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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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    老药的安全性不容忽视

    蔡晧东孟艳
    129-132页
    查看更多>>摘要：老药一般认为是上市时间较早，在临床使用多年，且被医药工作者和公众所了解的药品。老药的安全性尚存在很多未知、未解问题。老药的一些不良反应可能目前还不十分清楚；老药在特殊人群中应用的安全性还需要长期监测；老药许多不良反应发生机制研究需加强，大多数不良反应缺乏特异性诊断的生物标记物及有效的防治措施；老药说明书中不良反应相关内容需要不断完善，许多临床用药的安全性问题还有待制定规范的专家共识和指南。 Old drugs are generally considered as drugs that have been on the market for many years and are well known by medical workers and the public。 There are still many unsolved problems about the safety of older drugs。 Some adverse reactions of old drugs may not be fully understood at present， the safety of their application in special populations still needs long-term monitoring， the study on mechanism of many adverse reactions of old drugs need to be strengthened， and most adverse reactions lack specific diagnostic biomarkers and effective prevention and treatment measures。 The adverse reaction content in the old drug labels needs to be continuously improved， and many safety issues in drug application still require standardized expert consensus and guidance。

    药物相关副作用和不良反应安全性患者安全

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    基于中国山东省药品不良反应监测中心和美国FDA不良事件报告系统数据库的注射用砷剂心脏毒性风险信号挖掘

    衣巧艳谢彦军舒雨童张秋红...
    133-137页
    查看更多>>摘要：目的 挖掘注射用砷剂心脏不良事件风险信号，提高临床对砷剂心脏毒性的认识。 方法 采用报告比值比（ROR）法、比例报告比值比（PRR）法和英国药品和保健品管理局（MHRA）综合标准法3种方法对山东省药品不良反应监测中心数据库（山东数据）2003年第1季度至2022年第4季度和美国FDA不良事件报告系统（FAERS）数据库2003年第4季度至2023年第3季度的药物不良反应/事件报告中注射用砷剂心脏毒性风险信号进行挖掘。ROR法和PRR法中，报告数≥3、ROR和PRR值的95%CI下限>1定义为不良事件风险信号；MHRA综合标准法中，报告数≥3、PRR>2且χ2>4定义为不良事件风险信号。 结果 山东数据中共有注射用砷剂相关报告358例，与亚砷酸氯化钠注射液有关者275例（76。8%），与注射用三氧化二砷（ATO）有关者83例（23。2%）；358例报告中25例（7。0%）报告了心脏不良反应，严重者占28。0%（7/25）。FAERS数据库中共有ATO相关报告1 294例，其中418例（32。3%）报告了心脏不良事件，严重者占62。2%（260/418）。对山东数据中275例亚砷酸氯化钠注射液报告的数据挖掘结果显示，QT间期延长、胸闷、心悸和心慌为风险信号，其中QT间期延长的信号最强。在FAERS数据中共挖掘出35个心脏不良事件信号，其中QT间期延长和长QT综合征的信号最强；6个心律失常信号（缓慢型心律失常、室上性期前收缩、室性期前收缩、尖端扭转型室速、室性心动过速和房室阻滞）和6个心脏器质性病变信号（心包炎、心内膜炎、心包积液、心肌炎、二尖瓣关闭不全和心脏扩大）的强度也排名较前。 结论 注射用砷剂与心脏毒性发生的关联性较强，且严重病例占比较高。注射用砷剂的心脏毒性主要影响QT间期，也可表现为多种类型心律失常和某些心脏器质性病变。 Objective To explore the adverse cardiac event risk signals in arsenical for injection， improve the clinical understanding of the cardiac toxicity of arsenical。 Methods The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods， including reporting odds ratio (ROR) method， proportional reporting ratio (PRR) method， and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023。 The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval (CI) of ROR and PRR >1。 The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3， PRR>2， andχ2>4。 Results There were a total of 358 reports on arsenical for injection in Shandong data， of which 275 (76。8%) were related to arsenious acid and sodium chloride injection， and 83 (23。2%) were related to arsenic trioxide for injection。 Among the 358 reports， adverse cardiac reactions were reported in 25 reports (7。0%)， and severe cases accounted for 28。0% (7/25)。 There were a total of 1 294 reports on ATO in FAERS， and adverse cardiac events were reported in 418 reports (32。3%)， of which severe cases accounted for 62。2% (260/418)。 The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged， chest tightness， cardiopalmus， and palpitations were risk signals。 Among them， the signal strength of QT interval prolonged was the strongest。 A total of 35 adverse cardiac event signals were mined in FAERS data， of which the signal strength of QT interval prolonged and long QT syndrome were the strongest。 In addition， the strength of 6 arrhythmia signals (bradyarrhythmia， supraventricular premature contraction， ventricular premature contraction， torsade de pointes， ventricular tachycardia， and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis， endocarditis， pericardial effusion， myocarditis， mitral regurgitation， and cardiac enlargement) also ranked high。 Conclusions Arsenical for injection is strongly associated with cardiotoxicity， and the proportion of severe cases is relatively high。 The cardiotoxicity mainly affects the QT interval， and can also manifest as various types of arrhythmias and some cardiac organic lesions。

