Article(id=1291704836458836126, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.18.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1749139200000, receivedDateStr=2025-06-06, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896031727, onlineDateStr=2026-08-05, pubDate=1758988800000, pubDateStr=2025-09-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896031727, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896031727, creator=13701087609, updateTime=1785896031727, updator=13701087609, issue=Issue{id=1291704811443999077, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='18', pageStart='2551', pageEnd='2700', issueExtLink='null', onlineDate='null', pubDate='1758988800000', pubDateStr='2025-09-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896025763, creator='13701087609', updateTime=1785896871490, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708358743053253, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708358743053254, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2599, endPage=2604, ext={EN=ArticleExt(id=1291704838220443807, articleId=1291704836458836126, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical study of zanubrutinib combined with lenalidomide and rituximab in the treatment of refractory or relapsed diffuse large B-cell lymphoma, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate the efficacy and safety of zanubrutinib capsules-rituximab injection-lenalidomide capsules(ZR2) in the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Method Patients with R/R DLBCL were divided into control group and treatment group according to a random number table. The control group received rituximab injection 375 mg·m-2 by intravenous infusion on day 1 of the treatment cycle, and orally took lenalidomide capsules 25 mg once daily from day 1 to day 14 of the cycle. The treatment group received oral zanubrutinib capsule 160 mg twice daily from day 1 to day 21 of the cycle, in addition to the treatment given to the control group. Both groups were treated in 21-day cycles for a total of 6 cycles. The clinical efficacy, immune environment-related indicators, inflammation-related indicators, angiogenesis and metabolism-related indicators, rogression-free survival (PFS) and overall survival (OS) were compared between the two groups.
Results In control group, 2 cases were lost to follow-up and 1 case withdrew, resulting in 40 cases actually included; in treatment group, 3 cases were lost to follow-up, resulting in 40 cases actually included. After treatment, the disease control rates (DCR) of the control group and the treatment group were 60.00% and 82.50%, respectively; cluster of differentiation 3 positive T lymphocyte (CD3+) were (62.17±8.23)% and (67.29±7.95)%, respectively; cluster of differentiation 4 positive T lymphocyte (CD4+)/cluster of differentiation 8 positive T lymphocyte (CD8+) were 1.44±0.36 and 1.65±0.47, respectively; T helper 17 cell (Th17) were (1.37±0.34)% and (1.62±0.46)%, respectively; natural killer cell (NK) were (22.47±3.69)% and (24.86±4.12)%, respectively; tumor necrosis factor-alpha (TNF-α) were (23.35±6.28) and (19.62±5.31) pg·mL-1, respectively; soluble interleukin-2 receptor (sIL-2r) were (621.74±134.89) and (539.48±116.83) U·mL-1, respectively; lactate dehydrogenase (LDH) were (278.64±56.84) and (251.37±48.43) U·L-1, respectively; beta-2-microglobulin (β2-MG) were (1.86±0.87) and (1.49±0.74) mg·L-1, respectively; the PFS rates were 22.50% and 52.50%, respectively; the OS rates were 45.00% and 67.50%, respectively. The differences in the above data between the two groups of patients were statistically significant (all P<0.05). The total incidence of adverse drug reactions in the control group and the experimental group were 67.50% (27 cases/40 cases) and 77.50% (31 cases/40 cases) respectively, with no statistically significant difference, (P>0.05).
Conclusion ZR2 regimen can improve the tumor immune microenvironment, suppress inflammatory responses and tumor angiogenesis in patients with R/R DLBCL, thereby leadingto higher DCR and improved long-term survival benefits, without increasing the risk of treatment-related adverse events.
, authors=Fang ZHAO
a, Shu-chen LI
b, Jing-jing LIU
a, Feng-lei YIN
a, Jing LIU
a, Bo YANG
c, Juan WANG
a, authorsList=Fang ZHAO, Shu-chen LI, Jing-jing LIU, Feng-lei YIN, Jing LIU, Bo YANG, Juan WANG, authorCompany=null, correspAuthors=Fang ZHAO, 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, fund=null), CN=ArticleExt(id=1291704839109636256, articleId=1291704836458836126, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=泽布替尼联合来那度胺及利妥昔单抗治疗难治或复发性弥漫大B细胞淋巴瘤的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 探究泽布替尼胶囊联合来那度胺胶囊及利妥昔单抗注射液方案（zanubrutinib-rituximab-lenalidomide，ZR2）治疗难治或复发性（R/R）弥漫大B细胞淋巴瘤（DLBCL）的疗效和安全性。
方法 按照随机数表法将R/R DLBCL患者分为对照组和试验组。对照组于疗程第1 d给予利妥昔单抗注射液375 mg·m-2静脉滴注，并于疗程第1~14 d口服来那度胺胶囊25 mg qd。试验组在对照组的基础上于疗程1~21 d予以泽布替尼口服160 mg bid。2组均以21 d为一个周期，治疗6个周期。比较2组患者的临床疗效、免疫环境相关指标、炎症相关指标、血管生成及代谢相关指标、无进展生存期（PFS）和总生存期（OS），并进行安全性评价。
结果 对照组脱落2例，退出1例，实际纳入40例；试验组脱落3例，实际纳入40例。治疗后，对照组和试验组的疾病控制率（DCR）分别为60.00%和82.50%，CD3+ T淋巴细胞（CD3+）分别为（62.17±8.23）%和（67.29±7.95）%，CD4+ T淋巴细胞（CD4+）/CD8+ T淋巴细胞（CD8+）分别为1.44±0.36和1.65±0.47，辅助性T细胞17（Th17）分别为（1.37±0.34）%和（1.62±0.46）%，自然杀伤细胞（NK）分别为（22.47±3.69）%和（24.86±4.12）%，肿瘤坏死因子-α（TNF-α）分别为（23.35±6.28）和（19.62±5.31）pg·mL-1，可溶性白细胞介素-2受体（sIL-2r）分别为（621.74±134.89）和（539.48±116.83）U·mL-1，乳酸脱氢酶（LDH）分别为（278.64±56.84）和（251.37±48.43）U·L-1，β2-微球蛋白（β2-MG）分别为（1.86±0.87）和（1.49±0.74）mg·L-1，PFS率分别为22.50%和52.50%，OS率分别为45.00%和67.50%。2组患者以上数据在统计学上差异均有统计学意义（均P<0.05）。对照组和试验组的总药物不良反应发生率分别为67.50%（27例/40例）和77.50%（31例/40例），在统计学上差异无统计学意义（P>0.05）。
结论 ZR2治疗R/R DLBCL患者可通过改善R/R DLBCL患者的免疫微环境、抑制炎症反应及肿瘤血管生成，从而提高患者的DCR和长期生存获益，且不会增加用药风险。
, authors=赵芳
a, 李淑晨
b, 刘敬敬
a, 尹凤雷
a, 刘静
a, 杨博
c, 王娟
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赵芳，（1980-），女，主任医师，主要从事内科血液病学方面的临床工作和研究
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