奇正消痛贴膏联合推拿手法治疗肩关节周围炎的临床疗效评价

Clinical effect of Qizheng Xiaotong plasters combined with massage for patients with scapulohumeral periarthritis

目的通过观察奇正消痛贴膏联合推拿手法治疗肩关节周围炎的临床疗效,为临床治疗肩关节周围炎提供依据。方法选取2015年7月至2018年8月于广东省中医院推拿门诊部就诊的肩关节周围炎患者225例。本研究为临床随机对照试验,采用随机数字表法将研究对象分为试验组和对照组。试验组113例,其中男43例,女70例;年龄(51.82±11.63)岁;对照组112例,其中男45例,女67例;年龄(50.57±12.94)岁。两组患者均予推拿手法松解肩关节局部肌肉,试验组加用奇正消痛贴膏外用治疗,对照组加用双氯芬酸二乙胺乳膏外用治疗。比较两组的临床总有效率,选择视觉模拟j量表(visualanaloguescale,VAS)、Constant-MurleyScore(CMS)肩关节评定以及不良反应发生率作为临床疗效及安全性评价指标。统计分析选用SPSS 22.0软件,计量资料比较采用t检验或Mann-Whitney U检验,等级资料选择Wilcoxon秩和检验,计数资料选用χ^(2)检验,P<0.05为差异有统计学意义。结果试验组总有效率为85.85%(97/113),优于对照组的65.18%(73/112),差异有统计学意义(χ^(2)=13.002,P<0.001)。治疗后两组患者的VAS评分较治疗前明显下降(均P<0.05);治疗后试验组VAS为(25.36±16.45)分,对照组为(38.59±12.67)分,试验组VAS评分下降幅度较对照组显著(t=6.754,P=0.006)。治疗后,两组患者的CMS总分及各项目得分均较治疗前有显著改善(均P<0.05);治疗后试验组疼痛、日常生活活动、主动活动范围的缓解、肌力分别为(7.45±2.23)分、(12.43±4.06)分、(23.45±7.57)分、(24.23±4.32)分、(69.84±6.67)分,对照组分别为(6.08±3.12)分、(9.87±5.67)分、(24.34±6.91)分、(23.78±3.45)分、(61.23±7.23)分,试验组对患者疼痛、日常生活活动、主动活动范围的缓解均优于对照组(均P<0.05),而在肌力改善上,试验组和对照组改善程度相当(P>0.05)。与对照组相比,试验组对提高患者CMS总分更具优势,差异有统计学意义(P<0.05)。两组患者在治疗观察期间均出现皮肤过敏等不良反应,但差异无统计学意义(P>0.05)。结论奇正消痛贴膏联合推拿手法能有效改善肩关节周围炎患者疼痛症状,缓解关节功能障碍,安全性较好,是临床治疗肩关节周围炎的有效方法。但仍需更多高质量、多中心、随机、双盲临床研究,严格的安全性评价以及长期随访加以验证。

Objective To observe the clinical efficacy of Qizheng Xiaotong plasters combined with massage in the treatment of scapulohumeral periarthritis,and to provide evidences for its clinical management.Methods Two hundred and twenty-five patients with scapulohumeral periarthritis were selected from Massage Department,Guangdong Hospital of Traditional Chinese Medicine from July 2015 to August 2018.This study was a clinical randomized controlled trial.The patients were randomly divided into an experimental group and a control group by the random number table method.The experimental group had 113 cases,including 43 males and 70 females,and were(51.82±11.63)years old.The control group had 112 cases,including 45 males and 67 females,and were(50.57±12.94)years old.Both groups were massaged to relax their shoulder joint muscles;in addition,the experimental group externally used Qizheng Xiaotong plasters,and the control group diclofenac diethylamine cream.The total clinical effective rate,scores of Visual Analogue Scale(VAS)and Constant-Murley Score(CMS),and incidence of adverse reactions were selected as the evaluation indicators of clinical efficacy and safety.The SPSS22.0 software was used for statistical analysis.t-test or Mann-Whitney U test was used to compare the measurement data between the two groups.Wilcoxon rank sum test was used for grade data.χ^(2) test was used to compared the enumeration data between the two groups.When P<0.05,there is a statistical difference.Results The total effective rate of the experimental group was 85.85%(97/113),which was better than that of the control group[65.18%(73/112)],with a statistical difference(χ^(2)=13.002,P<0.001).After the treatment,the VAS scores of the two groups were significantly lower than those before the treatment(both P<0.05);and the score of VAS in the experimental group was significantly lower than that in the control group[(25.36±16.45)vs.(38.59±12.67)],with a statistical difference(t=6.754,P=0.006).After the treatment,the total score of CMS and the scores of each part of CMS of the two groups were significantly improved as compared with those before the treatment(all P<0.05);the scores of pain,daily life activity,and range of motion in the experimental group were better than those in the control group[(7.45±2.23)vs.(6.08±3.12),(12.43±4.06)vs.(9.87±5.67),and(23.45±7.57)vs.(24.34±6.91);all P<0.05];there was no statistical difference in the muscle strength between the experimental group and the control group[(24.23±4.32)vs.(23.78±3.45);P>0.05].The total score of CMS in the experimental group was better than that in the control group,with a statistical difference(P<0.05).During the period of treatment and observation,adverse reactions such as skin allergy occurred in both groups,and there was no statistical difference between the two groups(P>0.05).Conclusion Qizheng Xiaotong plasters combined with massage for patients with scapulohumeral periarthritis can effectively alleviate their pain and joint dysfunction,and is safe and effective.However,the evidences still need to be verified by more high-quality,multicenter,randomized,double-blind clinical studies,strict safety evaluation,and long-term follow-up.