参芪化瘀方配合TACE术治疗原发性肝的疗效观察及机理探讨
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摘要
研究目的:
通过随机对照的临床研究,观察参芪化瘀方配合TACE术治疗原发性肝癌的临床疗效,并通过动物实验观察参芪化瘀方对小鼠H22移植性肝癌VEGF表达的影响,以探讨该方抑制肿瘤的作用与抑制肿瘤血管生成的关系。
方法:
(1)实验部分:将50只昆明小鼠(雌雄各半),随机分成5组(分别为生理盐水组,环磷酰胺组,参芪化瘀方高、中、低剂量组),每组10只,于右腋皮下接种0.2ml H22肿瘤细胞悬液(浓度为1×10~7/ml),造模24小时后分别予生理盐水、参芪化瘀方浓缩药液灌胃,环磷酰胺腹腔注射,连续治疗14天,观察瘤体大小,计算胸腺指数、脾脏指数、抑瘤率,用免疫组化法检测肿瘤组织中VEGF的表达程度。
(2)临床部分:将40例符合纳入标准的原发性肝癌患者随机分为治疗组和对照组,每组20例。治疗组术后第1天开始服用参芪化瘀方,同时辅以西医一般对症支持治疗,对照组术后仅予西医对症支持治疗。疗程结束后对两组患者化疗栓塞后综合征症状程度及持续时间变化、临床症状缓解情况、肝功能指标变化、机体功能状态、瘤体大小变化、化疗栓塞后毒副反应的程度进行比较分析,将结果输入电子计算机,建立数据库,应用SPSS13.0软件进行统计分析。
结果:
(1)实验部分:参芪化瘀方高剂量组抑瘤率、胸腺指数、脾脏指数增高,VEGF阳性率降低,与生理盐水组比较均有显著性差异,P＜0.05。
(2)临床部分:①介入术后不良反应方面:治疗组患者介入术后发热(术后3～5天)、肝区疼痛(术后2～7天)、恶心及呕吐(术后3～5天)、腹胀(术后3～7天)等症状的程度和持续时间与对照组比较有明显差异(P＜0.05)。治疗组与对照组比较,患者介入术后白细胞、血小板减少等化疗药物毒副反应有显著性差异(P＜0.05)。表明参芪化瘀方用于肝癌介入后,能有效减轻化疗栓塞引起的不良反应。
②机体功能状态方面:治疗后2周评估两组患者的机体功能状态,有显著性差异(P＜0.05),表明参芪化瘀方能有效改善TACE术后患者机体功能状态。
③肝功能方面:介入术后第1周,治疗组与对照组患者血清AST、ALT、GGT、TB均较治疗前升高,而A/G较治疗前降低,但治疗组AST、ALT、GGT、TB升高程度与对照组比较,P＜0.05,有统计学意义;介入术后2周,两组患者血清AST、ALT、GGT、TB与术后第1周相比均下降,但治疗组下降程度比对照组大,经t检验,有显著性差异(P＜0.05)。结果表明:肝癌患者行TACE治疗后,予参芪化瘀方口服可减轻介入治疗所致肝功能损害。
④中医证侯方面:治疗组与对照组比较,有显著性差异(P＜0.05),显示治疗组中医证候疗效优于对照组。
⑤瘤体变化方面:治疗组与对照组比较,两者无明显差异(P＞0.05)。
结论:
采用参芪化瘀方联合经皮肝动脉化疗栓塞术治疗原发性肝癌,在提高介入治疗疗效、减轻化疗栓塞后综合征、改善患者机体功能状态及减轻肝功能损害等方面优于单纯西药组。动物实验提示参芪化瘀方可提高H22肝癌荷瘤小鼠胸腺及脾脏指数,增强小鼠免疫功能,并能通过降低肿瘤组织中VEGF水平而抑制肿瘤生长。
Objectives:
To evaluate the therapeutic effects of Chinese herbal medicine by Shenqi Hua Yu Fang(a decoction for supplying Qi and transforming stasis accordding to TCM)with TACE in the treatment of Hepatocellular Carcinoma.We carried out a prospective random trial by observing 40 primary liver cancer patients treated by the Chinese herbal medicine and TACE.And to observe the mechanism on the decation of inhibitting the liver cancer.