    三氧化二砷药物不良反应报告系统心脏毒性药物警戒药品说明书

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    呋喃唑酮诱导的间质性肺疾病：病例系列分析及文献复习

    张叶金刘华勇谢利霞蔡晧东...
    138-144页
    查看更多>>摘要：目的 探讨呋喃唑酮所致间质性肺疾病（ILD）的临床特征。 方法 收集2022年4月1日至2023年4月1日在华中科技大学协和深圳医院呼吸科住院治疗的7例呋喃唑酮相关ILD患者（医院病例）的基本信息、药物治疗信息、ILD特征及治疗和转归进行回顾性分析。检索国内外相关数据库，收集呋喃唑酮相关ILD病例报告（文献病例）中文献基本信息，涉及患者的基本信息，呋喃唑酮治疗适应证、剂量，相关ILD的潜伏期、主要症状、实验室检查及辅助检查结果，进行描述性统计分析。 结果 7例医院病例中男性2例、女性5例，中位年龄34岁，均因患幽门螺杆菌（HP）相关胃炎应用含呋喃唑酮（0。2 g、1次/d）的铋剂四联方案治疗。从服药至出现临床症状的中位时间为10 d；所有患者均有发热，6例有呼吸系统症状（干咳、呼吸困难、胸痛等）；胸部影像学检查均符合ILD改变，其中1例有胸腔积液。7例患者的嗜酸粒细胞计数均正常，1例有轻度的低氧血症。ILD严重程度6例为2级，1例为3级。7例患者均停用呋喃唑酮片，4例使用了糖皮质激素。住院3~10 d，7例患者均获痊愈。共检索到18例呋喃唑酮相关ILD的文献病例，其中15例来自中国，14例用于治疗HP感染。从首次用药到出现临床症状的时间为2~14 d，其中13例时间>7 d。16例患者有发热症状，14例有呼吸系统症状，其中1例呼吸衰竭。12例患者末梢血嗜酸粒细胞计数或百分比升高。18例患者均停用呋喃唑酮，7例使用了糖皮质激素，1例接受呼吸机辅助通气；所有患者均好转或痊愈。2例患者再激发阳性，1例体外淋巴细胞转化试验对呋喃唑酮呈强阳性反应。 结论 ILD是呋喃唑酮的罕见不良反应，以发热和呼吸系统症状为主要表现，多发生在呋喃唑酮治疗7 d后，早期发现并及时停药治疗一般预后良好。 Objective To explore the clinical characteristics of interstitial lung disease (ILD) caused by furazolidone。 Methods Clinical data of 7 patients with furazolidone-related ILD (hospital cases) hospitalized in the Department of Respiratory Medicine， Huazhong University of Science and Technology Union Shenzhen Hospital from April 1， 2022 to April 1， 2023 were collected and retrospectively analyzed， including patient basic information， medication treatments， and characteristics， treatment and outcomes of ILD。 Relevant databases at home and abroad were searched， and case reports of furazolidone-related ILD (literature cases) were collected。 The basic information of literature， involving patient information， indications and treatment doses of furazolidone， as well as the latentperiod， main symptoms， laboratory tests， and auxiliary examination related to ILD was descriptively analyzed。 Results Among the 7 hospital cases， 2 were males and 5 were females， with a median age of 34 years。 All patients were treated with a bismuth quadruple therapy containing furazolidone (0。2 g， once daily) due to Helicobacter pylori (HP)-associated gastritis。 The median time from taking medicine to the onset of clinical symptoms of interstitial lung disease was 10 days。 All patients had fever， and 6 had respiratory symptoms (dry cough， dyspnea， chest pain， etc。)。 ILD changes were found in all patients in their chest imaging， and pleural effusion was also found in 1 patient。 Seven patients had normal eosinophil counts， and 1 had mild hypoxemia。 The severity of ILD was grade 2 in 6 patients and grade 3 in 1 patient。 All 7 patients stopped using furazolidone， and 4 received glucocorticoids additionally。 After the hospitalization of 3-10 days， all the 7 patients recovered。 Eighteen literature cases of furazolidone-related ILD were retrieved， of which 15 were from China and 14 used furazolidone to treat HP infection。 The time from taking medicine to the onset of clinical symptoms was 2-14 days， and the time was >7 days in 13 patients。 Sixteen patients had fever， 14 had respiratory symptoms， and 1 had respiratory failure。 The peripheral blood eosinophil count or percentage increased in 12 patients。 All 18 patients stopped using furazolidone 7 received glucocorticoids and 1 received ventilator assisted ventilation。 All patients recovered or were improved。 ILD recured in rechallenge with furazolidone in 2 patients， and 1 of them had a strong positive reaction to furazolidone in vitro lymphocyte transformation test。 Conclusions ILD is a rare adverse reaction of furazolidone， main manifests as fever and respiratory symptoms and mostly occurs 7 days after furazolidone treatment。 Early detection and timely withdrawal of furazolidone generally lead to a good prognosis。

