芪胶升白胶囊治疗癌因性气血两虚证患者的临床效果

Cancer-related Qi and Blood Deficiency Treated by Qijiao Shengbai Capsule:Clinical Study of 309 Cases

目的:评价芪胶升白胶囊治疗癌因性气血两虚证的临床疗效。方法:选取2016年3月至2018年3月8个医疗中心拟行化疗的气血两虚证肺癌及乳腺癌患者312例作为研究对象。采用中央随机法,受试者按2∶1随机进入观察组或对照组。观察组口服芪胶升白胶囊,对照组口服安多霖胶囊,2组患者均口服包装编盲药物,4粒/次,3次/d,疗程均为20 d(1个化疗周期)。主要疗效指标为气血两虚证候总积分改善率,次要疗效指标包括单项症状改善率、治疗前后证候积分差值。结果:共纳入309例癌因性气血两虚证患者,符合方案集(PPS)共266例(观察组185例、对照组81例)。2组患者气血两虚证候总积分均较治疗前明显下降,2组证候总积分改善率差异无统计学意义(P>0.05)。观察组心悸失眠单项症状改善率优于对照组(P<0.05)。2组均未发生严重不良反应。结论:芪胶升白胶囊能有效治疗癌因性气血两虚证,可有效防治化疗进一步耗伤气血。

Objective:To evaluate the clinical efficacy of Qijiao Shengbai Capsule(Qijiao Shengbai Jiaonang)in treating of cancer-related deficiency of both qi and blood.Methods:A randomized,double-blind,double-simulated,positive drug parallel control,multi-center clinical trial design was adopted in 8 centers,to enroll 312 lung cancer or breast cancer patients that underwent chemotherapy with qi and blood deficiency syndrome.The subjects were randomly divided into treatment group or control group at a ratio of 2∶1 by central randomization.The treatment group took Qijiao Shengbai Capsule orally,while the control group took Anduolin Capsule orally.Patients in both groups took 4 pills of packaged blinding drugs each time,3 times a day,and the course of treatment in both groups was one chemotherapy cycle(20 days).The main efficacy index is the improvement rate of the total integral of qi and blood deficiency syndrome,while the secondary efficacy index includes the improvement rate of the single symptom of the deficiency,and the difference of the integral of the deficiency before and after treatment.Results:A total of 309 patients with cancer-related qi and blood deficiency were included,266 patients of per protocol set(PPS)(185 patients in the treatment group and 81 patients in the control group)were collected.The total score of qi and blood deficiency syndrome in the two groups was significantly lower than that before treatment.There was no significant difference between the two groups in the improvement rate of the total score of qi and blood deficiency(P>0.05).The improvement rate of single symptom of palpitation and insomnia in the treatment group was significantly higher than that in the control group(P=0.01).No serious adverse reactions occurred in both groups.Conclusion:Qijiao Shengbai Capsule can effectively treat cancer-related qi and blood deficiency,which can effectively prevent and treat further qi and blood consumption caused by chemotherapy.