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Article(id=1195362265701597974, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195362264082592240, articleNumber=1001-2494(2025)08-0883-08, orderNo=null, doi=10.11669/cpj.2025.08.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1733414400000, receivedDateStr=2024-12-06, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1762926172899, onlineDateStr=2025-11-12, pubDate=1744646400000, pubDateStr=2025-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762926172899, onlineIssueDateStr=2025-11-12, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762926172899, creator=13701087609, updateTime=1762926172899, updator=13701087609, issue=Issue{id=1195362264082592240, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='8', pageStart='777', pageEnd='890', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1762926172514, creator=13701087609, updateTime=1762928092119, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1195370315556635165, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195362264082592240, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1195370315560829470, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195362264082592240, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=883, endPage=890, ext={EN=ArticleExt(id=1195362265886147352, articleId=1195362265701597974, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Comprehensive Analysis of Adverse Drug Reaction Reports of Different Levels of Medical Institutions by Pareto Diagram Method, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To multi-dimensionally analyze the characteristics of adverse drug reaction (ADR) reports of medical institutions at different levels by the method of Pareto anlysis to provide accurate data reference for ADR monitoring and safe drug use in clinic thus to better guarantee public medication safety. METHODS ADR reports of 5 tertiary medical institutions, 7 secondary medical institutions, and 12 primary medical institutions and 7 private medical institutions in a district of Shanghai from 2021 to 2023 were retrospectively collected. The characteristics of ADRs were first explored from the time and the medical institution level dimensions. Then, these collected ADR reports were further analyzed using the method of Pareto diagram analysis to identify the mainly and high-frequencily involved drug categories and organ systems. RESULTS A total of 4 279 ADR reports were collected in this study. General ADRs accounted for 85.91% and chemical drug-induced ADRs accouted for 79.48%. From temporal perspective, the number of ADR reports displayed increasing tendency from 2021 to 2023. The elderly were the most involved age groups of human population. Females were more involved than males. From the perspective of medical institution level, ADR reports of tertiary and secondary medical institutions were much more than primary and private medical institutions. In tertiary and secondary medical institutions, the majority of ADRs were induced by anti-infective drugs, anti-tumor and tumor adjuvant drugs, and medication for mental illnesses. Diseases of skin and its subcutaneous tissues, as well as gastrointestinal system were the most common ADR symptoms. In primary medical units, ADRs were most commonly occurred in elderly people, accounting for 81.58%. The majority of ADRs were induced by traditional Chinese medicine (TCM)preparations and cardiovascular drugs, accounting for 29.26% and 23.07%, respectively. Diseases of gastrointestinal symptoms accounted for 34.21% which were the most common ADR symptoms. CONCLUSION Based on the criteria of Pareto classification, there are significant differences in the main drug categories causing ADRs in different levels of medical institutions, but no significant differences were found in the ADR-involved organ systems. Pareto analysis is a reliable menthod to identify drug categories and ADR symptoms needing intensive monitoring. It would facilitate precise adverse reaction monitoring and enhance clinical medication safety.

, correspAuthors=Xiaolan BIAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Hui LI, Beiming XU, Xiaolan BIAN), CN=ArticleExt(id=1195362343577240453, articleId=1195362265701597974, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=帕累托分析法在不同级别医疗机构药品不良反应报告综合分析中的应用, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 随着我国分级诊疗制度的发布和实施,利用帕累托分析法探索不同级别医疗机构药品不良反应的特点,为不良反应监测工作和临床安全用药提供精准的数据参考,能更好地保障公众用药安全。方法 回顾性收集2021—2023年上海某辖区5家三级、7家二级、12家一级和7家民营医疗机构的药品不良反应报告,首先从时间和医疗机构级别维度分析不良反应的特点,然后利用帕累托分析法明确发生不良反应的主要药品因素和累及器官系统。结果 本研究共收集4 279份药品不良反应,一般不良反应占比85.91%,涉及化学药品的不良反应占比79.48%。从时间维度看,2021年至2023年的药品不良反应数量呈增加趋势。不良反应涉及最多的是老年人,女性多于男性。从医疗机构级别维度看,三级和二级医疗机构的药品不良反应数量远大于一级和民营医疗机构。三级和二级医疗机构的抗感染药、抗肿瘤和肿瘤辅助用药、精神类疾病用药的不良反应最多,最常累及皮肤及其皮下组织、胃肠道系统。一级医疗机构的药品不良反应主要涉及老年人占比高达81.58%,中药制剂占比29.26%、心血管药物占比23.07%,胃肠道系统症状占比34.21%,前述占比显著高于三级和二级医疗机构。结论 基于帕累托分类标准,不同级别医疗机构发生不良反应的主要药品有差异,但不良反应主要累及器官系统无明显差异。帕累托分析法是制定重点监测药品类别和不良反应症状的可靠方法,促进不良反应监测实现精准化,助力临床用药安全。

, correspAuthors=卞晓岚, authorNote=null, correspAuthorsNote=
*卞晓岚,女,硕士,主任药师 研究方向:医院药学 Tel:(021)64370045
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李慧,女,博士,主管药师 研究方向:药物毒理

