二术解毒汤治疗中晚期脾虚湿热型原发性肝癌的疗效观察

Efficacy of Erzhu Jiedu Decoction on Mid-to-Late Stage Primary Liver Cancer with Spleen-Deficiency and Damp-Heat Type

目的:观察二术解毒汤治疗中晚期脾虚湿热型原发性肝癌的临床疗效和安全性。方法:选取2021年1月—2023年1月期间在上海中医药大学附属曙光医院、复旦大学附属肿瘤医院闵行分院、复旦大学附属华山医院和上海浦东新区传染病医院收治的中晚期脾虚湿热型原发性肝癌患者132例,随机分为对照组和治疗组,每组66例。对照组给予常规临床治疗,疗程3个月,随访3个月。治疗组在常规临床治疗基础上,给予二术解毒汤颗粒剂口服,疗程和随访同对照组。观察患者生存率,检测肝功能和AFP水平,采用KPS评分量表研究患者生活质量,采用尼莫地平法计算中医证候疗效,监测安全性评价指标。结果:本研究最终完成研究116例,其中对照组57例,治疗组59例。对照组6个月生存率为52.63%,治疗组为69.50%,差异具有统计学意义(P<0.05)。对照组肝功能(ALT、AST、GGT、TBIL和ALB)较治疗前明显恶化(P<0.05,P<0.01),治疗组肝功能与治疗前比较变化不大(P>0.05)。对照组和治疗组AFP较治疗前显著升高(P<0.05,P<0.01),但治疗组升高幅度显著低于对照组(P<0.05)。治疗后对照组患者KPS评分中位数为70(60,80),治疗组患者KPS评分中位数为70(63,90),治疗组KPS评分中位数高于对照组,差异具有统计学意义(P<0.05)。对照组中医证候疗效总有效率为52.63%,治疗组为77.97%,治疗组总有效率显著高于对照组(P<0.01)。研究期间患者未出现与治疗药物相关的不良反应。结论:二术解毒汤能够显著提高中晚期脾虚湿热型肝癌患者的临床疗效,具有较好的安全性。

Objective:To observe the clinical efficacy and safety of Erzhu Jiedu decoction(EJD)in the treatment of mid-to-late stage primary liver cancer with spleen-deficiency and damp-heat type.Methods:A hundred and thirty-two patients with primary liver cancer of spleen deficiency and dampness-heat type admitted to Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Minhang Branch of Cancer Hospital Affiliated to Fudan University,Huashan Hospital Affiliated to Fudan University and Shanghai Pudong New Area Infectious Disease Hospital from January 2021 to January 2023 were selected and randomly divided into control group and treatment group,with 66 patients in each group.The control group received routine clinical treatment,while the treatment group was given the same treatment plus EJD granules orally,with a course of 3 months and a follow-up of 3 months.Patient survival rate was observed and calculated,and liver function and AFP level were detected.KPS score scale was used to study the quality of life of patients,Nimodipine method was used to calculate the efficacy of TCM syndromes,and the safety evaluation index was monitored.Results:A hundred and sixteen patients completed the study and were included in the analysis,including 57 in the control group and 59 in the treatment group.The 6-month survival rate was 52.63%in the control group and 69.50%in the treatment group,and the difference was statistical significant(P<0.05).The liver function of the control group(ALT,AST,GGT,TBIL,and ALB)significantly deteriorated compared to the time of enrollment,while the liver function of the treatment group showed little change during this period.The AFP levels in the control group and treatment group were significantly increased compared to the time of enrollment,but the increase in the treatment group was significantly lower than that in the control group(P<0.05).After treatment,the median KPS score of the control group was 70(60,80),and that of the treatment group was 70(63,90).The median KPS score of the treatment group was higher than that of the control group,with statistical significance(P<0.05).The total effective rate was 52.63%in the control group and 77.97%in the treatment group.The total effective rate in the treatment group was significantly higher than that in the control group(P<0.01).During the study period,patients did not experience any adverse reactions related to the treatment medication.Conclusion:Erzhu Jiedu decoction can significantly improve the clinical efficacy and is safe for patients with mid-to-late stage liver cancer of spleen-deficiency and dampness-heat type.