消癌平注射液联合化疗治疗晚期胃癌疗效与安全性的Meta分析
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摘要
目的:系统评价消癌平注射液联合化疗治疗晚期胃癌的临床疗效和安全性。方法:通过计算机检索中国期刊全文数据库、中国生物医学文献数据库、万方数据库、维普数据库、Cochrance Library、PubMed、Embase关于消癌平注射液联合化疗治疗晚期胃癌的随机对照临床试验文献。通过Review Manager 5.2软件和stata 14软件对研究进行偏倚风险评估、Meta分析。结果:有14篇文献符合纳入标准,共计1035例患者,文献有一定的偏倚风险,Meta分析结果显示:联合治疗组的治疗有效率[OR=1.815,95%CI(1.409,2.335),Z=4.61,P<0.000,01]、生存质量状况(PFS)改善率[OR=2.79,95%CI(1.86,4.18),Z=4.94,P<0.000,01]和无疾病进展期时间[HR=0.74,95%CI(0.54,0.94),Z=7.19,P<0.000,01]均优于单用化疗对照组;在毒性反应比较中,联合治疗组的白细胞减少[RR=0.65,95%CI(0.56,0.74),P=0.0001]、血小板减少[RR=0.57,95%CI(0.45,0.72),P=0.0001]、恶心呕吐[RR=0.76,95%CI(0.65,0.89),P=0.001]、手足综合征[RR=0.63,95%CI(0.48,0.81),P=0.0001]和口腔炎[RR=0.75,95%CI(0.65,0.76),P=0.0001]的发生率明显低于单用化疗对照组,以上结果均有统计学意义。结论:对于晚期胃癌的治疗,在化疗治疗的基础上联合消癌平注射液疗效更好且毒副作用更小。但受纳入研究质量所限,仍需更多高质量研究予以验证。
Objective: To evaluate the clinical efficacy and safety of Xiaoaiping injection combined with chemotherapy in the treatment of Advanced Gastric Cancer by Meta analysis. Methods: The randomized controlled trials were searched from CNKI, Wanfang Data, Weipu Data, CBM Data, Cochrance Library, PubMed,EMbase by computer. Review 5.2 Manager software and stata14 software were used to bias risk assessment and Meta analysis of the studies. Results: A total of 14 studies with 1035 patients were included into the review.There is a risk of bias in these studies. The Meta analysis results indicated that the treatment group showed better efficacy than the control group in terms of efficiency rate [OR =1.815,95% CI(1.409,2.335), Z =4.61, P <0.000,01], quality of life(PFS) improvement [OR=2.79,95% CI(1.86,4.18),Z=4.94, P<0.000,01]and the of time progression free survival(PFS) [HR=0.74,95% CI(0.54,0.94),Z=7.19, P<0.000,01]. In comparison of toxic reactions,the treatment group showed lower incidence rate than the control group in Leukopenia [RR =0.65, 95% CI(0.56,0.74), P=0.0001<0.05], Thrombocytopenia [RR=0.57, 95%CI(0.45,0.72), P=0.0001], Nausea and vomit [RR=0.76,95%CI(0.65,0.89),P=0.001], Hand-foot syndrome [RR=0.63,95%CI(0.48,0.81),P=0.0001] and Stomatitis[RR =0.75,95% CI(0.65,0.76),P =0.0001], and the above results were statistically significant. Conclusions: The present meta-analysis suggests that Xiaoaiping injection combined with chemotherapy shows better curative effect on advanced gastric cancer with less toxic side effects; because the quality of included RCTs in this study is poor, more RCTs with high quality are needed for confirming this conclusions.
Objective: To evaluate the clinical efficacy and safety of Xiaoaiping injection combined with chemotherapy in the treatment of Advanced Gastric Cancer by Meta analysis. Methods: The randomized controlled trials were searched from CNKI, Wanfang Data, Weipu Data, CBM Data, Cochrance Library, PubMed,EMbase by computer. Review 5.2 Manager software and stata14 software were used to bias risk assessment and Meta analysis of the studies. Results: A total of 14 studies with 1035 patients were included into the review.There is a risk of bias in these studies. The Meta analysis results indicated that the treatment group showed better efficacy than the control group in terms of efficiency rate [OR =1.815,95% CI(1.409,2.335), Z =4.61, P <0.000,01], quality of life(PFS) improvement [OR=2.79,95% CI(1.86,4.18),Z=4.94, P<0.000,01]and the of time progression free survival(PFS) [HR=0.74,95% CI(0.54,0.94),Z=7.19, P<0.000,01]. In comparison of toxic reactions,the treatment group showed lower incidence rate than the control group in Leukopenia [RR =0.65, 95% CI(0.56,0.74), P=0.0001<0.05], Thrombocytopenia [RR=0.57, 95%CI(0.45,0.72), P=0.0001], Nausea and vomit [RR=0.76,95%CI(0.65,0.89),P=0.001], Hand-foot syndrome [RR=0.63,95%CI(0.48,0.81),P=0.0001] and Stomatitis[RR =0.75,95% CI(0.65,0.76),P =0.0001], and the above results were statistically significant. Conclusions: The present meta-analysis suggests that Xiaoaiping injection combined with chemotherapy shows better curative effect on advanced gastric cancer with less toxic side effects; because the quality of included RCTs in this study is poor, more RCTs with high quality are needed for confirming this conclusions.
