【摘要】：目的本研究采用前瞻性干涉性開放單臂多中心試驗設(shè)計評價海蘭G-F20(欣維可#174;)注射治療癥狀性膝關(guān)節(jié)骨關(guān)節(jié)炎的有效性和安全性。方法入選患膝關(guān)節(jié)骨關(guān)節(jié)炎的合格受試者237例,接受連續(xù)3次隔周關(guān)節(jié)腔內(nèi)注射2 ml海蘭G-F20。在給藥后第8周、第12周、第26周,對受試者進行膝關(guān)節(jié)檢查并對Western Ontario and Mc Master Universities(WOMAC),患者對目標膝關(guān)節(jié)的整體評價(patient global assessment,PTGA)、研究者對患者疾病的整體評價(clinical observer global assessment,COGA)問卷調(diào)查進行評估。結(jié)果注射海蘭G-F20后,232例受試者在第8周、12周、第26周時目標膝關(guān)節(jié)行走痛評分均值較基線期都顯著降低。其中給藥后第26周時,主要觀察指標目標膝關(guān)節(jié)行走痛(WOMAC A1)評分均值較基線期顯著降低33.0±17.71(x-±s),(P0.0001)。與基線期比較,降低幅度達59%。此外,第26周時受試者目標膝關(guān)節(jié)的疼痛程度(WOMAC A)、僵硬程度(WOMAC B)和關(guān)節(jié)功能(WOMAC C)評分均值較基線期顯著降低121.5±77.2、36.6±39.8、358.4±270.5(P0.0001)。受試者PTGA和COGA在第8周、第12周和第26周時的分布相對于其在基線期時的分布變化差異有統(tǒng)計意義,說明受試者自評或研究者評價受試者的總體狀況隨試驗進行不斷改善。共66例(27.8%)受試者發(fā)生不良事件(AE),其中9例(3.8%)受試者發(fā)生了與治療相關(guān)的AE。整個試驗期間,無治療相關(guān)的嚴重不良事件(SAE),無死亡病例。結(jié)論使用海蘭G-F20,患者關(guān)節(jié)疼痛、關(guān)節(jié)僵硬、關(guān)節(jié)功能都得到了有統(tǒng)計學意義的改善,其中關(guān)節(jié)行走痛的改善程度具有臨床意義。在整個研究過程中,海蘭G-F20治療的臨床副作用少,嚴重程度低,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 鹵17.71 (x- 鹵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 鹵77.2 鹵36.6 鹵39.8358.4 鹵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.
【作者單位】： 上海交通大學醫(yī)學院附屬第九人民醫(yī)院骨科;蘇州大學附屬第一醫(yī)院;北京醫(yī)院骨科;浙江大學醫(yī)學院附屬第二醫(yī)院骨科;華中科技大學同濟醫(yī)學院附屬同濟醫(yī)院骨科;東南大學附屬中大醫(yī)院骨科;
【分類號】：R684.3

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