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Article(id=1218290945141953227, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1218290941232861879, articleNumber=1001-2494(2024)15-1361-05, orderNo=null, doi=10.11669/cpj.2024.15.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1709222400000, receivedDateStr=2024-03-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1768392796073, onlineDateStr=2026-01-14, pubDate=1723046400000, pubDateStr=2024-08-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1768392796073, onlineIssueDateStr=2026-01-14, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1768392796073, creator=13701087609, updateTime=1768392796073, updator=13701087609, issue=Issue{id=1218290941232861879, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='15', pageStart='1361', pageEnd='1452', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1768392795141, creator=13701087609, updateTime=1768394622953, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1218298607682376061, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1218290941232861879, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1218298607682376062, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1218290941232861879, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1361, endPage=1365, ext={EN=ArticleExt(id=1218290945414582995, articleId=1218290945141953227, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Clinical Research Progress of Hetrombopag in Thrombocytopenia, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Thrombocytopenia is a disorder characterized by a decreased platelet count in the peripheral blood, which can be caused by various congenital and acquired diseases. Currently, thrombopoiesis-promoting drugs used for thrombocytopenia primarily include recombinant human interleukin-11 (rhIL-11), recombinant human thrombopoietin (rhTPO), and thrombopoietin receptor agonist (TPO-RA). Hetrombopag is an innovative oral non-peptide TPO-RA that has been approved for treating chronic adult primary immune thrombocytopenia (ITP) with inadequate response to glucocorticoids and immunoglobulin, as well as severe aplastic anemia (SAA) with poor response to immunosuppressive therapy in China. Clinical studies have demonstrated that hetrombopag is safe and well-tolerated in ITP and SAA patients. Currently, there is an ongoing phase Ⅲ clinical trial investigating the efficacy of hetrombopag in managing chemotherapy-induced thrombocytopenia (CIT). This article provides a review on the research progress of hetrombopag in treating thrombocytopenia, aiming to offer valuable insights for clinical practice.

, correspAuthors=Zhenxin WANG, 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=Ziying ZHANG, Lingzhi WU, Ni YIN, Zhenxin WANG), CN=ArticleExt(id=1218290946064700135, articleId=1218290945141953227, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=海曲泊帕在血小板减少症中的临床研究进展, columnId=1190352408384471863, journalTitle=中国药学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

血小板减少症是一种以外周血中血小板计数减少为特征的疾病,可由多种先天性和后天疾病引起。目前治疗血小板减少症的促血小板生成药物主要包括重组人白细胞介素11(rhIL-11)、重组人血小板生成素(rhTPO)以及血小板生成素受体激动剂(TPO-RA)。海曲泊帕(hetrombopag)是一种新型的口服非肽类TPO-RA,已在中国获批用于治疗既往对糖皮质激素和免疫球蛋白等治疗反应不佳的慢性成人原发免疫性血小板减少症(ITP)和免疫抑制治疗疗效不佳的重型再生障碍性贫血(SAA)。临床研究数据表明,海曲泊帕用于ITP及SAA治疗的安全性及耐受性良好。目前海曲泊帕治疗化疗所致血小板减少症(CIT)的一项Ⅲ期临床研究正在进行中。本文就海曲泊帕在血小板减少症中的最新研究进展作一综述,以期为临床制定应对血小板减少症的有效策略或个性化防治方案提供参考。

, correspAuthors=王振欣, authorNote=null, correspAuthorsNote=
* 王振欣,男,博士,副教授 研究方向:肿瘤学 Tel:(0512)67972909
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张子颖,女,硕士研究生 研究方向:肿瘤学

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张子颖,女,硕士研究生 研究方向:肿瘤学

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张子颖,女,硕士研究生 研究方向:肿瘤学

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海曲泊帕在血小板减少症中的临床研究进展
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张子颖 , 吴灵芝 , 印妮 , 王振欣 *
中国药学杂志 | 综述 2024,59(15): 1361-1365
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中国药学杂志 | 综述 2024, 59(15): 1361-1365
海曲泊帕在血小板减少症中的临床研究进展
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张子颖, 吴灵芝, 印妮, 王振欣*
作者信息
  • 苏州大学附属第一医院肿瘤科, 江苏 苏州 215000

