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Article(id=1200147948949570370, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147945191469403, articleNumber=1001-2494(2024)12-1161-04, orderNo=null, doi=10.11669/cpj.2024.12.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1700150400000, receivedDateStr=2023-11-17, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1764067168700, onlineDateStr=2025-11-25, pubDate=1718985600000, pubDateStr=2024-06-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764067168700, onlineIssueDateStr=2025-11-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764067168700, creator=13701087609, updateTime=1764067168700, updator=13701087609, issue=Issue{id=1200147945191469403, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='12', pageStart='1065', pageEnd='1170', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1764067167804, creator=13701087609, updateTime=1764067403507, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1200148933856035173, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147945191469403, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1200148933856035174, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147945191469403, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1161, endPage=1164, ext={EN=ArticleExt(id=1200147949209617223, articleId=1200147948949570370, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Literature Case Analysis of Kounis Syndrome Induced by Sulbactam and Its Compound Preparations, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To discuss the occurrence and clinical characteristics of Kounis syndrome (KS) induced by antibacterial drugs containing sulbactam in order to provide references for clinical safety drug use. METHODS The case reports of KS induced by antibacterial drugs containing sulbactam were retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang and VIP database from establishment of each database to October 2023. The relevant data were collected and analyzed. RESULTS A total of 11 cases from 11 articles were identified and included in the analysis. There were 7 males (63.6%) and 4 females (36.4%). The patients were aged from 44 to 89 years with an average age of (70.0±13.1) years old, and there were 9 patients aged 70 and above (81.8%). The drugs involved included cefoperazone sulbactam in 5 cases (45.5%), ampicillin sulbactam in 4 cases (36.4%) and piperacillin sulbactam in 2 cases (18.2%). The 81.8% of the patients developed acute anaphylaxis within 30 min after treatment and electrocardiogram indicated abnormal ST segment changes. Type Ⅰ, Ⅱ and Ⅲ KS were 8 cases (72.7%), 2 cases (18.2%) and 1 case (9.1%), respectively. After anti-allergic and anti-myocardial ischemia therapy, 10 patients (90.9%) had good prognosis, and 1 patient (9.1%) died of cardiogenic shock. CONCLUSION KS could be induced by a variety of antibacterial drugs containing sulbactam, especially in older patients and mostly within 30 min. KS should be highly suspected once acute anaphylaxis accompanied by abnormal changes in electrocardiogram. Timely withdrawal of medication and targeted treatment according to KS types are the key to improve the prognosis of patients.

, correspAuthors=Cheng XIE, 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=Zhenfeng PAN, Yan LI, Zenghui ZHOU, Jianguo ZHU, Cheng XIE), CN=ArticleExt(id=1200147949499024211, articleId=1200147948949570370, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=舒巴坦制剂致Kounis综合征的文献病例分析, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 探讨含舒巴坦成分的抗菌药物致Kounis综合征(Kounis syndrome,KS)的发生情况和特点,为临床安全使用该类药物提供参考。方法 检索建库至2023年10月收录在PubMed、Embase、Cochrane Library、中国知网、万方和维普期刊数据库有关含有舒巴坦成分的抗菌药物致KS的病例报道,并对相关数据进行统计和分析。结果 共检索到11篇文献合计11例患者,男性7例(63.6%),女性4例(36.4%),年龄44~89(70.0±13.1)岁,≥70岁的有9例(81.8%)。涉及药物包括头孢哌酮舒巴坦5例(45.5%)、氨苄西林舒巴坦4例(36.4%)和哌拉西林舒巴坦2例(18.2%)。81.8%的患者在用药后30 min内出现急性过敏反应且心电图提示ST段异常改变。KS分型Ⅰ型、Ⅱ型和Ⅲ型分别为8例(72.7%)、2例(18.2%)和1例(9.1%)。经抗过敏和抗心肌缺血等治疗后10例(90.9%)患者转归良好,1例(9.1%)最终死于心源性休克。结论 多种含有舒巴坦成分的抗菌药物可诱发KS,且以老年患者居多,多在30 min内发生。临床在使用该类制剂过程中一旦出现急性过敏反应并伴有心电图异常改变时应高度怀疑可能为其诱发的KS,及时停药并根据KS分型进行针对性治疗是改善患者预后的关键。

