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南昌大学 附属感染病医院,南昌 330029
王文英,硕士,从事脾胃肝胆疾病的中医研究,E-mail:315709329@qq.com
张克勤,副主任医师,从事肝脏肿瘤科临床工作,E-mail:737394596@qq.com
收稿日期:2021-06-22,
网络出版日期:2022-01-10,
纸质出版日期:2022-04-05
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王文英,张克勤,刘金明等.加味小柴胡汤联合微波消融治疗原发性肝细胞癌的临床疗效[J].中国实验方剂学杂志,2022,28(07):121-126.
WANG Wen-ying,ZHANG Ke-qin,LIU Jin-ming,et al.Clinical Study of Jiawei Xiaochaihutang Combined with Microwave Ablation in Treatment of Primary Hepatocellular Carcinoma[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(07):121-126.
王文英,张克勤,刘金明等.加味小柴胡汤联合微波消融治疗原发性肝细胞癌的临床疗效[J].中国实验方剂学杂志,2022,28(07):121-126. DOI: 10.13422/j.cnki.syfjx.20220794.
WANG Wen-ying,ZHANG Ke-qin,LIU Jin-ming,et al.Clinical Study of Jiawei Xiaochaihutang Combined with Microwave Ablation in Treatment of Primary Hepatocellular Carcinoma[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(07):121-126. DOI: 10.13422/j.cnki.syfjx.20220794.
目的
2
观察加味小柴胡汤联合微波消融(MWA)治疗原发性肝细胞癌(HCC)的临床疗效及对肿瘤微环境的影响。
方法
2
将128例患者随机分为对照组(64例,脱失2例、剔除2例,完成60例)和观察组(64例,脱失3例、剔除2例,完成59例),两组于MWA术后给予综合治疗措施。对照组,口服鳖甲煎丸,3 g/次,3次/d。观察组,口服加味小柴胡汤,1剂/d。两组均连续治疗3个月。进行治疗前后实体肿瘤大小评价,记录无进展生存期(PFS);检测治疗前后甲胎蛋白异质体(AFP-L3)、脱-
γ
-羧基-凝血酶原(DCP)、高尔基体糖蛋白73(GP73)、肿瘤坏死因子-
α
(TNF-
α
)、转化生长因子-
β
(TGF-
β
)、血管内皮生长因子(VEGF)和基质金属蛋白酶-2(MMP-2)水平,进行治疗前后体力状况(PS)评分、肝功能评价和肝郁气滞证评分;比较Ⅲ级及以上不良反应的发生率。
结果
2
观察组实体肿瘤疗效总有效率为91.53%(54/59),高于对照组的76.67%(46/60),差异具有统计学意义(
χ
2
=4.895
,P
<
0.05);观察组PFS为(7.16±0.95)个月,多于对照组的(6.24±0.89)个月(
P
<
0.01);观察组中医证候疗效有效率为88.14%(52/59),高于对照组的70.00%(42/60),差异具有统计学意义(
χ
2
=5.897
,P
<
0.05),观察组中医证候显效率为57.63%(34/59),显著高于对照组的31.67%(19/60),差异具有统计学意义(
χ
2
=8.116
,P
<
0.01);观察组AFP-13、DCP、GP73、TNF-
α
、TGF-
β
、VEGF和MMP-2水平低于对照组(
P
<
0.01);观察组PS评分、肝功能评分和肝郁气滞证积分低于对照组(
P
<
0.01);观察组Ⅲ级及以上不良反应累积发生率为16.95%,低于对照组的33.33%(
χ
2
=4.261
,P
<
0.05)。
结论
2
原发性肝癌MWA术后给予加味小柴胡汤巩固治疗,可减轻症状和不良反应,改善体力状况和肝功能,调节肿瘤微环境,抑制肿瘤标志物,延长生存期,临床疗效优于鳖甲煎丸,值得临床使用。
Objective
2
To observe the clinical efficacy of Jiawei Xiaochaihutang combined with microwave ablation (MWA) in the treatment of primary hepatocellular carcinoma (HCC) and its influence on tumor microenvironment.
Method
2
A total of 128 patients were randomly divided into control group (64 cases: 2 cases of dropout,2 cases of elimination,and 60 cases of completion) and observation group (64 cases: 3 cases of dropout,2 cases of elimination,and 59 cases of completion). Both groups were given comprehensive treatment after MWA surgery. Patients in control group took Biejiajian Wan orally (3 g/time,3 times/d), and those in observation group took Jiawei Xiaochaihutang (1 dose/d). The treatment lasted for 3 consecutive months. The size of solid tumor before and after treatment was evaluated to record the progression-free survival (PFS). The alpha-fetoprotein-L13 (AFP-L3),des-γ-carboxy prothrombin (DCP),Golgi protein 73 (GP73),tumor necrosis factor-
α
(TNF-
α
),transforming growth factor-
β
(TGF-
β
),vascular endothelial growth factor (VEGF) and matrix metalloproteinase-2 (MMP-2) levels,as well as performance status (PS),liver function and syndrome of liver depression and Qi stagnation scores were also detected before and after treatment. In addition, the incidence of side effects of grade Ⅲ and above was compared.
Result
2
The total effective rate of solid tumor in observation group was 91.53% (54/59),higher than that (76.67%, 46/60) in control group(
χ
2
=4.895,
P
<
0.05). The PFS in observation group was (7.16±0.95) months, longer than that (6.24±0.89 months) in control group (
P
<
0.01). The effective rate of traditional Chinese medicine (TCM) syndrome in observation and control groups were 88.14% (52/59)and 70.00% (42/60), respectively (
χ
2
=5.897,
P
<
0.05). The observation group (57.63%,34/59) had higher marked effective rate of TCM syndrome than control group (31.67%,19/60) (
χ
2
=8.116,
P
<
0.01). The AFP-13,DCP,GP73,TNF-
α
,TGF-
β
,VEGF and MMP-2 levels and the PS,liver function and syndrome of liver depression and Qi stagnation scores in observation group were lower than those in control group (both
P
<
0.01). The cumulative incidence of side effects of grade Ⅲ and above in observation and control groups was 16.95% and 33.33%, respectively(
χ
2
=4.261,
P
<
0.05).
Conclusion
2
Consolidation treatment of HCC after MWA surgery with Jiawei Xiaochaihutang relieved symptoms and side effects,improved PS and liver function,regulated tumor microenvironment,inhibited tumor markers and prolonged survival time. The clinical effect was better than that of Biejia decoction pill, and thus it was worthy of clinical use.
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