康艾注射液联合化疗治疗胃癌疗效与安全性的系统评价
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摘要
目的:从循证医学的角度,系统评价康艾注射液联合化疗治疗胃癌的疗效与安全性,为临床用药提供依据。方法:计算机检索2005—2015年中国期刊全文数据库、PubMed及万方数据库等中英文数据库中关于康艾注射液联合全身化疗方案治疗胃癌的临床随机对照试验(观察组患者给予康艾注射液联合全身化疗方案,对照组患者单纯给予全身化疗方案),依据Cochrane评价手册评价文献质量,提交数据并进行文献荟萃分析(Meta分析)。结果:共纳入16篇文献,Meta分析结果显示,康艾注射液联合化疗在改善胃癌患者生活质量(P<0.000 01)、提高化疗有效率(P<0.000 01)和降低白细胞计数降低发生率(P<0.000 01)、肠胃道反应发生率(P<0.000 01)及肝损伤发生率(P=0.002)等方面的作用明显优于单纯化疗;两种方案降低肾损伤发生率作用的差异无统计学意义(P=0.15)。结论:基于现有临床证据,康艾注射液联合化疗治疗胃癌可提高化疗有效率,改善患者生活质量,减轻化疗的部分不良反应;但由于纳入研究数量较少,上述结论需谨慎对待,期待高质量、长期和大样本的试验进一步验证。
OBJECTIVE: From the perspective of evidence-based medicine, to systematically review the efficacy and safety of Kang'ai injection combined with chemotherapy in treatment of gastric cancer, so as to provide references for clinical medication. METHODS: Randomized controlled trials(the observation group was given Kang'ai injection combined with systematic chemotherapy, the control group was given systematic chemotherapy alone) on Kang'ai injection combined with chemotherapy in treatment of gastric cancer during 2005-2015 were retrieved from CNKI, PubMed and Wanfang, data were submitted and Meta-analysis was conducted according to the Cochrane evaluation manual. RESULTS: A total of 16 studies were involved, results of Meta-analysis indicated that the effects of Kang'ai injection combined with chemotherapy in improving living quality(P<0.000 01), increasing the effective rate of chemotherapy(P<0.000 01), reducing incidence of white blood cell count reduction(P<0.000 01), reducing incidences of gastrointestinal reaction(P<0.000 01) and liver injury(P=0.002) were significantly better than those of chemotherapy alone; there was no statistical significance in difference in reducing the incidence of renal injury between two therapeutic regimens(P=0.15). CONCLUSIONS: Based on present clinical evidence, Kang'ai injection combined with chemotherapy in treatment of gastric cancer can improve the effective rate of chemotherapy and quality of life, reduce part of adverse drug reactions; however, due to the small number of involved studies, the above conclusions should to be treated with caution, which need further verification by high quality, long-term and large-sample trials.
OBJECTIVE: From the perspective of evidence-based medicine, to systematically review the efficacy and safety of Kang'ai injection combined with chemotherapy in treatment of gastric cancer, so as to provide references for clinical medication. METHODS: Randomized controlled trials(the observation group was given Kang'ai injection combined with systematic chemotherapy, the control group was given systematic chemotherapy alone) on Kang'ai injection combined with chemotherapy in treatment of gastric cancer during 2005-2015 were retrieved from CNKI, PubMed and Wanfang, data were submitted and Meta-analysis was conducted according to the Cochrane evaluation manual. RESULTS: A total of 16 studies were involved, results of Meta-analysis indicated that the effects of Kang'ai injection combined with chemotherapy in improving living quality(P<0.000 01), increasing the effective rate of chemotherapy(P<0.000 01), reducing incidence of white blood cell count reduction(P<0.000 01), reducing incidences of gastrointestinal reaction(P<0.000 01) and liver injury(P=0.002) were significantly better than those of chemotherapy alone; there was no statistical significance in difference in reducing the incidence of renal injury between two therapeutic regimens(P=0.15). CONCLUSIONS: Based on present clinical evidence, Kang'ai injection combined with chemotherapy in treatment of gastric cancer can improve the effective rate of chemotherapy and quality of life, reduce part of adverse drug reactions; however, due to the small number of involved studies, the above conclusions should to be treated with caution, which need further verification by high quality, long-term and large-sample trials.
引文
[1] 郑晓珂.多西紫杉醇+顺铂方案联合康艾注射液治疗晚期胃癌的近期疗效及安全性[J].中国老年学杂志,2015,35(13):3619-3621.
[2] 姜书明,张利强,王海英,等.康艾注射液对胃癌化疗患者免疫功能的影响[J].实用临床医药杂志,2008,12(12):89.
[3] 李淑青.康艾注射液联合FLO化疗方案治疗晚期胃癌的安全性及可行性分析[J].河北医药,2015,37(8):1144-1147.
[4] 李瑜英.康艾注射液联合FOLFOX4方案治疗进展期胃癌疗效观察[J].新中医,2008,40(11):23-24.
