聚异丁烯型骨通贴膏用于中国成人骨关节炎的有效性、安全性和经济性

Efficacy,safety and cost-effectiveness of polyisobutylene-type Gutong plaster in the treatment of osteoarthritis in Chinese adults

目的评估聚异丁烯(PIB)型骨通贴膏(简称“PIB骨通贴膏”)对比非甾体抗炎药(NSAIDs)用于中国骨关节炎成人患者的有效性、安全性和经济性。方法基于一项真实世界研究数据,采用倾向评分匹配后,评估PIB骨通贴膏对比3种NSAIDs(塞来昔布、双氯芬酸钠、布洛芬)的疼痛视觉模拟(VAS)评分的下降值、健康效用增加值、疼痛消失时间、关节活动度复常时间以及总不良事件发生情况;采用成本-效用分析法,从全社会角度计算患者使用PIB骨通贴膏相对3种NSAIDs的增量成本-效果比(ICER),并进行敏感性分析。结果有效性方面,PIB骨通贴膏组患者的关节活动度复常时间显著长于塞来昔布组,VAS评分下降值显著大于布洛芬但显著小于双氯芬酸钠,疼痛消失时间显著长于双氯芬酸钠组与布洛芬组,健康效用增加值显著低于双氯芬酸钠组(P<0.05)。安全性方面,PIB骨通贴膏患者的总不良事件发生率及不良事件严重程度与3种NSAIDs比较,差异均无统计学意义(P>0.05)。经济性方面,与塞来昔布、双氯芬酸钠比较,PIB骨通贴膏为绝对劣势方案;与布洛芬比较,ICER值为178611.58元/QALY,即现有价格下,若以3倍人均国内生产总值为阈值,PIB骨通贴膏方案具有经济性。敏感性分析结果与基础分析结果一致。结论PIB骨通贴膏用于我国骨关节炎患者短期治疗的疗效优于布洛芬,与塞来昔布相当,但不及双氯芬酸钠,安全性与3种NSAIDs一致,其经济性还有待提高。

OBJECTIVE To evaluate the efficacy,safety and cost-effectiveness of polyisobutylene(PIB)-type Gutong plaster(called“PIB Gutong plaster”for short)versus non-steroidal anti-inflammatory drugs(NSAIDs)in the treatment of osteoarthritis in Chinese adults.METHODS Based on a real-world study,after propensity score matching,the decrease in pain visual simulation score,utility increase,time to pain resolution,time to return to normal range of motion and total adverse events of PIB Gutong plaster versus three NSAIDs(celecoxib,diclofenac sodium,and ibuprofen)were evaluated.Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio(ICER)of patients using PIB Gutong plaster versus the three NSAIDs from the perspective of the whole society,and sensitivity analysis was carried out.RESULTS In terms of effectiveness,the recovery time of joint activity in PIB Gutong plaster group was significantly longer than that in celecoxib group,the decrease in VAS score of PIB Gutong plaster was significantly higher than that of ibuprofen but significantly lower than that of diclofenac sodium;the time of pain disappearance was longer than that in diclofenac sodium group and ibuprofen group,and the increase in health utility was significantly lower than that in diclofenac sodium group(P<0.05).In terms of safety,there were no significant differences in the incidence and severity of adverse events of PIB Gutong plaster,compared with the three NSAIDs,without statistical significance(P<0.05).In terms of cost-effectiveness,compared with celecoxib and diclofenac sodium,PIB Gutong plaster was dominant.Compared with ibuprofen,the ICER value of PIB Gutong plaster was 178611.58 yuan/QALY,indicating that at the current price,PIB Gutong plaster was cost-effective if the threshold was 3 times GDP per capita.The results of sensitivity analysis were consistent with those of basic analysis.CONCLUSIONS The efficacy of PIB Gutong plaster was better than that of ibuprofen,similar to that of celecoxib,but worse than that of diclofenac sodium,the safety was consistent with the three NSAIDs,and the cost-effectiveness of PIB Gutong plaster needs to be improved.