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Article(id=1239222197710017452, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239222192311948159, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.11.09, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1696953600000, receivedDateStr=2023-10-11, revisedDate=null, revisedDateStr=null, acceptedDate=1720627200000, acceptedDateStr=2024-07-11, onlineDate=1773383195569, onlineDateStr=2026-03-13, pubDate=1732464000000, pubDateStr=2024-11-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773383195569, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773383195569, creator=13701087609, updateTime=1773383195569, updator=13701087609, issue=Issue{id=1239222192311948159, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='11', pageStart='801', pageEnd='880', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1773383194282, creator=13701087609, updateTime=1773384015681, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239225637551002124, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239222192311948159, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239225637551002125, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239222192311948159, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=845, endPage=851, ext={EN=ArticleExt(id=1239222198674707414, articleId=1239222197710017452, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Evaluation on rational application of irinotecan based on weighted TOPSIS method, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=
AIM

To evaluate the rationality of irinotecan application based on weighted TOPSIS method.

METHODS

Based on the drug label of irinotecan, combined with relevant guidelines and literatures, weighted TOPSIS method was used to establish the evaluation criteria for the rationality of irinotecan clinical application, with “indications,contraindications, application and dosage, solvent selection, baseline examination, pretreatment, administration sequence,blood routine monitoring, dosage adjustment and ADR monitoring” as evaluation indicators. The archived medical records of inpatients who had used irinotecan in Binhu Hospital of Hefei from January 1, 2022 to May 31, 2023 were evaluated for the rationary of irinotecan administration.

RESULTS

Among the 10 evaluation indicators, the highest relative weighted index was indication（0.133 1）, while the lowest was pretreatment（0.084 9）. Among the included 97 cases, 10 cases（10%）had relative proximity（Ci）≥0.8, with the evaluation result as rational drug application; 79 cases（81%）had 0.6≤ Ci< 0.8,with the evaluation result as basic rational drug application; 8 cases（8%）had 0.4≤Ci < 0.6, with the evaluation result as irrational drug application.

CONCLUSION

The weighted TOPSIS method can be used to evaluate the rational usage of irinotecan. In our hospital, the use of irinotecan is basically reasonable, however, there are still some problems about baseline examination, blood routine monitoring and unreasonable indications.

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目的

基于加权TOPSIS法评价伊立替康的用药合理性。

方法

以国内药品说明书为基础，结合相关指南和文献，以“适应证、禁忌证、用法用量、溶媒选择、基线检查、预处理、给药顺序、血常规监测、剂量调整、不良反应监测”为评价指标，采用加权TOPSIS法建立伊立替康用药合理性评价标准，对合肥市滨湖医院2022年1月1日至2023年5月31日使用伊立替康的住院患者的归档病历进行伊立替康用药合理性评价。

结果

10项评价指标中，相对权重系数最高的为适应证（0.133 1），最低的为预处理（0.084 9）。共纳入97份病历，其中相对接近度（Ci）≥0.8的有10份（10%），评价为合理用药；0.6≤Ci < 0.8的有79份（81%），评价为基本合理用药；Ci < 0.6的有8份（8%），评价为不合理用药。

结论

加权TOPSIS法可用于伊立替康用药合理性评价，本院伊立替康的使用基本合理，但仍存在基线检查、血常规监测和适应证不合理等问题。

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王旭东，男，主管药师，主要从事临床药学工作，E-mail:

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王旭东，男，主管药师，主要从事临床药学工作，E-mail:

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王旭东，男，主管药师，主要从事临床药学工作，E-mail:

