Department of Traditional Chinese Medicine, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China.
J Adv Nurs. 2020 Jun;76(6):1416-1424. doi: 10.1111/jan.14338. Epub 2020 Apr 14.
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 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.
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.
评估新癀片皮肤贴片治疗急性痛风性关节炎患者的疗效和安全性。
在中国，急性痛风性关节炎患者受益于中药皮肤贴片。但新癀片皮肤贴片的临床疗效鲜有报道。
随机、双盲、阳性药物对照试验。
该试验于 2015 年 1 月至 2018 年 12 月在中国中山大学附属第一医院进行，设 1 个干预组（新癀片皮肤贴片，N=30）和 1 个阳性药物对照组（双氯芬酸二乙胺乳胶剂皮肤贴片，N=31）。参与者和研究人员均对治疗分配情况设盲。主要结局为关节症状的改善。次要结局为白细胞、红细胞沉降率和 C 反应蛋白的变化。
新癀片皮肤贴片在治疗第 3 天即可迅速缓解关节疼痛，而只有在第 7 天，双氯芬酸二乙胺乳胶剂才明显降低关节疼痛。新癀片在改善关节肿胀和活动度以及降低 C 反应蛋白和红细胞沉降率水平方面也优于双氯芬酸二乙胺乳胶剂。新癀片皮肤贴片治疗未见不良反应。
新癀片皮肤贴片治疗急性痛风性关节炎缓解关节症状安全有效，其机制可能与降低 C 反应蛋白和红细胞沉降率水平有关。
新癀片皮肤贴片在改善关节疼痛、肿胀和活动度方面比双氯芬酸二乙胺乳胶剂更有效。新癀片在降低 C 反应蛋白和红细胞沉降率方面优于双氯芬酸二乙胺乳胶剂。急性痛风性关节炎患者可能受益于新癀片皮肤贴片，以有效缓解关节疼痛和肿胀。
ChiCTR-TRC-13004122。
