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Article(id=1190352409403691341, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1190352404290831102, articleNumber=1001-2494(2024)16-1545-06, orderNo=null, doi=10.11669/cpj.2024.16.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1700064000000, receivedDateStr=2023-11-16, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1761731730080, onlineDateStr=2025-10-29, pubDate=1724256000000, pubDateStr=2024-08-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1761731730080, onlineIssueDateStr=2025-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1761731730080, creator=13701087609, updateTime=1761731730080, updator=13701087609, issue=Issue{id=1190352404290831102, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='16', pageStart='1453', pageEnd='1550', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1761731728860, creator=13701087609, updateTime=1761732143204, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1190354142230053404, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1190352404290831102, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1190354142230053405, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1190352404290831102, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1545, endPage=1550, ext={EN=ArticleExt(id=1190352409625989454, articleId=1190352409403691341, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Comparison of Efficacy and Safety of Different Preparations of Intravenous Human Immunoglobulin for Kawasaki Disease Treatment in Children, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To investigate the efficacy and safety of different preparations of intravenous immunoglobulin (IVIG) for Kawasaki disease treatment in children. METHODS A retrospective analysis of medical records of pediatric Kawasaki disease patients at our institution in recent three years was conducted. Patients were divided into preparation A group and preparation B group based on the type of IVIG preparations used. Both groups received IVIG (2 g·kg-1) in conjunction with aspirin therapy following Kawasaki disease diagnosis. Changes in body temperature, white blood cell count, platelet count, C-reactive protein levels, IVIG cost, length of hospital stay, and adverse events were compared. RESULTS According to the drug labeling, there are certain differences between preparation A and preparation B. Preparation B exhibited a significantly shorter duration of fever resolution compared with preparation A (P<0.005), and at the first temperature test after infusion, the body temperature of preparation B group was significantly lower than that of preparation A group (P<0.05). Furthermore, preparation B demonstrated a more significant reduction in white blood cell count following treatment (P=0.010). In terms of hospital stay duration and IVIG monotherapy costs, preparation B had significantly shorter hospital stay (P<0.05) and lower per-unit IVIG expense (P<0.001). No significant differences were observed between the two groups in terms of adverse events, including rashes, infusion interruptions due to high fever, liver injury, and coronary dilation. CONCLUSION There is significant difference in efficacy between different preparations of intravenous immunoglobulin in the treatment of Kawasaki disease in children, but the safety is similar.

, correspAuthors=Jing MIAO, 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=Huawei ZHAO, Yuefang SHEN, Wuxiao ZHOU, Yinghua NI, Yanhong LI, Yangyang SUN, Jing MIAO), CN=ArticleExt(id=1190352492669014541, articleId=1190352409403691341, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=静注人免疫球蛋白不同制剂对儿童川崎病治疗有效性和安全性的比较分析, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 比较分析不同静注人免疫球蛋白(intravenous immunoglobulin,IVIG)制剂对儿童川崎病治疗的有效性和安全性。方法 回顾性分析我院近3年的川崎病患儿的病历,使用2种IVIG制剂,分别定义为制剂A和制剂B。纳入患儿均在确诊川崎病后给予IVIG(2g·kg-1)联合阿司匹林治疗,进而对比2种IVIG制剂治疗前后的体温变化、白细胞计数、血小板计数、C-反应蛋白及IVIG单药费用、住院时间和不良事件的情况。结果 根据药品说明书,制剂A和制剂B的药品相关信息存在一定的差异。制剂B退热所需时间比制剂A更短,两者之间存在显著性差异(P<0.005),在输注结束后第一次体温检测中,制剂B组患者体温值显著低于制剂A组(P<0.05),并且与制剂A相比,制剂B治疗后患者白细胞下降更为显著(P=0.010)。在住院时间和IVIG单药费用方面,制剂B显著缩短住院时间(P<0.05),单位体质量的IVIG费用更低(P<0.001)。在不良事件方面,包括皮疹、高热中断输液、肝损伤和冠脉扩张的发生,2组之间没有显著差异。结论 静注人免疫球蛋白不同制剂对儿童川崎病治疗的临床有效性存在差异,但治疗安全性相当。

, correspAuthors=缪静, authorNote=null, correspAuthorsNote=
* 缪静,女,博士,主任药师 研究方向:临床药学 Tel:(0571)86670401
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赵华伟和沈月芳为共同第一作者

赵华伟,女,硕士,副主任药师 研究方向:临床药学和神经药理学;

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2 浙江大学临床药学研究中心, 杭州 310058, bio={"content":"

赵华伟,女,硕士,副主任药师 研究方向:临床药学和神经药理学;

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赵华伟,女,硕士,副主任药师 研究方向:临床药学和神经药理学;