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Anti-cancer Drugs, 2014, 25（10）: 1122-1128., articleTitle=A systematic review of raltitrexed-based first-line chemotherapy in advanced colorectal cancer, refAbstract=null), Reference(id=1239232822393762281, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, doi=null, pmid=null, pmcid=null, year=2009, volume=20, issue=8, pageStart=597, pageEnd=600, url=null, language=null, rfNumber=[24], rfOrder=28, authorNames=付向阳, 许新华, 薛 峰, journalName=中国药房, refType=null, unstructuredReference=付向阳, 许新华, 薛 峰, 等.伊立替康联合卡培他滨与卡培他滨单药二线治疗晚期结直肠癌对比观察[J].中国药房, 2009, 20（8）: 597-600., articleTitle=伊立替康联合卡培他滨与卡培他滨单药二线治疗晚期结直肠癌对比观察, refAbstract=null), Reference(id=1239232822486036970, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, doi=null, pmid=null, pmcid=null, year=2009, volume=20, issue=8, pageStart=597, pageEnd=600, url=null, language=null, rfNumber=[24], rfOrder=29, authorNames=FU XY, XU XH, XUE F, journalName=China Pharm, refType=null, unstructuredReference=FU XY, XU XH, XUE F, et al.Capecitabine alone or in combination with irinotecan in the second line treatment for advanced colorectal cancer[J]. China Pharm,2009, 20（8）: 597-600., articleTitle=Capecitabine alone or in combination with irinotecan in the second line treatment for advanced colorectal cancer, refAbstract=null), Reference(id=1239232822544757227, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, doi=null, pmid=null, pmcid=null, year=2013, volume=22, issue=17, pageStart=2093, pageEnd=2102, url=null, language=null, rfNumber=[25], rfOrder=30, authorNames=刘慧龙, 王 飞, 刘彦芳, journalName=中国新药杂志, refType=null, unstructuredReference=刘慧龙, 王 飞, 刘彦芳, 等. 2种FOLFIRI方案治疗晚期结直肠癌不良反应分析[J].中国新药杂志, 2013, 22（17）:2093-2102., articleTitle=2种FOLFIRI方案治疗晚期结直肠癌不良反应分析, refAbstract=null), Reference(id=1239232822624449004, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, doi=null, pmid=null, pmcid=null, year=2013, volume=22, issue=17, pageStart=2093, pageEnd=2102, url=null, language=null, rfNumber=[25], rfOrder=31, authorNames=LIU HL, WANG F, LIU YF, journalName=Chin J New Drugs, refType=null, unstructuredReference=LIU HL, WANG F, LIU YF, et al. Analysis of adverse effects related to two different FOLFIRI regimens in patients with advanced colorectal cancer[J]. Chin J New Drugs, 2013, 22（17）:2093-2102., articleTitle=Analysis of adverse effects related to two different FOLFIRI regimens in patients with advanced colorectal cancer, refAbstract=null), Reference(id=1239232822704140781, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, doi=null, pmid=null, pmcid=null, year=2014, volume=16, issue=3, pageStart=183, pageEnd=184, url=null, language=null, rfNumber=[26], rfOrder=32, authorNames=赵 霞, 李 妍, 徐 巍, journalName=药物不良反应杂志, refType=null, unstructuredReference=赵 霞, 李 妍, 徐 巍, 等.伊立替康致重度迟发性腹泻与骨髓抑制[J].药物不良反应杂志, 2014, 16（3）: 183-184., articleTitle=伊立替康致重度迟发性腹泻与骨髓抑制, refAbstract=null), Reference(id=1239232822775443950, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, doi=null, pmid=null, pmcid=null, year=2014, volume=16, issue=3, pageStart=183, pageEnd=184, url=null, language=null, rfNumber=[26], rfOrder=33, authorNames=ZHAO X, LI Y, XU W, journalName=Adv Drug React J, refType=null, unstructuredReference=ZHAO X, LI Y, XU W, et al. Severe delayed diarrhea and myelosuppression caused by irinotecan[J]. Adv Drug React J,2014, 16（3）: 183-184., articleTitle=Severe delayed diarrhea and myelosuppression caused by irinotecan, refAbstract=null)], funds=[Fund(id=1239232818828603852, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, awardId=AHWJ2022b104, language=CN, fundingSource=安徽省卫生健康科研项目(AHWJ2022b104), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1239232813661221200, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, xref=1a., ext=[AuthorCompanyExt(id=1239232813669609809, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813661221200, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1a.Department of Pharmacy, Binhu Hospital of Hefei, Hefei ANHUI 230000, China), AuthorCompanyExt(id=1239232813677998418, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813661221200, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1a.