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培美曲塞：提前1周 or 同期应用叶酸及VB12？超全用药说明来了

2022-04-20 与非 MedSci原创

培美曲塞预防用药
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培美曲塞是一种多靶点的叶酸拮抗剂。

培美曲塞是常用的抗肿瘤药物，常用于非鳞状非小细胞肺癌、恶性胸膜间皮瘤的治疗。本文总结了培美曲塞的作用机制、不良反应及其相关的预防用药和用药调整。

 

一、作用机制

 

培美曲塞是一种多靶点的叶酸拮抗剂。作用机制如图1所示。培美曲塞能够通过还原型叶酸载体和叶酸结合蛋白进入细胞，在细胞内转化为聚谷氨酸的形式，抑制胸腺苷酸合成酶（TS）、二氢叶酸还原酶（DHFR）和甘氨酰胺核苷酸甲酰转移酶（GARFT）的作用，进而抑制胸腺嘧啶核苷酸和嘌呤核苷酸的生物再合成来破坏肿瘤细胞的复制。
 
 
 
图片
图1.培美曲塞作用机制
 
二、不良反应
 
下表1总结了培美曲塞的不良反应及临床表现。其中血液学毒性是培美曲塞的剂量限制性毒性。其他较为常见（>10%）的不良反应包括乏力、皮疹、脱屑、恶心、呕吐、咽炎等。
 
表1.培美曲塞的不良反应
 
图片
三、预防用药
 
为了预防不良反应的发生、降低不良反应的严重程度，临床上采取了预防用药的方法。主要的预防用药包括叶酸、维生素B12和地塞米松，给药方案总结见下表2。
 
表2.培美曲塞的预防用药方案
图片
早期的临床试验发现，培美曲塞的血液学毒性和严重的胃肠道反应的增加与患者治疗前的同型半胱氨酸（Hcy）和甲基丙二酸（MMA）增高有着显著的关联[3]。同型半胱氨酸代谢成为蛋氨酸的过程中需要蛋氨酸合成酶和5-甲基四氢叶酸的参与。叶酸作为5-甲基四氢叶酸的前体，维生素B12作为蛋氨酸合成酶的辅因子是这一代谢过程的重要部分。
 
因此，同型半胱氨酸的升高提示了可能的叶酸和维生素B12的缺乏。因甲基丙二酸的代谢依赖于维生素B12，血清甲基丙二酸的升高提示维生素B12的缺乏。由此提示，培美曲塞的不良反应与叶酸和维生素B12的缺乏有关。后续的临床试验表明，在预防使用叶酸和维生素B12能够显著降低培美曲塞的相关不良反应[4]。
 
叶酸和维生素B12要在培美曲塞首个治疗周期前一周给药？
 
关于叶酸和维生素B12是否一定要在首个治疗周期开始前一周给药仍具有争议。目前相关药物的使用说明书仍推荐在培美曲塞使用前7天内使用叶酸和维生素B12。而对此方案提出质疑的人表示这一方案会延迟抗肿瘤药物的使用，且并不一定能够更好地预防不良反应。
 
一项近期的随机试验[5]比较了在首次使用培美曲塞联合铂的局部晚期或者转移性的非鳞状非小细胞肺癌的150位病人中，培美曲塞给药前5-7天开始和给药同时开始补充叶酸和维生素B12对血液学毒性的发生的影响。结果显示，与给药前5-7天补充叶酸和维生素B12的组相比，同时给药的组并未表现出明显的更严重的血液学毒性。
 
值得一提的是，数据显示在给药前5-7天开始预防用药的组中，叶酸和维生素B12的水平在基线、给药当天、3个治疗周期后持续上升，而给药当天的同型半胱氨酸浓度与基础水平相当，给药3个周期后的同型半胱氨酸浓度则明显降低。
 
前瞻性和回顾性的研究[6-8]也提示培美曲塞的相关毒性与开始使用叶酸和维生素B12的给药间隔无关。关于给药间隔的优化仍需更多临床证据的支持。
 
除了预防用药，在培美曲塞治疗开始前，应对病人进行生化检查，确保：
 

  • ANC≥1500 cells/mm3

  • 血小板计数≥100000 cells/mm3

  • CrCl≥45 ml/min

  • 总胆红素≤1.5倍正常值上限

  • ALP、AST和ALT≤3倍正常值上限，或5倍正常值上限（肿瘤影响肝脏时可考虑）

此外，在后续的治疗过程中，应密切监测相关生化指标，并根据不良反应的发生对培美曲塞进行用药剂量的调整。总结见表3。
 
表3.培美曲塞基于不良反应的用药调整
 
图片
总的来说，临床在使用培美曲塞的过程中，应了解相关的不良反应，根据给药计划安排预防用药，并在治疗的周期中密切关注病人的相关生化指标和症状以及时调整给药方案。
缩写：

  • ANC：绝对嗜中性粒细胞计数绝对值

  • CrCl：肌酐清除率

  • ALP：碱性磷酸酶

  • AST：天冬氨酸氨基转移酶

  • ALT：丙氨酸氨基转移酶

参考文献：

1.    Lexicomp Online, Lexi-Drugs Online. Waltham,MA: UpToDate, Inc.; April 1, 2022. https://online.lexi.com. Accessed April 18, 2022.

