Ren Shuang, Meng Fanyan, Liu Yantong, Meng Yun, Tao Ning, Liu Ruoshi, Zhang Jie
Department of Traditional Chinese Medicine, The First Hospital of China Medical University, Shenyang, 110001, China.
Key Laboratory of Ministry of Education for TCM Viscera-State Theory and Applications, Ministry of Education of China (Province-Ministry Co-Construct), Shenyang, China.
Chin Med. 2020 Nov 7;15(1):117. doi: 10.1186/s13020-020-00398-8.
The use of anti-inflammatory and analgesic drugs such as nonsteroidal anti-inflammatory drugs(NSAIDs) for treating acute gout has limitations, such as adverse reactions in the gastrointestinal tract and toxicity in the liver, kidney, and heart. Hence, a new safe and effective treatment approach needs to be explored to reduce the use of anti-inflammatory and analgesic drugs, incidence of adverse reactions, and patients' burden. This randomized controlled clinical trial aimed to investigate the clinical efficacy and safety of the external application of compound Qingbi granules (CQBG) in treating acute gouty arthritis(AGA), providing evidence for designing a safe, effective, and optimized protocol for AGA comprehensive treatment.
A total of 90 patients in line with the diagnostic standard of AGA were recruited and randomly divided into control, T1, and T2 groups (30 in each group). All the participators in the three groups all received Western-medicine-basic treatment (low-purine diet, drinking water more than 2000 mL/days, oral loxoprofen, and NAHCO). Besides, the T1 group received an external application of diclofenac diethylamine emulgel, while the T2 group received an external application of CQBG. The participants in the control group received single-use Western-medicine-basic treatment. With a treatment course of 7 days and a follow-up of 7 days, the three groups were compared in terms of primary outcome indicators, including swelling, pain improvement, and change in pain duration and secondary outcome indicators, including serum C-reactive protein (CRP) level, uric acid (UA) level, and change in the thickness of the inflammatory synovium of joints under ultrasound. Meanwhile, the safety of the protocol was evaluated.
The three groups of patients had no apparent differences in age, body mass index, history of gout, complications, and so on before recruitment. A comparison between pretreatment and post-treatment revealed remarkable reductions in the arthralgia visual analog scale score(VAS) and the swelling score in the three groups after the treatment and the improvements in the T2 group were more significant than those in the T1 and control groups (P < 0.05). Regarding the onset time of pain improvement and pain duration, the T2 group had more significant efficacy compared with the other two groups (P < 0.05). The serum CRP and blood UA levels in the three groups significantly decreased after the treatment, but with no significant intergroup difference. The improvement in the thickness of the inflammatory synovium in joints tested by ultrasound was more significant in the T2 group than in the control group (P < 0.05). For safety evaluations, no significant difference in the incidence of adverse events was found.
The external application of CQBG combined with Western-medicine-basic treatment in patients with AGA improved arthralgia and swelling, shortened the period of taking NSAIDs, and reduced the levels of CRP and serum UA. Its therapeutic effect was significantly better than the effect of single-use Western-medicine-basic treatment. The study provided evidence for the clinical application of CQBG combined with Western medicine in treating AGA.
ChiCTR, ChiCTR1800018020. Registered 27 August 2018, https://www.chictr.org.cn/showproj.aspx?proj=27138.
使用非甾体抗炎药等抗炎镇痛药治疗急性痛风存在局限性，如胃肠道不良反应以及肝、肾、心脏毒性。因此，需要探索一种新的安全有效的治疗方法，以减少抗炎镇痛药的使用、不良反应的发生率和患者负担。本随机对照临床试验旨在研究复方青痹颗粒（CQBG）外用治疗急性痛风性关节炎（AGA）的临床疗效和安全性，为设计安全、有效、优化的AGA综合治疗方案提供依据。
共招募90例符合AGA诊断标准的患者，随机分为对照组、T1组和T2组（每组30例）。三组所有参与者均接受西药基础治疗（低嘌呤饮食，每日饮水超过2000 mL，口服洛索洛芬和碳酸氢钠）。此外，T1组外用双氯芬酸二乙胺乳胶剂，T2组外用CQBG。对照组仅接受西药基础治疗。治疗疗程为7天，随访7天，比较三组的主要结局指标，包括肿胀、疼痛改善情况以及疼痛持续时间变化，次要结局指标包括血清C反应蛋白（CRP）水平、尿酸（UA）水平以及超声检查下关节炎症滑膜厚度变化。同时评估方案的安全性。
三组患者入选前在年龄、体重指数、痛风病史、并发症等方面无明显差异。治疗前后比较，三组治疗后关节疼痛视觉模拟评分（VAS）和肿胀评分均显著降低，且T2组改善程度优于T1组和对照组（P < 0.05）。在疼痛改善起效时间和疼痛持续时间方面，T2组疗效优于其他两组（P < 0.05）。三组治疗后血清CRP和血尿酸水平均显著下降，但组间差异无统计学意义。超声检查显示，T2组关节炎症滑膜厚度改善程度优于对照组（P < 松0.05）。安全性评估方面，不良事件发生率无显著差异。
CQBG外用联合西药基础治疗AGA患者可改善关节疼痛和肿胀，缩短非甾体抗炎药服用时间，降低CRP和血清UA水平。其治疗效果明显优于单纯西药基础治疗。本研究为CQBG联合西药治疗AGA的临床应用提供了依据。
中国临床试验注册中心，ChiCTR1800018020。2018年8月27日注册，https://www.chictr.org.cn/showproj.aspx?proj=27138 。