引文
[1]蒋伯刚,王之霞,王利花.XELOX方案联合鸦胆子油乳治疗进展期胃癌32例临床观察[J].中医药导报,2011,17(11):60.
[2]林琪,陈明聪,徐雪明,等.XELOX方案联合消癌平注射液治疗进展期胃癌疗效观察[J].中国中西医结合消化杂志,2015,23(6):435-437.
[3]高明,刘丽英,安战峰.晚期胃癌患者消癌平注射液联合化疗的疗效及不良反应观察[J/OL].中华肿瘤防治杂志:1[2018-08-13].https:/doi.org/10.16073/j.cnki.cjcpt.20170705.031.
[4]李妮,冉建波.消癌平联合CPT-11化疗方案治疗老年晚期胃癌的临床疗效观察[J].河北医学,2016,22(2):198-201.
[5]洪海军,方黎.消癌平联合CPT-11化疗在老年晚期胃癌患者中应用观察[J].医药论坛杂志,2017,38(5):129-130.
[6]霍岩,程刚.消癌平联合化疗治疗晚期胃癌的临床观察[J].中国社区医师(医学专业半月刊),2009,11(18):138.
[7]赛福丁·克尤木,马兰英,唐勇.消癌平注射液联合FOL-FOX6方案化疗治疗晚期胃癌的疗效观察[J].肿瘤基础与临床,2012,25(5):397-399.
[8]马亚军.消癌平注射液联合SOX方案治疗晚期胃癌的疗效观察[J].临床医药文献电子杂志,2015,2(32):6731-6732.
[9]邓文英,许勇飞,李宁,等.消癌平注射液联合TP方案治疗晚期胃癌临床效果观察[J].中国老年保健医学,2016,14(6):51-52.
[10]张皓,李晓林.消癌平注射液联合XELOX方案治疗老年晚期胃癌的疗效[J].江苏医药,2015,41(6):642-644.
[11]高亮,卢丽琴,洪朝金,等.消癌平注射液联合XELOX方案治疗晚期胃癌的效果分析[J].中华中医药学刊,2015,33(5):1259-1261.
[12]郑振东,王沈玉,宋娜莎.消癌平注射液联合多西他赛+奥沙利铂二线治疗晚期胃癌的有效性和安全性临床研究[J].中国医院药学杂志,2017,37(22):2292-2295.
[13]刘淮东,朱子元.消癌平注射液联合化疗治疗晚期胃癌的临床研究[J].河北医学,2012,18(12):1704-1707.
[14]熊林,孟以秀,李丹.消癌平注射液用于晚期胃癌化疗患者效果观察[J].山东医药,2015,55(14):71-72.
[15]武阳.伊立替康单药与联合消癌平治疗老年晚期胃癌的比较研究[J].中国药房,2016,27(5):657-659.
[16]王权,何曦冉,蒋林.风险比在生存资料Meta分析中的应用[J].中国循证心血管医学杂志,2013,5(6):559-560.
[17]周支瑞,张天嵩,李博.生存曲线中Meta分析适宜数据的提取与转换[J].中国循证心血管医学杂志,2014,6(3):243-247.
[18]王美鑑,杜丹玉,范薇,等.消癌平注射液抗血管生成作用及其机制研究[J].药学学报,2016,51(2):309-315.
[19]Fan W,Sun L,Zhou J Q,et al.Marsdenia tenacissima extract induces G0/G1 cell cycle arrest in human esophageal carcinoma cells by inhibiting mitogen-activated protein kinase(MAPK)signaling pathway[J].Chin JNat Med,2015,13(6):428-437.
[20]Koumtebaye E,Su N,Hu W F,et al.Antitumor activity of Xiaoaiping in-jection on human gastric cancer SGC-7901cells[J].Chin J Nat Med,2012,10(5):339-346.
[21]李茂全,沈建平,胥彬,等.消癌平对SGC-7901胃癌细胞的作用及机制的实验研究[J].介入放射学杂志,2001,10(4):228-231.
[22]韩淑燕,郑文献,何曦冉,等.消癌平注射液联合吉非替尼对耐药非小细胞肺癌H460和H1975裸鼠移植瘤的抑制作用[J].中国药理学与毒理学杂志,2016,30(1):44-52.
[23]Hu Y J,Shen X L,Lu H L,et al.Tenacigenin Bderivatives reverse P-gly-coprotein-mediated multidrug resistance in HepG2/Dox cells[J].J NatProd,2008,71(6):1049-1051.
