Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas

Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical safe medication.Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed,Web of Science,Springer Link,CNKI,Wanfang and VIP database were retrieved from December 2019 to May 2021.Then we extracted and analyzed the effective information included in the literature.Results and Conclusion According to the pre-developed retrieval plan,a total of 136 documents were obtained,and a total of 6 documents met the inclusion criteria finally.553 patients used three Chinese patent medicines and three herbal formulas,and there were 133 cases of adverse reactions.The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine,and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine.

A Time to Event Analysis of Adverse Drug Reactions Due to Tenofovir, Zidovudine and Stavudine in a Cohort of Patients Receiving Antiretroviral Treatment at an Outpatient Clinic in Zimbabwe

Background: Achieving the long terms goals of antiretroviral treatment (ART) requires a careful approach during treatment initiation that takes into account patient’s psychosocial state, availability and accessibility of treatment combinations, and adherence support. Adverse drug reactions that occur during the initial phases have a bearing on treatment outcomes and thus need to be monitored and treated. Objective: This study was done to assess length of time (survival time) it took for clinically significant adverse drug reactions to occur in patients taking Nucleoside Reverse Transcriptase Inhibitors (N(t)RTI) available for treatment of Human Immunodeficiency Virus (HIV) infection in Zimbabwe. Methods: A retrospective cohort of patient data collected from January 2009 to December 2012 was extracted from an Electronic Health Record database. Data from patients who were initiated on antiretroviral (ARV) drug regimens containing N(t)RTI drugs were analysed for survival time. A sample of 205 patient files was extracted for the time period for survival analysis using adverse drug reactions due to N(t)RTI drugs. Results: After data extraction, a total of 205 patient records were used in determining the time to event analysis of ADR’s in the cohort. The age range for the patients included in the study was 9 - 76 with a mean of 41 years (s.d = 14.8). Patients initiated on stavudine had a lower survival time before a clinically significant ADR compared to tenofovir (-365 days, p-value < 0.0005). Patients on zidovudine also had a less time before a significant reaction compared to those on tenofovir (-230 days;p-value = 0.008). Patients on zidovudine fared better compared to those on stavudine (-134 days;p-value < 0.0005). The mean survival time was highest for tenofovir (618 days), followed by zidovudine (388 days), and then stavudine (254 days).Conclusion: Patients on tenofovir have a longer survival time before a clinically significant adverse reaction. Treatment programmes need to continue commencing patients on tenofovir containing regimens as patients can be maintained for longer periods on this regimen.

Analysis of 8611 Cases of Adverse Reaction Reports of Breviscapine for Injection

[Objectives]To analyze the occurrence rules and factors influencing adverse reactions of breviscapine for injection,explore potential drug risks,and guide the clinical rational medication.[Methods]The retrospective analysis method was used to analyze the case reports of adverse reactions of breviscapine for injection,and analyze the gender and age distribution of the cases,the patient's medication status,the adverse reactions involving organ/system damage and clinical manifestations,the occurrence time,duration,and outcome of the adverse reactions.[Results]Adverse reactions of breviscapine for injection were mainly concentrated in middle-aged and elderly patients aged 45 and above,accounting for 85.35%;in the gender distribution,females were higher than males;adverse reactions involved multiple organ/system damages.Among them,75.86%of patients had adverse reactions after the first medication,and 11.77%of reported patients had concomitant medications.[Conclusions]The adverse reactions caused by breviscapine for injection may be related to the patient's age,gender and irrational medication.

Meta-analysis of single strain probiotics for the eradication of Helicobacter pylori and prevention of adverse events

