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药物不良反应杂志
药物不良反应杂志

程经华

双月刊

1008-5734

cadrj@sina.com

010-83198246

100053

北京长椿街45号

药物不良反应杂志/Journal Adverse Drug Reactions JournalCSCDCSTPCD北大核心
查看更多>>本刊专门报道药物不良反应及安全用药，其内容密切结合临床，学术性与实用性。
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    重视对乙酰氨基酚相关重要器官损伤的防范和监管

    樊婷婷张娟利丁莉坤张迪...
    65-69页
    查看更多>>摘要：对乙酰氨基酚（APAP）是目前临床使用最广泛的解热镇痛药，常规剂量安全可靠，长期大量用药会导致重要器官损伤。近年来对APAP的安全性问题有一些新发现，如APAP可使高血压患者血压升高，含钠APAP与心血管疾病风险和全因死亡率增加相关，新发现多种预测、诊断APAP相关肝损伤及其预后的生物标志物，APAP可导致肾损伤风险增加等。APAP相关重要器官损伤的安全防范策略包括严格限制用药剂量和疗程、关注特殊人群用药安全等；对于已出现重要器官损伤的患者，应对其因果关系进行评价、及时停药、给予特异性治疗和对症支持治疗。 Acetaminophen is currently the most widely used antipyretic analgesics in clinical practice。 The conventional dose of acetaminophen is safe and reliable， and long-term use in large quantities can cause damage to important organs。 In recent years， some new safety issues of acetaminophen have been found， such as its possibility to increase blood pressure in patients with hypertension， its association with increased risk of cardiovascular disease and all-cause mortality with sodium-containing acetaminophen， the discovery of multiple biomarkers for predicting and diagnosing acetaminophen-related liver injury and its prognosis， and its possibility to increase the risk of kidney injury。 The safety prevention strategies for important organ injuries related to acetaminophen include strict restrictions on medication dosage and duration， and attention to medication safety for special populations。 For patients who have experienced significant organ damages， their causal relationship should be evaluated， acetaminophen should be stopped， and specific treatment， and symptomatic and supportive treatments should be provided。

