Analysis of Innovations in Monitoring Adverse Drug Reaction and Application

Objective To systematically study foreign adverse drug reaction monitoring technologies and applications to extract valuable experience,and provide reference for promoting its application in China.Methods Literature research,comparative research and other methods were used to investigate foreign adverse drug reaction(ADR)monitoring technologies and applications such as passive reporting systems,active monitoring systems,electronic health records and real-world data,and analyze the problems in the application of the above technologies in China.Results and Conclusion At present,China is relatively mature in the application of ADR passive reporting system,but there are some problems in the application of ADR active monitoring system,electronic health records and real-world data.In the future,we should improve the application of adverse drug reaction active monitoring system,establish close cooperation with universities,research institutes and other institutions to improve the evaluation of adverse drug reactions.Besides,we should promote the construction of the Chinese medical language processing system and strengthen the understanding of real-world data.This will improve the level of monitoring adverse drug reactions in China and promote rational drug use.

The Construction and Thinking of the National Sentinel Alliance for Adverse Drug Reaction Monitoring

Objective To briefly introduce the construction and operation of the National Sentinel Alliance for Adverse Drug Reaction(ADR)Monitoring,and provide reference for strengthening the safety monitoring of drugs after listing in China.Methods The literature research method was used to analyze the establishment and promotion measures of the National Sentinel Alliance for ADR Monitoring,and then some countermeasures and suggestions were put forward to enhance the construction of the alliance.Results and Conclusion The alliance based on Chinese hospital pharmacovigilance system(CHPS)has played an important role in ADR monitoring and reporting.Promoting the construction of the alliance can provide a new method for improving the scientific evaluation system and active supervision system of drug safety after listing.Therefore,the construction of alliances at the national and provincial levels should be strengthened.Besides,relevant laws and regulations must be improved to accelerate the research and development of information systems,which will deepen the active monitoring of the alliance continuously.

Patterns of adverse drug reaction reporting in Ethiopia:A database analysis of spontaneous reports from 2013 to 2018

Objective:To examine the frequency and profile of spontaneous reports of adverse drug reactions(ADRs)sent to Ethiopia's pharmacovigilance(PV)database system.Methods:The descriptive and retrospective study analysed spontaneous ADR complaints reported to the PV database by healthcare professionals between 2013 and 2018.Spontaneous ADR reports that reached the PV center and met the minimum reporting criteria were identified and assessed in terms of reporting rate,patient characteristics,type of ADRs,suspected drugs,report sources,and reporters’profession.Results:A total of 657 spontaneous ADR reports were filed to the PV center between 2013 and 2018.During the study period,the reporting pattern of ADRs changed dramatically.The number of reports increased from 2013(n=12)and peaked in 2015(n=205),and then declined from 2016 to 2018(n=144,142 and 65 in 2016,2017 and 2018,respectively).Females had a higher percentage of reported cases(56.3%)than males(43.7%).The highest number of ADRs was reported in the age categories of 15-64 years(475,72.3%),followed by 0-14 years(154,23.4%),and 65 years and above(21,3.2%).Pharmacists reported the majority of ADRs(81.7%),followed by health officers(7.2%),nurses(5.8%),and physicians(5.2%).Skin and subcutaneous tissue abnormalities were the most commonly reported ADRs.The anatomical therapeutic chemicals code class"anti-infective for systemic use"was the most usually suspected medication.Trimethoprim with sulfamethoxazole as a combination ADRs was the most commonly reported drug that cause ADRs(14.2%).Conclusions:The number of ADRs reported in Ethiopia was small and unpredictable compared to developed countries,indicating the performance of PV system and level of awareness of health care professionals towards ADR reporting was not satisfactory.In order to increase the frequency of spontaneous reports,more efficient PV methods and public policies must be implemented.

Random Forest Analysis the Influencing Factors on Adverse Drug Reactions of Qingkailing Injection

