基于Meta分析的复方苦参注射液治疗乳腺癌系统评价研究
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摘要
目的:系统评价复方苦参注射液联合化疗治疗乳腺癌的临床疗效及安全性,为临床治疗与合理用药提供循证医学依据。方法:计算机检索中国期刊全文数据库、中文科技期刊全文数据库、万方数据库、中国生物医学文献数据库、PubMed、Embase和the Cochrane Library等数据库,检索时间为建库至2018年5月1日,全面检索复方苦参注射液治疗乳腺癌的随机对照试验(对照组患者采用化疗,观察组患者在对照组基础上加用复方苦参注射液),采用Cochrane风险评价表评价其研究质量,提取资料并通过RevMan5.3软件进行文献荟萃分析(Meta分析)。结果:共纳入24篇文献,累计受试者1 896例。Meta分析结果显示,观察组患者临床治疗总有效率(RR=1.33,95%CI=1.19~1.48,P<0.000 01)明显高于对照组,生活质量改善情况明显优于对照组(RR=1.63,95%CI=1.33~2.01,P<0.000 01),白细胞计数降低发生率(RR=0.53,95%CI=0.45~0.61,P<0.000 01)、胃肠道反应发生率(RR=0.58,95%CI=0.51~0.66,P<0.000 01)明显低于对照组,肝功能异常改善情况明显优于对照组(RR=0.29,95%CI=0.19~0.45,P=0.000 01),上述差异均有统计学意义。结论:复方苦参注射液联合化疗治疗可以显著提高乳腺癌患者临床治疗总有效率,改善患者生活质量,减少不良反应的发生。但本研究结论尚需更多设计良好的大样本随机对照、双盲试验加以证实。
OBJECTIVE: To systematically review the clinical efficacy and safety of compound Kushen injection in treatment of breast cancer,so as to provide evidence-based references for rational medication. METHODS: Randomized controlled trials on compound Kushen injection in treatment of breast cancer( the control group was given chemotherapy,the observation group was given compound Kushen injection combined with chemotherapy) from database-building to May 1st,2018 were retrieved from CNKI,VIP,Wanfang,CBM,PubMed,Cochrane Library and Embase. Cochrane bias assessment tool was adopted to evaluate the literature quality,data extracting was conducted and RevMan 5. 2 was used to carry out Meta analysis. RESULTS: A total of 24 studies was involved,including 1 896 subjects. Results of Meta analysis indicated the clinical total effective rate of observation group was significantly higher than that of the control group( RR = 1. 33,95% CI = 1. 19-1. 48,P < 0. 000 01),the improvement of life quality( RR = 1. 63,95% CI = 1. 33-2. 01,P < 0. 000 01),incidence of white blood cell count decreasing( RR = 0. 53,95% CI = 0. 45-0. 61,P < 0. 000 01) and incidence of gastrointestinal reaction( RR = 0. 58,95% CI = 0. 51-0. 66,P < 0. 000 01) of observation group were significantly lower than those of the control group,the improvement of abnormal liver function of observation group was significantly better than that of the control group( RR = 0. 29,95% CI = 0. 19-0. 45,P = 0. 000 01),all with statistically significantly differences.CONCLUSIONS: The combination of compound Kushen injection with chemotherapy can significantly improve the total efficacy and patients' life quality in treatment of breast cancer,with few adverse drug reactions. However,this conclusion still needs further verification by double blind trials and RCT with better design and larger sample.
OBJECTIVE: To systematically review the clinical efficacy and safety of compound Kushen injection in treatment of breast cancer,so as to provide evidence-based references for rational medication. METHODS: Randomized controlled trials on compound Kushen injection in treatment of breast cancer( the control group was given chemotherapy,the observation group was given compound Kushen injection combined with chemotherapy) from database-building to May 1st,2018 were retrieved from CNKI,VIP,Wanfang,CBM,PubMed,Cochrane Library and Embase. Cochrane bias assessment tool was adopted to evaluate the literature quality,data extracting was conducted and RevMan 5. 2 was used to carry out Meta analysis. RESULTS: A total of 24 studies was involved,including 1 896 subjects. Results of Meta analysis indicated the clinical total effective rate of observation group was significantly higher than that of the control group( RR = 1. 33,95% CI = 1. 19-1. 48,P < 0. 000 01),the improvement of life quality( RR = 1. 63,95% CI = 1. 33-2. 01,P < 0. 000 01),incidence of white blood cell count decreasing( RR = 0. 53,95% CI = 0. 45-0. 61,P < 0. 000 01) and incidence of gastrointestinal reaction( RR = 0. 58,95% CI = 0. 51-0. 66,P < 0. 000 01) of observation group were significantly lower than those of the control group,the improvement of abnormal liver function of observation group was significantly better than that of the control group( RR = 0. 29,95% CI = 0. 19-0. 45,P = 0. 000 01),all with statistically significantly differences.CONCLUSIONS: The combination of compound Kushen injection with chemotherapy can significantly improve the total efficacy and patients' life quality in treatment of breast cancer,with few adverse drug reactions. However,this conclusion still needs further verification by double blind trials and RCT with better design and larger sample.
引文
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[36]黄哲宙,陈万青,吴春晓,等.中国女性乳腺癌的发病和死亡现况——全国32个肿瘤登记点2003—2007年资料分析报告[J].肿瘤,2012,32(6):435-439.
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[2]Boyle P,Levin B.World Cancer Report 2008[M].Lyon:IARC Press,2008:412-417.
