槐耳颗粒辅助治疗乳腺癌的疗效及安全性分析

Analysis on the Efficacy and Safety of Huaier Granules in Adjuvant Treatment of Breast Cancer

[目的]评价槐耳颗粒治疗乳腺癌的疗效及安全性。[方法]检索2000年1月至2021年8月国内外数据库公开发表的治疗乳腺癌的临床随机对照试验(randomized controlled trial,RCT),根据考克兰手册偏倚风险评估工具进行文献质量评价,提取相关数据资料,应用RevMan 5.3对效应指标的相对危险度(relative risk,RR)或优势比(odds ratio,OR)进行Meta分析,并列出其95%置信区间(confidence interval,CI)。[结果]最终纳入23个RCT研究,共包含2183例患者,其中治疗组1075例、对照组1108例。Meta分析结果显示,槐耳颗粒能提高患者的治疗有效率[OR=2.07,95%CI(1.37,3.13),P<0.05)];提高患者3、5年总生存率,分别为[OR=2.043,95%CI(1.16,3.55),P=0.01)]、[OR=1.74,95%CI(1.18,2.57),P=0.005)];降低2、3年的复发转移率,分别为[OR=0.28,95%CI(0.16,0.48),P<0.00001)]、[OR=0.21,95%CI(0.13,0.34),P<0.00001)],但对5年的复发转移率没有显著影响(P=0.24);改善患者的各项免疫指标,对CD3^(+)、CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+)、NK值均有显著影响(P<0.05);减少不良反应发生率,主要包括消化道不良反应[OR=0.69,95%CI(0.51,0.94),P=0.02)]及血液毒性[OR=0.46,95%CI(0.26,0.82),P=0.008)]。[结论]槐耳颗粒对于乳腺癌的疗效及安全性优于单用西医治疗,可显著提高治疗有效率及总生存率,降低复发转移率及不良反应,并有助于改善免疫系统功能。

[Objective]To evaluate the efficacy and safety of Huaier Granules in the treatment of breast cancer.[Methods]Through searching the clinical randomized controlled trials(RCT)published in domestic and foreign databases from January 2000 to August 2021 for the treatment of breast cancer,the quality of the literature according to the Cochran Manual bias risk assessment tool was evaluated.After extracting relevant data,Rev Man 5.3 was used to perform Meta-analysis on the relative risk(RR)or the odds ratio(OR)as effective indicators,and its 95%confidence interval(CI)was listed.[Results]Twenty-three RCT studies were finally included,including a total of 2183 patients,1075 cases in treatment group and 1108 cases in control group.Meta-analysis results showed that Huaier Granules can improve the effective rate of treatment of patients[OR=2.07,95%CI(1.37,3.13),P<0.05)]and the overall survival rate of patients in 3 and 5 years,respectively[OR=2.043,95%CI(1.16,3.55),P=0.01)],[OR=1.74,95%CI(1.18,2.57),P=0.005)].It can reduce the recurrence and metastasis rates in 2 and 3 years,respectively[OR=0.28,95%CI(0.16,0.48),P<0.00001)],[OR=0.21,95%CI(0.13,0.34),P<0.00001)],but for the 5-year recurrence and metastasis rate,there was no significant effect(P=0.24).It can also improve the patients'immune indicators,and had a significant impact on CD3^(+),CD4^(+),CD8^(+),CD4^(+)/CD8^(+),and NK values(P<0.05).It can reduce the incidence of adverse reactions,mainly including the digestive tract adverse reactions[OR=0.69,95%CI(0.51,0.94),P=0.02)]and blood toxicity[OR=0.46,95%CI(0.26,0.82),P=0.008)].[Conclusion]The efficacy and safety of Huaier Granules for breast cancer are better than those treated with only radiotherapy or/and chemotherapy.Huaier Granules can significantly improve the treatment efficiency and survival rate,reduce the recurrence and metastasis rate and adverse reactions,and help improve the immune system function.