草乌甲素片治疗轻度、中度癌痛的多中心、随机、对照、非劣效性临床研究

A Multi-center, Randomized, Controlled, Non-inferiority Clinical Study of Bulleyaconitine A in the Treatment of Mild and Moderate Cancer Pain

摘要:

目的：通过多中心、随机、对照、非劣效性临床研究,证实草乌甲素治疗轻度、中度癌痛的疗效。 方法：筛选病例，随机数字表法区组随机，区组长度为4，由总中心登记入组。患者1:1分入对照组和试验组。三家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）。对照组和试验组在患者年龄、性别、体重指数BMI、疼痛性质、ID-PAIN量表评估基本一致。对照组口服布洛芬缓释胶囊（轻度）或曲马多缓释片（中度）、试验组口服草乌甲素片。观察时间7天。 结果：每日平均疼痛NRS评分，轻度癌痛患者对照组与试验组之间没有差异；中度癌痛患者对照组在第4天低于试验组（P＜0.05），其余时间两组之间无差异。中度癌痛患者对照组发生14例次不良反应，试验组发生2例次，有显著性差异（P＜0.001）。中度癌痛患者生活质量评估试验组情绪功能更佳、疼痛和腹泻症状评分更低（P＜0.05）。 结论：轻中度癌痛患者在第一阶梯、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镇痛治疗。

Abstract:

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: Screening cases and using district-group random method through random digital tables by its length 4. The 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 assessment of age, sex, body mass index (BMI), nature of pain, and ID-pain scale was basically the same 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. Observation was 7 days. Results:Mean daily pain 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 (P<0.05), and there was no difference between the two groups in the rest time. There were 14 cases of adverse reactions in the control group and 2 cases in the experimental group, with significant difference (P<0.001). The quality of life assessment of patients with moderate cancer pain showed better emotional function and lower pain and diarrhea symptom scores (P<0.05). Conclusion: Patients with mild to moderate cancer pain can be considered to choose Bulleyaconitine A treatment if the drugs in the first step and the second step are ineffective or intolerant。