Patch test reactions in atopic patients

Patch testing was carried out in 851 atopic patients; 181 atopic dermatitis (AD) patients were additionally tested with 50% dilutions of the test substances. The occurrence of allergic and irritant reactions was frequent, being 57% and 33% for AD patients aged 28-41 years and 19-27 years, respectively. Among age-matched allergic rhinitis (AR)/allergic conjunctivitis (AC) or asthma (A) patients, the number of allergic reactions varied from 25 to 30%, and for irritant reactions was 24%. In all groups, nickel, fragrance-mix, balsam of Peru and neomycin were the commonest allergens. Contact allergy to ingredients of topical medicaments was common among AD patients and patients with severe and long-lasting dermatitis were most frequently sensitized. However, sensitivity to multiple substances was not common among those patients. The number of irritant reactions was considerable, but 50% dilution of the test substances did not solve the problem.     

Erythema multiforme during cytomegalovirus infection and oral therapy with terbinafine: a virus–drug interaction

The authors report a case of erythema multiforme in a 32-year-old woman who was also taking oral terbinafine for an onychomycosis. The patient data analysis showed serological positivity for cytomegalovirus (IgM and IgG) and hepatitis C virus and serological titre of antinuclear antibody was elevated. After a brief review of the literature the authors propose the possibility of virus-drug interaction as a model of adverse drug reactions.     

Maculopapular eruption with enlarged macrophages in eight patients receiving G-CSF or GM-CSF

In the last years, granulocyte and granulocyte-macrophage colony-stimulating factors (G-CSF and GM-CSF) are being increasingly used and several cutaneous eruptions have been reported in relation to these treatments. In 1991 Horn et al. described three patients with maculopapular eruption that paralleled the time of infusion of GM-CSF. Two of the cases showed an increase in the number and size of macrophages in the biopsy specimen. Since then, several cases have been reported showing this histopathological alteration that has been considered characteristic of reaction to G-CSF or GM-CSF. Although maculopapular eruption with enlarged macrophages can appear after chemotherapy treatment, we have found that the presentation of this eruption after the beginning of cytokine treatment is suggestive of the involvement of G-CSF and GM-CSF in the eruption. We described eight cases of patients treated with G-CSF or GM-CSF that developed maculopapular eruptions with enlarged macrophages.     

平阳霉素治疗脉管性疾病不良反应105例临床分析

目的:总结平阳霉素(PYM)治疗口面部等脉管性疾病的不良反应,为临床预防或减少其不良反应提供依据。方法:收集1991年6月至2004年6月,用PYM治疗各种脉管性疾病1 142例,其中有不良反应的105例,男49例,女56例,年龄3个月至30岁的病人,作回顾性统计分析。结果:用PYM治疗脉管性疾病的病例中,有不良反应105例,不良反应率为9.19%(105/1 142),其中食欲不振45例占3.94%,发热42例占3.68%,皮疹17例占1.49%,休克1例占0.08%。结论:食欲不振与用PYM相对剂量较大有关,预防的方法是适当减少PYM的剂量。注射PYM前先肌注DXM不仅可预防或减少PYM的发热反应,还可防治PYM的过敏反应。用PYM治疗脉管性疾病时,一旦出现皮疹等过敏反应,就不能再用此药冶疗。     

Epirubicin as a single agent therapy for the treatment of breast cancer — A pharmacokinetic and clinical study

Sixty women with breast cancer (mean age: 61 years; range 36-78 years) were treated with Epirubicin (4’epi-Dox-orubicin), 60 mg m^-2 , as single drug therapy. The drug was administered as 2 hours’ constant rate infusions. The pharmacokinetics of the drug during the first course of treatment was evaluated by measurements of the plasma concentration of Epirubicin at the end of the infusion period. There was a five-fold inter-individual variation of the dose-normalized maximum plasma concentration, which increased with increasing age of the patients. There was no correlation between this pharmacokinetic parameter and degree of obesity.     

Contact dermatitis in patients with leg ulcers

100 patients with leg ulcers were patch tested against a standard battery of allergens. The readings were carried out daily from the 2nd to the 7th days. 55 patients showed positive reactions to one or more allergens. 32% of positive reactions developed for the first time after 48 h and 11% after 72 h. No single day or combination of two days gave 100% positive results. A single reading on the 4th day gave the highest number of positive reactions at 92%. The prevalence of positive patch tests was significantly higher in patients with surrounding eczema, and in patients with positive patch tests the ulcer duration was significantly longer than in those with negative patch tests. The total number of positive results in individuals increased linearly with the duration of the ulcer. Of allergens to which the ulcer was exposed, the occurrence of multiple sensitivity was significantly greater than predicted from the prevalence of individual sensitivities. However, there was no association between medicaments and metal sensitivity. This, together with the absence of an exponential rise in the number of allergens with the duration of ulcer, does not support the theory of systemic ampliative allergy.     

药物不良反应事件民事赔偿问题研究

在药物不良反应事件中，药品存在设计缺陷、制造缺陷或警示缺陷的，药品的生产者应当承担赔偿责任。医疗机构无视药物不良反应的警示说明导致不良反应发生的，应当承担医疗差错的赔偿责任。国家疏于药物监管导致不良反应发。生的，从法学理论上讲，也应当承担赔偿责任。     

伊曲康唑不良反应的国内文献综述

目的：了解伊曲康唑的不良反应及安全性。资料与方法：手工检索《中华皮肤科杂志》等3种中文专业期刊，从对照试验的文献中提取治疗例数和各种不良反应例数，计算发生率。结果：共有14725例涉及有关安全性的报道。伊曲康唑不良反应总的发生率约为1．57％。结论：伊曲康唑较为安全。     

Spontaneous reporting of adverse drug reactions in an Italian region: Six years of analysis and observations

Pharmacovigilance started in Italy in 1965, and from 1987 reporting of ADRs has been mandatory. Doctors have to send the filled forms on suspected ADRs to the Local Health Districts which transmit biannually all the reports to the Health Department. In a Northern Italian Region (Veneto) spontaneous reporting of adverse drug reactions (ADRs) has been studied during the period 1988–1993. This Region contributes a substantial percentage of the total Italian reports. The total number of reports was 3700, most of these (54 per cent) coming from GPs. A great variability in the reporting rate among the 36 districts of Veneto Region (range: 0–8.8 per 10,000 inhabitants per year) and an important under-reporting have been evident. Underreporting is also emphasized by the fact that in 1993 the Veneto doctors who sent at least one report were only 2.7 per cent. On the whole about 35 per cent of reports concerned minor reactions caused by drugs which have a well known toxicological profile. Comparison between reports coming from Veneto and the UK in some cases show a similar safety profile (omeprazole and simvastatin), whereas in other cases (e.g. terfenadine, glafenine, fluoxetine) no correspondence can be found. This article reveals the limits of the actual spontaneous reporting in Italy and suggests some possible measures for improving it.