海兰G-F20治疗症状性膝关节骨关节炎有效性与安全性的前瞻性单臂多中心临床研究
发布时间：2018-11-19 13:53
【摘要】：目的本研究采用前瞻性干涉性开放单臂多中心试验设计评价海兰G-F20(欣维可#174;)注射治疗症状性膝关节骨关节炎的有效性和安全性。方法入选患膝关节骨关节炎的合格受试者237例,接受连续3次隔周关节腔内注射2 ml海兰G-F20。在给药后第8周、第12周、第26周,对受试者进行膝关节检查并对Western Ontario and Mc Master Universities(WOMAC),患者对目标膝关节的整体评价(patient global assessment,PTGA)、研究者对患者疾病的整体评价(clinical observer global assessment,COGA)问卷调查进行评估。结果注射海兰G-F20后,232例受试者在第8周、12周、第26周时目标膝关节行走痛评分均值较基线期都显著降低。其中给药后第26周时,主要观察指标目标膝关节行走痛(WOMAC A1)评分均值较基线期显著降低33.0±17.71(x-±s),(P0.0001)。与基线期比较,降低幅度达59%。此外,第26周时受试者目标膝关节的疼痛程度(WOMAC A)、僵硬程度(WOMAC B)和关节功能(WOMAC C)评分均值较基线期显著降低121.5±77.2、36.6±39.8、358.4±270.5(P0.0001)。受试者PTGA和COGA在第8周、第12周和第26周时的分布相对于其在基线期时的分布变化差异有统计意义,说明受试者自评或研究者评价受试者的总体状况随试验进行不断改善。共66例(27.8%)受试者发生不良事件(AE),其中9例(3.8%)受试者发生了与治疗相关的AE。整个试验期间,无治疗相关的严重不良事件(SAE),无死亡病例。结论使用海兰G-F20,患者关节疼痛、关节僵硬、关节功能都得到了有统计学意义的改善,其中关节行走痛的改善程度具有临床意义。在整个研究过程中,海兰G-F20治疗的临床副作用少,严重程度低,患者耐受性好。
[Abstract]:Objective to evaluate the efficacy and safety of G-F20 injection in the treatment of symptomatic knee osteoarthritis. Methods two hundred and thirty-seven eligible subjects with osteoarthritis of knee joint were treated with 2 ml G-F20 intraarticular injection for 3 consecutive times. At week 8, week 12, week 26, knee examination was performed on the subjects and (patient global assessment,PTGA was evaluated on the target knee joint in patients with Western Ontario and Mc Master Universities (WOMAC),. The researchers evaluated the overall assessment of the patient's disease by the (clinical observer global assessment,COGA) questionnaire. Results after injection of G-F20, the mean score of walking pain of the knee joint in 232 subjects was significantly lower than that in the baseline period at week 8, week 12 and week 26. At the 26th week after administration, the mean score of walking pain (WOMAC A1) of the target knee joint was significantly decreased by 33.0 卤17.71 (x- 卤s), (P0.0001) compared with the baseline period. Compared with the baseline period, the decrease was 59%. In addition, at the 26th week, (WOMAC B) and (WOMAC C) scores of (WOMAC A), stiffness and joint function in the target knee joint were significantly decreased by 121.5 卤77.2 卤36.6 卤39.8358.4 卤270.5 (P0.0001) compared with the baseline period. The distribution of PTGA and COGA in subjects at week 8, week 12 and week 26 had statistical significance compared with their distribution at baseline, indicating that the overall status of subjects evaluated by self-assessment or researcher was improved with the experiment. A total of 66 (27.8%) subjects developed adverse events (AE), of which 9 (3.8%) developed treatment-related AE.. There were no severe adverse events associated with treatment, (SAE), and no death during the trial period. Conclusion there were significant improvements in joint pain, joint stiffness and joint function in patients with Hailan G-F20, and the improvement of joint walking pain was of clinical significance. During the course of the study, the clinical side effects, severity and patient tolerance of G-F20 were low.
【作者单位】： 上海交通大学医学院附属第九人民医院骨科;苏州大学附属第一医院;北京医院骨科;浙江大学医学院附属第二医院骨科;华中科技大学同济医学院附属同济医院骨科;东南大学附属中大医院骨科;
【分类号】：R684.3
[Abstract]:Objective to evaluate the efficacy and safety of G-F20 injection in the treatment of symptomatic knee osteoarthritis. Methods two hundred and thirty-seven eligible subjects with osteoarthritis of knee joint were treated with 2 ml G-F20 intraarticular injection for 3 consecutive times. At week 8, week 12, week 26, knee examination was performed on the subjects and (patient global assessment,PTGA was evaluated on the target knee joint in patients with Western Ontario and Mc Master Universities (WOMAC),. The researchers evaluated the overall assessment of the patient's disease by the (clinical observer global assessment,COGA) questionnaire. Results after injection of G-F20, the mean score of walking pain of the knee joint in 232 subjects was significantly lower than that in the baseline period at week 8, week 12 and week 26. At the 26th week after administration, the mean score of walking pain (WOMAC A1) of the target knee joint was significantly decreased by 33.0 卤17.71 (x- 卤s), (P0.0001) compared with the baseline period. Compared with the baseline period, the decrease was 59%. In addition, at the 26th week, (WOMAC B) and (WOMAC C) scores of (WOMAC A), stiffness and joint function in the target knee joint were significantly decreased by 121.5 卤77.2 卤36.6 卤39.8358.4 卤270.5 (P0.0001) compared with the baseline period. The distribution of PTGA and COGA in subjects at week 8, week 12 and week 26 had statistical significance compared with their distribution at baseline, indicating that the overall status of subjects evaluated by self-assessment or researcher was improved with the experiment. A total of 66 (27.8%) subjects developed adverse events (AE), of which 9 (3.8%) developed treatment-related AE.. There were no severe adverse events associated with treatment, (SAE), and no death during the trial period. Conclusion there were significant improvements in joint pain, joint stiffness and joint function in patients with Hailan G-F20, and the improvement of joint walking pain was of clinical significance. During the course of the study, the clinical side effects, severity and patient tolerance of G-F20 were low.
【作者单位】： 上海交通大学医学院附属第九人民医院骨科;苏州大学附属第一医院;北京医院骨科;浙江大学医学院附属第二医院骨科;华中科技大学同济医学院附属同济医院骨科;东南大学附属中大医院骨科;
【分类号】：R684.3
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