紫杉醇脂质体与紫杉醇治疗乳腺癌有效性和安全性的Meta分析
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摘要
目的:采用Meta分析方法评价紫杉醇脂质体注射剂和紫杉醇注射液治疗乳腺癌的临床有效性与安全性。方法:计算机检索CNKI、WanFang Data、VIP、SinoMed、PubMed、Embase、The Cochrane Library数据库,搜集有关紫杉醇脂质体注射剂和紫杉醇注射液治疗乳腺癌的随机对照试验(RCT),检索时限均从建库至2018年6月,语言限于中文和英文。由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5. 3软件进行Meta分析。结果:共纳入16个RCTs,共1 340例患者。Meta分析结果显示:紫杉醇脂质体注射剂与紫杉醇注射液治疗乳腺癌总有效率相当[OR=1. 17,95%CI (0. 92,1. 49),P=0. 19];紫杉醇脂质体注射剂治疗乳腺癌患者导致血液系统毒性(白细胞减少、血小板减少)和神经系统毒性(周围神经炎)的发生率低于紫杉醇注射液,差异有统计学意义(P <0. 05),紫杉醇脂质体注射剂与紫杉醇注射液导致关节肌肉痛、胃肠道反应(恶心呕吐)和过敏反应(皮疹、皮肤潮红、呼吸困难)发生率的差异有统计学意义(P <0. 01),导致血红蛋白降低、脱发和肝功能异常发生率的差异无统计学意义(P> 0. 05)。结论:紫杉醇脂质体注射剂与紫杉醇注射液治疗乳腺癌有效性相当,紫杉醇脂质体注射剂安全性明显优于紫杉醇注射液。
Objective: To explore the efficacy and safety of paclitaxel liposomes and paclitaxel in the treatment of breast cancer. Methods: CNKI,WanFang Data,VIP,SinoMed,PubMed,Embase and Cochrane Library were searched to collect the relative randomized controlled trials( RCTs) of paclitaxel liposomes and paclitaxel in the treatment of breast cancer from the inception to June 2018 in Chinese and English. Two reviewers screened the literatures,extracted the data and assessed the bias risk of the included studies independently. Meta-analysis was performed using RevMan 5. 3 software. Results: Totally 16 RCTs involving 1 340 patients were included. The results of meta-analysis suggested the following aspects: no statistical difference was found in the efficacy between paclitaxel liposomes and paclitaxel against breast cancer [OR = 1. 17,95% CI(0. 92,1. 49),P =0. 19],while statistical differences were found in leukopenia,thrombocytopenia and peripheral neuritis( P < 0. 05); Significantly statistical differences were found in aches of joint and muscle,nausea and vomiting and anaphylaxis( rush,flushing and dyspnea)(P < 0. 01). No statistical differences were found in hemoglobin reduction,alopecia and abnormity of liver function(P > 0. 05).Conclusion: The efficacy of paclitaxel liposomes and paclitaxel against breast cancer is equal,and the safety of paclitaxel liposomes is much better.
Objective: To explore the efficacy and safety of paclitaxel liposomes and paclitaxel in the treatment of breast cancer. Methods: CNKI,WanFang Data,VIP,SinoMed,PubMed,Embase and Cochrane Library were searched to collect the relative randomized controlled trials( RCTs) of paclitaxel liposomes and paclitaxel in the treatment of breast cancer from the inception to June 2018 in Chinese and English. Two reviewers screened the literatures,extracted the data and assessed the bias risk of the included studies independently. Meta-analysis was performed using RevMan 5. 3 software. Results: Totally 16 RCTs involving 1 340 patients were included. The results of meta-analysis suggested the following aspects: no statistical difference was found in the efficacy between paclitaxel liposomes and paclitaxel against breast cancer [OR = 1. 17,95% CI(0. 92,1. 49),P =0. 19],while statistical differences were found in leukopenia,thrombocytopenia and peripheral neuritis( P < 0. 05); Significantly statistical differences were found in aches of joint and muscle,nausea and vomiting and anaphylaxis( rush,flushing and dyspnea)(P < 0. 01). No statistical differences were found in hemoglobin reduction,alopecia and abnormity of liver function(P > 0. 05).Conclusion: The efficacy of paclitaxel liposomes and paclitaxel against breast cancer is equal,and the safety of paclitaxel liposomes is much better.