2.    药物说明书, 培美曲塞二钠, AccessedApril 18, 2022.

3.    Niyikiza C, Baker SD, Seitz DE, et al.Homocysteine and methylmalonic acid: markers to predict and avoid toxicity frompemetrexed therapy. Mol Cancer Ther. 2002;1(7):545-552.

4.    Vogelzang NJ, Rusthoven JJ, Symanowski J, etal. Phase III study of pemetrexed in combination with cisplatin versuscisplatin alone in patients with malignant pleural mesothelioma. J ClinOncol. 2003;21(14):2636-2644. doi:10.1200/JCO.2003.11.136

5.    Singh N, Baldi M, Kaur J, et al. Timing offolic acid/vitamin B12 supplementation and hematologic toxicity duringfirst-line treatment of patients with nonsquamous non-small cell lung cancerusing pemetrexed-based chemotherapy: The PEMVITASTART randomized trial. Cancer.2019;125(13):2203-2212. doi:10.1002/cncr.32028

6.    Kim YS, Sun JM, Ahn JS, Ahn MJ, Park K. Theoptimal duration of vitamin supplementation prior to the first dose ofpemetrexed in patients with non-small-cell lung cancer. Lung Cancer.2013;81(2):231-235. doi:10.1016/j.lungcan.2013.04.011

7.    Takagi Y, Hosomi Y, Sunami K, et al. Aprospective study of shortened vitamin supplementation prior tocisplatin-pemetrexed therapy for non-small cell lung cancer. Oncologist.2014;19(11):1194-1199. doi:10.1634/theoncologist.2014-0221

8.     Schlei Z, Tan W, Faber MG, Chen H, Meagher A, Dy GK. Safetyof same-day vitamin B12 supplementation in patients receiving pemetrexed forthe treatment of non-small-cell lung cancer or pleural mesothelioma: aretrospective analysis. Clin Lung Cancer. 2018;19(6):467–75.

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    2022-08-19 zywlvao

    #同期#

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    2023-01-05 陈吴1234

    #美曲塞#

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    2022-04-24 1439d6d2m28暂无昵称

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    2022-04-22 12498dabm77暂无昵称

    #培美曲塞#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1709148, encodeId=7c621e0914877, content=<a href='/topic/show?id=cd013896021' target=_blank style='color:#2F92EE;'>#同期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38960, encryptionId=cd013896021, topicName=同期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8dd731593408, createdName=zywlvao, createdTime=Fri Aug 19 14:49:57 CST 2022, time=2022-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1807512, encodeId=6bf5180e512f6, content=<a href='/topic/show?id=f248e99592d' target=_blank style='color:#2F92EE;'>#美曲塞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79959, encryptionId=f248e99592d, topicName=美曲塞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cbf451, createdName=陈吴1234, createdTime=Thu Jan 05 22:49:57 CST 2023, time=2023-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1213826, encodeId=b119121382667, content=***, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7f5c4802521, createdName=1439d6d2m28暂无昵称, createdTime=Sun Apr 24 08:29:41 CST 2022, time=2022-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1395306, encodeId=e79e139530621, content=<a href='/topic/show?id=0e7041632f3' target=_blank style='color:#2F92EE;'>#培美曲塞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41632, encryptionId=0e7041632f3, topicName=培美曲塞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=78c32500188, createdName=12498dabm77暂无昵称, createdTime=Fri Apr 22 10:49:57 CST 2022, time=2022-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1212991, encodeId=ddab12129919f, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bd891361130, createdName=chenfang193, createdTime=Wed Apr 20 22:45:39 CST 2022, time=2022-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1212990, encodeId=d3e612129904c, content=感谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220313/1fccd8869aca4c2bbabb274c6aada833/8cdb5c5762b54b208703fcac43dcca47.jpg, createdBy=872f5678021, createdName=jing0309, createdTime=Wed Apr 20 22:38:33 CST 2022, time=2022-04-20, status=1, ipAttribution=)]
    2022-04-20 chenfang193

    学习

    0

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    2022-04-20 jing0309

    感谢分享

    0

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