塞来昔布联合地奥司明治疗中重度膝骨关节炎的疗效与安全性观察

张汉东; 王功腾; 张镇斌; 李广兴; 王旭凤; 张文琦; 孙华强; 李树锋

doi:10.16766/j.cnki.issn.1674-4152.004284

塞来昔布联合地奥司明治疗中重度膝骨关节炎的疗效与安全性观察

doi: 10.16766/j.cnki.issn.1674-4152.004284

1.
山东第一医科大学第一附属医院(山东省千佛山医院)骨外科学，山东省风湿免疫病转化医学重点实验室，山东济南 250014
2.
山东中医药大学第一临床医学院，山东济南 250013

基金项目:

山东省自然科学基金项目 ZR2022MH128

详细信息

通讯作者:
李树锋，E-mail：shufenglisd@126.com

中图分类号: R684.3
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- 被引次数: 0
出版历程
- 收稿日期: 2024-12-02
- 网络出版日期: 2026-03-13

Observations on the efficacy and safety of celecoxib combined with diosmin in the treatment of moderate to severe knee osteoarthritis

1.
Department of Orthopedic Surgery, the First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Shandong Key Laboratory of Rheumatic Disease and Translational Medicine, Jinan, Shandong 250014, China

摘要

摘要: 目的评估塞来昔布联合地奥司明治疗中重度膝骨关节炎(KOA)的临床疗效和安全性，以探讨优化KOA治疗方案的可行性。方法本研究为前瞻性随机对照研究，纳入2024年6—7月山东第一医科大学第一附属医院(山东省千佛山医院)收治的86例KOA患者，采用随机数字表法分为塞来昔布组(对照组)和塞来昔布联合地奥司明组(观察组)，每组43例，治疗周期为8周。评估2组患者用药前、用药后4周、用药后8周及停药后4周、8周、12周的西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分、膝关节肿胀评分和VAS评分，并记录不良反应发生情况。结果用药后4周、8周及停药后4周、8周、12周，观察组的WOMAC评分[用药后8周：15(13, 19) vs. 25(19, 33)，P＜0.001]、膝关节肿胀评分[用药后8周：1(1, 1) vs. 1(1, 2)，P＜0.001]和VAS评分[用药后8周：3(2，3) vs. 3(3，4)，P＜0.001]均显著低于对照组。观察组不良反应发生率低于对照组[9.3%(4/43) vs. 37.2%(16/43)，P=0.002]。结论塞来昔布联合地奥司明较单用塞来昔布能更有效地缓解中重度KOA的疼痛和肿胀，并降低不良反应发生率，具有较高的临床应用价值。
- 膝骨关节炎 /
- 塞来昔布 /
- 地奥司明 /
- 疗效
Abstract: Objective To evaluate the clinical efficacy and safety of celecoxib combined with diosmin in the treatment of moderate to severe knee osteoarthritis (KOA) and to explore an optimized therapeutic strategy. Methods This prospective randomized controlled study included 86 KOA patients admitted to the First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) from June to July 2024. Patients were assigned to the celecoxib group (control) or the celecoxib combined with diosmin group (observation) according to random number table method, with 43 cases in each group. The treatment duration was 8 weeks. The Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scores, knee joint swelling scores and visual analogue scale (VAS) scores of the two groups of patients before taking the medicine, at 4 and 8 weeks after taking the medicine, and at 4, 8 and 12 weeks after discontinuation of treatment were evaluated. The adverse reactions were recorded. Results At 4 and 8 weeks post-treatment and 4, 8, and 12 weeks after discontinuation, the observation group showed significantly lower WOMAC scores [8 weeks after taking the medicine: 15 (13, 19) vs. 25 (19, 33), P < 0.001], knee swelling scores [8 weeks after taking the medicine: 1 (1, 1) vs. 1 (1, 2), P < 0.001], and VAS scores [8 weeks after taking the medicine: 3 (2, 3) vs. 3 (3, 4), P < 0.001] compared to the control group. The incidence of adverse reactions was lower in the observation group than in the control group [9.3% (4/43) vs. 37.2% (16/43), P=0.002]. Conclusion The combination of celecoxib and diosmin provides superior efficacy in reducing pain and swelling in moderate to severe KOA compared to celecoxib alone, with a lower incidence of adverse events, making it a valuable clinical treatment option.
- Knee osteoarthritis /
- Diosmin /
- Celecoxib /
- Efficacy