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李慧,女,博士,主管药师 研究方向:药物毒理

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李慧,女,博士,主管药师 研究方向:药物毒理

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Cap Med (首都食品与医药), 2022, 20(29): 92-94., articleTitle=Analysis of irrational use of Chinese patent medicine in seven community health service centers, refAbstract=null), Reference(id=1195390711978832075, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, doi=null, pmid=null, pmcid=null, year=2020, volume=396, issue=10258, pageStart=1204, pageEnd=1222, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=DISEASES G B D, INJURIES C, journalName=null, refType=null, unstructuredReference=DISEASES G B D, INJURIES C. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019[J]. 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Adverse Drug React J(药物不良反应杂志), 2020, 22(14):252-256., articleTitle=Survey and analysis of the cognition and behavioral intention of the public on adverse drug reactions, refAbstract=null), Reference(id=1195390712238878927, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, doi=null, pmid=null, pmcid=null, year=2015, volume=24, issue=2, pageStart=223, pageEnd=227, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=XU B M, CHEN H F, XU L, journalName=Chin J Pharmacoepidemiol(药物流行病学杂志), refType=null, unstructuredReference=XU B M, CHEN H F, XU L, et al. Investigation of the awareness of ADR in medical staff in our hospital[J]. 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Chin Pharm J(中国药学杂志), 2023, 58(20): 1876-1881., articleTitle=Curent situation and development of clinical pharmacy in China, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1195390707599978641, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, xref=null, ext=[AuthorCompanyExt(id=1195390707604172946, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, companyId=1195390707599978641, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Pharmacy, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China), AuthorCompanyExt(id=1195390707608367251, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, companyId=1195390707599978641, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=上海交通大学医学院附属瑞金医院药剂科, 上海 200025)])], figs=[ArticleFig(id=1195390709374169259, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=aYqrkz3mVZfm1zbvpV5iFQ==, figureFileBig=G1klB1NinOjwyHuNVIyU8g==, tableContent=null), ArticleFig(id=1195390709466443948, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=图1, caption=不同级别医疗机构药品不良反应涉及药品分布的帕累托图, figureFileSmall=aYqrkz3mVZfm1zbvpV5iFQ==, figureFileBig=G1klB1NinOjwyHuNVIyU8g==, tableContent=null), ArticleFig(id=1195390709562912941, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=uIk/JhZqyWzP9ueDywbkFg==, figureFileBig=GRQXFxqbuodncAkK/52rlw==, tableContent=null), ArticleFig(id=1195390709634216110, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=图2, caption=不同级别医疗机构药品不良反应累及器官系统分布的帕累托图, figureFileSmall=uIk/JhZqyWzP9ueDywbkFg==, figureFileBig=GRQXFxqbuodncAkK/52rlw==, tableContent=null), ArticleFig(id=1195390709730685103, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
项目 2021年 2022年 2023年 合计
不良反应类型药品类别
化学药品 1 160(79.34) 1 046(79.79) 1 195(79.35) 3 401(79.48)
中药制剂 215(14.71) 174(13.27) 171(11.35) 560(13.09)
生物制品 65(4.45) 63(4.80) 106(7.04) 234(5.47)
无法分类 22(1.50) 28(2.14) 34(2.26) 84(1.96)
不良反应类型
一般不良反应 1 206(82.49) 1 160(88.48) 1 310(86.99) 3 676(85.91)
新的一般不良反应 169(11.56) 79(6.03) 72(4.78) 320(7.48)
严重不良反应 82(5.61) 72(5.49) 122(8.10) 276(6.45)
新的严重不良反应 5(0.34) 0(0) 2(0.13) 7(0.16)
总计 1 462(34.17) 1 311(30.63) 1 506(35.20) 4 279(100)
), ArticleFig(id=1195390709831348400, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=表1, caption=

2021—2023年不良反应报告的分布。n(百分比/%)

, figureFileSmall=null, figureFileBig=null, tableContent=
项目 2021年 2022年 2023年 合计
不良反应类型药品类别
化学药品 1 160(79.34) 1 046(79.79) 1 195(79.35) 3 401(79.48)
中药制剂 215(14.71) 174(13.27) 171(11.35) 560(13.09)
生物制品 65(4.45) 63(4.80) 106(7.04) 234(5.47)
无法分类 22(1.50) 28(2.14) 34(2.26) 84(1.96)
不良反应类型
一般不良反应 1 206(82.49) 1 160(88.48) 1 310(86.99) 3 676(85.91)
新的一般不良反应 169(11.56) 79(6.03) 72(4.78) 320(7.48)
严重不良反应 82(5.61) 72(5.49) 122(8.10) 276(6.45)
新的严重不良反应 5(0.34) 0(0) 2(0.13) 7(0.16)
总计 1 462(34.17) 1 311(30.63) 1 506(35.20) 4 279(100)
), ArticleFig(id=1195390709898457265, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
人群分组 2021年 2022年 2023年 合计
性别
男 543(37.14) 557(42.49) 627(41.63) 1 727(40.36)
女 919(62.86) 754(57.51) 879(58.37) 2 552(59.64)
年龄分层
儿童(≤14岁) 11(0.75) 7(0.53) 20(1.33) 38(0.89)
成年人(>14且<65岁) 690(47.20) 632(48.21) 712(47.28) 2 034(47.53)
老年人(≥65岁) 761(52.05) 672(51.26) 774(51.39) 2 207(51.58)
), ArticleFig(id=1195390709965566130, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=表2, caption=

药品不良反应涉及人群分布。n(百分比/%)

