金黄膏治疗肱骨外上髁炎的随机双盲对照研究

A randomized double-blind controlled study of Jinghuang Ointments in the treatment of external humeral epicondylitis

目的:观察金黄膏治疗肱骨外上髁炎的临床疗效。方法:将符合纳入标准的80例患者随机分成治疗组与对照组,每组各40例。治疗组给予金黄膏外敷,对照组使用安慰剂外敷,患肢均悬吊制动。两组疗程均为2周,按照治疗前、治疗1周后、治疗2周后的肘部SF-McGill量表评分及《中医病证诊断疗效标准》进行疗效的评估。结果:治疗前,治疗组与对照组SF-McGill量表评分相比差异无统计学意义(P>0.05);治疗1、2周后两组SF-McGill量表评分均呈下降趋势。重复测量资料的方差分析结果显示,不同时间的治疗效果差异有统计学意义(P<0.01),存在时间效应,SF-McGill量表评分随治疗时间延长呈下降趋势。药物与时间的交互作用差异有统计学意义(P<0.01)。治疗1周后及治疗2周后SF-McGill量表评分显示治疗组效果优于对照组,差异均有统计学意义(P<0.01)。治疗2周后,治疗组总有效率为90.00%,显著高于对照组的37.50%(P<0.01)。结论:金黄膏外敷治疗肱骨外上髁炎,能显著减轻患者肘部疼痛,改善关节活动,使用简单、经济安全、副作用小,值得在临床推广。

Objective: To observe the clinical effect of Jinghuang Ointments in the treatment of external humeral epicondylitis. Methods: 80 patients who met the inclusion criteria were randomized and divided into a treatment group and a control group, with 40 in each group. The treatment group was given external application of Jinghuang Ointments, and the control group was externally applied with placebo, both arms were suspended and fixed. Both groups were treated for 2 weeks. The efficacy was evaluated and judged according to the SF- McGill scale score of the elbow and the therapeutic standard of diagnosis and treatment of TCM syndrome before treatment, 1 week after treatment, and 2 weeks after treatment. Results: Before treatment, there was no significant difference in the SF- McGill scale between the treatment group and the control group ( P> 0.05). After 1 week of treatment and 2 weeks after treatment, the SF- McGill scale scores of both groups showed a downward trend. One week and 2 weeks after treatment, the SF- McGill scale was significantly different between the treatment group and the control group ( P< 0.01). After analysis of variance of repeated measures, the results showed that the treatment effect at different times was statistically significant ( P< 0.01). The SF- McGill scale score presented a time- dependent decreasing trend in the two groups. The interaction between drug and time was statistically significant ( P< 0.01). There was a statistically significant difference between the 1 week and 2 weeks after treatment ( P< 0.01). According to the SF- McGill scale score, the effect of Jinghuang Ointments was better than that of placebo, and the difference was statistically significant ( P< 0.01). The total effective rate of treatment group was 90%,while the control group was37.50%. The total effective rate of control group was significantly lower than that of the treatment group ( P< 0.01). Conclusion: External application of Jinghuang Ointments in the treatment of external humeral epicondylitis can significantly reduce pain and improve joint activity. It is worthy of clinical promotion because of its simple operation, low price, safety and little side effects.