[槐耳颗粒辅助治疗原发性肝癌的系统评价]
[Systematic evaluation of Huaier Granules adjuvant treatment of primary liver cancer].
作者信息
Zhang Rong-Rong, Shao Ming-Yi, Fu Yu, Zhao Rui-Xia, Wang Jing-Wen, Li Man, Zhao Yun-Xia, Shao Fan-Lei
机构信息
Henan University of Traditional Chinese Medicine Zhengzhou 450046, China.
the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan Center for Evidence-based Medicine of Traditional Chinese Medicine Zhengzhou 450000, China.
出版信息
Zhongguo Zhong Yao Za Zhi. 2021 Jan;46(2):478-487. doi: 10.19540/j.cnki.cjcmm.20200716.502.
To systematically evaluate the efficacy and safety of Huaier Granules in the adjuvant treatment of primary liver cancer. The databases of CNKI, Wanfang, VIP, CBMdisc, PubMed, Cochrane Library and EMbase were searched by computer to screen out the randomized controlled trial on Huaier Granules combined with Western medicine in the treatment of primary liver cancer from the establishment of the databases to January 2020. Data extraction and quality evaluation were conducted for the included literature. Meta-analysis was conducted with RevMan 5.3 software, and evidence quality evaluation was conducted for the outcomes by GRADE profiler software. A total of 24 articles were included, with a total sample size of 2 664 cases. Meta-analysis showed that as compared with Western medicine alone, Huaier Granules combined with Western medicine could improve the objective remission rate(RR=1.38, 95%CI[1.26, 1.51], P<0.000 01), disease control rate(RR=1.29, 95%CI[1.10, 1.52], P=0.002) and 6-month survival rate(RR=1.20, 95%CI[1.10, 1.32], P<0.000 1), 1-year survival rate(RR=1.39, 95%CI[1.23, 1.58], P<0.000 01), 2-year survival rate(RR=1.95, 95%CI[1.28, 2.96], P=0.002), KPS score(MD=17.15, 95%CI[6.47, 27.83], P=0.002) and the improvement rate of KPS score(RR=2.02, 95%CI[1.47, 2.77], P<0.000 1), AFP decline rate(RR=1.40, 95%CI[1.20, 1.62], P<0.000 1), CD3+(MD=17.34, 95%CI[9.28, 25.40], P<0.000 1), CD4+(MD=8.62, 95%CI[1.59, 15.64], P=0.02), CD8+(MD=1.95, 95%CI[-3.93, 7.82], P=0.52), CD4+/CD8~+(MD=0.42, 95%CI[-0.33, 1.17], P=0.27); reduce the level of AFP(MD=-71.57, 95%CI[-80.42,-62.72], P<0.000 01), recurrence rate(RR=0.76, 95%CI[0.67, 0.85], P<0.000 01), and incidence of adverse reactions(RR=0.60, 95%CI[0.41, 0.89], P=0.01) in patients with primary liver cancer. According to the GRADE system, the evidence for outcome measures was low to very low. The results show that Huaier Granules have certain efficacy and high safety in adjuvant treatment of primary liver cancer, but its effect in reducing adverse reactions and improve immunity remains to be verified. Due to the poor quality of the included studies and evidences, the conclusions still need to be further verified by multi-center, large sample, and randomized double-blind controlled studies.
系统评价槐耳颗粒在原发性肝癌辅助治疗中的疗效和安全性。通过计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Cochrane图书馆和EMbase数据库，筛选自建库至2020年1月期间有关槐耳颗粒联合西药治疗原发性肝癌的随机对照试验。对纳入文献进行资料提取和质量评价。采用RevMan 5.3软件进行Meta分析，并用GRADEprofiler软件对结局进行证据质量评价。共纳入24篇文章，总样本量为2664例。Meta分析结果显示，与单纯西药治疗相比，槐耳颗粒联合西药可提高客观缓解率（RR=1.38，95%CI[1.26，1.51]，P<0.00001）、疾病控制率（RR=1.29，95%CI[1.10，1.52]，P=0.002）、6个月生存率（RR=1.20，95%CI[1.10，1.32]，P<0.0001）、1年生存率（RR=1.39，95%CI[1.23，1.58]，P<0.00001）、2年生存率（RR=1.95，95%CI[1.28，2.96]，P=0.002）、KPS评分（MD=17.15，95%CI[6.47，27.83]，P=0.002）及KPS评分改善率（RR=2.02，95%CI[1.47，2.77]，P<0.0001）、甲胎蛋白下降率（RR=1.40，95%CI[1.20，1.62]，P<0.0001）、CD3+（MD=17.34，95%CI[9.28，25.40]，P<0.0001）、CD4+（MD=8.62，95%CI[1.59，15.64]，P=0.02）、CD8+（MD=1.95，95%CI[-3.93，7.82]，P=0.52）、CD4+/CD8+（MD=0.42，95%CI[-0.33，1.17]，P=0.27）；降低原发性肝癌患者的甲胎蛋白水平（MD=-71.57，95%CI[-80.42，-62.72]，P<0.00001）、复发率（RR=0.76，95%CI[0.67，0.85]，P<0.00001）及不良反应发生率（RR=0.60，95%CI[0.41，0.89]，P=0.01）。根据GRADE系统，结局指标的证据质量为低至极低。结果表明，槐耳颗粒在原发性肝癌辅助治疗中具有一定疗效且安全性较高，但其在降低不良反应及提高免疫力方面的作用尚有待验证。由于纳入研究和证据质量较差，结论仍需多中心、大样本、随机双盲对照研究进一步验证。
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