To evaluate the effectiveness and safety of Xin Huang Pian skin patches for patients with acute gouty arthritis.
In China, patients with acute gouty arthritis benefit from skin patcheses with herbal medicines. But the clinical effects of skin patches with Xin Huang Pian are rarely reported.
A Randomized, Double-Blind, Active-Controlled Trial.
The trial was performed from January 2015-December 2018 at the First Affiliated Hospital of Sun Yat-sen University in China. It was conducted with one intervention group (skin patches of Xin Huang Pian, N = 30) and one active control group (skin patches of Diclofenac Diethylamine Emulgel, N = 31). Participants and study investigators were both blinded to the treatment assignments. The primary outcomes were the improvement of joints' symptoms. The secondary outcomes were changes in white blood cells, erythrocyte sedimentation rate and C-reactive protein.
Skin patches of Xin Huang Pian showed quick effect on decreasing joint pain at 3rd day of treatment. Wherever only at 7th day, Diclofenac Diethylamine Emulgel markedly lowered joint pain. Xin Huang Pian also showed superior effect than Diclofenac Diethylamine Emulgel on improving joint swelling and range of motion and decreasing the levels of C-reactive protein and erythrocyte sedimentation rate. No adverse reactions were observed in skin patches of Xin Huang Pian treatment.
Skin-patcheses with Xin Huang Pian are more effective than Diclofenac Diethylamine Emulgel on improving joint pain, swelling and range of motion. Xin Huang Pian treatment showed superior effects compared with Diclofenac Diethylamine Emulgel on decreasing levels of C-reactive protein and erythrocyte sedimentation rate. Patients with acute gouty arthritis may benefit from skin patches of Xin Huang Pian for effective relief from joint pain and swelling. Chinese Clinical Trial Registration: ChiCTR-TRC-1300 4122.
目的: 评估新癀片贴剂治疗急性痛风性关节炎的有效性和安全性。 背景: 在中国,患有急性痛风性关节炎的患者可使用草药药贴。但关于新癀片贴剂临床疗效的报道较少。 设计: 随机、双盲、阳性对照试验。 方法: 于2015年1月至2018年12月在中国中山大学附属第一医院开展此项试验。该试验分为干预组1例(新癀片贴剂,N=30)和阳性对照组1例(双氯芬酸二乙胺乳胶剂贴剂,N=31)。在治疗任务中,随机分配受试者和研究人员。主要研究结果是发现关节症状得到改善,其次是白细胞、红细胞沉降率和C反应蛋白的变化。 结果: 治疗第3天,新癀片贴剂对缓解关节疼痛有明显疗效。而双氯芬酸二乙胺乳胶剂贴剂仅在治疗第7天发现对缓解关节疼痛有明显疗效。在改善关节肿胀和活动度以及降低C反应蛋白水平和红细胞沉降率方面,新癀片疗效优于双氯芬酸二乙胺乳胶剂。使用新癀片贴剂未见不良反应。 结论: 新癀片贴剂在治疗急性痛风性关节炎方面安全有效,其作用机制可能与C反应蛋白水平和红细胞沉降率降低有关。 影响: 在改善关节疼痛、肿胀和活动度方面,新癀片疗效优于双氯芬酸二乙胺乳胶剂。与双氯芬酸二乙胺乳胶剂相比,新癀片在降低C反应蛋白水平和红细胞沉降率方面的作用更为明显。急性痛风性关节炎患者可使用新癀片贴剂有效缓解关节疼痛和肿胀。 中国临床试验注册中心: ChiCTR-TRC-1300 4122.
Skin patches of Xin Huang Pian appeared to be safe and efficacious for relieving joint symptoms in patients with acute gouty arthritis. The mechanism might be associated with the decreased levels of C-reactive protein and erythrocyte sedimentation rate.