软坚散结法治疗非小细胞肺癌的疗效及安全性的Meta分析
|
摘要
[目的]系统评价软坚散结方药治疗非小细胞肺癌(NSCLC)的有效性和安全性。[方法]计算机检索中文全文期刊数据库、万方数据库、中国生物医学文献数据库及PubMed、Embase、The Cochrane Library数据库,搜集软坚散结方药治疗非小细胞肺癌的临床随机对照试验(RCT),检索时限均为建库至2017年10月16日。由2位评价员独立筛选文献、提取资料并评价纳入文献的方法学质量,采用Stata 12.0软件进行统计分析。[结果]共纳入40个RCT共计3 201例NSCLC患者,涉及汤剂、丸剂、胶囊、合剂、注射剂5种剂型,34种干预措施。Meta分析结果显示,与单纯化疗药相比,软坚散结方药联合化疗药可提高NSCLC患者的临床疗效,改善患者的生活质量,延长NSCLC患者无进展生存期,降低化疗药物不良反应。[结论]软坚散结方联合化疗药的临床疗效、生存质量及降低不良反应方面优于单纯的化疗组。由于纳入研究质量较低,该结论仍需开展高质量研究进行验证。
[Objective] This systematic review aims to systematically evaluate the efficacy and safety of resolving hard lump on the treatment of non-small cell lung cancer(NSCLC). [Methods] We searched CNKI datebases, WanFang, SinoMed, PubMed, Embase, The Cochrane Library from the inception to October 16th 2017, to collect randomized controlled trials(RCTs)of the resolving hard lump in treating NSCLC. Two reviewers independently screened literature, extracted date and assessed the methodological quality of included studies. Then, statistical analysis was performed by using Stata12.0 and WinBUGS1.4.3 sofware. [Resluts] A total of 40 RCTs nvolved 3201 patients were finally included,in which 5 different dosage forms and 34 interventions. There mainly were decoction, pill, capsule,mixture, and injection. The result of direct Meta-analysis showed that compared with the simple chemotherapy group, resolving hard lump prescription combined with chemotherapeutic drugs could significantly improve the clinical efficacy, improve the quality of life of patients, prolong progression free survival and decrease adverse reactions of chemotherapeutic drugs. [Conclusion] Resolving hard lump prescription combined with chemotherapeutics were more effective than the simple chemotherapy group in terms of clinical efficacy, the quality of life, and decrease adverse reactions. Due to the low quality of included studies,more high quality RCTs are needed to verify the above conclusion.
[Objective] This systematic review aims to systematically evaluate the efficacy and safety of resolving hard lump on the treatment of non-small cell lung cancer(NSCLC). [Methods] We searched CNKI datebases, WanFang, SinoMed, PubMed, Embase, The Cochrane Library from the inception to October 16th 2017, to collect randomized controlled trials(RCTs)of the resolving hard lump in treating NSCLC. Two reviewers independently screened literature, extracted date and assessed the methodological quality of included studies. Then, statistical analysis was performed by using Stata12.0 and WinBUGS1.4.3 sofware. [Resluts] A total of 40 RCTs nvolved 3201 patients were finally included,in which 5 different dosage forms and 34 interventions. There mainly were decoction, pill, capsule,mixture, and injection. The result of direct Meta-analysis showed that compared with the simple chemotherapy group, resolving hard lump prescription combined with chemotherapeutic drugs could significantly improve the clinical efficacy, improve the quality of life of patients, prolong progression free survival and decrease adverse reactions of chemotherapeutic drugs. [Conclusion] Resolving hard lump prescription combined with chemotherapeutics were more effective than the simple chemotherapy group in terms of clinical efficacy, the quality of life, and decrease adverse reactions. Due to the low quality of included studies,more high quality RCTs are needed to verify the above conclusion.
引文
[1]Zheng R,Zeng H,Zhang S,et al.National estimates of cancer prevalence in China,2011[J].Cancer Lett,2016,370(1):33-38.
[2]Siegel RL,Miller KD,Jemal A.Cancer statistics,2015[J].CA Cancer J Clin,2015,65(1):5-29.
