富血小板血浆（PRP）治疗膝骨关节炎的临床疗效评价

发布时间：2018-06-09 04:51

本文选题：骨关节炎 + 富血小板血浆　；参考：《山东大学》2017年博士论文

【摘要】：研究背景骨关节炎(osteoarthritis,OA)是影响人类健康最常见的关节疾患之一,没有明显的种族差异和地区差异,以疼痛和丧失活动能力为主要临床表现,以关节软骨退变和软骨下骨改变、骨赘形成和非细菌性滑膜炎为病理特征。在超过50岁以上人群中,骨关节炎在导致长期残疾的疾病中仅次于心血管疾病排名第二[1],其中膝关节发生骨关节炎的发生率最高。膝骨关节炎(Knee Osteoarthritis,KOA)是指以膝关节软骨发生原发性或继发性退变及结构紊乱,伴随软骨下骨质增生硬化、软骨剥脱、滑膜无菌性炎症为病理特征,从而使关节逐渐破坏、畸形,最终导致膝关节功能障碍的一种退行性疾病,是老年人膝关节疼痛和功能障碍的主要原因[2]。近年来,KOA发病率逐年增高,在55岁以上的人群中约6O%有KOA的X线影响表现,在65岁以上的人群中约80%有KOA的X线影像表现,是导致50岁以上人群功能残疾、造成经济损失和影响社会发展的主要疾病之一。其发病因素较多,与:高龄、性别、遗传、激素、供应关节的血流减少导致关节软骨细胞的功能和软骨性质改变、对细胞因子和生长因子的应答改变、慢性劳损、肥胖、骨质疏松、外伤和力学的改变、遗传因素等均有关系。骨关节炎的治疗可分为手术治疗(四期及部分三期患者)和保守治疗(所有患者)。保守治疗包括理疗、药物、注射疗法和中医中药治疗等,均为对症治疗。关节腔内注射目前常用药物大体包括激素、玻璃酸钠两大类。激素注射可以显著改善症状,但会加速关节退变,不建议使用第三次;玻璃酸钠广泛应用,有一定的症状缓解率,但最新的询证医学没有明显的证据支持其对骨关节炎的治疗有效,2013年美国骨科医师协会《膝骨关节炎治疗指南》不推荐玻璃酸钠作为关节腔内注射的治疗,推荐等级为强烈[3];2014年国际骨关节炎研究协会在KOA保守治疗指南中认为关节腔内注射玻璃酸钠疗效不确切[4]。2013年美国骨科医师协会《膝骨关节炎治疗指南》中首次探讨了富血小板血浆(plate-rich-plasma,PRP)对于KOA的治疗效果,依据2012年以前的病例对照研究和1项随机对照研究,得出的结论是既不赞成,也不反对,推荐等级为不确定[3];PRP是通过分离自体静脉血制备的含有高浓度血小板的血浆,其内含有大量的活性生长因子和炎症调节因子,能够促进软骨细胞的再生,消除关节滑膜的无菌性炎症[5-8],理论上具有类似于KOA病因治疗的可能性。目前国内缺乏高质量系统性的PRP治疗KOA的临床研究,故本研究通过比较PRP和玻璃酸钠(Hyaluronic acid,HA)、PRP+HA关节腔内注射治疗KOA的临床治疗效果。第一部分:富血小板血浆(PRP)治疗Ⅱ、Ⅲ期膝骨关节炎的临床疗效评价目的评价关节腔内注射富血小板血浆(PRP)相对于玻璃酸钠(HA)钠治疗II、Ⅲ期膝骨关节炎的临床疗效。方法选择2013年2月-2014年5月,山东大学附属省立医院和威海市立医院门诊收治的126例Ⅱ、Ⅲ期(Keligren Lawrence分级)126膝关节骨性关节炎的患者,随机分为HA组(63例,63膝)和PRP组(63例,63膝),两组患者性别、年龄、体重指数、Keligren Lawrence分级、视觉模拟评分(VAS)、国际膝关节文献委员会(IKDC)评分、美国西部Ontario与McMaster大学骨关节炎指数(WOMAC)评分比较,差异均无统计学意义(P0.05),具有可比性。分别采用2ml HA(施沛特,共5次,分别在第0、1、2、3、4周注射)和3.5ml PRP(威高富血小板血浆制备套装,共3次,分别在第0、1、2周注射)关节腔内注射进行治疗。患者在治疗前和完成全部注射后的第1月、3月、6月、12月进行复诊并记录VAS评分值、IKDC评分、WOMAC评分,比较治疗后不同时间点的疗效。结果PRP组58例、HA组55例患者获得随访12个月。PRP组患者16例40次出现不良反应,HA组14例37次;两组不良反应起始时间、终止时间及持续时间比较,差异均无统计学意义(P0.05)。两组治疗后VAS评分、IKDC评分及WOMAC评分与治疗前比较,差异均有统计学意义(P0.05);PRP组治疗后1、3、6、12个月间比较,差异均无统计学意义(P0.05);HA组治疗后6、12月各评价指标较1、3月差,差异有统计学意义(P0.05)。两组治疗1、3月后,VAS评分、IKDC评分及WOMAC评分比较,差异无统计学意义(P0.05);但是6、12月时,PRP组各指标均优于HA组(P0.05)。结论关节内注射PRP治疗膝关节软骨退行性变安全有效,可缓解疼痛,改善功能,提高生活质量。治疗后短期效果与HA无明显差异,但长期效果要优于HA。第二部分PRP+HA联合治疗与仅使用富血小板血浆治疗膝骨性关节炎的对比研究背景与目的:玻璃酸钠(HA)联合使用富血小板血浆(PRP)治疗膝骨关节炎的确切效果尚不清楚。本文的目的是比较PRP + HA混合物与单纯使用富血小板血浆关节腔内注射治疗膝骨关节炎患者的疗效。材料和方法:纳入了一批总数为126的膝关节骨性关节炎患者为研究对象:PRP+HA组和PRP组各63例。在临床和影像学评估后,患者接受每周一次的HA+PRP混合物(2mlHA+3.5mlPRP)关节腔内注射或只注射PRP(3.5ml)治疗持续3周。在第1、3、6和12个月进行随访。结果:在使用PRP+HA混合物和单纯PRP治疗的患者中,相比治疗前患者的状态,VAS评分明显降低,膝关节的功能(WOMAC)明显改善。就VAS和WOMAC而言,两组之间没有观察到显著性差异;然而,PRP+HA混合物组有一种能获得更好的功能性评分的趋势(VAS,P = 0.392;WOMAC,P = 0.082)。PRP+HA 组发现了 6 个失败病例和PRP组有11个。而两组中没有发现重大不良事件或并发症。结论:PRP+HA的联合使用治疗患有轻中度膝骨关节炎的患者是安全有效的。虽然在功能性结果上两组没有明显差异,但是PRP+HA组有可以获得相对更好的功能评分的趋势。
[Abstract]:Background osteoarthritis (OA) is one of the most common joint disorders affecting human health. There is no obvious racial difference and regional difference. The main clinical manifestations are pain and loss of activity. Articular cartilage degeneration and subchondral bone change, osteophyte formation and non bacterial synovitis are pathological features. It is over 50 years old. In the above population, osteoarthritis is ranked next to second [1] in the cause of chronic disability after cardiovascular disease, of which the incidence of osteoarthritis of the knee is the highest. Knee osteoarthritis (Knee Osteoarthritis, KOA) refers to the occurrence of primary or secondary degeneration and structural disorder in the cartilage of the knee joint with subchondral osseosis and sclerosis. Cartilage exfoliation and synovial aseptic inflammation are the pathological features of the knee, resulting in a gradual destruction of the joints, deformity, and