Department of Pharmacology, SRM Medical College Hospital & Research Centre, SRM Institute of Science and Technology, Chengalpattu, India.
Curr Drug Saf. 2022;17(3):193-198. doi: 10.2174/1574886316666211026114803.
Cutaneous Adverse Drug Reactions (ADRs) are common and pose a serious challenge to physicians, especially in cases when the patient has many comorbidities, is polypharmacy, or self-administers over-the-counter medications.
The objective of this study is to analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo's scale. The severity of the reactions was determined by the Hartwig scale.
This was conducted as a prospective observational study in patients admitted to SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance of all adverse drug reactions reported at the hospital.
Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drugs which produced cutaneous adverse reactions were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18% (82) as probable, and 14.85% (15) as possible, whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82% as moderate.
It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve the outcome of the treatment.
皮肤不良反应（ADR）很常见，对医生来说是一个严重的挑战，尤其是在患者有多种合并症、同时使用多种药物或自行使用非处方药物的情况下。
本研究旨在分析皮肤 ADR 的临床模式和发生率，并使用 WHO-UMC 量表和 Naranjo 量表进行因果关系评估。反应的严重程度通过 Hartwig 量表来确定。
这是一项在印度泰米尔纳德邦 Kattankulathur 的 SRM 医学院进行的前瞻性观察性研究，在获得医院报告的所有药物不良反应的机构伦理委员会批准后，于 2016 年 11 月至 2018 年 8 月期间对患者进行了研究。
在报告的 158 例 ADR 中，有 101 例是皮肤 ADR，其中最常见的表现是斑丘疹（n=42；41.58%）。引起皮肤不良反应的最常见药物是抗生素（n=58；57.42%），其次是 NSAIDs（n=35；34.6%）。根据 Naranjo 量表进行因果关系评估，有 3.96%（4 例）为确定，81.18%（82 例）为很可能，14.85%（15 例）为可能；而根据 WHO 量表，有 9 例（89.10%）为肯定，64 例（63.36%）为很可能，28 例（27.72%）为可能。根据 Hartwig 量表确定的病例严重程度，82.17%为轻度，17.82%为中度。
及时识别 ADR 并在未来使用时谨慎行事非常重要。这可以最大限度地减少对患者身体和经济上的伤害，并改善治疗效果。