[3]Huang YT,Heist RS,Chirrieac LR,et al.Genome-wide analysis of survival in early-stage non-small-cell lung cancer[J].J Clin Oncol,2009,27(16):2660.
[4]李杰,林洪生,侯伟,等.中医药治疗肿瘤理念及策略[J].中国肿瘤,2010,19(11):735.
[5]薛娜,林洪生.晚期非小细胞肺癌的中医维持治疗[J].临床肿瘤学杂志,2012,17(1):1.
[6]王洪娟.益气消癥饮联合化疗治疗晚期非小细胞肺癌临床研究[J].山东中医杂志,2017,37(6):463-466.
[7]陆晔,陈美云,许尤琪.“益肺散结方”联合化疗治疗晚期肺癌30例临床研究[J].江苏中医药,2017,62(3):32-35.
[8]张燕,杨树利,张红蕊,等.养正消积胶囊联合GP方案化疗对晚期非小细胞肺癌的疗效及血清MMP-9的影响[J].亚太传统医药,2017,13(4):127-128.
[9]肖敏,刘瑛,龚璐.扶正散结方联合GP方案治疗晚期非小细胞肺鳞癌(气虚瘀滞)随机平行对照研究[J].实用中医内科杂志,2017,31(1):33-35.
[10]张俊萍,赵一,魏征.基于真实世界研究解毒散结胶囊治疗晚期非小细胞肺癌患者疗效评价及生存分析[J].时珍国医国药,2016,27(10):2561-2562.
[11]陆群英,刘俊波,杨红伟,等.清肺散结汤配合化疗治疗晚期非小细胞肺癌30例临床疗效观察[J].中医临床研究,2016,29(24):130-133.
[12]崔自慧.养正消积胶囊应用于非小细胞肺癌提高化疗疗效观察[J].中国现代药物应用,2016,10(13):219-220.
[13]李寿杰,陈高峰,付啸风.扶正消瘤汤联合吉西他滨与顺铂治疗非小细胞肺癌的临床疗效观察[J].齐齐哈尔医学院学报,2016,33(15):1912-1914.
[14]步许海.益气补肺、化痰散结类中药配合西药治疗中晚期非小细胞肺癌临床研究[J].亚太传统医药,2016,12(2):111-112.
[15]况建荣,余丽娟,刘铮.养正消积胶囊联合化疗治疗晚期非小细胞肺癌的疗效及对患者免疫功能的影响[J].中国处方药,2016,15(1):62-63.
[16]严小萍,杨杰,沈爱云.清肺消瘤汤内服联合化疗治疗中晚期非小细胞肺癌的临床研究[J].现代中西医结合杂志,2016,25(3):284-286.
[17]刘杰.扶正消积胶囊对晚期非小细胞肺癌化疗患者近期疗效及生活质量的影响[J].临床医学研究与实践,2016,1(14):105-106.
[18]王蜀梅,李钧.平消胶囊与参丹散结胶囊辅助培美曲塞联合卡铂治疗Ⅳ期非小细胞肺癌的疗效比较[J].中国药房,2015,16(30):4200-4202.
[19]贺天临,谢国群,陈洁,等.夏枯草消瘤合剂联合化疗治疗中晚期非小细胞肺癌30例[J].上海中医药大学学报,2015,56(5):29-32.
[20]逄艳,赵美蓉,王兆凯,等.消瘤汤配合化疗治疗脾虚痰湿型中晚期非小细胞肺癌的临床研究[J].中国实用医药,2015,10(19):125-127.
[21]景霆.芪杞祛痰合剂配合西药治疗中晚期非小细胞肺癌临床分析[J].北方药学,2015,12(7):165.
[22]陈武进,华杭菊,卢丽莎,等.养正消积胶囊对晚期非小细胞肺癌免疫功能的影响[J].福建中医药,2015,60(1):16-17.
[23]李创业,高立伟,张保伟.理肺散结丸治疗中晚期非小细胞肺癌临床研究[J].光明中医,2015,31(2):271-273.
