Tandon V R, Sharma S, Khajuria V, Mahajan V, Gillani Z
Department of Biotechnology, Arni University, Indora, Himachal Pradesh, India.
Indian J Med Microbiol. 2015 Jul-Sep;33(3):393-400. doi: 10.4103/0255-0857.158564.
To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3-year period.
A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI).
A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intravenous (IV) route of drug administration accounted maximum ADRs (53.32%), followed by oral route (45.41%). Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%), followed by tab. azithromycin (7.39%), tab. ofloxacin+ornidazol (5.35%), ofloxacin (3.57%), ciprofloxacin (2.29%), amoxicillin (2.55%), tab. cefixime (2.29%), inj. linezolid (2.04%). Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%), followed by gastrointestinal (GI) (39.28%), central nervous system (CNS) (5.35%), cardiovascular system (CVS) (3.57%) and renal and genitourinary (1.78%). While 47.96% ADR's were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention.
The current study suggest that ADRs due to antimicrobials is a significant health problem.
评估三年期间抗菌药物的不良反应（ADR）情况。
采用印度药物警戒计划（PvPI）下的疑似药物不良反应数据收集表进行回顾性横断面研究。
三年共记录了2586例ADR事件，其中392例（15.15%）是由抗菌药物引起的。男女比例为1.02:1。医学科室贡献最大（98.97%）。静脉给药途径导致的ADR最多（53.32%），其次是口服途径（45.41%）。单一疗法占80.87%，联合疗法占19.13%。联合疗法中79.67%不合理。导致ADR最常见的抗生素是注射用头孢曲松（35.71%），其次是阿奇霉素片（7.39%）、氧氟沙星 + 奥硝唑片（5.35%）、氧氟沙星（3.57%）、环丙沙星（2.29%）、阿莫西林（2.55%）、头孢克肟片（2.29%）、注射用利奈唑胺（2.04%）。皮疹仍然是最常见的ADR，其次是腹泻和胃炎。最常累及的器官系统是皮肤（47.44%），其次是胃肠道（GI）（39.28%）、中枢神经系统（CNS）（5.35%）、心血管系统（CVS）（3.57%）以及肾脏和泌尿生殖系统（1.78%）。47.96%的ADR是潜伏性的，26.785%是急性的，25.26%是亚急性的。此外，89.79%的ADR性质为中度，26.88%为重度，3.33%为轻度。再者，92.86%为非严重的，7.14%为严重的。另外，65.06%的抗菌药物引起的ADR是A型反应，34.64%是B型反应。根据世界卫生组织 - 乌普萨拉监测中心（WHO - UMC）标准，73.98%的ADR很可能/可能，26.02%为可能。然而，99.47%的ADR需要干预。
当前研究表明抗菌药物引起的ADR是一个重大的健康问题。
