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目的:探讨扶正化毒消癌方治疗原发性肝癌中晚期患者的临床疗效及对细胞免疫功能及血管生成相关因子的影响。方法:72例中晚期肝癌患者随机按数字法分为观察组和对照组各36例。两组均给予对症支持治疗:联苯双酯片50mg/次,3次/d,连续使用3个月;人血白蛋白,50 mL/次,1次/d,必要时连续使用7~10 d;盐酸曲马多缓释片,0.1 g/次,口服,必要时服用,一次不超0.4 g。观察组在对照组基础上加服扶正化毒消癌方,1剂/d,常规水煎分2次服用。疗程为3个月。检测血清甲胎蛋白(AFP)水平、外周血T淋巴细胞亚群(CD3+,CD4+,CD8+,CD4+/CD8+)水平、血管内皮生长因子(VEGF)和基质金属蛋白酶-9(MMP9)水平;监测肝功能(ALT,AST,TBIL);记录主要症状、体征评分、生活质量变化(KPS评分)及生存率(治疗后6个月和12个月)。结果:观察组生活质量评价有效率(增加+稳定)为86.1%,优于对照组的58.3%;观察组6个月和12个月生存率均优于对照组(P<0.05);治疗后观察组血清ALT,AST及TBIL低于对照组(P<0.01);治疗后观察组血清AFP水平低于对照组(P<0.01);治疗后观察组疲劳、恶心与呕吐、疼痛、失眠、纳食、腹胀评分均低于对照组(P<0.01);治疗后观察组外周血VEGF和MMP9水平低于对照组(P<0.01);治疗后观察组CD3+,CD4+和CD4+/CD8+高于对照组,CD8+低于对照组(P<0.05或P<0.01)。结论:扶正化毒消癌方用于中晚期原发性肝癌患者能减轻临床症状、体征、改善肝功能、提高患者生存质量,降低外周血AFP,VEGF和MMP9水平,并延长患者生存期;其作用机制可能与提高患者机体免疫功能,抑制肿瘤血管新生有关。
Objective: To investigate the clinical effects of Fuzheng Huatuoxiaojie decoction in the treatment of patients with advanced primary hepatocellular carcinoma (HCC) and its effects on cellular immune function and angiogenesis related factors. Methods: 72 patients with advanced hepatocellular carcinoma were randomly divided into observation group and control group according to the digital method of 36 cases. Both groups were given symptomatic and supportive treatment: bifendate 50mg / time, 3 times / d, continuous use for 3 months; human serum albumin, 50mL / time, once / d, if necessary, continuous use of 7 to 10 d; tramadol hydrochloride sustained-release tablets, 0.1 g / time, taken orally, if necessary, not to exceed 0.4 g. On the basis of the control group, the observation group added Fuzheng Huoxu Huayao Fang, 1 dose / d, and conventional decoction 2 times. Treatment for 3 months. The levels of serum AFP, peripheral blood T lymphocyte subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +), vascular endothelial growth factor (VEGF) and matrix metalloproteinase-9 Function (ALT, AST, TBIL). The main symptoms, signs, quality of life changes (KPS scores) and survival rate (6 months and 12 months after treatment) were recorded. Results: The effective rate (increase + stability) of the observation group was 86.1%, which was better than that of the control group (58.3%). The survival rate of the observation group at 6 and 12 months was better than that of the control group (P <0.05) The levels of serum ALT, AST and TBIL in the observation group were lower than those in the control group (P <0.01); the levels of serum AFP in the observation group were lower than those in the control group after treatment (P <0.01); After treatment, the observation group had fatigue, nausea and vomiting, pain, The levels of VEGF and MMP9 in the peripheral blood of the observation group were lower than those of the control group after treatment (P <0.01). After treatment, the levels of CD3 +, CD4 + and CD4 + / CD8 + in the observation group were higher than those in the control group , CD8 + was lower than the control group (P <0.05 or P <0.01). Conclusion: Fuzheng Huatuo Jiaowanfang can reduce clinical symptoms and signs, improve liver function, improve patients’ quality of life, reduce the levels of AFP, VEGF and MMP9 in peripheral blood and prolong the survival of patients with advanced primary liver cancer. Mechanism may be related to improving the immune function of patients and inhibiting tumor angiogenesis.