eventually a degenerative disease of the knee joint dysfunction. It is the main cause of pain and dysfunction of the knee joint in the elderly [2]., the incidence of KOA has increased year by year, and about 6O% in the population over 55 years old has the X - ray effect of KOA. About 80% of the people over 65 years old have KOA X - ray imaging, which is one of the major diseases that lead to functional disability in the population over 50 years old and cause economic loss and social development. The response changes of cytokines and growth factors, chronic strain, obesity, osteoporosis, trauma and mechanical changes, genetic factors are related. The treatment of osteoarthritis can be divided into surgical treatment (phase four and part three patients) and conservative treatment (all patients). Conservative treatment includes physiotherapy, medicine, injection therapy, and traditional Chinese medicine treatment, etc. The commonly used drugs in the joint intracavitary injection include hormone and sodium hyaluronate in two major categories. Hormone injection can significantly improve symptoms, but it will accelerate joint degeneration, not recommended for use third times; sodium hyaluronate is widely used and has a certain rate of relief, but the latest evidence medicine has no obvious evidence to support its bone clearance. The treatment of arthritis is effective. The American Association of Department of orthopedics physicians, 2013 guidelines for the treatment of knee osteoarthritis, does not recommend sodium hyaluronate as an intracavitary injection, and the recommended grade is strong [3]. In 2014, the International Association of osteoarthritis studies found that intraarticular injection of sodium hyaluronate in the KOA conservative treatment guideline was not accurate for [4].2013 years of American bone For the first time, the association of physicians' Association of knee osteoarthritis (plate-rich-plasma) was the first to discuss the therapeutic effect of plate-rich-plasma (PRP) on the treatment of KOA. According to the case control study before 2012 and the randomized controlled study, the conclusion was that it was neither in favor nor objection, and that the recommendation grade was uncertain [3]; PRP was by separating autologous vein blood. The plasma containing high concentration of platelets contains a large number of active growth factors and inflammatory regulators, which can promote the regeneration of cartilage cells and eliminate the aseptic inflammation of the synovial membrane of the joint [5-8]. It is theoretically similar to the possibility of KOA etiological treatment. At present, a clinical study of high quality and systematic PRP for KOA is lacking in China. So by comparing PRP and sodium hyaluronate (Hyaluronic acid, HA), PRP+HA intra-articular injection for the treatment of KOA, the first part: evaluation of the clinical efficacy of platelet rich plasma (PRP) treatment II, stage III knee osteoarthritis objective evaluation of intraarticular injection of platelet rich plasma (PRP) relative to sodium hyaluronate (HA) sodium (HA) for the treatment of II, III Methods the clinical efficacy of knee osteoarthritis was selected in February 2013 -2014 -2014 May, 126 patients with 126 knee osteoarthritis (63 cases, 63 knees) and PRP group (63 cases, 63 knees) treated in the outpatient department of the provincial and Weihai municipal hospitals affiliated to the Shandong University were randomly divided into group HA (63 cases, 63 knees), and two groups of patients, sex, age and weight. Index, Keligren Lawrence