    对乙酰氨基酚药物相关副作用和不良反应化学和药物性肝损伤心脏毒性急性肾损伤安全管理

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    米氮平相关血小板减少临床及文献病例分析

    谢清宋子杨满春霞卢翠莲...
    70-75页
    查看更多>>摘要：目的 探讨米氮平相关血小板减少的临床特点。 方法 报道航天中心医院收治的1例米氮平相关血小板减少患者的诊治经过，并对该例以及检索有关数据库（截至2023年8月31日）收集到的相关病例的主要临床资料（性别、年龄、米氮平用药指征、米氮平用法用量、联合用药情况、用药前后血小板计数、应用米氮平至发生血小板减少的时间、临床处理及转归等）进行描述性统计分析。 结果 纳入分析的患者共9例，男性4例，女性5例；年龄28~74岁，中位年龄52岁；用药指征为抑郁症者8例，1例无记录；米氮平日剂量15 mg者4例、30 mg者3例，2例无记录；单独使用米氮平者2例，合并使用其他药物者6例，1例无记录。9例患者应用米氮平至发生血小板减少的时间为2~28 d，中位时间8 d，血小板减少严重程度1、3、4级者分别为3、3、2例，1例无记录；发生严重血小板减少的5例患者中3例有出血症状，1例出现皮肤瘀斑。2例患者行药物依赖性抗血小板抗体检测，结果呈阳性。发生血小板减少后9例患者均停用米氮平，6例未予特殊干预，3例给予对症治疗；停药2~43 d（中位时间9 d）后，7例患者血小板计数恢复至参考值范围，1例PLT回升，1例不详但皮肤症状改善。 结论 米氮平相关血小板减少多发生于用药后10 d内，停药多可好转。建议应用米氮平前后注意监测患者的血常规。 Objective To explore the clinical characteristics of mirtazapine-related thrombocytopenia。 Methods The diagnosis and treatment of a patient with mirtazapine-related thrombocytopenia who was admitted to the Aerospace Center Hospital was reported， and the main clinical data (gender， age， indications of mirtazapine use， dosage of mirtazapine， combined medication， platelet count before and after medication， time from application of mirtazapine to thrombocytopenia occurrence， clinical treatment and prognosis， etc。) of the case and similar cases collected by searching relevant databases (up to August 31， 2023) were analyzed by descriptive statistic method。 Results A total of 9 patients were enrolled in the analysis， including 4 males and 5 females the age ranged from 28 to 74 years， with a median age of 52 years。 The indication of medication was depression in 8 patients， and 1 had no record。 The daily dose of mirtazapine was 15 mg in 4 patients， 30 mg in 3 patients， and no record in 2 patients。 Two patients were treated with mirtazapine alone， 6 patients were treated with mirtazapine combined with other drugs， and it was not recorded in 1 patient。 The time from the application of mirtazapine to occurrence of thrombocytopenia in the 9 patients ranged from 2 to 28 days， with a median time of 8 days。 The severity of thrombocytopenia was grade 1， 3， and 4 in 3， 3， and 2 patients， respectively 1 patient had no relevant record。 Of the 5 patients with severe thrombocytopenia， 3 developed bleeding， and 1 had skin ecchymosis。 The results of drug-dependent antiplatelet antibody test in 2 patients were positive。 Nine patients stopped mirtazapine treatment after diagnosis of thrombocytopenia， 6 patients did not receive special intervention， and 3 patients were given symptomatic treatments。 After drug withdrawal for 2-43 days with the median time of 9 days， platelet counts returned to the reference range in 7 patients， platelet count increased in 1 patient， and platelet count was unknown but skin symptom was improved in 1 patient。 Conclusions Mirtazapine-related thrombocytopenia usually occurs within 10 days of treatments， which can be improved after drug withdrawal。 It is suggested to monitor the blood routine before and after the application of mirtazapine。

    血小板减少全血细胞减少米氮平药物不良反应

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    局部枸橼酸抗凝在重症患者肾脏替代治疗中的使用现状

