培元抗癌汤联合针刺治疗中晚期肝癌气虚血瘀证的临床研究

Clinical study of Peiyuan Kangai Decoction combined with acupuncture in the treatment of advanced liver cancer with qi deficiency and blood stasis syndrome

目的评价培元抗癌汤联合针刺治疗中晚期肝癌气虚血瘀证的疗效。方法随机对照试验设计。选取2019年5月-2021年5月乐山市市中区肿瘤医院162例中晚期肝癌气虚血瘀证患者作为观察对象,采用随机抽签法分为3组,每组54例。全部患者均给予FOLFOX4化疗方案,在此基础上,对照1组服用培元抗癌汤,对照2组结合针刺疗法,联合组给予培元抗癌汤+针刺疗法。3组均治疗6周。分别于治疗前后进行中医证候评分,采用Piper疲乏调查量表评估患者疲乏程度;采用ELISA法检测血清波形蛋白(VIM)、高尔基体跨膜糖蛋白73(GP73)、趋化因子配体1(CXCL1)水平;观察治疗期间的不良反应,评价临床疗效。结果联合组客观缓解率为61.11%(33/54)、疾病控制率为72.22%(39/54),对照1组客观缓解率为40.74%(22/54)、疾病控制率为53.70%(29/54),对照2组客观缓解率为38.89%(21/54)、疾病控制率为51.85%(28/54),联合组客观缓解率、疾病控制率高于对照1组、对照2组(χ^(2)值分别为6.59、5.68,P值分别为0.037、0.043)。联合组治疗后肝区肿痛、神疲气短、食欲减退、面黄消瘦积分低于对照1组、对照2组(F值分别为13.90、15.69、13.20、10.55,P<0.01);情感、感觉、行为、认知评分低于对照1组、对照2组(F值分别为49.55、27.42、19.69、20.55,P<0.01)。治疗后,联合组血清VIM[(52.54±6.69)ng/L比(61.29±7.89)ng/L、(65.11±7.92)ng/L,F=39.63]、GP73[(19.72±3.90)ng/L比(24.42±4.23)ng/L、(25.12±4.76)ng/L,F=25.05]、CXCL1[(3.12±0.72)ng/L比(4.85±0.95)ng/L、(4.98±0.91)ng/L,F=77.67]水平低于对照1组、对照2组(P<0.01)。治疗期间,联合组毒副作用发生率为18.52%(10/54)、对照1组为27.78%(15/54)、对照2组为24.07%(13/54),3组毒副作用发生率比较,差异无统计学意义(χ^(2)=1.31,P=0.520)。结论在FOLFOX4化疗方案基础上,予培元抗癌汤+针刺治疗,可明显改善中晚期肝癌患者中医症状和疲乏程度,降低血清VIM、GP-73、CXCL1水平,提高疗效且安全性较好。

Objective To evaluate the efficacy of Peiyuan Kangai Decoction combined with acupuncture in the treatment of advanced liver cancer with qi deficiency and blood stasis syndrome.Methods Randomized controlled trial.From May 2019 to May 2021,162 advanced liver cancer patients with qi deficiency and blood stasis syndrome in Shizhong District Cancer Hospital of Leshan were randomly divided into three groups by random drawing method,with 54 in each group.All patients were given FOLFOX4 chemotherapy regimen.Based on the chemotherapy,the 1st control group was given Peiyuan Kangai Decoction,and the 2nd control group was given acupuncture therapy,and the combined group was given decoction and acupuncture therapy.All three groups were treated for 6 weeks.Traditional Chinese Medicine syndrome score was performed before and after treatment,Piper fatigue scale was used to evaluate the fatigue degree of patients.Vimentin(VIM),Golgi transmembrane glycoprotein 73(GP73)and chemokine ligand 1(CXCL1)were determined by ELISA.The adverse reactions during treatment were observed and the clinical efficacy was evaluated.Results The combined group showed the response rate was 61.11%(33/54),the disease control rate was 72.22%(39/54),the 1st control group showed the response rate was 40.74%(22/54),the disease control rate was 53.70%(29/54),and the 2nd control group showed the response rate was 38.89%(21/54),and the disease control rate was 51.85%(28/54).The response rate and disease control rate of the combined group were significantly higher than either the control group 1 and 2(χ^(2)values were 6.59,5.68,respectively,and P values were 0.037,0.043,respectively).After treatment,the scores of liver swelling and pain,fatigue and shortness of breath,anorexia,sallow and emaciation in the combined group were significantly lower than those in the control group 1 and the control group 2(F values were 13.90,15.69,13.20,10.55,respectively,P<0.01);the scores of emotions,feeling,behavior and cognition were significantly lower than those in the control group 1 and control group 2(F values were 49.55,27.42,19.69,20.55,respectively,P<0.01).After treatment,the levels of serum VIM[(52.54±6.69)ng/L vs.(61.29±7.89)ng/L,(65.11±7.92)ng/L,F=39.63],GP73[(19.72±3.90)ng/L vs.(24.42±4.23)ng/L,(25.12±4.76)ng/L,F=25.05],CXCL1[(3.12±0.72)ng/L vs.(4.85±0.95)ng/L,(4.98±0.91)ng/L,F=77.67]in the combined group were significantly lower than those in the control group 1 and the control group 2(P<0.01).During the treatment,the incidence of toxic and side effects in the combined group was 18.52%(10/54),the control group 1 was 27.78%(15/54),and the control group 2 was 24.07%(13/54).There was no statistically significant difference in the incidence of toxic and side effects among the three groups(χ^(2)=1.31,P=0.520).Conclusion On the basis of FOLFOX4 chemotherapy,combined therapy with Peiyuan Kangai Decoction and acupuncture treatment can improve the symptoms and fatigue of patients with advanced liver cancer,reduce the levels of serum VIM,GP-73,CXCL1,improve the efficacy safely.