单纯中医辨证治疗中晚期原发性肝癌的疗效及生存分析

目的观察单纯中医辨证治疗中晚期原发性肝癌的疗效,并根据中医证型、中药疗程、瘤体近期疗效等因素进行亚组分析,总结生存获益的相关因素。方法共收集122例中晚期原发性肝癌患者,剔除4例,脱落11例,共观察107例,辨证分为肝郁血瘀证、脾虚痰凝证、肝肾阴虚证,均采用单纯中医辨证治疗,观察总体生存期(OS)及生存率,并对中医证型、中药疗程、实体瘤近期疗效等因素进行亚组分析,统计分析其与OS的关系。结果在可评价的98例患者中,瘤体客观缓解率为11.22%,疾病控制率为60.20%。对所有病例进行生存分析显示中位OS为7.4个月,半年生存率为47%,1年生存率35%,2年生存率35%,3年生存率10%。脾虚痰凝证型组与肝郁血瘀证型组OS无明显差异。中药不同疗程亚组间OS比较差异有统计学意义(P0.05),且两两之间比较差异均有统计学意义(P0.05)。CR+PR组、SD组、PD组之间OS比较差异有统计学意义(P0.05),且两两之间比较差异均有统计学意义(P0.05)。结论单纯中医辨证治疗可以起到缩小肿瘤、稳定瘤体的作用,可以改善中晚期原发性肝癌患者的OS,但其生存获益可能与用药疗程、瘤体客观缓解等因素相关,尚未发现中医证型对生存疗效产生明显影响。

Curative effects and survival analysis of traditional Chinese medicine syndrome differentiation on middle-advanced stage primary liver cancer

Objective To observe the curative effects of traditional Chinese medicine (TCM) only on the treatment of middle-advanced stage primary liver cancer, and subgroup analysis of TCM syndrome type, course of Chinese medicine treatment and short-term effects of tumor is performed, summarize the correlative factor of survival benefit.Methods 107 middle-advanced stage primary liver cancer, were selected form totally 122 patients (4 cases were eliminated, 11 cases were lost).Patients were divided into three TCM syndrome types including liver-depression and blood-stasis type, spleen deficiency and phlegm-stasis type and liver-kidney yin deficiency type, received differentiation and treatment of TCM only.The overall survival (OS) and survival rate were observed.The subgroup analysis of TCM syndrome type, course of Chinese medicine treatment and short-term effects of tumor was performed, as well as its relationship with OS.Results The tumor objective remission rate and disease control rate were 11.22% and 60.20% in 98 available patients.The survival analysis showed that median OS was 7.4 months, half-year survival rate was 47%, one-year survival rate was 35%, two-year was 35% and three-year was 10%.There were no significant differences on OS between spleen deficiency and phlegm-stasis group and liver-depression and blood-stasis group.There were statistical differences on OS among difference course of Chinese medicine treatment (P<0.05),as well as comparison between any two groups (P<0.05).There were statistical differences on OS among complete remission (CR) + partial remission (PR) group, stable disease (SD) group and progression disease (PD) group (P<0.05),as well as comparison between any two groups (P<0.05).Conclusion Simple TCM treatment can shrink and stable the tumor, improve os of middle-advanced stage primary liver cancer patients, and its survival benefit may be related with the factors of course of medicine, tumor objective response and so on, but there are no evidences show that TCM syndrome type has significant influence on survival effects.