    • 张子颖,女,硕士研究生 研究方向:肿瘤学

通讯作者:

* 王振欣,男,博士,副教授 研究方向:肿瘤学 Tel:(0512)67972909
Clinical Research Progress of Hetrombopag in Thrombocytopenia
Ziying ZHANG, Lingzhi WU, Ni YIN, Zhenxin WANG*
Affiliations
  • Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou 215000, China
出版时间: 2024-08-08 doi: 10.11669/cpj.2024.15.001
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摘要
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血小板减少症是一种以外周血中血小板计数减少为特征的疾病,可由多种先天性和后天疾病引起。目前治疗血小板减少症的促血小板生成药物主要包括重组人白细胞介素11(rhIL-11)、重组人血小板生成素(rhTPO)以及血小板生成素受体激动剂(TPO-RA)。海曲泊帕(hetrombopag)是一种新型的口服非肽类TPO-RA,已在中国获批用于治疗既往对糖皮质激素和免疫球蛋白等治疗反应不佳的慢性成人原发免疫性血小板减少症(ITP)和免疫抑制治疗疗效不佳的重型再生障碍性贫血(SAA)。临床研究数据表明,海曲泊帕用于ITP及SAA治疗的安全性及耐受性良好。目前海曲泊帕治疗化疗所致血小板减少症(CIT)的一项Ⅲ期临床研究正在进行中。本文就海曲泊帕在血小板减少症中的最新研究进展作一综述,以期为临床制定应对血小板减少症的有效策略或个性化防治方案提供参考。

海曲泊帕  /  血小板生成素受体激动剂  /  免疫性血小板减少症  /  再生障碍性贫血  /  化疗所致血小板减少症

Thrombocytopenia is a disorder characterized by a decreased platelet count in the peripheral blood, which can be caused by various congenital and acquired diseases. Currently, thrombopoiesis-promoting drugs used for thrombocytopenia primarily include recombinant human interleukin-11 (rhIL-11), recombinant human thrombopoietin (rhTPO), and thrombopoietin receptor agonist (TPO-RA). Hetrombopag is an innovative oral non-peptide TPO-RA that has been approved for treating chronic adult primary immune thrombocytopenia (ITP) with inadequate response to glucocorticoids and immunoglobulin, as well as severe aplastic anemia (SAA) with poor response to immunosuppressive therapy in China. Clinical studies have demonstrated that hetrombopag is safe and well-tolerated in ITP and SAA patients. Currently, there is an ongoing phase Ⅲ clinical trial investigating the efficacy of hetrombopag in managing chemotherapy-induced thrombocytopenia (CIT). This article provides a review on the research progress of hetrombopag in treating thrombocytopenia, aiming to offer valuable insights for clinical practice.

