草乌甲素片治疗轻中度癌痛多中心、随机对照、非劣效性研究

A multi-center,randomized,controlled,non-inferiority clinical study of bulleyaconitine A in the treatment of mild and moderate cancer pain

目的:通过多中心、随机、对照、非劣效性临床研究,证实草乌甲素的疗效。方法:随机数字表法区组随机筛选病例。病人1:1分入对照组和试验组。三家研究中心共筛选入组轻度癌痛32例(对照组16例,试验组16例),中度癌痛63例(对照组29例,试验组34例)。对照组口服布洛芬缓释胶囊或曲马多缓释片、试验组口服草乌甲素片。观察时间7天。结果:每日平均疼痛数字评分法(numerical rating scale,NRS)评分,轻度癌痛病人对照组与试验组之间无差异;中度癌痛病人对照组在第4天低于试验组。中度癌痛病人对照组发生14例次不良反应,试验组发生2例次,有显著性差异。中度癌痛病人生活质量评估试验组情绪功能更佳。结论:轻中度癌痛病人在第一阶梯、第二阶梯药物无效或者不耐受情况下,可以考虑选择草乌甲素片镇痛治疗。

Objective:The efficacy of bulleyaconitine A in the treatment of mild and moderate cancer pain was confirmed by multicenter,randomized,controlled and non-inferior clinical research.Methods:The cases were randomly screened with random-number table,and all patients registrated at the general centre.Patients were divided into the control group and the experimental group(1:1).A total of 32 cases of mild cancer pain(16 cases in the control group and 16 cases in the experimental group)and 63 cases of moderate cancer pain(29 cases in the control group and 34 cases in the experimental group)were screened in the three centers.The age,sex,body mass index(BMI),nature of pain,and ID-pain scale were not statistically different between the control group and the experimental group.The control group took Ibuprofen sustained-release capsules(mild)or tramadol sustained-release tablets(moderate),and the experimental group took Bulleyaconitine A tablets.They were observed for 7 days.Results:Mean daily pain numerical rating scale(NRS)score showed no difference between the control group and the experimental group in the patients with mild cancer pain.The control group of patients with moderate cancer pain was lower than the experimental group on the 4th day,and there was no difference between the two groups in the rest time points.There were 14 cases with adverse reactions in the control group and 2 cases in the experimental group,with significant difference.The assessment of life quality of patients with moderate cancer pain showed better emotional function and lower pain and diarrhea symptom scores.Conclusion:Patients with mild to moderate cancer pain can be considered to choose Bulleyaconitine A if the drugs in the first step and the second step are ineffective or intolerant。