    呋喃唑酮肺疾病,间质性药物相关副作用和不良反应幽门螺杆菌

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    基于国家药品不良反应监测系统数据库的琥珀酰明胶注射液不良反应报告分析

    王力剑樊若曦朱旭关瑜...
    145-149页
    查看更多>>摘要：目的 分析琥珀酰明胶注射液不良反应的一般规律及特点，为临床安全合理用药提供参考。 方法 收集国家药品不良反应监测系统数据库2004年1月至2021年8月上报的琥珀酰明胶注射液不良反应报告，回顾性分析涉及患者的性别、年龄、原患疾病、用药原因、合并用药，用药后发生不良反应的时间、临床表现、严重程度和转归等信息，参考《国际医学用语词典》的系统器官分类（SOC）进行分类统计。 结果 共纳入3 036例琥珀酰明胶注射液不良反应报告，其中严重不良反应710例（23。39%），涉及的SOC居前5位者依次为免疫系统疾病、全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病、血管与淋巴管类疾病和呼吸系统/胸及纵隔疾病，主要症状为过敏性休克、类速发严重过敏反应、寒战、发热等速发型严重过敏反应的表现。3 036例患者中1 543例痊愈，1 480例好转，3例未好转，2例有后遗症，2例死亡，6例结果不详。说明书以外不良反应涉及的SOC包括眼器官疾病、各种肌肉骨骼及结缔组织疾病、代谢及营养类疾病和肾脏及泌尿系统疾病等。 结论 琥珀酰明胶注射液ADR多与过敏反应有关，严重不良反应符合速发型严重过敏反应的特征，但可能存在说明书中未涉及的相关风险。 Objective To analyze the general rules and characteristics of adverse reactions of succinylated gelatin injection and provide reference for safe and rational clinical use。 Methods Adverse reaction reports related to succinylated gelatin injection in National Adverse Drug Reaction Monitoring System database from January 2004 to August 2021 were collected。 Retrospective analysis of patients′ gender， age， primary disease， reason for drug use， combined drugs， and time of adverse reaction occurrence from drug use， clinical manifestations， severity and patient outcomes were performed， and classified statistics were performed according to systematic organ class (SOC) and preferred terms of Medical Dictionary for Regulatory Activities。 Results A total of 3 036 adverse reaction reports of succinylated gelatin injection were entered， including 710 serious cases (23。39%)， and the top 5 SOCs involved diseases of the immune system， systemic diseases and various reactions at the administration site， skin and subcutaneous tissue diseases， vascular and lymphatic diseases， and respiratory/thoracic and mediastinal diseases。 The main symptoms were anaphylactic shock， similar rapid severe allergic reaction， chills， fever， and other rapid severe allergic reactions。 Among the 3 036 patients， 1 543 were cured， 1 480 were improved， 3 were not improved， 2 had sequelae， 2 died， and 6 had unknown results。 The SOCs involved in adverse reactions and not recorded in labels included ocular organ diseases， various musculoskeletal and connective tissue diseases， metabolic and nutritional diseases， kidney and urinary system diseases， etc。 Conclusions The adverse reactions related to succinylated gelatin injection are mostly associated with anaphylaxis。 Severe adverse reactions are consistent with the characteristics of rapid severe anaphylaxis， but there may be related risks not covered in labels。

