复方苦参注射液治疗中晚期结直肠癌的临床观察

目的:观察复方苦参注射液对中、晚期结直肠癌患者的近期疗效和不良反应。方法:对132例中、晚期结直肠癌患者采用投币法随机分为4组。化疗组(A组,32例)采用FOLFOX(5-氟尿嘧啶+亚叶酸钙+奥沙利铂)方案化疗+复方苦参注射液20mL·d-1,静脉滴注;化疗对照组(B组,36例)仅采用FOLFOX方案化疗;复方苦参组(C组,34例)仅采用复方苦参注射液20mL·d-1,静脉滴注治疗;复方苦参对照组(D组,30例)仅采用一般支持的保守治疗。A组连用复方苦参注射液10d,C组连用14d,各组28d为1个周期,2个周期为1个疗程。观察患者的化疗不良反应、生存质量、肿瘤病灶疗效、临床症状和外周血免疫指标等。结果:A组较B组可减轻化疗致外周血白细胞和肝功能损害(Ⅰ～Ⅱ度)(P<0.05),提高KPS评分(P<0.05),改善免疫功能(P<0.05),而2组肿瘤疗效比较无显著性差异(P>0.05);A、C组治疗后较治疗前在睡眠、情绪、生活兴趣等方面有所改善,而B、D组有所恶化(P<0.05,P<0.01);A、C组偶见面色潮红,未见其他明显不良反应。结论:复方苦参素注射液能减轻中、晚期结直肠癌患者化疗的不良反应,改善生存质量,提高免疫功能,未见明显不良反应。

Clinical Observation of Compound Sophora flavescens Injection in the Treatment of Medium and Advanced Colorectal Carcinoma

OBJECTIVE： To observe the short-term efficacy and toxic reaction of Compound Sopkora flavescens injection in the treatment of medium and advanced colorectal carcinoma. METHODS： 132 patients with medium and advanced colorectal carcinoma were randomly assigned into 4 groups. Chemotherapy group（group A, 32 cases）was given FOLFOX chemotherapy （5-fluoro- uracil＋calcium folinate＋oxaliplatin）＋ Compound S. flavescens injection 20 mL·d-1 via i.v. Chemotherapy control group（group B, 36 cases）was given FOLFOX chemotherapy. Compound S. flavescens injection group（group C, 34 cases）was given Compound S. flavescens injection 20 mL·d-1 via i.v. Compound S. flavescens inject/on control group（group D, 30 cases） was given general treatment. In group A, Compound S. flavescens injection 20 mL·d-1 via i.v. were additionally given in group A for 10 days and in group C for 14 days. 28 days was as one cycle and one treatment course lasted for two cycles. Toxic reaction, quality of life, thera- peutic efficacy, clinical symptom and peripheral blood immunity index were observed. RESULTS： White blood cell of peripheral blood, liver functions impaiment （Ⅰ-Ⅱ degree）, KPS scores and immune function of peripheral blood were significantly im- proved in group A, compared with group B（P〈0.05）. There was no significant difference in the tumor response rate between 2 groups （P〉0.05）. The sleep, mood and interest of patients were significantly improved in group A,C after treatment while group B,D were reverse （P〈0.05 or P〈0.01）. Occasionally flushing was found in group A,C and other toxic reaction was not found. CONCLUTION ： Compound S. flavescens injection can reduce toxic reaction of chemotherapy, improve quality of life and immunity activity in patients with medium and advanced colorectal carcinoma without significant toxic reaction.