[5] 祁玉娟.康艾注射液联合FOLFOX4方案治疗晚期胃癌的疗效观察及血清VEGF水平变化[J].中国中药杂志,2008,33(16):2051-2052.
[6] 王继红.康艾注射液联合OLF方案治疗晚期胃癌的临床观察[J].中国卫生产业,2011,8(26):35.
[7] 莫艳艳.康艾注射液联合奥沙利铂、亚叶酸钙、氟尿嘧啶化疗治疗晚期胃癌临床分析[J].中华实用诊断与治疗杂志,2010,24(10):1008-1009.
[8] 曹凤.康艾注射液联合化疗对胃癌治疗的临床分析[J].中医临床研究,2015,7(21):147-148.
[9] 叶延程,张玉花,薛虎,等.康艾注射液联合化疗用于晚期胃癌患者的近期疗效、安全性及对调节性T细胞水平和P21蛋白、VEGF表达的影响[J].中国药房,2015,26(6):737-740.
[10] 本巴吉.康艾注射液联合化疗治疗老年晚期胃癌38例[J].陕西中医,2010,31(5):546-547.
[11] 张凌,熊建萍.康艾注射液联合化疗治疗晚期胃癌[J].肿瘤防治研究,2009,36(4):328-330.
[12] 王达,陈树泉.康艾注射液联合化疗治疗胃癌的临床观察[J].临床医药实践杂志,2005,14(5):369.
[13] 杨雪梅.康艾注射液联合FLO化疗方案治疗晚期胃癌40例[J].中国实验方剂学杂志,2012,18(22):325-327.
[14] 周文杰,吴骏,朱丹霞,等.康艾注射液联合FLO化疗方案治疗晚期胃癌80例临床观察[J].现代诊断与治疗,2015,26(21):4840-4842.
[15] 吴莉,杨怡.康艾注射液联合化疗治疗晚期胃癌的临床研究[J].临床医药实践,2009,18(19):493-496.
[16] 王鹰,章跃平,徐安.康艾注射液治疗晚期癌症患者的临床疗效[J].中国现代医生,2008,46(27):95-96.
[17] 薛瑞萍.重视康艾注射液的临床应用[J].求医问药:下半月,2012,10(7):185-186.
[2] 姜书明,张利强,王海英,等.康艾注射液对胃癌化疗患者免疫功能的影响[J].实用临床医药杂志,2008,12(12):89.
[3] 李淑青.康艾注射液联合FLO化疗方案治疗晚期胃癌的安全性及可行性分析[J].河北医药,2015,37(8):1144-1147.
[4] 李瑜英.康艾注射液联合FOLFOX4方案治疗进展期胃癌疗效观察[J].新中医,2008,40(11):23-24.
[5] 祁玉娟.康艾注射液联合FOLFOX4方案治疗晚期胃癌的疗效观察及血清VEGF水平变化[J].中国中药杂志,2008,33(16):2051-2052.
[6] 王继红.康艾注射液联合OLF方案治疗晚期胃癌的临床观察[J].中国卫生产业,2011,8(26):35.
[7] 莫艳艳.康艾注射液联合奥沙利铂、亚叶酸钙、氟尿嘧啶化疗治疗晚期胃癌临床分析[J].中华实用诊断与治疗杂志,2010,24(10):1008-1009.
[8] 曹凤.康艾注射液联合化疗对胃癌治疗的临床分析[J].中医临床研究,2015,7(21):147-148.
[9] 叶延程,张玉花,薛虎,等.康艾注射液联合化疗用于晚期胃癌患者的近期疗效、安全性及对调节性T细胞水平和P21蛋白、VEGF表达的影响[J].中国药房,2015,26(6):737-740.
[10] 本巴吉.康艾注射液联合化疗治疗老年晚期胃癌38例[J].陕西中医,2010,31(5):546-547.
[11] 张凌,熊建萍.康艾注射液联合化疗治疗晚期胃癌[J].肿瘤防治研究,2009,36(4):328-330.
[12] 王达,陈树泉.康艾注射液联合化疗治疗胃癌的临床观察[J].临床医药实践杂志,2005,14(5):369.
[13] 杨雪梅.康艾注射液联合FLO化疗方案治疗晚期胃癌40例[J].中国实验方剂学杂志,2012,18(22):325-327.
[14] 周文杰,吴骏,朱丹霞,等.康艾注射液联合FLO化疗方案治疗晚期胃癌80例临床观察[J].现代诊断与治疗,2015,26(21):4840-4842.
[15] 吴莉,杨怡.康艾注射液联合化疗治疗晚期胃癌的临床研究[J].临床医药实践,2009,18(19):493-496.
[16] 王鹰,章跃平,徐安.康艾注射液治疗晚期癌症患者的临床疗效[J].中国现代医生,2008,46(27):95-96.
[17] 薛瑞萍.重视康艾注射液的临床应用[J].求医问药:下半月,2012,10(7):185-186.