    药物相关副作用和不良反应药物不良反应报告系统数据分析琥珀酰明胶

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    注射用伏立康唑致中重度肾功能不全患者急性肾损伤的危险因素及其风险预测模型

    王书波焦婷婷董洪亮张有才...
    150-156页
    查看更多>>摘要：目的 探讨中重度肾功能不全患者接受注射用伏立康唑后发生急性肾损伤（AKI）的危险因素并建立预测AKI发生风险的模型。 方法 研究设计为回顾性研究。研究对象选自2020年1月1日至2022年12月31日在河南省焦作市人民医院住院并接受注射用伏立康唑治疗的中重度肾功能不全患者。通过医院信息系统，收集患者临床资料，包括基本信息、临床诊断、实验室检查指标、合并疾病和联合用药等。根据是否发生伏立康唑相关AKI将患者分为AKI组和无AKI组。采用多因素logistic回归法分析AKI危险因素，并依此建立预测模型。采用R 4。2。3软件绘制校准曲线，并用k折交叉验证法对模型进行内部验证。 结果 共有146例患者纳入研究，年龄（72。4±13。8）岁，男性84例、女性62例，发生伏立康唑相关AKI者61例（41。8%）。与无AKI组比较，AKI组用药前白细胞计数、中性粒细胞百分比、合并肾脏基础疾病者占比、合并心血管系统疾病者占比较高，注射用伏立康唑用药天数、合并血液系统疾病者占比、并用糖肽类药物者占比较低，差异均有统计学意义（P<0。05）。多因素logistic回归分析结果显示，白蛋白[X1，比值比（OR）=0。946，95%置信区间（CI）：0。915~0。977，P=0。001]、中性粒细胞百分比（X2，OR=1。013，95%CI：1。000~1。026，P=0。001）、合并肾脏基础疾病（X3，OR=2。230，95%CI：1。110~4。483，P=0。046）是中重度肾功能不全患者静脉应用伏立康唑发生AKI的独立影响因素。建立预测模型，得到联合预测因子Y=14。32X1+0。23X2-X3。当Youden指数最大值为0。382，对应其受试者工作特征曲线切点最佳值为-11。33。内部交叉验证结果显示，该模型准确率为0。70、Kappa系数（一致性）为0。37。 结论 中重度肾功能不全患者接受注射用伏立康唑后AKI的发生率为41。8%，白蛋白、中性粒细胞百分比、合并肾脏疾病是其独立影响因素。基于上述指标计算联合预测因子有助于预测AKI的发生风险，对临床有一定的参考价值。 Objective To explore the risk factors of acute kidney injury (AKI) in patients with moderate and severe renal insufficiency after receiving voriconazole for injection and to establish a model for predicting the occurrence risk。 Methods The study was designed as a retrospective study。 The subjects were selected from patients with moderate to severe renal insufficiency who were hospitalized in Jiaozuo People′s Hospital of Henan Province from January 1， 2020 to December 31， 2022 and received treatment with voriconazole for injection。 Through the hospital information system， clinical data of patients were collected， including basic information， clinical diagnosis， laboratory test indexes， comorbid diseases， and co-medication。 Patients were divided into AKI and non-AKI groups according to whether voriconazole-related AKI occurred。 AKI risk factors were analyzed using multiple logistic regression， and prediction models were established accordingly。 Calibration curves were plotted using R4。2。3 software， and the model was internally validated using the k-fold cross-validation method。 Results A total of 146 patients were enrolled in the study with an age of 72。4±13。8 years， including 84 males and 62 females 61 patients (41。8%) of which developed voriconazole-related AKI。 Compared with the non-AKI group， the white blood cell count， neutrophils percentage， proportion of patients with basic renal diseases， and proportion of patients with cardiovascular diseases were higher in the AKI group the days of voriconazole injection treatment， proportion of patients with hematological diseases， and proportion of patients receiving glycopeptide drugs were lower in the AKI group。 The results of multiple logistic regression showed that albumin [X1， odds ratio(OR)=0。946， 95% confidence interval(CI): 0。915-0。977， P=0。001]， neutrophil percentage (X2， OR=1。013， 95%CI: 1。000- 1。026， P=0。001)， and complicated with underlying renal diseases (X3， OR=2。230， 95%CI: 1。110-4。483， P= 0。046) were independent influencing factors of AKI caused by voriconazole for injection in patients with moderate and severe renal insufficiency。 The prediction model was established and the joint prediction factor Y=14。32X1+0。23X2-X3。 When the maximum value of Youden index was 0。382， the best tangent point of receiver operating characteristic curve was -11。33。 The internal cross-validation results showed that the accuracy of the model was 0。70 and the Kappa coefficient (consistency) was 0。37。 Conclusions The incidence of AKI in patients with moderate and severe renal insufficiency after receiving voriconazole for injection was 41。8%。 Albumin， neutrophil percentage and underlying renal diseases were the independent influencing factors。 The calculation of joint predictors based on the above indicators was helpful to predict the risk of AKI and had a certain reference value for clinic。

