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杜青青，女，副主任药师，讲师，博士，主要从事临床药学相关研究，E-mail:

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Stevens-Johnson综合征/中毒性表皮坏死松解症诊疗专家共识[J].中华皮肤科杂志, 2021, 54（5）: 376-381., articleTitle=Stevens-Johnson综合征/中毒性表皮坏死松解症诊疗专家共识, refAbstract=null), Reference(id=1239232810242855863, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222194312631189, doi=null, pmid=null, pmcid=null, year=2021, volume=54, issue=5, pageStart=376, pageEnd=381, url=null, language=null, rfNumber=[1], rfOrder=1, authorNames=Adverse Drug Reaction Research Center of Chinese Society of Dermatology, journalName=Chin J Dermatol, refType=null, unstructuredReference=Adverse Drug Reaction Research Center of Chinese Society of Dermatology.Expert consensus on the diagnosis and treatment of Stevens-Johnson syndrome/toxic epidermal necrolysis[J]. Chin J Dermatol, 2021,54（5）: 376-381., articleTitle=Expert consensus on the diagnosis and treatment of Stevens-Johnson syndrome/toxic epidermal necrolysis, refAbstract=null), Reference(id=1239232810339324858, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222194312631189, doi=null, pmid=null, pmcid=null, year=1993, volume=129, issue=1, pageStart=92, pageEnd=96, url=null, language=null, rfNumber=[2], rfOrder=2, authorNames=BASTUJI-GARIN S, RZANY B, STERN RS, journalName=Arch Dermatol, refType=null, unstructuredReference=BASTUJI-GARIN S, RZANY B, STERN RS, et al. Clinical classification of cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme[J]. 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序号评分标准得分/分
卡铂紫杉醇哌拉西林他唑巴坦泮托拉唑
1（1）从药物使用到线索日a的时间：5 ~ 28 d（3分）；29 ~ 56 d（2分）；1 ~ 4 d（1分）；> 56 d（-1分），药物在线索日当日或之后使用（-3分）1233
（2）既往使用同一药物发生了过敏反应：1 ~ 4 d（3分）；5 ~ 56 d（1分）
2线索日患者体内是否存在药物：线索日仍在使用或停药< 5个半衰期（0分），停药> 5个半衰期但肝肾功异常或怀疑药物相互作用（-1分），停药> 5个半衰期并且无肝肾功异常和药物相互作用（-3分）0000
3使用相同或相似药物的情况：使用相同药物引起SJS / TEN（4分）；使用相似药物引起SJS / TEN或使用相同药物引起其他过敏反应（2分）；使用相似药物引起其他过敏反应（1分）；既往从未用过该药（0分）；既往用相同/相似药物未发生过敏反应（-2分）-2-2-2-2
4线索日后药物使用情况：停药/未知（0分）；药物继续使用症状未加重（-2分）0000
5药物恶名度b：高风险（3分）；低风险（2分）；监测中的药物（1分）；风险未知（包括新上市的药物）（0分）；以往流行病学研究提示没有相关性（-1分）0011
6有可能是其他病原学原因：如果有1种药物的得分>3，则其他药物的得分减1
合计-1-122
), ArticleFig(id=1239232809777288095, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222194312631189, language=CN, label=表1, caption=

