复方土茯苓口服液对发作间期及慢性痛风的降尿酸和减少关节炎复发作用：一项双盲、安慰剂对照、多中心随机试验
Hypouricemic and arthritis relapse-reducing effects of compound tufuling oral-liquid in intercritical and chronic gout: A double-blind, placebo-controlled, multicenter randomized trial.
作者信息
Xie Zhijun, Wu Huaxiang, Jing Xiaoqing, Li Xiuyang, Li Yasong, Han Yongmei, Gao Xiangfu, Tang Xiaopo, Sun Jing, Fan Yongshen, Wen Chengping
机构信息
College of Basic Medical Science, Zhejiang Chinese Medical University Department of Rheumatism, The Second Affiliated Hospital of Zhejiang University Medical College Department of Rheumatism, Zhejiang Hospital Department of Public Health, Medical College, Zhejiang University Department of Rheumatism, Zhejiang People's Hospital Department of Rheumatism, Sir Run Run Shaw Hospital of Zhejiang University Medical College Department of Rheumatism, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou Department of Rheumatism, Chinese Medical Academy Gate Hospital, Beijing Department of Rheumatism, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, P.R. China.
出版信息
Medicine (Baltimore). 2017 Mar;96(11):e6315. doi: 10.1097/MD.0000000000006315.
TRIAL DESIGN
In the double-blind, randomized, controlled trial, we aimed to evaluate the effects of compound tufuling oral liquid (CoTOL) on serum uric acid (sUA) levels and recurrence of acute gouty arthritis in intercritical and chronic gout treatment.
METHODS
A total of 210 patients with gout were screened from 8 hospitals to observe the sUA and acute gouty arthritis recurrence rate-reducing effects of CoTOL in intercritical and chronic gout during a 12-week treatment. We treated 139 and 71 patients with CoTOL and the placebo, respectively, and evaluated their sUA levels, acute gouty arthritis recurrence rate, and adverse events at week 0, 6, and 12.
RESULTS
Twenty-five and 12 patients in the treatment and control groups, respectively, had interrupted treatments, whereas 114 and 59 cases, respectively, completed their treatments. At the end of the 12-week treatment, the average decrease in sUA was 74.26 (95% confidence interval [CI]: 56.74-91.77 μmol/L) and 28.81 μmol/L (95% CI: 4.91-52.71 μmol/L) in the treatment and control groups, respectively (P = 0.004). The average decrease rate of sUA was 12.76% (95% CI: 9.82%-15.70%) and 4.57% (95% CI: 0.42%-8.71%) in the treatment and control groups, respectively (P = 0.004), and the gouty arthritis recurrence rate of the treatment group was lower than that of the control group (from week 6 to 12, 21.93% and 50.88% in the treatment and control group, respectively, P < 0.001; from baseline to week 12, 38.5% and 63.16%, respectively, P = 0.003). Severe adverse events were not observed in either groups, and fewer leucopenia incidences were observed in the treatment group than those in the control group (3/139 vs. 7/71, respectively, P = 0.033).
CONCLUSION
CoTOL reduced sUA levels and effectively prevented acute arthritis recurrence in intercritical and chronic gout without serious adverse events.
试验设计
在这项双盲、随机、对照试验中，我们旨在评估复方土茯苓口服液（CoTOL）在痛风间歇期和慢性期治疗中对血清尿酸（sUA）水平及急性痛风性关节炎复发的影响。
方法
从8家医院筛选出210例痛风患者，观察CoTOL在12周治疗期间对痛风间歇期和慢性期患者sUA及急性痛风性关节炎复发率的降低作用。我们分别用CoTOL和安慰剂治疗139例和71例患者，并在第0、6和12周评估他们的sUA水平、急性痛风性关节炎复发率及不良事件。
结果
治疗组和对照组分别有25例和12例患者中断治疗，而分别有114例和59例完成治疗。在12周治疗结束时，治疗组和对照组的sUA平均下降值分别为74.26（95%置信区间[CI]：56.74 - 91.77μmol/L）和28.81μmol/L（95% CI：4.91 - 52.71μmol/L）（P = 0.004）。治疗组和对照组的sUA平均下降率分别为12.76%（95% CI：9.82% - 15.70%）和4.57%（95% CI：0.42% - 8.71%）（P = 0.004），且治疗组痛风性关节炎复发率低于对照组（从第6周到12周，治疗组和对照组分别为21.93%和50.88%，P < 0.001；从基线到第12周，分别为38.5%和63.16%，P = 0.003）。两组均未观察到严重不良事件，且治疗组白细胞减少的发生率低于对照组（分别为3/139和7/71，P = 0.033）。
结论
CoTOL可降低sUA水平，并有效预防痛风间歇期和慢性期急性关节炎复发，且无严重不良事件。
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