hetrombopag  /  thrombopoietin receptor agonist  /  immune thrombocytopenia  /  aplastic anemia  /  chemotherapy-induced thrombocytopenia
张子颖, 吴灵芝, 印妮, 王振欣. 海曲泊帕在血小板减少症中的临床研究进展. 中国药学杂志, 2024 , 59 (15) : 1361 -1365 . DOI: 10.11669/cpj.2024.15.001
Ziying ZHANG, Lingzhi WU, Ni YIN, Zhenxin WANG. Clinical Research Progress of Hetrombopag in Thrombocytopenia[J]. Chinese Pharmaceutical Journal, 2024 , 59 (15) : 1361 -1365 . DOI: 10.11669/cpj.2024.15.001
正文
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血小板减少症是临床较为常见的疾病或疾病表现,以外周血中血小板计数减少为特征,可由多种先天性和后天疾病引起,相关发生机制可概括为血小板生成减少、血小板消耗与破坏增加、血小板分布异常及血液稀释[1]。许多药物或疾病可干扰骨髓干细胞生成骨髓巨核细胞,或干扰巨核细胞生成血小板[2]。血小板破坏可能发生于凝血功能紊乱引起的血小板消耗增加,而脾肿大可导致血小板分布异常[3]。欧美国家通常将血小板减少症定义为血小板计数<150×109·L-1[4],但综合考虑出血倾向及临床实际工作,中国人群血小板减少症的判定标准为血小板计数<100×109·L-1[1]。血小板计数≥50×109·L-1时,大多数人是无症状的;当血小板计数<50×109·L-1时,外科手术并发出血的几率增大;当血小板计数<20×109·L-1时,有较高的自发性出血风险[3]。
目前,血小板减少症的治疗主要包括输注血小板和使用促血小板生长因子[4-5]。促血小板生长因子主要包括重组人白细胞介素11(recombinant human interleukin-11,rhIL-11)如巨和粒、重组人血小板生成素(recombinant human thrombopoietin,rhTPO)如特比澳,以及血小板生成素受体激动剂(thrombopoietin receptor agonists, TPO-RA)如罗米司亭、艾曲泊帕、阿伐曲泊帕、海曲泊帕等[6-8]。其中,TPO-RA作为一种不具有免疫原性、口服给药的促血小板生成药物[9],使用更为便捷,可为临床治疗血小板减少症提供新的选择。
海曲泊帕(hetrombopag)是一种新型的口服二代小分子、非肽类血小板生成素受体激动剂,其化学结构与艾曲泊帕、阿伐曲泊帕等同类药物不同。既往研究发现联苯结构可能具有肝毒性,海曲泊帕以杂环羧基取代,降低肝脏毒性;用苯并饱和碳环取代二甲苯,增强亲脂性,提高药效,是化学药品1类新药[10]。本文对海曲泊帕在血小板减少症中的研究进展进行介绍。
1 药理学特征
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1.1 作用机制
血小板生成素/血小板生成素受体(TPO/TPOR)信号通路在调节巨核细胞与血小板生成中起着核心作用。海曲泊帕通过与人TPORs在祖细胞上的跨膜结构域结合,激活TPO特异性信号转导,刺激信号转导和转录激活因子3(STAT3)、STAT5、蛋白激酶B(Akt)和细胞外调节蛋白激酶(ERK1/2)的磷酸化,并促进CD34+造血祖细胞的增殖,使其向巨核细胞分化,导致血小板生成增加[10]。由于rhTPO与TPOR的胞外结构域结合,与海曲泊帕的作用互补,因此,当海曲泊帕与rhTPO联合使用时,可表现出额外的激动作用[11-12]。
1.2 药动学
海曲泊帕口服给药后7~8 h达到峰浓度。血药浓度在每日1次给药后的第7天达到稳定状态[13]。海曲泊帕口服吸收受食物影响十分显著,给药与进食间隔时间越短,暴露量降低的程度越明显。与高脂肪、高热量食物配合使用时,血浆AUC0-t和cmax分别下降98.7%和95.0%[14]。因此,海曲泊帕应空腹或餐前≥2 h服用,以避免食物对生物利用度和血小板计数的影响[15]。海曲泊帕的代谢主要通过肼键裂解、葡萄糖醛酸结合、乙酰化和丙酰化,血浆中检测到的主要代谢产物为葡萄糖醛酸结合物M5[16]。其排泄的主要途径是通过粪便排出(89.05%),其次是从尿中排出(8.62%)[11]。