, correspAuthors=谢诚, authorNote=null, correspAuthorsNote=
*谢诚,男,硕士,副主任药师 研究方向:临床药学 Tel:(0512)67780997
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潘振峰和李岩为共同第一作者

潘振峰,男,本科,主管药师 研究方向:医院药学 Tel:(0512)67780678;

李岩,男,本科,主管药师 研究方向:医院药学 Tel:(0512)67780282。

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潘振峰,男,本科,主管药师 研究方向:医院药学 Tel:(0512)67780678;

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李岩,男,本科,主管药师 研究方向:医院药学 Tel:(0512)67780282。

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Interact Cardiovasc Thorac Surg, 2009, 9(4): 736-738., articleTitle=Surgical extraction of occluded stents: when stenting becomes a problem, refAbstract=null)], funds=[Fund(id=1200147953051598857, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, awardId=国家卫生健康委员会办公厅国卫办医函〔2018〕292号, language=CN, fundingSource=国家临床重点专科（临床药学）建设项目(国家卫生健康委员会办公厅国卫办医函〔2018〕292号), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1200147949742293852, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, xref=1, ext=[AuthorCompanyExt(id=1200147949750682461, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, companyId=1200147949742293852, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou 215000, China), AuthorCompanyExt(id=1200147949754876766, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, companyId=1200147949742293852, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 苏州大学附属第一医院药学部, 江苏 苏州 215000)]), AuthorCompany(id=1200147949842957155, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, xref=2, ext=[AuthorCompanyExt(id=1200147949851345764, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, companyId=1200147949842957155, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 Department of Pharmacy, Dushu Lake Hospital Affiliated to Soochow University, Suzhou 215000, China), AuthorCompanyExt(id=1200147949859734373, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, companyId=1200147949842957155, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 苏州市独墅湖医院药学部, 江苏 苏州 215000)])], figs=[ArticleFig(id=1200147952787358716, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
发表年限及
参考文献		 性
别		 年龄
/岁		 药物 单次
剂量/g		 给药
途径		 KS发生
时间/min		 既往
病史		 临床
表现		 心肌损伤
标志物		 心电图 CAG KS
分型		 临床
处置		 转归
DING P 2022[7] 男 79 头孢哌酮
舒巴坦		 NA ivgtt 28 PCI术
后/HT/
AF/TB		 休克 cTnI升高 ST段抬高 支架内血
栓形成		 Ⅲ 肾上腺素,去甲肾上腺素,甲泼尼龙 7 d后死于心源性休克
ITO K 2020[8] 男 74 头孢哌酮
舒巴坦		 1.0 ivgtt 10 HT/HLP
/AP		 心脏骤停,
皮疹		 CKMB
升高		 室颤,ST
段抬高		 冠状动脉
狭窄		 Ⅰ 氢化可的松,去甲肾上腺素,硝酸甘油 1 d后好转
SCIATTI E 2018[9] 男 70 氨苄西林
舒巴坦		 NA ivgtt 输液过
程中		 IHD/AF
/MI/LC		 胸痛,晕厥 cTnI升高 ST段抬高 冠状动脉
狭窄		 Ⅱ 倍他米松,赖氨匹林,麻黄碱 好转
KESKIN M 2016[10] 男 44 氨苄西林
舒巴坦		 1.0 ivgtt 10 NA 胸痛,血压
下降		 cTnI和
CKMB
升高		 ST段抬高 冠状动脉
痉挛		 Ⅰ 硝酸甘油,泼尼松龙,雷尼替丁,苯海拉明,单硝酸异山梨酯 2 d后好转
YANG C L 2015[11] 男 89 哌拉西林
舒巴坦		 3.0 ivgtt 20 CAD 皮肤瘙痒,
胸闷,血
压下降		 正常 ST段抬高,室
性早搏		 NA Ⅰ 地塞米松,异丙嗪,阿司匹林,他汀,低分子肝素钙,单硝酸异山梨酯,胺碘酮 好转
BAKTIR A O 2014[12] 女 70 氨苄西林
舒巴坦		 NA NA NA HT
/CAD		 心肺骤停 cTn升高 缺血性ST段改变,非ST段抬高 冠状动脉
闭塞		 Ⅱ 阿司匹林,氯吡格雷,阿托伐他汀,培哚普利,氨氯地平 1 d后好转
LI Y 2013[13] 女 81 哌拉西林
舒巴坦		 5.0 ivgtt 60 CAD 全身发抖,肢端厥冷,血压下降 升高 心梗表现 NA Ⅰ 肾上腺素,地塞米松 好转
CHEN M Z 2012[14] 女 49 头孢哌酮
舒巴坦		 2.0 ivgtt 5 NA 休克 正常 Ⅱ°Ⅰ型AVB,
ST段抬高		 NA Ⅰ 地塞米松,异丙嗪 1 d后好转
NIE M P 2011[15] 女 70 头孢哌酮
舒巴坦		 3.0 ivgtt 5 CAD/MI 背痛,休克 正常 Ⅲ°AVB,ST
段抬高		 NA Ⅰ 肾上腺素,地塞米松,阿托品,抗凝,抗血小板 3 d后好转
KILIC D 2009[16] 男 72 氨苄西林
舒巴坦		 NA po 15 NA 休克 升高 AF,ST段抬
高,急性
下壁损伤		 冠状动脉
痉挛		 Ⅰ 肝素,阿司匹林,沙丁胺醇,异丙托溴铵 好转
FUJITA Y 2001[17] 男 72 头孢哌酮
舒巴坦		 1.5 ivgtt 10 HT 低血压,心
动过速		 CK和
CKMB
升高		 ST段抬高 无明显
异常		 Ⅰ 麻黄碱,肾上腺素,多巴胺,儿茶酚胺,硝酸异山梨酯,甲泼尼龙 好转
), ArticleFig(id=1200147952867049474, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147948949570370, language=CN, label=表1, caption=

