从基层药品不良反应工作者的角度看我国药物不良反应救济现状

人类运用药品治疗疾病中发现一些与用药目的无关的，甚至对人体有害的作用，说明药物是一柄双刃剑。特别是近百年来，世界上频频发生致死、致残的药害事件，引起了世界各国药品监管部门、医疗工作者、消费者的密切关注。据文献报道，药物不良反应的发生率在住院病人中占10％～20％；住院病人因药物不良反应死亡者为0．24％-2．9％；因药物不良反应而住院的病人为0．3％-5．0％。     

试论老年心血管病用药

心血管病是老年的常见多发病，据统计，老年心血管病约占心血管病的30％，防治老年心血管病已成为老年医学的重要课题。药物做为治疗老年心血管病的主要手段，近十年来有了明显的进展。但由于老年人生理，生化机制的老年化及药代动力学，药效学的改变，使得老年人对药物的处置能力及药物反应性降低，药源性疾病，药物不良反应增加。目前，临床对老年人的用药特殊性缺乏了解，本文对已应用于临床的老年心皿管用药作以阐述和评价。1．老年高血压美国有学者统计，60岁一65岁老年人中高血压患病率为30％，65岁以上为4O％，70岁以上为50％。其特…     

关注老年心血管病的合理用药

随着人们对心血管病危害认识的不断加深，心血管病治疗学也在迅速进展，因此如何合理使用药物预防和治疗老年心血管病，减少药物不良反应，提高老年人的生活质量等问题，已迫在眉睫地摆在广大医务人员面前。现对老年人心血管疾病合理用药的几个要点作一概述。[第一段]     

老年人药物不良反应及用药原则

老年人由于药物代谢动力学的改变，神经系统、内分泌系统、各种器官功能及代偿等逐渐衰退，机体耐受性降低，对药物的敏感性发生变化，因此发病率也随之上升，药物不良反应发生率增高。据统计表明，50～60岁患者的药物不良反应发生率为14．4％，61～70岁为15．7％，71～81岁为18．3％，80岁以上为24．0％，据国家药品监督管理局不良     

抗菌药物386例使用合理性调查分析

目的探讨德阳市人民医院住院患者抗菌药物使用率及合理性。方法调查2004—03内科系统出院病历562份，对抗菌药物使用适应症、疗程及预防用药是否正确进行评价。结果抗菌药物使用率为68．68％；按适应症评价，用药合理60．0％、基本合理24．3％、不合理15．7％；按疗程评价，用药合理64．3％、基本合理25．6％、不合理10．1％。结论在抗菌药物使用方面，应严格掌握适应症、禁忌症，合理规范使用抗菌药物，以防止浪费，减少耐药菌株的产生，减轻患者的经济负担。     

702例抗结核药物所致不良反应分析

目的分析结核病专科医院住院患者抗结核药物所致药物不良反应（ADR）的发生情况。方法由结核科专业医师提供病程记录、医嘱单、实验室检查及辅助检查结果，回顾性分析抗结核药物所致不良反应的发生情况。结果1222例住院患者中发生不良反应702例（57．4％），共25种。287例合并多种不良反应。总的不良反应为1097例次。其中332例（332／1222，27．17％）因不良反应严重需要调整治疗方案。最多见的不良反应为血尿酸增高，占所有不良反应的37．28％（409／1097）。96％的不良反应发生在60d之内。结论应重视抗结核药物所致的不良反应，加强对相关专业人员的培训和对患者的宣教，对具有危险因素的人群采取个体化治疗并密切监测以便及时发现各种不良反应，需进一步完善抗结核药物所致不良反应的呈报系统。     

谈老年人安全合理用药

老年人由于年龄的增大,体内环境的变化,生理功能及解剖结构多有不同程度的衰退,因而药物在老年人体内的药动学、药物对机体产生的不良反应等都产生一系列的变化。老年人常会出现各种疾病,越来越多的老年人同时接受多种药物治疗,而老年人对药物的吸收、代谢、排泄等能力却不断降低。据统计,老年人出现药物不良反应的为27．3％,是成年人的4—8倍。所以安全合理用药是关系到老年人健康的大问题。为保证老年人安全合理用药,医生、药师尤其是临床药师应着重开展对老年人用药的指导。老年人用药应注意的几个问题进行总结。     

