基质诱导的自体软骨细胞移植术修复膝关节软骨缺损10例术后2年的随访

Matrix-induced autologous chondrocytes implantation for cartilage repair of knee:a two-year follow-up in 10 patients

目的应用基质诱导的自体软骨细胞移植技术(MACI,Genzyme,America)对膝关节软骨损伤的患者进行治疗,通过对患者进行术后2年的随访分析,评价MACI治疗的安全性和有效性。方法从2004年至2008年11月,对10例患者实施MACI手术。患者平均年龄34.9岁(14～57岁),缺损的平均面积(3.69±2.62)cm2/处(0.4～8cm2,n=20)。MACI技术是从患者非负重区取自体关节软骨,进行体外消化并分离出软骨细胞,培养扩增后接种在Ⅰ/Ⅲ型双层胶原膜上。移植前按缺损的部位修剪成相应形状,用生物蛋白胶将胶原膜粘贴在关节软骨缺损处。分别于术前1周、术后3个月、6个月、1年和2年使用KOOS评分问卷进行临床康复效果的评估并进行术后核磁共振的检测(MRI)。此外,术后对2例患者进行了3次关节镜检查和2次组织学检测。结果 10例患者术后均未发生并发症及与手术相关的不良事件。患者术后3个月KOOS评分显示疼痛明显改善(P<0.05);术后6个月KOOS评分显示:疼痛、症状、日常生活、运动及娱乐和生活质量5项均明显升高,5项评分间有统计学差异(P<0.05)。术后1年和2年患者的情况得到了持续的改善(P<0.05)。患者术后3个月的MRI显示软骨缺损部位得到大部分填充和修复;6个月移植软骨基本与周围软骨完全整合;1年后修复组织呈等信号,软骨下骨髓水肿消失;2年后大部分患者软骨修复组织信号与周围组织信号强度一致,软骨下骨无骨髓水肿。术后15个月和2年的组织学检查显示新生的软骨组织以透明软骨为主。MACI手术一般都能在2h内完成,术中出血量小于100ml。结论 MACI技术是修复关节软骨缺损安全、可靠和有效的治疗措施,具有操作简单、手术时间短和术中出血量少等特点。

Objective To evaluate the safety and efficacy of matrix-induced autologous chondrocytes implantation treatment（MACI,Genzyme,America） for patients suffering from cartilage lesions of knee in a follow-up study for two years.Methods MACI operation wasperformed in a total of 10 patients（13 knees）,with an average age of 34.9 years and average defect size of 3.69 cm2 from 2004 to 2008.The procedure of MACI began with harvesting cartilage tissue which obtained from autologous nonweight-bearing region for proliferation in vitro.The cultivated chrondrocytes were seeded onto type Ⅰ/type Ⅲ collagen bilayer membrane which was glued by fibrin sealant to cartilage defect area after suitable shaped.Knee injury and Osteoarthritis Outcome Score（KOOS） and Magnetic resonance imaging（MRI） were used to evaluate clinical rehabilitation in three,six,12 and 24 months postoperatively.In addition,three arthroscopic look and two histological examinations were performed post-surgery.Results There were no postoperative complications in 10 patients and no adverse events related with MACI operation.Three months after operation,evaluation of KOOS in pain showed significant improving compared with baseline（P 0.05）.Six months after surgery,KOOS results demonstrated significant improvement（P 0.05） in pain,symptoms,activities of daily life（ADL）,sports and recreation functions,and other knee-related QOL（quality of life）.MRI exhibited that new generated cartilage completely filled defect regions.Postoperative MRI in 12 and 24 months presented significant improving in defect filling,integration,signal intensity and subchondral bone.Postoperative histological evaluation of 15 and 24 months presented the predominate hyaline cartilage in new generated tissue.MACI operation time was controlled within two hours with less than 100 ml bleeding.Conclusions Our clinical results of two-year follow-up study affirmed that MACI  technique was a safe,reliable and valid treatment for cartilage lesions with characteristics of noncomplicated technique,short operating time and small amount of surgical bleeding