舒巴坦制剂致Kounis综合征患者的临床资料

, figureFileSmall=null, figureFileBig=null, tableContent=
发表年限及
参考文献		 性
别		 年龄
/岁		 药物 单次
剂量/g		 给药
途径		 KS发生
时间/min		 既往
病史		 临床
表现		 心肌损伤
标志物		 心电图 CAG KS
分型		 临床
处置		 转归
DING P 2022[7] 男 79 头孢哌酮
舒巴坦		 NA ivgtt 28 PCI术
后/HT/
AF/TB		 休克 cTnI升高 ST段抬高 支架内血
栓形成		 Ⅲ 肾上腺素,去甲肾上腺素,甲泼尼龙 7 d后死于心源性休克
ITO K 2020[8] 男 74 头孢哌酮
舒巴坦		 1.0 ivgtt 10 HT/HLP
/AP		 心脏骤停,
皮疹		 CKMB
升高		 室颤,ST
段抬高		 冠状动脉
狭窄		 Ⅰ 氢化可的松,去甲肾上腺素,硝酸甘油 1 d后好转
SCIATTI E 2018[9] 男 70 氨苄西林
舒巴坦		 NA ivgtt 输液过
程中		 IHD/AF
/MI/LC		 胸痛,晕厥 cTnI升高 ST段抬高 冠状动脉
狭窄		 Ⅱ 倍他米松,赖氨匹林,麻黄碱 好转
KESKIN M 2016[10] 男 44 氨苄西林
舒巴坦		 1.0 ivgtt 10 NA 胸痛,血压
下降		 cTnI和
CKMB
升高		 ST段抬高 冠状动脉
痉挛		 Ⅰ 硝酸甘油,泼尼松龙,雷尼替丁,苯海拉明,单硝酸异山梨酯 2 d后好转
YANG C L 2015[11] 男 89 哌拉西林
舒巴坦		 3.0 ivgtt 20 CAD 皮肤瘙痒,
胸闷,血
压下降		 正常 ST段抬高,室
性早搏		 NA Ⅰ 地塞米松,异丙嗪,阿司匹林,他汀,低分子肝素钙,单硝酸异山梨酯,胺碘酮 好转
BAKTIR A O 2014[12] 女 70 氨苄西林
舒巴坦		 NA NA NA HT
/CAD		 心肺骤停 cTn升高 缺血性ST段改变,非ST段抬高 冠状动脉
闭塞		 Ⅱ 阿司匹林,氯吡格雷,阿托伐他汀,培哚普利,氨氯地平 1 d后好转
LI Y 2013[13] 女 81 哌拉西林
舒巴坦		 5.0 ivgtt 60 CAD 全身发抖,肢端厥冷,血压下降 升高 心梗表现 NA Ⅰ 肾上腺素,地塞米松 好转
CHEN M Z 2012[14] 女 49 头孢哌酮
舒巴坦		 2.0 ivgtt 5 NA 休克 正常 Ⅱ°Ⅰ型AVB,
ST段抬高		 NA Ⅰ 地塞米松,异丙嗪 1 d后好转
NIE M P 2011[15] 女 70 头孢哌酮
舒巴坦		 3.0 ivgtt 5 CAD/MI 背痛,休克 正常 Ⅲ°AVB,ST
段抬高		 NA Ⅰ 肾上腺素,地塞米松,阿托品,抗凝,抗血小板 3 d后好转
KILIC D 2009[16] 男 72 氨苄西林
舒巴坦		 NA po 15 NA 休克 升高 AF,ST段抬
高,急性
下壁损伤		 冠状动脉
痉挛		 Ⅰ 肝素,阿司匹林,沙丁胺醇,异丙托溴铵 好转
FUJITA Y 2001[17] 男 72 头孢哌酮
舒巴坦		 1.5 ivgtt 10 HT 低血压,心
动过速		 CK和
CKMB
升高		 ST段抬高 无明显
异常		 Ⅰ 麻黄碱,肾上腺素,多巴胺,儿茶酚胺,硝酸异山梨酯,甲泼尼龙 好转
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舒巴坦制剂致Kounis综合征的文献病例分析
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潘振峰 1 , 李岩 1 , 周增慧 2 , 朱建国 1 , 谢诚 1, *
中国药学杂志 | 论著 2024,59(12): 1161-1164
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中国药学杂志 | 论著 2024, 59(12): 1161-1164
舒巴坦制剂致Kounis综合征的文献病例分析
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潘振峰1, 李岩1, 周增慧2, 朱建国1, 谢诚1, *
作者信息
  • 1 苏州大学附属第一医院药学部, 江苏 苏州 215000
  • 2 苏州市独墅湖医院药学部, 江苏 苏州 215000