grading, visual analogue scale (VAS), International Knee Joint literature Committee (IKDC) score, compared to the Ontario and McMaster University bone arthritis index (WOMAC) scores in western United States, the difference was not statistically significant (P0.05), with a comparability. The division adopted 2ml HA (5 times, respectively, 0,1,2,3,4 week injection) and 3.5ml. PRP (VH high platelet plasma preparation set, 3 times, respectively in the 0,1,2 week) was injected into the articular cavity for treatment. The patients were retreated before and after first months of all injection, in March, June, and December to record the VAS score, IKDC score, and WOMAC score, compared with 58 cases in group PRP and 55 in group HA. Patients were followed up for 12 months in group.PRP, 16 cases had 40 adverse reactions and 14 cases were 37 times in group HA. The difference was not statistically significant (P0.05). The difference was statistically significant (P0.05) between the two groups after the treatment of the two groups (P0.05). The difference was statistically significant (P0.05). There was no significant difference between 1,3,6,12 months after treatment (P0.05), and the evaluation indexes of 6,12 months after treatment in group HA were worse than that of 1,3 months, and the difference was statistically significant (P0.05). There was no statistical difference between the two groups after 1,3 months, VAS score, IKDC score and WOMAC score, but all the indexes were better than those in the 6,12 month. It is safe and effective to treat the degenerative knee cartilage by intra-articular injection of PRP, which can relieve pain, improve function and improve the quality of life. The short-term effect after treatment is not significantly different from that of HA, but the long-term effect is better than the comparative study background and purpose of the combined treatment of HA. second part PRP+HA and the only use of platelet rich plasma for the treatment of knee osteoarthritis. The exact effect of sodium hyaluronate (HA) combined with platelet rich plasma (PRP) in the treatment of knee osteoarthritis is not clear. The purpose of this article is to compare the efficacy of the PRP + HA mixture with the simple use of platelet rich plasma in the treatment of patients with knee osteoarthritis. Materials and methods were included in a group of 126 knee osteoarthritis. Patients were studied: 63 cases in group PRP+HA and group PRP. After clinical and imaging evaluation, patients received intra-articular injection of HA+PRP mixture (2mlHA+3.5mlPRP) per week or only PRP (3.5ml) for 3 weeks. Follow up in 1,3,6 and 12 months. Results: compared to patients with PRP+HA mixture and simple PRP treatment. The VAS score was significantly lower and the function of the knee (WOMAC) was obviously improved. As for VAS and WOMAC, there was no significant difference between the two groups; however, the PRP+HA mixture group had a tendency to gain a better functional score (VAS, P = 0.392; WOMAC, P = 0.082) and the.PRP+HA group found 6 failed cases and PR. There were 11 groups in the group P. And no major adverse events or complications were found in the two group. Conclusion: the combined use of PRP+HA for patients with mild and moderate knee osteoarthritis is safe and effective. Although there is no significant difference in the functional results between the two groups, the PRP+HA group has a tendency to obtain a better functional score.
【学位授予单位】：山东大学
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R684.3

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