, figureFileSmall=null, figureFileBig=null, tableContent=
人群分组 2021年 2022年 2023年 合计
性别
男 543(37.14) 557(42.49) 627(41.63) 1 727(40.36)
女 919(62.86) 754(57.51) 879(58.37) 2 552(59.64)
年龄分层
儿童(≤14岁) 11(0.75) 7(0.53) 20(1.33) 38(0.89)
成年人(>14且<65岁) 690(47.20) 632(48.21) 712(47.28) 2 034(47.53)
老年人(≥65岁) 761(52.05) 672(51.26) 774(51.39) 2 207(51.58)
), ArticleFig(id=1195390710024286387, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
项目 三级医疗机构 二级医疗机构 一级医疗机构 民营机构 合计
年龄分层
儿童(≤14岁) 25(1.22) 9(0.60) 0(0) 4(5.56) 38(0.89)
成年人(>14且<65岁) 1 168(57.06) 691(45.64) 119(18.42) 56(77.78) 2 034(47.53)
老年人(≥65岁) 854(41.72) 814(53.76) 527(81.58) 12(16.66) 2 207(51.58)
性别
男 811(39.62) 634(41.88) 256(39.63) 26(36.11) 1 727(40.36)
女 1 236(60.38) 880(58.12) 390(60.37) 46(63.99) 2 552(59.64)
不良反应类型
一般不良反应 1 817(88.76) 1 306(86.26) 494(76.47) 59(81.94) 3 676(85.91)
新的一般不良反应 76(3.71) 84(5.55) 148(22.91) 12(16.67) 320(7.48)
严重不良反应 150(7.33) 123(8.12) 2(0.31) 1(1.39) 276(6.45)
新的严重不良反应 4(0.20) 1(0.07) 2(0.31) 0(0) 7(0.16)
总计 2 047(47.84) 1514(35.38) 646(15.10) 72(1.68) 4 279(100)
), ArticleFig(id=1195390710099783860, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=表3, caption=

不同医疗机构的药品不良反应报告类型和涉及人群分布。n(百分比/%)

, figureFileSmall=null, figureFileBig=null, tableContent=
项目 三级医疗机构 二级医疗机构 一级医疗机构 民营机构 合计
年龄分层
儿童(≤14岁) 25(1.22) 9(0.60) 0(0) 4(5.56) 38(0.89)
成年人(>14且<65岁) 1 168(57.06) 691(45.64) 119(18.42) 56(77.78) 2 034(47.53)
老年人(≥65岁) 854(41.72) 814(53.76) 527(81.58) 12(16.66) 2 207(51.58)
性别
男 811(39.62) 634(41.88) 256(39.63) 26(36.11) 1 727(40.36)
女 1 236(60.38) 880(58.12) 390(60.37) 46(63.99) 2 552(59.64)
不良反应类型
一般不良反应 1 817(88.76) 1 306(86.26) 494(76.47) 59(81.94) 3 676(85.91)
新的一般不良反应 76(3.71) 84(5.55) 148(22.91) 12(16.67) 320(7.48)
严重不良反应 150(7.33) 123(8.12) 2(0.31) 1(1.39) 276(6.45)
新的严重不良反应 4(0.20) 1(0.07) 2(0.31) 0(0) 7(0.16)
总计 2 047(47.84) 1514(35.38) 646(15.10) 72(1.68) 4 279(100)
), ArticleFig(id=1195390710162698421, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
项目 三级医疗机构 二级医疗机构 一级医疗机构 民营机构 合计
药品类别
化学药品 1 666(81.39) 1 241(81.97) 438(67.80) 56(77.78) 3 401(79.48)
中药制剂 160(7.81) 200(13.21) 189(29.26) 11(15.28) 560(13.09)
生物制品 185(9.04) 46(3.04) 1(0.15) 2(2.78) 234(5.47)
无法分类 36(1.76) 27(1.78) 18(2.79) 3(4.16) 84(1.96)
药品分类
抗感染药 469(22.91) 258(17.04) 97(15.02) 18(25.00) 842(19.68)
抗肿瘤和肿瘤辅助用药 483(23.60) 220(14.53) 1(0.15) 4(5.55) 708(16.54)
心血管用药 118(5.76) 103(6.80) 149(23.07) 3(4.16) 373(8.72)
激素及影响内分泌药物 149(7.28) 57(3.76) 54(8.36) 2(2.78) 262(6.12)
精神类疾病用药 29(1.42) 288(19.02) 5(0.77) 2(2.78) 324(7.57)
神经系统用药 141(6.89) 120(7.93) 49(7.59) 10(13.89) 320(7.48)
消化系统用药 37(1.80) 29(1.92) 13(2.01) 1(1.39) 80(1.87)
呼吸系统用药 37(1.80) 26(1.72) 9(1.39) 2(2.78) 74(1.73)
泌尿系统用药 13(0.64) 9(0.59) 5(0.77) 0(0) 27(0.63)
血液和造血器官用药 95(4.64) 34(2.25) 14(2.17) 1(1.39) 144(3.37)
免疫系统用药 66(3.22) 7(0.46) 1(0.15) 0(0) 74(1.73)
维生素调节水电解质及酸碱平衡药 60(2.93) 63(4.16) 31(4.8) 3(4.17) 157(3.67)
抗过敏药物 3 (0.15) 12 (0.79) 4 (0.62) 1(1.39) 20(0.47)
中药制剂 160(7.82) 200(13.21) 189(29.26) 11(15.28) 560(13.09)
妇科用药 44(2.15) 1(0.07) 0(0) 2(2.78) 47(1.1)
肌肉骨骼系统用药 73(3.57) 58(3.83) 22(3.41) 5(6.94) 158(3.69)
造影剂 64(3.13) 28(1.85) 0(0) 1(1.39) 93(2.17)
其他 6(0.29) 1(0.07) 3(0.46) 6(8.33) 16(0.37)
), ArticleFig(id=1195390710229807286, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=表4, caption=

不同级别医疗机构药品不良反应分布特点。n(百分比/%)