Objective:To investigate the influencing factors of adverse drug reaction(ADR)in Qingkailing injection.Methods:Based on the hospitals centralized monitoring data of multicenter and prospective,the patients who used Qingkailing injection from January 2013 to March 2016 were monitored in 48 medical institutions in China.The nesting case-control study was used and the random forest was used for analysis.The main contents of the analysis are as follows:past history,past allergy history and ADR history,clinical diagnosis,dosage,interval drug,solvent type,combined drug use,etc.Results:A total of 30842 cases with Qingkailing injection were included,with 92 cases of adverse reactions and the incidence of adverse reactions was 3‰.According to the nested case-control study design,the influencing factors of 92 patients with ADR and 276 non-drug-related adverse reactions were displayed on the basis of statistical description(significance level P≤0.2 and clinical information)using Random forest analysis shows that the factors affecting the ADR of the Qingkailing injection according to the MeandecaseGini are from high to low in the first 15 positions:Vitamin supplements,tumors,gastrointestinal diseases,traditional Chinese medicine,previous allergic history,cerebral insufficiency,rash,urinary tract infection,vascular and lymphovascular diseases,pioglitazone,metabolic and endocrine system drugs,past ADR history,respiratory and mediastinal diseases,dioxpromazide,pneumonia.Conclusion:The incidence of adverse reactions in Qingkailing injection hospital is 3%.The factors closely related to the occurrence of ADR are previous tumors,gastrointestinal diseases,history of adverse reactions of rash,urinary tract infection,insufficient cerebral blood supply,respiratory system and other diseases,pioglitazone and other combined drugs.

Application and Effect Evaluation of the Integrated“5A and 3+3”Management Model in the Safe Medication Use for Chemotherapy Patients

Objective:To explore the application and effect evaluation of the integrated“5A and 3+3”management model in ensuring safe medication use for chemotherapy patients.Methods:A total of 100 intravenous chemotherapy patients admitted to the oncology department of Shaanxi Provincial People’s Hospital were randomly divided into two groups using a random number list method.Both groups received conventional nursing management during chemotherapy,while the study group additionally received the integrated“5A and 3+3”safety management model.The nursing intervention effects between the two groups were compared.Results:After the intervention,the study group showed higher levels of self-management ability,compliance,and nursing satisfaction compared to the control group.The overall incidence of adverse events during hospitalization was lower in the study group,with statistically significant differences(P<0.05).The knowledge scores of medical staff in the study group,related to the prevention and treatment of chemotherapy drug side effects,daily symptom management,and daily life management,were higher than those in the control group,with statistically significant differences(P<0.05).Conclusion:Implementing the integrated“5A and 3+3”model in the safe medication management of intravenous chemotherapy patients can effectively enhance patients’self-management abilities and compliance,improve medical staff’s ability to safely administer chemotherapy drugs,reduce adverse events caused by chemotherapy,and increase patient satisfaction.

Analysis of Data on Adverse Drug Events Reported to the Food and Drugs Administration of the United States of America

Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.

Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database

Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.

Awareness and attitudes of healthcare professionals in Wuhan,China to the reporting of adverse drug reactions

Background A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However,only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting,the authors investigated the awareness and attitudes of healthcare professionals (doctors,nurses,and administrators) toward the ADR system in China. In addition,the authors sought to formulate approaches to improve the current ADR reporting system.Methods Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan,Hubei Province,China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.Results The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However,only 28.5% of doctors,22.8% of nurses,and 29.7% of administrators actually submitted a report. For the most part,they reported ADRs to the hospital pharmacy (66.0%),to other departments in the hospital (72.5%),and to the pharmaceutical industry (23.0%),rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs,yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%),unavailability of the reporting center mailing address (67.9%),unavailability of the ADR report form (60.4%),lack of knowledge of the existence of a national ADR reporting system (52.2%),and belief that the ADR in question was already well known (44.1%). Conclusions Healthcare professionals in Wuhan,China have little basic knowledge of ADR and of the voluntary reporting system. The main reasons for underreporting were lack of basic knowledge about ADRs and the voluntary reporting procedure. Education and training of healthcare professionals is needed to improve the current ADR reporting system.

Anlotinib-induced sick sinus syndrome:Two case reports

BACKGROUND This manuscript describes the first known cases of sick sinus syndrome(SSS)associated with the use of anlotinib in non-small cell lung cancer patients,highlighting the need for increased vigilance and cardiac monitoring.CASE SUMMARY Two patients with non-small cell lung cancer developed SSS after 15 months and 5 months of anlotinib treatment,respectively,presenting with syncope and palpit-ations.Electrocardiogram confirmed SSS,and different treatment approaches were taken for each patient.One patient received a dual-chamber permanent pacemaker,while the other discontinued the medication and experienced symptom resolution.CONCLUSION Anlotinib can induce SSS,suggesting that cardiac monitoring is crucial during anlotinib treatment.Individualized management strategies are necessary for affected individuals.