    注射,静脉内急性肾损伤危险因素预测模型伏立康唑抗真菌药

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    基于美国FDA不良事件报告系统数据库的多西环素儿童相关不良事件风险信号挖掘

    王克华郭琼杰王娜李菁锦...
    157-161页
    查看更多>>摘要：目的 了解儿童使用多西环素相关不良事件（AE）风险信号，为安全使用该药提供参考。 方法 收集美国FDA不良事件报告系统（FAERS）数据库2004年第1季度至2023年第3季度以多西环素为首要怀疑药物的儿童AE报告，采用《国际医学用语词典》26。1版首选术语（PT）和系统器官分类（SOC）对AE进行标准化和分类。采用报告比值比（ROR）法进行多西环素AE风险信号挖掘，AE报告数≥3且ROR的95%置信区间（CI）>1定义为风险信号，并对其进行描述性分析。 结果 共收集到儿童使用多西环素相关AE报告637份，涉及107个PT和21个SOC。AE报告数居前10位（含并列）的PT依次为呕吐、抑郁、吞咽困难、赫克斯海默反应、硬化性胆管炎、头痛、溃疡性结肠炎、食管溃疡、恶心、食管炎、自杀想法，其中抑郁、赫克斯海默反应、硬化性胆管炎、溃疡性结肠炎、自杀想法为说明书未记载的不良反应。信号强度居前10位的PT依次为赫克斯海默反应、光照性指甲松离、醒前幻觉、食管溃疡、食管损伤、睡前幻觉、玻璃体炎、指甲剥离、硬化性食管炎、糜烂性食管炎，其中赫克斯海默反应、醒前幻觉、睡前幻觉、玻璃体炎、硬化性胆管炎为说明书未记载的不良反应。精神疾病为该药说明书不良反应中未涉及的SOC。 结论 多西环素儿童相关AE主要为呕吐、吞咽困难、食管溃疡、恶心、食管炎等药品说明书已记载的不良反应。此外，多西环素还可能导致赫克斯海默反应、硬化性胆管炎、溃疡性结肠炎、精神疾病等药品说明书未记载的AE。 Objective To understand the adverse event (AE) risk signal of doxycycline in children and provide reference for the safe use of the drug in clinic。 Methods AE reports of children with doxycycline as primary suspect drug were collected from the US FDA Adverse Event Reporting System (FAERS) database during the 1st quarter of 2004 to the 3rd quarter of 2023。 AEs were standardized and classified according to the preferred term (PT) and system organ class (SOC) in Medical Dictionary for Regulatory Activities 26。1。 The AE risk signals of doxycycline were mined using reporting odds ratio (ROR) method。 An AE with reports ≥3 and the lower limit of the 95%CI of ROR >1 was defined as a risk signal。 Descriptive analysis on the risk signals was performed。 Results A total of 637 AE reports related to doxycycline in children were collected， involving 107 PTs and 21 SOCs。 The top 10 PTs in the number of reports (including juxtaposition) were vomiting， depression， dysphagia， Jarisch-Herxheimer reaction， cholangitis sclerosing， headache， colitis ulcerative， oesophageal ulcer， nausea， oesophagitis， and suicidal ideation。 Among them， depression， Jarisch-Herxheimer reaction， cholangitis sclerosing， colitis ulcerative and suicidal ideation were not recorded in labels。 The top 10 PTs in signal intensity were Jarisch-Herxheimer reaction， photoonycholysis， hypnopompic hallucination， oesophageal ulcer， oesophageal injury， hypnagogic hallucination， vitritis， onycholysis， cholangitis sclerosing， erosive oesophagitis。 Among them， Jarisch-Herxheimer reaction， hypnopompic hallucination， hypnagogic hallucination， vitritis and cholangitis sclerosing were not recorded in labels。 Psychiatric disorders were not covered by adverse reactions in the label。 Conclusions The main AEs of doxycycline in children are vomiting， dysphagia， oesophageal ulcer， nausea， oesophagitis， all of which are recorded in the drug label。 In addition， doxycycline may also cause AEs that are not recorded in drug label， such as Jarisch-Herxheimer reaction， sclerosing cholangitis， ulcerative colitis， and psychiatric disorders。

