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米诺环素减轻腕管综合征和扳机指松解术后疼痛的双盲安慰剂随机对照试验

A Double-Blind Placebo Randomized Controlled Trial of Minocycline to Reduce Pain After Carpal Tunnel and Trigger Finger Release.

作者信息

Curtin Catherine M, Kenney Debbie, Suarez Paola, Hentz Vincent R, Hernandez-Boussard Tina, Mackey Sean, Carroll Ian R

机构信息

Department of Surgery, Palo Alto VA, Palo Alto, CA; Division of Plastic Surgery, Department of Surgery, Stanford University, Palo Alto, CA.

Department of Orthopedic Surgery, Stanford University, Palo Alto, CA.

出版信息

J Hand Surg Am. 2017 Mar;42(3):166-174. doi: 10.1016/j.jhsa.2016.12.011.

Abstract

PURPOSE

Minocycline is a microglial cell inhibitor and decreases pain behaviors in animal models. Minocycline might represent an intervention for reducing postoperative pain. This trial tested whether perioperative administration of minocycline reduced time to pain resolution (TPR) after standardized hand surgeries with known prolonged pain profiles: carpal tunnel release (CTR) and trigger finger release (TFR).

METHODS

This double-blinded randomized controlled trial included patients undergoing CTR or TFR under local anesthesia. Before surgery, participants recorded psychological and pain measures. Participants received oral minocycline, 200 mg, or placebo 2 hours prior to procedure, and then 100 mg of minocycline or placebo 2 times a day for 5 days. After surgery, participants were called daily assessing their pain. The primary end point of TPR was when participants had 3 consecutive days of 0 postsurgical pain. Futility analysis and Kaplan-Meier analyses were performed.

RESULTS

A total of 131 participants were randomized and 56 placebo and 58 controls were analyzed. Median TPR for CTR was 3 weeks, with 15% having pain more than 6 weeks. Median TPR for TFR was 2 weeks with 18% having pain more than 6 weeks. The overall median TPR for the placebo group was 2 weeks (10% pain > 6 weeks) versus 2.5 weeks (17% pain > 6 weeks) for the minocycline group. Futility analysis found that the likelihood of a true underlying clinically meaningful reduction in TPR owing to minocycline was only 3.5%. Survival analysis found minocycline did not reduce TPR. However, subgroup analysis of those with elevated posttraumatic distress scores found the minocycline group had longer TPR.

CONCLUSIONS

Oral administration of minocycline did not reduce TPR after minor hand surgery. There was evidence that minocycline might increase length of pain in those with increased posttraumatic stress disorder symptoms.

TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.

摘要

目的

米诺环素是一种小胶质细胞抑制剂,可减轻动物模型中的疼痛行为。米诺环素可能是一种减轻术后疼痛的干预措施。本试验旨在测试在具有已知长时间疼痛特征的标准化手部手术(腕管松解术[CTR]和扳机指松解术[TFR])后,围手术期给予米诺环素是否能缩短疼痛缓解时间(TPR)。

方法

这项双盲随机对照试验纳入了在局部麻醉下接受CTR或TFR的患者。手术前,参与者记录心理和疼痛指标。参与者在手术前2小时口服200毫克米诺环素或安慰剂,然后每天2次,每次100毫克米诺环素或安慰剂,持续5天。手术后,每天致电参与者评估其疼痛情况。TPR的主要终点是参与者连续3天术后疼痛为0。进行了无效性分析和Kaplan-Meier分析。

结果

共有131名参与者被随机分组,分析了56名安慰剂组和58名对照组。CTR的TPR中位数为3周,15%的人疼痛超过6周。TFR的TPR中位数为2周,18%的人疼痛超过6周。安慰剂组的总体TPR中位数为2周(10%疼痛>6周),而米诺环素组为2.5周(17%疼痛>6周)。无效性分析发现,米诺环素使TPR真正在临床上有意义地降低的可能性仅为3.5%。生存分析发现米诺环素并未缩短TPR。然而,对创伤后应激评分升高者的亚组分析发现,米诺环素组的TPR更长。

结论

手部小手术后口服米诺环素并未缩短TPR。有证据表明,米诺环素可能会增加创伤后应激障碍症状加重者的疼痛持续时间。

研究类型/证据水平:治疗性I级。

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