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中华关节外科杂志(电子版)

中华关节外科杂志(电子版) ›› 2022, Vol. 16 ›› Issue (03) : 261 -266. doi: 10.3877/cma.j.issn.1674-134X.2022.03.001

临床论著

布洛芬联合体外冲击波治疗膝骨关节炎的随机对照研究
刘俊利1, 曾一平1, 崔京钦2, 金正2,†()   
  1. 1. 400038　重庆市人民医院/中国科学院大学重庆医院骨科
    2. 266100　青岛，解放军海军第九七一医院崂山医疗区
  • 收稿日期:2020-02-12 出版日期:2022-06-01
  • 通信作者: 金正
  • 基金资助:
    重庆市自然科学基金面上项目(cstc2021jcyj-msxmX0231)

Randomized controlled trial on combination of ibuprofen and extracorporeal shockwave therapy for knee osteoarthrits

Junli Liu1, Yiping Zeng1, Jingqing Cui2, Zheng Jin2,†()   

  1. 1. Department of Orthopedics, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing 400038, China
    2. Laoshan Hospital of PLA Naval 971 Hospital, Qingdao 266100, China
  • Received:2020-02-12 Published:2022-06-01
  • Corresponding author: Zheng Jin
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刘俊利, 曾一平, 崔京钦, 金正. 布洛芬联合体外冲击波治疗膝骨关节炎的随机对照研究[J]. 中华关节外科杂志(电子版), 2022, 16(03): 261-266.

Junli Liu, Yiping Zeng, Jingqing Cui, Zheng Jin. Randomized controlled trial on combination of ibuprofen and extracorporeal shockwave therapy for knee osteoarthrits[J]. Chinese Journal of Joint Surgery(Electronic Edition), 2022, 16(03): 261-266.

目的

探讨布洛芬缓释胶囊联合体外冲击波对膝关节骨关节炎的治疗效应。

方法

2018年9月至2019年9月，从重庆市人民医院纳入膝关节骨关节炎患者作为前瞻性随机对照临床研究。纳入标准：初治单侧膝关节骨关节炎；依从性良好者。排除标准：既往有其他膝关节疾患；膝关节强(僵)直；Kellgren-Lawrence分级为Ⅳ级的患者；对非甾体类抗炎药(NSAIDs)类药物禁忌或过敏的患者；合并其他内科系统疾病等。共198例患者通过随机数字表法分别分入联合组、布洛芬组、冲击波组。联合组给予布洛芬缓释胶囊联合体外冲击波治疗；布洛芬组给予单纯布洛芬缓释胶囊治疗；冲击波组给予单纯体外冲击波治疗，疗程5周。于治疗开始后8周时采用膝关节损伤和骨关节炎评分(KOOS)、加拿大西安大略和麦克玛斯特大学骨关节炎指数(WOMAC)及SF-12生活质量评分对三组患者进行评价，并记录三组患者并发症发生率。结果用单因素方差分析、LSD-t检验、配对t检验和卡方检验进行分析。

结果

布洛芬缓释胶囊联合体外冲击波治疗可显著改善骨关节炎患者膝关节KOOS、WOMAC及SF-12生活质量评分。联合组患者的疼痛(F＝174.5，P<0.001)、症状(F＝12.991，P<0.001)及功能评分(F＝6.009，P＝0.003)等显著改善，效应较单纯给予布洛芬缓释胶囊或体外冲击波治疗更佳。同时，并不明显增加治疗相关并发症的发生率(χ2＝2.479，P>0.05)。

结论

布洛芬缓释胶囊联合体外冲击波对骨关节炎具有良好的治疗效应，效果优于单用布洛芬缓释胶囊或冲击波治疗。

关键词: 布洛芬, 体外冲击波治疗, 膝, 骨关节炎
Objective

To evaluate the clinical results of combination of the ibuprofen sustained release capsules and extracorporeal shockwave therapy of knee osteoarthritis.

Methods

From September 2018 to September 2019 in Chongqing General Hospital, the patients with knee osteoarthritis were enrolled in this prospective, randomized and comparative clinical study. Inclusion criteria: initial treatment of unilateral knee osteoarthritis, good compliance. Exclusion criteria: previous knee disorders; arthroclisis (stiff) of knee; Kellgren-lawrence grade Ⅳ; the patients who were contraindicated or allergic to non-steroidal anti-inflammatory drug(NSAIDs) or complicated with other systematic diseases. One hundred and ninety-eight patients were randomized divided into the combination group, the ibuprofen group, and the shockwave group by the random number table. The combination group were treated with ibuprofen sustained release capsules and extracorporeal shockwave therapy; the ibuprofen group were treated with ibuprofen sustained release capsulesalone; the shockwave group were treated with extracorporeal shockwave therapy alone. The clinical results were evaluate by the knee injury and osteoarthritis outcome score (KOOS), Western Ontario and McMaster Universities osteoarthrtis index(WOMAC) and the 12-item short-form health survey (SF-12) at eight weeks following the treatment. The complications related to the treatment were also recorded. The results were analyzed by one-way analysis of variance, LSD-t test, paired-samples t test and chi square test.

