奇正消痛贴膏治疗渐冻期冻结肩的多中心随机对照临床试验

The efficacy of Cheezheng Xiaotong Plaster for frozen shoulder:a multicenter randomized controlled clinical trial

目的对比观察消痛贴膏与局部药物注射治疗冻结肩的效果,评价消痛贴膏在缓解冻结肩疼痛以及增加其关节功能恢复方面的疗效。方法采用多中心随机对照的研究方法,将国内8个中心的280例冻结肩受试者以随机数字表法分为治疗组和对照组,每组各140例。治疗组采用奇正消痛贴膏(外用),每次1贴,每次8 h。第1~2周每日1贴,第3~4周,每隔1天1贴。对照组采用玻璃酸钠+1%利多卡因1 ml肩峰下注射1次。记录两组患者初诊时、治疗14 d、28 d、90 d的视觉模拟评分(visual analogue scale,VAS)、牛津大学肩关节功能评分(Oxford shoulder score,OSS)以及肩关节活动度。本研究以用药28 d后的VAS评分减分率为主要疗效指标,减分率>30%为有效。记录两组患者的生命体征,实验室检查数据及不良事件。结果符合方案集的治疗组的有效率为91.3%,对照组为84.1%,两组差异无统计学意义(P>0.05)。用药14 d对照组和治疗组的VAS减分率差异明显,治疗组和对照组分别为70.5%和42.7%,治疗组优于对照组(P<0.01)。用药90 d治疗组和对照组的有效率分别为95.3%和90.3%(P>0.05)。治疗组和对照组用药14 d、28 d、90 d OSS均有下降,治疗组下降更加显著(P<0.05)。用药14 d、28 d、90 d治疗组和对照组的VAS评分相比于基线期均下降,治疗组下降更加显著(P<0.01)。治疗组和对照组肩关节活动度在用药14 d、28 d、90 d均有所提高,相较于对照组,治疗组外展和外旋活动度的提高更加显著(P<0.05)。结论消痛贴膏治疗冻结肩有较好的疗效,能够缓解疼痛,并改善肩关节功能障碍,提高肩关节活动度,其疗效非劣于玻璃酸钠+利多卡因注射。消痛贴膏具有较好的安全性,无严重不良事件发生。

Background Frozen shoulder,also known as periarthritis of shoulder,fifty shoulder,etc.,is aseptic inflammation of soft tissue around shoulder joint caused by degenerative changes of shoulder joint,with shoulder pain and mobility disorders as the main symptoms,seriously affecting the quality of life.Frozen shoulder is more common in patients of 40-70 years old,and the prevalence rate is 2%-5%.At present,the pathogenesis of frozen shoulder is still not completely clear,and the main treatment purpose is to relieve pain and restore function.Currently,non-steroidal anti-inflammatory drugs are mainly used to relieve pain in clinical practice,but the efficacy is limited.Surgical release is effective in reducing adhesion and restoring joint activity,but it is easy to relapse and the cost is high.It is of great significance to find long-term effective,economical and convenient therapeutic drugs to improve patients’life quality.Cheezheng Xiaotong Plaster is a traditional Tibetan medicine prescription,with the effect of promoting blood circulation,removing blood stasis,reducing swelling and relieving pain,which is widely used in acute and chronic torsion and contusion,stiff neck,periarthritis of shoulder,lumbar muscle strain and other diseases.Objective To compare the effect of Cheezheng Xiaotong Plaster and local drug injection in the treatment of frozen shoulder,and evaluate the advantages of Cheezheng Xiaotong Plaster in relieving pain of frozen shoulder patients and increasing the recovery of shoulder function.Methods A multicenter randomized controlled trial was developed,and a total of 280 subjects with frozen shoulder,from 8 domestic centers were divided into treatment group or control group with random digital table,140 cases in each group.The treatment group was treated with Cheezheng Xiaotong Plaster of 1 post for 8 hours every day from the first week to the second week,and 1 post every other day from the third week to the fourth week.The control group was given sodium hyaluronate+1%lidocaine 1 ml by subacromial injection once.The visual analogue scale(VAS)score of pain,Oxford shoulder function score(OSS)and shoulder range of motion of the two groups were recorded at the time of initial diagnosis,14 days,28 days and 90 days after treatment.In this study,the VAS score reduction rate after 28 days of medication was taken as the main efficacy index,and reduction rate>30%was regarded as effective.Vital signs,laboratory data and adverse events were recorded.Results The effective rate was 91.3%in the treatment group and 84.1%in the control group conforming to the protocol population set,with no significant difference between the two groups(P>0.05).After 14 days of treatment,there was a significant difference in VAS score reduction rate between the two groups(P<0.01),which was 70.5%and 42.7%respectively in the treatment group and the control group.The effective rates of the treatment group and the control group were 95.3%and 90.3%,respectively after 90 days of treatment(P>0.05).After 14 days,28 days and 90 days of treatment,OSS in the two groups declined,and decline in the treatment group was more significant(P<0.05).Compared with the baseline period,the VAS scores of two groups both declined after 14 days,28 days and 90 days of treatment,and the decline of the treatment group was more significant(P<0.01).The range of motion of two groups both improved after 14 days,28 days and 90 days of treatment.The improvement of abduction and external rotation in the treatment group was more significant(P<0.05).Conclusion Cheezheng Xiaotong Plaster has good curative effect on frozen shoulder,and its curative effect is not inferior to sodium hyaluronate+lidocaine injection.Cheezheng Xiaotong Plaster has significant effect in relieving pain and improving shoulder dysfunction,which could improve the range of motion of shoulder joint.Cheezheng Xiaotong Plaster are safe in clinical practice with no serious adverse events occurred.