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中药低频超声透入疗法与双氯芬酸钠治疗膝骨关节炎的疗效比较:一项双盲、随机、安慰剂对照临床试验

Therapeutic effects of low-frequency phonophoresis with a Chinese herbal medicine versus sodium diclofenac for treatment of knee osteoarthritis: a double-blind, randomized, placebo-controlled clinical trial.

作者信息

Zhao Jun, Wang Qingfu, Wu Ji, Shi Xinchao, Qi Qingxue, Zheng Haoyun, Lang Song, Yang Lili, Zhang Dong

出版信息

J Tradit Chin Med. 2016 Oct;36(5):613-7. doi: 10.1016/s0254-6272(16)30080-2.

DOI:10.1016/s0254-6272(16)30080-2
PMID:29933529
Abstract

OBJECTIVE

To evaluate the therapeutic effects of low-frequency phonophoresis with a Chinese herbal medicine (CHM) compared with sodium diclofenac (SD) for knee osteoarthritis (KOA).

METHODS

In this double-blind, randomized, placebo-controlled trial, 100 KOA patients were assigned randomly to a placebo group, a CHM group, or SD group. Low-frequency phonophoresis was used to improve the efficiency of drug delivery. Pain at rest [using a visual analog scale (VAS)], pain on movement (VAS), and range of motion (degrees) in the three groups were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMACAI) scores. Safety assessments comprised emergency adverse events, as well as laboratory tests of blood biochemistry, creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase.

RESULTS

Significant improvements were found after treatment in all outcome measures except stiffness and range of motion in patients in the CHMP group and SDP group (P < 0.05). No significant differences in all outcome measures were found between the CHMP group and SDP group.

CONCLUSION

CHMP and SDP can show good therapeutic effects for KOA in terms of relieving pain and improving physical function.

摘要

目的

评估中药低频超声药物透入疗法与双氯芬酸钠(SD)治疗膝骨关节炎(KOA)的疗效。

方法

在这项双盲、随机、安慰剂对照试验中,100例KOA患者被随机分配到安慰剂组、中药组或SD组。采用低频超声药物透入疗法提高药物递送效率。使用西安大略和麦克马斯特大学骨关节炎指数(WOMACAI)评分评估三组患者的静息痛[采用视觉模拟量表(VAS)]、运动痛(VAS)和活动范围(度数)。安全性评估包括紧急不良事件以及血液生化、肌酐、血尿素氮、丙氨酸氨基转移酶和天冬氨酸氨基转移酶的实验室检查。

结果

中药组(CHMP)和双氯芬酸钠组(SDP)患者除僵硬和活动范围外,所有结局指标在治疗后均有显著改善(P<0.05)。CHMP组和SDP组在所有结局指标上均未发现显著差异。

结论

CHMP和SDP在缓解疼痛和改善身体功能方面对KOA均显示出良好的治疗效果。

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