富血小板血浆关节内注射治疗膝骨关节炎的前瞻性随机对照研究

Intra-articular injection of platelet-rich plasma for treatment of knee osteoarthritis： a prospective, randomized, controlled trial

目的观察富血小板血浆（PRP）治疗膝骨关节炎（KOA）的临床疗效，评估年龄、体重指数和KOA严重程度等对PRP疗效的影响。方法采用前瞻性随机对照研究方法选取2013年12月-2014年11月100例KOA患者，其中男28例，女72例；年龄35～85岁，平均58．0岁。其中退行性关节炎68例，创伤性关节炎32例。Kellgren—Lawrence（K—L）分级Ⅰ级35例，Ⅱ级46例，Ⅲ级19例。通过随机数字表法按1：1分为玻璃酸钠组（HA组，50例）和PRP组（50例），两组年龄、性别、体重指数（BMI）、K—L分级等差异均无统计学意义。HA组膝关节内注射HA，PRP组注射PRP，各每周1次，连续3周。根据西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、视觉模拟评分（VAS）和软骨损伤评分系统（CaLs）对两组患者治疗前后的临床表现和MRI上骨异常信号和软骨损伤面积进行比较。随访时患者的WOMAC评分下降≥36％则被认为治疗有效。结果100例患者治疗后均获得6个月随访。PRP组3次治疗结束后和随访6个月时的有效率分别为84％（42例）和60％（30例），而HA组分别为68％（34例）和36％（18例）（P〉0．05，〈0．05）。PRP组的VAS及两组的WOMAC评分较治疗前均有显著改善（P〈0．01），而HA组的VAS与治疗前比较差异无统计学意义（P〉0．05）。PRP组内K—L分级Ⅱ级的患者，治疗后平均VAS和平均WOMAC评分高于I级的患者（P〈0．05）；Ⅲ级的患者，治疗后平均WOMAC评分高于Ⅱ级的患者（p〈0．05）。针对PRP组内7例患者膝关节MRI的研究显示，治疗前后CaLs差异无统计学意义（P〈0．05），但在1例患者的MRI上观察到软骨下骨异常信号面积缩小和软骨损伤面积减少等征象。随访显示，PRP组年龄、K—L分级与随访疗效呈负相关（P〈0．05），与BMI无明确相关性（P〉0．05）。随着随访时间的延长，PRP和HA的疗效均呈逐渐下降趋势。结论关节内注射PRP治疗KOA具有减轻疼痛、减少炎症反应、促进组织修复的作用，在低年龄段和低K—L分级的患者中疗效更加显著，而BMI对于PRP疗效无明确相关性。

Objective To study the clinical efficacy of platelet-rich plasma （PRP） in the treatment of knee osteoarthritis （KOA） and evaluate whether the age, body mass index and grade of KOA are associated with the treatment outcomes. Methods Using the prospective, randomized, controlled study, 100 KOA patients hospitalized between December 2013 and November 2014 were enrolled. Twenty- eight patients were men and 72 were women. Mean age was 58 years （ range, 35-85 years）. Degenerative arthritis occurred in 68 patients and traumatic arthritis in 32 patients. Kellgren-Lawrence （K-L） score was grade Ⅱ in 35 patients, grade Ⅱ in 46 and grade Ⅲ in 19. The patients were assigned to receive hyaluronic acid （HA） （HA group, n = 50 ） and PRP （PRP group, n = 50 ） by an intraartieular route once weekly for 3 weeks, according to the random number table. Between-group differences were insignificant in age, gender, body mass index （BMI） and K-L grade. Western Ontario and McMaster Universities Arthritis Index （WOMAC） , visual analog scale （VAS） and cartilage lesions score （CaLs） were used for clinical and MRI evaluations. At follow-up evaluation, the effective rate was defined at least 36% improvement from the baseline WOMAC score. Results All patients were followed up for 6 months. The effective rate in PRP group was 84% versus 68% in HA group after the last treatment （P 〉 0. 05 ）, and was 60% versus 36% in HA group at the final follow-up （P 〈 0.05 ）. WOMAC score in both groups had significant improvement after operation, while VAS improved only in PRP group （ P 〈 0. 01 ）. In PRP group patients with K-L grade Ⅰ had better VAS and WOMAC scores than those with grade 11 （P 〈 0.05 ）, and patients with grade Ⅱ had better WOAMC score than those with grade m （ P 〈 0. 05 ）. MRI findings showed seven patients in PRP group had similar CaLs before and after operation （ P 〉 0. 05 ） , and the area of abnormal signal in subchondral bone and the depth of cartilage lesion gradually decreased in one of them. Follow-up study showed the outcomes had negative correlation with age and K-L grade （ P 〈 0.05 ）, but no certain correlation with BMI in PRP group （ P 〉 0.05 ）. Clinical effects in both groups were decreased over time. Conclusions Intraarticular injection of PRP benefits to pain relief, decreased inflammation and tissue repair, and has much better outcome in patients with younger age and lower K-L grade. However, BMI is not associated with the outcome.