引文
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2中国抗癌协会乳腺癌专业委员会.中国抗癌协会乳腺癌诊治指南与规范(2017年版)[J].中国癌症杂志,2017,27(9):695-759
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5吴静娜,李亮,王秋明.紫杉醇脂质体与普通紫杉醇治疗晚期乳腺癌效果对比[J].中国医学创新,2016,13(25):93-96
6张丹华,周恩相.紫杉醇注射液、紫杉醇脂质体以及多西他赛治疗乳腺癌的疗效及安全性[J].中国癌症杂志,2013,23(12):1014-1016
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10李晓红.紫衫类药物用于老年乳腺癌患者新辅助化疗疗效及不良反应分析[J].实用临床医药杂志,2013,17(15):74-76
11潘艳霞,徐峰,张志红.紫杉醇脂质体与紫杉醇联合表阿霉素在乳腺癌新辅助化疗中的疗效对比[J].医学信息,2015,28(8):330
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13王佳蕾,洪小南,印季良,等.紫杉醇脂质体与紫杉醇治疗非小细胞肺癌64例和乳腺癌62例的疗效[J].中国新药与临床杂志,2006,25(1):1-4
14耿丽,陈小兵,陈清江,等.紫杉醇脂质体与紫杉醇新辅助化疗对乳腺癌的影响及机制[J].山东医药,2011,51(33):89-90
15闫伟.紫杉醇脂质体辅助治疗乳腺癌的安全性和有效性[J].海峡药学,2013,25(2):79-80
16黄伟炜,郑弘宇,陈强,等.紫杉醇脂质体与紫杉醇联合表阿霉素在乳腺癌新辅助化疗中的对照研究[J].临床肿瘤学杂志,2010,15(3):235-238
17黎剑.紫杉醇脂质体与传统紫杉醇治疗乳腺癌的临床对比分析[J].药品评价,2017,14(21):62-64
18叶建增.乳腺癌应用紫杉醇与紫杉醇脂质体治疗的效果对照[J].北方药学,2016,13(2):65
19李林宇,李艳茹.脂质体紫杉醇周疗方案与普通紫杉醇治疗乳腺癌的疗效及不良反应比较[J].中外医疗,2016,35(15):138-139
20薛原,陈永法.紫杉醇脂质体与紫杉醇在乳腺癌新辅助化疗中随机对照研究的Meta分析[J].中国药物经济学,2013(4):29-32
21石亚飞,陈伟,王会凌,等.紫杉醇脂质体联合顺铂治疗晚期非小细胞肺癌有效性与安全性的meta分析[J].临床药物治疗杂志,2017,15(11):31-36
22刘在亮,蔡剑雄,张瑚.紫杉醇脂质体注射液与普通紫杉醇治疗胃癌疗效与安全性的Meta分析[J].中国实验方剂学杂志,2016,22(5):221-225
23唐慕菲,朱余兵,李杨,等.紫杉醇脂质体与紫杉醇分别联合卡铂治疗卵巢癌疗效的Meta分析[J].中国药师,2018,21(4):657-661
24王玲欢,胡家红.2种剂型紫杉醇联合卡铂一线治疗晚期卵巢癌的成本-效果分析[J].中国药房,2012,23(24):2268-2270
2中国抗癌协会乳腺癌专业委员会.中国抗癌协会乳腺癌诊治指南与规范(2017年版)[J].中国癌症杂志,2017,27(9):695-759