合肥市滨湖医院药学部，安徽 合肥　230000，)]), AuthorCompany(id=1239232813778661717, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, xref=1b., ext=[AuthorCompanyExt(id=1239232813787050326, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813778661717, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1b.Department of Oncology, Binhu Hospital of Hefei, Hefei ANHUI 230000, China), AuthorCompanyExt(id=1239232813799633239, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813778661717, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1b.合肥市滨湖医院肿瘤内科，安徽 合肥　230000)]), AuthorCompany(id=1239232813875130714, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, xref=2., ext=[AuthorCompanyExt(id=1239232813883519323, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813875130714, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.Department of Pharmacy, the Third People’s Hospital of Bengbu, Bengbu ANHUI 233099, China), AuthorCompanyExt(id=1239232813891907932, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813875130714, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.蚌埠市第三人民医院 药学部，安徽 蚌埠　233099)]), AuthorCompany(id=1239232813988376928, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, xref=3., ext=[AuthorCompanyExt(id=1239232813992571234, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813988376928, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Department of Pharmacy, the Second Affiliated Hospital of Bengbu Medical College, Bengbu ANHUI 233040, China), AuthorCompanyExt(id=1239232814005154146, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, companyId=1239232813988376928, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.蚌埠医学院第二附属医院 药学部，安徽 蚌埠　233040)])], figs=[ArticleFig(id=1239232817951994304, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标评价依据评价结果
适应证（1）说明书适应证：
　①伊立替康+5-氟尿嘧啶（5-FU）+亚叶酸钙（LV）（FOLFIRI方案）治疗既往未接受化疗的晚期结直肠癌患者
　②伊立替康单药治疗经含5-FU化疗方案治疗失败的晚期结直肠癌患者
（2）超说明书适应证：
　①伊立替康+卡培他滨（XELIRI方案）一线治疗晚期结直肠癌[4]
　②伊立替康+顺铂（IP方案）或伊立替康+卡铂（IC方案）二线治疗宫颈癌[5，6]
　③伊立替康+顺铂（IP方案）或伊立替康+卡铂（IC方案）一线治疗广泛期小细胞肺癌[7，8]
　④FOLFIRI方案一线治疗或伊立替康单药二线治疗晚期食管癌[9,10]
　⑤FOLFIRI方案一线治疗胃癌或伊立替康单药二线治疗胃癌或XELIRI方案二线治疗胃癌[11,12]
　⑥含伊立替康化疗方案二线治疗铂类难治性卵巢癌[13]
　⑦伊立替康+奥沙利铂+5-FU+LV（FOLFIRINOX方案）一线治疗体能状态好的局部进展期或晚期胰腺癌[14,15]		0：符合（1）或（2）中任意一项；
1：不符合（1）或（2）中任意一项
禁忌证（1）慢性炎性肠病/肠梗阻
（2）TBIL>3 ULN
（3）严重骨髓抑制
（4）WHO体力状态评分>2
（5）对伊立替康三水合物或其辅料过敏
（6）备孕、妊娠期或哺乳期妇女		0：不符合（1）~（6）中任意一项；
1：符合（1）~（6）中任意一项
用法用量（1）联合用药：伊立替康与5-FU和LV联用：180 mg·m-2静脉滴注30~90 min，第1日，每2周重复
（2）单药治疗：每周方案为125 mg·m-2静滴90 min以上，第1、8、15、22日，休息2周，每6周重复；3周方案为350 mg·m-2静滴90 min以上，第1日，每3周重复		0：符合（1）或（2）中任意一项；
1：不符合（1）或（2）中任意一项
溶媒选择（1）溶媒品种：5%葡萄糖注射液或氯化钠注射液
（2）终浓度：稀释至终浓度0.12~2.8 mg·mL-1		0：符合（1）和（2）；
1：不符合（1）或（2）中任意一项
基线检查（1）NEU≥1.5×109·L-1
（2）PLT≥100×109·L-1
（3）Hb≥100 g·L-1
（4）TBIL≤1.5 ULN
（5）CrCl≥60 mL·min-1
（6）ALT≤2.5 ULN
（7）AST≤2.5 ULN		0：符合（1）~（7）中所有项；
1：不符合（1）~（7）中任意一项
预处理[16]伊立替康为中度致吐风险的抗肿瘤药物，可采用以下任一止吐方案：
（1）5-HT3受体拮抗剂+地塞米松
（2）帕洛诺司琼+奥氮平+地塞米松
（3）5-HT3受体拮抗剂+NK-1受体拮抗剂+地塞米松		0：符合（1）~（3）中任意一项；
1：不符合（1）~（3）中任意一项
给药顺序[17,18]（1）IP/IC方案：顺铂/卡铂→伊立替康
（2）FOLFIRI方案：伊立替康→LV→5-FU
（3）FOLFIRINOX方案：伊立替康→奥沙利铂→LV→5-FU		0：符合（1）~（3）中任意一项；
1：不符合（1）~（3）中任意一项
血常规监测剂量调整治疗周期内进行血常规监测基于NCI-CTC4.0标准进行剂量调整：
（1）患者若出现4级血液学毒性，则中断治疗，待恢复至0~1级继续治疗，并于下一周期将伊立替康剂量减少10%；若延迟超过2周仍未恢复至0~1级，则停止伊立替康治疗，最多允许2次减量，若第3次出现不良反应，则停止伊立替康治疗
（2）患者若出现3级中性粒细胞减少伴发热，则中断治疗并恢复至0~1级，并于下一周期将伊立替康剂量减少10%；若延迟超过2周仍未恢复至0~1级，则停止伊立替康治疗，最多允许2次减量，若第3次出现不良反应，则停止伊立替康治疗
（3）患者若出现3级非血液学毒性，如腹泻、呕吐、乏力、外周神经反应等，则中断治疗并恢复至0~1级，并于下一周期将伊立替康剂量减少10%；若延迟超过2周仍未恢复至0~1级，则停止伊立替康治疗，最多允许2次减量，若第3次出现不良反应，则停止伊立替康治疗		0：符合；1：不符合
0：符合（1）~（3）中任意一项；
1：不符合（1）~（3）中任意一项
不良反应监测（1）严密监测胃肠道不良反应，表现为腹泻、恶心和呕吐
（2）注意监测胆碱能综合征，表现为鼻炎、流涎增多、瞳孔缩小、流泪、多汗、潮红和可引起腹部痉挛或早发性腹泻的肠蠕动亢进等
（3）注意监测电解质，预防由腹泻、恶心和呕吐引起的脱水
（4）注意监测肝脏不良反应，如肝酶异常、腹水和黄疸等
（5）监测脱水患者发生直立性低血压，以及继发的头晕、失眠等神经系统不良反应		0：符合（1）~（5）中所有项；
1：不符合（1）~（5）中任意一项
), ArticleFig(id=1239232818023297474, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=CN, label=表1, caption=