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China Mod Med(中国当代医药), 2021, 28(19), 264-266., articleTitle=Application of clinical nursing path in pediatric transfusion nursing, refAbstract=null)], funds=[Fund(id=1190364518971707983, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, awardId=82003720, language=CN, fundingSource=国家自然科学基金青年基金项目(82003720), fundOrder=null, country=null), Fund(id=1190364519026233936, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, awardId=LYY22H310002, language=CN, fundingSource=浙江省基础公益研究计划项目(LYY22H310002), fundOrder=null, country=null), Fund(id=1190364519097537105, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, awardId=2022年度医坛新秀, language=CN, fundingSource=浙江省新一轮卫生高层次人才培养工程(2022年度医坛新秀), fundOrder=null, country=null), Fund(id=1190364519156257362, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, awardId=CHZJU2023YS006, language=CN, fundingSource=浙江大学医学院附属儿童医院青年临床科学家培育专项基金(CHZJU2023YS006), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1190364514714489344, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, xref=1, ext=[AuthorCompanyExt(id=1190364514722877953, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, companyId=1190364514714489344, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 National Clinical Research Center for Child Health, Department of Pharmacy, Children's Hospital of Zhejiang University School of Medicine, Hangzhou 310052, China), AuthorCompanyExt(id=1190364514731266562, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, companyId=1190364514714489344, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 浙江大学医学院附属儿童医院药剂科,国家儿童健康与疾病临床医学研究中心, 杭州 310052)]), AuthorCompany(id=1190364514785792515, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, xref=2, ext=[AuthorCompanyExt(id=1190364514794181124, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, companyId=1190364514785792515, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 Research Center for Clinical Pharmacy, Zhejiang University, Hangzhou 310058, China), AuthorCompanyExt(id=1190364514802569733, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, companyId=1190364514785792515, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 浙江大学临床药学研究中心, 杭州 310058)]), AuthorCompany(id=1190364514878067206, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, xref=3, ext=[AuthorCompanyExt(id=1190364514882261512, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, companyId=1190364514878067206, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3 Department of Pharmacy, Wuyi Maternal and Child Care Hospital, Jinhua 321200, China), AuthorCompanyExt(id=1190364514890650120, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, companyId=1190364514878067206, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3 武义县妇幼保健院药剂科, 浙江 金华 321200)])], figs=[ArticleFig(id=1190364517637919293, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, language=EN, label=null, caption=null, figureFileSmall=0jnattkpxOsWDEc9t7cH5A==, figureFileBig=FuNL4gEdrlcWPJZkr4wAsg==, tableContent=null), ArticleFig(id=1190364517742776894, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, language=CN, label=图1, caption=川崎病病例筛选纳入与排除流程图, figureFileSmall=0jnattkpxOsWDEc9t7cH5A==, figureFileBig=FuNL4gEdrlcWPJZkr4wAsg==, tableContent=null), ArticleFig(id=1190364517826662975, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
制剂代码 制剂A 制剂B
名称 静注人免疫球蛋白(pH4) 静注人免疫球蛋白(pH4)
成分 主要成分为人免疫球蛋白 95%以上的蛋白质为免疫球蛋白
辅料 含适量麦芽糖作稳定剂,不含抑菌剂和抗生素 麦芽糖
工艺 由健康人血浆经低温乙醇蛋白分离法分离纯化,去除抗补体活性并经纳米膜过滤去除病毒及低pH孵化法灭活
病毒制成。免疫球蛋白G(IgG)亚类分布接近正常人血清水平,保留了IgG的Fc段生物学活性		 未提及
规格 每瓶5 g 每瓶10 g
用量 川崎病:发病10 d内应用,儿童治疗剂量2.0 g·kg-1体质量,1次输注。 川崎病:发病10 d内应用,儿童治疗剂量2.0 g·kg-1体质量,1次输注
包装 玻璃瓶、卤化丁基橡胶塞 中性硼硅玻璃输液瓶
执行标准 国家药品注册标准YBS01332021 《中国药典》2020年版三部
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川崎病治疗用两种静注人免疫球蛋白制剂的主要异同点