[24]曾建伦.扶正消瘤汤联合化疗对非小细胞肺癌患者免疫功能及生活质量的影响[J].中国中医药现代远程教育,2015,13(23):37-38.
[25]李爽.益气除痰散结法治疗中晚期非小细胞肺癌患者的临床分析[J].中华肿瘤防治杂志,2015,22(22):164-165.
[26]张朝霞,倪建林,郑立军.软坚散联合CP方案在老年肺癌术后治疗中的临床研究[J].内蒙古中医药,2014,33(15):43-44.
[27]毛彦彬,梁志会,张志辉,等.清肺散结丸与长春瑞滨和顺铂联用对晚期非小细胞肺癌的疗效观察[J].现代生物医学进展,2014,9(11):2118-2121.
[28]夏瑞丽.消积汤联合GP方案治疗晚期非小细胞肺癌临床疗效观察[J].中华全科医学,2014,17(3):462-464.
[29]刘彧宏,魏克民,吴益萍,等.扶正消积方加减联合化疗治疗晚期非小细胞肺癌临床疗效观察[J].中国现代医生,2013,7(6):70-72.
[30]文晓萍,何滨.NC方案结合中医治疗晚期非小细胞肺癌90例临床观察[J].中医药导报,2013,20(9):21-23.
[31]刘霞,张科源,朱兆峰,等.养正消积胶囊联合化疗对晚期非小细胞肺癌患者生存质量的影响[J].上海中医药杂志,2013,59(8):57-59.
[32]张永杰,冯莹.消积汤与铂类化疗联合治疗晚期非小细胞肺癌临床观察[J].中医临床研究,2013,26(11):38-39.
[33]束家和,周荣耀,吴丽英,等.养正消积胶囊联合化疗治疗中晚期非小细胞肺癌35例临床观察[J].世界中医药,2013,8(4):465-468.
[34]卢利员,黄斌,李永浩,等.益气养阴消积饮结合化疗治疗晚期非小细胞肺癌的临床疗效观察[J].北京中医药大学学报,2013,55(3):192-195.
[35]张晓丽,黄挺,黄伶,等.固本消积汤联合DP方案治疗晚期非小细胞肺癌临床观察[J].浙江中西医结合杂志,2012,22(11):872-874.
[36]张丽丽,贾彦焘,赵娜,等.养正消积胶囊联合GP方案治疗晚期非小细胞肺癌对照观察[J].实用中医内科杂志,2012,26(15):21-23.
[37]尤建良,阮纪恺.中药宁肺散结方联合GP方案治疗晚期非小细胞肺癌的临床研究[J].辽宁中医杂志,2012,39(10):1983-1986.
[38]贺小霞,邓晓明.扶正消瘤汤联合顺铂、多西他赛治疗非小细胞肺癌的疗效[J].中国实用医刊,2012,39(4):99-100.
[39]贾学科,胡立新,刘建国,等.慈桃软坚胶囊对非小细胞肺癌抑瘤作用的临床研究[J].中国实验方剂学杂志,2011,17(16):265-266.
[40]何伟凤.中西医结合治疗晚期非小细胞性肺癌30例临床观察[J].中医药导报,2011,18(6):29-30.
[41]要全保,王丽新,倪伟,等.养阴软坚法治疗晚期非小细胞肺癌临床观察[J].浙江中医药大学学报,2011,35(4):501-503.
[42]刘源,王淑玲.补肾散结方联合GP方案治疗晚期非小细胞肺癌临床疗效观察[J].中华中医药杂志,2011,26(4):864-867.
[43]周延峰,刘朝霞,李秀荣,等.消瘤方治疗非小细胞肺癌的临床观察[J].山东中医药大学学报,2006,30(5):358-360.
[44]王忱,王毓敏,谢广茹.艾迪注射液合并化疗治疗非小细胞肺癌的疗效观察[J].天津中医,2002,19(4):61.
[45]李邦华,曾纪权,袁国庆.益气养阴散结加化疗治疗Ⅲ期非小细胞肺癌临床观察[J].江西中医药,2001,51(1):21-22.