    王婷婷姜利王美平康彦红...
    76-81页
    查看更多>>摘要：目的 了解重症监护病房（ICU）局部枸橼酸抗凝（RCA）在肾脏替代治疗中的开展现状及ICU医师对RCA的认知情况。 方法 本研究设计为现况调查。研究者自行设计问卷（包括3个部分，共20个问题），主要了解接受调查者一般信息，对RCA的认知情况和所在ICU目前RCA实施的具体流程。问卷通过线上平台发放及回收，国内ICU临床医师自愿参与。调查时间为2022年4月15日至2022年4月30日。对获得的数据进行描述性统计分析。 结果 共回收630份电子问卷，确认有效的为616份（问卷有效率为97。8%）。616位医师来自全国21个省、4个直辖市、4个自治区和1个特别行政区的587个ICU，其中来自三级医院者530位，具有高级职称者302位。488个（83。1%，488/587）ICU开展了RCA（503位医师），ICU性质（综合、内科、外科、专科ICU）与是否开展RCA无明显相关性。ICU开展RCA的主要原因为出血风险小（96。4%，485/503），监测方便（62。2%，313/503）和指南推荐（62。0%，312/503）。99个（16。9%，99/587）ICU未开展RCA（113位医师），不开展的原因主要为医院无枸橼酸钠抗凝剂（58。4%，66/113），其次为无使用经验或方案、价格贵（各14。2%，16/113）等。所在ICU开展RCA的503位医师中，443位（88。1%）医师认为严重肝功能不全（Child分级B以上）是RCA禁忌证；分别有388位（77。1%）和377位（75。0%）医师认为代谢性碱中毒和低钙血症是RCA并发症；273位医师执行每日规律监测总钙/离子钙比值；分别有276位（54。9%）和181位（36。1%）医师将血流速度设置在120~150 ml/min和151~180 ml/min；377位（74。9%）医师选择成品血液滤过基础液，252位（50。1%）医师稀释方式选择前稀释+后稀释；239位（47。6%）医师通过单独静脉通路补充碳酸氢钠注射液；400位（79。5%）医师选择枸橼酸钠剂量方案为每小时输注速度是每分钟血流速度的1。2~1。5倍。 结论 目前国内综合性ICU在肾脏替代治疗中普遍开展RCA，且相关临床医师对RCA的禁忌证和潜在并发症等已有一定的认识，但不同医院在实施RCA时所采用的方案各异，监测手段也尚未形成统一标准。 Objective To understand the current status of regional citrate anticoagulation (RCA) application in patients of Intensive Care Units (ICUs) and physicians′ thoughts on RCA。 Methods This study was designed as a status quo survey。 Researchers independently designed a questionnaire (3 parts， 20 questions in total) and gathered data from 3 aspects， including general information of respondents， their thoughts of RCA， and the specific processes of RCA implementation in their ICUs。 The survey was conducted online， and clinicians in ICUs across the country voluntarily participated from April 15 to April 30， 2022。 Descriptive statistical analysis was performed to analyze the collected data。 Results A total of 630 electronic questionnaires were collected， of which 616 were confirmed as valid (an effective rate of 97。8%)。 These 616 physicians came from 587 ICUs in 21 provinces， 4 municipalities， 4 autonomous regions， and 1 special administrative region across the country。 Among them， 530 were from hospitals of 3A-level， and 302 held senior professional titles。 RCA was implemented in 488 (83。1%， 488/587) ICUs (involving 503 physicians)， and no significant correlation was found between the type of ICU (general， internal medicine， surgical， or specialized) and whether RCA was conducted or not。 The main reasons for RCA implementation in ICUs included having lower risk of bleeding (96。4%， 485/503)， convenient monitoring (62。2%， 313/503)， and guideline recommendations (62。0%， 312/503)。 RCA was not implemented in 99 (16。9%， 99/587) ICUs (involving 113 physicians)， and the main reasons for not carrying out RCA were the absence of citrate sodium in hospitals (58。4%， 66/113)， followed by lack of experience or protocols and higher cost (each 14。2%， 16/113)。 Among the 503 physicians in ICUs implementing RCA， 443 physicians (88。1%) believed that severe liver dysfunction (Child grade B and above) was a contraindication for RCA 388 physicians (77。1%) and 377 physicians (75。0%) recognized metabolic alkalosis and hypocalcemia as complications of RCA， respectively 273 physicians regularly monitored the total calcium/ionized calcium ratio daily 276 physicians (54。9%) and 181 physicians (36。1%) set the blood flow rate at 120-150 ml per minute and 151-180 ml per minute， respectively 377 physicians (74。9%) chose prepackaged replacement fluids， with pre-dilution+post-dilution as the dilution method (252 physicians， 50。1%) 239 physicians (47。6%) added sodium bicarbonate injection via a separate intravenous route 400 physicians (79。5%) used a citrate sodium dosage plan of 1。2-1。5 times the blood flow rate per minute per hour。 Conclusions Currently， RCA is widely implemented in comprehensive ICUs in China， and relevant clinical physicians have certain knowledge of its contraindications and potential complications。 However， different hospitals use varied protocols in implementing RCA， and a unified standard of monitoring method have not yet formed。

    重症监护病房抗凝药肾脏替代治疗局部枸橼酸抗凝

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    基于医院不良反应报告数据的妊娠期心脏和神经系统药物不良反应的信号挖掘

