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目的:评价艾迪注射液配合肝动脉栓塞化疗(Transcatheter arterial chemoembolization TACE)或全身化疗与照单纯TACE或单纯化疗(干预Ⅰ与干预Ⅱ)治疗原发性肝细胞癌的有效性和安全性。方法:采用Cochrane系统评价方法,计算机检索MEDLINE、CENTRAL、EMBASE、CBM、CNKI、VIP和万方数据库、Cochrane图书馆临床对照试验库等;同时互联网检索正在进行的临床试验;手工检索相关期刊和附加检索相关会议论文集。对纳入的同质研究采用RevMan5.0进行Meta分析。结果:Meta分析结果表明:干预Ⅰ在提高近期疗效有效率、生活质量提高率、减少骨髓抑制率、提高免疫力、提高生存率等方面优于干预Ⅱ,差异有统计学意义。但艾迪注射液联合全身化疗在提高近期疗效有效率方面无统计学意义。结论:艾迪注射液对原发性肝癌有一定的治疗作用,但由于纳入试验的方法学质量普遍较低,期待更多设计合理、严格执行的大样本随机双盲对照试验提供高质量的证据。
Objective: To evaluate the efficacy and safety of Aidi injection combined with transcatheter arterial chemoembolization (TACE) or systemic chemotherapy with simple TACE or chemotherapy alone (intervention Ⅰ and intervention Ⅱ) in the treatment of primary hepatocellular carcinoma. Methods: The Cochrane systematic review method was used to search MEDLINE, CENTRAL, EMBASE, CBM, CNKI, VIP and Wanfang database, Cochrane Library clinical control trial database, etc .; Meanwhile, the Internet was searched for ongoing clinical trials; Retrieve related conference proceedings. Meta-analysis was performed using RevMan 5.0 for the homogeneous study included. Results: The results of Meta analysis showed that intervention Ⅰ was superior to intervention Ⅱ in improving the effective rate of immediate curative effect, improving the quality of life, decreasing the rate of myelosuppression, improving the immunity and improving the survival rate. The difference was statistically significant. However, Aidi injection combined with systemic chemotherapy in improving the effectiveness of recent efficacy was not statistically significant. CONCLUSION: Aidi injection has a therapeutic effect on primary liver cancer. However, due to the generally low methodology involved in the trials, more high-quality evidence is expected from more well-designed and strictly executed large-scale randomized double-blind controlled trials .