    • 潘振峰,男,本科,主管药师 研究方向:医院药学 Tel:(0512)67780678;

    李岩,男,本科,主管药师 研究方向:医院药学 Tel:(0512)67780282。

通讯作者:

*谢诚,男,硕士,副主任药师 研究方向:临床药学 Tel:(0512)67780997
Literature Case Analysis of Kounis Syndrome Induced by Sulbactam and Its Compound Preparations
Zhenfeng PAN1, Yan LI1, Zenghui ZHOU2, Jianguo ZHU1, Cheng XIE1, *
Affiliations
  • 1 Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou 215000, China
  • 2 Department of Pharmacy, Dushu Lake Hospital Affiliated to Soochow University, Suzhou 215000, China
出版时间: 2024-06-22 doi: 10.11669/cpj.2024.12.013
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目的 探讨含舒巴坦成分的抗菌药物致Kounis综合征(Kounis syndrome,KS)的发生情况和特点,为临床安全使用该类药物提供参考。方法 检索建库至2023年10月收录在PubMed、Embase、Cochrane Library、中国知网、万方和维普期刊数据库有关含有舒巴坦成分的抗菌药物致KS的病例报道,并对相关数据进行统计和分析。结果 共检索到11篇文献合计11例患者,男性7例(63.6%),女性4例(36.4%),年龄44~89(70.0±13.1)岁,≥70岁的有9例(81.8%)。涉及药物包括头孢哌酮舒巴坦5例(45.5%)、氨苄西林舒巴坦4例(36.4%)和哌拉西林舒巴坦2例(18.2%)。81.8%的患者在用药后30 min内出现急性过敏反应且心电图提示ST段异常改变。KS分型Ⅰ型、Ⅱ型和Ⅲ型分别为8例(72.7%)、2例(18.2%)和1例(9.1%)。经抗过敏和抗心肌缺血等治疗后10例(90.9%)患者转归良好,1例(9.1%)最终死于心源性休克。结论 多种含有舒巴坦成分的抗菌药物可诱发KS,且以老年患者居多,多在30 min内发生。临床在使用该类制剂过程中一旦出现急性过敏反应并伴有心电图异常改变时应高度怀疑可能为其诱发的KS,及时停药并根据KS分型进行针对性治疗是改善患者预后的关键。