AIM:To assess the efficacy and safety of single strain probiotics for the:(1) eradication of Helicobacter pylori(H.pylori);(2) prevention of adverse events;and(3) prevention of antibiotic-associated diarrhea associated with eradication therapy.METHODS:We searched Pub Med(1960-2014),EMBASE(1974-2014),Cochrane Database of Systematic Reviews(1990-2014),and ISI Web of Science(2000-2014).Additionally,we conducted a grey literature search including contact with National Institutes of Health Clinical Trials Registry,abstracts from annual infectious disease and gastroenterology meetings,experts in the field and correspondence with authors.Randomized controlled trials of H.pylori positive adults or children treated with eradication therapy and assessing the adjunctive therapy with a single strain of probiotics were included.The primary outcomes were the rates of eradication of H.pylori and frequency of patients with adverse events or antibiotic-associated diarrhea.Outcomes were pooled using fixed or random-effects models to calculate the relative risk and corresponding 95%CI and weighted on study size.To explore possible explanations for heterogeneity,a priori subgroup analyses were conducted on daily probiotic dose,study population,and quality of the study.The overall quality of the evidence for each probiotic strain was assessed using the GRADE criteria.RESULTS:A total of 25 randomized controlled trials(28 treatment arms,with a total of 3769 participants) assessed one of six single probiotic strains as adjunctive treatments to standard eradication therapy.Only one probiotic strain significantly improved H.pylori eradication rates:Saccharomyces boulardii(S.boulardii) CNCM I-745 [pooled relative risks(p RR) = 1.11,95%CI:1.07-1.16].Only one probiotic strain(S.boulardii CNCM I-745) significantly prevented any adverse events(p RR = 0.42,95%CI:0.28-0.62).Both S.boulardii CNCM I-745 and Lactobacillus rhamnosus GG significantlyreduced antibiotic-associated diarrhea(p RR = 0.47,95%CI:0.37-0.60 and p RR = 0.29,95%CI:0.17-0.48,respectively) associated with H.pylori eradication therapy.Meta-regression of sub-groups did not detect significant differences by dose,adult vs pediatric,symptom status,or study quality,but did find significant differences by the strain of probiotic.Potential mild publication bias was found for antibiotic-associated diarrhea,but not for eradication or adverse event outcomes.Analysis of the study quality illuminated areas for improvement in future studies(use of placebos,study size calculations,attrition reasons and discussion of limitations and generalizability).CONCLUSION:The pooled evidence suggests that the adjunctive use of a few probiotic strains may improve H.pylori eradication rates and prevent the development of adverse events and antibiotic-associated diarrhea in those treated with standard eradication therapies.The type of probiotic strain was the most important factor in predicting efficacy.

Efficacy and Safety of SGLT2 Inhibitors in Patients with Type 1 Diabetes:A Meta-analysis of Randomized Controlled Trials

Objective To assess the efficiency and safety of a novel sodium-glucose co-transporter 2(SGLT2) inhibitor—SGLT2 inhibitors,in combination with insulin for type 1 diabetes mellitus(T1DM). Methods We searched Medline,Embase,and the Cochrane Collaboration Library to identify the eligible studies published between January 2010 and July 2016 without restriction of language. The Food and Drug Administration(FDA) data and Clinical Trials(http://www.clinicaltrials.gov) were also searched. The included studies met the following criteria:randomized controlled trials; T1DM patients aged between 18 and 65 years old; patients were treated with insulin plus SGLT2 inhibitors for more than 2 weeks; patients' glycosylated hemoglobin(HbA1c) levels were between 7% and 12%. The SGLT2 inhibitors group was treated with SGLT2 inhibitors plus insulin,and the placebo group received placebo plus insulin treatment. The outcomes should include one of the following items:fasting blood glucose,HbA1c,glycosuria,or adverse effects. Data were analyzed by two physicians independently. The risk of bias was evaluated by using the Cochrane Collaboration's Risk of Bias tool and heterogeneity among studies was assessed using Chi-square test. Random effect model was used to analyze the treatment effects with Revman 5.3. Results Three trials including 178 patients were enrolled. As compared to the placebo group,SGLT2 inhibitor absolutely decreased fasting blood glucose [mean differences(MD)-2.47 mmol/L,95% confidence interval(CI)-3.65 to-1.28,P<0.001] and insulin dosage(standardized MD-0.75 U,95%CI-1.17 to-0.33,P<0.001). SGLT2 inhibitors could also increase the excretion of urine glucose(MD 131.09 g/24 h,95%CI 91.79 to 170.39,P<0.001). There were no significant differences in the incidences of hyperglycemia [odds ratio(OR) 1.82,95%CI 0.63 to 5.29,P=0.27],urinary tract infection(OR 0.95,95%CI 0.19 to 4.85,P=0.95),genital tract infection(OR 0.27,95%CI 0.01 to 7.19,P=0.43),and diabetic ketoacidosis(OR 6.03,95%CI 0.27 to 135.99,P=0.26) between the two groups. Conclusion SGLT2 inhibitors combined with insulin might be an efficient and safe treatment modality for T1DM patients.