伊立替康合理用药评价标准

, figureFileSmall=null, figureFileBig=null, tableContent=
指标评价依据评价结果
适应证（1）说明书适应证：
　①伊立替康+5-氟尿嘧啶（5-FU）+亚叶酸钙（LV）（FOLFIRI方案）治疗既往未接受化疗的晚期结直肠癌患者
　②伊立替康单药治疗经含5-FU化疗方案治疗失败的晚期结直肠癌患者
（2）超说明书适应证：
　①伊立替康+卡培他滨（XELIRI方案）一线治疗晚期结直肠癌[4]
　②伊立替康+顺铂（IP方案）或伊立替康+卡铂（IC方案）二线治疗宫颈癌[5，6]
　③伊立替康+顺铂（IP方案）或伊立替康+卡铂（IC方案）一线治疗广泛期小细胞肺癌[7，8]
　④FOLFIRI方案一线治疗或伊立替康单药二线治疗晚期食管癌[9,10]
　⑤FOLFIRI方案一线治疗胃癌或伊立替康单药二线治疗胃癌或XELIRI方案二线治疗胃癌[11,12]
　⑥含伊立替康化疗方案二线治疗铂类难治性卵巢癌[13]
　⑦伊立替康+奥沙利铂+5-FU+LV（FOLFIRINOX方案）一线治疗体能状态好的局部进展期或晚期胰腺癌[14,15]		0：符合（1）或（2）中任意一项；
1：不符合（1）或（2）中任意一项
禁忌证（1）慢性炎性肠病/肠梗阻
（2）TBIL>3 ULN
（3）严重骨髓抑制
（4）WHO体力状态评分>2
（5）对伊立替康三水合物或其辅料过敏
（6）备孕、妊娠期或哺乳期妇女		0：不符合（1）~（6）中任意一项；
1：符合（1）~（6）中任意一项
用法用量（1）联合用药：伊立替康与5-FU和LV联用：180 mg·m-2静脉滴注30~90 min，第1日，每2周重复
（2）单药治疗：每周方案为125 mg·m-2静滴90 min以上，第1、8、15、22日，休息2周，每6周重复；3周方案为350 mg·m-2静滴90 min以上，第1日，每3周重复		0：符合（1）或（2）中任意一项；
1：不符合（1）或（2）中任意一项
溶媒选择（1）溶媒品种：5%葡萄糖注射液或氯化钠注射液
（2）终浓度：稀释至终浓度0.12~2.8 mg·mL-1		0：符合（1）和（2）；
1：不符合（1）或（2）中任意一项
基线检查（1）NEU≥1.5×109·L-1
（2）PLT≥100×109·L-1
（3）Hb≥100 g·L-1
（4）TBIL≤1.5 ULN
（5）CrCl≥60 mL·min-1
（6）ALT≤2.5 ULN
（7）AST≤2.5 ULN		0：符合（1）~（7）中所有项；
1：不符合（1）~（7）中任意一项
预处理[16]伊立替康为中度致吐风险的抗肿瘤药物，可采用以下任一止吐方案：
（1）5-HT3受体拮抗剂+地塞米松
（2）帕洛诺司琼+奥氮平+地塞米松
（3）5-HT3受体拮抗剂+NK-1受体拮抗剂+地塞米松		0：符合（1）~（3）中任意一项；
1：不符合（1）~（3）中任意一项
给药顺序[17,18]（1）IP/IC方案：顺铂/卡铂→伊立替康
（2）FOLFIRI方案：伊立替康→LV→5-FU
（3）FOLFIRINOX方案：伊立替康→奥沙利铂→LV→5-FU		0：符合（1）~（3）中任意一项；
1：不符合（1）~（3）中任意一项
血常规监测剂量调整治疗周期内进行血常规监测基于NCI-CTC4.0标准进行剂量调整：
（1）患者若出现4级血液学毒性，则中断治疗，待恢复至0~1级继续治疗，并于下一周期将伊立替康剂量减少10%；若延迟超过2周仍未恢复至0~1级，则停止伊立替康治疗，最多允许2次减量，若第3次出现不良反应，则停止伊立替康治疗
（2）患者若出现3级中性粒细胞减少伴发热，则中断治疗并恢复至0~1级，并于下一周期将伊立替康剂量减少10%；若延迟超过2周仍未恢复至0~1级，则停止伊立替康治疗，最多允许2次减量，若第3次出现不良反应，则停止伊立替康治疗
（3）患者若出现3级非血液学毒性，如腹泻、呕吐、乏力、外周神经反应等，则中断治疗并恢复至0~1级，并于下一周期将伊立替康剂量减少10%；若延迟超过2周仍未恢复至0~1级，则停止伊立替康治疗，最多允许2次减量，若第3次出现不良反应，则停止伊立替康治疗		0：符合；1：不符合
0：符合（1）~（3）中任意一项；
1：不符合（1）~（3）中任意一项
不良反应监测（1）严密监测胃肠道不良反应，表现为腹泻、恶心和呕吐
（2）注意监测胆碱能综合征，表现为鼻炎、流涎增多、瞳孔缩小、流泪、多汗、潮红和可引起腹部痉挛或早发性腹泻的肠蠕动亢进等
（3）注意监测电解质，预防由腹泻、恶心和呕吐引起的脱水
（4）注意监测肝脏不良反应，如肝酶异常、腹水和黄疸等
（5）监测脱水患者发生直立性低血压，以及继发的头晕、失眠等神经系统不良反应		0：符合（1）~（5）中所有项；
1：不符合（1）~（5）中任意一项
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临床诊断治疗方案循证证据证据等级循证评价结果
晚期结直肠癌XELIRI系统评价[4]B级合理
宫颈癌IP/ICMicroMedex/NCCN指南[5]/国家卫生健康委指南[6]B级合理
小细胞肺癌IP/ICMicroMedex/NCCN指南[7]/国家卫生健康委指南[8]B级合理
晚期食管癌FOLFIRI/伊立替康单药MicroMedex/NCCN指南[9]/国家卫生健康委指南[10]B级合理
胃癌FOLFIRI/ XELIRI/伊立替康单药MicroMedex/NCCN指南[11]/国家卫生健康委指南[12]B级合理
局部进展期或晚期胰腺癌FOLFIRINOXMicroMedex/NCCN指南[14]/国家卫生健康委指南[15]B级合理
转移性结直肠癌BEV-IR系统评价[20]无循证证据不合理
小细胞肺癌伊立替康+安罗替尼RCT[21]无循证证据不合理
局部进展期或晚期胰腺癌IRISRCT[22]无循证证据不合理
晚期结直肠癌雷替曲塞+伊立替康系统评价[23]无循证证据不合理
鼻咽癌西妥昔单抗+伊立替康+卡培他滨+顺铂无无循证证据不合理
中耳癌西妥昔单抗+伊立替康无无循证证据不合理
), ArticleFig(id=1239232818262372805, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=CN, label=表2, caption=

