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自体条件血浆与安慰剂注射疗法治疗肘部外侧上髁炎:一项双盲随机研究。

Autologous Conditioned Plasma Versus Placebo Injection Therapy in Lateral Epicondylitis of the Elbow: A Double Blind, Randomized Study.

作者信息

Schöffl Volker, Willauschus Wolfgang, Sauer Felix, Küpper Thomas, Schöffl Isabelle, Lutter Christoph, Gelse Kolja, Dickschas Jörg

机构信息

Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG.

Alpha Med, Bamberg, FRG.

出版信息

Sportverletz Sportschaden. 2017 Jan;31(1):31-36. doi: 10.1055/s-0043-101042. Epub 2017 Feb 21.

DOI:10.1055/s-0043-101042
PMID:28222465
Abstract

There are various therapeutic approaches to the treatment of lateral epicondylitis, a highly prevalent musculoskeletal disorder. Recently, injection therapy with autologous conditioned plasma (ACP) has shown promise as a new approach.  Set up as a prospective, double-blind, randomized controlled clinical trial, this study involved 50 patients with lateral epicondylitis. Following external randomization, 25 patients received one round of injection therapy with ACP (platelet rich plasma, PRP), while the remaining 25 patients received a placebo of 0.9 % NaCl. All patients were re-evaluated with respect to lateral epicondylitis of the elbow at four-weeks and six-months post-injection.  Out of 50 patients, 36 qualified for reevaluation, 18 patients from the ACP therapy group and 18 from the placebo group. The initial Disability of the Arm, Shoulder and Hand (DASH) score for all reevaluated patients was 36.4 in the ACP group, and 41.0 in the placebo group; both groups exhibited decreased DASH scores at the four-week and six-month post-injection follow-up (6 months: ACP 30.1, placebo 25.8). The decrease of the DASH score after 4 weeks was greater and qualified as statistically significant in the placebo group (p = 0.041), compared to the DASH score decrease in the ACP treatment group, which was statistically non-significant. Additionally, the difference between the DASH scores of the treatment and placebo groups was statistically non-significant four weeks and six months after treatment.  The results of this study suggest a therapeutic effect in both the ACP and placebo groups, with no evidence for a therapeutically significant difference between ACP and placebo treatments. It is hypothesized that, in accordance with the study protocols, injection with a local anaesthetic prior to ACP therapy may have an influence on the therapeutic effect of ACP. Future studies have to confirm recent findings that demonstrated a minimizing, or even inhibiting, action of local anaesthetics on the effects of ACP/PRP.  The effect of ACP/PRP injections needs to be investigated in future studies under standardized conditions.

摘要

肱骨外上髁炎是一种非常常见的肌肉骨骼疾病,其治疗方法多种多样。最近,自体浓缩血浆(ACP)注射疗法已显示出作为一种新方法的前景。本研究作为一项前瞻性、双盲、随机对照临床试验开展,涉及50例肱骨外上髁炎患者。经过外部随机分组,25例患者接受一轮ACP(富血小板血浆,PRP)注射治疗,而其余25例患者接受0.9%氯化钠安慰剂注射。所有患者在注射后四周和六个月时就肘部肱骨外上髁炎进行重新评估。在50例患者中,36例符合重新评估条件,其中18例来自ACP治疗组,18例来自安慰剂组。所有重新评估患者的初始手臂、肩部和手部功能障碍(DASH)评分在ACP组为36.4,在安慰剂组为41.0;两组在注射后四周和六个月的随访中DASH评分均降低(6个月时:ACP组为30.1,安慰剂组为25.8)。与ACP治疗组DASH评分降低无统计学意义相比,安慰剂组在4周后DASH评分降低更大且具有统计学意义(p = 0.041)。此外,治疗组和安慰剂组的DASH评分在治疗后四周和六个月时差异无统计学意义。本研究结果表明,ACP组和安慰剂组均有治疗效果,没有证据表明ACP与安慰剂治疗之间存在具有治疗意义的差异。据推测,根据研究方案,在ACP治疗前注射局部麻醉剂可能会对ACP的治疗效果产生影响。未来的研究必须证实最近的发现,即局部麻醉剂对ACP/PRP的作用具有最小化甚至抑制作用。未来的研究需要在标准化条件下调查ACP/PRP注射的效果。

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