表皮坏死松解症药物因果关系算法（ALDEN）评分标准及结果

, figureFileSmall=null, figureFileBig=null, tableContent=
序号评分标准得分/分
卡铂紫杉醇哌拉西林他唑巴坦泮托拉唑
1（1）从药物使用到线索日a的时间：5 ~ 28 d（3分）；29 ~ 56 d（2分）；1 ~ 4 d（1分）；> 56 d（-1分），药物在线索日当日或之后使用（-3分）1233
（2）既往使用同一药物发生了过敏反应：1 ~ 4 d（3分）；5 ~ 56 d（1分）
2线索日患者体内是否存在药物：线索日仍在使用或停药< 5个半衰期（0分），停药> 5个半衰期但肝肾功异常或怀疑药物相互作用（-1分），停药> 5个半衰期并且无肝肾功异常和药物相互作用（-3分）0000
3使用相同或相似药物的情况：使用相同药物引起SJS / TEN（4分）；使用相似药物引起SJS / TEN或使用相同药物引起其他过敏反应（2分）；使用相似药物引起其他过敏反应（1分）；既往从未用过该药（0分）；既往用相同/相似药物未发生过敏反应（-2分）-2-2-2-2
4线索日后药物使用情况：停药/未知（0分）；药物继续使用症状未加重（-2分）0000
5药物恶名度b：高风险（3分）；低风险（2分）；监测中的药物（1分）；风险未知（包括新上市的药物）（0分）；以往流行病学研究提示没有相关性（-1分）0011
6有可能是其他病原学原因：如果有1种药物的得分>3，则其他药物的得分减1
合计-1-122
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1例中毒性表皮坏死松解症患者的致敏药物分析及监护
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幸小东 1a, 2 , 谢曌璐 1a , 王静 1b , 杜青青 1a
中国新药与临床杂志 | 药物警戒 2024,43(11): 877-880
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中国新药与临床杂志 | 药物警戒 2024, 43(11): 877-880
1例中毒性表皮坏死松解症患者的致敏药物分析及监护
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幸小东1a, 2 , 谢曌璐1a, 王静1b, 杜青青1a
作者信息
  • 1a.重庆医科大学附属第二医院药学部，重庆　400010，
  • 1b.重庆医科大学附属第二医院呼吸内科，重庆　400010
  • 2.重庆医科大学 药学院，重庆　400016

    • 幸小东，男，硕士在读，主要从事临床药学相关研究，E-mail：

    杜青青，女，副主任药师，讲师，博士，主要从事临床药学相关研究，E-mail:

通讯作者:

杜青青
Culprit drug analysis and pharmaceutical care of one patient with toxic epidermal necrolysis
Xiao-dong XING1a, 2 , Zhao-lu XIE1a, Jing WANG1b, Qing-qing DU1a
Affiliations
  • 1a.Department of Pharmacy, the Second Affiliated Hospital of Chongqing Medical University, CHONGQING 400010, China
  • 1b.Department of Respiratory Medicine, the Second Affiliated Hospital of Chongqing Medical University, CHONGQING 400010, China
  • 2.College of Pharmacy, Chongqing Medical University, CHONGQING 400016, China
出版时间: 2024-11-25 doi: 10.14109/j.cnki.xyylc.2024.11.14
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中毒性表皮坏死松解症  /  泮托拉唑  /  药物不良反应
toxic epidermal necrolysis  /  pantoprazole  /  adverse drug reaction
幸小东, 谢曌璐, 王静, 杜青青. 1例中毒性表皮坏死松解症患者的致敏药物分析及监护. 中国新药与临床杂志, 2024 , 43 (11) : 877 -880 . DOI: 10.14109/j.cnki.xyylc.2024.11.14
Xiao-dong XING, Zhao-lu XIE, Jing WANG, Qing-qing DU. Culprit drug analysis and pharmaceutical care of one patient with toxic epidermal necrolysis[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (11) : 877 -880 . DOI: 10.14109/j.cnki.xyylc.2024.11.14
正文
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中毒性表皮坏死松解症（toxic epidermal necrolysis，TEN）是一种严重的皮肤-黏膜反应，绝大多数由药物引起，以水疱及泛发性表皮松解为特征，可伴有多系统受累[1]。TEN和Stevens-Johnson综合征（Stevens-Johnson syndrome，SJS）是同一组疾病谱的两种不同表型，通过受累皮肤的体表面积（body surface area，BSA）进行区分——SJS患者的BSA<10%，而TEN患者的BSA>30%，介于两者之间的即为重叠型SJS-TEN[2]。常见诱发SJS/TEN的药物包括磺胺类抗菌药、抗癫痫药、昔康类非甾体抗炎药、别嘌醇、奈韦拉平及近年来广泛应用的免疫检查点抑制剂等[3,4]，目前国内外鲜有质子泵抑制剂（proton pump inhibitors，PPIs）致SJS/TEN的报道[5-10]。本文报道了1例疑似泮托拉唑诱发TEN的老年晚期肺腺癌患者的病例，以期为致敏药物的识别及TEN的药学监护提供参考。
患者，男性，68岁，因“喘累加重1周”于2022年3月2日入我院。2021年11月，患者因“活动后喘累不适半月”于本院呼吸内科就诊，完善相关辅助检查后确诊为肺腺癌，肿瘤分期cT4N3M1cⅣb期，EGFR、ALK野生型，细胞程序性死亡受体配体1（programmed death-ligand 1，PD-L1）（22C3）5%，予卡瑞丽珠单抗联合紫杉醇（白蛋白结合型）、卡铂治疗。化疗结束后，患者出现Ⅲ度骨髓抑制，经人粒细胞刺激因子升白处理后，血常规逐渐恢复正常，于2022年1月6日出院。
2022年3月7日，患者随访CT发现双肺实性结节较前（2022年1月4日）明显增多；癌胚抗原、细胞角蛋白19片段抗原21-1（CYFRA21-1）、组织多肽抗原等肿瘤标志物动态升高；胸部超声示大量胸腔积液，临床考虑肿瘤进展。遂予患者入院治疗。入院予注射用哌拉西林钠他唑巴坦钠（瑞阳制药股份有限公司，批号21121241）4.5 g静脉滴注q8h（3月7—28日）抗感染，注射用甲泼尼龙琥珀酸钠40 mg静脉注射qd（3月8—14日）改善喘累，泮托拉唑钠肠溶片（杭州康恩贝制药有限公司，批号23211111）40 mg口服qd（3月8—14日）预防溃疡等对症支持治疗。患者身高170 cm，体重67 kg，体表面积1.78 m2，肌酐清除率57.16 mL·min-1，经临床药师会诊后予卡铂250 mg（3月9日中午12：20）+紫杉醇（白蛋白结合型）400 mg（3月11日）行第二次化疗。