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制剂代码 制剂A 制剂B
名称 静注人免疫球蛋白(pH4) 静注人免疫球蛋白(pH4)
成分 主要成分为人免疫球蛋白 95%以上的蛋白质为免疫球蛋白
辅料 含适量麦芽糖作稳定剂,不含抑菌剂和抗生素 麦芽糖
工艺 由健康人血浆经低温乙醇蛋白分离法分离纯化,去除抗补体活性并经纳米膜过滤去除病毒及低pH孵化法灭活
病毒制成。免疫球蛋白G(IgG)亚类分布接近正常人血清水平,保留了IgG的Fc段生物学活性		 未提及
规格 每瓶5 g 每瓶10 g
用量 川崎病:发病10 d内应用,儿童治疗剂量2.0 g·kg-1体质量,1次输注。 川崎病:发病10 d内应用,儿童治疗剂量2.0 g·kg-1体质量,1次输注
包装 玻璃瓶、卤化丁基橡胶塞 中性硼硅玻璃输液瓶
执行标准 国家药品注册标准YBS01332021 《中国药典》2020年版三部
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制剂
代码		 川崎病休克
综合征/例		 皮肤黏膜淋巴结
综合征/例		 静注人免疫球蛋白(IVIG)
无应答型川崎病/例
制剂A 10 674 115
制剂B 4 390 68
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川崎病相关的诊断分布

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制剂
代码		 川崎病休克
综合征/例		 皮肤黏膜淋巴结
综合征/例		 静注人免疫球蛋白(IVIG)
无应答型川崎病/例
制剂A 10 674 115
制剂B 4 390 68
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基本特征类别 A组(n=105) B组(n=101) 统计值 P值
年龄/月 27.89±21.83 31.72±19.87 t=1.382 0.168
体质量/kg 12.25±4.38 13.32±3.80 t=1.798 0.074
性别(男,%) 63(60.00) 57(56.44) χ2=0.269 0.604
IVIG前发热天数/d 5.49±1.52 5.72±2.18 t=0.928 0.355
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纳入川崎病患者的基本特征

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基本特征类别 A组(n=105) B组(n=101) 统计值 P值
年龄/月 27.89±21.83 31.72±19.87 t=1.382 0.168
体质量/kg 12.25±4.38 13.32±3.80 t=1.798 0.074
性别(男,%) 63(60.00) 57(56.44) χ2=0.269 0.604
IVIG前发热天数/d 5.49±1.52 5.72±2.18 t=0.928 0.355
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指标 组别 时间点1 时间点2 时间点3 时间点4 时间点5
体温/℃ A组(n=105) 38.49±4.34 37.94±2.42 37.72±2.38 37.2±4.96 37.12±5.83
B组(n=101) 38.30±4.05 37.84±2.13 37.46±3.39 37.09±4.98 36.93±6.54
统计值 双因素重复测量:F(1,204)=5.249,P=0.023
P值 0.151 0.656 0.0371) 0.443 0.063
发热人数/例 A组(n=105) 80 58 46 20 13
B组(n=101) 76 56 31 18 6
χ2值 0.025 0.001 3.784 0.051 2.55
P值 0.875 0.976 0.052 0.821 0.11
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IVIG对川崎患者发热的作用。$\bar{x}±s$

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指标 组别 时间点1 时间点2 时间点3 时间点4 时间点5
体温/℃ A组(n=105) 38.49±4.34 37.94±2.42 37.72±2.38 37.2±4.96 37.12±5.83
B组(n=101) 38.30±4.05 37.84±2.13 37.46±3.39 37.09±4.98 36.93±6.54
统计值 双因素重复测量:F(1,204)=5.249,P=0.023
P值 0.151 0.656 0.0371) 0.443 0.063
发热人数/例 A组(n=105) 80 58 46 20 13
B组(n=101) 76 56 31 18 6
χ2值 0.025 0.001 3.784 0.051 2.55
P值 0.875 0.976 0.052 0.821 0.11
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临床表现 组别 患者/例 治疗后消退/例 症状消退率/% χ2值 P值 消退时间/d t值 P值
眼结膜充血 A组 94 82 87.2 0.758 0.384 1 4.85±2.07 0.644 0.521
B组 91 83 91.2 5.06±2.05
口腔黏膜猩红 A组 87 52 59.8 0.218 0.640 2 5.25±2.28 0.836 0.405
B组 87 55 63.2 4.87±2.38
杨梅舌 A组 74 60 81.1 1.965 0.161 4.05±2.01 1.130 0.261
B组 73 52 71.2 3.65±1.64
颈部淋巴结肿大 A组 85 7 8.2 0.892 0.345 6.00±4.08 0.885 0.389
B组 87 11 12.6 4.63±2.50
皮疹 A组 76 59 77.6 0.003 0.959 3 5.14±2.69 0.841 0.403
B组 66 51 77.3 5.55±2.44
肢端手足硬肿 A组 45 30 66.7 1.541 0.214 4 4.43±2.06 0.488 0.627
B组 42 33 78.6 4.15±2.48
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川崎病患者临床症状消退情况

