摘要
OBJECTIVE: To assess the efficacy and safety of Aidi injection plus transarterial chemoembolization(TACE) in patients with primary hepatic carcinoma.METHODS: A comprehensive research of seven electronic databases was performed for comparative studies evaluating Aidi injection combined with TACE for primary hepatic carcinoma until September 2016. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool from the Cochrane Handbook version 5.1.0. Data was synthesized by using Rev Man 5.3 software.RESULTS: Forty-nine studies involving 3435 patients met the inclusion criteria, most of which were low methodological quality. Compared with TACE alone, Aidi injection plus TACE can significantly improve the efficiency rate [RR = 1.33, 95% CI(1.24, 1.43), P < 0.000 01], clinical beneficial rate[RR = 1.25, 95% CI(1.17, 1.33), P < 0.000 01], survival rate [6 months, RR = 1.19, 95% CI(1.09, 1.29), P <0.0001], 12 months, [RR = 1.37, 95% CI(1.24, 1.52),P < 0.000 01], 18 months, [RR = 2.00, 95% CI(1.26,3.20), P < 0.004], 24 months, [RR = 1.44, 95% CI(1.22, 1.70), P < 0.0001], 36 months, [RR = 1.50, 95%CI(1.07, 2.11), P = 0.02 < 0.05], quality of life [RR =1.84, 95% CI(1.64, 2.05), P < 0.000 01] and immune function [CD3+, MD = 11.12, 95% CI(7.93, 14.30),P < 0.000 01], CD4 +, [MD = 10.37, 95% CI(7.29,13.45), P < 0.000 01], CD4+/CD8+, [MD = 0.30, 95%CI(0.07, 0.53), P = 0.01 < 0.05], NK, [MD = 7.49, 95%CI(6.64, 8.34), P < 0.000 01]. A significant improvement was also found in improvement of symptoms[RR = 1.64, 95%CI(1.38, 1.94), P < 0.000 01], leukopenia [RR = 0.60, 95% CI(0.54, 0.66), P < 0.000 01],thrombocytopenia [RR = 0.46, 95% CI(0.34, 0.61),P < 0.000 01], nausea and vomiting incidence [RR =0.66, 95% CI(0.54, 0.81), P < 0.0001), liver damage rate [RR = 0.57, 95% CI(0.42, 0.77), P = 0.0003 <0.05), and kidney damage rate [RR = 0.18, 95% CI(0.05, 0.68), P = 0.01 < 0.05].CONCLUSION: The results suggested that Aidi injection plus TACE significantly improve the clinical effect of TACE, and reduce the incidence of adverse events. However, rigorous multicenter trials with larger size are warranted to further confirm the findings.
OBJECTIVE： To assess the efficacy and safety of Aidi injection plus transarterial chemoembolization（TACE） in patients with primary hepatic carcinoma.METHODS： A comprehensive research of seven electronic databases was performed for comparative studies evaluating Aidi injection combined with TACE for primary hepatic carcinoma until September 2016. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool from the Cochrane Handbook version 5.1.0. Data was synthesized by using Rev Man 5.3 software.RESULTS： Forty-nine studies involving 3435 patients met the inclusion criteria, most of which were low methodological quality. Compared with TACE alone, Aidi injection plus TACE can significantly improve the efficiency rate [RR = 1.33, 95% CI（1.24, 1.43）, P 〈 0.000 01], clinical beneficial rate[RR = 1.25, 95% CI（1.17, 1.33）, P 〈 0.000 01], survival rate [6 months, RR = 1.19, 95% CI（1.09, 1.29）, P 〈0.0001], 12 months, [RR = 1.37, 95% CI（1.24, 1.52）,P 〈 0.000 01], 18 months, [RR = 2.00, 95% CI（1.26,3.20）, P 〈 0.004], 24 months, [RR = 1.44, 95% CI（1.22, 1.70）, P 〈 0.0001], 36 months, [RR = 1.50, 95%CI（1.07, 2.11）, P = 0.02 〈 0.05], quality of life [RR =1.84, 95% CI（1.64, 2.05）, P 〈 0.000 01] and immune function [CD3＋, MD = 11.12, 95% CI（7.93, 14.30）,P 〈 0.000 01], CD4 ＋, [MD = 10.37, 95% CI（7.29,13.45）, P 〈 0.000 01], CD4＋/CD8＋, [MD = 0.30, 95%CI（0.07, 0.53）, P = 0.01 〈 0.05], NK, [MD = 7.49, 95%CI（6.64, 8.34）, P 〈 0.000 01]. A significant improvement was also found in improvement of symptoms[RR = 1.64, 95%CI（1.38, 1.94）, P 〈 0.000 01], leukopenia [RR = 0.60, 95% CI（0.54, 0.66）, P 〈 0.000 01],thrombocytopenia [RR = 0.46, 95% CI（0.34, 0.61）,P 〈 0.000 01], nausea and vomiting incidence [RR =0.66, 95% CI（0.54, 0.81）, P 〈 0.0001）, liver damage rate [RR = 0.57, 95% CI（0.42, 0.77）, P = 0.0003 〈0.05）, and kidney damage rate [RR = 0.18, 95% CI（0.05, 0.68）, P = 0.01 〈 0.05].CONCLUSION： The results suggested that Aidi injection plus TACE significantly improve the clinical effect of TACE, and reduce the incidence of adverse events. However, rigorous multicenter trials with larger size are warranted to further confirm the findings.
基金
Supported by the Priority Academic Program Development of Jiangsu Higher Education Institutions(PAPD)SJZZ15_0119