舒巴坦  /  Kounis综合征  /  急性冠脉综合征  /  文献病例分析

OBJECTIVE To discuss the occurrence and clinical characteristics of Kounis syndrome (KS) induced by antibacterial drugs containing sulbactam in order to provide references for clinical safety drug use. METHODS The case reports of KS induced by antibacterial drugs containing sulbactam were retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang and VIP database from establishment of each database to October 2023. The relevant data were collected and analyzed. RESULTS A total of 11 cases from 11 articles were identified and included in the analysis. There were 7 males (63.6%) and 4 females (36.4%). The patients were aged from 44 to 89 years with an average age of (70.0±13.1) years old, and there were 9 patients aged 70 and above (81.8%). The drugs involved included cefoperazone sulbactam in 5 cases (45.5%), ampicillin sulbactam in 4 cases (36.4%) and piperacillin sulbactam in 2 cases (18.2%). The 81.8% of the patients developed acute anaphylaxis within 30 min after treatment and electrocardiogram indicated abnormal ST segment changes. Type Ⅰ, Ⅱ and Ⅲ KS were 8 cases (72.7%), 2 cases (18.2%) and 1 case (9.1%), respectively. After anti-allergic and anti-myocardial ischemia therapy, 10 patients (90.9%) had good prognosis, and 1 patient (9.1%) died of cardiogenic shock. CONCLUSION KS could be induced by a variety of antibacterial drugs containing sulbactam, especially in older patients and mostly within 30 min. KS should be highly suspected once acute anaphylaxis accompanied by abnormal changes in electrocardiogram. Timely withdrawal of medication and targeted treatment according to KS types are the key to improve the prognosis of patients.

