丁丙诺啡透皮贴剂在肩关节镜下肩袖修补术后的镇痛效果及安全性

盛静; 闫应朝; 孙瑜; 瞿杭波; 黄小琴

doi:10.16766/j.cnki.issn.1674-4152.001820

丁丙诺啡透皮贴剂在肩关节镜下肩袖修补术后的镇痛效果及安全性

doi: 10.16766/j.cnki.issn.1674-4152.001820

浙江医院骨科，浙江杭州 310030

基金项目:

浙江省中医药科学研究基金项目 2020ZA001

详细信息

通讯作者:
黄小琴，E-mail: Zjyyhxq@163.com

中图分类号: R684 R619
计量
- 文章访问数: 261
- HTML全文浏览量: 150
- PDF下载量: 3
- 被引次数: 0
出版历程
- 收稿日期: 2020-02-18
- 网络出版日期: 2022-02-19

The efficacy and safety of transdermal buprenorphine patch for postoperative analgesia after arthroscopic rotator cuff repair

Department of Orthopaedic Surgery, Zhejiang Hospital, Hangzhou, Zhejiang 310030, China

摘要

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。
- 丁丙诺啡透皮贴剂 /
- 肩袖损伤 /
- 关节镜 /
- 术后镇痛 /
- 药物不良反应
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.
- Transdermal buprenorphine patch /
- Rotator cuff injury /
- Arthroscope /
- Postoperative analgesia /
- Adverse drug reactions

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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		-0.675^a	-0.613^a	-0.465^a	-0.127^a	1.071^b	-0.392^a	0.601^b	0.069^b	-0.617^a	0.098^b	0.131^b	0.317^b
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。

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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±0.77^a	4.30±1.15^ab	3.20±0.76^abc	1.80±0.41^abcd
B组	30	7.27±0.87	5.27±0.98^a	3.70±0.99^ab	2.70±0.75^abc	1.30±0.60^abcd
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。

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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(°)
组别	例数	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±0.68^a	6.20±1.73	9.50±1.55^a	108.57±20.39	124.97±18.99^a	35.00±8.84	48.40±11.21^a
B组	30	5.70±0.98	1.50±0.63^a	6.53±1.36	9.80±1.38^a	103.53±22.50	135.20±19.34^a	32.10±8.11	49.83±11.44^a
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。

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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)
组别	例数	不良反应 [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)	5^a	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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参考文献(20)

