不同关节腔注射方法治疗早期冻结肩疗效与安全性分析

The efficacy and safety of different site corticosteriod injection for patient with frozen shoulder at early stage

目的比较双腔注射复方倍他米松、罗哌卡因及玻璃酸钠与单腔注射治疗早期冻结肩的疗效和安全性。方法 2015年5月—2017年5月纳入68例早期冻结肩患者并随机分为双腔注射组和单腔注射组,每组各34例。双腔注射组分别于盂肱关节腔注射复方倍他米松注射液1 mL+玻璃酸钠2 mL+罗哌卡因6 mL+生理盐水8 mL,肩峰下注射倍他米松注射液1 mL+玻璃酸钠2 mL+生理盐水2 mL+罗哌卡因2 mL;单腔注射组仅在盂肱关节腔注射与双腔注射组相同剂量的药物。给药后3、6、12周门诊随访,采用视觉模拟评分(Visual Analogue Scale,VAS)量表和Constant-Murley肩功能评分量表分别评估疼痛程度和肩功能,采用其治疗前后差值评估疼痛缓解程度和肩功能改善情况。结果 68例患者中63例完成随访,两组各2例失访,双腔注射组1例退出试验。两组治疗前后比较,疼痛评分降低,肩功能评分升高,差异有统计学意义(P<0.001)。单腔注射组治疗后6、12周与治疗后3周比较,疼痛缓解(ΔVAS)明显,差异有统计学意义(P<0.001),但治疗后6周与12周比较,差异无统计学意义(P=0.354)。双腔注射组治疗后3、6、12周两两比较,疼痛缓解明显,差异有统计学意义(3周vs. 6周:P<0.001;3周vs. 12周:P<0.001;3周vs. 6周:P=0.034)。各组肩功能在治疗后3、6、12周明显改善,各时间点两两比较差异均有统计学意义(P<0.001)。组间比较:两组间疼痛缓解(P=0.386)、肩功能改善(P=0.685)差异均无统计学意义。相同时间点两组间疼痛缓解(治疗后3周:P=0.898;6周:P=0.448;12周:P=0.216)和肩功能改善(治疗后3周:P=0.120;6周:P=0.152;12周:P=0.868)差异均无统计学意义。结论不同注射方法均能有效缓解早期冻结肩疼痛和改善肩功能,且耐受性好。但尚未发现双腔注射法的临床疗效和安全性优于单腔注射法。

Objective To evaluate the efficacy and safety of different site injection of compound betamethasone injection, ropivacaine and sodium hyaluronate for treatment of frozen shoulder at early stage. Methods A Total of 68 participants were included from May 2015 to May 2017 and randomly assigned to the glenohumeral joint and subacromial space group(IA+SA group, n=34) and glenohumeral joint group(IA group, n=34). In the IA+SA group, a solution of1 mL corticosteroid, 6 mL ropivacaine, 2 mL sodium hyaluronate, and 8 mL normal saline were prepared and injected to glenohumeral joint, and a solution of 1 mL corticosteroid, 2 mL ropivacaine, 2 mL sodium hyaluronate, and 2 mL normal saline were injected to subacromial space. In the IA group, participants were given the same dose of drugs to the glenohumeral joint. The Visual Analogue Scale(VAS) score and Constant-Murley score were used to assess pain and function of shoulder respectively. The change of VAS score and Constant-Murley score after treatment were used to evaluate pain relief and shoulder function improvement. Results Of the 68 participants, two in each group were lost to follow up and one in the IA+SA group dropped out. There was significant effect on pain relief and shoulder function improvement on all measurement in both groups(P<0.001) during the 12 weeks after treatment. In the IA group, groupby-time interaction were significant for pain relief at 6 and 12 weeks comparing with that at 3 weeks(P<0.001), while no significant difference at 6 weeks comparing with 12 weeks. In the IA+SA group, group-by-time interaction were significant for pain relief at all endpoints(3 weeks vs. 6 weeks: P<0.001; 3 weeks vs. 12 weeks: P<0.001; 3 weeks vs. 6 weeks:P=0.034). In both groups, there was significant effect on shoulder function improvement when compared at each endpoint within group(P<0.001). Between-group comparison revealed no significant effect on pain relief(P=0.386) or shoulder function improvement(P=0.685). There was also no significant effect on pain relief(3 weeks: P=0.898; 6 weeks: P=0.448;12 weeks: P=0.216) and shoulder function improvement(3 weeks: P=0.120; 6 weeks: P=0.152; 12 weeks: P=0.868) at each same endpoint. Conclusions Different site injection can effectively release pain and improve shoulder function for the patients with frozen shoulder at early stage and be well tolerated. However, it is not found that two site injection is inferior to single site injection.