Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in vietnamese spontaneous adverse drug reaction database: A subgroup approach to disproportionality analysis

被引:22
|
作者
Khac-Dung Nguyen [1 ,2 ,3 ]
Thuy-Ngan Tran [1 ]
Nguyen, Mai-Loan T. [1 ]
Hoang-Anh Nguyen [1 ]
Hoang-Anh Nguyen [1 ]
Dinh-Hoa Vu [1 ]
Van-Doan Nguyen [4 ]
Bagheri, Haleh [2 ,3 ]
机构
[1] Hanoi Univ Pharm, Natl Ctr Drug Informat & Adverse Drug React Monit, Hanoi, Vietnam
[2] Paul Sabatier Univ, Fac Med, Med & Clin Pharmacol Lab, Toulouse, France
[3] Toulouse Univ, Hosp Ctr, UMR INSERM 1027, Midi Pyrenees Ctr Pharmacovigilance Pharmacoepide, Toulouse, France
[4] Bach Mai Hosp, Ctr Allergol & Clin Immunol, Hanoi, Vietnam
关键词
drug safety; signal generation; Stevens-Johnson syndrome; toxic epidermal necrosis; Vietnamese spontaneous reporting database; HLA-B-ASTERISK-1502; ALLELE; BIAS; EPIDEMIOLOGY; ALLOPURINOL; ASSOCIATION; SYSTEM;
D O I
10.1111/jcpt.12754
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
What is known and objective Despite the numerous studies investigating drug-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), the understanding and quantitative data in developing countries remain limited. The study aimed to describe and quantify the drug-related risk of SJS/TEN in a resource-limited context using the Vietnamese spontaneous reporting database (VSRD) of adverse drug reactions. Methods Spontaneous reports relating to medium- and late-onset severe cutaneous adverse reactions (MLOSCAR) and SJS/TEN recorded in the VSRD from 2010 to 2015 were retrospectively analysed. The demographic characteristics and drug information were described and compared between SJS/TEN and other MLOSCAR reports. The drug-induced SJS/TEN signals were estimated using subgrouped disproportionality analysis with calculation of the reporting odds ratio (ROR) and the respective 95% confidence interval (CI). Results The VSRD received 2,849 MLOSCAR reports, 136 of which focus on SJS/TEN over a 6-year period. About 60% of SJS/TEN patients were male, and the majority of them were adults (mean age 42.5 +/- 22.9). Up to 91.8% of drugs induced SJS/TEN within 1-28 days, and 45% SJS/TEN cases were evaluated as life-threatening. Positive signals were generated with carbamazepine (n = 25, ROR [95% CI] = 11.99 [7.07-19.92]), allopurinol (n = 15, ROR [95% CI] = 4.2 [2.20-7.59]), traditional/herbal medicines (n = 7, ROR [95% CI] = 2.76 [1.12-5.86]), colchicine (n = 4, ROR [95% CI] = 6.22 [1.69-18.72]), valproic acid (n = 3, ROR [95% CI] = 8.71 [1.89-30.19]) and meloxicam (n = 3, ROR [95% CI] = 7.09 [1.55-24.29]), which are well known for SJS/TEN. Cefixime (n = 5, ROR [95% CI] = 3.34 [1.13-8.00]) and paracetamol (n = 22, ROR [95% CI] = 5.23 [3.10-8.49]) also generated positive signals despite their popularity in Vietnam. What is new and conclusion This first Vietnamese population-based study has highlighted original characteristics and signals of drug-induced SJS/TEN, which are relatively consistent with other worldwide data and typical for a developing country.
引用
收藏
页码:69 / 77
页数:9
相关论文
共 50 条
  • [41] Stevens-Johnson syndrome, drug-induced hypersensitivity syndrome and toxic epidermal Necrolysis caused by allopurinol in patients with a common HLA allele: What causes the diversity?
    Dainichi, Teruki
    Uchi, Hiroshi
    Moroi, Yoichi
    Furue, Masutaka
    DERMATOLOGY, 2007, 215 (01) : 86 - 88
  • [42] Systemic drug reactions with skin involvement: Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS
    Darlenski, Razvigor
    Kazandjieva, Jana
    Tsankov, Nikolai
    CLINICS IN DERMATOLOGY, 2015, 33 (05) : 538 - 541
  • [43] News in severe clinical adverse drug reactions: Stevens-Johnson syndrome (SJS']JS) and toxic epidermal necrolysis (TEN)
    Aide Martinez-Cabriales, Sylvia
    Gomez-Flores, Minerva
    Ocampo-Candiani, Jorge
    GACETA MEDICA DE MEXICO, 2015, 151 (06): : 777 - 787
  • [44] Clinical Features, Risk Factors, and Prognostic Markers of Drug-Induced Liver Injury in Patients with Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
    Zhang, Zhibin
    Li, Sisi
    Zhang, Zhixiong
    Yu, Kaihui
    Duan, Xunxin
    Long, Lin
    Zhang, Shulan
    Jiang, Meiying
    Liu, Ougen
    INDIAN JOURNAL OF DERMATOLOGY, 2020, 65 (04) : 274 - 278
  • [45] Spontaneous reporting of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with antiepileptic drugs
    Ordonez, L.
    Salgueiro, E.
    Jimeno, F. J.
    Manso, G.
    EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2015, 19 (14) : 2732 - 2737
  • [46] Fulminating Course of Drug Reaction with Eosinophilia and Systemic Symptoms exacerbated by a Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis overlap
    Har-Shai, Lior
    Savin, Ziv
    Canzoniero, Jenna VanLiere
    ISRAEL MEDICAL ASSOCIATION JOURNAL, 2016, 18 (05): : 304 - 305
  • [47] A Bayesian Network Meta-Analysis of the Effect of Targeted Therapies on the Total Length of Hospital Stay in Children with Drug-Induced Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Syndrome
    Ozerturk, Sahure
    Yildirim, Didem Derici
    Arikoglu, Tugba
    Kuyucu, Semanur
    Ozhan, Aylin Kont
    PEDIATRIC ALLERGY IMMUNOLOGY AND PULMONOLOGY, 2024, 37 (01) : 22 - 32
  • [48] Adefovir-induced Stevens-Johnson syndrome and toxic epidermal necrolysis overlap syndrome
    Chattopadhyay, P.
    Sarma, N.
    SINGAPORE MEDICAL JOURNAL, 2011, 52 (02) : E31 - E34
  • [49] Stevens-Johnson syndrome and toxic epidermal necrolysis: The Food and Drug Administration adverse event reporting system, 2004-2013
    Abe, Junko
    Mataki, Kanako
    Umetsu, Ryogo
    Ueda, Natsumi
    Kato, Yamato
    Nakayama, Yoko
    Kinosada, Yasutomi
    Hara, Hideaki
    Inagaki, Naoki
    Nakamura, Mitsuhiro
    ALLERGOLOGY INTERNATIONAL, 2015, 64 (03) : 277 - 279
  • [50] Pediatric Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: a national analysis of 2016 Kids' Inpatient Database
    Falotico, Julianne M.
    Desai, Amar D.
    Lipner, Shari R.
    ARCHIVES OF DERMATOLOGICAL RESEARCH, 2023, 315 (03) : 653 - 656