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. Trial Registration ISRCTN34355813. Registered on 25/01/2021.
目的 探讨"六君子汤加味"健脾泄浊治疗脾虚湿阻型高尿酸血症的疗效.方法 将2018年8月~2020年1月共226例某院门诊收治的脾虚湿阻型高尿酸血症患者随机分为试验组(生活干预+常规西药治疗+口服中药颗粒"六君子汤加味",每日1剂,2次分服,n=111例)和对照组(生活干预+常规西药治疗,n=115例),治疗周期为12周,观察两组治疗前后中医临床症状、血尿酸、甘油三酯、血清炎症因子水平的变化,比较两组患者生活质量水平和痛风发生情况.结果 试验组总有效率明显高于对照组(81.08%vs.65.22%,P<0.01).治疗后两组血尿酸、甘油三酯、超敏C反应蛋白(hs-CRP)水平较治疗前均明显下降,差异有统计学意义(P<0.01),治疗后两组血尿酸、甘油三酯比较差异无统计学意义(P>0.05),但hs-CRP水平比较差异有统计学意义(P<0.05).试验组治疗后中医临床症状(脘腹痞闷、腹满、头身困重、口淡不渴、口腻、大便不爽)较治疗前明显下降,差异有统计学意义(P<0.01);对照组治疗后中医临床症状较治疗前均无明显下降,差异无统计学意义(P>0.05).治疗后两组中医临床症状改善差异有统计学意义(P<0.01).治疗后试验组患者生活质量综合问卷(GQOLI-74)各维度评分较对照组均明显升高,差异有统计学意义(P<0.05).治疗结束后1年内,试验组患者痛风发生率较对照组明显降低,差异有统计学意义(14.41%vs.40.87%,P<0.01).结论 "六君子汤加味"口服联合常规生活方式干预治疗可明显降低脾虚湿阻型高尿酸血症患者的血尿酸及甘油三酯水平,相比单纯生活方式干预其能进一步改善脾虚湿阻患者的中医临床症状和生活质量水平,同时降低患者血清炎症细胞因子水平,从而减少痛风的发生.
目的 探讨晚蚕沙外熨联合甲钴胺对寒凝血瘀型糖尿病周围神经病变患者临床疗效.方法 将2017年3月 ~2019年5月231例北京中医药大学房山医院门诊收治的寒凝血瘀型糖尿病周围神经病变患者随机分为实验组(甲钴胺500μg,3次/天,口服+晚蚕沙外熨肢体麻凉痛部位,n=121例)和对照组(甲钴胺500μg,3次/天,口服,n=110例),治疗周期为4周,观察两组治疗前后临床有效率、临床症状积分、肢运动神经传导速度(MNCV)以及感觉神经传导速度(SNCV)、多伦多(Toronto)临床神经病变评分的差异.结果 实验组总有效率明显高于对照组(P<0.05).治疗后两组临床症状积分及Toronto临床评分较治疗前均明显下降,MNCV与SNCV较治疗前均明显升高,差异有统计学意义(P<0.05);治疗后,实验组临床症状积分较对照组下降更加明显(P<0.05)、MNCV与SNCV较对照组提升更加明显(P<0.05).结论 晚蚕沙外熨联合甲钴胺口服可有效改善寒凝血瘀型糖尿病周围神经病变患者的临床症状及多伦多临床神经病变评分,较单纯甲钴胺口服临床疗效更好,值得临床推广.