肝积康方辅助治疗正虚血瘀型乙型肝炎相关性原发性肝癌的回顾性队列研究

Adjuvant Ganjikang Formula(肝积康方)in Treatin Hepatitis B-related Primary Liver Cancer Patients of Healthy Qi Deficiency and Blood Stasis Pattern:A Retrospective Cohort Study

目的探讨肝积康方对正虚血瘀型乙型肝炎(以下简称乙肝)相关原发性肝癌(PLC)患者五年生存率的影响及相关影响因素分析。方法回顾性收集河南省中医院2010年1月至2014年9月首次确诊为乙肝相关PLC并使用肝积康方辅助治疗的患者(中药组80例),并根据年龄及性别按照1∶2的比例匹配未使用肝积康方的患者(对照组160例),随访患者存活时间,采集患者的人口学特征及相关临床指标信息,采用COX回归分析筛选出患者生存的保护因素,并对不同肝癌亚组即BCLC分期(0-B期、C-D期)、治疗方法(内科常规治疗、微创治疗、切除治疗)、HBeAg(HBeAg阳性、HBeAg阴性)的患者进行生存分析。结果中药组中位生存时间为28.58个月,五年生存率为35.00%;对照组中位生存时间为9.95个月,五年生存率为8.80%,两组比较差异均有统计学意义(P<0.01)。肝积康方的使用是乙肝相关PLC生存的保护因素[HR=0.416(0.295,0.586)]。进一步分析肝积康方对不同肝癌亚组患者的结局影响,结果提示使用肝积康方对不同亚组的肝癌患者均为保护因素,差异均有统计学意义(P<0.05)。对使用肝积康方疗程不同的患者进行生存分析,结果提示用药时间越长,生存时间越长(P<0.01)。结论肝积康方对乙肝相关PLC患者的生存有保护作用,且用药时间与生存时间呈正相关。

Objective To explore the impact of Ganjikang Formula(肝积康方) on the five-year survival rate in hepatitis B-related primary liver cancer(PLC) patients of healthy Qi deficiency and blood stasis pattern and to analyze the associated impact factors. Methods Eighty patients who were diagnosed as hepatitis B-related PLC for the first time and received adjuvant therapy of Ganjikang Formula in Henan Province Hospital of Traditional Chinese Me-dicine from January 2010 to September 2014 were included as Chinese medicine group;one hundred and sixty hepatitis B-related PLC patients who did not take Ganjikang Formula were matched to the Chinese medicine group by age and sex at a ratio of 1 ∶2. The survival time was assessed;the demographic characteristics and relevant clinical information were collected. The COX regression analysis was used to screen out the protective factors for survival of the patients. Survival analyses were conducted in different subgroups in terms of liver cancer type(BCLC stage: 0-B stage vs. CD stage), treatment method(routine medical treatment vs. minimally invasive treatment vs. resection treatment) and hepatitis B virus e antigen(HbeAg) type(HBeAg-positive vs. HBeAg-negative). Results The median survival time of the Chinese medicine group was 28.58 months, and the five-year survival rate was 35.00%;the median survival time of the control group was 9.95 months, and the five-year survival rate was 8.80%;the difference between the two groups was statistically significant(P<0.01). The adjuvant treatment of Ganjikang Formula was a protective factor for the survival of hepatitis B-related PLC(HR=0.416, 95% confidence interval 0.295 to 0.586). Further subgroup analysis in terms of different liver cancer types showed that Ganjikang Formula was a protective factor for all subgroups, and the differences between subgroups were statistically significant(P<0.05). The subgroup analysis in terms of different treatment course showed that the longer treatment of Ganjikang Formula was associated with longer survival time(P<0.01). Conclusion Ganjikang Formula is a protective factor associated with the survival of patients with hepatitis B-related PLC, and the treatment time is positively correlated with the survival time.