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临床表现 组别 患者/例 治疗后消退/例 症状消退率/% χ2值 P值 消退时间/d t值 P值
眼结膜充血 A组 94 82 87.2 0.758 0.384 1 4.85±2.07 0.644 0.521
B组 91 83 91.2 5.06±2.05
口腔黏膜猩红 A组 87 52 59.8 0.218 0.640 2 5.25±2.28 0.836 0.405
B组 87 55 63.2 4.87±2.38
杨梅舌 A组 74 60 81.1 1.965 0.161 4.05±2.01 1.130 0.261
B组 73 52 71.2 3.65±1.64
颈部淋巴结肿大 A组 85 7 8.2 0.892 0.345 6.00±4.08 0.885 0.389
B组 87 11 12.6 4.63±2.50
皮疹 A组 76 59 77.6 0.003 0.959 3 5.14±2.69 0.841 0.403
B组 66 51 77.3 5.55±2.44
肢端手足硬肿 A组 45 30 66.7 1.541 0.214 4 4.43±2.06 0.488 0.627
B组 42 33 78.6 4.15±2.48
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组别 WBC/×109·L-1 PLT/×109·L-1 CRP/mg·L-1
治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
A组 13.89 ±4.53 8.56 ±2.84 357.96 ±86.8 510.11 ±142.15 67.63 ±44.25 9.57 ±7.61
B组 14.35 ±4.65 7.55 ±2.81 369.66 ±103.98 508.86 ±128.93 61.92 ±43.36 9.05 ±6.81
t值 0.708 2.584 0.878 0.066 0.934 0.512
P值 0.479 0.0101) 0.381 0.947 0.352 0.609
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IVIG对纳入患者实验室指标的影响

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组别 WBC/×109·L-1 PLT/×109·L-1 CRP/mg·L-1
治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
A组 13.89 ±4.53 8.56 ±2.84 357.96 ±86.8 510.11 ±142.15 67.63 ±44.25 9.57 ±7.61
B组 14.35 ±4.65 7.55 ±2.81 369.66 ±103.98 508.86 ±128.93 61.92 ±43.36 9.05 ±6.81
t值 0.708 2.584 0.878 0.066 0.934 0.512
P值 0.479 0.0101) 0.381 0.947 0.352 0.609
), ArticleFig(id=1190364518594220619, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
IVIG费用类别 A组 B组 t值 P值
总费用/元 5 656.76 ±1 867.33 5 195.05 ±1 529.9 1.937 0.0541
每kg体质量费用/元 470.07 ±76.37 390.03 ±34.95 58.12 <0.0011)
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川崎病患者使用2种IVIG制剂的费用比较

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IVIG费用类别 A组 B组 t值 P值
总费用/元 5 656.76 ±1 867.33 5 195.05 ±1 529.9 1.937 0.0541
每kg体质量费用/元 470.07 ±76.37 390.03 ±34.95 58.12 <0.0011)
), ArticleFig(id=1190364518757798477, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190352409403691341, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
不良事件类别 A组 B组 χ2值 P值
输液反应(发热) 14 15 0.098 0.754
输液反应(皮疹) 2 2 0.002 0.969
冠状动脉扩张 20 13 1.460 0.227
肝功能损伤 9 8 0.029 0.865
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IVIG治疗川崎病的不良事件

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不良事件类别 A组 B组 χ2值 P值
输液反应(发热) 14 15 0.098 0.754
输液反应(皮疹) 2 2 0.002 0.969
冠状动脉扩张 20 13 1.460 0.227
肝功能损伤 9 8 0.029 0.865
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静注人免疫球蛋白不同制剂对儿童川崎病治疗有效性和安全性的比较分析
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赵华伟 1, 2 , 沈月芳 1 , 周武孝 3 , 倪映华 1 , 李彦红 1 , 孙洋洋 1 , 缪静 1, 2, *
中国药学杂志 | 论著 2024,59(16): 1545-1550
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中国药学杂志 | 论著 2024, 59(16): 1545-1550
静注人免疫球蛋白不同制剂对儿童川崎病治疗有效性和安全性的比较分析
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赵华伟1, 2, 沈月芳1, 周武孝3, 倪映华1, 李彦红1, 孙洋洋1, 缪静1, 2, *
作者信息
  • 1 浙江大学医学院附属儿童医院药剂科,国家儿童健康与疾病临床医学研究中心, 杭州 310052
  • 2 浙江大学临床药学研究中心, 杭州 310058
  • 3 武义县妇幼保健院药剂科, 浙江 金华 321200

    • 赵华伟,女,硕士,副主任药师 研究方向:临床药学和神经药理学;

通讯作者:

* 缪静,女,博士,主任药师 研究方向:临床药学 Tel:(0571)86670401
Comparison of Efficacy and Safety of Different Preparations of Intravenous Human Immunoglobulin for Kawasaki Disease Treatment in Children
Huawei ZHAO1, 2, Yuefang SHEN1, Wuxiao ZHOU3, Yinghua NI1, Yanhong LI1, Yangyang SUN1, Jing MIAO1, 2, *
Affiliations
  • 1 National Clinical Research Center for Child Health, Department of Pharmacy, Children's Hospital of Zhejiang University School of Medicine, Hangzhou 310052, China
  • 2 Research Center for Clinical Pharmacy, Zhejiang University, Hangzhou 310058, China
  • 3 Department of Pharmacy, Wuyi Maternal and Child Care Hospital, Jinhua 321200, China
出版时间: 2024-08-22 doi: 10.11669/cpj.2024.16.013
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摘要
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目的 比较分析不同静注人免疫球蛋白(intravenous immunoglobulin,IVIG)制剂对儿童川崎病治疗的有效性和安全性。方法 回顾性分析我院近3年的川崎病患儿的病历,使用2种IVIG制剂,分别定义为制剂A和制剂B。纳入患儿均在确诊川崎病后给予IVIG(2g·kg-1)联合阿司匹林治疗,进而对比2种IVIG制剂治疗前后的体温变化、白细胞计数、血小板计数、C-反应蛋白及IVIG单药费用、住院时间和不良事件的情况。结果 根据药品说明书,制剂A和制剂B的药品相关信息存在一定的差异。制剂B退热所需时间比制剂A更短,两者之间存在显著性差异(P<0.005),在输注结束后第一次体温检测中,制剂B组患者体温值显著低于制剂A组(P<0.05),并且与制剂A相比,制剂B治疗后患者白细胞下降更为显著(P=0.010)。在住院时间和IVIG单药费用方面,制剂B显著缩短住院时间(P<0.05),单位体质量的IVIG费用更低(P<0.001)。在不良事件方面,包括皮疹、高热中断输液、肝损伤和冠脉扩张的发生,2组之间没有显著差异。结论 静注人免疫球蛋白不同制剂对儿童川崎病治疗的临床有效性存在差异,但治疗安全性相当。

静注人免疫球蛋白  /  川崎病  /  制剂  /  退热时间  /  不良事件

OBJECTIVE To investigate the efficacy and safety of different preparations of intravenous immunoglobulin (IVIG) for Kawasaki disease treatment in children. METHODS A retrospective analysis of medical records of pediatric Kawasaki disease patients at our institution in recent three years was conducted. Patients were divided into preparation A group and preparation B group based on the type of IVIG preparations used. Both groups received IVIG (2 g·kg-1) in conjunction with aspirin therapy following Kawasaki disease diagnosis. Changes in body temperature, white blood cell count, platelet count, C-reactive protein levels, IVIG cost, length of hospital stay, and adverse events were compared. RESULTS According to the drug labeling, there are certain differences between preparation A and preparation B. Preparation B exhibited a significantly shorter duration of fever resolution compared with preparation A (P<0.005), and at the first temperature test after infusion, the body temperature of preparation B group was significantly lower than that of preparation A group (P<0.05). Furthermore, preparation B demonstrated a more significant reduction in white blood cell count following treatment (P=0.010). In terms of hospital stay duration and IVIG monotherapy costs, preparation B had significantly shorter hospital stay (P<0.05) and lower per-unit IVIG expense (P<0.001). No significant differences were observed between the two groups in terms of adverse events, including rashes, infusion interruptions due to high fever, liver injury, and coronary dilation. CONCLUSION There is significant difference in efficacy between different preparations of intravenous immunoglobulin in the treatment of Kawasaki disease in children, but the safety is similar.