3月13日查房时发现患者双手出现红斑，口唇黏膜见糜烂、脓疱，随后骶尾部及全身多处出现红斑，皮肤科会诊考虑“药物性皮炎”。停用甲泼尼龙并予以复方倍他米松注射液1 mL肌内注射1次，泮托拉唑钠肠溶片于3月15日换成注射用泮托拉唑钠（扬子江药业集团有限公司，批号20121932）40 mg静脉滴注qd，同时外用莫匹罗星、卤米松对症处理。后患者骶尾部出现破溃，病情反复，于3月25日加用甲泼尼龙40 mg静脉滴注qd以及氯雷他定治疗，泮托拉唑换回口服制剂。3月28日，患者面部、躯干及骶尾部见弥漫性暗红斑，部分皮肤松解剥脱，可见大疱及糜烂面。体格检查：体温36.5 ℃，脉搏81次·min-1，呼吸19次·min-1，血压129/77 mmHg；尼氏征（+）。实验室检查：白细胞计数6.26×109·L-1，中性粒细胞百分比75%，C反应蛋白<5 mg·L-1，碳酸氢盐21.7 mmol·L-1，尿素8.01 mmol·L-1，内生肌酐清除率77.4 mL·min-1。皮肤科会诊：TEN。临床药师会诊：怀疑哌拉西林他唑巴坦、化疗药物以及泮托拉唑引起TEN可能性大，建议停用上述药物。遂将哌拉西林他唑巴坦更换为比阿培南0.3 g静脉滴注q8 h（3月28日—4月13日），增加甲泼尼龙给药频次至q12 h（3月28日—4月3日，后逐渐减量停药）并联合人免疫球蛋白25 g静脉滴注qd（3月28日—4月1日）对症处理，泮托拉唑再次换回静脉制剂。此外，加用依匹斯汀、重组人表皮生长因子凝胶，其余用药同前。4月2日，患者唇部新发破溃，全身红斑颜色变暗，部分皮损开始脱屑，大疱有所吸收，糜烂面渗出减少，部分愈合；尼氏征（+）。患者骶尾部皮肤仍有局部破溃。临床药师会诊建议：停用泮托拉唑，加用雷尼替丁0.15 g口服bid预防溃疡。医师同意停用泮托拉唑，但未加用雷尼替丁。4月3日，粪便检查示大便隐血（+）。此后连续两日复查大便隐血均为阳性，故于4月5日加用雷尼替丁。4月8日，患者唇部痂壳基本脱落，躯干大片状浅褐色痂壳，部分脱落后见新生淡粉色皮肤。4月13日，患者皮肤基本结痂，无明显喘累症状，办理出院。
讨论
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极少数TEN发生在麻疹-腮腺炎-风疹疫苗接种[11]、肺炎支原体感染[12]、登革病毒感染[13]、巨细胞病毒再激活[14]及造影剂给药后[15]。结合本例患者情况排除以上非药物因素，考虑TEN由药物引起。TEN平均发病时间在药物使用后6 d~2周[16]，根据药物与不良反应之间的时序关系，卡铂、紫杉醇、哌拉西林他唑巴坦、泮托拉唑可疑性最大，故建议行表皮坏死松解症药物因果关系算法（algorithm of drug causality for epidermal necrolysis, ALDEN）评分。ALDEN评分可用于快速评估药物与SJS/TEN之间的因果关系[17]，总分为-12~10分，得分越高，表明药物越可能导致SJS/TEN，其中，得分< 0分为极不可能，0 ~ 1分为不可能，2 ~ 3分为可能，4~5分为很可能，≥6分为极有可能[18,19]。本例患者使用卡铂、紫杉醇、哌拉西林他唑巴坦、泮托拉唑的ALDEN评分结果见表1。
由表1可见，卡铂和紫杉醇的ALDEN评分均为-1分，判定为极不可能。卡铂为生物烷化剂，常见的不良反应为过敏[20]。铂类导致的过敏一般为免疫球蛋白E介导的速发型超敏反应[21]，通常在用药多个周期后发生，表现为呕吐、腹泻、呼吸困难、低血压等，但卡铂说明书中未标注有SJS/TEN的不良反应。检索中国知网、万方数据和PubMed等数据库笔者未见卡铂直接引起SJS/TEN的报道。紫杉醇（白蛋白结合型）的说明书“上市后经验”中提及SJS/TEN。结合本例患者的既往用药史和药品说明书，卡铂和紫杉醇都有可能参与了TEN的发生，但根据ALDEN评分结果和TEN的发生时间来看，考虑其他药物致TEN的可能性更大。
哌拉西林他唑巴坦和泮托拉唑的ALDEN评分均为2分，判定为可能。值得一提的是，两药的恶名度分级也相同，均为“监测中的药物”。目前，国内外已有多篇哌拉西林他唑巴坦致SJS/TEN的文献报道，且该药说明书中也有相关提及，属于该药的已知不良反应类型。相较之下，笔者未见泮托拉唑致SJS/TEN的文献报道，仅部分厂家的药品说明书中提及该不良反应。TEN可使患者消化道多部位甚至弥漫性胃肠道受累，且研究发现在剔除糖皮质激素系统治疗的情况下，TEN的消化道并发症发生率降低[22]。考虑到本例患者系统性使用甲泼尼龙面临消化道黏膜脱落出血及穿孔的风险，加之PPIs是预防消化道出血最有效的药物[23,24]，故治疗团队一开始仅予患者停用哌拉西林他唑巴坦而继续使用泮托拉唑。然而患者在应用人免疫球蛋白及甲泼尼龙加量给药等积极治疗下，TEN仍迁延不愈，表现为骶尾部长时间破溃、尼氏征（+）。4月2日早查房患者唇部又新发溃破，治疗团队当即予患者停用泮托拉唑。此后患者症状逐渐好转，且在治疗过程中全身未再见新发破溃，高度提示泮托拉唑与TEN的发生发展有关。