A meta-analysis of Chinese herbal medicines for vascular dementia

OBJECTIVE： To investigate the efficacy and safety of Chinese herbal medicines in the treatment of patients with vascular dementia. DATA RETRIEVAL： We retrieved publications from Cochrane Library （2004 to July 2011）, PubMed （1966 to July 2011）, the Chinese Science and Technique Journals Database （1977 to July 2011）, the China National Knowledge Infrastructure （1979 to July 2011）, Google Scholar （July 2011）, and the Chinese Biomedical Database （1977 to July 2011） using the key words ＂Chinese medicine OR Chinese herbal medicine＂ and ＂vascular dementia OR mild cognition impair OR multi-infarct dementia OR small-vessel dementia OR strategic infarct dementia OR hypoperfusion dementia OR hemorrhagic dementia OR hereditary vascular dementia＂. SELECTION CRITERIA： Randomized controlled trials comparing Chinese herbal medicines with placebo/western medicine in the treatment of patients with vascular dementia were included. Diagnostic standards included Diagnostic and Statistical Manual of Mental Disorders-IV, and National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et I＇Enseignement en Neurosciences. Two participants independently conducted literature screening, quality evaluation and data extraction. The quality of each trial was assessed according to the Cochrane Reviewers＇ Handbook 5.0. MAIN OUTCOME MEASURES： Effective rate, Mini-Mental State Examination scores, Hasegawa Dementia Scale scores, and incidence of adverse reactions. RESULTS： We identified 1 143 articles discussing the effects of Chinese medicine on vascular dementia. Thirty-one of these were included in the analysis. These studies involved a total of 2 868 participants （1 605 patients took Chinese medicine decoctions （treatment group）; 1 263 patients took western medicine or placebo）. The results of our meta-analysis revealed that Chinese herbal remedies in the treatment group were more efficacious than the control intervention （relative risk （RR） = 1.27; 95% confidence interval （C/）： 1.18-1.38, P 〈 0.01）. Mini-Mental State Examination scores were higher in patients taking Chinese herbal medicines than in those in the control group （weighted mean difference （WMD） = 2.83; 95%CI： 2.55-3.12, P 〈 0.01）. Patients in the treatment group showed better disease amelioration than those in the control group （Hasegawa Dementia Scale scores; WMD = 2.41, 95%CI： 1.48-3.34, P 〈 0.01）. There were also considerably fewer adverse reactions among those in the treatment group compared with those in the control group （RR = 0.20, 95%CI： 0.08-0.47, P 〈 0.01）. CONCLUSION： Chinese herbal medicine appears to be safer and more effective than control measures in the treatment of vascular dementia. However, the included trials were generally low in quality. More well-designed, high-quality trials are needed to provide better evidence for the assessment of the efficacy and safety of Chinese medicines for vascular dementia.

Meta-analysis on Efficacy of Yiqi Huoxue Chinese Drugs in the Treatment of Coronary Heart Disease after Coronary Revascularization