intravenous immunoglobulin  /  Kawasaki disease  /  preparation  /  fever resolution duration  /  adverse event
赵华伟, 沈月芳, 周武孝, 倪映华, 李彦红, 孙洋洋, 缪静. 静注人免疫球蛋白不同制剂对儿童川崎病治疗有效性和安全性的比较分析. 中国药学杂志, 2024 , 59 (16) : 1545 -1550 . DOI: 10.11669/cpj.2024.16.013
Huawei ZHAO, Yuefang SHEN, Wuxiao ZHOU, Yinghua NI, Yanhong LI, Yangyang SUN, Jing MIAO. Comparison of Efficacy and Safety of Different Preparations of Intravenous Human Immunoglobulin for Kawasaki Disease Treatment in Children[J]. Chinese Pharmaceutical Journal, 2024 , 59 (16) : 1545 -1550 . DOI: 10.11669/cpj.2024.16.013
正文
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川崎病,又名皮肤黏膜淋巴结综合征,是一种原因不明的急性、自限性的全身性血管炎,为小儿常见的发热性出疹性疾病。其特点为持续(多为5 d以上)发热伴多型性皮疹、双眼球结膜充血、口腔黏膜猩红、杨梅舌、急性非化脓性的颈部淋巴结肿大,以及恢复期指(趾)端特异性膜状脱皮等[1]。
2022年的《川崎病诊断和急性期治疗专家共识》优先推荐尽早使用大剂量静注人免疫球蛋白(introvenous immunoglobulin,IVIG)和阿司匹林作为首选用药[2]。根据《中国药典》2020年版: IVIG是由健康人血浆,经低温乙醇蛋白分离法或经批准的其他分离法分离纯化,并经病毒去除和灭活处理制成的生物制剂[3]。IVIG的生产过程包括原料血浆的控制、原液生产工艺、制剂生产工艺、病毒灭活工艺等多个环节,每个环节的质量控制都可能影响IVIG治疗的有效性和安全性。比如Mahadevia[4]的研究表明,与溶剂-洗涤剂方法制备的IVIG相比,辛酸沉淀和色谱纯化制备的IVIG可以节省原发性免疫缺陷或特发性血小板减少性紫癜(ITP)患者的治疗费用。日本的一项研究[5]还发现,高钠含量的IVIG与微量钠含量的IVIG制剂相比,能显著降低川崎病患者的冠状动脉瘤的发生率。在2019年的国家药品评价性抽检中,共抽检115个批次的IVIG制剂,在符合药典规定的基础上,其有效性和安全性指标也表现出了较大的差异[6]。
目前我院有2种不同的IVIG制剂,但尚不清楚不同的制剂是否会对儿童川崎病的疗效以及安全性造成影响。因此,本文通过临床数据的回顾性分析对该问题加以探讨分析。
1 资料与方法
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1.1 研究对象及纳入排除标准
回顾性分析近3年在我院住院接受IVIG的川崎病患儿的临床情况。我院IVIG有2种制剂,分别定义为制剂A和制剂B。研究对象纳入标准:①符合2017年美国心脏协会发布的川崎病诊断标准;②患儿一旦确诊,立即接受2 g·kg-1的IVIG及阿司匹林治疗,且IVIG单次给药;③临床资料及实验室资料完整。排除标准:①IVIG合用氯吡格雷等其他药物的患儿;②IVIG多次给药的;③合并使用激素治疗的;④输注IVIG过程中有输液中断暂停的;⑤临床资料不完整。
1.2 研究方法
回顾性收集患儿的住院病历资料,包括:主要结局指标为患者使用制剂A或者制剂B前后的体温变化,患者住院期间每4 h记录1次体温,分别在每天的2、6、10、14、18、22点检测体温值,根据体温记录,评价2组患者体温降至正常,且不再反弹所需要的时间,同时分析IVIG使用前后患者的体温变化趋势。次要结局指标为临床症状的消退及治疗前后白细胞 (white blood cell,WBC) 计数、血小板 (platelet,PLT)计数、C-反应蛋白 (C-reactive protein,CRP)等实验室指标、IVIG耐药性、住院时间和IVIG药品费用。临床症状的消退主要包括眼结膜充血、口唇变化、杨梅舌、颈部淋巴结、皮疹和肢端手足硬肿情况,记录患者从症状出现到症状消退所需的时间。IVIG耐药定义为使用总剂量≥2.0 g·kg-1的IVIG后36 h,体温仍高于38 ℃,需要再次使用IVIG或者激素治疗,此类患者诊断为“IVIG无应答型川崎病”。同时,也收集了患儿的基础信息,包括:年龄、性别、体质量、使用IVIG前的发热时间。
1.3 统计分析
采用 Graph Pad Prism 8 统计软件对数据进行统计学分析。正态分布的计量资料以均数±标准差($\bar{x}±s$)表示,2组间比较采用两样本t检验;若方差不齐,2组间比较采用 Mann-Whitney U 检验。计数资料采用例数或百分率(%)表示,组间比较采用卡方(χ2)检验。P<0.05 为有统计学意义上的显著性差异。
2 结果
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2.1 2种制剂的主要异同点