临床药师整理患者既往用药，未发现卡铂、紫杉醇、哌拉西林他唑巴坦及泮托拉唑和其他药物存在相互作用，且也未见有文献报道这4个药物之间具有临床意义的相互作用。综上，卡铂、紫杉醇及哌拉西林他唑巴坦可能在本例患者TEN的发生中存在一定的作用，但依次撤药后TEN仍进展，故考虑泮托拉唑引发TEN的可能性最大。
大量研究表明，SJS/TEN是由遗传、药理、免疫等多方面共同作用的结果，发病机制目前尚未完全明确，已确定的是，多种人类白细胞抗原（human leucocyte antigen，HLA）等位基因与特定药物引起的SJS/TEN相关[16]。BOSE等[25]对118例PPIs相关超敏反应的研究显示，大多数超敏反应（86%）由IgE介导，其余为T细胞介导的迟发型超敏反应（delayed type hypersensitivity reactions，DHR）。药物诱导的DHR可从轻度斑丘疹到致命的SJS/TEN[26]。本例患者的TEN即可能为泮托拉唑相关DHR所致。除药物外，本例患者还具备其他高危险因素，如老年[16]、长时间住院[27]、使用抑酸药[28]等，进一步增加了该患者的TEN发生风险。
TEN的死亡危险因素与全身表皮受累程度及是否合并基础疾病相关，TEN疾病严重程度评分（score of toxic epidermal necrolysis，SCORTEN）常用于评估SJS/TEN的严重程度并可预测患者的死亡率。SCORTEN得分0~1、2、3、4、≥5分对应的预测死亡率分别为3.2%、12.1%、35.3%、58.3%、90.0%[29,30]。根据该患者2022年3月28日的数据进行评分，年龄>40岁、伴恶性肿瘤、入院时表皮松解面积>10%体表面积各得1分，SCORTEN评分为3分，对应的预测死亡率为35.3%，提示患者病情凶险，需立即采取应对措施。
TEN诊断明确后，临床药师深入问诊，记录患者既往用药史和过敏史，建议立即停用上述可疑致敏药物。随着可疑药物逐一撤去，患者的TEN经积极处理得到控制，但大便隐血却多次检出阳性，考虑为TEN累及消化道黏膜、合并激素用药、泮托拉唑撤药以及急性应激等综合因素所致。查阅文献，LIN等[31]回顾性分析了台湾69例PPIs相关DHR（其中SJS/TEN 27例）后认为：再次使用致DHR的PPIs可能会危及生命，可选用结构不同的PPIs。考虑到其他PPIs的暴露同样也存在致敏风险，故对于本例患者，临床药师认为H2受体拮抗剂可能是更优的选择，建议加用雷尼替丁，医生采纳该建议。后患者大便隐血转阴，皮疹未再加重。治疗过程中，临床药师除密切关注患者的病情演变外，还关注到了药物的不良反应及注意事项，如本例患者在短期大剂量使用糖皮质激素后应减量撤药，通过勤换药、及时补充液体等方式预防和处理激素可能诱发的感染、低钾、低钙等。TEN治疗期间，除消化道出血外，患者未见其他不良反应发生。出院时临床药师还积极向患者进行宣教，告知患者可疑的致敏药物及其危害，以提高患者的自我保护意识。出院1个月后随访，患者一般情况可，未再出现上述情况。
基金
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  • 重庆医科大学药学院2021年院级教育教学研究项目(YXJY2101)
文献
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参考文献 引证文献
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2024年第43卷第11期
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doi: 10.14109/j.cnki.xyylc.2024.11.14
  • 接收时间：2022-10-08
  • 首发时间：2026-03-13
  • 出版时间：2024-11-25
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  • 收稿日期：2022-10-08
  • 录用日期：2024-07-07
基金
重庆医科大学药学院2021年院级教育教学研究项目(YXJY2101)
作者信息
    1a.重庆医科大学附属第二医院药学部，重庆　400010，
    1b.重庆医科大学附属第二医院呼吸内科，重庆　400010
    2.重庆医科大学 药学院，重庆　400016

通讯作者:

杜青青
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https://castjournals.cast.org.cn/joweb/zgxyylczz/CN/10.14109/j.cnki.xyylc.2024.11.14
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
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
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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