养正消积胶囊联合化疗治疗消化道恶性肿瘤疗效和安全性的Meta分析
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摘要
目的系统评价养正消积胶囊联合化疗治疗消化道恶性肿瘤的有效性和安全性。方法计算机检索CNKI、WangFang Data、PubMed、EMbase、SinoMed、The Cochrane Library数据库,搜集养正消积胶囊联合化疗治疗消化道恶性肿瘤的随机对照试验(RCT),检索时限均为建库至2017年11月20日。由2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15个RCT。Meta分析结果显示:与化疗比较,养正消积胶囊联合化疗治疗消化道恶性肿瘤的疾病控制率[RR=1.26,95%CI(1.07,1.49),P<0.000 01]、中医证候临床疗效[RR=1.71,95%CI(1.50,1.96),P<0.000 01]、患者生活质量[RR=1.44,95%CI(1.13,1.82),P=0.003]均优于单纯化疗,且可改善患者免疫功能,降低不良反应发生。结论化疗基础上加用养正消积胶囊治疗消化道恶性肿瘤,在疾病控制、中医证候疗效、生活质量及改善免疫功能方面均优于单纯化疗。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。
Objectives To systematically review the efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor.Methods CNKI,WanFang Data,PubMed,EMbase,SinoMed and The Cochrane Library databases were searched online to collect randomized controlled trials(RCTs) of Yangzhengxiaoji capsule combined with chemotherapy for malignant tumor of digestive tract from inception to November 20~(th),2017.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Meta-analysis was then performed using ReMan 5.3 software.Resluts A total of 15 RCTs were included.The results of meta-analysis showed that:compared with the chemotherapy alone,Yangzhengxiaoji capsule combined with chemotherapy could significantly improve the disease control rate(RR=1.26,95%CI 1.07 to 1.49,P<0.000 01),the clinical efficacy of TCM syndrome(RR=1.71,95%CI 1.50 to 1.96,P<0.000 01),and the quality of life scores of patients(RR=1.44,95%CI 1.13 to 1.82,P=0.003).The combination therapy could also improve the immune function of patients and reduce the incidence of adverse reactions.Conclusions Current evidence shows that chemotherapy combined with Yangzhengxiaoji capsule is superior to chemotherapy alone for disease control of malignant tumor of digestive tract,clinical efficacy of TCM syndrome,the quality of life,and improving immune function.Due to limited quality and quantity of the included studies,more high quality studies are required to verify above conclusions.
Objectives To systematically review the efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor.Methods CNKI,WanFang Data,PubMed,EMbase,SinoMed and The Cochrane Library databases were searched online to collect randomized controlled trials(RCTs) of Yangzhengxiaoji capsule combined with chemotherapy for malignant tumor of digestive tract from inception to November 20~(th),2017.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Meta-analysis was then performed using ReMan 5.3 software.Resluts A total of 15 RCTs were included.The results of meta-analysis showed that:compared with the chemotherapy alone,Yangzhengxiaoji capsule combined with chemotherapy could significantly improve the disease control rate(RR=1.26,95%CI 1.07 to 1.49,P<0.000 01),the clinical efficacy of TCM syndrome(RR=1.71,95%CI 1.50 to 1.96,P<0.000 01),and the quality of life scores of patients(RR=1.44,95%CI 1.13 to 1.82,P=0.003).The combination therapy could also improve the immune function of patients and reduce the incidence of adverse reactions.Conclusions Current evidence shows that chemotherapy combined with Yangzhengxiaoji capsule is superior to chemotherapy alone for disease control of malignant tumor of digestive tract,clinical efficacy of TCM syndrome,the quality of life,and improving immune function.Due to limited quality and quantity of the included studies,more high quality studies are required to verify above conclusions.
引文
1国家卫生计生委合理用药专家委员会.消化道恶性肿瘤合理用药指南.中国合理用药探索,2017,14(9):5-54.
2刘鹏,杜秀婷,韦海林,等.中国与美国恶性肿瘤的现状比较及差异分析.肿瘤预防与治疗,2017,30(4):299-304.
3张康乐,司文涛,邵宏敏.中医药治疗在肿瘤化疗不良反应中的应用.中国中医急症,2015,24(7):1212-1214.
4秦士川,杨立波.养正消积胶囊配合介入化疗或放疗治疗原发性肝癌的Meta分析.黑龙江医学,2016,40(1):5-7.
5杨立波,韩硕龙,高学东.养正消积胶囊配合介入化疗或放疗治疗原发性肝癌有效性和安全性的Meta分析.疑难病杂志,2015,14(10):1074-1077.
6李瑞林,许进秀,李鲁明,等.养正消积胶囊联合XELOX方案治疗晚期胃癌临床观察.中华肿瘤防治杂志,2017,24(12):855-857.
7孙波,胡雪玲.化疗联合养正消积胶囊治疗中晚期大肠癌临床研究.中医学报,2017,32(9):1586-1588.
8王兰荣.养正消积胶囊联合奥沙利铂+替吉奥方案对晚期胃癌的效果.当代医学,2016,22(30):138-139.
9王岩,卢艳龙.养正消积胶囊辅助治疗晚期结肠癌患者的疗效及安全性研究.现代中西医结合杂志,2016,25(27):3044-3047.
10刘宗瑜,李伟冬,周荣耀.养正消积胶囊联合化疗治疗大肠癌.结直肠肛门外科,2016,22(S1):111-113.
11周永清,陈旭,丁海斌.养正消积胶囊联合FOLFIRI方案治疗结直肠癌的临床研究.现代药物与临床,2016,31(6):868-872.
12惠文涛.胃癌根治术后养正消积胶囊联合ZELOX方案化疗对患者生存质量及免疫功能的影响.现代肿瘤医学,2015,23(18):2624-2627.