3 Higgins JP,Green S.Cochrane handbook for systematic reviews of interventions(Version5.1.0)[EB/OL].(2011-04)[2018-06]https://www.cochrane-handbrook.org
4刘晖,贾涛,赵宁,等.紫杉醇脂质体与紫杉醇在乳腺癌新辅助化疗中的疗效分析[J].现代中西医结合杂志,2010,19(18):2219-2220
5吴静娜,李亮,王秋明.紫杉醇脂质体与普通紫杉醇治疗晚期乳腺癌效果对比[J].中国医学创新,2016,13(25):93-96
6张丹华,周恩相.紫杉醇注射液、紫杉醇脂质体以及多西他赛治疗乳腺癌的疗效及安全性[J].中国癌症杂志,2013,23(12):1014-1016
7徐雨佳,方力.紫杉醇脂质体在乳腺癌新辅助化疗中的应用研究[J].实用临床医药杂志,2011,15(11):97-98
8曾庆安,刘星伟,杨光伟,等.紫杉醇脂质体在28例乳腺癌新辅助化疗中的应用[J].中国肿瘤,2008,17(8):726-728
9木亚林.紫杉醇与紫杉醇脂质体治疗乳腺癌的疗效及安全性对比研究[J].中外医疗,2015,34(5):138-139
10李晓红.紫衫类药物用于老年乳腺癌患者新辅助化疗疗效及不良反应分析[J].实用临床医药杂志,2013,17(15):74-76
11潘艳霞,徐峰,张志红.紫杉醇脂质体与紫杉醇联合表阿霉素在乳腺癌新辅助化疗中的疗效对比[J].医学信息,2015,28(8):330
12王辉.紫杉醇与紫杉醇脂质体在治疗乳腺癌过程中的疗效分析[J].北方药学,2017,14(5):41
13王佳蕾,洪小南,印季良,等.紫杉醇脂质体与紫杉醇治疗非小细胞肺癌64例和乳腺癌62例的疗效[J].中国新药与临床杂志,2006,25(1):1-4
14耿丽,陈小兵,陈清江,等.紫杉醇脂质体与紫杉醇新辅助化疗对乳腺癌的影响及机制[J].山东医药,2011,51(33):89-90
15闫伟.紫杉醇脂质体辅助治疗乳腺癌的安全性和有效性[J].海峡药学,2013,25(2):79-80
16黄伟炜,郑弘宇,陈强,等.紫杉醇脂质体与紫杉醇联合表阿霉素在乳腺癌新辅助化疗中的对照研究[J].临床肿瘤学杂志,2010,15(3):235-238
17黎剑.紫杉醇脂质体与传统紫杉醇治疗乳腺癌的临床对比分析[J].药品评价,2017,14(21):62-64
18叶建增.乳腺癌应用紫杉醇与紫杉醇脂质体治疗的效果对照[J].北方药学,2016,13(2):65
19李林宇,李艳茹.脂质体紫杉醇周疗方案与普通紫杉醇治疗乳腺癌的疗效及不良反应比较[J].中外医疗,2016,35(15):138-139
20薛原,陈永法.紫杉醇脂质体与紫杉醇在乳腺癌新辅助化疗中随机对照研究的Meta分析[J].中国药物经济学,2013(4):29-32
21石亚飞,陈伟,王会凌,等.紫杉醇脂质体联合顺铂治疗晚期非小细胞肺癌有效性与安全性的meta分析[J].临床药物治疗杂志,2017,15(11):31-36
22刘在亮,蔡剑雄,张瑚.紫杉醇脂质体注射液与普通紫杉醇治疗胃癌疗效与安全性的Meta分析[J].中国实验方剂学杂志,2016,22(5):221-225
23唐慕菲,朱余兵,李杨,等.紫杉醇脂质体与紫杉醇分别联合卡铂治疗卵巢癌疗效的Meta分析[J].中国药师,2018,21(4):657-661
24王玲欢,胡家红.2种剂型紫杉醇联合卡铂一线治疗晚期卵巢癌的成本-效果分析[J].中国药房,2012,23(24):2268-2270