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表 1 2组膝骨关节炎患者不同时间点WOMAC评分比较[M(P₂₅, P₇₅), 分]

Table 1. Comparison of WOMAC scores between the two groups of patients with knee osteoarthritis at different time [M(P₂₅, P₇₅), points]

组别	例数	用药前	用药后4周	用药后8周	停药后4周	停药后8周	停药后12周	Waldχ²值	P值
观察组	43	52(45, 67)	25(18, 32)^a	15(13, 19)^a	21(18, 27)^a	30(25, 35)^a	37(30, 40)^a	346.405	＜0.001
对照组	43	52(40, 68)	33(25, 38)^a	25(19, 33)^a	29(21, 37)^a	32(29, 37)^a	39(35, 45)^a	136.085	＜0.001
Waldχ²值		0.011	12.045	42.813	20.022	7.761	4.836
P值		0.916	0.001	＜0.001	＜0.001	0.005	0.028
注：P_交互=0.021；与本组用药前比较，^aP＜0.05。

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表 2 2组膝骨关节炎患者不同时间点膝关节肿胀评分比较[M(P₂₅, P₇₅), 分]

Table 2. Comparison of knee joint swelling scores between the two groups of patients with knee osteoarthritis at different time [M(P₂₅, P₇₅), points]

组别	例数	用药前	用药后4周	用药后8周	停药后4周	停药后8周	停药后12周	Waldχ²值	P值
观察组	43	3(3, 3)	2(2, 2)^a	1(1, 1)^a	1(1, 1)^a	2(2, 2)^a	2(2, 3)^a	1 563.793	＜0.001
对照组	43	3(3, 4)	2(2, 2)^a	1(1, 2)^a	1(1, 2)^a	2(2, 3)^a	3(2, 3)^a	366.546	＜0.001
Waldχ²值		0.245	10.314	12.243	15.249	15.130	6.667
P值		0.621	0.001	＜0.001	＜0.001	＜0.001	0.010
注：P_交互=0.042；与本组用药前比较，^aP＜0.05。

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表 3 2组膝骨关节炎患者不同时间点VAS评分比较[M(P₂₅, P₇₅), 分]

Table 3. Comparison of VAS scores between the two groups of patients with knee osteoarthritis at different time [M(P₂₅, P₇₅), points]

组别	例数	用药前	用药后4周	用药后8周	停药后4周	停药后8周	停药后12周	Waldχ²值	P值
观察组	43	7(5, 7)	4(4, 4)^a	3(2, 3)^a	4(2, 4)^a	5(4, 5)^a	5(5, 5)^a	826.113	＜0.001
对照组	43	7(6, 7)	4(4, 4)^a	3(3, 3)^a	4(4, 4)^a	5(5, 5)^a	5(5, 5)^a	4 600.185	＜0.001
Waldχ²值		0.066	10.994	17.022	35.871	19.161	9.617
P值		0.797	0.001	＜0.001	＜0.001	＜0.001	0.002
注：P_交互=0.003；与本组用药前比较，^aP＜0.05。

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表 4 2组膝骨关节炎患者不良反应发生率比较[例(%)]

Table 4. Comparison of the occurrence and incidence of adverse reactions between the two groups of patients with knee osteoarthritis [cases (%)]

组别	例数	胃肠道不适	头晕或乏力	心血管事件	总不良反应发生
对照组	43	10(23.2)	2(4.7)	4(9.0)	16(37.2)
观察组	43	2(4.7)	2(4.7)	0	4(9.3)
χ²值		6.198		2.360	9.382
P值		0.013		0.125	0.002

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