参芪扶正注射液依托EP方案治疗SCLC伴脑转移癌的临床疗效

Clinical Study of SCLC with Brain Metastasis by Shenqi Fuzheng Injection Based on EP Regimen

目的研究参芪扶正注射液配合后程三维适形放疗同步依托EP方案化疗治疗SCLC伴脑转移癌的临床疗效及不良反应。方法选取SCLC伴脑转移癌的患者120例,根据数字表法随机分为A、B组,各60例。2组同时行后程三维适形放疗依托EP方案进行化疗,间隔3周后用EP方案化疗,28天为1个周期,根据患者情况行3~8个周期。A组加用参芪扶正注射液,静脉滴注,1次/天,用量约为250 ml,持续用药2个周期以上。采用疗效评价、生活质量评价、不良反应评价联合评价,根据术后随访评价远期生存率。结果 A组患者疗效有效率(70.0%)略高于B组(61.7%),但差异无统计学意义(P>0.05)。A组患者的生活质量有效率(81.7%)高于B组(56.7%),差异有统计学意义(P<0.05)。A组患者的不良反应如恶心呕吐、白细胞下降、血小板下降、头痛发热等发生率均低于B组,差异均有统计学意义(P<0.05)。A组患者远期生存率略高于B组,但差异无统计学意义(P>0.05)。结论参芪扶正注射液配合后程三维适形放疗同步依托EP方案治疗SCLC,能够有效提高SCLC伴脑转移癌患者的临床疗效,改善患者生活质量,降低不良反应发生率,提高远期生存率,可进一步在临床推广应用。

Objective To study the clinical efficacy and adverse reactions of Shenqi Fuzheng Injection Combined with three-dimensional conformal radiotherapy based on EP chemotherapy in the treatment of brain metastases with SCLC. Methods120 patients with SCLC accompanied by brain metastasis were randomly divided into A group and B group,with 60 cases in each group. At the same time the 2 groups received three-dimensional conformal radiation therapy based on EP regimen,3 week interval after EP chemotherapy,28 days for 1 cycle,according to the conditions of patients undergoing 3 - 8 cycles. A group received Shenqi Fuzheng injection,intravenous drip,1 times/day,dosage of about 250 ml,continuous medication for more than 2 cycles. The long-term survival rate was evaluated by the combination of curative effect evaluation,quality of life evaluation and adverse reaction evaluation. Results The effective rate of A group（ 70. 0%） was slightly higher than that of group B（ 61. 7%）,but the difference was not statistically significant（ P〉0. 05）. The effective quality of life in group A（ 81. 7%） was higher than that of group B（ 56. 7%）,the difference was statistically significant（ P〈0. 05）; The incidence of adverse reactions such as nausea,vomiting,white blood cell decrease,thrombocytopenia,headache and fever in group A were lower than those of group B,the difference was statistically significant（ P〈0. 05）. The long-term survival rate of group A was slightly higher than that of group B,but the difference was not statistically significant（ P〉0. 05）. Conclusion Effect of Shenqi Fuzheng Injection Combined with threedimensional conformal radiotherapy based on EP regimen in the treatment of SCLC,can effectively improve the clinical efficacy of SCLC metastatic cancer patients with brain,improve the life quality of patients,reduce the incidence of adverse reactions,improve the long-term survival rate,can be further popularized in clinical application.