基于HACCP理论构建基层药品不良反应培训模式初探

目的探索基层药品不良反应培训模式。方法通过引入HACCP理论,对当前基层药品不良反应培训过程中潜在的风险和危害进行识别、分析并采取有效措施加以预防控制。结果从培训师资、培训内容、培训方式等方面初步构建了基层药品不良反应培训模式。结论在培训过程中,注重抓住关键控制点,即培训内容要结合实际、培训对象要分层次、培训方式要有创新、培训效果要有长期性。     

Elevation of serum KL-6 levels in 3 patients with rheumatoid arthritis treated with adalimumab

Abstract

We describe 3 cases of rheumatoid arthritis presenting with elevated serum KL-6 levels during treatment with adalimumab, which was discontinued because of suspected onset of complications. However, no complications were observed following discontinuation despite comprehensive assessments, and KL-6 levels subsequently returned to baseline levels. In our institutes, 3 out of 29 cases treated with adalimumab showed elevated KL-6 levels. The baseline levels were 445, 347, and 547 U/ml, while the peak levels were 1010, 546, and 2007 U/ml, respectively. The elevated KL-6 levels seem to have been innocuous; nevertheless, further careful observation is deemed necessary.     

克林霉素不良反应的调查分析

目的探讨克林霉素的不良反应,寻找防范措施。方法本文收集该院2011年2月—2013年1月我院应用克林霉素出现不良反应情况进行调查和分析。结果发生不良反应78例,不良反应发生率为9.0%,不良反应发生在皮肤34例,占43.6%,主要表现为皮肤瘙痒、皮疹,表现在神经系统方面有3例,占3.8%,主要表现为行走困难、晕厥,涉及到消化系统29例,占37.2%,主要表现为腹痛、腹泻、恶心,涉及到泌尿系统8例,占10.3%,主要表现为血尿,肾脏损害,发生过敏性休克1例,占1.3%,其他如血小板异常等3例,占3.8%。结论临床在应用克林霉素时一定严格遵循用药原则,掌握其适应症,才能降低不良反应的发生。     

Adverse events associated with the use of complementary medicine and health supplements: An analysis of reports in the Singapore Pharmacovigilance database from 1998 to 2009

Context. The use of complementary and alternative medicine (CAM), particularly herbal medicine and their derived products, have been increasing. However, sporadic reports of serious adverse effects associated with the use of these products have become a source of concern. Spontaneous adverse event reporting may be used to monitor the safety of these products. Objective. The objectives of this study is to analyze and describe the patterns of adverse events associated with the use of Chinese Proprietary Medicine, other complementary medicine and health supplements (termed CAM products) in the Singapore Pharmacovigilance database from 1998 to 2009 and to highlight areas of safety concerns. Methods. Adverse events associated with CAM products reviewed by the Vigilance Branch of the Health Sciences Authority for the period 1998–2009 were collated and analyzed. The following information was extracted and collated: patient demographics, type and indication of CAM products, system-organ class affected, seriousness of the adverse event, route of administration, hospitalization status, outcome of adverse event, concomitant use of conventional medicine, adulterant testing and profession of the reporter. Results. In the period 1998–2009, 627 cases of adverse events due to CAM products were reported. Most of these 627 cases (80.2%) were found to be serious and most of the patients used CAM products for sexual performance enhancement (291, 46.4%), to relieve pain such as joint and neck pain (36, 5.9%) and for slimming purposes (27, 4.3%). Of the 627 cases, endocrine disorders constituted 22.5% and central nervous system disorders constituted 20.6%. Liver was the main organ involved in the serious cases. Twenty-two fatalities were reported and hepatotoxicity was responsible for the deaths of 10 patients during the study period. Conclusions. In conclusion, 627 adverse event reports associated with CAM products had been successfully analyzed and described. They constituted ～3.8% of the total number of adverse events reported from 1998 to 2009. Outbreaks of severe hypoglycemia in 2008 and 2009 were associated with the use of adulterated and illegal sexual performance enhancement products. Further work to confirm the hepatotoxicity of implicated CAM products is warranted. Reporting of suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The analysis of spontaneously reported adverse events is important in monitoring the safety of CAM products and helps in the understanding of the benefits and risks associated with the use of such products.     

The Severity of Toxic Reactions to Ephedra: Comparisons to Other Botanical Products and National Trends from 1993–2002

Objective. Ephedra is a botanical product widely used to enhance alertness, as a weight loss aide, and as a decongestant. Its reported adverse effects led the Food and Drug Administration (FDA) to ban ephedra-containing products in the United States in 2004. This study's purpose was to compare toxicity from botanical products containing ephedra to nonephedra products. Methods. The Toxic Exposure Surveillance System (TESS), a national poison center database, was utilized to determine the number and outcomes of cases involving botanical products reported from 1993–2002. Cases listing both a botanical product and any other drugs or chemicals were excluded a priori. Ten-year hazard rates (moderate outcomes + major outcomes + deaths per 1000 exposures) were used to compare botanical product categories. Results. There were 21,533 toxic exposures with definitive medical outcomes reported over the 10 yrs where a botanical product was the only substance involved. Of these, 4,306 (19.9%) had moderate or major medical outcomes and there were two deaths, for an overall hazard score of 200 per 1000 exposures. The number of ephedra reports to poison centers increased 150-fold over the 10-yr period. The hazard rate for products that contained only ephedra was 250 per 1000 exposures and 267 per 1000 exposures for products that contained ephedra and additional ingredients; whereas the hazard score for only nonephedra botanical products was 96 per 1000 exposures. The rate ratios for multibotanical products with ephedra (RR 1.33; 95% C.I. 1.27–1.40) and for single-ingredient ephedra products (RR 1.25; 95% C.I. 1.11–1.40) were both two to six times higher than those of other common botanical products. Yohimbe-containing products had the highest hazard score (417) and rate ratio (2.08; 95% C.I. 1.59–2.80). Conclusion. Ephedra-containing botanical products accounted for a significant number of toxic exposures with severe medical outcomes reported to poison centers. Hazard rate analysis suggests poison center–reported events involving ephedra-containing botanical products were much more likely to result in severe medical outcomes than those involving nonephedra-containing botanical products. These data support recommendations by policymakers that the sale of ephedra should be prohibited to protect consumers. Our data suggest that the botanical product, yohimbe, may also be associated with unacceptably high risks of toxicity and should receive close scrutiny from health policymakers.     