高血压患者症状及药物不良反应的研究——附1026例报告

目的：通过随机,双盲、大系列及设正常人对照的研究方法,区别常用降压药治疗后真正的不良反应抑或高血压本身的症状。方法：前瞻性,随机,双盲并行研究,1026例患分为A组（卡托普利）,B组（氨酰心安）,C组（尼群地平）,D组（卡＋氨）,WE组（氨＋尼）,F组（尼＋卡）,观察药物降压效果,副作用,生活质量,观察期6个月,以正常人400例作为对照组,结果：联合用药降压较单用效果更好,心率更稳定,撤药率更低,患80％以上用药前存在各种症状,药后1／2以上症状消失。同时出现两种以上症状达74．4％,最多达12种症状,均非药物所致。有88．6％患用药后出现新症状,药物不良反应仅指此类症状,药前性功能障碍男,女分别达76％,79．5％,药后为52．7％及67．0％。结论：药物副作用及生活质量影响是选用药物的重要依据,可影响患依从属性及疗效,目前尚无只有疗效而无不良反应的降压药物,熟悉其不良反应,采取最低有效剂量方为上策。     

老年病人用药依从性改变问题分析

病人用药依从性为病人遵守医嘱的程度。依从性的高低是病人能否得到有效药物治疗的关键环节之一，但实践证明，尤其是在长期用药的慢性病人中，大约50％存在用药依从性差的问题，其中，老年病人占42％。而老年病人用药依从性的改变，会直接导致药物不良反应增加、药物疗效降低，甚至造成病人病情加重，使医疗资源浪费，医疗支出增加。因此，对于老年病人用药依从性的改变，必须引起广大药学工作者的高度重视。     

微卡配合治疗复难治结核病疗效观察

目的观察微卡配合抗结核药物治疗复难治菌阳肺结核的临床疗效、不良反应。方法将43例复难治菌阳肺结核患者随机分为治疗组：3微卡＋PaVZTH1321SM／15微卡＋PaVZTH132122例（Z用药9月取消），对照组：3PaVZTH1321SM／15PaVZTH132121例（z用药9月取消）。结果治疗3、6、9、15个月痰菌阴转率治疗组为50％,72．7％、81．8％、86．4％，对照组为38．1％、57．1％、61．9％、66．7％（P〈0．05）；治疗3月末胸片上治疗组与对照组病灶吸收率分别为31．8％、14．3％（P〈0．05）；空洞闭合率为50％、33．3％（P〈0．05）；治疗组在治疗3月末临床咳嗽、低热、乏力、盗汗消失率为94．4％、90％、100％、80％，对照组为81．3％、71．4％、80％、60％（P〈0．05）；无不良反应发生。结论微卡联合抗结核药物治疗复难治结核病较单用抗结核药治疗痰菌阴转、胸片病灶吸收和临床症状改善效果要好，是理想的结核病免疫治疗制剂。     

Pharmacovigilance through consumer feedback (reporting) in the mass treatment of lymphatic filariasis using diethylcarbamazine and albendazole in two districts of Sri Lanka

Objective  To document the types and severity of adverse drug reactions to diethylcarbamazine and albendazole in randomly selected urban populations from Colombo and rural populations from Gampaha, Sri Lanka.
Methods  Interviewers administered a pre-tested questionnaire to elicit information about the type and severity of adverse drug reactions experienced by recipients. Seeking medical treatment and requiring hospital admission for the adverse drug reactions were used as indicators for severity. The sample population was selected using the cluster sampling method.
Results  Two thousand three hundred and nineteen persons aged 10 to 90 years (median 40.0) responded to the questionnaire; 63.9% of them had received and ingested the drugs. 12.6% reported that they had experienced adverse drug reactions, the proportion being similar in urban and rural areas (χ² = 0.05; p = 0.82). Commonly reported reactions were drowsiness (34.7%), headache (23.1%), gastrointestinal symptoms (18.7%) and dizziness or faintness (11.9%). However, most symptoms were mild (96.3%) and did not interfere with daily activities or require medical attention. 3.2% said that they sought medical advice for their symptoms; one person (0.5%) who had severe abdominal pain was hospitalized.
Conclusions  Fewer people experienced adverse drug reactions than in previous years, possibly due to lower microfilariaemia prevalence after several rounds of mass drug administration against filariasis. Community awareness of adverse drug reactions is essential for improving compliance and for the success of the filariasis elimination programme.     

Spectrum of anti tubercular therapy induced cutaneous adverse drug reactions and its management through rechallenge: A prospective study at a Tertiary Care Centre

