华蟾素治疗中晚期胆囊癌47例临床研究

Clinical Research of Cinobufagin Therapy in Treating 47 Cases with Advanced Gallbladder Carcinoma

目的:观察华蟾素注射液治疗胆囊癌的临床疗效。方法:将确诊为胆囊癌的患者47例,随机分组为华蟾素治疗组24例和对照组23例。对照组:常规保肝及对症治疗,有梗阻性黄疸者首先解除梗阻症状。治疗组:在对照组的基础上,将华蟾素注射液20m L加入0.9%氯化钠注射液250m L中,静脉滴注,1次/d,15d为1个疗程,休息2周后再行下1个疗程。分别观察2组患者治疗前后的生存质量、部分肝功能指标TBIL、DBIL、ALT的变化、实体瘤的变化,分别于治疗后随访患者生存期。结果:华蟾素治疗组患者的生活质量有所提高,与对照组比较,差异无统计学意义。治疗组12个月以上的生存率(45.8%),显著高于对照组(30.4%);治疗组的恶化率显著低于对照组(P<0.05),表明华蟾素对抑制胆囊癌的进展有显著疗效;患者的肝功能指标中,华蟾素治疗组在治疗后明显降低,且华蟾素治疗组的各项指标优于对照组,而对照组呈现不同程度的上升。华蟾素治疗组治疗前后各项指标均有改善(P<0.05),与对照组比较结果差异明显(P<0.05)。治疗后观察,对照组与治疗组毒副反应差异不明显,表明华蟾素在发挥抗肿瘤疗效的同时,未产生明显的不良反应。结论:华蟾素用于治疗中晚期胆囊癌,以扶正固本为主,寓攻于补,有效抑制肿瘤的同时而不伤身,可以起到抑制肿瘤生长,延长生存期,提高和改善生存质量等作用,是一种安全有效的临床治疗方法。

Objective： Clinical observations of cinobufotalin injection treatment for gallbladder cancer. Methods：47patients diagnosed with gallbladder cancer were randomly divided into treatment group cinobufotalin （n=24） and control group （n=23）. Control group adopted the routine to protect liver and symptomatically treat, but obstructive jaundice was first removed from the obstruction symptoms. Treatment group added 20mL of cinobufotalin injection to 250mL of 0.9% sodium chloride injection for intravenous infusion on the basis of control group and treatment program was I time d, 15 days for a course of treatment. After resting for two weeks, the treatment group was again conducted for the next course of treatment. Quality of life was observed in two groups of patients before and after treatment, such as changes in solid tumors, changes in laboratory parameters part, and the follow-up of survival. Results： Quality of life for patients treated cinobufotalin was improved, but not significantly. The Survival （45.8%） of treatment group was signifi- cantly higher （30.4%） for 12 months or more than control group. The deterioration rate of the treatment group was sig- nificantly lower than the control group（P〈0.05）, suggesting that cinobufotatin inhibition of progress gallbladder cancer have a significant effect. Liver function significantly improved after treatment, and the indexes of cinobufotalin treat- merit group were better than the control group, which had a rise to some degree. The difference of results was statisti- cally significance before and after treatment. The difference of the control group and the treatment group in side effects was not significant after treatment, indicating that cinobufotalin exerted the anti-tumor effects, while not generating significant adverse reactions. Conclusion： Cinobufotalin for the treatment of advanced gallbladder cancer according tothe TCM principles of righting for the main, blending attack in making up, and effective inhibition of tumor but for bev- erages. Cinobufotalin could play a role in inhibi：ting tumor growth, prolonging survival and improving survival quality and so on. The treatment for advanced gallbladder cancer is a safe and effective method of treatment with cinobufotalin.