基于随机临床试验的颈舒颗粒治疗神经根型颈椎病的成本-效果分析

Cost-effectiveness analysis of Jingshu Granules in the treatment of cervical radiculopathy based on randomized clinical trials

目的探讨颈舒颗粒治疗神经根型颈椎病(CR)的成本-效果。方法基于多中心、随机、双盲、安慰剂对照的临床试验开展药物经济学平行研究。来自14个中心的480例患者按3:1比例分为颈舒组360例和安慰剂组120例。以颈椎功能障碍指数(NDI)、视觉模拟评分法(VAS)评分作为主要效果指标,以麻木VAS评分作为次要效果指标。以直接成本作为成本指标,站在全社会角度,采用成本-效果分析法对颈舒颗粒的经济性进行评价。结果患者服用颈舒颗粒可有效改善其的NDI值及疼痛VAS、麻木VAS评分(均P<0.05)。以NDI作为结局指标时,增量成本效果比(ICER)值为82.30,以疼痛VAS作为结局指标时,ICER为38.23,以麻木VAS作为结局指标时,ICER为70.85,均小于成本-效果阈值,敏感性分析证实了结果的稳健性。结论颈舒颗粒治疗CR的经济性可被接受。

Objective To evaluate the clinical efficacy and economic evaluation of Jingshu Granules in the treatment of cervical radiculopathy. Methods A parallel study of pharmacoeconomics was conducted based on a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 480 patients from 14 centers were divided into Jingshu group and placebo group at the ratio of 3:1. The Neck Disability Index(NDI) and Pain Visual Analogue Scale(VAS) were used as the main effect indicator, and the Numbness Visual Analogue Scale was used as the secondary effect indicator. The direct cost was used as the cost indicator. From the perspective of the whole society, the economics of Jingshu Granules was evaluated by cost-effectiveness analysis. Results The patients taking Jingshu Granules have achieved significant advantages in improving NDI, Pain VAS and Numbness VAS.When NDI was used as the outcome indicator, the ICER was 82.30; when the Pain VAS was used as the outcome indicator, the ICER was 38.23; when the Numbness VAS was used as the outcome indicator, the ICER was 70.85,which were less than the threshold of cost-effectiveness. The sensitivity analysis confirmed the robustness of the results. Conclusion The economics of Jingshu granules for the treatment of cervical radiculopathy is acceptable.