The Efficacy and Safety of Bionic Tiger Bone Powder for the Treatment of Knee Osteoarthritis in Early Stage: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

被引:0
|
作者
Chen, Zhigang [1 ]
Xu, Hui
Wang, Kunzheng [2 ]
Ma, Jianbing [3 ]
Gao, Shijun [4 ]
Yao, Wangxiang [5 ]
Wang, Xiaoxia [6 ]
Zuo, Jianlin [7 ]
Fei, Jun [8 ]
Liu, Jiangtao [9 ]
Wang, Zhanchao [10 ]
机构
[1] Beijing Jishuitan Hosp, Dept Orthopaed, Beijing, Peoples R China
[2] Xi An Jiao Tong Univ, Affiliated Hosp 2, Dept Bone & Joint Surg, Xian, Shaanxi, Peoples R China
[3] Xian Honghui Hosp, Dept Adult Knee Reconstruct, Xian, Shaanxi, Peoples R China
[4] Hebei Med Univ, Hosp 3, Dept Joint Surg, Shijiazhuang, Hebei, Peoples R China
[5] Zhejiang Univ, Sch Med, Hangzhou Peoples Hosp 1, Dept Orthopaed, Hangzhou, Zhejiang, Peoples R China
[6] Shanxi Med Univ, Hosp 2, Dept Rheumatol & Immunol, Taiyuan, Shanxi, Peoples R China
[7] Jilin Univ, China Japan Union Hosp, Dept Orthopaed, Changchun, Jilin, Peoples R China
[8] Zhejiang Chinese Med Univ, Affiliated Hosp, Zhejiang TCM&WM Hosp, Hangzhou Red Cross Hosp,Dept Orthpaed, Hangzhou, Zhejiang, Peoples R China
[9] Xiangyang 1 Peoples Hosp, Dept Orthopaed, Xiangyang, Hubei, Peoples R China
[10] Luoyang Orthoped Traumatol Hosp Henan Prov, Henan Prov Orthoped Hosp, Knee Ctr, Luoyang, Henan, Peoples R China
关键词
EXPERT CONSENSUS;
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中图分类号
R [医药、卫生];
学科分类号
10 ;
摘要
Objective center dot This study evaluated the efficacy and safety of bionic tiger bone powder (Jintiange) in comparison to placebo in treating knee osteoarthritis osteoporosis. Methods center dot A total of 248 patients were randomly allocated to a Jintiange group or a placebo group, undergoing 48 weeks of double-blind treatment. The Lequesne index, clinical symptoms, safety index (adverse events), and Patient's Global Impression of Change score were recorded at pre-determined time intervals. All P values <= .05 were deemed statistically significant. Results center dot Both groups showed a decreasing trend in the Lequesne index, with the Jintiange group's reduction significantly larger from the 12th week (P = .01). Similarly, the effective rate of Lequesne score in the Jintiange group was significantly higher (P < .001). After 48 weeks, clinical symptom score differences between the Jintiange group (2.46 +/- 1.74) and the placebo group (1.51 +/- 1.73) were statistically significant (P < .05), as were differences in the Patient's Global Impression of Change score (P < .05). Adverse drug reactions were minimal with no significant difference between the groups (P > .05). Conclusion center dot Jintiange demonstrated superior efficacy over placebo in treating knee osteoporosis, with comparable safety profiles. Findings warrant further comprehensive real-world studies.
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页码:370 / 376
页数:7
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