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一项双盲、随机、安慰剂对照研究,旨在评估红霉素治疗骨性关节炎膝关节积液患者的疗效。

A double blind, randomized, placebo controlled study to evaluate the efficacy of erythromycin in patients with knee effusion due to osteoarthritis.

机构信息

Tabriz University (Medical Sciences), Tabriz, Iran.

出版信息

Int J Rheum Dis. 2009 Apr;12(1):44-51. doi: 10.1111/j.1756-185X.2009.01379.x.


DOI:10.1111/j.1756-185X.2009.01379.x
PMID:20374316
Abstract

OBJECTIVE: The efficacy of erythromycin in treatment of knee effusion due to osteoarthritis was evaluated. METHOD: We assessed efficacy and safety of erythromycin during 16 weeks in patients enrolled in a randomized double-blind study. One hundred and eight patients with knee effusion due to osteoarthritis (OA) received 12-week courses of erythromycin or placebo allocated randomly, and were followed for 4 months. Acetaminophen 650 mg/day was used in both groups, while they received no other anti-inflammatory drugs (such as corticosteroid or nonsteroidal anti-inflammatory drugs) during the course of the study. Our patients were divided in two groups, erythromycin in doses of 200 mg four times per day was given to the first group (51 patients) over the first 3 months of the study and in the second group we used placebo with the same dosage and schedule (53 patients). Outcomes improvement for the erythromycin-treated group was assessed by a significantly higher mean score from baseline to the end of the trial, compared with placebo group. Patients were examined monthly during the treatment period. Measurement values included recording of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire subscales (pain, stiffness and function), range of motion and knee circumference. RESULTS: Erythromycin produced a higher response rate than placebo in treatment of knee effusion due to OA. Significant reduction in knee circumference (P < 0.0005) and pain (P < 0.001) with functional improvement (P < 0.0005) were seen. At the first month after treatment, 11.8% (6 patients) in erythromycin and 9.4% (5 patients) in placebo groups had 50% pain reduction, which was not significant (P = 0.75). At the fourth month, 50% reduction of pain was seen in 45.1% (23 patients) of the erythromycin and 11.3% (6 patients) of the placebo group. This was statistically significant (P < 0.0005). Erythromycin treatment was well tolerated and mild adverse events caused no discontinuation during the study. CONCLUSION: This is a placebo-controlled study of macrolid efficacy on knee effusion due to OA in a short period. Results of this research showed the better efficacy of erythromycin in controlling effusion and pain with functional improvement in patients with knee effusion due to OA.

摘要

目的:评估红霉素治疗骨关节炎性膝关节积液的疗效。

方法:我们评估了在一项随机双盲研究中,108 例骨关节炎性膝关节积液患者接受为期 16 周的红霉素治疗的疗效和安全性。108 例患者随机接受为期 12 周的红霉素或安慰剂治疗,并随访 4 个月。两组患者均在研究过程中使用对乙酰氨基酚 650mg/天,而不使用其他抗炎药物(如皮质类固醇或非甾体抗炎药)。我们将患者分为两组,第一组(51 例)在研究的前 3 个月内每天给予 200mg 红霉素 4 次,第二组(53 例)给予相同剂量和方案的安慰剂。与安慰剂组相比,接受红霉素治疗的患者在试验结束时的平均评分从基线显著升高,表明改善程度更高。在治疗期间,患者每月接受检查。测量值包括记录西部安大略省和麦克马斯特大学骨关节炎指数(WOMAC)问卷子量表(疼痛、僵硬和功能)、活动范围和膝关节周长。

结果:红霉素治疗骨关节炎性膝关节积液的反应率高于安慰剂。膝关节周长(P < 0.0005)和疼痛(P < 0.001)显著减少,功能改善(P < 0.0005)。治疗后第 1 个月,红霉素组有 11.8%(6 例)和安慰剂组有 9.4%(5 例)的患者疼痛减轻 50%,但无显著差异(P = 0.75)。治疗后第 4 个月,红霉素组有 45.1%(23 例)和安慰剂组有 11.3%(6 例)的患者疼痛减轻 50%,差异具有统计学意义(P < 0.0005)。红霉素治疗耐受性良好,轻度不良反应在研究期间未导致停药。

结论:这是一项在短时间内评估大环内酯类药物对骨关节炎性膝关节积液疗效的安慰剂对照研究。该研究结果表明,红霉素在控制骨关节炎性膝关节积液和疼痛方面的疗效优于安慰剂,且能改善膝关节功能。

相似文献

[1]
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Int J Rheum Dis. 2009-4

[2]
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[3]
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[5]
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[6]
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[7]
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[8]
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[10]
A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee.

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[3]
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