Ke Yan, Jiang Wenxue, Xu Yongsheng, Chen Yajun, Zhang Qingsong, Xue Qingyun, Lin Jianhao, Ngai Wilson, Nian Gaowei, Fazeli Mir Sohail, Xie Yao, Zhu Zhenan
Peking University People's Hospital, Beijing, China.
Tianjin First Central Hospital, Tianjin, China.
BMC Musculoskelet Disord. 2021 May 8;22(1):428. doi: 10.1186/s12891-021-04252-2.
Single 6 ml Hylan G-F 20 injection, is indicated for knee osteoarthritis patients who have failed to respond to non-pharmacologic therapy and/or simple analgesics. To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity.
This was a randomized, multi-center, double-blind, placebo-controlled clinical trial conducted in 21 centers across China. Four hundred forty adults with knee OA received a single 6 ml Hylan G-F 20 or placebo injection and were evaluated for clinical efficacy and safety outcomes over 26 weeks. Western Ontario and McMaster Universities OA (WOMAC) A1 index, treatment-emergent adverse events (TEAEs) and standard safety parameters were measured at pre-injection, and at weeks 1, 4, 8, 12, 16, 20 and 26 post-injection.
Four hundred forty patients (male: 98 [22.3%]; female: 342 [77.7%]) were randomized. The mean age [standard deviation (SD)] was 61.5 (7.9) years. All patients were of East Asian ethnicity. Mean WOMAC A1 score at baseline was 5.3 (1.2) and 5.2 (1.3) in single 6 ml Hylan G-F 20 injection and placebo groups, respectively. Significant reductions of WOMAC A1 score were observed in both treatment groups when compared to baseline at 26 weeks post-injection, with the mean reduction of [standard error (SE)/percentage] -2.146 (0.108)/- 40.5% and - 2.271 (0.110) /- 43.7% in the single 6 ml Hylan G-F 20 injection and the placebo groups, respectively. Additionally, clinically important reductions in pain at 26 weeks was reported in 67.0 and 68.2% in single 6 ml Hylan G-F 20 injection and placebo groups (p = 0.36). Regarding safety, TEAEs were similar between the two treatment groups (hylan G-F 20 single: 61.5%; placebo: 64.5%).
While the magnitude of the effect of a single 6 ml Hylan G-F 20 injection in this study is consistent with previously published literature with respect to the efficacy and safety of the drug, the current study shows a strong IA placebo effect and did not established superiority of single 6 ml Hylan G-F 20 injection over IA placebo in Chinese knee OA patients.
Prospectively registered Jun 16, 2017 at www.clinicaltrials.gov ( NCT03190369 ).
单次6毫升透明质酸钠凝胶- F20注射剂适用于对非药物治疗和/或简单镇痛药无反应的膝骨关节炎患者。为更全面地了解其临床疗效和安全性，开展了一项随机临床试验，比较单次6毫升透明质酸钠凝胶- F20关节内注射与安慰剂对中国汉族膝骨关节炎患者的疗效。
这是一项在中国21个中心进行的随机、多中心、双盲、安慰剂对照临床试验。440名成年膝骨关节炎患者接受单次6毫升透明质酸钠凝胶- F20或安慰剂注射，并在26周内评估临床疗效和安全性指标。在注射前以及注射后第1、4、8、12、16、20和26周测量西安大略和麦克马斯特大学骨关节炎指数（WOMAC）A1指标、治疗中出现的不良事件（TEAE）和标准安全性参数。
440名患者（男性98名[22.3%]；女性342名[77.7%]）被随机分组。平均年龄[标准差（SD）]为61.5（7.9）岁。所有患者均为东亚族裔。单次6毫升透明质酸钠凝胶- F20注射组和安慰剂组基线时的WOMAC A1平均评分分别为5.3（1.2）和5.2（1.3）。与注射后26周时的基线相比，两个治疗组的WOMAC A1评分均显著降低，单次6毫升透明质酸钠凝胶- F20注射组和安慰剂组的平均降低幅度[标准误（SE）/百分比]分别为-2.146（0.108）/-40.5%和-2.271（0.110）/-43.7%。此外，单次6毫升透明质酸钠凝胶- F20注射组和安慰剂组在26周时报告有临床意义的疼痛减轻的患者分别为67.0%和68.2%（p = 0.36）。在安全性方面，两个治疗组的TEAE相似（透明质酸钠凝胶- F20单次注射组：61.5%；安慰剂组：64.5%）。
虽然本研究中单次6毫升透明质酸钠凝胶- F20注射的效果在药物疗效和安全性方面与先前发表的文献一致，但本研究显示出强烈的关节内注射安慰剂效应，且未证实单次6毫升透明质酸钠凝胶- F20注射在中国膝骨关节炎患者中优于关节内注射安慰剂。
于2017年6月16日在www.clinicaltrials.gov前瞻性注册（NCT03190369）。