    陈婷婷陈朝鑫曾凡湘张进华...
    82-86页
    查看更多>>摘要：目的 对医院药物不良反应（ADR）自发报告数据进行分析，挖掘与妊娠期妇女心脏和神经系统ADR可能相关的药物风险信号。 方法 从中国医院药物警戒系统数据库中下载福建省妇幼保健院2000年1月1日至2022年12月31日的ADR报告，选取关于妊娠期妇女的报告，对其中系统器官分类为"心脏器官疾病"和"各类神经系统疾病"ADR的占比和临床表现进行描述性统计分析。采用报告比值比（ROR）法和贝叶斯置信传播神经网络（BCPNN）法对妊娠期妇女ADR报告中与心脏器官疾病和各类神经系统疾病ADR可能有关的药物进行数据挖掘。ROR法中目标药物的目标不良反应/事件报告数（a）≥3且ROR的95%置信区间（CI）下限>1，BCPNN法中信息成分-2倍标准差（IC-2SD）>0定义为一个风险信号。当2种方法检测结果均符合上述条件时，则判断该信号为可疑药物信号。 结果 共有783例妊娠期ADR报告纳入分析，其中涉及心脏器官疾病的报告94例（12。0%），主要表现为心悸；涉及各类神经系统疾病的报告121例（15。5%），主要表现为颤抖和头晕。心脏器官疾病和各类神经系统疾病的ADR多发生在孕晚期。ROR法及BCPNN法的结果均显示，利托君注射液（a=61，ROR=14。64，95%CI下限=9。08；IC-2SD=1。36）和利托君片（a=24，ROR=8。34，95%CI下限=4。64；IC-2SD=1。10）为导致妊娠期心脏器官疾病的风险药物，硫酸镁注射液（a=37，ROR=6。66，95%CI下限=4。10；IC-2SD=0。98）和利托君注射液（a=45，ROR=3。72，95%CI下限=2。44；IC-2SD=0。56）是导致妊娠期各类神经系统疾病的风险药物。 结论 利托君和硫酸镁与妊娠期的心脏和神经系统ADR可能存在一定的关联性，应当引起临床警惕。 Objective To analyze the spontaneous reports on adverse drug reaction (ADR) in a hospital and to mine the risk signals of drug that might be associated with cardiac and neurological ADRs in pregnant women。 Methods The ADR reports in the database of China Hospital Pharmacovigilance System reported by Fujian Maternal and Child Health Hospital from January 1st， 2000 to December 31st， 2022 was downloaded。 ADR reports about pregnancy women were collected， and the proportions and clinical manifestations of ADRs classified as "cardiac disorders" and "nervous system disorders" according to systems and organs were analyzed by descriptive statistic method。 Data mining was conducted on drugs that might be associated with cardiac disorders and nervous system disorders in ADR reports using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method。 The definition of risk signals in ROR method was the number of adverse reaction/event reports on the target drug (a) ≥3， and the lower limit of the 95% confidence interval (CI) of ROR >1。 The definition of risk signals in BCPNN method was the information component minus twice the standard deviation (IC-2SD) >0。 When the calculation results of an adverse reaction/event was in accordance with above-mentioned conditions in both methods， a suspected drug risk signal was determined。 Results A total of 783 ADR reports about pregnancy women were included in the analysis。 Ninety-four reports (12。0%) were about cardiac disorders， mainly manifested as palpitations 121 reports (15。5%) were about nervous system disorders， mainly characterized by trembling and dizziness。 These ADRs of cardiac disorders and nervous system disorders often occurred in the third trimester of pregnancy。 Through the ROR and BCPNN methods， results showed that ritodrine hydrochloride injection (a=61， ROR=14。64， the lower limit of 95%CI=9。08 IC-2SD=1。36) and ritodrine hydrochloride tablets (a=24， ROR=8。34， the lower limit of 95%CI=4。64 IC-2SD=1。10) were risk signals of drug leading to cardiac disorders during pregnancy， while magnesium sulfate injection (a=37， ROR=6。66， the lower limit of 95%CI=4。10 IC-2SD=0。98) and ritodrine hydrochloride injection (a=45， ROR=3。72， the lower limit of 95%CI=2。44 IC-2SD=0。56) were risk signals of drug leading to nervous system disorders during pregnancy。 Conclusion Ritodrine and magnesium sulfate may be associated with cardiac and nervous system ADR in women during pregnancy， which should arouse clinical vigilance。

    妊娠母亲暴露心脏毒性神经毒性药物不良反应报告系统信号检测

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    基于美国FDA不良事件报告系统数据库的依瑞奈尤单抗风险信号挖掘