, figureFileSmall=null, figureFileBig=null, tableContent=
项目 三级医疗机构 二级医疗机构 一级医疗机构 民营机构 合计
药品类别
化学药品 1 666(81.39) 1 241(81.97) 438(67.80) 56(77.78) 3 401(79.48)
中药制剂 160(7.81) 200(13.21) 189(29.26) 11(15.28) 560(13.09)
生物制品 185(9.04) 46(3.04) 1(0.15) 2(2.78) 234(5.47)
无法分类 36(1.76) 27(1.78) 18(2.79) 3(4.16) 84(1.96)
药品分类
抗感染药 469(22.91) 258(17.04) 97(15.02) 18(25.00) 842(19.68)
抗肿瘤和肿瘤辅助用药 483(23.60) 220(14.53) 1(0.15) 4(5.55) 708(16.54)
心血管用药 118(5.76) 103(6.80) 149(23.07) 3(4.16) 373(8.72)
激素及影响内分泌药物 149(7.28) 57(3.76) 54(8.36) 2(2.78) 262(6.12)
精神类疾病用药 29(1.42) 288(19.02) 5(0.77) 2(2.78) 324(7.57)
神经系统用药 141(6.89) 120(7.93) 49(7.59) 10(13.89) 320(7.48)
消化系统用药 37(1.80) 29(1.92) 13(2.01) 1(1.39) 80(1.87)
呼吸系统用药 37(1.80) 26(1.72) 9(1.39) 2(2.78) 74(1.73)
泌尿系统用药 13(0.64) 9(0.59) 5(0.77) 0(0) 27(0.63)
血液和造血器官用药 95(4.64) 34(2.25) 14(2.17) 1(1.39) 144(3.37)
免疫系统用药 66(3.22) 7(0.46) 1(0.15) 0(0) 74(1.73)
维生素调节水电解质及酸碱平衡药 60(2.93) 63(4.16) 31(4.8) 3(4.17) 157(3.67)
抗过敏药物 3 (0.15) 12 (0.79) 4 (0.62) 1(1.39) 20(0.47)
中药制剂 160(7.82) 200(13.21) 189(29.26) 11(15.28) 560(13.09)
妇科用药 44(2.15) 1(0.07) 0(0) 2(2.78) 47(1.1)
肌肉骨骼系统用药 73(3.57) 58(3.83) 22(3.41) 5(6.94) 158(3.69)
造影剂 64(3.13) 28(1.85) 0(0) 1(1.39) 93(2.17)
其他 6(0.29) 1(0.07) 3(0.46) 6(8.33) 16(0.37)
), ArticleFig(id=1195390710288527543, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
器官系统 三级医疗机构 二级医疗机构 一级医疗机构 民营机构 合计
皮肤及皮下组织类疾病 419(20.47) 409(27.02) 183(28.33) 22(30.56) 1033(24.15)
胃肠道系统疾病 394(19.25) 344(22.72) 221(34.21) 11(15.28) 970(22.67)
全身性疾病及给药部位各种反应 276(13.48) 42(2.77) 50(7.74) 13(18.05) 381(8.90)
神经系统疾病 192(9.38) 222(14.66) 85(13.16) 9(12.5) 508(11.87)
各类检查异常 173(8.45) 87(5.75) 19(2.94) 2(2.78) 281(6.57)
呼吸系统,胸及纵隔疾病 50(2.44) 37(2.45) 19(2.94) 1(1.39) 107(2.5)
心脏器官疾病 108(5.28) 65(4.29) 29(4.49) 2(2.78) 204(4.77)
血液及淋巴系统疾病 276(13.48) 209(13.8) 0(0) 2(2.78) 487(11.38)
血管及淋巴管类疾病 53(2.59) 26(1.72) 14(2.17) 3(4.16) 96(2.24)
其他 106(5.18) 73(4.82) 26(4.02) 7(9.72) 212(4.95)
), ArticleFig(id=1195390710372413624, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195362265701597974, language=CN, label=表5, caption=

不同级别医疗机构药品不良反应累及器官系统分布。n(百分比/%)

, figureFileSmall=null, figureFileBig=null, tableContent=
器官系统 三级医疗机构 二级医疗机构 一级医疗机构 民营机构 合计
皮肤及皮下组织类疾病 419(20.47) 409(27.02) 183(28.33) 22(30.56) 1033(24.15)
胃肠道系统疾病 394(19.25) 344(22.72) 221(34.21) 11(15.28) 970(22.67)
全身性疾病及给药部位各种反应 276(13.48) 42(2.77) 50(7.74) 13(18.05) 381(8.90)
神经系统疾病 192(9.38) 222(14.66) 85(13.16) 9(12.5) 508(11.87)
各类检查异常 173(8.45) 87(5.75) 19(2.94) 2(2.78) 281(6.57)
呼吸系统,胸及纵隔疾病 50(2.44) 37(2.45) 19(2.94) 1(1.39) 107(2.5)
心脏器官疾病 108(5.28) 65(4.29) 29(4.49) 2(2.78) 204(4.77)
血液及淋巴系统疾病 276(13.48) 209(13.8) 0(0) 2(2.78) 487(11.38)
血管及淋巴管类疾病 53(2.59) 26(1.72) 14(2.17) 3(4.16) 96(2.24)
其他 106(5.18) 73(4.82) 26(4.02) 7(9.72) 212(4.95)
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帕累托分析法在不同级别医疗机构药品不良反应报告综合分析中的应用
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李慧 , 许倍铭 , 卞晓岚 *
中国药学杂志 | 论著 2025,60(8): 883-890
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中国药学杂志 | 论著 2025, 60(8): 883-890
帕累托分析法在不同级别医疗机构药品不良反应报告综合分析中的应用
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李慧, 许倍铭, 卞晓岚*
作者信息
  • 上海交通大学医学院附属瑞金医院药剂科, 上海 200025