[1]	KIM J W, KIM Y N, LEE D K. The effect of combined exercise with slings and a flexi-bar on muscle, activity and pain in rotator cuff repair patients[J]. J Phys Ther Sci, 2016, 28(10): 2890-2893. doi: 10.1589/jpts.28.2890
[2]	阮仁芝, 余新颜, 李燕. 关节镜下肩袖修补术后快速康复护理路径的应用效果观察[J]. 中西医结合护理(中英文), 2018, 4(3): 49-52. https://www.cnki.com.cn/Article/CJFDTOTAL-ZXHL201803014.htm
[3]	成霞, 吴丹, 潘浩, 等. 细节性护理在肩袖损伤修补术后患者干预中的应用效果[J]. 中华全科医学, 2019, 17(11): 1965-1968. https://www.cnki.com.cn/Article/CJFDTOTAL-SYQY201911048.htm
[4]	ROBERSON T, THROCKMORTON T. Pain after rotator cuff repair[J]. Curr Orthop Pract, 2016, 27(2): 156-160. doi: 10.1097/BCO.0000000000000354
[5]	LU Y, LI Y, LI F L, et al. Do Different cyclooxygenase inhibitors impair rotator cuff healing in a rabbit model?[J]. Chin Med J, 2015, 128(17): 2354-2359. doi: 10.4103/0366-6999.163379
[6]	陈明伟, 邹士平, 司文腾. 丁丙诺啡透皮贴剂对膝关节置换术后疼痛的影响评估[J]. 中国执业药师, 2019, 16(2): 8-10. https://www.cnki.com.cn/Article/CJFDTOTAL-ZYYS201902004.htm
[7]	NIYOGI S, BHUNIA P, NAYAK J, et al. Efficacy of transdermal buprenorphine patch on post-operative pain relief after elective spinal instrumentation surgery[J]. Indian J. Anaesth, 2017, 61(11): 923-929. doi: 10.4103/ija.IJA_118_17
[8]	KIM H J, AHN H S, NAM Y, et al. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial[J]. Eur Spine J, 2017, 26(11): 2961-2968. doi: 10.1007/s00586-017-5213-5
[9]	DESAI S N, BADIGER S V, TOKUR S B, et al. Safety and efficacy of transdermal buprenorphine versus oral tramadol for the treatment of post-operative pain following surgery for fracture neck of femur: A prospective, randomised clinical study[J]. Indian J Anaesth, 2017, 61(3): 225-229. http://www.ncbi.nlm.nih.gov/pubmed/28405035
[10]	庞智晖, 郭富明, 周勇, 等. 丁丙诺啡透皮贴剂治疗骨科中重度慢性疼痛1241例回顾分析[J]. 中国疼痛医学杂志, 2019, 25(4): 309-314. https://www.cnki.com.cn/Article/CJFDTOTAL-ZTYZ201904017.htm
[11]	梁晓瑜, 陈金生, 万丽, 等. 比较丁丙诺啡透皮贴剂和氟比洛芬酯注射液在冻结肩患者手法松解术及康复训练中的近期镇痛效果[J]. 实用疼痛学杂志, 2019, 15(2): 114-117.
[12]	魏俊成, 颜世昌, 彭俊洋, 等. 关节镜下单纯双排缝合与缝合桥技术修复肩袖损伤的临床观察[J]. 中国医师进修杂志, 2018, 41(9): 833-836. doi: 10.3760/cma.j.issn.1673-4904.2018.09.017
[13]	郭伟康, 赖兵, 黄健, 等. 双滑轮结合缝线桥技术和双排固定术治疗肩袖全层撕裂的疗效对比[J]. 实用骨科杂志, 2019, 25(8): 676-680. https://www.cnki.com.cn/Article/CJFDTOTAL-SGKZ201908002.htm
[14]	鲁谊, 李岳, 李奉龙, 等. 肩袖修复术后非甾体类消炎药疗效的前瞻性随机对照观察[J]. 中华医学杂志, 2015, 95(29): 2337-2341. doi: 10.3760/cma.j.issn.0376-2491.2015.29.001
[15]	SHAH S A, KORMPAKIS I, HAVLIOGLU N, et al. Sclerostin antibody treatment enhances rotator cuff tendon-to-bone healing in an animal model[J]. J Bone Joint Surg Am, 2017, 99(10): 855-864. doi: 10.2106/JBJS.16.01019
[16]	曹寅生, 万云峰. 肩袖撕裂修补术后腱骨愈合的研究进展[J]. 中国骨伤, 2018, 31(12): 1172-1179. doi: 10.3969/j.issn.1003-0034.2018.12.020
[17]	谢卫东, 吴风军. 丁丙诺啡透皮贴剂辅助射频消融治疗腰椎间盘突出症有效性及安全性[J]. 中国疼痛医学杂志, 2017, 23(8): 589-593. doi: 10.3969/j.issn.1006-9852.2017.08.008
[18]	何亮, 赵晓光, 韩彬. 丁丙诺啡透皮贴剂对老年股骨转子间骨折术后的镇痛效果与安全性[J]. 中国临床药理学杂志, 2017, 33(4): 316-318. https://www.cnki.com.cn/Article/CJFDTOTAL-GLYZ201704008.htm
[19]	HYUP L J, JIN-HYOK K, JIN-HWAN K, et al. Efficacy and safety of transdermal buprenorphine versus oral tramadol/acetaminophen in patients with persistent postoperative pain after spinal surgery[J]. Pain Res Manag, 2017, 2017(1): 1-11. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5615987/
[20]	李潇, 徐繁, 曹向宇, 等. MRI对肩峰下撞击综合征合并肩袖撕裂的诊断应用[J]. 北京医学, 2019, 41(3): 217-218. https://www.cnki.com.cn/Article/CJFDTOTAL-BJYX201903016.htm