    孙文芳夏彬彬成华沈素...
    87-92页
    查看更多>>摘要：目的 挖掘并分析依瑞奈尤单抗主要不良事件信号，为该药临床安全应用提供参考。 方法 从美国FDA不良事件报告系统数据库提取2004年至第2023年第1季度关于依瑞奈尤单抗不良事件（AE）报告，分别对全数据和2018年以后数据进行分析。采用国际医学用语词典（MedDRA）23。0版的首选术语（PT）和系统器官分类（SOC）对AE进行分类统计。采用报告比值比（ROR）法和贝叶斯置信传播神经网络（BCPNN）法进行AE风险信号的挖掘。 结果 共收集到以依瑞奈尤单抗为首要怀疑药物的AE报告38 348份，涉及PT为2 629个。基于全数据和2018年以后数据，挖掘到依瑞奈尤单抗AE风险信号分别为99和115个，均涉及19个SOC，其中上报例数最多的AE为注射部位反应和便秘，与说明书记载一致。信号强度居前30位的PT中，13个未被说明书收录，包括松果体囊肿、体位性心动过速综合征、组蛋白抗体阳性、痉挛性眼球运动、注射恐惧、脑震荡后综合征、雷诺现象、精神性癫痫发作、冠状动脉夹层、过早绝经、脆发症、胶原病、睑痉挛。 结论 临床应用依瑞奈尤单抗时，除说明书中记载的不良反应外，本研究中挖掘出的不良事件也应给予关注。 Objective To mine and analyze the signals of the adverse event (AE) of erenumab and provide reference for the safe application of the drug。 Methods The reports of AE from 2004 to the first quarter of 2023 were extracted from the US FDA Adverse Event Reporting System database， and the full data and data after 2018 were analyzed respectively。 AEs were classified according to preferred term (PT) and the system organ class (SOC) of Medical Dictionary for Regulatory Activities (MedDRA) 23。0 version for statistical analysis。 The reported odds ratio (ROR) method and Bayesian confidence progressive neural network (BCPNN) method were used to mine the AE risk signals。 Results A total of 38 348 AE reports with erenumab as the primary suspect drug were collected， involving 2 629 PTs。 The number of risk signals screened by the ROR and BCPNN methods from the full data and data after 2018 was 99 and 115， respectively， involving 19 SOCs。 Among them， the most frequently reported AEs were injection site reactions and constipation， which were consistent with the label。 Among the top 30 PTs， 13 were not recorded in the label， including pineal cyst， postural tachycardia， positive histone antibody， spastic eye movements， fear of injection， post-concussion syndrome， Raynaud effect， psychogenic seizures， coronary artery dissection， premature menopause， trichorrhexis， collagen disease， and blepharospasm。 Conclusion In clinical application of erenumab， in addition to the adverse reactions recorded in the label， attention should also be paid to the adverse events mined in this study。

    药物不良反应报告系统偏头痛降钙素基因相关肽降钙素基因相关肽受体拮抗剂依瑞奈尤单抗

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    高效液相色谱-二极管阵列检测器技术在助眠保健品非法添加化学药物检测中的应用