    • 李慧,女,博士,主管药师 研究方向:药物毒理

通讯作者:

*卞晓岚,女,硕士,主任药师 研究方向:医院药学 Tel:(021)64370045
Comprehensive Analysis of Adverse Drug Reaction Reports of Different Levels of Medical Institutions by Pareto Diagram Method
Hui LI, Beiming XU, Xiaolan BIAN*
Affiliations
  • Department of Pharmacy, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
出版时间: 2025-04-15 doi: 10.11669/cpj.2025.08.013
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摘要
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目的 随着我国分级诊疗制度的发布和实施,利用帕累托分析法探索不同级别医疗机构药品不良反应的特点,为不良反应监测工作和临床安全用药提供精准的数据参考,能更好地保障公众用药安全。方法 回顾性收集2021—2023年上海某辖区5家三级、7家二级、12家一级和7家民营医疗机构的药品不良反应报告,首先从时间和医疗机构级别维度分析不良反应的特点,然后利用帕累托分析法明确发生不良反应的主要药品因素和累及器官系统。结果 本研究共收集4 279份药品不良反应,一般不良反应占比85.91%,涉及化学药品的不良反应占比79.48%。从时间维度看,2021年至2023年的药品不良反应数量呈增加趋势。不良反应涉及最多的是老年人,女性多于男性。从医疗机构级别维度看,三级和二级医疗机构的药品不良反应数量远大于一级和民营医疗机构。三级和二级医疗机构的抗感染药、抗肿瘤和肿瘤辅助用药、精神类疾病用药的不良反应最多,最常累及皮肤及其皮下组织、胃肠道系统。一级医疗机构的药品不良反应主要涉及老年人占比高达81.58%,中药制剂占比29.26%、心血管药物占比23.07%,胃肠道系统症状占比34.21%,前述占比显著高于三级和二级医疗机构。结论 基于帕累托分类标准,不同级别医疗机构发生不良反应的主要药品有差异,但不良反应主要累及器官系统无明显差异。帕累托分析法是制定重点监测药品类别和不良反应症状的可靠方法,促进不良反应监测实现精准化,助力临床用药安全。

帕累托分析法  /  药品不良反应报告  /  医疗机构级别  /  用药安全

OBJECTIVE To multi-dimensionally analyze the characteristics of adverse drug reaction (ADR) reports of medical institutions at different levels by the method of Pareto anlysis to provide accurate data reference for ADR monitoring and safe drug use in clinic thus to better guarantee public medication safety. METHODS ADR reports of 5 tertiary medical institutions, 7 secondary medical institutions, and 12 primary medical institutions and 7 private medical institutions in a district of Shanghai from 2021 to 2023 were retrospectively collected. The characteristics of ADRs were first explored from the time and the medical institution level dimensions. Then, these collected ADR reports were further analyzed using the method of Pareto diagram analysis to identify the mainly and high-frequencily involved drug categories and organ systems. RESULTS A total of 4 279 ADR reports were collected in this study. General ADRs accounted for 85.91% and chemical drug-induced ADRs accouted for 79.48%. From temporal perspective, the number of ADR reports displayed increasing tendency from 2021 to 2023. The elderly were the most involved age groups of human population. Females were more involved than males. From the perspective of medical institution level, ADR reports of tertiary and secondary medical institutions were much more than primary and private medical institutions. In tertiary and secondary medical institutions, the majority of ADRs were induced by anti-infective drugs, anti-tumor and tumor adjuvant drugs, and medication for mental illnesses. Diseases of skin and its subcutaneous tissues, as well as gastrointestinal system were the most common ADR symptoms. In primary medical units, ADRs were most commonly occurred in elderly people, accounting for 81.58%. The majority of ADRs were induced by traditional Chinese medicine (TCM)preparations and cardiovascular drugs, accounting for 29.26% and 23.07%, respectively. Diseases of gastrointestinal symptoms accounted for 34.21% which were the most common ADR symptoms. CONCLUSION Based on the criteria of Pareto classification, there are significant differences in the main drug categories causing ADRs in different levels of medical institutions, but no significant differences were found in the ADR-involved organ systems. Pareto analysis is a reliable menthod to identify drug categories and ADR symptoms needing intensive monitoring. It would facilitate precise adverse reaction monitoring and enhance clinical medication safety.