[24]Huang Z,Wang Y,Chen J,et al.Effect of Xiaoaiping injection on ad-vanced hepatocellular carcinoma in patients[J].J Tradit Chin Med,2013,33(1):34-38.
[25]李潇.消癌平注射液影响化疗导致骨髓毒性反应的探索性临床研究[D].北京:北京中医药大学,2014.
[2]林琪,陈明聪,徐雪明,等.XELOX方案联合消癌平注射液治疗进展期胃癌疗效观察[J].中国中西医结合消化杂志,2015,23(6):435-437.
[3]高明,刘丽英,安战峰.晚期胃癌患者消癌平注射液联合化疗的疗效及不良反应观察[J/OL].中华肿瘤防治杂志:1[2018-08-13].https:/doi.org/10.16073/j.cnki.cjcpt.20170705.031.
[4]李妮,冉建波.消癌平联合CPT-11化疗方案治疗老年晚期胃癌的临床疗效观察[J].河北医学,2016,22(2):198-201.
[5]洪海军,方黎.消癌平联合CPT-11化疗在老年晚期胃癌患者中应用观察[J].医药论坛杂志,2017,38(5):129-130.
[6]霍岩,程刚.消癌平联合化疗治疗晚期胃癌的临床观察[J].中国社区医师(医学专业半月刊),2009,11(18):138.
[7]赛福丁·克尤木,马兰英,唐勇.消癌平注射液联合FOL-FOX6方案化疗治疗晚期胃癌的疗效观察[J].肿瘤基础与临床,2012,25(5):397-399.
[8]马亚军.消癌平注射液联合SOX方案治疗晚期胃癌的疗效观察[J].临床医药文献电子杂志,2015,2(32):6731-6732.
[9]邓文英,许勇飞,李宁,等.消癌平注射液联合TP方案治疗晚期胃癌临床效果观察[J].中国老年保健医学,2016,14(6):51-52.
[10]张皓,李晓林.消癌平注射液联合XELOX方案治疗老年晚期胃癌的疗效[J].江苏医药,2015,41(6):642-644.
[11]高亮,卢丽琴,洪朝金,等.消癌平注射液联合XELOX方案治疗晚期胃癌的效果分析[J].中华中医药学刊,2015,33(5):1259-1261.
[12]郑振东,王沈玉,宋娜莎.消癌平注射液联合多西他赛+奥沙利铂二线治疗晚期胃癌的有效性和安全性临床研究[J].中国医院药学杂志,2017,37(22):2292-2295.
[13]刘淮东,朱子元.消癌平注射液联合化疗治疗晚期胃癌的临床研究[J].河北医学,2012,18(12):1704-1707.
[14]熊林,孟以秀,李丹.消癌平注射液用于晚期胃癌化疗患者效果观察[J].山东医药,2015,55(14):71-72.
[15]武阳.伊立替康单药与联合消癌平治疗老年晚期胃癌的比较研究[J].中国药房,2016,27(5):657-659.
[16]王权,何曦冉,蒋林.风险比在生存资料Meta分析中的应用[J].中国循证心血管医学杂志,2013,5(6):559-560.
[17]周支瑞,张天嵩,李博.生存曲线中Meta分析适宜数据的提取与转换[J].中国循证心血管医学杂志,2014,6(3):243-247.
[18]王美鑑,杜丹玉,范薇,等.消癌平注射液抗血管生成作用及其机制研究[J].药学学报,2016,51(2):309-315.
[19]Fan W,Sun L,Zhou J Q,et al.Marsdenia tenacissima extract induces G0/G1 cell cycle arrest in human esophageal carcinoma cells by inhibiting mitogen-activated protein kinase(MAPK)signaling pathway[J].Chin JNat Med,2015,13(6):428-437.
[20]Koumtebaye E,Su N,Hu W F,et al.Antitumor activity of Xiaoaiping in-jection on human gastric cancer SGC-7901cells[J].Chin J Nat Med,2012,10(5):339-346.
[21]李茂全,沈建平,胥彬,等.消癌平对SGC-7901胃癌细胞的作用及机制的实验研究[J].介入放射学杂志,2001,10(4):228-231.
[22]韩淑燕,郑文献,何曦冉,等.消癌平注射液联合吉非替尼对耐药非小细胞肺癌H460和H1975裸鼠移植瘤的抑制作用[J].中国药理学与毒理学杂志,2016,30(1):44-52.
[23]Hu Y J,Shen X L,Lu H L,et al.Tenacigenin Bderivatives reverse P-gly-coprotein-mediated multidrug resistance in HepG2/Dox cells[J].J NatProd,2008,71(6):1049-1051.
[24]Huang Z,Wang Y,Chen J,et al.Effect of Xiaoaiping injection on ad-vanced hepatocellular carcinoma in patients[J].J Tradit Chin Med,2013,33(1):34-38.
[25]李潇.消癌平注射液影响化疗导致骨髓毒性反应的探索性临床研究[D].北京:北京中医药大学,2014.