Article(id=1292126368687481703, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.04.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1758470400000, receivedDateStr=2025-09-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996532841, onlineDateStr=2026-08-06, pubDate=1772208000000, pubDateStr=2026-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996532841, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996532841, creator=13701087609, updateTime=1785996532841, updator=13701087609, issue=Issue{id=1292126355785802497, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996529766, creator='13701087609', updateTime=1786014519902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201811952292026, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201811952292027, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=492, endPage=499, ext={EN=ArticleExt(id=1292126368872031080, articleId=1292126368687481703, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of venetoclax combined with azacitidine for treatment of newly diagnosed acute myeloid leukemia patients, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate the clinical efficacy and safety of venetoclax tablet combined with azacitidine for injection in the treatment of newly diagnosed acute myeloid leukemia (AML) patients unsuitable for intensive chemotherapy.
Methods Newly diagnosed AML patients unsuitable for intensive chemotherapy were divided into control group and treatment group based on treatment regimen. The control group received 75 mg·m-2 azacitidine for injection by subcutaneous injection or intravenous infusion for 7 consecutive days per 28-day cycle. The treatment group received oral venetoclax tablet (dose escalation: 100 mg on day 1, 200 mg on day 2, and 400 mg daily from day 3 onwards) plus 75 mg·m-2 azacitidine for injection, by subcutaneous injection or intravenous infusion for 7 consecutive days per 28-day cycle. Both groups were treated for 2 cycles. Clinical efficacy, hematological parameters [hemoglobin (Hb), platelet count (PLT), absolute neutrophil count (ANC), white blood cell count (WBC)], bone marrow morphology and cytogenetic assessments (proportion of bone marrow blasts, bone marrow cellularity), liver function indices [alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL)], renal function index [serum creatinine (SCr)], coagulation parameters [prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), D-dimer], survival outcomes [overall survival (OS), event-free survival (EFS)], and safety indicators were compared between the two groups.
Results A total of 230 patients were enrolled with 112 in the control group and 118 in the treatment group. After treatment, the overall response rate (ORR) in the treatment group was 74.58% (88 cases/118 cases), significantly higher than the control group’s 53.57% (60 cases/112 cases). The complete remission (CR) rate in the treatment group was 49.15% (58 cases/118 cases), significantly higher than the control group’s 26.79% (30 cases/112 cases); both differences were statistically significant (P<0.05). After treatment, Hb levels of treatment group and control group were (94.85±18.67) and (85.51±17.84) g·L-1, respectively; PLT counts were (125.51±35.24) ×109·L-1 and (78.22±29.77) ×109·L-1, respectively; ANC levels were (4.23±1.87) ×109·L-1 and (2.79±1.16) ×109·L-1, respectively; WBC levels were (5.89±2.72) ×109·L-1 and (6.85±2.73) ×109·L-1, respectively;. the proportion of bone marrow blasts were (16.90±8.98)% and (29.16±14.18)%, respectively; the proportion of patients with active bone marrow hyperplasia were 80.51% (95 cases/118 cases) and 69.64% (78 cases/112 cases), respectively;. ALT levels were (58.56±25.14) and (45.78±16.57) U·L-1, respectively; AST levels were (52.34±17.07) and (41.12±17.31) U·L-1, respectively; TBIL levels were (31.65±12.10) and (25.33±9.12) μmol·L-1, respectively; SCr levels were (84.32±19.19) and (82.13±17.55) μmol·L-1, respectively; PT were (14.12±2.42) and (13.78±2.29) s, respectively; APTT were (34.12±5.10) and (33.22±4.65) s, respectively; FIB were (3.56±0.97) and (3.53±0.81) g·L-1, respectively; D-dimer levels were (0.58±0.22) and (0.52±0.21) mg·L-1, respectively. Except SCr, PT, APTT, FIB and D-dimer levels, comparion of other indicators between two groups showed statistically significant differences (all P<0.05). The median OS of treatment group and control group were 34.0 and 21.0 months, respectively;, median EFS was 28.0 and 11.0 months. Both median OS and median EFS were significantly longer in the treatment group compared to the control group (both P<0.05). The adverse event (AE) incidence rate was 28.57% (32 cases /112 cases) in the control group and 32.20% (38 cases/118 cases) in the treatment group, with no statistically significant difference (P>0.05).