伊立替康超适应证用药循证评价结果

, figureFileSmall=null, figureFileBig=null, tableContent=
临床诊断治疗方案循证证据证据等级循证评价结果
晚期结直肠癌XELIRI系统评价[4]B级合理
宫颈癌IP/ICMicroMedex/NCCN指南[5]/国家卫生健康委指南[6]B级合理
小细胞肺癌IP/ICMicroMedex/NCCN指南[7]/国家卫生健康委指南[8]B级合理
晚期食管癌FOLFIRI/伊立替康单药MicroMedex/NCCN指南[9]/国家卫生健康委指南[10]B级合理
胃癌FOLFIRI/ XELIRI/伊立替康单药MicroMedex/NCCN指南[11]/国家卫生健康委指南[12]B级合理
局部进展期或晚期胰腺癌FOLFIRINOXMicroMedex/NCCN指南[14]/国家卫生健康委指南[15]B级合理
转移性结直肠癌BEV-IR系统评价[20]无循证证据不合理
小细胞肺癌伊立替康+安罗替尼RCT[21]无循证证据不合理
局部进展期或晚期胰腺癌IRISRCT[22]无循证证据不合理
晚期结直肠癌雷替曲塞+伊立替康系统评价[23]无循证证据不合理
鼻咽癌西妥昔单抗+伊立替康+卡培他滨+顺铂无无循证证据不合理
中耳癌西妥昔单抗+伊立替康无无循证证据不合理
), ArticleFig(id=1239232818342064582, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
评价指标合理病例/例所占比例/%总评分/分相对权重
系数
适应证83868300.133 1
禁忌证971009700.132 2
用法用量63656300.110 0
溶媒选择971009700.096 2
基线检查70727000.087 8
预处理93969300.084 9
给药顺序80838000.086 9
血常规监测37383700.086 2
剂量调整90939000.093 3
不良反应监测971009700.089 3
), ArticleFig(id=1239232818446922183, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=CN, label=表3, caption=

各评价指标用药合理性评分汇总结果和相对权重系数

, figureFileSmall=null, figureFileBig=null, tableContent=
评价指标合理病例/例所占比例/%总评分/分相对权重
系数
适应证83868300.133 1
禁忌证971009700.132 2
用法用量63656300.110 0
溶媒选择971009700.096 2
基线检查70727000.087 8
预处理93969300.084 9
给药顺序80838000.086 9
血常规监测37383700.086 2
剂量调整90939000.093 3
不良反应监测971009700.089 3
), ArticleFig(id=1239232818522419657, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
相对接近度（Ci）病例数/例所占比例/%评价结果
1.01010.3合理
0.9≤Ci< 1.000合理
0.8≤Ci< 0.900合理
0.7≤Ci< 0.84344.3基本合理
0.6≤Ci< 0.73637.1基本合理
Ci<0.688.2不合理
), ArticleFig(id=1239232818597917131, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239222197710017452, language=CN, label=表4, caption=

相对接近度统计分布

, figureFileSmall=null, figureFileBig=null, tableContent=
相对接近度（Ci）病例数/例所占比例/%评价结果
1.01010.3合理
0.9≤Ci< 1.000合理
0.8≤Ci< 0.900合理
0.7≤Ci< 0.84344.3基本合理
0.6≤Ci< 0.73637.1基本合理
Ci<0.688.2不合理
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基于加权TOPSIS法的伊立替康用药合理性评价
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王旭东 1a , 汪龙 2 , 黄佩文 1a , 张莉 3 , 葛磊 1b , 邱季 1a
中国新药与临床杂志 | 论著 2024,43(11): 845-851
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中国新药与临床杂志 | 论著 2024, 43(11): 845-851
基于加权TOPSIS法的伊立替康用药合理性评价
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王旭东1a , 汪龙2, 黄佩文1a, 张莉3, 葛磊1b, 邱季1a
作者信息
  • 1a.合肥市滨湖医院药学部，安徽 合肥　230000，
  • 1b.合肥市滨湖医院肿瘤内科，安徽 合肥　230000
  • 2.蚌埠市第三人民医院 药学部，安徽 蚌埠　233099
  • 3.蚌埠医学院第二附属医院 药学部，安徽 蚌埠　233040

    • 王旭东，男，主管药师，主要从事临床药学工作，E-mail:

Evaluation on rational application of irinotecan based on weighted TOPSIS method
Xu-dong WANG1a , Long WANG2, Pei-wen HUANG1a, Li ZHANG3, Lei GE1b, Ji QIU1a
Affiliations
  • 1a.Department of Pharmacy, Binhu Hospital of Hefei, Hefei ANHUI 230000, China
  • 1b.Department of Oncology, Binhu Hospital of Hefei, Hefei ANHUI 230000, China
  • 2.Department of Pharmacy, the Third People’s Hospital of Bengbu, Bengbu ANHUI 233099, China
  • 3.Department of Pharmacy, the Second Affiliated Hospital of Bengbu Medical College, Bengbu ANHUI 233040, China
出版时间: 2024-11-25 doi: 10.14109/j.cnki.xyylc.2024.11.09
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摘要
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目的