    支原体,肺炎多西环素儿童数据挖掘药物不良事件报告系统

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    卡非佐米治疗复发/难治性多发性骨髓瘤真实世界疗效和安全性的单组率meta分析

    李芸李兵胜李义秀袁珍...
    162-169页
    查看更多>>摘要：目的 系统评价卡非佐米在真实世界中治疗复发/难治性多发性骨髓瘤（RRMM）的疗效和安全性。 方法 检索国内外相关数据库（截至2023年4月），收集卡非佐米治疗RRMM的真实世界研究文献。采用非随机研究方法学指标（MINORS）量表对文献质量进行评价。提取卡非佐米治疗RRMM的有效性和安全性数据。有效性指标包括总体缓解率（ORR）、中位无进展生存期（PFS）和中位总生存期（OS），安全性指标包括不良事件（AE）发生率、因AE终止治疗率等。采用Stata 13。0软件进行单组率meta分析，对主要AE的发生情况进行描述性统计分析。 结果 共纳入12项研究，包括2 615例患者。12项研究质量评价结果均为高质量。单组率meta分析结果显示，卡非佐米治疗RRMM的ORR为75%[95%置信区间（CI）：68%~82%]，≥3级AE发生率为46%（95%CI：44%~49%），因AE终止治疗率为14%（95%CI：10%~19%），主要AE（发生率>5%）包括血小板减少、贫血、中性粒细胞减少、感染、高血压、肝损伤和肾损伤等。 结论 真实世界中卡非佐米治疗RRMM的疗效低于临床试验。治疗期间需关注感染、血液系统、心血管系统、肝脏和肾脏毒性的发生。 Objective To systematically evaluate the efficacy and safety of carfilzomib in treating relapsed and/or refractory multiple myeloma (RRMM) in the real world。 Methods Relevant databases at home and abroad were searched (up to April 2023)， and the literature on real-world studies of carfilzomib in the treatment of RRMM was collected。 The quality of the literature was evaluated with the methodological index for non-randomized studies (MINORS) scale。 Research data on the effectiveness and safety in RRMM patients treated with carfilzomib were extracted。 The effectiveness indicators included the overall response rate (ORR)， median progression-free survival (PFS)， and overall survival (OS)。 The safety indicators included the incidence of adverse events (AEs) and the rate of treatment termination due to AEs， etc。 Stata 13。0 software was used for meta-analysis of single proportions， and the occurrence of major adverse events was analyzed by descriptive statistics。 Results A total of 12 studies were entered， including 2 615 patients。 The quality evaluation results showed that all of the 12 studies were with high quality。 The meta-analysis of single proportions showed that ORR of carfilzomib in the treatment of RRMM was 75%[95% confidence interval (CI): 68%-82%]， the incidence of ≥ grade 3 AEs was 46% (95%CI: 44%-49%)， and the incidence of treatment termination due to AEs was 14% (95%CI: 10%-19%)。 AEs with an incidence of >5% included thrombocytopenia， anemia， neutropenia， infection， hypertension， liver injury， and kidney injury。 Conclusions In the real world， the efficacy of carfilzomib in the treatment of RRMM is lower than that in clinical trials。 The occurrence of infection during carfilzomib treatment and drug toxicity to the hematological system， cardiovascular system， liver， and kidney need to be paid attention to。