哌拉西林/他唑巴坦致血细胞减少的回顾性研究

目的:比较儿童及成人使用哌拉西林/他唑巴坦致血液系统不良反应(ADR)的发生情况及其影响因素,为儿童安全用药提供参考。方法:回顾性分析某三甲医院2017 年4 月至2018 年3 月使用哌拉西林/ 他唑巴坦的5 176 例患者的病例资料,根据年龄分为0 ~28 d,1 ~12 月,>1 ~12 岁,>12 ~18 岁,>18 ~65 岁,>65 岁6 组,分析不同年龄组患者血细胞减少的发生率、发生时间、严重程度及转归等,并对患者血细胞减少相关危险因素进行Logistic 回归分析,探讨儿童与成人使用该药的安全性差异。结果:血液系统ADR 总发生率为2.99%,1 ~ 12 月龄婴幼儿ADR 发生率最高,达14.48%,>65 岁的老年人最低,仅1.38%。898 例儿童中有88 例(9.80%)血细胞(NEU、WBC、PLT)减少,15 例(1.67%)3 ~ 4 级严重中性粒细胞减少。Logistic 多因素分析结果显示,年龄<1 岁(OR =5.399)是用药后血细胞(NEU、WBC、PLT)严重减少的独立危险因素。结论:哌拉西林/ 他唑巴坦在各年龄段儿童患者中血液系统ADR 发生率均明显高于成人和药品说明书的报道,尤其是新生儿及1 ~ 12 月龄的婴幼儿,应高度关注其血液系统ADR,加强监测血常规。     

大剂量甲氨蝶呤治疗儿童急性淋巴细胞白血病的不良反应临床观察

目的:探讨大剂量甲氨蝶呤(HD-MTX)治疗儿童急性淋巴细胞白血病(ALL)的不良反应。方法:对40例ALL患儿采用HD-MTX 2.0～5.0 g/m2治疗,观察治疗后患儿的临床症状和体征,并统计不良反应发生率。结果:经过3个疗程的临床治疗后,患儿出现了骨髓抑制、胃肠道反应、感染、肝损害、黏膜损害、心脏损害、神经系统症状、皮疹及脱发等不良反应。其中,骨髓抑制发生率为61.3%,胃肠道反应发生率为51.9%,感染发生率为38.1%,肝损害发生率为41.3%,黏膜损害发生率为15.6%,心脏损害发生率为10.0%,神经系统症状发生率为15.0%,皮疹发生率为6.9%,脱发发生率为5.0%;未见明显的肾功能损害。结论:HD-MTX治疗ALL患儿的不良反应较多,要积极对症治疗,加强对MTX血药浓度的监测以及个体化治疗,以提高患儿的长期无病生存率。     

Extracellular Gd-CA: differences in prevalence of NSF

Until recently it was believed that extracellular gadolinium-based contrast agents were safe for both the kidneys and all other organs within the dose range up to 0.3 mmol/kg body weight. However, in 2006, it was demonstrated that some gadolinium-based contrast agents may trig the development of nephrogenic systemic fibrosis, a generalized fibrotic disorder, in renal failure patients. As no prospective studies can be performed we must rely on retrospective data. From those data it is obvious that the prevalence of NSF is significantly higher after the unstable agent gadodiamide than after any other gadolinium-based agent (3–7% versus 0–1% per injection) in patients with reduced renal function. Prevalence after exposure to two gadodiamide injections is as high as 36% in patients with chronic kidney disease (CKD) stage 5. No report of NSF after the most stable agents has been reported in the peer-reviewed literature documenting that there is a difference between the various agents regarding triggering NSF.     

孤立性肺结节临床分析及淋巴结转移的不良因素

目的：分析孤立性结节临床病理特征预测孤立性小肺癌的淋巴结转移不良因素。方法：选取天津市胸科医院2014年2－12月期间手术治疗结节＜2cm的孤立性肺结节（SPN）患者100例,收集术前1周内的癌胚抗原（CEA）、细胞角蛋白19片段（CYFRA21‐1）、术前CT和PET‐CT资料,整理术后病理结果和淋巴结转移情况。在良恶性病例间分析患者临床资料,在恶性病例间分析影响淋巴结转移的因素,探讨影响淋巴结转移的独立因素。结果：在70例孤立性小肺癌和30例良性肺结节（肿瘤均≤2cm ）的比较中,患者性别、年龄、吸烟史、结节部位、结节大小、血清Cy‐fra21‐1在良恶性结节病理之间无统计学意义。而患者的血清CEA水平则有统计学意义（ P＝0．026）,实性成分＞50％是淋巴结转移的独立影响因素（OR＝4．073,95％ CI：18．161～25．19,P＜0．05）。ROC曲线 AUC＝0.905。结论：SPN并非是肺癌的早期表现,有些患者已经存在了淋巴结转移,SPN实性成分＞50％的患者存在淋巴结转移的高风险。