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目的:评价八宝丹胶囊联合鸦胆子油乳经血管介入治疗湿热聚毒型原发性肝癌的临床疗效。方法:将53例确诊为原发性肝癌且辨证符合湿热聚毒证的患者随机分为八宝丹胶囊联合鸦胆子油乳介入组(治疗组)和单纯鸦胆子油乳介入组(对照组),比较两组在瘤体、肝功能、甲胎蛋白、中医临床证候积分、生活质量、毒副反应等方面的变化。结果:治疗组疾病控制率(85.2%)高于对照组(80.8%),但差异无统计学意义(P>0.05);治疗组治疗后ALT、AST、TBiL及AFP的改善均有统计学意义(P<0.05),其中ALT、AFP的改善优于对照组(P<0.05);治疗后中医临床证候积分差值,治疗组和对照组分别为(14.5±0.6)分和(11.3±0.4)分,差异有统计学意义(P<0.01);KPS功能状态有效率治疗组为96.3%,对照组为84.6%,差异有统计学意义(P<0.05);治疗组治疗后在心理功能、症状/副作用、总生活质量等方面评分均较治疗前有所提高(P<0.05),且优于对照组(P<0.05);治疗组腹痛、发热、恶心呕吐、肝毒性、骨髓抑制等毒副反应发生率均低于对照组,差异有统计学意义(P<0.05)。结论:八宝丹胶囊联合鸦胆子油乳介入治疗湿热聚毒型原发性肝癌,较单纯使用鸦胆子油乳在改善肝功能、提高生活质量、减轻术后毒副反应等方面均有优势,值得推广应用。
Objective: To evaluate the clinical efficacy of Babao Dan capsule combined with Brucea javanica oil transanalysis in the treatment of damp-heat polytoxin type primary liver cancer. Methods: Fifty-three patients diagnosed with primary hepatocellular carcinoma who were diagnosed as primary hepatocarcinoma and were diagnosed as damp-heat and polytoxin poisoning were randomly divided into two groups: Babao Dan capsule combined with Brucea javanica oil emulsion group (treatment group) and Brucea javanica oil emulsion intervention group (control group) The changes of tumor, liver function, alpha-fetoprotein, TCM clinical syndrome score, quality of life and toxic and side effects were compared between the two groups. Results: The disease control rate (85.2%) in the treatment group was higher than that in the control group (80.8%), but the difference was not statistically significant (P> 0.05). The improvement of ALT, AST, TBiL and AFP in the treatment group was statistically significant (P <0.05). The improvement of ALT and AFP was better than that of the control group (P <0.05). After treatment, the clinical syndrome scores of TCM were 14.5 ± 0.6 and 11.3 ± 0.4 respectively ), The difference was statistically significant (P <0.01); KPS functional status of the treatment group was 96.3%, the control group was 84.6%, the difference was statistically significant (P <0.05); treatment group after treatment in the psychological function, (P <0.05), and better than the control group (P <0.05). The treatment group had higher rates of abdominal pain, fever, nausea and vomiting, hepatotoxicity and myelosuppression The incidence of side effects were lower than the control group, the difference was statistically significant (P <0.05). Conclusion: The combination of Babao Dan capsule and Brucea javanica oil emulsion has the advantages of improving the liver function, improving the quality of life and alleviating postoperative side effects compared with using Brucea javanica oil emulsion alone in the treatment of TDH. Worth promoting application.