北京协和医院住院患者药疹发病率调查—一项前瞻性研究

发布时间：2018-03-09 07:43

本文选题：药疹　切入点：流行病学　出处：《北京协和医学院》2012年博士论文　论文类型：学位论文

【摘要】：背景药疹是临床上常见的药物不良反应,大多由免疫反应介导。随着新药的产生以及住院患者疾病谱的变化,药疹的发生也出现了新的变化。药疹的流行病学研究是皮肤病学中的一个热点,已经有多个国家进行了住院患者药疹发生率的前瞻性或回顾性研究。我国的药疹的流行病学资料主要来源于回顾性研究,尚缺乏住院患者药疹发生率的前瞻性研究的数据。目的1)确定我院住院患者中的轻型和重症药疹的发生率、死亡率;2)总结药疹发生的临床特点,包括药疹类型、致敏药物,以及发生药疹与既往药敏史、性别、年龄、原发疾病、科室等之间的相互关系;3)判断药疹发生的危险因素;4)将本研究的结果与现有其他国家的流行病学资料进行比较,找出其中的共同点及不同点。方法观察2012年1月1日至2012年4月30日期间北京协和医院的住院患者,住院期间是否出现新发药疹。为了保证信息的完善性,我们在高年级医学生中招募了一批志愿者作为药疹观察员分散在各个病房。由药疹观察员、临床医务人员、皮肤科院内会诊医生及研究联系人共同收集患者新发皮疹的信息,由研究联系人汇总后,皮肤科医生及时地诊断药疹的发生、识别致敏药物。每个阳性病例均被记录下一份标准问卷,包括统计学信息、药疹信息、药物信息以及治疗信息。最后对相关信息进行统计学分析。结果研究期间,共有66例住院患者新发药疹,同期住院患者共计22866例,新发药疹率为2.9‰。66例患者中,有4例发生了多次药疹过程,共计71人次药疹过程被记录。同期有15例患者因药疹收入院,药疹总发生率为3.5‰。66名阳性病例中,31.8%的患者住院前曾有过药物过敏史,高于其他住院患者的既往药物过敏发生率(P0.01)。原发疾病的前三位分别是肿瘤(39.4%)、感染性疾病(16.7%)和心脑血管疾病(16.7%)。皮肌炎/多发性肌炎患者的新发药疹率为其他患者的37.4倍(CI95%11.1-125.9,P0.01)。感染科为药疹发生率最高的科室,药疹发生率为6.2%,非手术科室的药疹发生率普遍高于手术科室。患者的性别、年龄分布未见显著差异。发疹型药疹(32.4%)和荨麻疹药疹(32.4%)为最常见的药疹类型；有3例阳性病例因为药物过敏产生了严重的生命威胁,包括1例药物超敏反应综合征(DIHS)和2例过敏性休克。抗感染药物(29.6%)、造影剂(16.9%)和血制品(12.7%)为最常见的致敏药物,抗感染药物中以头孢类最常见(15.5%)。大部分药疹患者经过治疗皮疹缓解,1例怀疑死于药物迟发过敏性休克,2例死于原发病。结论1)本项研究的药疹总发生率与近期国外的同类研究接近,但高于此前美国的研究(2%)；2)既往药物过敏为药物过敏的危险因素,皮肌炎／多发性肌炎患者药疹发病率高(P0.01)；3)与大多数同类研究一样,抗感染药物为最常见的致敏药物,但头孢类在本研究中最常见；4)与其他研究相比,碘造影剂及血制品在本研究中有更高的药疹发生率,荨麻疹的发生率也更高；5)大多数药疹预后良好,重症药疹罕见。
[Abstract]:The background of drug eruption is a common clinical adverse drug reactions, mostly mediated immune responses. With the formation of new drugs and hospital patients with changes in disease spectrum, eruption also appeared new changes. Epidemiological studies of drug eruption is a skin disease hotspots, many countries have carried out inpatients with drug eruption the incidence of prospective or retrospective study. Epidemiological data of China's drug eruption mainly originates from the retrospective study, the lack of a prospective study of the incidence of hospitalization in patients with drug eruption.
Objective to determine the incidence rate of 1), in patients with mild and severe drug eruption in our hospital mortality; 2) to summarize the clinical characteristics of drug eruption, including drug eruption types, allergenic drugs, and drug sensitive drug eruption and previous history, gender, age, primary disease, the relationship between departments; 3) risk the factors that determine drug eruption; 4) the results of this study and the existing epidemiological data in other countries are compared, and find out the similarities and differences among them.
Methods from January 1, 2012 to April 30, 2012 during the observation of hospitalized patients in Peking Union Medical College Hospital during hospitalization, new onset eruption. In order to ensure the perfect information, we recruited a group of volunteers in the high grade medical students as observers scattered in various wards. Drug drug eruption by observers, the clinical medical personnel contact consultation doctor and hospital department of Dermatology joint collection with new rash information, summarized by the research contacts, Department of Dermatology doctor timely diagnosis of eruption, identification of allergenic drugs. Each positive cases were recorded by a standard questionnaire, including statistical information, drug eruption information, drug information and treatment information. At the end of the relevant information for statistical analysis.
The results of the study period, a total of 66 cases of hospitalized patients with new onset of drug eruption, a total of 22866 cases of patients hospitalized in the same period, new drug eruption rate was 2.9 per thousand.66 patients, 4 cases had multiple drug eruption process, a total of 71 people were recorded during the same period of drug eruption. 15 patients with drug eruption admitted, drug rash occurrence the rate of 3.5 per thousand.66 positive cases, 31.8% hospitalized patients has had the history of drug allergy is higher than that of other hospital patients prior drug allergy incidence rates (P0.01). The primary diseases were the top three tumors (39.4%), infectious diseases (16.7%) and cardiovascular disease (16.7%). Dermatomyositis / polymyositis patients with new onset of drug eruption rate was 37.4 times that of the other patients (CI95%11.1-125.9, P0.01). The highest incidence rate of infection as drug department, drug eruption rate was 6.2%, non surgical departments of the drug eruption rate generally higher than that of surgical departments. The patient's sex, age distribution is not See the difference. Exanthematic eruption (32.4%) and drug rash urticaria (32.4%) is the most common type of drug eruption; there are 3 positive cases because of drug allergy caused a serious threat to life, including 1 cases of drug hypersensitivity syndrome (DIHS) and 2 cases of anaphylactic shock. Anti infection drugs (29.6%) the contrast agent, (16.9%) and blood products (12.7%) is the most common allergenic drugs, anti infective drugs in cephalosporin most common (15.5%). Most patients with drug eruption after treatment of skin rash alleviated, delayed anaphylactic shock in 1 cases died of suspected drug, 2 cases died of primary disease.
Conclusion: 1) the total study drug eruption rate and recent researches close, but higher than the previous studies in the United States (2%); 2) previous drug allergy drug allergy risk factors of DM / PM in patients with a high incidence of drug eruption (P0.01); 3) with the most similar studies, anti infection the drug is the most common allergenic drugs, but the most common cephalosporins in this study; 4) compared with other studies, the iodine contrast agent and blood products have the highest incidence of drug eruption in this study, the incidence of urticaria is higher; 5) the majority of drug eruption prognosis of severe drug eruption is rare.

【学位授予单位】：北京协和医学院
【学位级别】：博士
【学位授予年份】：2012
【分类号】：R758.25

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