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

doi:10.12117/jccmi.2020.07.009

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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.

Key words： Carcinoma, hepatocellular Embolization, therapeutic

Received: 18 December 2019

PACS:	Ｒ735.7
	Ｒ815

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	WANG Hai-rui
	LIU Zhao-yu

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WANG Hai-rui,LIU Zhao-yu. Treatment of unresectable hepatocellular carcinoma with Huaier granule combined with TACE: prospective cohort study[J]. JOURNAL OF CHINA MEDICAL IMAGING, 2020, 31(7): 490-494.

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http://www.jccmi.com.cn/EN/10.12117/jccmi.2020.07.009 OR http://www.jccmi.com.cn/EN/Y2020/V31/I7/490

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