[Objectives] To make a systematic evaluation on the therapeutic efficacy and safety of Yiqi Huoxue traditional Chinese drugs combined with western medicine in treatment of coronary heart disease( CHD) after coronary revascularization. [Methods] The literatures were retrieved from China Knowledge Infrastructure( CNKI),Chinese science and technology journal full-text database( VIP database,VIP),Wanfang Data,the Chinese biomedical Database,Pub Med,Embase,and the Cochrane Library. The retrieval time was set to the creation of the database to January 2017. The randomized controlled trial( RCT) was conducted on the comparison between Yiqi Huoxue Chinese drugs combined with western medicine and the western medicine alone in the treatment of CHD after coronary revascularization. The literature information was extracted and the methodological quality of the included literature was evaluated according to the bias risk assessment tool developed by the Cochrane Collaboration. Meta-analysis was performed with the aid of Rev Man 5. 3 software. Coronary artery restenosis rate,angina pectoris treatment efficiency,left ventricular ejection fraction( LVEF),left ventricular end-diastolic volume( LVEDV),B-type natriuretic peptide( BNP),6-minute walk test( 6 MWT),and adverse reactions were analyzed. [Results] A total of 29 articles were included,a total of2 518 patients,the literature quality was low. Meta-analysis results showed that compared with the treatment by western medicine alone,Yiqi Huoxue Chinese drugs combined with western medicine could further reduce coronary restenosis rate[RR = 0. 45,95% CI( 0. 34,0. 60),P <0. 000 01],improve the angina pectoris treatment efficiency[RR = 1. 13,95% CI( 1. 05,1. 21),P = 0. 000 5],raise LVEF[WMD = 4. 25,95% CI( 3. 46,5. 04),P < 0. 000 01],reduce LVEDV[WMD =-10. 41,95% CI(-17. 88,-2. 95),P = 0. 006],decrease the plasma BNP level[WMD =-32. 32,95% CI(-44. 92,-19. 72),P < 0. 000 01],and increase 6 MWT distance(WMD = 62. 25,95% CI( 21. 71,102. 78),P = 0. 003)[Conclusions]Yiqi Huoxue Chinese drugs combined with western medicine can alleviate the symptoms of angina pectoris,reduce the rate of coronary restenosis,improve heart function and improve exercise capacity,thereby improving clinical efficacy in patients with CHD after coronary revascularization.

44例氯吡格雷相关性血小板减少症的文献病例分析

目的探讨氯吡格雷相关性血小板减少症的发生特点,为临床安全用药提供参考。方法检索建库至2022年11月收录在PubMed、Embase、中国知网、万方和维普期刊数据库有关氯吡格雷致血小板减少症的病例报道并对其发生情况进行整理和分析。结果共纳入43篇文献合计44例患者;男30例(68.2%),女14例(31.8%);年龄37~88(65.0±11.4)岁,其中≥60岁30例(68.2%)。发生血小板减少症的时间为用药后8 h~9个月,其中29例(65.9%)出现在2周内。31例(70.5%)表现为重度血小板减少,38例(86.4%)伴有并发症,其中24例(63.2%)表现为出血,19例(50.0%)表现为血栓性血小板减少性紫癜。经停药和对症治疗后41例(93.2%)血小板计数恢复正常,3例(6.8%)死亡。结论氯吡格雷相关性血小板减少症以重度血小板减少居多,且常伴发出血或血栓性血小板减少性紫癜,但整体转归良好。临床在使用该药的前2周内应密切监测患者的血小板计数,一旦发现异常及时停药并予以对症处理。

阿达木单抗药品不良反应文献分析

目的 为临床合理使用阿达木单抗提供参考。方法 检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、PubMed数据库,获得以阿达木单抗为首要怀疑药物的中英文文献。检索时限为各数据库自建库起至2022年12月。收集患者的基本信息及阿达木单抗药品不良反应(ADR)相关信息,进行分类统计与分析。结果 共检索到文献283篇,筛选后得相关文献101篇,涉及患者101例。其中男56例(55.45%),女45例(44.55%);年龄8~82岁,平均(45.39±17.32)岁,以> 40~60岁居多(47例);来自美国的患者最多(16例),我国与英国并列第4(9例);原患疾病以克罗恩病居多(22例,21.78%);主要累及皮肤及其附件(40例,39.60%),最多见的临床表现为药疹(14例,13.86%);ADR严重程度以中度最多(64例,63.37%);关联性评价结果以很可能最多(79例,78.22%);联合用药21例(20.79%),包括二联用药18例,三联用药2例,四联用药1例;疗程以8周最多见;73例经停药和(或)药物治疗(包括对症支持治疗、换药或改变用药剂量等)后症状治愈或好转,但仍有2例经上述处理后死亡。结论 临床医师在应用阿达木单抗时应准确把握用药指征,严格按药品说明书用药,并熟悉其ADR常见类型和发生时间,加强ADR监测,确保用药安全。