Landscape of DILI-related adverse drug reaction in China Mainland

Drug-induced liver injury(DILI)is a type of bizarre adverse drug reaction(ADR)damaging liver(L-ADR)which may lead to substantial hospitalizations and mortality.Due to the general low incidence,detection of L-ADR remains an unsolved public health challenge.Therefore,we used the data of 6.673 million of ADR reports from January 1st,2012 to December 31st,2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation.Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from the original heterogeneous system.By cleaning and standardizing the data fields by the dictionary of synonyms and English translation,we resulted 94,593 ADR records reported to liver injury and then created a new database ready for computer mining.The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years.The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men.The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population,despite known underreporting situation in spontaneous ADR reporting system.The percentage of herbal and traditional medicines(H/TM)L-ADR reports in the whole number was 4.5%,while 80.60%of the H/TM reports were new findings.There was great geographical disparity of reported agents,i.e.more cardiovascular and antineoplastic agents were reported in higher socio-demographic index(SDI)regions and more antimicrobials,especially antitubercular agents,were reported in lower SDI regions.In conclusion,this study presented a large-scale,unbiased,unified,and computer-minable L-ADR database for further investigation.Age-,sex-and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.

Vancomycin-related convulsion in a pediatric patient with neuroblastoma:A case report and review of the literature

BACKGROUND Vancomycin is often used as an anti-infective drug in patients receiving antitumor chemotherapy.There are concerns about its adverse drug reactions during treatment,such as nephrotoxicity,ototoxicity,hypersensitivity reactions,etc.However,potential convulsion related to high plasma concentrations of vancomycin in children receiving chemotherapy has not been reported.CASE SUMMARY A 3.9-year-old pediatric patient with neuroblastoma receiving vancomycin to treat post-chemotherapy infection developed an unexpected convulsion.No other potential disease conditions could explain the occurrence of the convulsion.The subsequently measured overly high plasma concentrations of vancomycin could possibly provide a clue to the occurrence of this convulsion.The peak and trough plasma concentrations of vancomycin were 59.5 mg/L and 38.6 mg/L,respectively,which were much higher than the safe range.Simulation with the Bayesian approach using MwPharm software showed that the area under the concentration-time curve over 24 h was 1086.6 mg·h/L.Therefore,vancomycin was immediately stopped and teicoplanin was administered instead combined with meropenem and fluconazole as the anti-infective treatment strategy.CONCLUSION Unexpected convulsion occurring in a patient after chemotherapy is probably due to toxicity caused by abnormal pharmacokinetics of vancomycin.Overall evaluation and close therapeutic drug monitoring should be conducted to determine the underlying etiology and to take the necessary action as soon as possible.

COVID-19 and gastroenteric manifestations

Coronavirus disease 2019(COVID-19),caused by the infection of a novel coronavirus[severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)],has become a pandemic.The infection has resulted in about one hundred million COVID-19 cases and millions of deaths.Although SARS-CoV-2 mainly spreads through the air and impairs the function of the respiratory system,it also attacks the gastrointestinal epithelial cells through the same receptor,angiotensin converting enzyme 2 receptor,which results in gastroenteric symptoms and potential fecal-oral transmission.Besides the infection of SARS-CoV-2,the treatments of COVID-19 also contribute to the gastroenteric manifestations due to the adverse drug reactions of anti-COVID-19 drugs.In this review,we update the clinical features,basic studies,and clinical practices of COVID-19-associated gastroenteric manifestations.

Pregabalin induced balance disorder,asthenia,edema,and constipation in an elderly adult:A case report

BACKGROUND Pregabalin is widely used to treat neuropathic pain associated with postherpetic neuralgia.To our knowledge,this is the first report on simultaneously occurring dose-related adverse drug reactions(ADRs)of balance disorder,asthenia,peripheral edema,and constipation in an elderly patient after pregabalin.CASE SUMMARY A 76-year-old female with a history of postherpetic neuralgia was prescribed pregabalin(300 mg daily).After taking pregabalin for 7 d,the patient developed balance disorder,weakness,peripheral pitting edema(2+),and constipation.On days 8-14,the pregabalin dose was reduced to 150 mg/d based on creatinine clearance.The patient’s peripheral edema improved significantly with the disappearance of all other adverse symptoms.On day 15,the pregabalin dose was increased to 225 mg/d to relieve pain.Unfortunately,the symptoms mentioned earlier gradually reappeared after 1 wk of pregabalin treatment.However,the complaints were not as severe as when taking 300 mg/d pregabalin.The patient consulted her pharmacist by telephone and was advised to reduce the dose of pregabalin to 150 mg/d and add acetaminophen(0.5 g,q6h)to relieve pain.The patient’s ADRs gradually improved over the following week.CONCLUSION Older patients should be prescribed a lower initial dose of pregabalin.The dose should be titrated to the maximum tolerable dose to avoid dose-limiting ADR.Dose reduction and the addition of acetaminophen may help limit ADR and improve pain control.