查询2种制剂的药品说明书,并对2种制剂的差异进行比较总结,主要表现在成分、辅料、规格、工艺、包装和执行标准等方面,具体信息见表1。
2.2 纳入病例及基本特征
对本院近3年的病历系统进行检索,诊断与“川崎”相关的共有1 261条,包括“川崎病休克综合征”“皮肤黏膜淋巴结综合征(川崎病)”“IVIG无应答型川崎病”3种诊断,各诊断的病例分布见表2,其中使用制剂A的患者发生IVIG无应答的概率为14.4%,使用制剂B的患者发生IVIG无应答的概率为14.7%,两组之间没有显著差异。为进一步分析两种制剂对川崎病治疗效果的差异,本回顾性分析将仅针对诊断为“皮肤黏膜淋巴结综合征(川崎病)”的患者做详细分析。根据纳入排除标准,共纳入206名患者,其中,使用制剂A的(A组)有105名患者,使用制剂B的(B组)有101名患者,详细的纳排过程见图1。对纳入病例的基本信息进行总结分析,2组之间没有显著性差异,见表3。
2.3 IVIG治疗后退热时间
退热时间是指从IVIG输注结束至体温降至正常所需的时间,时间计算以0.5 h为最小单位,采用Mann-Whitney检验,A组的平均退热时间为(7.71±9.34)h,B组的平均退热时间为(4.38±5.72)h,P=0.002 2,B组退热所需的时间显著少于A组。
2.4 IVIG治疗前后的体温变化趋势
患者体温每4 h记录1次,以IVIG注射结束的时间为分界点,分别记录注射结束前两个时间点的体温值和注射结束后3个时间点的体温值。见表4,可以发现2组在给药前体温没有显著差异,在注射结束后的第一次体温检测中,发现与A组相比,B组的体温显著降低(P<0.05),同时,在此次体温检测时,B组仍然发热的患者减少的趋势,但差异无统计学意义。
2.5 临床表现消退时间
进一步分析临床相关症状发现,2组在眼结膜充血、口腔黏膜猩红、杨梅舌、颈部淋巴结肿大、皮疹、肢端手足硬肿等方面未呈现显著差异。此外,对于症状消退患者的消退时间进行了详细分析,结果显示2组在此方面也没有显著性差异。具体分析结果见表5。研究结果表明,2组在各临床表现的症状消退率和症状消退时间上均未显示出显著差异。
2.6 实验室指标
回顾性收集患者的实验室数据指标,两组间比较采用两样本t检验,治疗后,与A组相比,B组的白细胞计数下降得更为显著(P=0.010),而血小板计数和CRP两组之间没有显著性差异。详细数据见表6。
2.7 住院天数
对2组患者总的住院时长进行比较分析,A组的住院天数为(6.12±1.79)d,B组的住院天数为(5.65±1.59)d,P=0.048,B组患者的住院天数显著减少。
2.8 IVIG药品费用比较
住院期间患者使用制剂A和制剂B的单药费用,B组的IVIG总费用比A组略有下降,但没有显著性差异(P=0.054),具体信息见表7。由于IVIG是按体质量给予2 g·kg-1的剂量,因此本研究进一步分析每单位体质量(1 kg)所消耗的费用,结果发现,单位体重消耗的IVIG费用B组显著低于A组(P<0.001)。
2.9 不良事件
A组有16例患者在输注IVIG过程中暂停输液,其中14例是因为高热,2例是因为皮疹;B组有17例患者在输注IVIG过程中暂停输液,其中15例是因为高热,2例是因为皮疹。部分患者治疗后发生了冠状动脉扩张,A组有20例(19.0%),B组有13例(12.9%)。治疗后A组有9例出现肝损伤,B组有8例出现肝损伤。2组之间均没有显著性差异,见表8。
3 讨论
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大剂量IVIG和阿司匹林是川崎病的一线治疗药物,及时使用可以改善炎症,防止冠脉扩张,对于患者的预后具有重要作用[7]。在本回顾性研究当中,相比于制剂A,制剂B可以使患者的体温更快地降至正常,患者住院时间显著缩短,治疗后白细胞计数显著降低。
川崎病是一种发热性的急性小儿血管炎,粒细胞巨噬细胞集落刺激因子(GM-CSF)在炎症期间充当细胞迁移的潜在启动剂,WBC计数降低可能反映 GM-CSF 表达水平较低,IVIG治疗后WBC计数降低则表明患儿治疗效果良好[8-9]。长时间发热是川崎病发生冠状动脉病变的危险因素[10],体温变化趋势可能预示着川崎病对IVIG的应答水平[11],因此,消除炎症,使体温尽早降至正常水平,对患者的预后可能具有重要的意义。本研究对患者资料进行了详细的分析,结果发现,2种制剂在临床表现的消退时间上没有显著差异,但是制剂B比制剂A可以更快地降低川崎病患者的体温,并在一定程度上减少了后期冠状动脉扩张的发生概率(A组19.0%, B组12.9%)。这可能与制剂B更快地使白细胞计数下降有关[12]。
一项多中心研究表明[13],儿童川崎病住院患者的平均住院天数为5~7 d,住院过程中的药品费用约占住院总费用的一半左右,而药品费用的80%~90%为IVIG的药品费用,约为5 049~6 300元。本课题组的分析结果与该研究基本一致,在此范围内,制剂B比制剂A显著缩短了患者的住院天数,并且制剂B的单药费用比制剂A有所降低,这两方面均大大减少了患者的住院费用,减轻了家庭和社会负担。
