背景:本研究旨在评估青鹏软膏(QPO)的疗效和安全性,一种用于缓解急性痛风性关节炎(AGA)患者症状的藏药。
方法:这项研究是一项随机的,双盲,安慰剂对照试验涉及关节疼痛的AGA患者,在视觉模拟量表(VAS)从0到10测量,等于或大于3。参与者被随机分配到QPO或安慰剂组,并连续七天每天两次接受各自的治疗。如果疼痛无法忍受,参与者被允许使用双氯芬酸钠缓释片作为抢救药物.测量的主要结果是关节疼痛和肿胀,次要结果包括联合行动,发红,血清尿酸水平,C反应蛋白水平,以及剩余的救援药物的数量。还记录试验期间发生的任何不良事件。
结果:共203例,分为两组,基线平衡:QPO组102,安慰剂组101。对于关节痛,两组之间的VAS评分[1.75(0,3.00)对2.00(1.00,3.50);P=0.038],VAS的变化[5.00(3.00,6.00)对4.00(2.00,6.00);P=0.036],治疗后消失率[26.47%比15.84%;P=0.046]。关于关节肿胀,治疗完成时,两组间的VAS评分[1.00(0,2.30)对2.00(0.70,3.00);P=0.032]和消失率[33.33%对21.78%;P=0.046]差异显著.与安慰剂组相比,QPO组表现出统计学上显著的移动性改善(P=0.004)。在其他次要结果中没有发现显着差异。五个病人,四个来自QPO小组,一个来自另一个,遇到轻度不良事件,主要是皮肤刺激。所有这些病例在剂量减少或停药后都得到解决。
结论:与安慰剂相比,QPO通过减轻疼痛对AGA表现出积极作用,减少肿胀,增强关节的机动性,不会造成明显的不良影响。
背景:ISRCTN34355813。于2021年1月25日注册。
BACKGROUND: This study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA).
METHODS: This study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded.
RESULTS: A total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group (P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication.
CONCLUSIONS: Compared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects.
BACKGROUND: ISRCTN34355813. Registered on 25/01/2021.