摘要目的:观察槐耳颗粒联合TACE治疗不能手术切除肝细胞癌(HCC)的有效性和安全性,并探讨联合治疗效果的影响因素。方法:采用前瞻性队列研究,连续入组2014年9月—2016年12月中国医科大学附属盛京医院介入科收治的582例HCC患者,均符合纳入标准。实验组342例患者采用槐耳颗粒联合TACE治疗,对照组240例采用TACE联合其他治疗方法。随访期间主要观察指标为肿瘤进展时间(TTP),次要观察指标为药物不良反应,探讨影响槐耳颗粒联合TACE治疗效果的相关因素。结果:随访截至2019年6月,失访40例(实验组12例,对照组28例),余542例中实验组330例,对照组212例,死亡164例(实验组71例,21.52%,对照组93例,43.87%,P=0.001)。按照mRECIST标准评价,实验组中位肿瘤进展时间(mTTP)大于对照组(382 d vs. 217 d),差异有统计学意义(P=0.002)。多因素COX回归分析显示Child-Pugh分级、有无门脉癌栓是介入联合槐耳颗粒治疗预后的影响因素。随访期间,实验组药物明显相关不良反应发生41例(11.99%),症状主要为消化道症状,症状轻微,可忍受,36例自行缓解,5例药物减量后,症状缓解。结论:槐耳颗粒联合TACE治疗不能手术切除HCC具有良好的有效性及安全性,尽早联合使用槐耳颗粒可提高HCC介入手术疗效,延长肿瘤进展时间。
Abstract:Objective: To observe the efficacy and safety of Huaier granule combined with TACE in treatment of unresectable HCC, and to explore the factors influencing the curative effect of combined therapy. Methods: During the period from September 2014 to December 2016, a prospective cohort study was conducted in 582 patients who were continued to be enrolled. All patients meet the inclusion criteria and can not be surgically removed. In the experimental group, 342 patients were treated with Huaier granule and TACE. The HCC patients with the same baseline data were selected as the control group(240 cases), which use TACE combined with other treatment(targeted drug therapy, immunotherapy, chemoradiotherapy, etc). The primary outcome were time to progression(TTP), and the secondary outcome was adverse drug events. Finally, the factors influencing the curative effect of combined therapy were discussed. Results: Follow-up deadline was June 2019, 40 cases were lost(experimental group were 12 cases, control group 28 cases), safety assessment of 542 cases, the experimental group of 330 cases, the control group of 212 cases, 164 cases of death(experimental group of 71 cases, control group 93 cases). According to the mRECIST standard, the median tumor progression time(mTTP) of the experimental group was 582 days and control group 217 days, and the difference was statistically significant(Kaplan-Meier analysis)(P<0.05). In the experimental group, COX regression analysis showed that BCLC stage A, Child-Pugh grade A, no portal vein thrombosis with longer survival time, multivariate analysis showed that Child-Pugh grade, portal vein thrombosis or not was an independent predictive index of HCC combined therapy. During the follow-up period, the incidence of significantly related adverse reactions in the experimental group was 41 cases(11.99%), and the symptoms were digestive tract symptoms(nausea, vomiting, diarrhea, etc.), which were mild and tolerable. Thirty-six cases were relieved by themselves, and 5 cases were relieved after drug dosage reduction. Conclusion: A multicenter prospective cohort study confirmed that TACE combined with Huaier granule was effective and safe for inoperable resection of HCC. The early use of Jin Ke Huaier granule could improve the curative effect and prolong the time of tumor progression.
王海瑞,刘兆玉. 槐耳颗粒联合TACE治疗不可手术切除肝细胞癌的前瞻性队列研究[J]. 中国临床医学影像杂志, 2020, 31(7): 490-494.
WANG Hai-rui, LIU Zhao-yu. Treatment of unresectable hepatocellular carcinoma with Huaier granule combined with
TACE: prospective cohort study. JOURNAL OF CHINA MEDICAL IMAGING, 2020, 31(7): 490-494.
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