Clinical Study of Hepatectomy Combined with Jianpi Huayu Therapy for Hepatocellular Carcinoma
Clinical Study of Hepatectomy Combined with Jianpi Huayu Therapy for Hepatocellular Carcinoma
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DOI：
10.7314/apjcp.2014.15.14.5951
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发表时间：
2014-01-01
影响因子：
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通讯作者：
Guo, Rong-Ping
中科院分区：
文献类型：
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作者：
Zhong, Chong;Li, Hui-Dong;Guo, Rong-Ping
背景：中医在治疗肝细胞癌（HCC）方面具有若干优势。源于《金匮要略》的“健脾化瘀疗法”是这方面最重要的疗法之一。本研究旨在探讨肝切除术联合健脾化瘀疗法治疗HCC的临床疗效及安全性。材料与方法：120例HCC患者随机分为肝切除术联合健脾化瘀疗法组（治疗组，n=60）和单纯肝切除术组（对照组，n=60）。无病生存期（DFS）和总生存期（OS）是主要终点。比较两组术后1周末肝功能、并发症、平均住院天数及术后1月末运动状态（PS）。结果：两组基线分析差异无统计学意义（p < 0.05）。两组均未发生治疗相关死亡。治疗组术后并发症14例（23.3%），对照组12例（20.0%），差异有统计学意义（p=0.658）。术后1周末，治疗组丙氨酸转氨酶（ALT）低于对照组（p=0.042）。两组间其他肝功能指标无显著差异。治疗组平均住院天数较对照组减少0.9天（p=0.034）。随访期间104例（86.6%）复发。所有患者的1年、3年、5年DFS和中位DFS分别为77.4%、26.3%、9.0%和25.6个月（范围6.0相似于68.0）（治疗组48例患者为78.2%、29.2%、14.3%和28.7个月，对照组56例患者为75.0%、23.3%、6.4%和22.6个月（p=0.045））。101例患者死亡，所有患者的1、3、5年总生存率和中位生存率分别为97.5%、76.4%、40.5%和51.2个月（范围10.0相似于72.0）（治疗组98.3%、78.0%、43.6%和52.6个月，对照组96.7%、74.7%、37.4%和49.8个月，p=0.048）。结论：肝切除术联合健脾化瘀疗法治疗肝癌有效，可减少肝癌患者术后复发转移，改善肝癌患者的DFS和OS。
Background: Traditional Chinese Medicine (TCM) possesses several advantages for treating patients with hepatocellular carcinoma (HCC). The theory of 'Jianpi Huayu Therapy' rooted from 'Jin Kui Yao Lue'is one of the most important therapies in this respect. This study was conducted to investigate the clinical effect and safety of hepatectomy combining with 'Jianpi Huayu Therapy' in the treatment of HCC. Materials and Methods: One hundred and twenty patients with HCC were randomized allocated into hepatectomy combined with 'Jianpi Huayu Therapy' group (treatment group, n= 60) and hepatectomy alone group (control group, n=60). Disease-free survival (DFS) and overall survival (OS) were the primary end-points. Liver function at the end of one week after surgery, complications, average days of hospitalization as well as performance status (PS) at the end of one month post operation were also compared. Results: No significant differences existed between two groups on baseline analysis (p>0.05). No treatment related mortality occurred in either group. Post-operative complications were detected among 14 patients (23.3%) in the treatment group, and 12 (20.0%) in the control group (p=0.658). Alanine aminotransferase (ALT) at the end of one week after operation was lower in the treatment than control groups (p=0.042). No significant differences in other indexes of liver function were discovered between two groups. Average days of hospitalization reduced by 0.9 day in treatment group than in control (p=0.034). During follow-up, 104 patients (86.6%) developed recurrence. The rates of 1-, 3-, and 5-year DFS and median DFS for all patients were 77.4%, 26.3%, 9.0% and 25.6 months (range, 6.0 similar to 68.0), respectively (78.2%, 29.2%, 14.3% and 28.7 months for the 48 patients in the treatment group and 75.0%, 23.3%, 6.4%, and 22.6 months for the 56 patients in the control group (p=0.045)). 101 patients had died at the time of censor, with 1-, 3-, and 5-year overall survival rates and median survival for all patients of 97.5%, 76.4%, 40.5% and 51.2 months (range, 10.0 similar to 72.0), respectively (98.3%, 78.0%, 43.6% and 52.6 months, for treatment and 96.7%, 74.7%, 37.4%, and 49.8 months, for controls, respectively (p=0.048)). Conclusions: Hepatectomy combined with 'Jianpi Huayu therapy' was effective in the treatment of HCC, and reduced post-operative recurrence and metastasis and improved DFS and OS of HCC patients.