13魏艳静,卞红磊.养正消积胶囊对晚期结肠癌化疗减毒作用及生活质量的影响.中国现代医学杂志,2015,25(28):98-101.
14苏连明,李海林,王加良.养正消积胶囊减轻胃癌术后化疗不良反应的临床观察.中国药房,2014,25(7):657-659.
15高秋洁,王贵吉.养正消积胶囊联合SOX方案治疗晚期胃癌的临床疗效观察.中国实用医刊,2014,41(6):31-32.
16郜娜娜,贺新爱,吕晶晶.养正消积胶囊联合化疗治疗晚期食管癌临床观察.医学理论与实践,2014,27(13):1731-1732.
17裴俊文.养正消积胶囊联合替吉奥胶囊治疗老年晚期胃癌临床研究.中医学报,2013,28(8):1099-1101.
18束家和,周荣耀,龚航军,等.养正消积胶囊联合化疗治疗中晚期大肠癌160例.上海中医药杂志,2013,47(7):52-54.
19安爱军,曹晶杰.养正消积胶囊对晚期胃癌患者癌症相关疲劳的影响.国际中医中药杂志,2013,35(9):831-832.
20崔兴俊,马文龙,毕学杰.养正消积胶囊对进展期胃癌化疗患者细胞免疫功能的影响.疑难病杂志,2011,10(9):703-704.
21宋赵佶.圣济总录.北京:人民卫生出版社,1982.
22毕俊芳,李雪松,陈亦伟,等.养正消积胶囊治疗恶性肿瘤临床和实验研究近况.现代中西医结合杂志,2015,24(33):3757-3759.
23符文明,张爱琴,范丽萍,等.养正消积胶囊对Ca Es-17细胞成瘤组织及对荷瘤裸鼠生存状态与白细胞分类的影响.浙江中西医结合杂志,2014,24(12):1073-1075.
2刘鹏,杜秀婷,韦海林,等.中国与美国恶性肿瘤的现状比较及差异分析.肿瘤预防与治疗,2017,30(4):299-304.
3张康乐,司文涛,邵宏敏.中医药治疗在肿瘤化疗不良反应中的应用.中国中医急症,2015,24(7):1212-1214.
4秦士川,杨立波.养正消积胶囊配合介入化疗或放疗治疗原发性肝癌的Meta分析.黑龙江医学,2016,40(1):5-7.
5杨立波,韩硕龙,高学东.养正消积胶囊配合介入化疗或放疗治疗原发性肝癌有效性和安全性的Meta分析.疑难病杂志,2015,14(10):1074-1077.
6李瑞林,许进秀,李鲁明,等.养正消积胶囊联合XELOX方案治疗晚期胃癌临床观察.中华肿瘤防治杂志,2017,24(12):855-857.
7孙波,胡雪玲.化疗联合养正消积胶囊治疗中晚期大肠癌临床研究.中医学报,2017,32(9):1586-1588.
8王兰荣.养正消积胶囊联合奥沙利铂+替吉奥方案对晚期胃癌的效果.当代医学,2016,22(30):138-139.
9王岩,卢艳龙.养正消积胶囊辅助治疗晚期结肠癌患者的疗效及安全性研究.现代中西医结合杂志,2016,25(27):3044-3047.
10刘宗瑜,李伟冬,周荣耀.养正消积胶囊联合化疗治疗大肠癌.结直肠肛门外科,2016,22(S1):111-113.
11周永清,陈旭,丁海斌.养正消积胶囊联合FOLFIRI方案治疗结直肠癌的临床研究.现代药物与临床,2016,31(6):868-872.
12惠文涛.胃癌根治术后养正消积胶囊联合ZELOX方案化疗对患者生存质量及免疫功能的影响.现代肿瘤医学,2015,23(18):2624-2627.
13魏艳静,卞红磊.养正消积胶囊对晚期结肠癌化疗减毒作用及生活质量的影响.中国现代医学杂志,2015,25(28):98-101.
14苏连明,李海林,王加良.养正消积胶囊减轻胃癌术后化疗不良反应的临床观察.中国药房,2014,25(7):657-659.
15高秋洁,王贵吉.养正消积胶囊联合SOX方案治疗晚期胃癌的临床疗效观察.中国实用医刊,2014,41(6):31-32.
16郜娜娜,贺新爱,吕晶晶.养正消积胶囊联合化疗治疗晚期食管癌临床观察.医学理论与实践,2014,27(13):1731-1732.
17裴俊文.养正消积胶囊联合替吉奥胶囊治疗老年晚期胃癌临床研究.中医学报,2013,28(8):1099-1101.
18束家和,周荣耀,龚航军,等.养正消积胶囊联合化疗治疗中晚期大肠癌160例.上海中医药杂志,2013,47(7):52-54.
19安爱军,曹晶杰.养正消积胶囊对晚期胃癌患者癌症相关疲劳的影响.国际中医中药杂志,2013,35(9):831-832.
20崔兴俊,马文龙,毕学杰.养正消积胶囊对进展期胃癌化疗患者细胞免疫功能的影响.疑难病杂志,2011,10(9):703-704.
21宋赵佶.圣济总录.北京:人民卫生出版社,1982.
22毕俊芳,李雪松,陈亦伟,等.养正消积胶囊治疗恶性肿瘤临床和实验研究近况.现代中西医结合杂志,2015,24(33):3757-3759.
23符文明,张爱琴,范丽萍,等.养正消积胶囊对Ca Es-17细胞成瘤组织及对荷瘤裸鼠生存状态与白细胞分类的影响.浙江中西医结合杂志,2014,24(12):1073-1075.