基于加权TOPSIS法评价伊立替康的用药合理性。

方法

以国内药品说明书为基础，结合相关指南和文献，以“适应证、禁忌证、用法用量、溶媒选择、基线检查、预处理、给药顺序、血常规监测、剂量调整、不良反应监测”为评价指标，采用加权TOPSIS法建立伊立替康用药合理性评价标准，对合肥市滨湖医院2022年1月1日至2023年5月31日使用伊立替康的住院患者的归档病历进行伊立替康用药合理性评价。

结果

10项评价指标中，相对权重系数最高的为适应证（0.133 1），最低的为预处理（0.084 9）。共纳入97份病历，其中相对接近度（Ci）≥0.8的有10份（10%），评价为合理用药；0.6≤Ci < 0.8的有79份（81%），评价为基本合理用药；Ci < 0.6的有8份（8%），评价为不合理用药。

结论

加权TOPSIS法可用于伊立替康用药合理性评价，本院伊立替康的使用基本合理，但仍存在基线检查、血常规监测和适应证不合理等问题。

加权TOPSIS法  /  伊立替康  /  药物利用评审  /  合理用药
AIM

To evaluate the rationality of irinotecan application based on weighted TOPSIS method.

METHODS

Based on the drug label of irinotecan, combined with relevant guidelines and literatures, weighted TOPSIS method was used to establish the evaluation criteria for the rationality of irinotecan clinical application, with “indications,contraindications, application and dosage, solvent selection, baseline examination, pretreatment, administration sequence,blood routine monitoring, dosage adjustment and ADR monitoring” as evaluation indicators. The archived medical records of inpatients who had used irinotecan in Binhu Hospital of Hefei from January 1, 2022 to May 31, 2023 were evaluated for the rationary of irinotecan administration.

RESULTS

Among the 10 evaluation indicators, the highest relative weighted index was indication（0.133 1）, while the lowest was pretreatment（0.084 9）. Among the included 97 cases, 10 cases（10%）had relative proximity（Ci）≥0.8, with the evaluation result as rational drug application; 79 cases（81%）had 0.6≤ Ci< 0.8,with the evaluation result as basic rational drug application; 8 cases（8%）had 0.4≤Ci < 0.6, with the evaluation result as irrational drug application.

CONCLUSION

The weighted TOPSIS method can be used to evaluate the rational usage of irinotecan. In our hospital, the use of irinotecan is basically reasonable, however, there are still some problems about baseline examination, blood routine monitoring and unreasonable indications.

