Trueba Vasavilbaso Cesáreo, Rosas Bello Carlos David, Medina López Erla, Coronel Granado Maria Pilar, Navarrete Álvarez José Mario, Trueba Davalillo Cesáreo Angel, Gil Orbezo Félix Isaac
Orthopedics Department, Hospital Español de México, Mexico DF.
Orthopedics Department, Hospital Médica Sur, Mexico City, Mexico.
Open Access Rheumatol. 2017 Sep 25;9:171-179. doi: 10.2147/OARRR.S138353. eCollection 2017.
To assess the effectiveness of viscosupplementation or platelet-rich plasma (PRP), compared to standard care, for pain relief after knee arthroscopic debridement in patients with meniscal pathology and osteoarthritis (OA), under normal clinical practice conditions.
We conducted a prospective, randomized, evaluator-blind, pilot study. After arthroscopy, patients were randomized to receive 1) five injections of HA1 (Suprahyal/Adant); 2) four injections of HA2 (Orthovisc); 3) three injections of HA3 (Synvisc); 4) a single injection of PRP (GPS™ II); or 5) standard care (control). Patients were followed up for 18 months. Clinical outcomes were evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 6, 12, and 18 months. Minimally Clinical Important Improvement (MCII), as relative improvement ≥20 for pain and function, was also calculated.
Fifty patients were included. At early follow-up (3 months), total WOMAC scores improved in all groups compared to baseline with reductions of 44.79% (HA1), 24.02% (HA2), 40.38% (HA3), 39.77% (PRP), and 27.64% (control) (=0.002 HA1 compared to HA2). At 18 months, the higher improvement in total WOMAC was in HA1 with a 65.20% reduction, followed by PRP (55.01%), HA3 (49.57%), and HA2 (29.82%), whereas the control group had a 14.55% increase over baseline (=0.001 control compared to HA1 and HA3). The percentage of patients achieving the MCII for both pain and function at 18 months was 100% (HA1), 80% (HA3), 60% (HA2), and 60% (PRP), whereas, in the control group, all patients returned to pre-arthroscopy levels. There were no adverse events attributable to surgery or to intraarticular administration.
Viscosupplementation following arthroscopy is more effective than PRP in adequately selected patients with meniscal lesions occurring concomitantly with OA. Further controlled studies with a larger sample size and/or alternative regimens would be of interest for the scientific community.
在正常临床实践条件下，评估与标准护理相比，粘弹性补充疗法或富血小板血浆（PRP）对半月板病变和骨关节炎（OA）患者膝关节镜清创术后疼痛缓解的有效性。
我们进行了一项前瞻性、随机、评估者盲法的试点研究。关节镜检查后，患者被随机分为接受以下治疗：1）注射5次HA1（Suprahyal/Adant）；2）注射4次HA2（Orthovisc）；3）注射3次HA3（Synvisc）；4）单次注射PRP（GPS™ II）；或5）标准护理（对照组）。对患者进行18个月的随访。在3、6、12和18个月时，使用西安大略和麦克马斯特大学关节炎指数（WOMAC）评估临床结果。还计算了最小临床重要改善（MCII），即疼痛和功能的相对改善≥20%。
纳入50例患者。在早期随访（3个月）时，与基线相比，所有组的WOMAC总分均有所改善，HA1组降低44.79%，HA2组降低24.02%，HA3组降低40.38%，PRP组降低39.77%，对照组降低27.64%（HA1组与HA2组相比，P = 0.002）。在18个月时，WOMAC总分改善程度较高的是HA1组，降低了65.20%，其次是PRP组（55.01%）、HA3组（49.57%）和HA2组（29.82%），而对照组比基线增加了14.55%（对照组与HA1组和HA3组相比，P = 0.001）。在18个月时，疼痛和功能均达到MCII的患者百分比在HA1组为100%，HA3组为80%，HA2组为60%，PRP组为60%，而在对照组中，所有患者恢复到关节镜检查前水平。没有可归因于手术或关节内给药的不良事件。
在适当选择的伴有OA的半月板损伤患者中，关节镜检查后的粘弹性补充疗法比PRP更有效。科学界可能会对进一步的大样本量对照研究和/或替代方案感兴趣。