1.3 药效学
血小板反应与海曲泊帕血浆暴露量有显著相关性(P<0.000 1)[13]。在一项Ⅰ期研究[13]中,健康的中国志愿者接受每天1次2.5、5 或7.5 mg的海曲泊帕,连续10 d,6 d后血小板计数增加,12~14 d后达到峰值。这些剂量组较基线平均最大百分比增幅分别为34.1%、69.9%和98.2%,而安慰剂组为7.1%。在第28天(即最后一次给药后18 d),5 和7.5 mg剂量组的平均血小板计数比基线高18.8%和32.2%。Xie等[10]开展的一项研究表明,TPOR的强刺激活性使小剂量的海曲泊帕可达到与艾曲泊帕类似的药理作用,也可降低潜在的靶外毒性,提示海曲泊帕的效价更高。
2 临床研究
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2.1 原发免疫性血小板减少症
原发免疫性血小板减少症(primary immune thrombocytopenia,ITP)是一种获得性自身免疫性出血性疾病,主要是由机体免疫紊乱介导的血小板破坏增加和生成减少所致,以无明确诱因的孤立性外周血血小板计数减少为主要特点[17]。美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)已经批准3种TPO-RAs(罗米司亭、艾曲泊帕和阿伐曲泊帕)用于持续性或慢性ITP的管理,同时rhTPO和海曲泊帕在中国也被批准为治疗ITP的二线药物[18-19]。
一项多中心Ⅲ期试验(NCT03222843)[20]纳入了424例ITP患者,在一个随机、双盲、10周的治疗期中,对先前治疗无效或复发的患者采用海曲泊帕或安慰剂进行治疗,初始剂量2.5或5 mg,每日1次。接受安慰剂治疗的患者,10周后切换为艾曲泊帕治疗;接受海曲泊帕治疗的患者,在随后的14周开放标签治疗期间继续接受海曲泊帕治疗。主要终点是治疗8周后应答者的比例(定义为血小板计数≥50×109·L-1)。研究结果显示,海曲泊帕2.5 mg剂量组(58.9% vs 5.9%,P<0.000 1)及5 mg剂量组(64.3% vs 5.9%,P<0.000 1)与安慰剂组相比,达到主要终点的患者比例显著增加。在海曲泊帕2.5 mg剂量组和5 mg剂量组中,治疗后8周内从首次用药到首次应答的中位时间分别为21.0 d(95% CI 15.0~25.0 d)和14.0 d(95% CI 8.0~14.0 d)。在8周的治疗中,海曲泊帕在实现血小板反应、减少出血风险和抢救治疗方面也优于安慰剂。在24周治疗期内,海曲泊帕2.5 mg剂量组和5 mg剂量组分别有39.9%(95% CI:32.4%~47.7%)和49.7%(95% CI:42.0%~57.4%)的患者达到了≥75%应答,中位最长持续应答时间分别为64.0 d(95%CI:8.0~65.0 d)和64.0 d(95%CI:6.0~168.0 d),中位总应答时间分别为101.0 d(95%CI:8.0~165.0 d)和104.0 d(95%CI:6.0~168.0 d)。海曲泊帕2.5 mg剂量组和5 mg剂量组的血小板持续应答均可维持至治疗24周。
该Ⅲ期试验后续进行了一个≤6周、剂量逐渐减少至停药的试验和额外24周的长期延长试验[21],以进一步评估海曲泊帕减量至停药后的复发情况和长期疗效。结果显示,在进入剂量逐渐减少至停药阶段的194例患者中,有171例(88.1%)复发。自海曲泊帕减量开始到首次复发的中位时间为15.0 d(95% CI:14.0~16.0 d)。在进入24周的延长试验的269例患者中,144例(42.5%)患者达到了≥75%应答,254例(74.9%)患者至少有1次血小板计数≥30×109·L-1。
汇集了2项Ⅰ期临床试验和1项Ⅲ期临床试验的安全性数据[16,20-23],其中共有471例ITP患者接受海曲泊帕治疗,大多数不良反应的严重程度均为轻中度,重度不良反应的发生率为1.3%。发生频率≥10%的不良反应包括丙氨酸转氨酶升高(11.0%)、天冬氨酸转氨酶升高(10.4%)及血小板计数升高(10.0%)。