阿帕替尼血药浓度测定方法的建立及临床应用

目的 建立测定阿帕替尼血药浓度的方法并进行临床应用。方法 采用超高效液相色谱(UPLC)法进行血药浓度测定,色谱柱为ACQUITY UPLC BEH C18,流动相为乙腈-0.1%甲酸水溶液(梯度洗脱),流速为0.2 mL/min,柱温为40℃,进样量为5μL。收集26例服用阿帕替尼癌症患者的病例资料,检测其血药浓度,分析阿帕替尼血药浓度与患者年龄、给药剂量、不良反应及联合用药的相关性,并检测患者治疗前后血清肾损伤相关因子[胱抑素C(CysC)、肾损伤分子1(KIM-1)、白细胞介素18(IL-18)、肿瘤坏死因子α(TNF-α)]水平。结果 阿帕替尼检测质量浓度在500~2 000 ng/mL范围内线性关系良好,精密度试验RSD为3.7%,稳定性试验RSD为4.9%,平均加样回收率为96.0%(RSD为2.1%)。26例患者的阿帕替尼血药浓度最低为103 ng/mL,最高为1 932ng/mL。患者的血药浓度随年龄呈波动降低趋势。在0.125或0.25 g给药剂量下,服用阿帕替尼的患者体内血药浓度集中在1 000~2 000 ng/mL范围内。26例癌症患者中有13例发生不良反应,其中血药浓度500~<1 000 ng/mL者未见不良反应发生。20例患者同时联用了其他药物,其血药浓度高低不同。治疗后,患者的血清CysC、KIM-1、IL-18、TNF-α水平均显著高于治疗前(P<0.05)。结论 所建立的UPLC方法能快速检测阿帕替尼血药浓度。临床使用阿帕替尼时应综合考虑患者年龄和药物联用等情况,并注意防范阿帕替尼可能导致的急性肾损伤。

某院药品不良反应上报工作改进实践

目的为建立医院药品不良反应(ADR)上报管理模式提供参考。方法收集四川省邛崃市医疗中心医院2016年ADR上报情况,利用质量管理工具进行第1轮上报工作改进(2017年1月至2019年12月);运用触发管理工具进行第2轮上报工作改进(2020年1月至2022年12月)。分析改进后的效果。结果2016年,该院ADR上报125例,2017年至2019年分别升至163例、236例、149例。2016年上报新的+严重ADR比例和严重ADR比例分别为31.20%和8.80%,2022年分别大幅升至74.65%和57.94%。结论运用质量管理工具及触发管理工具,能促进医院ADR上报数量增加及质量的提升。

ICU患者多黏菌素B血药浓度及不良反应分析

目的 探讨重症监护室(ICU)患者多黏菌素B血药浓度达标情况及不良反应,为临床合理用药提供参考。方法 回顾性分析61例ICU患者使用多黏菌素B治疗后的稳态24 h浓度-时间曲线下面积(AUC_(ss,24h))达标情况、影响因素及不良反应。结果 61例患者多黏菌素B AUC_(ss,24h)达标率为37.70%(23/61)。肌酐清除率与谷浓度(C_(min))及AUC_(ss,24h)差异有统计学意义(P<0.05),肌酐清除率与C_(min)(r=-0.45)及AUC_(ss,24h)均为负相关(r=-0.34)。单因素和多因素分析显示,AUC_(ss,24h)与滴注时间显著相关(P<0.05),输注时间>1小时组AUC_(ss,24h)达标率高于1小时组。虽然AUC_(ss,24h)与年龄及肾功能差异无统计学意义(P>0.05),但是年龄增大或中重度肾功能不全,AUC_(ss,24h)达标率降低。多黏菌素B相关肾损伤发生率为45.24%(19/42),肾损伤组AUC_(ss,24h)>100 (mg·h)/L比例较高。结论 多黏菌素B AUC_(ss,24h)可能与年龄、输注时间及肾功能有关,多黏菌素B相关肾损伤与AUC_(ss,24h)>100(mg·h)/L有关,临床需根据患者情况进行血药浓度监测和个体化给药。

地高辛血药浓度和不良反应影响因素分析

目的:探讨影响地高辛血药浓度的危险因素以及地高辛血药浓度水平与不良反应间的关系,为地高辛的安全、合理使用提供依据。方法:通过酶放大免疫测定技术监测地高辛血药浓度,并通过病案系统收集患者的基本资料、实验室指标、合并用药和不良反应等资料。结果:55例患者中分别有12.73%、76.36%和10.91%的患者使用<0.125 mg/d、0.125 mg/d和0.25 mg/d的地高辛,血清药物浓度随剂量递增而增加。有11例(20%)患者出现不良反应,最常见的是心律失常,发生不良反应的患者血清地高辛浓度为(2.55±1.59)ng/mL,显著高于无不良反应组的(0.93±0.63)ng/mL(P<0.000 1)。血肌酐升高者地高辛血药浓度高于肌酐正常者。重度肾功能损害患者血清地高辛浓度显著高于肾功能正常患者(P<0.05),不良反应发生率也高于肾功能正常患者。未观察到合并用药对地高辛血药浓度的影响。结论:地高辛血药浓度个体差异大,其血药浓度受给药剂量、肾功能等的影响,血药浓度越高,不良反应发生率越高。因此,应加强地高辛血药浓度监测,提高个体化给药水平。

