Kubota K, Kubota N, Pearce G L, Prescott P, Mann R D
Drug Safety Research Unit, Southampton, UK.
Int J Clin Pharmacol Ther. 1995 Apr;33(4):219-25.
This study examines skin rash, as a reported event, in the patients who used one of the 36 drugs recently released to the UK market and studied by Prescription-Event Monitoring between 1985 and 1992. The results are also compared to the voluntary reports on rash as a possible adverse drug reaction sent to the Committee on Safety of Medicines (CSM). Specific types of skin rash (e.g. exfoliative dermatitis) are excluded. The rate of rash has been calculated for 2 periods, the first month (T1) and the subsequent 5 months (T2) after the first prescription for the drug. Despite the heterogeneity of the patient groups, the rate for rash between the 2nd and 6th months was consistent in the 36 drugs and probably represented the baseline rate of rash due to a variety of nonspecific causes. This rate (T2) was around 1 per 1,000 patients per month (ranging from 0.5 to 2 per 1,000 patients per month). On the other hand, in the first month after the first prescription for the drug, the rate (T1) varied substantially from 0.9 to 6.4 per 1,000 patients per month. Diltiazem had the highest first monthly rate. These rates are listed for the 36 drugs. The difference of the rates was tested by 2 methods: a standard statistical test assuming a Poisson model and a method based on the ratio of the rates for the 2 periods. When the 2 rates (T1 and T2) were similar to each other, drug induced rash was considered to be rare.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究调查了1985年至1992年间在英国市场新上市的36种药物使用者身上报告的皮疹事件。研究结果还与作为可能的药物不良反应发送给药品安全委员会（CSM）的皮疹自愿报告进行了比较。特定类型的皮疹（如剥脱性皮炎）被排除在外。计算了用药后第一个月（T1）和随后5个月（T2）两个时间段的皮疹发生率。尽管患者群体存在异质性，但36种药物在第2至6个月的皮疹发生率是一致的，这可能代表了由多种非特异性原因导致的皮疹基线发生率。该发生率（T2）约为每月每1000名患者1例（范围为每月每1000名患者0.5至2例）。另一方面，在首次用药后的第一个月，发生率（T1）差异很大，为每月每1000名患者0.9至6.4例。地尔硫䓬的首个月发生率最高。列出了这36种药物的发生率。采用两种方法检验发生率的差异：一种是假设泊松模型的标准统计检验，另一种是基于两个时间段发生率之比的方法。当两个发生率（T1和T2）彼此相似时，药物引起的皮疹被认为很少见。（摘要截断于250字）