Results

Ibuprofen sustained release capsules and extracorporeal shockwave therapy could significantly improve the KOOS, WOMAC and SF-12 quality of life scores. The pain (F=174.5, P<0.001), symptoms (F=12.991, P<0.001) and function scores (F=6.009, P=0.003) were significantly improved in the combination group, which were better than that of ibuprofen sustained release capsules or extracorporeal shockwave therapy only. The complications related to the treatment were not increased (χ2=2.479, P>0.05).

Conclusion

Ibuprofen sustained release capsules combined with extracorp oreal shockwave therapy has a good treatment effect for knee osteoarthritis, which is better than ibuprofen sustained release capsules or extracorporeal shockwave therapy alone.

Key words: Ibuprofen, Extracorporeal shockwave therapy, Knee, Osteoarthritis
图1 CONSORT(临床试验报告统一标准)流程图
表1 不同治疗组患者一般资料
组别 例数 性别(例) 年龄[岁，(±s) ] K-L分级(例) 身体质量指数[kg/m2，(±s)]
男 女 Ⅰ Ⅱ Ⅲ
联合组 66 28 38 49.7±10.8 12 13 10 26.8±3.9
Ⅰ/Ⅱ/Ⅲ]布洛芬组 66 24 42 53.1±9.8 25 27 31 25.6±3.5
冲击波组 66 22 44 52.4±10.2 29 26 25 26.2±4.0
统计值   χ2＝1.208 F＝1.962 χ2＝1.400 F＝1.613
P值   >0.05 >0.05 >0.05 >0.05
表2 不同治疗组KOOS评分(±s)
组别 例数 疼痛评分 症状评分 日常生活活动能力评分 运动及娱乐功能评分 膝关节相关生活质量评分
治疗前 末次随访 治疗前 末次随访 治疗前 末次随访 治疗前 末次随访 治疗前 末次随访
联合组 66 26.0±5.9 7.1±3.3ab 18.2±4.0 7.2±3.1ab 45.3±9.8 23.2±8.0ab 14.0±2.8 5.2±2.6ab 12.4±2.5 4.7±2.0ab
布洛芬组 66 26.4±6.1 8.8±6.3c 17.3±4.6 10.7±5.3 44.6±8.9 29.2±10.9 14.2±2.3 9.3±3.4 11.8±2.7 7.5±3.3
冲击波组 66 26.0±3.8 10.5±4.0 17.0±3.2 10.3±4.5 46.6±9.1 28.0±7.1 13.2±2.6 8.3±2.7 11.7±2.1 6.8±2.8
F值   2.440 174.5 1.777 12.991 0.789 8.666 2.422 34.412 1.386 17.893
P值   >0.05 <0.001 >0.05 <0.001 >0.05 <0.001 >0.05 <0.001 >0.05 <0.001
表3 不同治疗组WOMAC评分(±s)
组别 例数 疼痛评分 僵硬评分 功能评分
治疗前 末次随访 治疗前 末次随访 治疗前 末次随访
联合组 66 14.6±2.5 4.6±2.7ab 5.3±1.2 2.8±1.0ab 28.8±8.0 13.3±7.1ab
布洛芬组 66 14.8±2.8 5.7±2.8c 5.3±1.2 3.8±1.4c 28.0±8.2 15.9±6.8
冲击波组 66 14.7±2.8 6.8±2.7 5.4±1.3 3.3±1.0 28.3±7.9 17.2±5.0
F值   0.092 11.441 0.039 13.278 0.162 6.009
P值   >0.05 <0.001 >0.05 <0.001 >0.05 0.003
表4 不同治疗组SF-12生活质量评分(±s)
组别 例数 躯体健康评分 精神健康评分
治疗前 末次随访 治疗前 末次随访
联合组 66 13.7±2.6 21.8±2.7a 13.9±3.9 23.8±3.7ab
布洛芬组 66 13.9±3.3 19.5±3.2c 13.9±4.0 19.5±4.6c
冲击波组 66 13.7±3.6 20.9±3.0 13.5±4.4 21.8±5.2
F值   0.079 9.544 0.211 14.626
P值   >0.05 <0.001 >0.05 <0.001
表5 不同治疗组治疗期间并发症情况(例)
组别 例数 冲击波治疗相关并发症 口服NSAIDs类药物相关并发症 总并发症
联合组 66 5 7 12
布洛芬组 66 0 8 8
冲击波组 66 6 0 6
χ2值       2.479
P值       >0.05
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