基于BERT和CNN的药物不良反应个例报道文献分类方法

在临床上,药物不良反应导致的死亡和用药不当造成的住院及门诊费急剧升高,成为临床安全合理用药面临的主要问题之一。目前对药物不良反应的回顾性分析和文献分析多以公开发表的文献资料为依据。学术文献作为重要的数据来源之一,如何自动批量地对其进行数据处理尤为重要。针对医药文本独特的表述方式,基于BERT及其组合模型进行文本分类技术比对实验,建立对药物不良反应个例报道文献数据进行高效快速分类的方法,进而分辨出药物不良反应的类型,有效预警药害事件。实验结果表明,使用BERT模型的分类准确率达到99.75%,其可以准确高效地对药物不良反应个例报道文献进行分类,在辅助医疗、构建医学文本结构化数据等方面均具有重要的价值和意义,进而能够更好地维护公众健康。

唑尼沙胺不良反应个案分析

目的 为临床合理使用唑尼沙胺提供参考。方法 通过检索中国知网、万方、维普、PubMed、Web of Science数据库自建库起至2023年5月收录的唑尼沙胺药品不良反应(ADR)个案报道,提取并分析患者的基本信息及ADR发生特点,利用诺氏评估量表进行关联性评价。结果 共纳入37篇文献,其中中文1篇、英文36篇,涉及患者45例,ADR 47例次。其中男23例,女22例;年龄以50岁及以下多见(39例,86.67%)。37例(82.22%)原患疾病为癫痫或行预防癫痫治疗,且伴多种合并症;用药剂量多在400 mg/d以内(30例,66.67%);31例患者有联合用药记录(联用药物主要为抗癫痫药物、抗肿瘤药物、非甾体抗炎药等)。ADR最常在用药后1个月内发生(26例次,55.32%),主要累及皮肤及软组织系统、泌尿系统、精神系统等。临床表现以精神行为异常、泌尿结石、Stevens-Johnson综合征/中毒性表皮坏死松解症等较多见。关联性评价为“可能有关”8例,“很可能有关”36例,“肯定有关”1例。结论 唑尼沙胺易导致多种严重ADR,临床表现多样。在使用唑尼沙胺期间,应加强对其ADR的监测,并开展癫痫药学服务,从而保障患者用药安全。

以血凝酶为例的药品不良反应自动监测反馈系统体温异常数据分析

目的评价药品不良反应(ADR)自动监测反馈系统监测血凝酶致体温异常ADR的准确性,为建立基于自动监测反馈系统的血凝酶体温异常ADR监测方案提供参考。方法采用回顾性研究方法,提取医院ADR自动监测反馈系统2020年9月1日至2021年8月31日监测到的注射用尖吻蝮蛇血凝酶、注射用矛头蝮蛇血凝酶、注射用白眉蛇毒血凝酶致体温异常的ADR报告2434份(涉及患者2434例),以及该时段医院使用血凝酶的11602例患者的临床数据,以血凝酶药品说明书中的标准值作为该药ADR的判断标准,对数据进行多层次统计与分析,评价ADR自动监测反馈系统监测的准确性,并提出改进方案。结果ADR自动监测反馈系统监测到的上述3种血凝酶体温异常ADR发生率分别为19.05%,32.31%,17.51%,与设定的标准值存在较大差异;一过性低热(≤37.5℃)且无不适症状的发生率分别为64.46%,54.45%,73.86%,占比均较高;3种血凝酶引起体温异常ADR患者的年龄均存在显著差异(P<0.01);神经外科手术患者和肿瘤患者该ADR的判断不适合自动监测,其他患者的血凝酶单药引起中热、高热(>38℃)ADR的发生率分别为0.22%,0.20%,0.03%,与药品说明书中ADR发生率标准值接近。结论利用ADR自动监测反馈系统监测血凝酶单药引起的体温异常ADR发生率准确、快速,能较好地监测到一过性低热且无临床不适症状的ADR,漏报较少,但神经外科手术患者和肿瘤患者需药师结合临床判断。