    徐硕徐文峰邝咏梅金鹏飞...
    93-100页
    查看更多>>摘要：目的 利用高效液相色谱-二极管阵列检测器（HPLC-DAD）技术，建立助眠保健品中可能添加的舒必利、乙琥胺、拉莫三嗪、酒石酸唑吡坦、褪黑素、盐酸丁螺环酮、苯巴比妥、马来酸咪达唑仑、氟哌啶醇、卡马西平、苯妥英钠、奥沙西泮、硝西泮、阿普唑仑、氯硝西泮、艾司唑仑、盐酸氟哌噻吨、硫喷妥、盐酸硫利达嗪和地西泮等20种化学药物的检查方法。 方法 采用Agilent Zorbax C18色谱柱（250 mm×4。6 mm，5 μm），以乙腈-0。01 mol/L磷酸二氢铵水溶液（用磷酸调pH值至3。0）为流动相，梯度洗脱，流速0。8 ml/min，柱温25 ℃，检测波长为220和280 nm。从专属性、系统适应性、线性关系、检测限、定量限、回收率、精密度、稳定性和重复性等方面对HPLC-DAD技术在检测20种非法添加化学药物中的作用进行评估。 结果 HPLC-DAD技术在20种化学药物成分的检测专属性好，在一定质量浓度范围内与峰面积的线性关系良好（相关系数r ≥0。999 8）；20种化学药物低、中、高3个浓度9次进样的平均回收率为98。68%~99。85%，峰面积变异度的相对标准偏差（RSD）为0。57%~1。16%；检测20种化学药物的精密度、重复性和稳定性良好，检测限为0。05~1。59 μg/ml，定量限为0。16~5。09 μg/ml。应用该方法对6种助眠保健品样品进行检测，其中1种检出硝西泮。 结论 该方法准确、简便、易于推广，可用于助眠类保健品中20种可能非法添加化学药物的检测。 Objective To develop the method of high performance liquid chromatography with diode array detector (HPLC-DAD) technology for detection of 20 chemical drugs possibly added into sleep aid dietary supplements such as sulpiride， ethosuximide， lamotrigine， zolpidem tartrate， melatonine， burspirone hydrochloride， phenobarbital， midazolam maleate， haloperidol， carbamazepine， phenytoin sodium， oxazepam， nitrazepam， alprazolam， clonazepam， estazolam， fupentixol dihydrochloride， thiopental， thioridazine hydrochloride and diazepam。 Methods An Agilent Zorbax C18 column (250 mm×4。6 mm， 5 μm) was used for the separation， with gradient elution of acetonitrile and ammonium dihydrogen phosphate aqueous solution (adjust pH to 3。0 with phosphoric acid) as the mobile phase at the flow rate of 0。8 ml/min。 The column temperature was 25 ℃， and the detection wavelength was set at 220 and 280 nm。 The specificity， system adaptability， linear relationship， limit of detection， limit of quantitation， recovery， precision， stability and repeatability of the HPLC-DAD technology in detection of the above 20 chemical drugs was evaluated。 Results The HPLC-DAD technology had good specificity in detection of 20 chemical drugs， and the drug concentration had good linear relationship with peak area within certain ranges (correlation coefficients r ≥0。999 8)。 The average recoveries of 9 injections of 20 chemical drugs at low， medium， and high concentrations were 98。68%-99。85%， and the relative standard deviations of peak area variation were 0。57%-1。16%。 The precision， repeatability， and stability of the method in detecting 20 chemical drugs were good。 The limits of detection and quantitation were 0。05-1。59 μg/ml and 0。16-5。09 μg/ml， respectively。 The established method was used to test 6 samples， and nitrazepam was detected in 1 sample。 Conclusions The established method is accurate， easy to operate， and easy to promote。 It can be used for the detection of 20 chemical drugs that may be added into sleep aid dietary supplements。

    色谱法,高压液相二极管阵列检测器技术入睡和睡眠障碍营养保健品违禁药物催眠和镇静药物

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    利用企业微信为门诊癌痛患者提供药学服务的效果分析