艾司氯胺酮用于剖宫产术中镇静对新生儿的影响

目的 探讨艾司氯胺酮用于剖宫产术中镇静对新生儿的影响。方法 选择2022年1月—2023年12月于山东中医药大学附属医院和烟台市烟台山医院就诊的60例行择期子宫下段剖宫产术产妇,随机分为艾司氯胺酮组(K组,30例)和对照组(C组,30例)。蛛网膜下腔麻醉平面固定后,K组静脉注射艾司氯胺酮0.2 mg/kg,C组静脉注射等容积生理盐水。比较2组产妇牵拉不适感和桡动脉血气分析;胎儿剖出时采血,查脐动脉、脐静脉血气分析。结果 K组T_(2)、T_(3)、T_(4)、T_(5)、T_(6)时HR和MAP与C组比较,差异有统计学意义(P <0.05)。K组与C组切皮开始至胎儿剖出时间分别为(10.10±1.37)min和(15.40±1.77)min(P <0.05)。出胎时C组产妇牵拉不适感发生率高于K组(P <0.05)。K组脐动脉和脐静脉氧分压(partial pressure of oxygen,PO_(2))高于C组(P <0.05),乳酸(blood lactic acid,Lac)低于C组(P <0.05),血红蛋白饱和度(oxygen saturation of hemoglobin,SO_(2))高于C组(P<0.05)。所有产妇及新生儿均无严重不良反应发生。结论 艾司氯胺酮可安全用于剖宫产术中镇静,对新生儿Apgar评分及产妇和新生儿血气分析无明显不良影响。

EGFR-TKI单药与传统化疗方案治疗进展期NSCLC安全性的网状meta分析

目的对一至三代表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)与传统化疗方案治疗进展期非小细胞肺癌(NSCLC)的安全性进行比较,同时采用网状meta分析方法评价三代EGFR-TKI与一、二代之间的安全性。方法检索PubMed、Embase、Cochrane图书馆、中国生物医学文献数据库、中国知网、万方数字化期刊全文数据库、维普数据库,检索时限均为从建库至2020年12月,搜集EGFR-TKI单药对比铂类为基础培美曲塞化疗方案的随机对照试验(RCT)。筛选文献、提取资料,并用Cochrane系统评价偏倚风险评估工具对纳入研究的RCT进行偏倚风险评估,采用RevMan 5.3软件、STATA 15.1软件进行meta分析。结果meta分析结果显示,试验组(EGFR-TKI单药)、对照组(培美曲塞联合铂类)患者的腹泻[相对危险度(RR)=2.16,95%置信区间(CI)0.742~6.297,P>0.05]、便秘(RR=0.44,95%CI 0.187~1.039,P>0.05)发生率比较差异均无统计学意义。试验组白细胞减少发生率、中性粒细胞减少发生率、贫血发生率、血小板减少发生率、食欲不振发生率、恶心发生率均低于对照组(RR=0.21,95%CI 0.10~0.41,P<0.001;RR=0.21,95%CI 0.08~0.55,P<0.001;RR=0.26,95%CI 0.13~0.51,P<0.001;RR=0.39,95%CI 0.24~0.64,P<0.001;RR=0.39,95%CI 0.28~0.55,P<0.001;RR=0.30,95%CI 0.24~0.37,P<0.001);试验组皮疹发生率高于对照组(RR=9.63,95%CI 6.30~14.72,P<0.001)。对一至三代EGFR-TKI的不良反应进行网状meta分析结果显示,三代EGFR-TKI奥希替尼组白细胞减少发生率要高于一、二代EGFR-TKI,贫血发生率与埃克替尼组相似,但高于吉非替尼组和阿法替尼组(均P<0.05)。结论一至三代EGFR-TKI的血液系统、消化系统不良反应发生率均低于传统化疗方案;三代EGFR-TKI与一、二代相比,在白细胞减少及贫血发生率方面各具优势。

