摘要：
目的 探讨超声引导下两种药物肩峰下间隙注射治疗肩峰下撞击综合征的效果.方法 本研究为随机对照试验研究.前瞻性收集2015年1月至2017年8月在天津市第五中心医院骨科门诊确诊为肩峰下撞击综合征的患者资料.为确保研究的随机性,采用随机数字表法将患者随机分为两组,糖皮质激素组患者注射曲安奈德40 mg,非甾体抗炎药(NSAID)组患者注射氯诺昔康8 mg,每例患者注射前后分别进行疼痛[视觉模拟评分(VAS)]和肩关节功能[加州大学肩关节评分系统(UCLA)、肩外展度数]的评估.对于有多个时间点数据的连续性结局(UCLA评分和外展度数),首先进行正态性、方差齐性、Mauchly的球形度检验,满足条件后进行两因素重复测量资料的方差分析.结果 2015年1月至2017年8月共有52例肩峰下撞击综合征患者符合纳入和排除标准纳入研究,其中41例获得完全随访.糖皮质激素组22例,男性14例,女性8例,年龄(44.7±9.5)岁(范围:35～68岁),病变累及优势肩13例,注射超过1次4例;NSAID组19例,男性7例,女性12例,年龄(37.2±10.1)岁(范围:27～63岁),病变累及优势肩10例,注射超过1次1例.所有患者均于5 min内完成注射.糖皮质激素组和NSAID组疼痛和肩关节功能评估结果:(1)VAS:与注射前[5.0(4.0～6.0)和5.0(4.0～6.0)]相比,治疗组在注射后60 min[1.0(1.0～2.0)和1.0(1.0～2.0)]、6周[1.5(1.0～2.0)和1.0(1.0～2.0)]随访时疼痛明显减轻(x2=47.293、41.173和45.174、40.113 P值均＜0.01).(2)UCLA评分:与注射前(20.5±1.8和21.0±2.3)相比,两组在6周(30.2±2.5和30.5±3.0)随访时UCLA评分的差异均有统计学意义(MD=9.727,t=19.218,P＜0.01;MD=9.579,t=11.467,P＜0.01).两组UCLA评分改善程度的差异无统计学意义(P值均＞0.05).(3)肩外展度数:与注射前(92.7±9.4和93.2±11.6)相比,两组在注射后60 min(131.8±9.6和127.4±16.6)和6周(115.9±9.1和127.9±14.4)时外展度数均有明显改善,但60 min时两组外展度数改善程度差异无统计学意义(MD=4.450,t=1.069,P=0.292);6周随访时,NSAID组肩关节外展度数改善程度优于糖皮质激素组(MD=-11.986,t=-3.238,P=0.002).结论 超声引导下肩峰下注射两种药物均有助于减轻肩峰下撞击综合征患者的疼痛并改善肩关节活动度,注射NSAID药物在取得不差于甚至部分优于糖皮质激素药物治疗效果的前提下,还可以避免多次注射及局部糖皮质激素应用带来的并发症.%Objective To evaluate the clinical effects of ultrasound-guided subacromial injection of two drugs in treatment of subacromial impingement syndrome.Methods This was a randomized controlled trial study,prospective collection of patients' data who were diagnosed as subacmmial impingement syndrome at Orthopedic of Tianjin Fifth Central Hospital from January 2015 to August 2017.To ensure the randomness of the study,patients were randomized into two groups using a random number table.Pain (visual analogue scale(VAS)) and shoulder function (University of California Shoulder Score System(UCLA) and shoulder abduction) were performed before and after each injection.For continuous endings with multiple points in time,firstly,the normality,the homogeneity of variance,and the sphericity test of Mauchly were performed.After the condition was satisfied,the variance analysis of the two-factor repeated measurement data was performed.Results Fifty-two patients completed the injection within 5 minutes and 41 patients got the final follow-up.Twenty-two patients in the corticosteroid group,14 males and 8 females,aged (44.7±9.5) years old(range:35-68 years old).The lesion involved 13 cases of superior shoulder,more than 1 time injection in 4 cases.There were 19 patients in the NSAID group,7 males and 12 females,aged (37.2± 10.1) years old(range:27-63 years old),10 cases with lesions involving superior shoulders,and 1 case with more than one injection.(1) VAS score:compared with pre-injection(Corticosteroid group 5.0(4.0-6.0) and NSAIDS group 5.0 (4.0-6.0)),both groups showed significant pain relief at 60 minutes (1.0 (1.0-2.0) and 1.0 (1.0-2.0)) and 6 weeks(1.5(1.0-2.0)and 1.0(1.0-2.0)) after injection(x2=47.293,41.173,45.174,40.113;P＜0.01).(2) UCLA score:compared with pre-injection (30.2±2.5 and 30.5±3.0),UCLA scores improved significantly in both groups at the 6-week after injection(Corticosteroid group:MD =9.727,t=19.218,P＜0.001;NSAID Group:MD=9.579,t=11.467,P＜0.01).The UCLA score improvement between the two groups was no statistical difference (all P ＞ 0.05).(3) shoulder abduction degree:compared with pre-injection (92.7±9.4 and 93.2± 11.6),the abduction degree was significantly improved in both groups at 60 minutes (131.8±9.6 and 127.4± 16.6) and 6 weeks (115.9±9.1 and 127.9± 14.4) after the injection,but the improvement in each time point has no statistical correlation(MD=4.450,t =1.069,P =0.292).NSAID group had better improvement of shoulder abduction degree than corticostemid group at the 6 weeks after the injection (MD =-11.986,t =-3.238,P =0.002).Conclusions Ultrasound-guided subacromial injection can reduce pain in patients with subacromial impingement syndrome.The effect of injection of NSAID drugs is the same as corticosteroid drugs,it can avoid hormone-induced complications and reduce the repeat of the punctures.