    龚晓英郑晓娴虞勋曹秀芳...
    101-105页
    查看更多>>摘要：目的 探讨药学部利用企业微信为门诊癌痛患者提供药学服务的效果。 方法 收集2020年1月1日至2023年1月30日苏州大学附属第一医院门诊收治的首次和/或既往接受癌痛相关药物治疗的患者资料进行回顾性研究，按是否使用企业微信接受门诊癌痛药学服务将患者分为常规药学服务管理组（常规组）和企业微信模式药学服务管理组（企业微信组）。记录2组患者处方达标情况，经过治疗后癌痛程度及患者生活质量评价指标（包括生理机能、生理职能、躯体疼痛、精力、社会功能、情感职能、精神健康及总体健康等8个维度）的变化情况。 结果 共纳入符合标准的患者174例，常规组和企业微信组各87例。2组患者年龄、性别等一般资料差异无统计学意义（均P>0。05）。进行企业微信管理前，2组患者经止痛治疗后处于无痛、轻度疼痛、中度疼痛和重度疼痛的患者占比差异无统计学意义（均P>0。05）。常规组87例患者中处方不达标者13例，不达标率14。9%；企业微信组87例患者中处方不达标者2例，不达标率2。3%；组间比较差异有统计学意义（χ2=8。828，P<0。05）。实施企业微信管理后，企业微信组疼痛评分为无痛的患者数由19例增加到55例（63。2%），常规组由18例增加到41例（47。1%），企业微信组无痛者占比高于常规组，差异有统计学意义（χ2=4。555，P=0。033）。在进行企业微信管理前，2组患者生活质量各项指标的评分差异无统计学意义（均P>0。05）；经企业微信管理后，企业微信组患者的生活质量8个维度的评分均高于常规组，差异均有统计学意义（均P<0。05）。 结论 使用企业微信进行药学服务可改善癌痛患者的治疗效果，提高癌痛患者的生活质量，有助于提高药学服务质量，有一定的推广与利用价值。 Objective To explore the effects of pharmaceutical services through enterprise WeChat for outpatients with cancer pain。 Methods A retrospective study was conducted on patients who were first diagnosed and/or previously treated for cancer pain and visited Outpatient Department of the First Affiliated Hospital of Soochow University from January 1， 2020 to January 30， 2023。 The outpatients were divided into conventional pharmaceutical services management group (conventional group) and pharmaceutical services management group through enterprise WeChat (enterprise WeChat group) based on whether they received pharmaceutical services for cancer pain through enterprise WeChat。 Prescription appropriateness， changes in cancer pain and life quality evaluation indicators after treatment in patients between the 2 groups were recorded and compared。 Results A total of 174 patients were included， with 87 patients in each group。 There were no significant differences in age and gender between the 2 groups (all P>0。05)。 Before the pharmaceutical services management for cancer pain through enterprise WeChat， the differences in the proportion of patients with pain free， mild， moderate， and severe pain after pain relief treatments between the 2 groups were not significant (all P>0。05)。 In the conventional group， 13 out of 87 patients (14。9%) had inappropriate prescriptions， and 2 out of 87 (2。3%) in the enterprise WeChat group， with statistically significant difference (χ2=8。828， P<0。05)。 After management with enterprise WeChat， the patients of pain-free increased from 19 to 55 (63。2%) in the enterprise WeChat group， and from 18 to 41 (47。1%) in the conventional group。 The difference in the proportion of pain-free patients between the 2 groups was statistically significant (χ2=4。555， P=0。033)。 The differences in the scores of various indicators of life quality between the 2 groups before management with enterprise WeChat were not significant (all P>0。05)。 After the management with enterprise WeChat， life quality scores in all the 8 dimensions were significantly higher than those in the conventional group (all P<0。05)。 Conclusion The utilization of enterprise WeChat could improve the treatment effect of cancer pain， enhance their life quality， help improve the quality of pharmaceutical services， and have certain promotion and utilization value。

    药学服务癌痛门诊患者企业微信信息技术

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    第三代表皮生长因子受体酪氨酸激酶抑制剂相关心脏毒性研究进展