阿美替尼上市后不良反应分析

目的分析第三代表皮生长因子受体-酪氨酸激酶抑制剂(epidermal growth factor receptor-tyrosine kinase inhibitor,EGFR-TKI)阿美替尼不良反应发生的规律及特点,为该药临床安全使用提供参考。方法计算机检索PubMed、Embase、Web of Science、The Cochrane Library、中国知网、万方数据和中国生物医学文献服务系统数据库,对阿美替尼上市后不良反应文献进行分析,检索时限为建库至2024年1月16日。结果共纳入12篇文献,收集263名患者的安全性数据,据文献数据统计,阿美替尼所致不良反应共246例次,主要表现为皮疹/痤疮样皮疹(17.9%)、转氨酶增高(12.6%)、血液及淋巴系统疾病(6.1%)、全身乏力(5.7%)、甲沟炎(7.3%)等,共发生11例≥3级的不良反应,预后良好。结论阿美替尼的不良反应表现多样,对皮肤和肝功能的影响较为明显,应持续加强用药监测,警惕其不良反应发生。

活血化瘀类中成药治疗糖尿病视网膜病变的网状Meta分析

目的:应用网状Meta分析方法,比较不同活血化瘀类中成药治疗糖尿病视网膜病变(DR)的临床有效率、实验室指标改善情况及治疗的安全性。方法:通过检索中国知网(CNKI)、万方数据知识服务平台、维普期刊资源整合服务平台(VIP)、Web of Science及Pubmed等数据库获得关于活血化瘀类中成药治疗DR的临床随机对照研究,检索时限为建库至2023年4月10日,并对所检索到的文献进行筛选提取资料,通过Stata 16.0软件实施网状Meta分析。结果:最终纳入63项研究,分析结果显示:复方丹参滴丸+羟苯磺酸钙胶囊总体疗效最为显著;芪明颗粒+羟苯磺酸钙胶囊在改善DR患者视力方面疗效最为显著;复方血栓通胶囊+羟苯磺酸钙胶囊在改善DR患者黄斑厚度及视野灰度值方面疗效最好;和血明目片+羟苯磺酸钙胶囊在减小患者血管瘤体积方面疗效较好;治疗组与对照组均有不良反应报道,治疗组不良反应总体较少。结论:与单用羟苯磺酸钙胶囊比较,活血化瘀类中成药联合羟苯磺酸钙胶囊治疗DR患者,可提高临床有效率,改善患者实验室检查指标,减少不良反应。

补中益气汤合二陈汤联合针刺对慢阻肺患者的临床观察

目的分析补中益气汤合二陈汤加针刺对慢阻肺(COPD)患者的疗效。方法2019年8月至2022年8月郑州市中心医院康复分院收治COPD患者总共65例,经随机数字表法分成对照组(常规西医疗法)33例和观察组(在对照组基础上采取补中益气汤合二陈汤加针刺疗法)32例,比较两组疗效、症状评分;治疗前后咳嗽、喘息、咳痰和肺呼吸音症状评分;血氧分压(PaO_(2))及二氧化碳分压(PaCO_(2))血气分析指标;一秒用力呼气容积(FEV_(1))、用力肺活量(FVC)、一秒率(FEV_(1)/FVC)及肺活量(VC)肺功能指标;不良反应情况。结果观察组治疗有效率和对照组相比更高,差异具有统计学意义(P<0.05)。治疗前,两组咳嗽、喘息、咳痰和肺呼吸音症状评分差异无统计学意义(P>0.05);治疗后,观察组咳嗽、喘息、咳痰和肺呼吸音症状评分和对照组相比更低,差异具有统计学意义(P<0.05)。治疗前,两组PaO_(2)及PaCO_(2)水平差异无统计学意义(P>0.05);治疗后,观察组PaO_(2)水平和对照组相比更高,PaCO_(2)水平和对照组相比更低,差异均有统计学意义(P<0.05)。治疗前,两组FEV_(1)、FVC、FEV_(1)/FVC及VC水平差异无统计学意义(P>0.05);治疗后,观察组FEV_(1)、FVC、FEV_(1)/FVC及VC水平和对照组相比更高,差异具有统计学意义(P<0.05)。两组不良反应差异无统计学意义(P>0.05)。结论补中益气汤合二陈汤加针刺对COPD患者疗效理想,能改善其临床症状及血气分析指标,增强其肺功能,值得采用。