Methods:
(1) The experimental parts-50 Kunming mice were randomly divided into 5 group (saline group,cyclophosphamide group,Shenqi Hua Yu Fang high-dose group, the middle dose group,low-dose group),with 10 mice per group.,0.2ml H22 tumor cell suspension was inoculated in the right axillary(concentration of 1×10~7/ml),after 24 hours,the mice were treated respectively by saline for intragastric administration,Cyclophosphamide for abdominal cavity injection, Shenqi Hua Yu Fang for intragastric administration daily.14 days later,the tumor size,the thymus index,spleen index,inhibition rate,and expression of VEGF by immunohistochemical detection of tumor tissue were observed. (2) The clinical parts--40 primary liver cancer patients were randomized into two groups:treatment group and controlled group,with 20 patients in each group.The treatment group has been given Shenqi Hua Yu Fang one day post TACE, combined with some western medicine for symptom relief when necessary.The controlled group has been given western medicine only.Then we analyzed the degree and duration of Hepatocellular Carcinoma post-chemoembolization Syndrome,alleviation of clinical symptoms,tumor response rate,improvement of KPS,side effects of TACE and hepatic function.
Results:
(1) The experimental parts-- The rate of tumor suppression,the thymus index, spleen index were increased,VEGF-positive rate was decresed in the high dose of Shenqi Hua Yu Fang.
(2) The clinical parts
①There were significant differences between the treatment group and the controlled group in Hepatocellular Carcinoma post-chemoembolization Syndrome such as fever,pain,nausea and vomiting.There were also significant differences in the degree of adverse effect of TACE,such as anemia and leucocytopenia.
②There were significant differences between the treatment group and controlled group on the improvement of body common conditions.It shows that the treatment group is better than the controlled group in improvement of common conditions.
③There were significant differences between the treatment group and the controlled group in AST,ALT,GGT and TB of blood serum one and two weeks post TACE.but these datas in the treatment group were lower than the controlled group,P＜0.05.It showed that Shenqi Hua Yu Fang can relieve the impairment of Hepatic functions post TACE.
④There were significant differences between the treatment group and the controlled group in improving clinical symptoms.It shows that the treatment group is better than controlled group in improving clinical symptoms.
⑤In the changes of tumor size,the treatment group has no significant difference,p＞0.05 as compared with the controlled group.
Conclusions:Shenqi Hua Yu Fang is more effective,compared with western medicine only,on treating Hepatocellular Carcinoma post-Cbemoembolization Syndrome,as well as improving common conditions,Hepatic functions and clinical symptoms.Shenqi Hua Yu Fang could raise the H22 tumor-bearing mice thymus and spleen indexes,and enhance immune function in mice and reduce VEGF expression in tumor tissues.
通过随机对照的临床研究,观察参芪化瘀方配合TACE术治疗原发性肝癌的临床疗效,并通过动物实验观察参芪化瘀方对小鼠H22移植性肝癌VEGF表达的影响,以探讨该方抑制肿瘤的作用与抑制肿瘤血管生成的关系。
方法:
(1)实验部分:将50只昆明小鼠(雌雄各半),随机分成5组(分别为生理盐水组,环磷酰胺组,参芪化瘀方高、中、低剂量组),每组10只,于右腋皮下接种0.2ml H22肿瘤细胞悬液(浓度为1×10~7/ml),造模24小时后分别予生理盐水、参芪化瘀方浓缩药液灌胃,环磷酰胺腹腔注射,连续治疗14天,观察瘤体大小,计算胸腺指数、脾脏指数、抑瘤率,用免疫组化法检测肿瘤组织中VEGF的表达程度。
(2)临床部分:将40例符合纳入标准的原发性肝癌患者随机分为治疗组和对照组,每组20例。治疗组术后第1天开始服用参芪化瘀方,同时辅以西医一般对症支持治疗,对照组术后仅予西医对症支持治疗。疗程结束后对两组患者化疗栓塞后综合征症状程度及持续时间变化、临床症状缓解情况、肝功能指标变化、机体功能状态、瘤体大小变化、化疗栓塞后毒副反应的程度进行比较分析,将结果输入电子计算机,建立数据库,应用SPSS13.0软件进行统计分析。
结果:
(1)实验部分:参芪化瘀方高剂量组抑瘤率、胸腺指数、脾脏指数增高,VEGF阳性率降低,与生理盐水组比较均有显著性差异,P＜0.05。
(2)临床部分:①介入术后不良反应方面:治疗组患者介入术后发热(术后3～5天)、肝区疼痛(术后2～7天)、恶心及呕吐(术后3～5天)、腹胀(术后3～7天)等症状的程度和持续时间与对照组比较有明显差异(P＜0.05)。治疗组与对照组比较,患者介入术后白细胞、血小板减少等化疗药物毒副反应有显著性差异(P＜0.05)。表明参芪化瘀方用于肝癌介入后,能有效减轻化疗栓塞引起的不良反应。
②机体功能状态方面:治疗后2周评估两组患者的机体功能状态,有显著性差异(P＜0.05),表明参芪化瘀方能有效改善TACE术后患者机体功能状态。
