扶正化积丸辅助治疗中晚期原发性肝癌的临床观察

Clinical Observation of Fuzheng Huaji Pills in the Adjunctive Treatment of Middle and Advanced Primary Liver Cancer

目的:观察扶正化积丸辅助治疗中晚期原发性肝癌的疗效及不良反应。方法:选取不适合或不愿接受手术、放化疗的中晚期原发性肝癌患者122例,按随机数字表法分为观察组和对照组,各61例。对照组患者予保肝等保守治疗,观察组患者在保守治疗基础上加用扶正化积丸,1粒/次,3次/d。两组均治疗30 d。比较两组患者瘤体变化、主要临床症状评分、生存质量、血液流变学指标、甲胎蛋白(AFP)、实验室检查指标及不良反应等。结果:治疗后,观察组患者瘤体稳定率为67.2%,生存质量改善率为27.9%,AFP含量为(563.35±143.17)pg/L,肝区疼痛、腹胀、纳呆、乏力评分及血液流变学指标血浆黏度、全血黏度、血沉均显著下降,与对照组比较,差异均有统计学意义(P<0.05);仅观察组出现1例患者腹泻,对症治疗后缓解,未见其他明显不良反应。结论:扶正化积丸可稳定瘤体,改善患者主要临床症状、生存质量和血液流变学指标,对原发性肝癌具有良好的辅助治疗作用。

OBJECTIVE：To observe the clinical efficacy and ADR of Fuzheng huaji pills in the adjunctive treatment of middle and advanced primary liver cancer. METHODS：122 patients with middle and advanced primary liver cancer who had lost the chance or were unwilling to accept surgery,radiotherapy or chemotherapy were randomly divided into control group（61 cases）and study group（61 cases）. The control group received conservative treatment such as hepatoprotecives;the study group was treated with Fuzheng huaji pills 1 pills per time,3 times a day,additionally for 30 days. The tumor volume changes,major clinical symptom scores,quality of life,hemorheology indexes and alpha-fetal protein（AFP）,lab index and ADR were compared between2 groups. RESULTS：After treatment,tumor stable rate of study group was 67.2%,the improvement rate of life quality 27.9%,and AFP（563.35±143.17）pg/L;the scores of liver pain,abdominal distension,loss of appetite and fatigue,and plasma viscosity,whole blood viscosity,erythrocyte sedimentation rate decreased greatly,there were significant differences,compared to control group（P0.05）. One patient in study group suffered from diarrhea,and the symptom was relieved after symptomatic treatment;no obvious ADR was found. CONCLUSIONS：Through stabling tumor,improving major clinical symptom,life quality and hemorheology indexes,Fuzheng huaji pills play a synergistic treatment effect on primary liver cancer.