基于文献分析的疏血通注射液上市后临床安全性再评价

目的:对疏血通注射液上市后临床安全性的文献进行再评价研究,获取药品临床安全性信息,为临床安全用药提供参考。方法:检索截至2023年5月中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed中收载的疏血通注射液的药品不良反应(ADR)/药品不良事件(ADE)文献,采用描述性分析方法,对ADR/ADE发生特点进行总结分析。结果:纳入212篇符合标准的文献,其中临床研究151篇,个案报告41篇,安全性监测20篇,共报告ADR/ADE 1361例。疏血通注射液的不良反应累及16个器官和或(系统),90种临床表现,合计2109例次,主要集中在皮肤及其附件损害(637例次,占30.20%),表现为皮疹、瘙痒、皮肤红肿等;其次是胃肠系统损害(447例次,占21.19%),表现为恶心、呕吐、腹泻等。802例给出了具体用药剂量,其中发生ADR/ADE的单次超剂量(>6 mL)使用情况占11.10%(89例)。314例有ADR/ADE发生时间的具体描述,其中给药后0~30 min发生的占36.94%(116例),>7 d发生的占11.78%(37例)。319例记录了ADR/ADE处理转归情况,其中317例好转或痊愈。严重的ADR/ADE共发现9例,表现为上消化道出血、严重皮疹、过敏性休克等。结论:通过描述性文献研究可以系统梳理疏血通注射液相关ADR/ADE的发生时间、临床表现、累及器官和(或)系统、ADR转归及预后情况,为其临床合理应用和安全监管提供参考。

司美格鲁肽注射液不良反应的文献分析

目的通过对司美格鲁肽注射液所致药物不良反应(ADR)的个案报道进行整理和分析,探讨其发生特点和处置方案,为临床安全合理用药提供参考。方法检索中国知网、万方、维普、PubMed、Web of Science、Embase数据库自建库至2023年11月收载的司美格鲁肽注射液ADR个案报道,对患者相关信息(性别、年龄、原发疾病、用法用量、发生时间、临床表现、检验检查指标、干预措施及转归等)进行统计分析。结果共收集到10例司美格鲁肽注射液ADR个案报道,男5例(50%),年龄29~80岁,平均年龄(52.9±18.4)岁。原患疾病:2型糖尿病5例(50%)、肥胖5例(50%),ADR多发生在首次用药6个月内(9例,90%),累及免疫系统4例(40%)、泌尿系统3例(30%)、消化系统3例(30%),其中嗜酸性筋膜炎、大疱性类天疱疮(Bullous pemphigoid,BP)均为说明书未记载ADR。5例在停药和对症治疗后好转,2例出现急性肾损伤,经停药及对症治疗后未见好转,1例急性便秘经对症治疗和减量后好转。结论临床应用司美格鲁肽注射液的前6个月应密切防范ADR的发生,尤其是中老年患者,并且警惕免疫系统、泌尿系统ADR,确保用药安全。

艾曲泊帕致儿童不良反应文献分析

目的分析艾曲泊帕(Eltrombopag)在儿童患者中致不良反应(Adverse drug reaction,ADR)的临床特点和一般规律,为其临床合理、安全使用提供参考。方法检索中国知网(CNKI)、万方、维普(VIP)、PubMed等数据库收录的艾曲泊帕致儿童不良反应相关病例报道,检索时限为建库至2023年5月,并对纳入文献进行统计与分析。结果共纳入文献22篇,应用艾曲泊帕治疗的患儿共800例,ADR共计246例,主要累及消化系统和血液系统,绝大多数ADR为轻症,可自行缓解,或经减停药、对症处理后缓解。结论儿童群体应用艾曲泊帕整体耐受性良好,但仍需加强监测,保障用药安全。