总体来说,海曲泊帕在大多数ITP患者中实现了显著和持续的血小板计数增长,作为ITP患者的二线治疗药物是有效的,且耐受性良好。两项关于TPO-RA类药物治疗ITP患者的Meta分析提示,与安慰剂相比,TPO-RAs在治疗成人ITP患者中的血小板反应持续时间更长、血小板反应率更高、抢救治疗使用更少、出血事件发生率更低、接受TPO-RAs治疗的患者的不良事件和严重不良事件的发生率与安慰剂组相似[24-25]。一项(接受TPO-RAs治疗的安全性风险管理)纳入17项随机对照试验共2 105例患者和29项单臂研究共3 227例ITP患者的分析中,该研究亚组分析提示,与艾曲泊帕、阿伐曲泊帕、罗米司亭相比,海曲泊帕是唯一没有增加血栓风险的TPO-RA[26]。
2.2 再生障碍性贫血
再生障碍性贫血(aplastic anemia,AA)是一种骨髓造血衰竭综合征,主要是由于T淋巴细胞异常活化、功能亢进造成骨髓损伤引起[27]。在一项多中心Ⅱ期临床试验(NCT03557099)[28]中,55名符合条件的患者接受了海曲泊帕治疗。海曲泊帕初始剂量为7.5 mg,每日1次,最大剂量为15 mg,共52周,主要终点是在第18周实现血液学应答的患者比例。本研究达到了其主要终点,23例患者(41.8%,95% CI:28.7%~55.9%)在治疗开始后的第18周内实现了血液学应答,首次血液学应答的中位时间为7.9周(95% CI:2.0~32.1周)。在第18周达到血小板反应、红细胞反应和中性粒细胞反应的患者比例分别为14.5%、34.5%和25.5%,血液学反应与血小板和网织红细胞计数呈显著正相关。12个月无复发生存率为82.2%(95% CI:62.2%~92.2%),提示海曲泊帕的血液学应答持久。对此试验进行的事后分析[29]纳入了35例免疫抑制治疗难治性重型再生障碍性贫血(severe aplastic anemia, SAA)患者,并对其血清铁蛋白(serum ferritin,SF)的纵向变化进行评估。在海曲泊帕给药18周时,51.4%的患者SF水平较基线下降49.0%(95% CI:18.1%~95.5%)。其中,血液学应答者SF下降75.0%,无应答者SF下降31.6%。在24例铁负荷过重的患者中,12例患者的SF水平较基线水平下降51%。提示海曲泊帕具有强大而快速的铁螯合作用。
关于海曲泊帕治疗难治性SAA的一项多中心、随机、双盲、安慰剂对照Ⅲ期研究(NCT04961710)正在进行中[30]。该前瞻性研究初步分析了海曲泊帕联合免疫抑制治疗(immunosuppressive therapy, IST)作为SAA一线治疗的应答率,在接受海曲泊帕治疗的患者中有21.9%在3个月时完全缓解,而对照组仅有5.2%(P=0.005)。6个月时,海曲泊帕治疗组的完全缓解率为34.4%,对照组为14.6%(P=0.015)。海曲泊帕与对照组完全缓解的中位时间分别为96、214 d。提示在IST中加入海曲泊帕作为一线治疗可以提高SAA的疗效。
海曲泊帕治疗SAA的Ⅱ期试验所报告的大多数不良反应的严重程度均为轻中度。重度不良反应的发生率为1.8%,为γ-谷氨酰转移酶升高。最常见的治疗相关不良事件是γ-谷氨酰转移酶升高(12.7%),丙氨酸转氨酶升高(12.7%),天冬氨酸转氨酶升高(12.7%)[28]。目前Ⅱ期临床研究结果显示海曲泊帕在SAA治疗中疗效和安全性良好。在艾曲泊帕治疗SAA的研究中报道过克隆演变的风险[31],目前海曲泊帕治疗SAA的Ⅲ期临床研究尚未完成,克隆演变与海曲泊帕的关系尚不清楚。
《再生障碍性贫血诊断与治疗中国指南(2022年版)》已将IST联合TPO-RA方案确立为不适合移植SAA患者的一线治疗方案[32]。海曲泊帕目前已在中国获批用于治疗IST疗效不佳的SAA[11],艾曲泊帕在美国获批治疗初诊及难治性SAA[33]。研究证明,在标准的免疫抑制治疗中加入艾曲泊帕可以提高先前未经治疗的SAA患者血液反应的速度、效率和强度,且没有额外的毒性作用[34]。对海曲泊帕联合IST治疗SAA无效的患者,可尝试TPO-RAs之间的转换[35],但仍需更多临床研究数据指导用药选择。
2.3 肿瘤治疗所致血小板减少症
肿瘤治疗所致血小板减少症(cancer therapy induced thrombocytopenia,CTIT)是指肿瘤患者在疾病治疗过程中因抗肿瘤治疗导致的血小板减少症,包括既往临床常见的化疗所致血小板减少症(chemotherapy-induced thrombocytopenia,CIT),也包括放疗、靶向治疗和免疫治疗所致的血小板减少症[36]。CTIT是非血液系统恶性肿瘤治疗中的一种常见并发症[37],即抗肿瘤药物抑制巨核细胞分化,促进骨髓细胞凋亡,从而使外周血中血小板计数低于100×109·L-1[38]。
