Zhao Ye, Shen Zhi Bi, Ge Ji Rong, Liu Wen Gang, Yang Jun Xing, He Cheng Jian, Lu Min, Shen Lin, Yin Hong, Chen Yong Qiang, Li Zhi Bin, Sun Qing, Xie Li Ming, Yuan Wei An, Zheng Yu Xin, Zhan Hong Sheng
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Fujian Institute of Traditional Chinese Medicines, Fuzhou 350003, China.
Evid Based Complement Alternat Med. 2020 Jun 11;2020:8707256. doi: 10.1155/2020/8707256. eCollection 2020.
To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA).
A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276).
Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups ( < 0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group ( < 0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant ( < 0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group ( < 0.05). . A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention.
These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.
评估痛宁凝胶（TNG）对比安慰剂对照（PC）治疗膝关节骨性关节炎（KOA）的疗效和安全性。
对576例患者进行了一项多中心、随机、双盲、平行、安慰剂对照的临床试验（TNG组432例患者，PC组144例患者），实验组有1例患者因未用药而退出。患者被随机分为接受TNG或PC，每次3g涂抹于膝关节皮肤，每天2次，持续3周。采用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）疼痛评分评估TNG的主要疗效，采用WOMAC僵硬、身体功能及总分评估TNG的次要疗效。所有接受至少一剂研究药物的参与者都纳入安全性分析。本试验已在中国临床试验注册中心注册（注册号：CTR20131276）。
主要疗效指标：两组WOMAC疼痛评分下降值有显著差异（P<0.05），TNG组WOMAC疼痛评分下降值优于PC组（P<0.05）。次要疗效指标：两组患者治疗后WOMAC总分、WOMAC僵硬评分、WOMAC身体功能评分及上述指标下降情况均有统计学意义（P<0.05），TNG组上述指标改善情况优于PC组（P<0.05）。共有29例患者报告了42例不良事件：实验组16例患者报告25例不良事件（3.71%），对照组13例患者报告17例不良事件（9.03%）。6例患者报告了8例不良反应，其中实验组2例患者报告2例不良反应（0.46%），对照组4例患者报告6例不良反应（2.78%）。实验组发生2例严重不良事件。两组各有1例严重不良事件，均与干预无关。
本试验结果表明，TNG治疗KOA患者优于安慰剂，且TNG可改善KOA的其他症状，如僵硬和身体功能。总体而言，TNG治疗膝关节骨性关节炎是安全的。
