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关节内注射A型肉毒杆菌毒素治疗犬骨关节炎关节疼痛:一项随机、双盲、安慰剂对照临床试验

Intra-articular botulinum toxin A for the treatment of osteoarthritic joint pain in dogs: a randomized, double-blinded, placebo-controlled clinical trial.

作者信息

Heikkilä H M, Hielm-Björkman A K, Morelius M, Larsen S, Honkavaara J, Innes J F, Laitinen-Vapaavuori O M

机构信息

Department of Equine and Small Animal Medicine, Faculty of Veterinary Medicine, P.O. Box 57, 00014 University of Helsinki, Finland.

Department of Equine and Small Animal Medicine, Faculty of Veterinary Medicine, P.O. Box 57, 00014 University of Helsinki, Finland.

出版信息

Vet J. 2014 Apr;200(1):162-9. doi: 10.1016/j.tvjl.2014.01.020. Epub 2014 Feb 5.

DOI:10.1016/j.tvjl.2014.01.020
PMID:24675370
Abstract

The aim of this study was to investigate the efficacy of intra-articular (IA) botulinum toxin A (IA BoNT A) for the treatment of osteoarthritic joint pain in dogs. The study was a placebo-controlled, randomized, double-blinded clinical trial with parallel group design and 12-week follow-up. Thirty-six dogs with chronic lameness due to stifle, hip or elbow osteoarthritis were randomized to receive an IA injection of 30IU of BoNT A or placebo. The main outcome variables were vertical impulse (VI) and peak vertical force (PVF) measured with a force platform, and Helsinki chronic pain index (HCPI). Subjective pain score and the need for rescue analgesics were secondary variables. The response to treatment was assessed as the change from baseline to each examination week. The variables were analyzed by ANOVA with repeated measurements and results were considered statistically significant if P ⩽ 0.05. The improvement from baseline to 12 weeks after baseline was statistically significant in VI, PVF and HCPI in the treatment group (P=0.001, P=0.054 and P=0.053, respectively). Additionally, there were statistically significant improvements in VI in the treatment group at 2, 4 and 8 weeks after baseline (P=0.037, P=0.016 and P=0.016, respectively). The difference between groups in improvement in VI was statistically significant at 12weeks after baseline (P=0.005). There was no significant change in the subjective pain score or in the requirement for rescue analgesics in either group. No major adverse events thought to be related to trial protocol were detected. These results suggest that IA BoNT A has some efficacy in reducing osteoarthritic pain in dogs.

摘要

本研究的目的是调查关节内注射A型肉毒杆菌毒素(IA BoNT A)治疗犬骨关节炎关节疼痛的疗效。该研究是一项安慰剂对照、随机、双盲的平行组设计临床试验,随访期为12周。三十六只因 stifle、髋关节或肘关节骨关节炎导致慢性跛行的犬被随机分为两组,分别接受30IU的IA BoNT A注射或安慰剂注射。主要结局变量是通过测力平台测量的垂直冲量(VI)和峰值垂直力(PVF),以及赫尔辛基慢性疼痛指数(HCPI)。主观疼痛评分和急救镇痛药的需求为次要变量。治疗反应通过从基线到各检查周的变化进行评估。变量采用重复测量的方差分析进行分析,如果P⩽0.05,则结果被认为具有统计学意义。治疗组从基线到基线后12周,VI、PVF和HCPI的改善具有统计学意义(分别为P = 0.001、P = 0.054和P = 0.053)。此外,治疗组在基线后2、4和8周时VI有统计学意义地改善(分别为P = 0.037、P = 0.016和P = 0.016)。基线后12周时,两组间VI改善的差异具有统计学意义(P = 0.005)。两组的主观疼痛评分或急救镇痛药的需求均无显著变化。未检测到与试验方案相关的重大不良事件。这些结果表明,IA BoNT A在减轻犬骨关节炎疼痛方面有一定疗效。

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