目前,一项在曾因化疗方案导致CIT的患者中开展的海曲泊帕Ⅲ期临床研究正在进行中。该研究的目的是评估海曲泊帕作为接受新化疗方案时一级预防对比安慰剂的效果[11]。2023年欧洲内科医学大会公布了海曲泊帕治疗CIT的随机、双盲、安慰剂对照Ⅱ期试验(NCT03976882)的最新进展[39],这项试验纳入因在化疗后发生≥2级血小板减少症(血小板计数≤75×109·L-1)导致化疗时间延迟≥7 d的实体瘤患者,与安慰剂组相比,海曲泊帕 (初始剂量为7.5 mg·d-1)可显著提高实体瘤CIT患者的治疗有效率(60.7% vs 12.9%,P=0.000 1),更快恢复血小板计数水平(两组血小板计数恢复至≥100×109·L-1的中位时间是7.5 d vs 13.0 d)。在恢复第1个周期化疗的受试者中,海曲泊帕组和安慰剂组分别有72%和29%的患者能够完成2个连续化疗周期,同时未因血小板减少导致化疗方案调整或使用升血小板抢救治疗。
已有一些小样本研究初步证实了海曲泊帕在CTIT中的疗效。2022年美国血液学会(American Society of Hematology, ASH)年会上公布的一项研究[40]显示,在血小板计数≤50×109·L-1的实体瘤CTIT患者中,海曲泊帕5 mg·d-1联合rhTPO 300 U·kg-1·d-1治疗7 d内应答率(无血小板输注时,血小板计数比基线增加≥50×109·L-1或增加1倍以上或血小板计数达到≥100×109·L-1)显著优于rhTPO单药(75.0% vs 30.0%,P<0.05),且中位治疗时间显著短于rhTPO组(6.5 vs 9.5 d,P<0.000 1)。在CTIT患者的一级预防上,2022年欧洲肿瘤内科学会亚洲会议上公布的一项前瞻性真实世界研究[41]结果显示,化疗结束后预防性口服海曲泊帕(7.5 mg·d-1),所有患者血小板计数在第10天均维持正常水平(≥100×109·L-1)。
海曲泊帕治疗CIT的Ⅱ期临床试验[39]提示,在海曲泊帕治疗组与安慰剂组患者中,≥3级不良反应发生的比例无显著差异(39.3% vs 38.7%),最常见的是中性粒细胞计数下降(35.7% vs 35.5%)和白细胞计数下降(17.9% vs 19.4%)。3.6%的海曲泊帕患者和9.7%的安慰剂患者发生了严重的不良反应。在国内小样本研究中,rhTPO联合海曲泊帕对比rhTPO单药治疗CTIT,不良反应无显著差异[40,42],总体不良反应均较轻微且可控。
在发生≥2级血小板减少症的CTIT患者的治疗中,中国临床肿瘤学会《肿瘤治疗所致血小板减少症诊疗指南(2023年版)》已将海曲泊帕单药(证据2A类)或联合方案(证据2B类)作为Ⅱ级推荐用于CTIT治疗,而其他TPO-RAs作为Ⅲ级推荐。此外,在CTIT二级预防方面,海曲泊帕为Ⅱ级推荐(证据2A类),而其他TPO-RAs为Ⅲ级推荐或未被推荐[43]。《中国肿瘤药物相关血小板减少诊疗专家共识(2023版)》也推荐将TPO-RAs用于对rhTPO或rhIL-11疗效不佳或不耐受的CTIT患者[44]。
目前,海曲泊帕对CTIT治疗的研究大多集中于CIT,对靶向治疗、免疫治疗、放疗及其他原因引起的CTIT的治疗缺少探讨。现有研究[[39-40,42]]结果表明,海曲泊帕在治疗CTIT时具有良好的耐受性,海曲泊帕联合rhTPO治疗CTIT在提高疗效的同时不增加安全性顾虑。海曲泊帕治疗CTIT的有效性及安全性仍需多中心、大样本数据研究的支持。
2.4 其他适应证的临床研究
一项回顾性研究[45]分析了20例自体造血干细胞移植(autologous hematopoietic stem cell transplantation,auto-HSCT)血小板减少患者的具体特征及疗效,给予TPO-RAs(包括艾曲泊帕、海曲泊帕、阿伐曲泊帕)治疗后,总缓解率为85%,70%的患者完全缓解,15%的患者部分缓解,15%的患者无缓解,且90%患者实现了成功停药,保证了本病的维持治疗,提高了患者的生存期,且不良反应轻微。提示TPO-RAs是治疗auto-HSCT后发生血小板减少症的安全可靠的选择。目前海曲泊帕对移植相关性血小板减少症的研究数据较少,未来仍需开展更多临床研究或真实世界研究予以明确。