Conclusion Venetoclax tablet combined with azacitidine for injection significantly improved the ORR, CR rate, survival outcomes (OS, EFS), hematological recovery, and reduced bone marrow leukemic burden in newly diagnosed AML patients unsuitable for intensive chemotherapy. Although associated with an increased risk of liver toxicity, the overall safety profile was manageable. This combination regimen demonstrates significant clinical value.
, authors=Wen-hui XU, Rong HU, authorsList=Wen-hui XU, Rong HU, authorCompany=null, correspAuthors=Rong HU, 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=1292126369102717801, articleId=1292126368687481703, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=维奈克拉联合阿扎胞苷治疗急性髓性白血病的临床研究, 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 探讨维奈克拉片联合注射用阿扎胞苷治疗不适合强化化疗的新诊断急性髓性白血病（AML）患者的临床疗效和安全性。
方法 将不适合强化化疗的新诊断AML患者按照治疗方法分为对照组和试验组。对照组给予75 mg·m-2注射用阿扎胞苷，皮下注射或静脉滴注，连续7 d，28 d为1个疗程。试验组给予维奈克拉片，口服给药，剂量递增方案为第1天100 mg，第2天200 mg，第3天及以后400 mg，qd；联合75 mg·m-2注射用阿扎胞苷，皮下注射或静脉滴注，连续7 d，28天d为1个疗程。2组均治疗2个疗程。比较2组患者的临床疗效、血液学指标[血红蛋白（Hb）、血小板计数（PLT）、中性粒细胞绝对值（ANC）、白细胞计数（WBC）]、骨髓形态学与细胞遗传学评估（骨髓原始细胞比例、骨髓增生程度）、肝功能指标[丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）]、肾功能指标[血肌酸酐（Scr）]、凝血功能指标[凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FIB）、D-二聚体]、生存期（OS）和无事件生存期（EFS）并进行安全性评价。
结果 本研究共纳入230例，对照组112例，试验组118例。治疗后，试验组的总缓解率为74.58%（88例/118例），显著高于对照组的53.57%（60例/112例）；试验组的完全缓解率为49.15%（58例/118例），显著高于对照组的26.79%（30例/112例），在统计学上差异均具有统计学意义（均P<0.05）。治疗后，试验组和对照组的Hb分别为（94.85±18.67）和（85.51±17.84）g·L-1，PLT分别为（125.51±35.24）×109·L-1和（78.22±29.77）×109·L-1，ANC分别为（4.23±1.87）×109·L-1和（2.79±1.16）×109·L-1，WBC水平分别为（5.89±2.72）×109·L-1和（6.85±2.73）×109·L-1；骨髓原始细胞比例分别为（16.90±8.98）%和（29.16±14.18）%；骨髓增生活跃比例分别为80.51%（95例/118例）和69.64%（78例/112例）；ALT分别为（58.56±25.14）和（45.78±16.57）U·L-1，AST分别为（52.34±17.07）和（41.12±17.31）U·L-1，TBIL分别为（31.65±12.10）和（25.33±9.12）μmol·L-1；SCr水平分别为（84.32±19.19）和（82.13±17.55）μmol·L-1；PT分别为（14.12±2.42）和（13.78±2.29）s，APTT分别为（34.12±5.10）和（33.22±4.65）s，FIB分别为（3.56±0.97）和（3.53±0.81）g·L-1，D-二聚体水平分别为（0.58±0.22）和（0.52±0.21）mg·L-1，除SCr、PT、APTT、FIB和D-二聚体水平外，上述指标在2组间比较，在统计学上差异均有统计学意义（均P<0.05）。治疗后，试验组和对照组的中位OS分别为34.0和21.0个月、中位EFS分别为28.0和11.0个月，试验组的中位OS、中位EFS与对照组比较，在统计学上差异有统计学意义（均P<0.05）。对照组药物不良反应发生率为28.57%（32例/112例），试验组为32.20%（38例/118例），2组间比较在统计学上差异无统计学意义（P>0.05）。
结论 维奈克拉片联合注射用阿扎胞苷可显著提高不适合强化化疗的新诊断AML患者的总缓解率、完全缓解率及生存期，改善血液学恢复并降低骨髓白血病负荷，虽存在一定肝毒性风险，但总体安全性可控，具有重要临床价值。
, authors=徐文慧, 胡荣, authorsList=徐文慧, 胡荣, authorCompany=null, correspAuthors=胡荣, authorNote=
徐文慧（1987-），女，主治医师，主要从事恶性血液病诊治方面的临床工作和研究
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