weighted TOPSIS method  /  irinotecan  /  drug utilization review  /  rational use of drug
王旭东, 汪龙, 黄佩文, 张莉, 葛磊, 邱季. 基于加权TOPSIS法的伊立替康用药合理性评价. 中国新药与临床杂志, 2024 , 43 (11) : 845 -851 . DOI: 10.14109/j.cnki.xyylc.2024.11.09
Xu-dong WANG, Long WANG, Pei-wen HUANG, Li ZHANG, Lei GE, Ji QIU. Evaluation on rational application of irinotecan based on weighted TOPSIS method[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (11) : 845 -851 . DOI: 10.14109/j.cnki.xyylc.2024.11.09
正文
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伊立替康（irinotecan，CPT-11）于1994年由日本研发并上市，1996年获准在美国上市，2001年3月在中国上市。伊立替康起初主要用于晚期结直肠癌患者的治疗，后来大量的临床研究和应用表明，其对胃癌、小细胞肺癌、胰腺癌、宫颈癌、卵巢癌等多个癌种均有良好的治疗效果，现已广泛应用于临床。2022年，伊立替康被纳入第七批全国药品集中采购目录，临床可及性和经济性进一步提升。TOPSIS法是一种对多目标值进行优选、排序、评价和决策的有效方法。应用属性层次模型（AHM）加权的TOPSIS法强调各指标的重要性不同，发挥了充分利用数据资料的优点，使评价结果更趋合理[1, 2]。本研究对使用伊立替康的归档病历进行回顾性研究，制定伊立替康的合理性评价标准，利用加权TOPSIS法建立用药合理性评价细则，为促进伊立替康的临床合理应用提供参考。
资料与方法
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资料来源
应用美康合理用药软件（PASS）提取合肥市滨湖医院（下文称“本院”）2022年1月1日至2023年5月31日使用过伊立替康的住院患者信息，共收集到临床资料97份。
评价标准建立
以伊立替康国内药品说明书为基础，参考《抗肿瘤药物处方审核要点》[3]，初步建立包括适应证、禁忌证、用法用量、溶媒选择、基线检查、预处理、给药顺序、血常规监测、剂量调整、不良反应监测共10项内容的合理用药评价标准。评价标准制定过程由两名药师独立完成并交叉核对，如有争议，由第三名药师审核并达成一致意见。伊立替康合理用药评价标准见表1[4-18]。
超说明书用药评价
该评价标准的重点是超适应证用药评价标准的建立。参照广东省药学会发布的《超说明书用药循证评价规范》[19]的操作流程，对超说明书用药按如下流程进行循证评价。（1）查询美国食品和药物管理局（FDA）、欧洲药品管理局（EMA）、日本药品和医疗器械管理局（PMDA）的药品说明书注册情况，如果该适应证有记载，认为其超说明书用药有循证医学证据，评价为合理。（2）查询循证医学数据库MicroMedex，其中收录的超说明书用药，认为有循证医学证据，评价为合理。（3）查询国家卫生健康委员会、中华医学网、美国国立综合癌症网络（NCCN）、美国国立指南数据库（NGC）等国内外权威机构发布的指南推荐的超说明书用药，采用指南研究与评估系统第2版（AGREEⅡ）进行评价，如果A级、B级推荐使用，认为有循证医学证据，评价为合理。（4）按照PICOS原则，检索Cochrane Library中的系统评价数据库（CDSR），其中有收载的超说明书用药，评价为合理。（5）检索PubMed、Embase、中国知网、万方、维普文献数据库，主要收集系统评价或Meta分析，利用RevMan5.3软件对纳入系统评价的随机对照试验（RCT）进行偏倚风险评估，然后采用GRADEprofiler 3.6.1软件对证据质量等级进行分析，证据级别为中级及以上，评价为合理。如果没有找到符合条件的系统评价，则继续检索RCT，并对检索到的RCT进行Meta分析，然后进行GRADE证据分级，证据级别为中级及以上，评价为合理。根据MicroMedex分级定义，对超说明书用药的证据等级与有效性等级进行判定，提出伊立替康超说明书用药循证评价意见，提交医院药事管理与药物治疗学委员会审核。
运用加权TOPSIS法进行评价
1　处方点评并建立点评数据库
设计伊立替康点评表，包括患者的基本信息（住院号、年龄、性别、科室、入院时间、出院时间等）和10项评价指标，药师对每份病历依据伊立替康合理用药评价标准进行点评，对不能独自确定评价结果的病历，与具有高级职称的药师或医师进行讨论后得到最终评价结果。分别用X1、X2、……X10指代10项评价指标，对每份临床资料中的各项指标评价结果分别赋值，0（合理）赋予10分，1（不合理）赋予0分。以赋分结果建立合理用药评价数据矩阵。
2　确定各评价指标权重
对10个评价指标（Xj，j=1、2、3……10）进行综合评价，分别确立各指标的相对权重。查阅相关文献[1, 2]，结合伊立替康药物特点、各评价指标不合理可能造成的不良后果严重程度以及临床治疗的实际情况，点评小组成员独立给各评价指标的重要性打分，然后充分讨论达成一致意见，应用AHM赋值法确立各评价指标的相对权重系数，数值越大则表示指标重要性越高，反之则越低。μji代表第j个评价指标相比于第i个评价指标的重要性，μij反之；μii代表第i个评价指标的自身对比。因此，μji+μij=1，μii=0。构造判断性矩阵，并对判断性矩阵按公式（3）进行一致性检验，再按公式（4）求得指标相对属性权重。
3　最优解和最劣解的确立
应用TOPSIS法寻找理想状态下所有指标均评价合理的最优解，（m=1，2，…，10），以及理想状态下全部评价不合理的最劣解，（m=1，2，…，10）。分别表示评价对象i在第j个评价指标上的最大值和最小值。
4　计算各评价对象与最优解和最劣解的加权欧式距离
根据公式（5）和（6）计算各评价对象Zij分别与的加权欧式距离和。
5　计算各评价对象与最优解的接近程度
根据公式（7）计算各评价对象与的接近程度Ci。
6　将各评价对象排序
Ci值越接近1，表明用药越合理。根据文献[1, 2]报道，将Ci≥0.8的病历评价为用药合理，将0.6≤Ci<0.8的病历评价为用药基本合理，将Ci<0.6的病历评价为用药不合理。
结果
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患者基本情况
2022年1月1日至2023年5月31日本院共有37例患者使用伊立替康97例次，其中男性29例（78%），女性8例（21%），患者年龄35~79岁，平均年龄（66.2±8.8）岁。其中结直肠癌17例，小细胞肺癌6例，胰腺癌4例，食管癌2例，胃癌/十二指肠癌5例，宫颈癌、鼻咽癌、中耳癌各1例。
超适应证循证评价结果
XELIRI方案治疗晚期结直肠或胃癌、IP/IC方案治疗宫颈癌或小细胞肺癌、FOLFIRINOX方案治疗局部进展期或晚期胰腺癌有高质量循证证据支持，评价为合理；伊立替康+安罗替尼治疗小细胞肺癌、西妥昔单抗+伊立替康治疗中耳癌等缺乏高质量循证证据，评价为不合理。对伊立替康的超适应证用药循证评价结果见表2。