IntroductionThe use of multi-drug regimens including 1st and 2nd line anti tubercular drugs in management of tuberculosis (TB) has been associated with undesirable adverse drug reactions including cutaneous one. Re-challenge remains the only option to restart the safe therapy and combat the tuberculous infection simultaneously.Materials and methodologyThis cross-sectional study was conducted via prospective review of outpatients as well as indoor patients who presented with cutaneous adverse drug reactions to ATT between March 2020 and March 2021. Data were analysed regarding demographic profile, site of TB, ATT regimen, pattern of cutaneous lesions, offending drugs, past history of drug allergy, and reinstitution of ATT after re-challenge.ResultsOut of total 56 registered tubercular patients presented with cutaneous adverse drug reaction 30 were females (53.57%). The most common site of TB was pulmonary followed by cervical lymph node TB. The three most common adverse drug reaction detected were maculopapular rash 32 (57.1%) followed by lichenoid drug eruptions in 6 (10.7%) and urticaria in 2 (3.6%). Ethambutol was found to be common offending drug followed by other first line anti-tubercular drugs. 5 patients developed multiple drug hypersensitivity on re-challenging and have to introduce steroids along with ATT.ConclusionAdverse cutaneous drug reactions to ATT is like a double-edged sword as stopping ATT and starting treatment with systemic steroids can further flare up the infection with increased risk of disseminated and multidrug resistant tuberculosis. Re-challenge was found out to be safest way in identifying culprit drug and hence to restart a safer alternate ATT regimen for better management.     

Adverse reactions to prolonged treatment with high doses of carbenicillin and ureidopenicillins

Charts were reviewed for 63 patients whose chronic pseudomonas osteomyelitis was treated with high doses of extended-spectrum penicillins for prolonged periods. The incidence of untoward drug reactions was significantly higher than expected. Carbenicillin evoked adverse reactions in 22.8% of patients. However, most of these reactions were mild, and a change of drug was required in only 5.7% of cases. No adverse drug reactions were observed with cumulative doses of less than 750 g. In contrast to carbenicillin, the ureidopenicillins were associated with adverse reactions in 67.7% of patients; most reactions were moderate to severe in intensity; a cumulative dose of greater than 250 g produced adverse reactions; and discontinuation or change of therapy was required in 51.6% of cases. The main adverse reactions to both carbenicillin and the ureidopenicillins included rash, drug fever, leukopenia, eosinophilia, thrombocytopenia, and hepatic damage.     

702例抗结核药物所致不良反应分析

目的分析结核病专科医院住院患者抗结核药物所致药物不良反应(ADR)的发生情况。方法由结核科专业医师提供病程记录,医嘱单,实验室检查及辅助检查结果,回顾性分析抗结核药物所致不良反应的发生情况。结果1 222例住院患者中发生不良反应702例(57.4%),共25种。287例合并多种不良反应。总的不良反应为1 097例次。其中332例(332/1 222,27.17%)因不良反应严重需要调整治疗方案。最多见的不良反应为血尿酸增高,占所有不良反应的37.28%(409/1 097)。96%的不良反应发生在60 d之内。结论应重视抗结核药物所致的不良反应,加强对相关专业人员的培训和对患者的宣教,对具有危险因素的人群采取个体化治疗并密切监测以便及时发现各种不良反应,需进一步完善抗结核药物所致不良反应的呈报系统。     

Iatrogenic syncopes and malaises

Syncope or presyncope related to adverse drug reactions are well-known. On the other hand, little is known about the specific role of different drugs. Over one six year period, 1611 patients were referred in our hospital for syncope or presyncope, including 688 in the cardiology department. Among these patients, 420 were 70 years old or more. The search for an adverse drug reaction was systematic, with the help of the French method for causality of adverse drug reaction: knowledge of "extrinsic" criteria (bibliographical data relating to the drug involved); moreover, score on the basis of "intrinsic", chronological and symptomatic criteria. Seventy five patients (11% of the group with syncope leading to admission in cardiology department) were thus retained: score = I2, "possible adverse drug reaction", for 28 patients (37%); score = I3, "probable adverse drug reaction", for 47 patients (63%). Score I4, "definite adverse drug reaction" was not used since it required the readministration of the drug to prove the iatrogenic effect. Average age was 78 years, with a female majority of 69%. Seventy two patients (96%) had previous cardiovascular disease, 37 (50%) previously experienced syncope or presyncope. In addition to the basic assessment, a Holter recording was performed among 56 patients, finding a drug-induced arrhythmia in three cases. In the majority of the patients (59 patients, 79%), the adverse drug reaction consisted of hypotension, clinically obvious in 49 cases. In ten cases, vasovagal syndrome facilitated by the drugs was diagnosed by a tilt-test. The other side effects were eight rhythm disorders and eight severe metabolic disorders. The treatments were always multiple. The involved drug was a cardiovascular therapy in 66% of the cases. The other drug classes were primarily represented by uroselective alpha 1-adrenergic blocking drugs (12%) and psychotropic ones (22%). Among the cardiovascular treatments, ACE inhibitors and diuretics, generally in association, were involved (59%). This study confirms the role for antihypertensive drugs in iatrogenic syncope, its great frequency in elderly patients but also the responsibility of another drug class less often reported, the uroselective alpha 1-adrenergic blocking drugs.     