    多发性骨髓瘤卡非佐米疗效安全性meta分析

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    基于《药物不良反应杂志》病例报告数据集的语义信息检索研究

    肖雅艺雷毅王欣白向荣...
    170-177页
    查看更多>>摘要：目的 基于《药物不良反应杂志》病例报告数据集，探索语义信息检索（语义检索）的应用价值。 方法 本研究所用数据集由《药物不良反应杂志》1999至2022年发表的共计2 597篇病例报告的PDF文件构成。语义检索系统基于百度飞浆（PaddlePaddle）的深度学习框架搭建，代码用Python语言书写，文本编码模型为百度RocketQA模型。采用排名前k位文档的精确率（P@k）、召回率（R@k）、平均排序倒数（MRR）、平均精度均值（MAP）及精确率-召回率（P-R）曲线对语义检索的效果进行评价。本研究通过计算语义检索和关键词匹配检索的召回率，对2种方式的检索效果进行比较。 结果 预处理后题目字段作为待检索对象（item）的集合包含2 597个文档；去重整理后检索词（query）的集合包含药品名称1 388条，不良反应/事件1 118条。以药品名称和不良反应/事件为检索词进行语义检索的精确率分别为0。667~1和0。566~1，召回率分别为0。667~0。871和0。566~0。863；采用药品名称和不良反应/事件检索词进行语义检索结果中排名前1、3、5和10文档的P-R曲线显示，随着召回率的升高，排名前1、3的精确率下降趋势较缓，排名前5、10的精确率下降趋势明显。2类检索词的MRR分别为0。854和0。871，MAP分别为0。778和0。773。以不良反应/事件为检索词，语义检索的召回率高于关键词匹配检索；以药品名称为检索词，关键词匹配检索的召回率总体高于语义检索。 结论 基于百度飞浆深度学习框架搭建的语义检索系统对于《药物不良反应杂志》病例报告数据集的检索性能良好。语义检索与关键词匹配检索相比，以不良反应/事件为检索词时语义检索的检索效果较好，以药品名称为检索词时关键词匹配检索效果较好。 Objective To explore the application value of semantic information retrieval (semantic retrieval) based on case reports dataset of Adverse Drug Reactions Journal。 Methods The dataset used in this study consists of 2 597 PDF files of case reports published on Adverse Drug Reactions Journal from 1999 to 2022。 The semantic retrieval system is built by Baidu PaddlePaddle′s deep learning framework， the code was written in Python， and the text encoding model was Baidu RocketQA model。 The precision at position k (P@k)， recall at position k (R@k)， mean reciprocal rank (MRR)， mean average precision (MAP) and precision-recall (P-R) curve were used to evaluate the performance of semantic retrieval。 The performance of semantic retrieval and keyword matching retrieval were compared by calculating the recall。 Results The set of preprocessed theme fields as items to be retrieved contained 2 597 documents， the set of search terms (queries) after removing deplicates and reorganizing included 1 388 drug name queries and 1 118 adverse reactions/events queries。 The precision of drug name queries and adverse reactions/events queries by semantic retrieval were 0。667-1 and 0。566-1， and their recall were 0。667-0。871 and 0。566-0。863， respectively。 The P-R curves of the top 1， 3， 5 and 10 documents in the semantic retrieval results using drug names queries and adverse reactions/events search terms showed that the precision decreased slowly in top 1 and 3 documents but significantly in top 5 and 10 documents with the increase of recall。 The MRR of the 2 types of search terms were 0。854 and 0。871， and the MAP were 0。778 and 0。773， respectively。 Using adverse reactions/events as search terms， semantic retrieval has a higher recall rate than keyword matching retrieval using drug names as search terms， the recall rate of keyword matching retrieval is generally higher than that of semantic retrieval。 Conclusions The semantic retrieval system based on Baidu PaddlePaddle deep learning framework has good retrieval performance on the case reports dataset of Adverse Drug Reactions Journal。 The semantic retrieval performs better with adverse reactions/events queries， while the keyword matching retrieval performs better with drug name queries。