Pareto diagram analysis  /  ADR report  /  medical institution  /  medication safety
李慧, 许倍铭, 卞晓岚. 帕累托分析法在不同级别医疗机构药品不良反应报告综合分析中的应用. 中国药学杂志, 2025 , 60 (8) : 883 -890 . DOI: 10.11669/cpj.2025.08.013
Hui LI, Beiming XU, Xiaolan BIAN. Comprehensive Analysis of Adverse Drug Reaction Reports of Different Levels of Medical Institutions by Pareto Diagram Method[J]. Chinese Pharmaceutical Journal, 2025 , 60 (8) : 883 -890 . DOI: 10.11669/cpj.2025.08.013
正文
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分级诊疗是按照疾病轻重缓急及治疗难易程度进行分级,不同级别医疗机构承担不同疾病的治疗,逐步实现从全科到专业化的医疗过程。2015年颁布的《国务院办公厅关于推进分级诊疗制度建立的指导意见》明确提出推进分级诊疗制度建立包括建立以强基层为重点的分级诊疗服务体系。随着我国分级诊疗制度实施,疾病尤其是常见病、多发病和慢性病呈现出新的医疗机构分布特点,药品使用同样也呈现出新特点。通过收集不同级别医疗机构的不良反应报告明确不良反应的特点和规律,助力患者用药安全,具有重要的临床意义。截至目前,从医疗机构级别角度分析不良反应的研究鲜见报道。
药品不良反应监测是提高安全用药水平,更好保障公众用药安全的重要举措。我国自2011年5月4日颁布《药品不良反应报告和监测管理办法》[1],始终高度重视药品安全。2022年国家颁布《“十四五”国民健康规划》也进一步强调要提高合理用药水平,加强药品不良反应监测。国家每年会发布《国家药品不良反应监测年度报告》来全面反馈药品不良反应监测情况和列出存在安全隐患的药品以便及时采取相应风险控制措施,为全国的安全用药提供数据参考[2-4]。参考前述国家年度报告内容,我们采用帕累托分析法分析分级诊疗背景下的药品不良反应的分布特点和规律,以期为不同级别医疗机构的安全用药提供精准的参考数据。
帕累托分析法是一种帮助识别问题关键因素的决策工具。此方法已在药学领域广泛使用如药品调剂部门运行优化、药学门诊、处方点评和不良反应管理等[5-7]。为促进分级诊疗背景下的公众用药安全,本研究回顾性收集2021—2023年上海某辖区的药品不良反应报告,从时间、报告单位级别多维度综合分析,再利用帕累托分析法制定基于医疗机构级别的高频不良反应涉及药物和累及器官目录,为不良反应监测提供精准的参考数据。
1 资料与方法
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1.1 数据来源
本研究数据来源于2021年1月—2023年12月上海市某辖区不良反应监测中收集到的5家三级医疗机构、7家二级医疗机构、12家一级医疗机构和7家民营医疗机构的所有药品不良反应报告。医疗机构的级别是由卫生行政部门根据相应标准核定。
1.2 方法
本研究纳入的不良反应类型根据《药品不良反应报告和监测管理办法》定义的严重药品不良反应、新的药品不良反应进行分类。研究所涉及药品的分类参考《国家基本药物目录(2018年版)》和《国家基本医疗保险、工伤保险和生育保险目录(2023年)》,其中所有中药制剂归为一类。不良反应累及器官系统参考2023年国家药品不良反应监测年度报告的标准进行分类。本研究先从时间和医疗机构级别两个维度综合分析该区不良反应报告的特点,再利用帕累托分析法明确不同级别医疗机构的高风险药物类别和高频累及器官系统。帕累托分析法的分类标准:根据百分比将影响因素分为A、B、C 3类。累及占比为0~80%区间的为A类即主要因素,80%~90%区间的为B类即次要因素,90%~100%区间的为C类即一般因素[8]。
2 结果
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2.1 不良反应报告的时间分布特点
2.1.1 不良反应报告的年度分布特点
本研究共收集到4 279份药品不良反应报告。2021—2023年的不良反应报告总数,类型及涉及药品类别见表1。除2022年受新冠疫情的影响,不良反应报告总数整体呈现逐年升高趋势。每年度报告中位居首位的均为一般不良反应占比超过80%,其次为新的一般和严重不良反应,新的严重不良反应最少占比小于1%。每年不良反应报告涉及药品类别相似,以化学药品为主,其次为中药制剂。因药物分类和累及器官系统未呈现明显的年度变化特点,故本文未再单独分析。
2.1.2 不良反应涉及人群的年度分布特点
本研究的不良反应涉及人群的分布特点见表2。从性别看,每年不良反应报告所涉及的女性人数均略多于男性,可能与该辖区包括1家三级妇产科专科医院有关。从年龄看,不良反应报告涉及最多的人群是老年人,其次为成年人,最少的为儿童。这与人口老龄化、辖区无儿童专科医院等有关。
2.2 不良反应报告的医疗机构级别分布特点
2.2.1 不良反应类型及涉及人群的医疗机构级别分布特点
来自一级、二级、三级医疗机构的不良反应报告数量共4 207份,分别占比15.10%、35.38%、47.84%,具体见表3。三级和二级医疗机构的不良反应报告数量远多于一级医疗机构。剩余的72份则来自民营医疗机构占比近1.68%。从不良反应类型看,四类医疗机构上报数量最多的均为一般不良反应,占比均高于75%,上报数量最少的为新的严重不良反应占比均低于0.5%。三级和二级医疗机构位居第二位的是严重不良反应,而一级和民营医疗机构位居第二位的则是新的一般不良反应。从年龄来看,二级医疗和一级医疗机构的老年人相关不良反应报告例数超过成年人,尤其是一级医疗机构占比高达81.58%。儿童相关的不良反应报告占比低于1%主要来自三级和二级医疗机构。从性别看,四级别医疗机构的女性相关不良反应数量均高于男性。
