Article(id=1292135520226799966, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1769702400000, receivedDateStr=2026-01-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998714739, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998714739, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998714739, creator=13701087609, updateTime=1785998714739, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1351, endPage=1358, ext={EN=ArticleExt(id=1292135520444903775, articleId=1292135520226799966, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of daratumumab combined with lenalidomide and dexamethasone in the treatment of multiple myeloma, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To compare the clinical efficacy of daratumumab injection combined with lenalidomide capsules and dexamethasone injection in the treatment of multiple myeloma (MM).
Methods Patients with MM were divided into control group and treatment group according to the treatment method. Patients in the control group received the bortezomib for injection, lenalidomide capsules and dexamethasone injection (VRd) regimen; patients in the treatment group received the daratumumab injection, lenalidomide capsules and dexamethasone injection (DRd) regimen. The VRd regimen: Within each 28-day cycle, bortezomib for injection at 1.3 mg·m-2, lenalidomide capsules at 25 mg·d-1 and dexamethasone injection at 20 mg·d-1 were administered according to the standard protocol. The DRd regimen: Based on lenalidomide capsules and dexamethasone injection , daratumumab injection at 16 mg·kg-1 was added (once weekly in cycles 1-2, once every 2 weeks in cycles 3-6, and once every 4 weeks thereafter). Efficacy was evaluated after 3 cycles of treatment in both groups. Clinical efficacy, MM-related biomarkers and adverse reactions were compared between the two groups.
Results The study enrolled 88 patients, with 45 cases in the control group and 43 cases in the treatment group. Post-treatment evaluation revealed objective response rates (ORR) of 77.78% (35 cases/45 cases) and 90.70% (39 cases/43 cases) for the control and treatment groups, respectively, demonstrating no statistically significant intergroup difference (P>0.05). After treatment, the levels of hemoglobin of control group and treatment group were (102.85±15.87) and (109.71±16.24) g·L-1, respectivley; the levels of β2-microglobulin (β2-MG) were (4.29±1.12) and (3.67±1.03) mg·L-1, respectivley; the levels of lactate dehydrogenase (LDH) were (167.29±30.92) and (152.32±29.67) U·L-1, respectivley; the levels of monoclonal protein (M protein) were (17.42±3.87) and (15.39±3.42) g·L-1, respectivley; bone marrow plasma cells were (10.25±2.13)% and (8.92±2.06)%, respectivley; cluster of differentiation 3 positive (CD3+) were (62.45±8.74)% and (67.06±9.12)%, respectivley; CD4+ levels were (34.26±5.12)% and (37.68±5.33)%, respectivley; CD4+/CD8+ ratios were 1.16±0.24 and 1.28±0.22, respectivley. Compared the control group with treatment group, the differences of above indexes were all statistically significant (all P<0.05). The total incidence of peripheral neuropathy of control group and treatment group were 22.22% (10 cases/45 cases) and 2.33% (1 case/43 cases), respectivley; myelosuppression were 15.56% (7 cases/45 cases) and 37.21% (16 cases/43 cases), respectivley; infection were15.56% (7 cases/45 cases) and 34.88% (15 cases/43 cases), respectivley, all with statistically significant differences (P<0.05, P<0.01).
Conclusion While ensuring clinical efficacy, the DRd regimen exerts more significant effects in improving immune function, levels of MM-related biomarkers, and quality of life, and significantly reduces the incidence of peripheral neuropathy. However, it is associated with increased risks of myelosuppression and infection.
, authors=Xiu-hui CHEN
1a, Xiu-yun SHENG
1b, authorsList=Xiu-hui CHEN, Xiu-yun SHENG, authorCompany=null, correspAuthors=Xiu-yun SHENG, 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=1292135520734310752, articleId=1292135520226799966, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=达雷妥尤单抗联合来那度胺及地塞米松治疗多发性骨髓瘤的临床研究, 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 观察达雷妥尤单抗注射液联合来那度胺胶囊及地塞米松注射液治疗多发性骨髓瘤（MM）的临床疗效和安全性。
方法 将MM患者根据治疗方法分为对照组和试验组。对照组患者给予注射用硼替佐米、来那度胺胶囊及地塞米松注射液（VRd）方案治疗；试验组患者给予达雷妥尤单抗注射液、来那度胺胶囊及地塞米松（DRd）注射液方案治疗。VRd方案：每28天周期内，按标准方案给注射用予硼替佐米1.3 mg·m-2、来那度胺胶囊25 mg·d-1及地塞米松注射液20 mg·d-1。DRd方案：在来那度胺胶囊及地塞米松注射液基础上，加用达雷妥尤单抗注射液16 mg·kg-1（第1~2周期每周1次，第3~6周期每2周1次，之后每4周1次）。2组均治疗3个周期后评估疗效。比较2组临床疗效、多发性骨髓瘤标志物、免疫功能、血清细胞因子水平，并进行安全性评价。
结果 共纳入88例MM患者，其中对照组45例，试验组43例。治疗后，对照组和试验组的客观缓解率分别为77.78%（35例/45例）和90.70%（39例/43例），在统计学上差异无统计学意义（P>0.05）。治疗后，对照组和试验组的血红蛋白分别为（102.85±15.87）和（109.71±16.24）g·L-1，β2-微球蛋白分别为（4.29±1.12）和（3.67±1.03）mg·L-1，乳酸脱氢酶分别为（167.29±30.92）和（152.32±29.67）U·L-1，M蛋白分别为（17.42±3.87）和（15.39±3.42）g·L-1，骨髓浆细胞分别为（10.25±2.13）%和（8.92±2.06）%，分化簇3阳性（CD3+）的水平分别为（62.45±8.74）%和（67.06±9.12）%，CD4+水平分别为（34.26±5.12）%和（37.68±5.33）%，CD4+/CD8+比值分别为1.16±0.24和1.28±0.22，在统计学上差异均有统计学意义（均P<0.05）。对照组和试验组的周围神经病变总发生率分别为22.22%（10例/45例）和2.33%（1例/43例），骨髓抑制总发生率分别为15.56%（7例/45例）和37.21%（16例/43例），感染总发生率分别为15.56%（7例/45例）和34.88%（15例/43例），在统计学上差异均有统计学意义（P<0.05，P<0.01）。
结论 DRd方案在保证临床疗效的基础上，改善免疫功能、多发性骨髓瘤标志物水平、生活质量的效果更为显著，且显著降低周围神经病变的发生率，但骨髓抑制与感染风险增加。
, authors=陈秀慧
1a, 盛秀云
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陈秀慧（1988-），女，主治医师，主要从事血液肿瘤病学相关治疗方面的临床工作和研究
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