③肝功能方面:介入术后第1周,治疗组与对照组患者血清AST、ALT、GGT、TB均较治疗前升高,而A/G较治疗前降低,但治疗组AST、ALT、GGT、TB升高程度与对照组比较,P＜0.05,有统计学意义;介入术后2周,两组患者血清AST、ALT、GGT、TB与术后第1周相比均下降,但治疗组下降程度比对照组大,经t检验,有显著性差异(P＜0.05)。结果表明:肝癌患者行TACE治疗后,予参芪化瘀方口服可减轻介入治疗所致肝功能损害。
④中医证侯方面:治疗组与对照组比较,有显著性差异(P＜0.05),显示治疗组中医证候疗效优于对照组。
⑤瘤体变化方面:治疗组与对照组比较,两者无明显差异(P＞0.05)。
结论:
采用参芪化瘀方联合经皮肝动脉化疗栓塞术治疗原发性肝癌,在提高介入治疗疗效、减轻化疗栓塞后综合征、改善患者机体功能状态及减轻肝功能损害等方面优于单纯西药组。动物实验提示参芪化瘀方可提高H22肝癌荷瘤小鼠胸腺及脾脏指数,增强小鼠免疫功能,并能通过降低肿瘤组织中VEGF水平而抑制肿瘤生长。
Objectives:
To evaluate the therapeutic effects of Chinese herbal medicine by Shenqi Hua Yu Fang(a decoction for supplying Qi and transforming stasis accordding to TCM)with TACE in the treatment of Hepatocellular Carcinoma.We carried out a prospective random trial by observing 40 primary liver cancer patients treated by the Chinese herbal medicine and TACE.And to observe the mechanism on the decation of inhibitting the liver cancer.
Methods:
(1) The experimental parts-50 Kunming mice were randomly divided into 5 group (saline group,cyclophosphamide group,Shenqi Hua Yu Fang high-dose group, the middle dose group,low-dose group),with 10 mice per group.,0.2ml H22 tumor cell suspension was inoculated in the right axillary(concentration of 1×10~7/ml),after 24 hours,the mice were treated respectively by saline for intragastric administration,Cyclophosphamide for abdominal cavity injection, Shenqi Hua Yu Fang for intragastric administration daily.14 days later,the tumor size,the thymus index,spleen index,inhibition rate,and expression of VEGF by immunohistochemical detection of tumor tissue were observed. (2) The clinical parts--40 primary liver cancer patients were randomized into two groups:treatment group and controlled group,with 20 patients in each group.The treatment group has been given Shenqi Hua Yu Fang one day post TACE, combined with some western medicine for symptom relief when necessary.The controlled group has been given western medicine only.Then we analyzed the degree and duration of Hepatocellular Carcinoma post-chemoembolization Syndrome,alleviation of clinical symptoms,tumor response rate,improvement of KPS,side effects of TACE and hepatic function.
Results:
(1) The experimental parts-- The rate of tumor suppression,the thymus index, spleen index were increased,VEGF-positive rate was decresed in the high dose of Shenqi Hua Yu Fang.
(2) The clinical parts
①There were significant differences between the treatment group and the controlled group in Hepatocellular Carcinoma post-chemoembolization Syndrome such as fever,pain,nausea and vomiting.There were also significant differences in the degree of adverse effect of TACE,such as anemia and leucocytopenia.
②There were significant differences between the treatment group and controlled group on the improvement of body common conditions.It shows that the treatment group is better than the controlled group in improvement of common conditions.
③There were significant differences between the treatment group and the controlled group in AST,ALT,GGT and TB of blood serum one and two weeks post TACE.but these datas in the treatment group were lower than the controlled group,P＜0.05.It showed that Shenqi Hua Yu Fang can relieve the impairment of Hepatic functions post TACE.
④There were significant differences between the treatment group and the controlled group in improving clinical symptoms.It shows that the treatment group is better than controlled group in improving clinical symptoms.
⑤In the changes of tumor size,the treatment group has no significant difference,p＞0.05 as compared with the controlled group.
Conclusions:Shenqi Hua Yu Fang is more effective,compared with western medicine only,on treating Hepatocellular Carcinoma post-Cbemoembolization Syndrome,as well as improving common conditions,Hepatic functions and clinical symptoms.Shenqi Hua Yu Fang could raise the H22 tumor-bearing mice thymus and spleen indexes,and enhance immune function in mice and reduce VEGF expression in tumor tissues.
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