2642例碳青霉烯类抗菌药物相关不良反应自发报告分析及风险信号挖掘

目的 了解碳青霉烯类抗菌药物相关药品不良反应(ADR)发生情况和特点,挖掘相关风险信号,为临床安全使用此类药物提供参考。方法 调取解放军总医院药品不良反应监测中心数据库中2008年1月—2022年10月的碳青霉烯类抗菌药物相关ADR自发报告,对患者一般情况、累及系统/器官、涉及ADR名称等信息进行回顾性分析。采用报告比值比法、比例报告比值法、综合标准法、信息成分法挖掘碳青霉烯类抗菌药物相关ADR的风险信号。结果 碳青霉烯类抗菌药物相关ADR报告共2 642份,其中严重的ADR 410例(15.52%);主要涉及5种碳青霉烯类抗菌药物品∶种,按构成比降次排序为亚胺培南西司他丁(51.28%)、美罗培南(32.13%)、比阿培南(8.10%)、厄他培南(7.68%)、帕尼培南倍他米隆(0.79%)。患者男女比例为1.74> 60岁最多(59.69%);14个“药品-ADR名称”组合在4种数据挖掘方法中均生成阳性信号,其中美罗培南相关信号最多;亚胺培南西司他丁与厄他培南在神经系统疾病ADR中报告数较多。结论 风险信号挖掘结果与已知的碳青霉烯类抗菌药物相关ADR信息基本一致。临床在使用碳青霉烯类抗菌药物时,应监测患者肝肾功能以及血液生化指标,强化临床使用此类药物的警戒意识,及时识别并处理ADR,规避严重ADR的发生。

1例艾沙康唑致患者全血细胞减少的病例分析

目的正确识别和应对艾沙康唑引起的全血细胞减少的不良反应,为该药的安全使用提供参考。方法临床药师通过参与1例严重感染合并肾功能不全的患者使用艾沙康唑后出现全血细胞减少的病例分析,筛查患者住院期间所用药物,并结合药物的半衰期和相关文献,评估了该不良反应与艾沙康唑的关系及可能的发生机制。结果与结论患者全血细胞减少与艾沙康唑的关系评估为“可能相关”。使用艾沙康唑时应提高警惕,避免同时联用相同机制或有潜在相互作用的药物。如疗程大于2周或用药前血液系统异常或合并肝肾功能损害或需要联合使用相同机制的药物者,可考虑增加血常规监测频率。

阿帕替尼上市后的ADR文献分析

目的探讨阿帕替尼所致药物不良反应(ADR)的特点及规律,为其临床安全用药提供参考。方法检索自阿帕替尼2014年上市以来,中国知网、万方医学网、维普及PubMed等中英文数据库中关于其ADR及安全性评估的个案和群体报道,经筛选后对文献资料进行提取及分析。结果共纳入病例101例,涉及ADR 221例次。发生ADR的患者中,男女比例为1.24∶1,年龄以51~70岁最多,给药剂量以500 mg及以上者居多,但其中给予小剂量阿帕替尼并联合使用了其他抗肿瘤药物的患者也较易发生ADR。ADR的种类以1~2种居多,而种类最多者可高达6种。该药的ADR多发生在用药后30 d内,累及器官/系统以心血管系统损害、皮肤及其附件损害、胃肠系统损害和泌尿系统损害为主,主要临床表现为高血压/加重、手足综合征、腹痛腹泻和蛋白尿等,其严重ADR以高血压/加重、手足综合征和骨髓抑制多见。多数ADR均可通过停药、减量及对症处理实现好转/痊愈。4例死亡患者均存在基础病,且美国东部肿瘤协作组评分均≥2分。特殊ADR(如可逆性后部脑病综合征、精神异常和认知障碍等)多由阿帕替尼自身引起,亦存在阿帕替尼与原发疾病或基础疾病共同引起的可能。结论高龄、剂量较大、联合用药、存在基础病及体力状态不佳是使用阿帕替尼患者发生ADR的高危因素。建议对所有使用该药患者的血压、尿蛋白及手足皮肤进行日常监测,并注意特殊ADR的发生,以便及时发现并给予有效干预,从而避免ADR加重及继发其他ADR。