藏药奇正消痛贴膏治疗踝关节扭伤的真实世界临床观察

The Real World Observation of Tibetan Medicine Qizheng Xiaotong Plaster on the Treatment of Ankle Sprain

目的:探讨藏药奇正消痛贴膏治疗踝关节扭伤的疗效及安全性。方法:采用实效性自身前后对照临床设计,纳入多家医院2021年10月至2022年10月踝关节扭伤患者1228例。藏药奇正消痛贴膏治疗1次/d,1周1个疗程,共2个疗程,每周随访1次,并记录每位患者的真实治疗措施,以视觉模拟量表(VAS)评分、压痛程度、功能障碍评分及美国足与踝关节协会(AOFAS)踝与后足功能评分,采用科研云线上平台进行数据收集和管理。结果:用药1周后患者疼痛、压痛、活动受限、功能障碍等评分均得到明显改善,差异有统计学意义(P<0.01);用药2周后症状改善较治疗1周后更为明显,差异有统计学意义(P<0.01)。治疗过程中出现不良反应21例,停药后症状消失。结论:采用奇正消痛贴膏外敷治疗踝关节扭伤具有缓解患者疼痛、肿胀临床表现和改善踝关节功能等功效,其疗效显著,安全性高。

Objective:To explore the efficacy and safety of Tibetan medicine Qizheng Xiaotong plaster on the treatment of ankle sprain.Methods:A total of 1228 patients with ankle sprain were enrolled in multiple hospitals from October 2021 to October 2022 using an effective self-controlled clinical design.Once a day,once a week for a course of treatment,a total of 2 courses of treatment,follow-up once a week,and the real intervention measures of each patient were recorded.Visual analogue scale(VAS)scores,tenderness,dysfunction scores,and American Orthopedic Foot and Ankle Society(AOFAS)ankle and hindfoot function scores were used.The online platform of scientific research cloud is adopted for data collection and management.Results:The scores of pain,tenderness,mobility restriction and dysfunction were significantly improved,with statistical significance after 1 week of medication(P<0.01).The symptom improvement after 2 weeks of treatment was more obvious than that after 1 week of treatment,the difference was statistically significant(P<0.01).There were 12 cases of adverse reactions during treatment,among which 9 cases disappeared after drug withdrawal and 3 cases disappeared after treatment.Conclusion:The application of Qizheng Xiaotong plaster on the treatment of ankle sprain has the efficacy of relieving pain and swelling clinical manifestations and improving the function of ankle joint.The efficacy is significant and the safety is high.