各评价指标相对权重系数
相对权重系数前三位分别为适应证（0.133 1）、禁忌证（0.132 2）和用法用量（0.110 0），最低的为预处理（0.084 9）。各指标评分汇总结果和相对权重系数见表3。
Ci统计结果
对97份使用伊立替康患者的病历采用TOPSIS法评价，Ci统计结果见表4。Ci最高为1.0，最低为0.525 9。Ci≥0.8的病历有10份，评价为合理用药；0. 6≤Ci< 0.8的病历有79份，评价为基本合理用药；Ci< 0.6的病历有8份，评价为不合理用药。
讨论
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采用AHM赋值法确定指标权重时，对属性判断矩阵必须进行一致性检验，若初始构造的属性判断矩阵不满足一致性，须加以适当调整，只有通过一致性检验，才能计算相对权重。这保证了指标重要性的传递性，限制了确定指标权重时的主观随意性。传统方法不区分评价指标的重要性或直接根据经验赋予权重，导致点评结果主观性太强，一致性差。本研究相对权重最高的是适应证，与当前处方点评工作重点和《抗肿瘤药物临床应用管理办法（试行）》对医疗机构处方点评的要求是一致的。不同药物的同一个评价指标，其相对权重系数也是不一样的。用药前的指标比用药过程中的指标更重要，例如适应证、禁忌证影响药物遴选，而用法用量不适宜将直接影响药物疗效或增加不良反应发生率甚至导致死亡。治疗过程中的监测指标和预防措施相比用药前指标影响更小，所以治疗周期内血常规监测、不良反应监测、预处理的相对权重系数更小。TOPSIS法的基本思想是基于归一化后的原始数据矩阵，找出有限方案中的最优解和最劣解，然后分别计算各评价对象与最优解和最劣解的距离，获得各评价对象与最优解的相对接近程度，以此作为评价优劣的依据。有相关研究[1, 2]将TOPSIS法与AHM赋值法计算出的相对权重系数结合起来，建立了加权TOPSIS法，使其综合判断更合理。目前，医疗机构合理用药评价逐渐开始使用该方法。由于肿瘤相关的药物治疗涉及多个方面，用药评价也需要综合考虑，传统的处方点评往往只评价病历“合理”或“不合理”，或评价单个指标的合理率，临床对点评结果认可度不高。本研究采用的TOPSIS法不仅可以计算每个指标的总合理率，还可以判断每份临床资料的合理性，适用于质量改进。
本研究结果显示，97份病历中，Ci ≥ 0.6的有89例（92%），Ci < 0.6的仅有8例（8%），表明本院使用伊立替康基本合理，但也存在一些用药不合理情况。基线检查、血常规监测、适应证等指标是导致用药不合理的主要因素。通过本研究的超适应证用药循证评价，对于有循证医学证据支持的化疗方案，在本院规范备案后，经患者知情同意可以酌情使用；循证证据不充分的超说明书用药方案，建议禁止使用。
伊立替康的主要不良反应有急性胆碱能综合征、迟发性腹泻、骨髓抑制、恶心呕吐、肝损害等，FDA说明书黑框警告其可能导致危及生命的迟发性腹泻和严重的骨髓抑制。血常规检查、动态监测、预处理和剂量调整不合理都可能会导致不良反应发生或加重。付向阳等[24]对比观察伊立替康联合卡培他滨与卡培他滨单药治疗FOLFOX方案一线化疗失败的晚期结直肠癌患者的疗效及安全性，发现联合治疗组中重度不良反应（Ⅱ度及以上）发生率明显高于单药治疗组，差异有显著意义，联合治疗组特有的不良反应主要是急性胆碱能综合征及迟发性腹泻。刘慧龙等[25]观察和分析经典FOLFIRI方案和改良FOLFIRI方案治疗晚期结直肠癌相关不良反应发生情况，结果发现迟发性腹泻（43.8%）和粒细胞减少（42.1%）是主要的剂量限制性毒性，入组的121例患者中，5例因严重腹泻、4例因重度骨髓抑制退出治疗。赵霞等[26]报道了伊立替康致重度迟发性腹泻与骨髓抑制而死亡的案例。综上，实施包含伊立替康的化疗方案，应该在用药前和治疗周期中进行血常规监测，并根据不良反应调整给药剂量，保证患者用药安全。严重的恶心、呕吐可能导致厌食、水电解质代谢紊乱和营养不良，给肿瘤患者带来严重的生理和心理负担[16]。因此，规范的抗肿瘤药物预防性止吐方案可以减少不良反应的发生，提高患者的用药依从性。
抗肿瘤药物给药顺序不合理也会影响药物疗效或增加不良反应发生率，本院伊立替康给药顺序不合理主要为FOLFIRI方案和IP方案。FALCONE等[17]研究发现，FOLFIRI方案按伊立替康→亚叶酸钙→氟尿嘧啶的顺序给药，伊立替康中间体SN-38的药物浓度-时间曲线下面积较相反给药顺序下降40.1%（P < 0.05），不良反应发生率下降，耐受性更好。HAN等[18]进行的伊立替康和顺铂两种给药顺序治疗晚期非小细胞肺癌的Ⅱ期临床试验中，多因素logistic回归分析显示，顺铂→伊立替康给药顺序有更高的缓解率，两种给药顺序的总体毒性特征和药动学参数相似，研究者建议采用IP方案化疗时按顺铂→伊立替康的顺序给药。
综上所述，本研究建立了伊立替康合理用药评价标准，使用的加权TOPSIS法直观反映各病历与最优解的接近程度，该法能消减常规评价方法的主观随意性，评价结果与实际情况更相符，且计算方法简单，值得进一步推广应用。本研究也存在一些不足：病历来源于单个医疗机构，可能存在选择性偏倚；本标准的建立是基于现有的临床指南、系统评价和临床研究，随着相关研究的不断深入，评价标准需要不断改进。笔者将根据最新的研究成果细化、完善评价标准，进一步规范伊立替康的临床合理应用。
基金
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  • 安徽省卫生健康科研项目(AHWJ2022b104)
文献
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2024年第43卷第11期
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doi: 10.14109/j.cnki.xyylc.2024.11.09
  • 接收时间：2023-10-11
  • 首发时间：2026-03-13
  • 出版时间：2024-11-25
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  • 收稿日期：2023-10-11
  • 录用日期：2024-07-11
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安徽省卫生健康科研项目(AHWJ2022b104)
作者信息
    1a.合肥市滨湖医院药学部，安徽 合肥　230000，
    1b.合肥市滨湖医院肿瘤内科，安徽 合肥　230000
    2.蚌埠市第三人民医院 药学部，安徽 蚌埠　233099
    3.蚌埠医学院第二附属医院 药学部，安徽 蚌埠　233040
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https://castjournals.cast.org.cn/joweb/zgxyylczz/CN/10.14109/j.cnki.xyylc.2024.11.09
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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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