国内抗结核药物不良反应发生率的综合分析

目的了解我国抗结核治疗导致各种药物不良反应尤其是肝损害的发生率情况。方法于2006年采用系统综述方法，以“结核＋药物”为关键词搜索国内发表于1996至2005年的文献，对文献的报道内容进行综合分析，包括抗结核治疗引起的各种不良反应的发生情况、发生率、可能的影响因素及不良反应预后等。结果根据检索结果、入选及排除标准，共纳入文献117篇。近10年文献报道抗结核药物引起的不良反应合计发生率为12．62％，其中以肝损害的报告发生率最高，合计发生率为11．90％。不同诊断标准、不同性质研究单位、不同研究类型报道的肝损害发生率有区别，但前两者无统计学意义。回顾性队列研究证明乙型肝炎病毒标志物阳性或曾有肝病史的结核病患者，其肝损害发生率明显高于一般结核病患者。肝损害的转归较好，在报告了转归的文章中，85．84％的患者不良反应治愈。结论我国抗结核治疗导致各种药物不良反应尤其是肝损害的发生率较高，应重视对不良反应的防治，以增强患者服药的依从性。     

老年患者服用小剂量肠溶阿司匹林的不良反应和有效性分析

目的调查小剂量肠溶阿司匹林在年龄≥75岁老年患者中使用的不良反应及有效性。方法选择长期服用肠溶阿司匹林100mg/d的心脑血管病及糖尿病患者,年龄≥75岁226例(老年组),年龄<75岁270例(成年组),比较2组在服用阿司匹林过程中的不良反应。另对坚持服用阿司匹林的老年组患者178例,成年组患者249例检测血小板聚集率。结果老年组阿司匹林不良反应发生率明显高于成年组(43.8%vs 23.7%,P<0.01)。老年组与成年组血小板聚集率差异无统计学意义(11.3%vs 12.7%,P>0.05)。结论年龄≥75岁老年人长期服用小剂量肠溶阿司匹林与成年人同样有效,但不良反应明显增加,需要仔细评价风险并密切监测。     

急性冠脉综合征患者PCI术后应用国产硫酸氢氯吡格雷的疗效

比较急性冠脉综合征（ACS）患者择期PCI术后国产氯吡格雷（泰嘉,Talcom）和进口氯吡格雷（波立维,Plavix）应用的有效性和安全性。方法：158例行择期PCI的ACS患者随机分为：国产氯吡格雷组和进口氯吡格雷组,各79例。随访12个月以上,观察两组术后不良心血管事件及药物不良反应情况。结果：进口氯吡格雷组心源性死亡1例、非致死性心肌梗死1例、靶血管再次血运重建1例、脑卒中1例。国产氯吡格雷组心源性死亡0例、非致死性心肌梗死1例、靶血管再次血运重建2例、脑卒中1例。两组心血管不良事件发生率无显著差异（5.06%比5.06%,P〉0.05）。药物不良反应：进口氯吡格雷组胃肠道反应5例、出血1例、血小板减少1例。国产氯吡格雷组胃肠道反应7例、出血1例、血小板减少2例,两组不良反应发生率无显著差异（8.86%比12.66%,P〉0.05）。结论：与进口氯吡格雷相比,国产氯吡格雷应用于PCI术后患者是安全、有效的。     

Efficacy and safety of rabeprazole in non-steroidal anti-inflammatory drug-induced ulcer in Japan

AIM: To investigate the efficacy and safety of rabeprazole under continuous non-steroidal anti-inflammatory drug (NSAID) administration for NSAID-induced ulcer in Japan.METHODS: Subjects comprised patients undergoing NSAID treatment in whom upper gastrointestinal endoscopy revealed an ulcerous lesion (open ulcer) with diameter ≥ 3 mm, who required continuous NSAID treatment. Endoscopies were performed at the start of treatment, during the treatment period, and at the conclusion (or discontinuation) of treatment. Findings were evaluated as size (maximum diameter) and stage based on the Sakita-Miwa classification. An ulcer was regarded as cured when the "white coating" was seen to have disappeared under endoscopy. As criteria for evaluating safety, all medically untoward symptoms and signs (adverse events, laboratory abnormalities,accidental symptoms, etc.) occurring after the start of rabeprazole treatment were handled as adverse events.RESULTS: Endoscopic cure rate in 38 patients in the efficacy analysis (endoscopic evaluation) was 71.1% (27/38). Among those 38 patients, 35 had gastric ulcer with a cure rate of 71.4% (25/35), and 3 had duodenal ulcer with a cure rate of 66.7% (2/3). Three adverse drug reactions were reported from 64 patients in the safety analysis (interstitial pneumonia, low white blood cell count and pruritus); thus, the incidence rate for adverse drug reactions was 4.7% (3/64).CONCLUSION: The treatment efficacy of rabeprazole for NSAID-induced ulcer under continuous NSAID administration was confirmed.