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上海中医药大学附属市中医医院血液病科,上海200040
住院医师,博士。研究方向:中西医结合防治血液病的临床与基础。E-mail:2536414669@qq.com
副主任医师,副教授,硕士生导师,博士。研究方向:中西医结合防治血液病的临床与基础。E-mail:xyzsbjz@126.com
收稿日期:2023-10-20,
修回日期:2024-03-13,
录用日期:2024-03-14,
纸质出版日期:2024-05-15
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李晓靖,胡琦,陆嘉惠,等.沙利度胺联合CAG方案治疗老年急性髓系白血病患者有效性与安全性的Meta分析[J].中国药房,2024,35(09):1139-1144.
LI Xiaojing,HU Qi,LU Jiahui,et al.Meta-analysis on efficacy and safety of thalidomide combined with CAG regimen in the treatment of elderly patients with acute myeloid leukemia[J].ZHONGGUO YAOFANG,2024,35(09):1139-1144.
李晓靖,胡琦,陆嘉惠,等.沙利度胺联合CAG方案治疗老年急性髓系白血病患者有效性与安全性的Meta分析[J].中国药房,2024,35(09):1139-1144. DOI: 10.6039/j.issn.1001-0408.2024.09.20.
LI Xiaojing,HU Qi,LU Jiahui,et al.Meta-analysis on efficacy and safety of thalidomide combined with CAG regimen in the treatment of elderly patients with acute myeloid leukemia[J].ZHONGGUO YAOFANG,2024,35(09):1139-1144. DOI: 10.6039/j.issn.1001-0408.2024.09.20.
目的
2
系统评价沙利度胺联合阿克拉霉素、粒细胞集落刺激因子与阿糖胞苷(CAG)方案治疗老年急性髓系白血病(AML)患者的疗效与安全性。
方法
2
检索中国知网、万方数据、维普网、Sino Med、PubMed、Embase、 the Cochrane Library、Web of Science,检索时限为数据库建库至2023年8月27日。收集沙利度胺联合CAG方案(试验组)对比CAG方案(对照组)治疗老年AML患者的临床随机对照试验,对纳入的研究采用RevMan 5.3软件进行Meta分析。
结果
2
最终纳入7项临床随机对照试验,共计601例患者,其中试验组307例、对照组294例。Meta分析结果显示,试验组在提升总有效率[
Z
=4.75,
P
<0.000 01,OR=2.80,95%CI(1.83,4.28)
]
、完全缓解率[
Z
=2.82,
P
=0.005,OR=1.61,95%CI(1.16,2.25)
]
,改善血小板计数[
Z
=2.70,
P
=0.007,MD=64.02,95%CI(17.53,110.51)
]
、血管内皮生长因子水平[
Z
=13.63,
P
<0.000 01,MD=-65.17,95%CI(-74.54,-55.80)
]
、血管内皮生长因子受体水平[
Z
=12.03,
P
<0.000 01,MD=-499.01,95%CI(-580.31,-417.71)
]
、碱性成纤维细胞生长因子水平[
Z
=4.17,
P
<0.000 1,MD=-0.23,95%CI(-0.35,-0.12)
]
等方面均显著优于对照组,不良反应发生率[
Z
=0.99,
P
=0.32,OR=0.52,95%CI(0.14,1.89)
]
以及恶心呕吐[
Z
=1.06,
P
=0.29,OR=0.66,95%CI(0.30,1.43)
]
、便秘或腹泻[
Z
=0.92,
P
=0.36,OR=0.65,95%CI(0.26,1.63)
]
、嗜睡[
Z
=1.38,
P
=0.17,OR=0.57,95%CI(0.26,1.27)
]
、骨髓抑制[
Z
=0.88,
P
=0.38,OR=0.68,95%CI(0.28,1.62)
]
的发生率与对照组比较,差异均无统计学意义。
结论
2
沙利度胺联合CAG方案治疗老年AML患者能显著增加疗效,且安全性较好。
OBJECTIVE
2
To systematically evaluate the efficacy and safety of thalidomide combined with aclacinomycin, granulocyte colony-stimulating factor and cytarabine (CAG) regimen in the treatment of elderly patients with acute myeloid leukemia (AML).
METHODS
2
CNKI, Wanfang data, VIP, Sino Med, PubMed, Embase, the Cochrane Library and Web of Science were searched comprehensively from the inception to Aug. 27th, 2023. Randomized controlled trials (RCTs) about thalidomide combined with CAG regimen (trial group) versus CAG regimen (control group) in the treatment of elderly AML patients were collected, and RevMan 5.3 software was used for meta-analysis of included studies.
RESULTS
2
Finally, 7 RCTs were included, with a total of 601 patients, including 307 patients in the trial group and 294 patients in the control group. Meta-analysis results showed that the tri
al group was superior to the control group in enhancing the overall response rate [
Z
=4.75,
P
<0.000 01, OR=2.80, 95%CI (1.83,4.28)
]
, complete remission rate [
Z
=2.82,
P
=0.005, OR=1.61, 95%CI (1.16, 2.25)
]
, and improving platelet count [
Z
=2.70,
P
=0.007, MD=64.02, 95%CI (17.53, 110.51)
]
, vascular endothelial growth factor [
Z
=13.63,
P
<0.000 01, MD=-65.17, 95%CI(-74.54, -55.80)
]
, vascular endothelial growth factor receptor [
Z
=12.03,
P
< 0.000 01, MD=-499.01, 95%CI (-580.31, -417.71)
]
and basic fibroblast growth factor [
Z
=4.17,
P
<0.000 1, MD=-0.23, 95%CI(-0.35, -0.12)
]
. And there was no statistical difference between the trial group and the control group in the incidence of adverse drug reaction [
Z
=0.99,
P
=0.32, OR=0.52, 95%CI(0.14,1.89)
]
, nausea and vomiting [
Z
=1.06,
P
=0.29, OR=0.66, 95%CI (0.30,1.43)
]
, constipation or diarrhea [
Z
=0.92,
P
=0.36, OR=0.65, 95%CI(0.26, 1.63)
]
, drowsiness [
Z
=1.38,
P
=0.17, OR=0.57, 95%CI(0.26, 1.27)
]
or myelosuppression [
Z
=0.88,
P
=0.38,OR=0.68,95%CI(0.28,1.62)
]
.
CONCLUSIONS
2
The combination of thalidomide and CAG regimen in the treatment of elderly AML patients can significantly improve clinical efficacy and has high safety.
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