[2]Siegel RL,Miller KD,Jemal A.Cancer statistics,2015[J].CA Cancer J Clin,2015,65(1):5-29.
[3]Huang YT,Heist RS,Chirrieac LR,et al.Genome-wide analysis of survival in early-stage non-small-cell lung cancer[J].J Clin Oncol,2009,27(16):2660.
[4]李杰,林洪生,侯伟,等.中医药治疗肿瘤理念及策略[J].中国肿瘤,2010,19(11):735.
[5]薛娜,林洪生.晚期非小细胞肺癌的中医维持治疗[J].临床肿瘤学杂志,2012,17(1):1.
[6]王洪娟.益气消癥饮联合化疗治疗晚期非小细胞肺癌临床研究[J].山东中医杂志,2017,37(6):463-466.
[7]陆晔,陈美云,许尤琪.“益肺散结方”联合化疗治疗晚期肺癌30例临床研究[J].江苏中医药,2017,62(3):32-35.
[8]张燕,杨树利,张红蕊,等.养正消积胶囊联合GP方案化疗对晚期非小细胞肺癌的疗效及血清MMP-9的影响[J].亚太传统医药,2017,13(4):127-128.
[9]肖敏,刘瑛,龚璐.扶正散结方联合GP方案治疗晚期非小细胞肺鳞癌(气虚瘀滞)随机平行对照研究[J].实用中医内科杂志,2017,31(1):33-35.
[10]张俊萍,赵一,魏征.基于真实世界研究解毒散结胶囊治疗晚期非小细胞肺癌患者疗效评价及生存分析[J].时珍国医国药,2016,27(10):2561-2562.
[11]陆群英,刘俊波,杨红伟,等.清肺散结汤配合化疗治疗晚期非小细胞肺癌30例临床疗效观察[J].中医临床研究,2016,29(24):130-133.
[12]崔自慧.养正消积胶囊应用于非小细胞肺癌提高化疗疗效观察[J].中国现代药物应用,2016,10(13):219-220.
[13]李寿杰,陈高峰,付啸风.扶正消瘤汤联合吉西他滨与顺铂治疗非小细胞肺癌的临床疗效观察[J].齐齐哈尔医学院学报,2016,33(15):1912-1914.
[14]步许海.益气补肺、化痰散结类中药配合西药治疗中晚期非小细胞肺癌临床研究[J].亚太传统医药,2016,12(2):111-112.
[15]况建荣,余丽娟,刘铮.养正消积胶囊联合化疗治疗晚期非小细胞肺癌的疗效及对患者免疫功能的影响[J].中国处方药,2016,15(1):62-63.
[16]严小萍,杨杰,沈爱云.清肺消瘤汤内服联合化疗治疗中晚期非小细胞肺癌的临床研究[J].现代中西医结合杂志,2016,25(3):284-286.
[17]刘杰.扶正消积胶囊对晚期非小细胞肺癌化疗患者近期疗效及生活质量的影响[J].临床医学研究与实践,2016,1(14):105-106.
[18]王蜀梅,李钧.平消胶囊与参丹散结胶囊辅助培美曲塞联合卡铂治疗Ⅳ期非小细胞肺癌的疗效比较[J].中国药房,2015,16(30):4200-4202.
[19]贺天临,谢国群,陈洁,等.夏枯草消瘤合剂联合化疗治疗中晚期非小细胞肺癌30例[J].上海中医药大学学报,2015,56(5):29-32.
[20]逄艳,赵美蓉,王兆凯,等.消瘤汤配合化疗治疗脾虚痰湿型中晚期非小细胞肺癌的临床研究[J].中国实用医药,2015,10(19):125-127.
[21]景霆.芪杞祛痰合剂配合西药治疗中晚期非小细胞肺癌临床分析[J].北方药学,2015,12(7):165.
[22]陈武进,华杭菊,卢丽莎,等.养正消积胶囊对晚期非小细胞肺癌免疫功能的影响[J].福建中医药,2015,60(1):16-17.
[23]李创业,高立伟,张保伟.理肺散结丸治疗中晚期非小细胞肺癌临床研究[J].光明中医,2015,31(2):271-273.