sulbactam  /  Kounis syndrome  /  acute coronary syndrome  /  literature case analysis
潘振峰, 李岩, 周增慧, 朱建国, 谢诚. 舒巴坦制剂致Kounis综合征的文献病例分析. 中国药学杂志, 2024 , 59 (12) : 1161 -1164 . DOI: 10.11669/cpj.2024.12.013
Zhenfeng PAN, Yan LI, Zenghui ZHOU, Jianguo ZHU, Cheng XIE. Literature Case Analysis of Kounis Syndrome Induced by Sulbactam and Its Compound Preparations[J]. Chinese Pharmaceutical Journal, 2024 , 59 (12) : 1161 -1164 . DOI: 10.11669/cpj.2024.12.013
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Kounis综合征(Kounis syndrome,KS)是一种由严重过敏反应诱发的急性冠脉综合征,主要表现为冠状动脉痉挛、急性心肌梗死和支架内血栓形成[1],但由于发生率低,临床上常被低估[2]。目前已发现多种因素可诱发KS,其中最常见的是抗菌药物(27.4%)[3]。2022年2月,日本厚生劳动省药品和医疗器械管理局发布消息,要求对同时含有头孢哌酮和舒巴坦的药品说明书进行修订,将其“临床显著不良反应”项下的“休克、过敏反应(呼吸困难等)”修订为“休克、过敏反应(呼吸困难等)、过敏反应相关的急性冠状动脉综合征”[4]。同年,Fang等[5]对22例头孢菌素类药物引起的KS进行文献病例分析,结果发现,以头孢呋辛、头孢曲松和头孢唑林居多,头孢哌酮舒巴坦仅2例。鉴于目前临床上各种原因导致的耐药菌不断出现,含舒巴坦成分的抗菌药物使用日益广泛,本研究拟系统检索和收集国内外已发表的舒巴坦制剂致KS病例报道并对其进行回顾性分析,以期为临床安全使用该类药物提供参考。
1 资料与方法
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1.1 资料来源
以“sulbactam”“Kounis syndrome”“KS”“acute coronary syndrome”“ACS”“myocardial infarction”“MI”“angina”等为检索词检索PubMed、Embase和Cochrane Library数据库,以“舒巴坦”“Kounis综合征”“急性冠脉综合征”“心肌梗死”“心绞痛”等为检索词检索中国知网、万方和维普期刊数据库。检索时限均从建库至2023年10月。
1.2 文献纳入与排除标准
1.2.1 纳入标准
①含舒巴坦成分的抗菌药物致KS的病例报道;②病例描述相对完整,至少包括患者的性别、年龄、具体药物的使用情况及KS的临床表现等;③中文和英文文献。
1.2.2 排除标准
①重复、综述以及基础研究性文献;②无法获取原文。
1.3 研究方法
详细阅读纳入的病例报道,提取作者姓名和发表年限、患者性别、年龄、既往病史、含舒巴坦成分的药物名称及用法用量、KS的发生时间、临床表现、心电图、心肌损伤标志物、冠状动脉造影、临床处置和转归等信息,并利用Excel 2020进行统计分析,同时采用诺氏量表[6]对其关联性进行评估,其中≥9分为肯定,5~8分为很可能,1~4分为可能。
2 结果
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2.1 文献筛选结果
通过去重、阅读题目、摘要和全文后最终筛选出11篇文献[7-17],其中英文文献7篇,中文文献4篇。
2.2 患者基本情况
共纳入11例患者,其中男性7例(63.6%),女性4例(36.4%),年龄44~89(70.0±13.1)岁,≥70岁的有9例(81.8%)。8例描述有原发疾病的患者中6例伴有冠心病病史。见表1。
2.3 药物使用情况
11 例患者所涉及的药物包括头孢哌酮舒巴坦5例(45.5%)、氨苄西林舒巴坦4例(36.4%)和哌拉西林舒巴坦2例(18.2%)。10例患者对其用法用量进行了描述,其中9例为静脉给药,1例为口服给药[16],单次剂量均符合药品说明书中的推荐剂量。见表1。
2.4 KS的发生时间及其临床表现
10例患者描述了KS的发生时间,除最长的1例为用药后60 min[13]外其余9例(81.8%)均在30 min内,其中最短的2例为用药后5 min[14-15]。11例患者均有过敏的相关表现,包括晕厥、心脏骤停、血压下降、心动过速和皮疹等,其中4例(36.4%)伴有胸闷胸痛,8例(72.7%)伴有心肌损伤标志物升高。所有患者均进行了心电图检查,其中9例(81.8%)表现为ST段抬高,1例(9.1%)表现为非ST段抬高,1例(9.1%)仅描述为“心肌梗死”。根据Kounis分型标准,Ⅰ型、Ⅱ型和Ⅲ型分别为8例(72.7%)、2例(18.2%)和1例(9.1%)。见表1。
2.5 临床处理和转归
所有患者在发生KS后均予以停药,其中分别有9例(81.8%)和4例(36.4%)予以糖皮质激素和肾上腺素抗过敏及抗休克治疗,分别有4例(36.4%)和3例(27.3%)接受了抗血小板和抗凝治疗,另有4例(36.4%)使用了硝酸酯类药物以缓解冠状动脉痉挛。经上述处理后,10例(90.9%)患者转归良好,1例(9.1%)最终死于心源性休克[7]。见表1。
2.6 关联性评价结果
经诺氏量表评估后所有病例均为很可能。
