流行的慢性阿基里斯腱损伤治疗是无效的


  【24drs.com】January 12, 2010 — 根据一项发表于1月13日美国医学会期刊(JAMA)的研究结果,相较于安慰剂,注射富含血小板的血浆(PRP),一种热门的慢性阿基里斯腱疾患或是肌腱病变治疗方式,显然无法降低疼痛或增加运动活性。
  
  荷兰鹿特丹Erasmus大学医学中心的Robert J. de Vos医师与其同事们写到,最近三项综论报告使用PRP于肌腱病变的效果卓越,尽管这些结论是根据实验室研究,以及有重要限制的临床研究。虽然我们没有有关使用这个治疗方法的盛行率数据,但最近发表的两项综论指出注射PRP治疗肌腱病变在临床上越来越常见。
  
  阿基里斯跟腱部位以及其它部位的疾患,占所有运动伤害的30%至50%,它会导致长时间无法运动,且经常干扰日常生活。
  
  这项双盲、随机分派、安慰剂控制研究合并PRP与安慰剂注射生理食盐水,配合离心运动。研究对象是54位年龄介于18~79岁的病患,这些病患在2008年8月到2009年1月之间于荷兰莱岑丹Antoniushove Hague医学中心就诊,罹患中段阿基里斯腱肌腱病变。他们采用一种问卷(Victorian Institute of Sports Assessment-Achilles[VISA-A])来评估试验开始时,以及第6、12与24周时的疼痛与运动活性。
  
  根据过去的研究来进行预测,作者们假设PRP组的VISA-A分数比安慰剂组高12分。然而,他们的发现并非如此。
  
  24周后的研究结果显示,在PRP组,VISA-A平均分数改善了21.7分(95%信赖区间[CI]为13.0-30.5)。安慰剂组的分数增加了20.5分(95% CI为11.6-29.4)。在校正变项后,包括试验前VISA-A分数(P=0.03)、以及症状时程(P=0.06),在任一测量期间,两组之间都没有显著差异。组与组之间的变异数在6周时为2.5(95% CI为-6.9-11.9)、12周时为-1.6(95% CI为-11.9-8.7)、而在24周时为-0.9(95% CI为-12.4-10.6)。正面值代表偏好PRP组。
  
  除此之外,次级预后方面同样没有显著差异。这些包括病患主观满意度(在24周后为-4.1%;95% CI为-25.8%-17.7%),以及可从事运动的病患数目(在24周后为1.4%;95% CI为-17.0%-19.8%)。再次地,正面值代表偏好PRP组。运动与耐受性在两组之间都没有显著差异。
  
  作者们写到,在我们的研究中,有关两个治疗组何以表现出临床恶化的原因仍然不明。在过去的临床研究中,离心运动已经被证实是有效的。
  
  试验作者表示有两个重要限制:一是无法建立注射PRP的血小板与活化型生长因子数目、以及缺乏接受PRP注射且未进行离心运动组别,使得这项研究无法确认对PRP治疗的负面效应。
  
  作者们建议,需要进一步针对处理肌腱病变进行研究,这个疾病过去被称为肌腱炎。他们也表示,寻找非使用注射方式治疗的重要性。
  
  作者们写到,保守治疗是令人失望的,且25%~45%患者最终需要外科手术。因此,改善保守治疗有其必要性。
  
  Biomet生技公司LLC赞助这项研究。研究作者们表示已无相关资金上的往来。

Trendy Chronic Achilles Tendon Injury Therapy Is Ineffective

By Nancy Fowler Larson
Medscape Medical News

January 12, 2010 — Injections of platelet-rich plasma (PRP), an up-and-coming treatment for chronic Achilles tendon disorder, or tendinopathy, does not appear to reduce pain or increase activity more than placebo, according to a study published in the January 13 issue of the Journal of the American Medical Association.

"Three recent reviews reported promising results of the use of PRP in tendinopathy, although these conclusions were based on laboratory studies and on clinical studies with important limitations," write Robert J. de Vos, MD, from the Department of Orthopedics, Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues. "Although we are unaware of published data on the prevalence of use of this therapy, 2 recent reviews have suggested that PRP injections for tendinopathy are increasingly used in the clinical setting."

Tendon disorders in the Achilles heel and other locations make up 30% to 50% of all sports injuries, can lead to long interruptions in sports participation, and often interfere with daily life.

This double-blind, block randomized, placebo-controlled trial combined both PRP and placebo saline injections with eccentric exercises. Researchers studied 54 patients, ages 18 to 79 years, who had midportion Achilles tendinopathy at The Hague Medical Center Antoniushove, Leidschendam, the Netherlands, between August 2008 and January 2009. They employed a questionnaire (Victorian Institute of Sports Assessment-Achilles [VISA-A]) to measure pain and activity at the study's onset and at 6, 12, and 24 weeks.

Making a prediction based on previous studies, the authors hypothesized that the VISA-A score of the PRP group would be 12 points higher than that of the placebo group. However, their findings proved otherwise.

Results after 24 weeks showed that for the PRP group, the mean VISA-A score improved by 21.7 points (95% confidence interval [CI], 13.0 - 30.5). The placebo group's score increased by 20.5 points (95% CI, 11.6 - 29.4). After adjustment for variables, including the baseline VISA-A score (P = .03) and duration of symptoms (P = .06), there was no significant distinction between the 2 groups during any measurement period. Between-group variations were 2.5 (95% CI, ?6.9 to 11.9) at 6 weeks, ?1.6 (95% CI, ?11.9 to 8.7) at 12 weeks, and ?0.9 (95% CI, ?12.4 to 10.6) at 24 weeks. Positive values favor the PRP group.

Furthermore, no significant differences were seen in secondary outcome measures. These include subjective patient satisfaction (after 24 weeks, ?4.1%; 95% CI, ?25.8% to 17.7%) and the number of patients returning to their sport (after 24 weeks, 1.4%; 95% CI, ?17.0% to 19.8%). Again, positive values favor the PRP group. Neither were there any important differences between the groups in terms of exercise compliance.

"The reason why both treatment groups show clinical progression in our study, but also in other studies on PRP, is likely due to the fact that exercises were performed. Eccentric exercises have been shown to be effective in previous randomized trials," the authors write.

The study authors reported 2 limitations: numbers could not be established for the amount of platelets and activated growth factors in the PRP injections, and the absence of a group receiving PRP injection but no eccentric exercises prohibited the study from determining whether exercise actually has a negative effect on PRP therapy.

The authors recommended further investigation of injections to remedy tendinopathy, formerly known as tendinitis. They also noted the importance of finding effective treatments that do not involve injections.

"Conservative treatment is disappointing and 25% to 45% of patients eventually require surgery," the authors write. "There is a clear need for improved conservative therapy."

Biomet Biologics LLC supported the study. The study authors have disclosed no relevant financial relationships.

JAMA. 2010;303(2):144-149.

    
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