2.2.2 不良反应报告涉及药品类别和累及器官系统的医疗机构级别分布特点
不同级别医疗机构不良反应上报数量最多的均为化学制品,其次中药制剂。值得注意的是,二级医疗机构、一级医疗机构和民营医疗机构的中药制剂相关不良反应占比高于三级医疗机构,尤其是一级医疗占比高达29.26%。为进一步明确不同级别医疗不良反应涉及药物的分布特点,我们参考《国家基本药物目录(2018年版)》和《国家基本医疗保险、工伤保险和生育保险目录(2023年)》将所涉及的药品分为18类,具体见表4。三级医疗机构不良反应报告数量排名前三的抗感染药、抗肿瘤和肿瘤辅助用药、激素及影响内分泌药;二级医疗机构排名前三的为精神类疾病用药、抗感染药、抗肿瘤和肿瘤辅助用药;一级医疗机构排名前三的则为中药制剂、心血管药物、抗感染药物。三级和二级医疗机构的抗感染药物种类多、需预防感染或已感染患者人数多、感染尤其是严重患者会从一级转诊至二级或三级单位等导致抗感染药品不良反应占比高。而三级和二级医疗机构的抗肿瘤药品不良反应多则与抗肿瘤药物毒性强、患者更倾向选择医疗水平更高的二、三级医疗机构诊治、二、三医疗机构设置肿瘤专科床位多等密切相关。本研究的二级医疗机构包括1家精神卫生专科医院可能是导致精神类疾病用药不良反应数量排名首位的原因。一级医疗机构的中药制剂和心血管药品不良反应高多因中药制剂用药量占比高、老年患者多等。
2.2.3 不良反应报告累及器官系统的医疗机构级别分布特点
从不良反应累及器官系统看,各级医疗机构排名前两位的均是皮肤及皮下组织、胃肠道系统(表5)。其中,来自二、三级医疗机构和民营机构的不良反应最常累及的是皮肤及皮下组织,以皮疹、瘙痒等症状最为常见,一级医疗机构最常见的是胃肠道系统疾病,以恶心、呕吐、腹泻、便秘等常见症状为主。
2.3 帕累托分析法明确不同级别医疗机构不良反应的高风险药物和高频累及器官系统
2.3.1 帕累托分析法制定不同级别医疗机构的高风险药物目录
本研究的药品不良反应报告共涉及881种药品,数量巨大。从医疗机构级别角度,利用帕累托图分析法鉴别发生不良反应的高风险药物和高频累及器官系统能为不良反应监测工作提供更精准的参考数据能更好地保障临床用药安全。基于帕累托的分类标准,抗肿瘤和肿瘤辅助用药、抗感染药、激素及影响内分泌药物、神经系统用药、中药制剂、心血管用药、血液和造血器官用药、肌肉骨骼系统用药为三级医疗机构的A类主要因素;精神类疾病用药、抗感染药、抗肿瘤和肿瘤辅助用药、中药制剂、神经系统用药、心血管用药、维生素调节水电解质及酸碱平衡药物、血液和造血器官用药为二级医疗机构的A类主要因素;中药制剂、心血管用药、抗感染药、激素及影响内分泌药物、神经系统用药为一级医疗机构的A类主要因素(图1)。除需共同关注抗感染药、心血管用药、神经系统用药、中药制剂外,三级和二级医疗机构还需重点关注抗肿瘤和肿瘤辅助用药、血液和造血器官用药。因民营医疗机构的不良反应报告数量非常有限本研究未进行帕累托图分析。
2.3.2 帕累托分析法制定不同级别医疗机构的高频累及器官系统目录
参考国家药品不良反应监测年度报告的不良反应症状分类,本研究也分为10类,具体见图2。基于帕累托的分类标准,皮肤及皮下组织类疾病、胃肠道系统疾病、血液及淋巴系统系统疾病、神经系统疾病、全身性疾病及给药部位反应、各类检查异常为三级医疗机构的A类主要因素;皮肤及皮下组织类疾病、胃肠道系统疾病、神经系统疾病、血液及淋巴系统系统疾病、各类检查异常为二级医疗机构的A类主要因素;胃肠道系统疾病、皮肤及皮下组织类疾病、神经系统疾病、全身性疾病及给药部位反应为一级医疗机构的A类主要因素。不良反应累及器官系统未呈现医疗机构级别相关的分布特点。
3 讨论
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同国家年度不良反应报告,本研究的4 279例药品不良反应报告以一般不良反应为主,新的和严重不良反应占同期报告总数的11.52%~17.51%[2-4]。涉及最多的药品类型是化学药品,其次是中药制剂,未呈现明显的年度变化特点。不良反应报告中,女性多于男性,可能与不良反应报告来源包括1家三级妇产科专科医院有关。与既往发表的研究结果相一致,本研究的老年人相关不良反应数量也位居首位。老年患者因不良反应入院的人数占总入院人数的16.6%而年轻患者仅占4.1%[9]。我国年龄大于等于70岁的187名老年住院患者存在672个药物相关问题,以药物安全性问题最常见包括271个不良反应占比40.32%[10]。门诊老年患者的潜在不适当用药发生率为31.72%,与药物相关的潜在不适当用药11 134次,与疾病相关的潜在不适当用药仅23次[11]。针对中国社区老年人潜在不适当用药发生率及其相关因素的Meta分析指出不适当用药发生率为34.8%,与年龄大于等于75岁,合并5种及以上疾病,合并5种及以上药物密切相关[12]。老年人的器官功能逐渐衰退[13]和多病共存需同时服用多种药物[14]等影响药代和药效等因素是导致不良反应更容易发生的原因。因本研究的不良反应来源包括1家三级妇产科专科医院,1家二级精神卫生中心,无儿童专科医院导致数据有些偏畸是研究的限制之处。