[3]金惠,王水英,孙宇,等.中药联合放化疗药物治疗乳腺癌的作用及其机制研究进展[J].中国药师,2013,16(5):751-755.
[4]马悦,张启伟,王智民,等.复方苦参注射液研究进展[J].中国实验方剂学杂志,2012,18(23):342-345.
[5]王晓红,李义慧,杨俊泉,等.复方苦参注射液对乳腺癌术后化疗患者的疗效及免疫功能的影响[J].中国全科医学,2011,14(23):2696-2698.
[6]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:2015版[J].中国癌症杂志,2015,25(9):692-754.
[7]World Health Organization(WHO).WHO handbook for reporting results of cancer treatment[M].Offset Publish No.48.Geneva(Switzerland):WHO,1979:484-485.
[8]抗癌药急性及亚急性毒性反应分度标准:WHO标准[J].癌症,1992(3):254.
[9]Higgins JP,Altman DG,Gtzsche PC,et al.The Cochrane Collaboration's tool for assessing risk of bias in randomized trials[J].BMJ,2011,343:d5928.
[10]Review Manager(Computer program).Version 5.3.Copenhagen:The Nordic Cochrane Centre,The Cochrane Collaboration,2014[N/OL].http://community.cochrane.org/sites/default/files/uploads/inline-files/Rev Man_5.3_User_Guide.pdf.
[11]郑明华.Meta分析软件应用与实例解析[M].北京:人民卫生出版社,2013:1.
[12]王雷,刘洁.CTF方案联合岩舒注射液在乳腺癌新辅助化疗中的临床观察[J].中国医药导报,2007,4(24):55.
[13]马永全,杨曼春,王辉,等.复方苦参联合化疗治疗中晚期乳腺癌的临床观察[J].医药前沿,2011,1(21):90-91.
[14]孙晓,裴飞舟,屈中玉.复方苦参注射液(岩舒注射液)联合化疗治疗晚期乳腺癌临床观察[J].中外医疗,2008,27(22):67.
[15]杨煊.复方苦参注射液对乳腺癌化疗毒副作用的影响[J].实用临床医药杂志,2013,17(5):105-107.
[16]翟晓建.复方苦参注射液对乳腺癌术后化疗患者毒副反应及免疫功能的影响[J].中国中医基础医学杂志,2014,20(6):829-831.
[17]张新明,高伟,潘琪,等.复方苦参注射液辅助治疗Her-2/neu过表达乳腺癌的疗效观察[J].肿瘤研究与临床,2011,23(9):629-631.
[18]顾锡冬,赵虹,谢小红.复方苦参注射液联合新辅助化疗对局部晚期乳腺癌患者疗效观察[J].浙江中医杂志,2015,50(1):74.
[19]宋荣峰,万以叶,程楚.复方苦参注射液合并化疗治疗晚期乳腺癌临床观察[J].江西医药,2009,44(4):343-344.
[20]张之君.复方苦参注射液联合AC方案治疗早期乳腺癌改良根治术后患者临床观察[J].光明中医,2015,30(9):1963-1965.
[21]任建鸿,王红,刘丽梅,等.复方苦参注射液联合CAF方案治疗早期乳腺癌改良根治术后患者123例的临床观察[J].中国医院用药评价与分析,2010,10(8):736-739.
[22]曹蔚.复方苦参注射液联合化疗药物治疗乳腺癌的临床研究[J].现代中西医结合杂志,2012,21(36):4044-4045.
[23]安爱军,安广文,吴亚丛.复方苦参注射液联合化疗治疗乳腺癌术后35例效果观察[J].解放军医药杂志,2012,24(10):43-46.
[24]李英霞.复方苦参注射液联合化疗治疗晚期乳腺癌60例临床观察[J].中国医药指南,2012,10(36):302-303.
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[27]黄永惠,廖志英,范春花,等.复方苦参注射液联合紫杉醇加阿霉素治疗中晚期乳腺癌的临床观察[J].西部医学,2012,24(9):1699-1701.
[28]李立业.复方苦参注射液联合紫杉醇加阿霉素治疗中晚期乳腺癌临床观察[J].新中医,2016,48(1):158-159.
[29]任明云,张燕,杨树利,等.复方苦参注射液配合ET化疗方案治疗初治晚期乳腺癌的疗效及复发随访研究[J].中国现代药物应用,2016,10(22):128-129.
[30]赵彩霞.复方苦参注射液在乳腺癌化疗中的临床观察[J].世界最新医学信息文摘,2016,16(6):103.
[31]沈玉静.复方苦参注射液在乳腺癌术后化疗患者治疗中的应用价值[J].中国药物经济学,2016,11(6):69-70.
[32]许贺娟.苦参注射液联合化疗治疗乳腺癌术后患者的临床观察[J].中医临床研究,2017,9(8):120-121.
[33]钱小英,卓曼云,林海锋,等.三阴乳腺癌应用复方苦参注射液联合铂类+吉西他滨化疗的临床观察[J].实用癌症杂志,2017,32(2):305-307,316.
[34]王程,王晓丽.岩舒注射液对54例乳腺癌化疗毒副反应的疗效观察[J].宁夏医学杂志,2004,26(12):832.
[35]徐宁.应用复方苦参注射液治疗乳腺癌术后化疗患者的临床疗效及对其外周血T细胞亚群的影响研究[J].中国民康医学,2017,29(7):16-18.
[36]黄哲宙,陈万青,吴春晓,等.中国女性乳腺癌的发病和死亡现况——全国32个肿瘤登记点2003—2007年资料分析报告[J].肿瘤,2012,32(6):435-439.
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