Wu Kerui, Zhu Zehao, He Yaxing, Huang Lanlin, Yan Xia, Wang Dawei
The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.
Shunde Hospital Affiliated of Guangzhou University of Chinese Medicine, Shunde 528300, China.
Evid Based Complement Alternat Med. 2019 May 19;2019:3821053. doi: 10.1155/2019/3821053. eCollection 2019.
Xiao Ai Ping injection (XAPI), extracted from the Chinese herbal medicine , is widely used in the adjuvant treatment of tumors in China. The present study aimed to evaluate the efficacy and safety of XAPI combined with chemotherapy for treating patients with advanced gastric cancer. Seven databases were searched for relevant studies published up to October 1, 2018, and Review Manager 5.3 software and Stata 12.0 software were used for meta-analysis. Fourteen studies, representing 1097 enrolled patients, were included in our analysis. Compared with chemotherapy alone, combination treatment with XAPI and the XELOX regimen (capecitabine plus oxaliplatin) was found to improve the objective response rate (ORR) [RR=1.36; 95%CI (1.10, 1.70); P=0.006], disease control rate (DCR) [RR=1.15; 95% CI (1.04, 1.28); P=0.010], and Karnofsky Performance Status (KPS) improvement rate [RR=1.51; 95%CI (1.14, 2.00)=0.004] and to reduce the incidence of leukopenia [RR=0.68; 95%CI (0.55,0.84); =0.0005], liver damage [RR=0.59; 95% CI (0.37, 0.92); =0.02], renal impairment [RR=0.39; 95% CI (0.18, 0.85); =0.02], and hand-foot syndrome [RR=0.56; 95%CI (0.35,0.90); =0.02]. However, median progression-free survival (PFS), 1-year survival rate, and median overall survival (OS) were not extended by XAPI plus XELOX. Combination treatment with XAPI and the SOX regimen (tegafur plus oxaliplatin) did not improve ORR or DCR, but it did enhance the KPS improvement rate [RR=1.73; 95%CI (1.23,2.43); =0.002] and reduce the incidence of nausea and vomiting [RR=0.66; 95% CI (0.50, 0.88); =0.004]. XAPI in combination with the FOLFOX regimen (fluorouracil/calcium folinate/oxaliplatin) enhanced only the KPS improvement rate [RR=1.68; 95%CI (1.18,2.39); =0.004] and had no significant effect on ORR or DCR or the incidence of adverse events. A single study reported that XAPI combined with the CPT-11 regimen (irinotecan) was superior to chemotherapy alone with respect to DCR and also reduced the incidence of leukopenia, liver damage, and hand-foot syndrome during chemotherapy, while prolonging PFS. Finally, one study reported that XAPI combined with the TP regimen (palitaxel plus cisplatin) improved ORR and KPS improvement rate to a greater extent than TP alone. Although the present review has some limitations, the findings suggest that XAPI combined with chemotherapy may represent a beneficial treatment strategy, particularly the combination of XAPI and XELOX.
消癌平注射液（XAPI）是从中药材中提取的，在中国被广泛用于肿瘤的辅助治疗。本研究旨在评估XAPI联合化疗治疗晚期胃癌患者的疗效和安全性。检索了7个数据库中截至2018年10月1日发表的相关研究，并使用Review Manager 5.3软件和Stata 12.0软件进行荟萃分析。我们的分析纳入了14项研究，共1097例入组患者。与单纯化疗相比，发现XAPI与XELOX方案（卡培他滨加奥沙利铂）联合治疗可提高客观缓解率（ORR）[RR = 1.36；95%CI（1.10，1.70）；P = 0.006]、疾病控制率（DCR）[RR = 1.15；95%CI（1.04，1.28）；P = 0.010]以及卡氏功能状态（KPS）改善率[RR = 1.51；95%CI（1.14，2.00）= 0.004]，并降低白细胞减少症[RR = 0.68；95%CI（0.55，0.84）；= 0.0005]、肝损伤[RR = 0.59；95%CI（0.37，0.92）；= 0.02]、肾功能损害[RR = 0.39；95%CI（0.18，0.85）；= 0.02]和手足综合征[RR = 0.56；95%CI（0.35，0.90）；= 0.02]的发生率。然而，XAPI加XELOX并未延长中位无进展生存期（PFS）、1年生存率和中位总生存期（OS）。XAPI与SOX方案（替加氟加奥沙利铂）联合治疗未提高ORR或DCR，但确实提高了KPS改善率[RR = 1.73；95%CI（1.23，2.43）；= 0.002]并降低了恶心和呕吐的发生率[RR = 0.66；95%CI（0.50，0.88）；= 0.004]。XAPI与FOLFOX方案（氟尿嘧啶/亚叶酸钙/奥沙利铂）联合仅提高了KPS改善率[RR = 1.68；95%CI（1.18，2.39）；= 0.004]，对ORR或DCR以及不良事件的发生率无显著影响。一项研究报告称，XAPI与CPT - 11方案（伊立替康）联合在DCR方面优于单纯化疗，还降低了化疗期间白细胞减少症、肝损伤和手足综合征的发生率，同时延长了PFS。最后，一项研究报告称，XAPI与TP方案（紫杉醇加顺铂）联合比单纯TP方案在更大程度上提高了ORR和KPS改善率。尽管本综述有一些局限性，但研究结果表明XAPI联合化疗可能是一种有益的治疗策略，尤其是XAPI与XELOX的联合。