阿伐曲泊帕的两项多中心、随机、双盲、Ⅲ期临床试验[46]分别纳入了231例和204例择期行手术的重度慢性肝病相关性血小板减少症患者,所有患者均连续5 d按2:1随机口服阿伐曲泊帕或安慰剂治疗,在最后一次给药后5~8 d进行手术,两项研究的主要终点均为随机分组后和择期手术后7 d内不需要输血或抢救处理出血的患者比例。研究结果显示,阿伐曲泊帕导致了血小板计数增加,并增加了手术当天达到目标血小板计数50×109·L-1的患者比例,且阿伐曲泊帕组和安慰剂组的不良事件发生率和严重程度相似。两项安慰剂对照试验[47-48]对芦曲泊帕的疗效进行了评估,结果显示,与安慰剂相比,到达主要终点(在术前不需要输注血小板)的患者比例显著升高。阿伐曲泊帕和芦曲泊帕治疗慢性肝病相关性血小板减少症均已在FDA、EMA获批[49]。目前,尚无海曲泊帕用于慢性肝病相关性血小板减少症的临床研究或个案报道。
TPO-RAs在移植相关性血小板减少症、慢性肝病相关性血小板减少症等疾病的治疗中展现出了良好的疗效。然而,对TPO-RAs在骨髓增生异常综合征(myelodysplastic syndrome,MDS)中的疗效研究未能显示出生存益处,并且可能增加其向白血病进展的可能[50]。因此,在开展海曲泊帕对MDS的疗效研究时应谨慎评估患者的风险,对患者进行筛选,并且充分权衡利弊。
3 总结与展望
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作为一种新型的口服TPO-RA,海曲泊帕已被证明可安全、有效地增加ITP和SAA患者的血小板计数,且耐受性良好。在治疗CTIT方面,已有小样本数据证实了海曲泊帕的疗效及安全性。海曲泊帕的Ⅲ期临床研究正在进行中,其疗效和安全性仍需未来开展更多的临床研究或真实世界研究予以明确。海曲泊帕能显著提升ITP、SAA及CTIT患者的血小板计数,降低患者的出血风险,总体不良反应均较轻微且可控,为治疗血小板减少症带来了新的可能,也为血小板减少的患者提供了高效、安全、便利的选择。海曲泊帕用于治疗慢性肝病相关性血小板减少症、移植相关性血小板减少症、骨髓增生异常综合征等疾病的研究正在探索中。
基金
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  • 江苏省社会发展面上项目(BE2022728)
文献
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2024年第59卷第15期
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doi: 10.11669/cpj.2024.15.001
  • 接收时间：2024-03-01
  • 首发时间：2026-01-14
  • 出版时间：2024-08-08
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  • 收稿日期：2024-03-01
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江苏省社会发展面上项目(BE2022728)
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    苏州大学附属第一医院肿瘤科, 江苏 苏州 215000

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* 王振欣,男,博士,副教授 研究方向:肿瘤学 Tel:(0512)67972909
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2种不同金属材料的力学参数
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species		 占总种数比例
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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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