秦皮总香豆素对原发性急性痛风性关节炎止痛效应的探索性临床试验

Explorative clinical trial on effect of relieving pain in treatment of patients with primary acute gouty arthritis by cortex fraxini total coumarin

目的:评价秦皮总香豆素制剂对急性痛风性关节炎湿热阻络证的止痛效应。方法:采用随机、双盲、安慰剂平行组对照、剂量 反应研究设计和优效性检验。观察急性痛风性关节炎湿热阻络证共10 9例,其中低剂量组36例,高剂量组36例,对照组37例。结果:秦皮总香豆素治疗5d后,患者对关节疼痛记分改善程度的评价,以及医生对关节压痛程度改善的评价均优于安慰剂,呈现一定的剂量 效应关系;但关节疼痛消失率及关节压痛消失率与安慰剂组的差别没有统计学意义。结论:秦皮总香豆素对急性痛风性关节炎有一定的止痛效应。

AIM: To evaluate the effect of cortex fraxini total coumarin on relieving pain in treatment of patients with primary acute gouty arthritis which belongs to the sign of dampness obstructing connecting vessel of TCM. METHODS: Cortex fraxini total coumarin was involved in a randomized, double-blind, placebo parallel control, dosage-reaction design and superiority test. The total case number of observed primary acute gouty arthritis with the sign of dampness obstructing connecting vessel was 109, which included 36 cases of low-dosage group, 36 cases of high-dosage group, and 37 cases of control group. RESULTS: After 5 day-treatment of cortex fraxini total coumarin, both the evaluation of patients on the improvement of joint pain grades and the appraisement of physicians on relieving joint tenderness were superior to those in the placebo group, and they were in a dosage-related manner. But the disappearance rate of joint pain and joint tenderness had no difference between two groups. CONCLUSION: Cortex fraxini total coumarin has somewhat pain relieving effect on acute gouty arthritis.