[24]曾建伦.扶正消瘤汤联合化疗对非小细胞肺癌患者免疫功能及生活质量的影响[J].中国中医药现代远程教育,2015,13(23):37-38.
[25]李爽.益气除痰散结法治疗中晚期非小细胞肺癌患者的临床分析[J].中华肿瘤防治杂志,2015,22(22):164-165.
[26]张朝霞,倪建林,郑立军.软坚散联合CP方案在老年肺癌术后治疗中的临床研究[J].内蒙古中医药,2014,33(15):43-44.
[27]毛彦彬,梁志会,张志辉,等.清肺散结丸与长春瑞滨和顺铂联用对晚期非小细胞肺癌的疗效观察[J].现代生物医学进展,2014,9(11):2118-2121.
[28]夏瑞丽.消积汤联合GP方案治疗晚期非小细胞肺癌临床疗效观察[J].中华全科医学,2014,17(3):462-464.
[29]刘彧宏,魏克民,吴益萍,等.扶正消积方加减联合化疗治疗晚期非小细胞肺癌临床疗效观察[J].中国现代医生,2013,7(6):70-72.
[30]文晓萍,何滨.NC方案结合中医治疗晚期非小细胞肺癌90例临床观察[J].中医药导报,2013,20(9):21-23.
[31]刘霞,张科源,朱兆峰,等.养正消积胶囊联合化疗对晚期非小细胞肺癌患者生存质量的影响[J].上海中医药杂志,2013,59(8):57-59.
[32]张永杰,冯莹.消积汤与铂类化疗联合治疗晚期非小细胞肺癌临床观察[J].中医临床研究,2013,26(11):38-39.
[33]束家和,周荣耀,吴丽英,等.养正消积胶囊联合化疗治疗中晚期非小细胞肺癌35例临床观察[J].世界中医药,2013,8(4):465-468.
[34]卢利员,黄斌,李永浩,等.益气养阴消积饮结合化疗治疗晚期非小细胞肺癌的临床疗效观察[J].北京中医药大学学报,2013,55(3):192-195.
[35]张晓丽,黄挺,黄伶,等.固本消积汤联合DP方案治疗晚期非小细胞肺癌临床观察[J].浙江中西医结合杂志,2012,22(11):872-874.
[36]张丽丽,贾彦焘,赵娜,等.养正消积胶囊联合GP方案治疗晚期非小细胞肺癌对照观察[J].实用中医内科杂志,2012,26(15):21-23.
[37]尤建良,阮纪恺.中药宁肺散结方联合GP方案治疗晚期非小细胞肺癌的临床研究[J].辽宁中医杂志,2012,39(10):1983-1986.
[38]贺小霞,邓晓明.扶正消瘤汤联合顺铂、多西他赛治疗非小细胞肺癌的疗效[J].中国实用医刊,2012,39(4):99-100.
[39]贾学科,胡立新,刘建国,等.慈桃软坚胶囊对非小细胞肺癌抑瘤作用的临床研究[J].中国实验方剂学杂志,2011,17(16):265-266.
[40]何伟凤.中西医结合治疗晚期非小细胞性肺癌30例临床观察[J].中医药导报,2011,18(6):29-30.
[41]要全保,王丽新,倪伟,等.养阴软坚法治疗晚期非小细胞肺癌临床观察[J].浙江中医药大学学报,2011,35(4):501-503.
[42]刘源,王淑玲.补肾散结方联合GP方案治疗晚期非小细胞肺癌临床疗效观察[J].中华中医药杂志,2011,26(4):864-867.
[43]周延峰,刘朝霞,李秀荣,等.消瘤方治疗非小细胞肺癌的临床观察[J].山东中医药大学学报,2006,30(5):358-360.
[44]王忱,王毓敏,谢广茹.艾迪注射液合并化疗治疗非小细胞肺癌的疗效观察[J].天津中医,2002,19(4):61.
[45]李邦华,曾纪权,袁国庆.益气养阴散结加化疗治疗Ⅲ期非小细胞肺癌临床观察[J].江西中医药,2001,51(1):21-22.