华蟾素注射液腹腔灌注治疗恶性腹水102例的临床观察

Clinical observation of Cinobufacini Injection intraperitoneal perfusion treatment of 102 cases with malignant ascites

目的：探讨华蟾素注射液腹腔灌注治疗恶性腹水的临床效果和安全性。方法回顾性分析北京中医药大学东方医院肿瘤科2010年1月-2013年12月收治的102例恶性腹水患者应用华蟾素注射液腹腔灌注治疗的临床资料。观察1个疗程后（每周给予药物灌注2次,每2周为1个疗程）,患者腹水量、腹水质（腹水红细胞、乳酸脱氢酶、肿瘤标志物水平）、中医症状积分以及卡氏评分（KPS评分）的变化,根据此变化评价疗效。分层观察消化系统恶性腹水与非消化系统恶性腹水、局部辨证湿热毒证与寒湿毒证的疗效差异。结果腹水量的有效率为65.7%,腹水中红细胞水平下降逸25%者占61.8%,乳酸脱氢酶下降逸25%者占63.7%、肿瘤标志物下降逸25%者占57.8%。治疗后中医临床症状积分较治疗前明显下降,KPS评分较治疗前明显升高。分层统计显示消化系统恶性腹水疗效优于非消化系统恶性腹水（P〈0.05或〈0.01）,局部辨证湿热毒证者优于寒湿毒证者（P〈0.05或〈0.01）。102例患者治疗过程中均未发生严重的不良反应。结论华蟾素注射液腹腔灌注治疗是一种安全有效、副作用低、中晚期肿瘤患者接受度好的治疗方法,尤其对消化系统恶性腹水以及局部辨证为湿热毒者疗效更佳,值得进一步推广和研究。

Objective To explore the clinical efficacy and safety of Cinobufacini Injection intraperitoneal perfusion treatment of malignant ascites. Methods The clinical data of 102 patients who were given Cinobufacini Injection in-traperitoneal perfusion treatment from January 2010 to December 2013 in Oncology of Dongfang Hospital of Beijing U-niversity of Chinese Medicine was analyzed retrospectively. After 1 course of treatment （twice a week, every two weeks as a course of treatment）, according to the changes of quantity and quality（red blood cells, lactate dehydrogenase, tumor markers） of malignant ascites, and the symptom integral and karnofsky, curative effect was judged. The curative effect difference between digestive system malignant ascites and non digestive system malignant ascites and the curative effect difference between local dialectical damp-heat toxin syndrome and cold-damp toxin syndrome were observed respec-tively. Results The efficiency of quantity of malignant ascites was 65.7%, the level of red blood cells decreased ≥25% accounted for 61.8%, the level of lactate dehydrogenase decreased≥ 25% accounted for 63.7%, the level of tu-mor markers decreased≥ 25% accounted for 57.8%. After treatment, the clinical symptom score was significantly low-er than that before treatment, the KPS score was signifi-cantly higher than the pre-treatment. The study showed that the curative effect of Cinobufacini Injection in-traperitoneal perfusion treatment in digestive system ma-lignant ascites was better than that of non digestive sys-tem malignant ascites （P 〈0.05 or P 〈 0.01）, and in damp-heat toxin syndrome malignant ascites was better than that of cold-damp toxin syndrome malignant ascites （P 〈 0.05 or P 〈 0.01）. In the course of treatment, 102 patients had no serious adverse reactions. Conclusion Cinobufacini Injection intraperitoneal perfusion treatment is a good method of treatment, which is safe and effective, with low side effect, wide indications, middle-late tumor patients can accept, especially for the digestive system malignant ascites, and damp-heat toxin syndrome malignant ascites has a better effect, which deserves further promotion and research.