肝复乐方剂治疗晚期原发性肝癌的前瞻性、随机对照临床研究

Prospective randomized controlled study on advanced primary hepatic cancer treated by Ganfule prescription

原发性肝癌为常见的恶性肿瘤之一,其起病隐匿,大多数病人在确诊时已达中晚期,失去手术治疗时机。因此化疗和中药治疗成为晚期原发性肝癌的主要姑息治疗方法。该研究旨在观察肝复乐方剂联合化疗治疗晚期原发性肝癌的疗效。研究中将58例晚期原发性肝癌患者随机分为治疗组30例和对照组28例,治疗组给予口服肝复乐方剂配合化疗,对照组给予单纯化疗。治疗每3个周期评价肿瘤进展情况、患者生存质量及血清AFP水平,并随访1年生存率。研究结果显示,治疗后,2组治疗有效率(RR)及疾病控制率(DCR)组间比较差异均无统计学意义(30.0%vs 25.0%,P=0.670;66.7%vs60.7%,P=0.637);治疗组KPS评分改善率明显高于对照组(43.33%vs 21.43%,P<0.05);治疗组血清AFP水平下降幅度较对照组明显(P<0.05);随访治疗组1年生存率26.67%,对照组1年生存率为25.00%,2组差异无统计学意义。通过该研究可得出以下结论,口服肝复乐方剂治疗原发性肝癌可提高患者生存质量,降低血清AFP水平,并维持患者的疾病控制率及1年生存率。

Primary hepatic cancer is one of common malignant tumors. When being diagnosed, most patients were in middle and advanced stage and missed opportunities for surgical treatment. Therefore, chemotherapy and Chinese medicines become the main therapies for advanced primary hepatic cancer. This study was designed to observe the efficacy of Ganfule prescription combined with chemotherapy in treating advanced primary hepatic cancer. In the study, 58 cases of advanced primary hepatic cancer were randomly divided into the treatment group （30 cases） and the control group （28 cases）. The treatment group was administered with Ganfule prescription combining with chemotherapy, while the control group was given chemotherapy alone. The tumors progress, quality of life, serum AFP level were evaluated in every three treatment cycles; and the survival rate was followed up for one year. According to the results of this study, after the treatment, there was no statistical significance in the comparison between the two groups in terms of response rate （RR） and disease control rate （DCR） （30.0% vs 25.0%, P=0.670; 66.7% vs 60.7%, P=0.637）. The improvement rate of KPS score in the treatment group was significantly higher than that of the control group （43.33% vs 21.43%, P〈0.05）. The reduction of serum AFP level in the treatment group was more significant than that of the control group （P〈0.05）. During the one-year follow-up visit, the survival rate of the treatment group was 26.67%, and the control group was 25.00%, which indicated no statistical significance. This study drew the following conclusion that the oral administration of Ganfule prescription could improve the quality of life of patients of primary hepatic cancer, decrease the serum AFP level and maintain the disease control rate and the one-year survival rate.