■整骨已广泛用于治疗膝骨关节炎(KOA)。然而,缺乏关于Osteoking抗KOA的临床疗效以及与非甾体类抗炎药(NSAIDs)的比较的高质量证据.
■评价Osteoking治疗KOA的疗效和安全性。
■在当前的研究中,从20个医疗中心共招募了501名受试者,分为Osteoking治疗组(n=428)和NSAIDs治疗组(n=73)。采用倾向评分匹配法平衡不同组的基线数据。然后,使用VAS评分评估Ostoking和NSAIDs对KOA的治疗效果,WOMAC得分,EQ-5D-3L和EQ-VAS,虽然两种治疗的安全性都是基于口干评估的,头晕,腹泻,等。
■治疗8周后,将Ostoking组与NSAIDs组进行比较,VAS评分[2.00(1.00,3.00)与3.00(2.00,4.00)],WOMAC疼痛评分[10.00(8.00,13.00)vs.11.00(8.00,16.00)],WOMAC身体功能评分[32.00(23.00,39.00)vs.39.07±16.45],WOMAC总分[44.00(31.00,55.00)与53.31±22.47)],EQ-5D-3L得分[0.91(0.73,0.91)vs.0.73(0.63,0.83)]和EQ-VAS评分[80.00(79.00,90.00)与80.00(70.00,84.00)]通过Osteoking治疗8周比通过NSAIDs治疗更有效地改善。用Ostoking治疗8周后,治疗8周KOA患者的VAS评分从6.00(5.00,7.00)降低到2.00(1.00,3.00)(p<0.05),在此临床观察期间,从2周开始,这比NSAIDs治疗更好。重要的是,进一步的亚组分析显示,Osteoking的治疗更适合于缓解65岁以上KOA患者的各种临床症状,与女性,KLII-III级和VAS4-7分,而NSAIDs在65岁以下且VAS评分为8~10分的KOA患者中的临床疗效较好。值得注意的是,两种药物治疗组的不良事件和不良反应无差异.
■Osteoking在减轻关节疼痛和提高KOA患者的生活质量方面可能具有令人满意的疗效,且无任何不良反应。特别是对于KLII-III级和VAS4-7评分的患者。
■https://www.chictr.org.cn/showproj.html?proj=55387,标识符ChiCTR2000034475。
UNASSIGNED: Osteoking has been extensively used for the treatment of knee osteoarthritis (KOA). However, it is lack of high-quality evidence on the clinical efficacy of Osteoking against KOA and the comparison with that of nonsteroidal anti-inflammatory drugs (NSAIDs).
UNASSIGNED: To evaluate the efficacy and safety of Osteoking in treating KOA.
UNASSIGNED: In the current study, a total of 501 subjects were recruited from 20 medical centers, and were divided into the Osteoking treatment group (n = 428) and the NSAIDs treatment group (n = 73). The Propensity Score Matching method was used to balance baseline data of different groups. Then, the therapeutic effects of Osteoking and NSAIDs against KOA were evaluated using VAS score, WOMAC score, EQ-5D-3L and EQ-VAS, while the safety of the two treatment were both assessed based on dry mouth, dizziness, diarrhea, etc.
UNASSIGNED: After 8 weeks of treatment, the Osteoking group was compared with the NSAIDs group, the VAS score [2.00 (1.00, 3.00) vs. 3.00 (2.00, 4.00)], WOMAC pain score [10.00 (8.00, 13.00) vs. 11.00 (8.00, 16.00) ], WOMAC physical function score [32.00 (23.00, 39.00) vs. 39.07 ± 16.45], WOMAC total score [44.00 (31.00, 55.00) vs. 53.31 ± 22.47) ], EQ-5D-3L score [0.91 (0.73, 0.91) vs. 0.73 (0.63, 0.83) ] and EQ-VAS score [80.00 (79.00, 90.00) vs. 80.00 (70.00, 84.00) ] were improved by the treatment of Osteoking for 8 weeks more effectively than that by the treatment of NSAIDs. After 8 weeks of treatment with Osteoking, the VAS scores of KOA patients with the treatment of Osteoking for 8 weeks were reduced from 6.00 (5.00, 7.00) to 2.00 (1.00, 3.00) (p < 0.05), which was better than those with the treatment of NSAIDs starting from 2 weeks during this clinical observation. Importantly, further subgroup analysis revealed that the treatment of Osteoking was more suitable for alleviating various clinical symptoms of KOA patients over 65 years old, with female, KL II-III grade and VAS 4-7 scores, while the clinical efficacy of NSAIDs was better in KOA patients under 65 years old and with VAS 8-10 scores. Of note, there were no differences in adverse events and adverse reactions between the treatment groups of the two drugs.
UNASSIGNED: Osteoking may exert a satisfying efficacy in relieving joint pain and improving life quality of KOA patients without any adverse reactions, especially for patients with KL II-III grades and VAS 4-7 scores.
UNASSIGNED: https://www.chictr.org.cn/showproj.html?proj=55387, Identifier ChiCTR2000034475.