根据以往研究[5-6],不同的制剂工艺可能会影响IVIG的治疗效果。国家药品监督管理局药品审评中心的一项综述分析显示[14],为提高产量,部分企业会对生产工艺进行改进,而在工艺改进或规模扩大的过程中,产品有可能会发生非预期变化[15-16]。有报道称用于病毒灭活的低pH值灭活工艺,能够在一定程度降低IVIG产品的凝血因子活性,因此改变低pH值灭活工艺可能不仅影响产品的病毒安全性,还可能造成变更后产品凝血因子活性的非预期改变[17]。生产工艺除了会影响凝血因子,还会影响IgG亚型分布、IgA、IgM以及其他杂质的含量,从而对治疗效果带来一定的影响。为了获取更好的疗效,企业对于IVIG生产工艺的探索仍在进行,传统的乙醇分馏至少基于3个沉淀步骤,步骤多,耗时长,对IVIG疗效影响的因素多。而目前尚在研究中的层析法,可使IgG浓度高达10%,患者的输注时间更短,同时生产工艺可控,杂质含量低,不良事件发生少,为临床应用提供了更好的前景[18]。
为评价不同IVIG制剂的临床有效性和安全性,Guo等[6]分别对不同IVIG制剂开展了不良反应影响因素(IgA残留量、促凝血物质残留)、病毒残留风险及 Fc段生物学活性等3个方面的探索性研究。结果发现,所有制剂中均无病毒残留,IgA含量与FXIa活性差异较大,与IVIG的临床疗效密切相关的Fc段生物学活性,在59批制剂样品中呈现了78%~319%的差异。Fc段是IgG与效应分子、细胞相互作用的部分,具有激活补体系统等生物学作用。这也可能是导致本研究中制剂A与制剂B临床疗效存在差异的重要原因。
同时,制剂B规格较大,可以减少患者输液时的换瓶次数,从而减少输液微粒和输液风险[19-21]。静脉输液中的微粒污染除了来源于药物和输液装置本身,还可能来自穿刺胶塞和室内环境[22],病房空气污染是不溶性微粒污染的重要原因。因此,对于大规格的制剂B可以减少来自反复穿刺胶塞和室内环境引入的微粒污染,从而减少输液微粒可能带来的风险。另外,输液时往往存在一定的输液残留,在Chen[23]的研究中发现,不同的更换输液瓶法可导致输液残留量的显著性差异。而在一项输液护理研究中,发现输液残留竟然高达15 mL以上[24]。因此,减少换瓶次数,除了可以减少输液风险,还能减少药物损耗,保证足量用药,提高临床疗效。
虽然本研究从多角度对2种制剂的临床作用差异进行了分析,但还存在一定的局限性。首先,由于制剂B产品说明书制剂工艺的缺失,使得这些差异的具体机制研究无法进一步展开。其次,由于各种原因本研究仅回顾分析了3年间的病历数据,研究期限相对较短。此外,本研究为回顾性研究,本研究的发现还需要后续更高质量的临床随机对照研究进行进一步的验证。
综上所述,与制剂A相比,制剂B在川崎病的急性期能够使患者的体温更快地降至正常水平,缩短住院时间,而不良事件并未增加。这提示临床需要注意,不同的IVIG制剂在儿童川崎病的治疗中可能存在疗效的差异。这种差异可能与Fc段生物学活性或制剂工艺和规格等因素有关,还需进一步研究。
基金
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  • 国家自然科学基金青年基金项目(82003720)
  • 浙江省基础公益研究计划项目(LYY22H310002)
  • 浙江省新一轮卫生高层次人才培养工程(2022年度医坛新秀)
  • 浙江大学医学院附属儿童医院青年临床科学家培育专项基金(CHZJU2023YS006)
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参考文献 引证文献
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2024年第59卷第16期
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doi: 10.11669/cpj.2024.16.013
  • 接收时间：2023-11-16
  • 首发时间：2025-10-29
  • 出版时间：2024-08-22
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  • 收稿日期：2023-11-16
基金
国家自然科学基金青年基金项目(82003720)
浙江省基础公益研究计划项目(LYY22H310002)
浙江省新一轮卫生高层次人才培养工程(2022年度医坛新秀)
浙江大学医学院附属儿童医院青年临床科学家培育专项基金(CHZJU2023YS006)
作者信息
    1 浙江大学医学院附属儿童医院药剂科,国家儿童健康与疾病临床医学研究中心, 杭州 310052
    2 浙江大学临床药学研究中心, 杭州 310058
    3 武义县妇幼保健院药剂科, 浙江 金华 321200

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* 缪静,女,博士,主任药师 研究方向:临床药学 Tel:(0571)86670401
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2种不同金属材料的力学参数
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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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