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传统草药预防小肝细胞癌术后复发:一项随机对照研究。

Traditional herbal medicine prevents postoperative recurrence of small hepatocellular carcinoma: A randomized controlled study.

机构信息

Department of Traditional Chinese Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China.

Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Cancer. 2018 May 15;124(10):2161-2168. doi: 10.1002/cncr.30915. Epub 2018 Mar 2.

Abstract

BACKGROUND

To explore the clinical efficacy of traditional herbal medicine (THM) in the prevention of disease recurrence of small hepatocellular carcinoma after surgery, a prospective randomized controlled study was conducted between October 2006 and May 2010. The results indicated that THM prevented the recurrence of SHCC with an efficacy that was superior to that of transarterial chemoembolization (TACE) during a median follow-up of 26.61 months.

METHODS

The patients were followed up every 6 months, and the clinical data before October 20, 2015 were analyzed. The primary outcome measure was recurrence-free survival (RFS), and the secondary outcome measure was overall survival (OS).

RESULTS

The 364 patients included 180 in the THM group and 184 in the TACE group. At the time of the data cutoff of October 20, 2015, a total of 205 patients demonstrated disease recurrence, including 85 patients in the THM group and 120 patients in the TACE group. The median RFS of the THM and TACE groups demonstrated a statistically significant difference (P<.001). Until October 20, 2105, there were 91 deaths, including 34 in the THM group and 57 in the TACE group. The median OS demonstrated a significant difference between the 2 groups (P = .008). Multivariate analysis indicated that THM was an independent factor influencing RFS and OS.

CONCLUSIONS

The efficacy of THM was found to be superior to that of TACE in preventing disease recurrence in patients with small hepatocellular carcinoma and prolonging OS. Cancer 2018;124:2161-8. © 2018 American Cancer Society.

摘要

背景

为了探索中草药(THM)在预防小肝癌手术后疾病复发方面的临床疗效,我们于 2006 年 10 月至 2010 年 5 月进行了一项前瞻性随机对照研究。结果表明,在中位随访 26.61 个月期间,与肝动脉化疗栓塞(TACE)相比,THM 可预防 SHCC 复发,疗效更佳。

方法

患者每 6 个月随访一次,并对 2015 年 10 月 20 日之前的临床数据进行分析。主要观察指标是无复发生存率(RFS),次要观察指标是总生存率(OS)。

结果

共纳入 364 例患者,其中 THM 组 180 例,TACE 组 184 例。截止 2015 年 10 月 20 日的数据截止时,共有 205 例患者出现疾病复发,其中 THM 组 85 例,TACE 组 120 例。THM 组和 TACE 组的中位 RFS 差异有统计学意义(P<0.001)。截至 2015 年 10 月 20 日,共 91 例死亡,其中 THM 组 34 例,TACE 组 57 例。两组的中位 OS 差异有统计学意义(P=0.008)。多因素分析表明,THM 是影响 RFS 和 OS 的独立因素。

结论

THM 预防小肝癌患者疾病复发和延长 OS 的疗效优于 TACE。癌症 2018;124:2161-8。© 2018 美国癌症协会。

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