随着《国务院办公厅关于推进分级诊疗制度建设的指导意见》颁布,分级诊疗在全国广泛推广取得卓越成绩,促进医疗资源的合理配置,医药卫生事业的长远健康发展,人民健康水平的提高。上海市采取医疗体和“1+1+1”家庭签约医生等模式来贯彻落实分级诊疗获得老年群体的认可,以上海市闵行区居民为对象的问卷调查研究指出80%的居民愿意选择基层首诊[15]。本研究的社区一级医疗上报的不良反应总数646份占比15.10%,但严重不良反应占比仅为0.62%。但一级医疗机构81.58%的不良反应报告来自老年患者。这从侧面进一步佐证了上海市分级诊疗的卓越成效和老年人对分级诊疗的认可。分级诊疗导致不同级别医疗机构诊治患者的疾病谱逐渐变化。本研究的二级和三级医疗机构上报不良反应涉及最多的仍是化学制品,其次为中药制剂。但一级医疗机构的中药制剂不良报告占比最高且远大于其他医疗机构。因中药制剂是在中药汤剂的基础上改良而来,提取繁杂,制备的中药注射液或添加的制剂辅料会产生不良反应[16-17]。此外,一项针对7家社区服务中心的中药制剂处方的分析发现存在适应证不适宜和用法、用量不适宜等相关的不合理处方,也是导致中药制剂药品不良反应的原因[18]。鉴于中药制剂说明书的不良反应相关内容非常有限,医疗机构尤其是一级医疗机构应主动监测、评估中药制剂不良反应,定期汇总分析进行反馈。临床药师积极开展不良反应科普活动提高公众的认知度并鼓励其积极上报。有条件的医院可申请安装中国医院药物警戒系统增加药物尤其是中药制剂的不良反应来源。中药制剂的用药安全一旦引起广泛大家的关注和重视,笔者坚信中国古代科学的瑰宝中药制剂能更有效、更安全地为公众身体健康保驾护航。
不同区域和级别的医疗机构分布和患者人群等存在差异,如何制定精准的药品不良反应监测计划来保障用药安全是非常有必要和重要的。帕累托分析法是以意大利经济学家V. Pareto命名的,将出现的质量问题和质量改进项目按照重要程度依次排列而采用的一种图表。本研究利用此方法将药品类别和累及器官系统分别按照百分占比依次排列后划分为主要、次要和一般因素3类,发现不同级别医疗机构的不良反应高风险药物有所差异,但累及器官系统无明显差异。除需共同关注抗感染药物和中药制剂外,三级和二级医疗机构需重点关注抗肿瘤和肿瘤辅助用药,一级医疗机构则需关注心血管药物,这与分级诊疗和疾病发病率等密切相关。通过检索国内外文献发现,截至目前尚无对比不同级别医疗机构不良反应的研究发表。2019年的全球疾病负担研究指出,疾病负担最重的是新生儿疾病、缺血性心脏病、中风等。其中0~9岁儿童疾病负担最重的是感染,而50岁以上则是缺血性心脏病和中风[19]。在中国,2016年因心血管疾病患者高达9 400万,死亡人数从1990年的251万增加到2016年的397万[20]。因这些慢性病发病率随着人口老龄化加剧而逐步提升,所以分级诊疗政策下的一级医疗机构相关药物不良反应占比增高。此外,疾病负担报告也指出癌症疾病负担呈现逐年增加趋势。2019年,全球新增癌症患者约2 360万,死亡患者约1 000万,约250百万伤残调整寿命年[21]。抗肿瘤药物与治疗方案与日俱新,每年都会有新的诊疗指南发布,因此肿瘤患者更倾向于去二、三级医疗机构获取最新、最优的治疗方案,这在二、三级医疗机构的药物不良反应分布中也有所体现。参考不良反应累及器官系统的结果,医护人员和药师在临床实践中需重点关注皮肤及皮下组织、胃肠道系统、神经系统、全身性疾病及给药部位反应。这些系统的症状属于可直观观察和可主观感受到的症状较容易发现并及时采取治疗。但易引发检查结果(如肝肾功)异常的药品,临床医生和临床药师需及时提醒患者定期监测来保证尽早发现。
药品不良反应监测是保障用药安全的一项重要举措,需要医护人员、药师和患者的共同参与。虽然患者是不良反应的第一感受人,但其对药品不良反应的认知度普遍较低更不了解报告部门和报告途径[22]。此外,部分医护人员也不了解药品不良反应的相关制度、不熟悉上报途径,或者认为认为不良反应未造成严重后果或没有时间等未能主动上报不良反应[23]。参考我国临床药学的现状与发展的文献计量分析,合理用药是临床药学三大主要发展领域之一[24]。因此,临床药师可通过定期开展不良反应相关的宣教活动,提高公众和医护人员认知和上报积极性能,为保障用药安全贡献自己的力量。
基于帕累托的分类标准,不同级别医疗机构发生不良反应的主要药品有差异,但不良反应主要累及器官系统无明显差异。三级和二级医疗机构的抗感染和抗肿瘤药物不良反应占比高,一级医疗机构不良反应占比高的多为中药制剂和心血管药物,不良反应最常累及器官系统为皮肤及皮下组织和胃肠道系统。参考本研究的时间和医疗机构级别多维度综合分析结果,建议不同级别医疗机构都定期开展不良反应宣教活动,提高医务人员和患者的认知度及主动上报积极性,重点关注不良反应占比高的药物和最常累及的器官系统,更精准地监测不良反应。综上,帕累托分析法是制定精准的重点监测药品类别和不良反应症状的可靠方法,能促进不良反应监测的个体化,更好地保障公众用药安全。
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doi: 10.11669/cpj.2025.08.013
  • 接收时间：2024-12-06
  • 首发时间：2025-11-12
  • 出版时间：2025-04-15
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  • 收稿日期：2024-12-06
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    上海交通大学医学院附属瑞金医院药剂科, 上海 200025

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*卞晓岚,女,硕士,主任药师 研究方向:医院药学 Tel:(021)64370045
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
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