The efficacy and safety of transdermal buprenorphine patch for postoperative analgesia after arthroscopic rotator cuff repair
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摘要:
目的 探究丁丙诺啡透皮贴剂(TBP)抑制肩袖修补术后疼痛的效果及药物不良反应。 方法 回顾分析2017年10月—2019年10月在浙江医院行单侧肩关节镜下肩袖修补术后未接受和接受TBP止痛治疗患者(各30例)的临床资料,分为A、B 2组。A组患者术后应用氟比洛芬酯100 mg每日2次镇痛至术后5 d;B组患者术前1 d应用丁丙诺啡透皮贴剂至术后2周,术后应用氟比洛芬酯方法同A组。追踪2组患者术前1 d及术后第1、2、3、5、14天疼痛视觉模拟评分(VAS),统计药物不良反应。术后12周进行VAS和肩关节简单功能评分(SST),测量前屈上举(FE)和体侧外旋(ER),与术前对比并组间比较。 结果 B组术后第3、5、14天VAS评分明显低于A组,差异有统计学意义(均P<0.05);术后12周随访时,A组和B组VAS、SST、FE、ER均较术前有明显改善(均P<0.05)。组间比较显示B组FE较A组范围大,差异有统计学意义(P<0.05);2组VAS、SST、ER差异无统计学意义。B组的药物不良反应发生率(5/30, 16.67%)较A组药物不良反应(2/30, 6.67%)高,2组差异无统计学意义。 结论 TBP应用于肩袖修补术后镇痛效果良好,且不影响肩关节功能恢复。 Abstract:Objective To explore the effect of transdermal buprenorphine patch (TBP) for postoperative analgesia after arthroscopic rotator cuff repair (ARCR) and to count the incidence of adverse drug reactions (ADR). Methods The clinical data of patients (30 cases in each group) who did not receive and received buprenorphine transdermal patch after ARCR under arthroscope in Zhejiang hospital from October 2017 to October 2019 were retrospectively analyzed. Group A were only treated with flurbiprofen axetil (FA) 100 mg twice a day for 5 days postoperatively. Group B were treated with FA as in A group postoperatively and 5mg TBP for 14 days (from 1 day before operation). The visual analogue score (VAS) of each group was tracked 1 day before operation and 1, 2, 3, 5 and 14 day after operation, and the incidence of ADR was counted. The simple shoulder test score (SST), range of shoulder forward elevation (FE) and external rotation (ER) were recorded, and compared between the same patients preoperatively and postoperatively and compared also between two groups.The statistical data was analyzed with t-test, analysis of variance and chi-squared test. Results On 3, 5 and 14 day after operation, the VAS of group B was lower than that of group A (P < 0.05).At 12 weeks follow-up, compared with preoperative values, the VAS, SST, FE and ER of two groups were significantly improved (P < 0.05). At 12 weeks, group B showed a larger FE range compared with group A (P < 0.05), while the difference of VAS, SST and ER between two groups had no statistical significance. The ADR of group A and group B was 2/30 (6.67%) and 5/30 (16.67%). No significant difference was found between two groups. Conclusion TBP has good effect for postoperative analgesia after ARCR and does not delay the recovery of shoulder joint function. -
表 1 2组单侧肩袖修补术患者术前一般情况比较
(x ±s) 组别 例数 年龄
(岁)身高
(cm)体重
(kg)BMI 性别
(男/女,例)病程
(月)手术部位
(左/右,例)ASA分级
(Ⅰ/Ⅱ,例)手术时间
(min)高血压
(例)糖尿病
(例)吸烟
(例)A组 30 44.43±11.68 162.80±8.24 59.90±10.59 22.46±2.58 14/16 5.23±4.36 16/14 13/17 103.20±19.71 7 5 8 B组 30 46.40±10.87 164.20±9.41 61.23±11.57 22.55±2.83 18/12 5.73±5.45 13/17 12/18 105.97±14.67 6 4 10 统计量 -0.675a -0.613a -0.465a -0.127a 1.071b -0.392a 0.601b 0.069b -0.617a 0.098b 0.131b 0.317b P值 0.502 0.542 0.643 0.899 0.301 0.696 0.438 0.793 0.54 0.754 0.718 0.573 注:a为t值,b为χ2值。ASA分级为美国麻醉医师协会分级;SST为肩关节简单评分;FE为前屈上举;ER为体侧外旋。 表 2 2组单侧肩袖修补术患者术后不同时间点VAS比较
(x ±s,分) 组别 例数 术后1 d 术后2 d 术后3 d 术后5 d 术后14 d A组 30 7.03±0.85 5.60±0.77a 4.30±1.15ab 3.20±0.76abc 1.80±0.41abcd B组 30 7.27±0.87 5.27±0.98a 3.70±0.99ab 2.70±0.75abc 1.30±0.60abcd t值 1.106 2.145 4.703 6.571 14.404 P值 0.297 0.148 0.034 0.013 < 0.001 注:与术后1 d比较,aP < 0.001;与术后2 d比较,bP < 0.001;与术后3 d比较,cP < 0.001;与术后5 d比较,dP < 0.001。 表 3 术后12周2组单侧肩袖修补术患者疼痛、功能评分及活动度比较
(x ±s) 组别 例数 VAS(分) SST(分) FE(°) ER(°) 术前1 d 术后12周 术前1 d 术后12周 术前1 d 术后12周 术前1 d 术后12周 A组 30 5.93±0.91 1.57±0.68a 6.20±1.73 9.50±1.55a 108.57±20.39 124.97±18.99a 35.00±8.84 48.40±11.21a B组 30 5.70±0.98 1.50±0.63a 6.53±1.36 9.80±1.38a 103.53±22.50 135.20±19.34a 32.10±8.11 49.83±11.44a t值 0.953 0.394 -0.830 -0.794 0.908 -2.068 1.324 -0.490 P值 0.345 0.695 0.410 0.431 0.368 0.043 0.191 0.626 注:与术前1 d比较,aP < 0.05。 表 4 2组单侧肩袖修补术患者药物不良反应比较
组别 例数 不良反应
[例(%)]具体表现(例) 头晕头痛 恶心呕吐 皮肤过敏及其他 A组 30 2(6.67) 0 2 0 B组 30 5(16.67) 5a 4 0 注:2组不良反应比较,χ2=0.647,P=0.421。a为其中4例合并恶心呕吐。 -
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