    信息存储和检索病例报告数据库语义检索关键词检索深度学习

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    EGFR和ALK酪氨酸激酶抑制剂治疗非小细胞肺癌的量-效-毒关系研究进展

    裴一涵李悦毕云彦郭楠...
    178-183页
    查看更多>>摘要：靶向治疗是目前治疗非小细胞肺癌（NSCLC）的重要手段之一，酪氨酸激酶抑制剂（TKI）具有疗效高、毒性低的特点，用于基因突变NSCLC患者的精准治疗。常见的基因突变包括编码表皮生长因子受体（EGFR）和间变性淋巴瘤激酶（ALK）的基因。不同患者对TKI的反应存在差异，监测TKI血药浓度可以更好地预测临床结局（疗效/毒性），优化治疗策略。本文检索近10年国内外相关文献，对临床常用的EGFR-TKI和ALK-TKI血药谷浓度与疗效/毒性关系进行了综述。 Targeted therapy is one of the important methods of treatment for non-small cell lung cancer (NSCLC)。 Tyrosine kinase inhibitors (TKIs) have the characteristics of high efficacy and low toxicity， and are used in the precise treatment in NSCLC patients with gene mutation。 Common gene mutations include genes encoding epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)。 Different patients have different responses to TKIs。 Monitoring the blood concentration of TKIs can help better predict the clinical outcome (efficacy/toxicity) and optimize the treat strategies。 In this paper， the relevant literature at home and abroad in the past 10 years are searched， and the relationship between the blood trough concentration of EGFR-TKI and ALK-TKI commonly used in clinic and the efficacy/toxicity are reviewed。

    分子靶向治疗剂量效应关系,药物受体,表皮生长因子间变性淋巴瘤激酶酪氨酸激酶抑制剂药物不良反应

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    左炔诺孕酮分散片致慢性乙型肝炎患者急性肝损伤

    王彬付敬敬范振平蔡晧东...
    184-185页
    查看更多>>摘要：1例37岁慢性乙型肝炎女性患者因月经紊乱自行口服左炔诺孕酮分散片（1。5 mg/d，每个月连续口服21 d、停药7 d）治疗。3个月后相继出现恶心、呕吐、纳差和黄疸，实验室检查示丙氨酸转氨酶93 U/L，天冬氨酸转氨酶68 U/L，γ-谷氨酰转移酶100 U/L，总胆红素206。1 μmol/L，直接胆红素138。9 μmol/L。经实验室检查排除慢性乙型肝炎再活动和其他嗜肝病毒感染后，考虑肝损伤与左炔诺孕酮有关。停用左炔诺孕酮，给予保肝及对症治疗后症状逐渐消失，2个月后肝功能恢复正常。肝穿刺病理学检查结果支持慢性乙型肝炎合并急性药物性肝损伤的诊断。 A 37-year-old female patient with chronic hepatitis B was treated with levonorgestrel dispersible tablets (1。5 mg daily， 21 days of medication and 7 days off in a month) due to menstrual disorder。 Three months later， the patient developed nausea， vomiting， poor appetite， and jaundice successively。 Laboratory tests showed alanine aminotransferase 93 U/L， aspartate aminotransferase 68 U/L， γ-glutamyltransferase 100 U/L， total bilirubin 206。1 μmol/L， and direct bilirubin 138。9 μmol/L。 After excluding chronic hepatitis B reactivation and other hepatotropic virus infections by laboratory indicators， the liver injury was considered to be related to levonorgestrel。 Levonorgestrel was stopped， liver protective and symptomatic treatments were given， the patient′s symptoms gradually disappeared， and liver function returned to normal after 2 months。 The pathological examination result of liver puncture supported the diagnosis of chronic hepatitis B complicated with acute drug-induced liver injury。

    左炔诺孕酮化学和药物性肝损伤乙型肝炎避孕药用药错误

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