    陈昇万畅张以若康彦红...
    106-110页
    查看更多>>摘要：奥希替尼（osimertinib）、阿美替尼（almonertinib）和伏美替尼（furmonertinib）等第三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）是EGFR基因突变晚期非小细胞肺癌的重要治疗手段，其心脏毒性不容忽视。目前发现的该类药物的心脏毒性以校正的QT间期延长为主，其次可见左心室射血分数下降和心力衰竭。这些心脏毒性症状可单独出现，也可同时发生。第三代EGFR-TKI心脏毒性的相关机制尚不明确，可能与抑制人表皮生长因子受体-2（HER-2）信号通路、磷脂酰肌醇3-激酶（PI3K）/Akt通路、hERG钾通道（即由hERG基因编码的钾离子通道）、电压门控钠离子通道（Nav1。5）和L型钙离子通道等相关。临床需谨慎应用第三代EGFR-TKI，提前识别心脏毒性高风险人群并做好治疗药物监测。 The third generation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)， such as osimertinib， almonertinib， and furmonertinib， played a crucial role in the treatment of advanced non-small cell lung cancer with EGFR gene mutations。 However， it was essential to consider their potential cardiotoxicity。 Currently， the primary cardiotoxicity associated with this kind of drugs was prolongation of the corrected QT interval， followed by decline in left ventricular ejection fraction and heart failure。 These manifestations could occur independently or concurrently。 The underlying mechanism responsible for the cardiotoxicity of the third generation EGFR-TKIs remained unknown but might be attributed to inhibition of the human epidermal growth factor receptor 2 (HER-2) signal pathway， suppression of the phosphoinositide 3-kinase (PI3K)/Akt pathway， blockade of the human ether-à-go-go-related gene (hERG) potassium channel， inhibition of the voltage-gated sodium channel (Nav1。5)， and modulation of the L-type calcium channel。 Therefore， caution should be exercised when using the third generation EGFR-TKIs clinically by promptly identifying high-risk individuals susceptible to cardiotoxicity and closely conducting therapeutic drug monitoring。

    癌,非小细胞肺表皮生长因子受体酪氨酸激酶抑制剂心脏毒性奥希替尼阿美替尼伏美替尼

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    局部麻醉药的安全性及其新剂型研究进展

    朱愿超张亚同梁良蔡晧东...
    111-117页
    查看更多>>摘要：局部麻醉（局麻）药是一类能在用药局部可逆性地阻断感觉神经冲动发生与传导的药品，临床上广泛用于皮肤黏膜麻醉、周围神经阻滞麻醉、脊髓神经麻醉和治疗慢性疼痛等。局麻药的不良反应主要包括过敏反应、心脏毒性和神经毒性。局麻药的新剂型包括经皮给药剂型和缓控释剂型。经皮给药剂型的优点是实现表面局麻，避免肝脏首过效应，减少注射麻醉对患者局部的损伤和刺激，提高患者的耐受性；缓控释剂型可维持较长效的麻醉效果，避免因局麻药吸收过快产生血药浓度过高，从而减轻药物不良反应。 Local anesthetics are a class of medications that can reversibly block the occurrence and transmission of sensory nerve impulses in the local administration area， which are widely used in clinic for skin and mucous membrane anesthesia， peripheral nerve block anesthesia， spinal nerve anesthesia， and the treatment of chronic pain。 The adverse reactions of local anesthetics mainly include allergic reactions， cardiotoxicity， and neurotoxicity。 The new dosage forms of local anesthetics include cutaneous administration and sustained-release formulations。 The advantage of cutaneous administration is to achieve surface local anesthesia， avoid liver first pass effect， reduce local damage and stimulation caused by injection anesthesia， and improve patient tolerance。 The sustained-release dosage form can help maintain a longer lasting anesthetic effect， avoid excessive blood drug concentration caused by rapid absorption of local anesthetic drugs， and thus reduce adverse drug reactions。

    麻醉药,局部经皮给药剂型安全性药物相关副作用和不良反应

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    药物不良事件报告系统监测已知安全性问题没有价值：罗非昔布和其他药物相关心肌梗死的病例研究

    王大猷
    117页
    查看更多>>摘要：50多年来，自发报告系统（SRS）是识别产品上市后非预期作用的唯一选择。SRS的高灵敏度使其特别适合于识别罕见的药物使用或疫苗接种相关的结局。SRS在识别安全信号方面的重要作用预计将继续存在，但自发报告的处理需要大量的资源。一项单个组织的研究报告了每份自发报告获取数据的中位时间为69 min，而GSK估计处理每份自发报告的平均花费为33美元。这些估计还不包括多个组织处理同一份报告或遵照法规与其他组织分享报告所产生的费用。而在全球范围内，数据库中数以百万计的自发报告中，有许多报告与旧的（甚至已停产的）产品或已知的不良反应有关。
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