Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy :A Randomized Clinical Trial．

富血小板血浆注射液与假注射治疗慢性中段跟腱病肌腱功能障碍的随机对照研究

   供稿: 差劲先森。                 排版:Onion

IMPORTANCE Platelet-rich plasma injections are used as a treatment for chronic midportion Achilles tendinopathy, but evidence for this treatment is limited．

富含血小板的血浆注射被用于治疗慢性中段跟腱病变,但这种治疗的证据有限

OBJECTIVE In adults with midportion Achilles tendinopathy, to assess the effects of a single platelet-rich plasma injection, compared with sham injection, on the outcome of the Victorian Institute of Sport Assessment-Achilles (VISA-A) score (a single composite measure of Achilles tendinopathy severity)．

评价在成人跟腱中段病变患者中,与假注射相比,单次注射富血小板血浆对维多利亚运动评估-跟腱(VISA-A)评分(跟腱病变严重程度的单一综合测量)结果的影响

DESIGN,SETTING,AND PARTICIPANTSA participant-blinded, multicenter randomized clinical trial that included 240 people from 24 sites assigned to either a platelet-rich plasma injection or a sham injection between April 2016 and February 2020． Final follow-up was July 2020． Participants were older than 18 years with midportion Achilles tendon pain for more than 3 months as confirmed by ultrasound, magnetic resonance imaging, or both

盲法多中心随机临床试验,包括来自24个地点的240人,在2016年4月至2020年2月期间被分配到富血小板血浆注射或假注射。最后一次跟进是在2020年7月。受试者年龄超过18岁,经超声、磁共振成像或两者同时证实,跟腱中段疼痛超过3个月

INTERVENTIONSA single intratendinous platelet-rich plasma injection (n = 121) or a single sham injection (insertion of a subcutaneous dry needle not entering the tendon) (n = 119)

介入治疗:单次腱内富血小板血浆注射(n=121)或单次假注射(未进入肌腱的皮下干针)(n=119)。

MAIN OUTCOMES AND MEASURES The primary outcome was the VISA-A score, measured 6 months after treatment allocation． The VISA-A score contains 8 questions that cover 3 domains of pain, function, and activity, analyzed as a composite score (range, 0 [worst symptoms] to 100 [no symptoms]; minimal clinically important difference in score, 12 points)． The primary analysis was adjusted for laterality, age, sex, and baseline VISA-A score．

主要结果和测量主要结果是VISA-A评分,在治疗分配6个月后测量。VISA-A评分包括8个问题,涵盖疼痛、功能和活动三个领域,综合评分分析(范围从0[最严重的症状]到100[无症状];最小的临床重要性评分差异,12分)。初步分析根据偏侧、年龄、性别和基线VISA-A评分进行了调整

RESULTS Among 240 patients assigned to a platelet-rich plasma or sham injection (mean age, 52 years; 138 [58%] women), 221 (92%) completed the trial． At 6-month follow-up, mean VISA-A score values in the plasma-rich plasma group vs the sham injection group were 54．4 vs 53．4 (adjusted mean difference, −2．7 [95% CI, −8．8 to 3．3])． The most common adverse events compared between patients in the platelet-rich plasma group vs the sham group were injection site discomfort (97 vs 73 patients), swelling (56 vs 52 patients) and bruising (48 vs 49 patients)．

结果240例接受富血小板血浆或假注射的患者(平均年龄为52岁,138例(58%)女性),221例(92%)完成了试验。在6个月的随访中,富血浆组和假注射组的平均VISA-A积分值分别为54．4vs53．4(调整后的平均差值,−2．7[95%CI,−8．8～3．3])。富含血小板血浆组与假手术组比较最常见的不良事件是注射部位不适(97例比73例)、肿胀(56例比52例)和瘀伤(48例比49例)。

CONCLUSIONS AND RELEVANCE Among patients with chronic midportion Achilles tendinopathy, treatment with a single injection of intratendinous platelet-rich plasma, compared with insertion of a subcutaneous dry needle, did not reduce Achilles tendon dysfunction at 6 months． These findings do not support the use of this treatment for chronic midportion Achilles tendinopathy．

结论和结论在慢性跟腱中段病变患者中,与皮下注射干针相比,一次注射富血小板血浆并不能减少6个月后跟腱功能障碍的发生率。结果表明,在慢性中段跟腱病患者中,与皮下注射干针相比,一次注射富血小板血浆并不能减少6个月后跟腱功能障碍。这些发现不支持使用这种疗法治疗慢性中段跟腱病变。