Shen Zhengjie, Cheng Haibo, Shen Weixing, Tao Lihuiping, Zeng Yun, Wu Mianhua, Sun Dongdong, Gu Wenzhe Department Of Otolaryngology
First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing 210046, China.
Department of Medical Oncology, Zhangjiagang First People's Hospital, Zhangjiagang 215600, China.
J Tradit Chin Med. 2017 Oct;37(5):567-587.
To assess the efficacy and safety of Aidi injection plus transarterial chemoembolization (TACE) in patients with primary hepatic carcinoma.
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 RevMan 5.3 software.
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].
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.
评估艾迪注射液联合经动脉化疗栓塞术（TACE）治疗原发性肝癌患者的疗效和安全性。
对七个电子数据库进行全面检索，以查找评估艾迪注射液联合TACE治疗原发性肝癌的比较研究，检索截至2016年9月。两名作者独立提取数据，并使用Cochrane手册5.1.0版中的Cochrane偏倚风险工具评估纳入试验的方法学质量。使用RevMan 5.3软件进行数据合成。
49项研究涉及3435例患者符合纳入标准，其中大多数研究的方法学质量较低。与单纯TACE相比，艾迪注射液联合TACE可显著提高有效率[RR = 1.33，95%CI（1.24，1.43），P < 0.00001]、临床受益率[RR = 1.25，95%CI（1.17，1.33），P < 0.00001]、生存率[6个月，RR = 1.19，95%CI（1.09，1.29），P < 0.0001]、12个月[RR = 1.37，95%CI（1.24，1.52），P < 0.00001]、18个月[RR = 2.00，95%CI（1.26，3.20），P < 0.004]、24个月[RR = 1.44，95%CI（1.22，1.70），P < 0.0001]、36个月[RR = 1.50，95%CI（1.07，2.11），P = 0.02 < 0.05]、生活质量[RR = 1.84，95%CI（1.64，2.05），P < 0.00001]和免疫功能[CD3 +，MD = 11.12，95%CI（7.93，14.30），P < 0.00001]、CD4 +，[MD = 10.37，95%CI（7.29，13.45），P < 0.00001]、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 < 0.00001]。在症状改善[RR = 1.64，95%CI（1.38，1.94），P < 0.00001]、白细胞减少症[RR = 0.60，95%CI（0.54，0.66），P < 0.00001]、血小板减少症[RR = 0.46，95%CI（0.34，0.61），P < 0.00001]、恶心和呕吐发生率[RR = 0.66，95%CI（0.54，0.81），P < 0.0001]、肝损伤率[RR = 0.57，95%CI（0.42，0.77），P = 0.0003 < 0.05]和肾损伤率[RR = 0.18，95%CI（0.05，0.68），P = 0.01 < 0.05]方面也发现有显著改善。
结果表明，艾迪注射液联合TACE可显著提高TACE的临床疗效，并降低不良事件的发生率。然而，需要进行更严格的多中心大样本试验以进一步证实这些发现。
