shi-qin, XU Yang. Correlation of Proton Pump Inhibitors and Gastric Carcinoma with Fundic Gland Polyps[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(2): 249-253. DOI: 10.3969/j.issn.1674-9081.2020.00.016
    [6]Hui-zhen JIANG, Lian MA, Wei-guo ZHU. Medical Big Data "Deception" and Strategies[J]. Medical Journal of Peking Union Medical College Hospital, 2020, 11(5): 542-546. DOI: 10.3969/j.issn.1674-9081.2020.05.009
    [7]Yan-meng QI, Ye-cheng LIU, Hua-dong ZHU. Predictive Value of Ranson Score for Typing Moderately Severe and Severe Hyperlipidemic Acute Pancreatitis[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(5): 489-493. DOI: 10.3969/j.issn.1674-9081.2019.05.011
    [8]Zai-yi LIU. Clinical Value and Challenges of Radiomics[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(4): 295-297. DOI: 10.3969/j.issn.1674-9081.2018.04.002
    [10]Ming-sheng MA, Xü-de ZHANG, Min WEI, Shi-min ZHAO, Zheng-qing QIU. Efficacy of Low Dose Corticosteroid Therapy in Duchenne Muscular Dystrophy[J]. Medical Journal of Peking Union Medical College Hospital, 2014, 5(4): 384-388. DOI: 10.3969/j.issn.1674-9081.2014.04.006

  • Cited by

    Periodical cited type(9)

    1. 郎晓琴，罗宇飞，谷文睿，徐佳强，枉前. 基于FAERS的四环素类药物致急性胰腺炎药品不良事件信号挖掘与分析. 中国药业. 2025(02): 105-109 .
    2. 王丽，于文雯，柳克浩，李敏，郭瑞惠，戚迎梅. 长期使用质子泵抑制剂所致不良反应及机制. 中国药物经济学. 2024(04): 100-103+108 .
    3. 焦萍，陈伟，李国辉. 药物致妊娠期急性泛发型发疹性脓疱病文献病例分析. 药学研究. 2024(07): 706-712 .
    4. 陈龙，陈高艳，丁楠楠. 基于FAERS数据库对8岁以下儿童使用四环素类药物的ADR信号挖掘. 中南药学. 2024(10): 2819-2825 .
    5. 程一美，郑明昱，谷文睿. 基于FAERS的B细胞成熟抗原靶向嵌合抗原受体T细细胞胞药物警戒研究. 中国药业. 2024(21): 110-115 .
    6. 郎晓琴，谷文睿，郑明昱，马欢. 碳青霉烯类抗菌药物致史-约综合征和中毒性表皮坏死松解症的真实世界药物警戒研究. 中国药业. 2023(07): 51-55 .
    7. 戴睿，张青霞，胡扬，王焕玲，赵彬，合理用药国际网络中国中心组临床安全用药组. 国内药物不良反应信号检测文献研究设计问题的调查和分析. 药物不良反应杂志. 2023(08): 475-481 .
    8. 郎晓琴，枉前，刘通. 基于FAERS数据库的周期蛋白依赖性激酶4/6抑制剂相关颌骨坏死不良事件信号挖掘与重构. 中国药业. 2023(19): 129-133 .
    9. 郎晓琴，郑明昱，马欢，谷文睿. 免疫检查点抑制剂致大疱性类天疱疮：基于真实世界的药物警戒研究. 中国药物应用与监测. 2023(03): 184-188 .

    Other cited types(0)

Catalog

    Get Citation
    PDF
    XML

    Article Metrics

    Article views (733) PDF downloads (70) Cited by(9)
    Related
    Links: National Health Commission of the People's Republic of China Chinese Academy of Medical Sciences(CAMS) AMLC Check CNKI Database CNKI Term Online Chinese General Practice
    Address：Room 302,Third Floor,Building 7, No. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing 100730, China
    Tel：010-69154261/4262
    E - mail：medj@pumch.cn mjpumch@126.com
    Copyright of website：Editorial Office of Medical Journal of Peking Union Medical College Hospital

    Supported by: Beijing Renhe Information Technology Co., Ltd.  Baidu Analytics

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return
    x Close Forever Close