3 讨论
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KOUNIS和ZAVRAS于1991年首次将冠状动脉痉挛发展为过敏性急性心肌梗死称为“过敏性心绞痛综合征”[18]。2003年该综合征被定义为KS,亦称为过敏性心肌缺血综合征[19]。KS可由膜翅目昆虫叮咬、食物过敏和药物引起,造影剂、静脉麻醉药、非甾体抗炎药等都有引起KS的报道[20]。
舒巴坦为人工合成的不可逆的竞争性β内酰胺酶抑制剂,国内已有单药制剂,本身抗菌活性弱,但对鲍曼不动杆菌感染具有良好的抗菌活性[21]。更多情况下,舒巴坦常与β内酰胺类抗生素组成复合制剂,用于各种革兰阳性及阴性菌所引起的感染性疾病。本研究纳入的病例均为含有舒巴坦的β内酰胺类复方制剂,并未发现舒巴坦单药制剂引起KS的报道。虽经诺氏量表评估后所有病例均为很可能,但无法排除舒巴坦外的其他成分致KS的可能性,仅有1篇病例报道描述患者主诉有头孢菌素类过敏史,表现为四肢荨麻疹,但在之前的住院期间曾注射过多种头孢菌素后均没有发生过敏反应,但在使用头孢哌酮舒巴坦后发生了KS,提示舒巴坦的可能性更大[7]。
Zeng等[22]和Abdelghany等[3]分别对63例和175例各种原因导致的KS患者进行统计分析后发现男性明显多于女性,前者的平均年龄为52.6岁,后者最常发生的年龄段是40~70岁。本研究纳入的11例患者中亦以男性居多,但主要集中在70岁及以上人群,考虑可能是与上述病例半数以上合并冠心病有关。此外,本研究显示81.8%的患者在用药后30 min内发生KS,这与Fang等针对头孢菌素类药物相关性KS的发生时间进行统计分析后发现80%的患者集中在30 min内极为相似[5],提示临床对患者使用β内酰胺类药物后30 min内应对KS的相关临床表现进行重点关注。
KS的主要病理基础是心脏组织、冠状动脉及斑块中的肥大细胞释放大量炎症介质从而导致一系列反应[22],其诊断主要是基于患者的临床症状和体征以及实验室检查、心电图、心脏超声和冠状动脉造影等结果[23]。如果患者有急性过敏反应的临床表现且心电图和心肌酶谱提示存在心肌缺血,则应该高度怀疑KS[24]。本研究纳入的所有病例用药后均出现过敏反应的相关表现,心电图可见ST段异常改变,且多数患者伴有心肌损伤标志物的升高,部分患者合并有胸闷胸痛,符合KS的诊断。此外,本研究显示舒巴坦制剂导致的KS均为单次给药后短时间内发生,且口服给药亦可导致KS,提示临床无论何种途径给药后30 min内均应密切关注患者有急性冠脉综合征的相关表现。
现阶段国内外急性冠脉综合征的相关指南均缺乏对KS的管理,大多数证据都来源于病例报告或是系统综述。目前认为,一旦发生KS应根据患者的临床症状及KS分型进行针对性治疗。由于Ⅰ型KS是过敏反应导致的冠脉痉挛,故经抗过敏治疗通常可取得满意疗效。最常用的治疗药物包括糖皮质激素、H1和H2受体阻滞剂及硝酸酯类药物[8],而肾上腺素作为过敏性休克的一线治疗药物,有研究显示其可能加重心脏缺血、延长QT间期并诱发心律失常,甚至可能促进动脉粥样斑块破裂和血压骤然增加,故应在权衡利弊后谨慎使用[25]。对于Ⅱ型KS患者往往是在冠状动脉痉挛的基础上伴有斑块侵蚀或破裂,导致急性心肌梗死,因此除了抗过敏治疗外还需进行抗心肌缺血治疗,尽早行冠脉造影并予以抗血小板治疗[26]。至于Ⅲ型KS患者则为过敏反应导致的冠状动脉支架血栓,通常需要行支架内血栓抽吸术并予以糖皮质激素和抗组胺类药物以稳定肥大细胞而缓解症状,如经上述处理后仍未缓解则可能需要行支架取出术[27]。本研究纳入的11例患者以Ⅰ型居多,症状出现后经及时停药并予以对症处理后整体转归良好。
综上所述,多种舒巴坦制剂可诱发KS,且以老年患者居多,多在30 min内发生。临床在使用该类药物过程中一旦出现急性过敏反应并伴有心肌缺血的临床症状和心电图及心肌酶谱异常时应高度怀疑可能为其诱发的KS,及时停药并根据KS分型进行针对性治疗是改善患者预后的关键。
基金
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  • 国家临床重点专科（临床药学）建设项目(国家卫生健康委员会办公厅国卫办医函〔2018〕292号)
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参考文献 引证文献
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2024年第59卷第12期
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doi: 10.11669/cpj.2024.12.013
  • 接收时间：2023-11-17
  • 首发时间：2025-11-25
  • 出版时间：2024-06-22
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  • 收稿日期：2023-11-17
基金
国家临床重点专科（临床药学）建设项目(国家卫生健康委员会办公厅国卫办医函〔2018〕292号)
作者信息
    1 苏州大学附属第一医院药学部, 江苏 苏州 215000
    2 苏州市独墅湖医院药学部, 江苏 苏州 215000

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*谢诚,男,硕士,副主任药师 研究方向:临床药学 Tel:(0512)67780997
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