扶正化毒消癌方干预原发性肝癌中晚期患者36例

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50 mg/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。

Intervention of Fuzheng Huadu Xiaoai Decoction on 36 Cases Middle-late Stage Patients of Primary Liver Cancer

Objective: The purpose is to study the clinical efficacy and the influences on cellular immune function and angiogenesis correlation factor of Fuzheng Huadu Xiaoai decoction on middle-late stage patients of primary liver cancer. Method: Seventy-two cases of liver cancer patients in middle-late stage were randomly divided into control group and observation group each 36 cases,according to digital method.Two groups were both given symptomatic support treatment:PCB double ester 50 mg/time, 3 times/day, treatment course 3 months;Human blood albumin, 50 mL/second, 1 does/day, 7-10 consecutive days when necessary;tramadol hydrochloride zyban, 0.1 g/second, take orally when it is necessary, one take not more than 0.4 g Patients in observation group took Fuzheng Huadu Xiaoai decoction 1 dose/day, conventional water frying 2 times/day on the basis of the control group, treatment course 3 months. Serum alpha fetoprotein(AFP) level, peripheral blood T lymphocyte subsets (CD3⁺,CD4⁺,CD⁺, CD4⁺/CD8⁺) level, vascular endothelial growth factor (VEGF) and matrix metalloproteinase 9 (MMP9) level were measured. Liver function (ALT, AST, TBIL) was monitored. The cardinal symptom, physical sign score, change of life quality (KPS score) and survival rate (6 months and 12 months) were recorded. Result: The effective rate (increasing+stable) of life quality evaluation of the observation group was 86.1%, superior to 58.3% of the control group. The survival rate of 6 months and 12 months of observation group were better than the control group (P<0.05). The serum levels of ALT, AST, TBIL and AFP were lower than the control group (P<0.01).After treatment, the scores of fatigue, nausea and vomiting, pain, insomnia and abdominal distention of observation group were lower than control group (P<0.01). The levels of VEGF and MMP9 in peripheral blood were lower than the control group (P<0.01). The levels of CD3⁺,CD4⁺ and CD4⁺/CD8⁺ in observation group were higher than the control group, while CD8⁺ was lower than the control group (P<0.05 or P<0.01). Conclusion: Directed at primary liver cancer patients in middle-late stage, Fuzheng Huadu Xiaoai decoction can relieve the clinical symptoms and signs, improve liver function and the life quality of survival, reduce the levels of AFP, VEGF, MMP9 in peripheral blood and prolong lifetime of survival. Its mechanism may be related to improve patients' immune function and inhibit tumor angiogenesis.