Predicting and verifying outcome of Tripterygium wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial.
Predicting and verifying outcome of Tripterygium wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial.
复制标题
预测和验证Tripterygium wilfordii钩子F.基于类风湿关节炎的疗法：从开放到双盲随机试验。
DOI：
10.1038/srep09700
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发表时间：
2015-04-15
影响因子：
4.6
通讯作者：
Lu A
中科院分区：
文献类型：
--
作者：
Jiang M;Zha Q;Zhang C;Lu C;Yan X;Zhu W;Liu W;Tu S;Hou L;Wang C;Zhang W;Liang Q;Fan B;Yu J;Zhang W;Liu X;Yang J;He X;Li L;Niu X;Liu Y;Guo H;He B;Zhang G;Bian Z;Lu A
基于雷公藤 (TwHF) 的疗法已被证明可有效治疗类风湿性关节炎 (RA)，但其反应的预测因素仍不清楚。设计了一项两阶段试验来识别和验证该疗法的基线症状预测因子。 167 名活动性 RA 患者入组接受为期 24 周的 TwHF 治疗，并在一项开放试验中确定了症状预测因子；然后在随机临床试验（RCT）中进行验证，入组218名RA患者，分为预测阳性（P+）和预测阴性（P−）组，并随机分配接受基于TwHF的治疗和甲氨蝶呤和柳氮磺吡啶联合治疗（M&S），疗程24周。确定了五个预测因子（利尿、多汗、盗汗为阳性；舌苔黄、关节热痛为阴性）。在RCT中，TwHF/P+组的ACR 20反应率为82.61%，显着高于TwHF/P−组（P = 0.0001）和M&S/P+组（P < 0.05），但不高于M&S/P−组。 ACR 50 中产生了类似的结果，但 ACR 70 响应中没有产生类似的结果。各组之间的安全性没有发现显着差异。确定的预测因子使基于 TwHF 的疗法能够更有效地治疗 RA 亚群。
Tripterygium wilfordii Hook F. (TwHF) based therapy has been proved as effective in treating rheumatoid arthritis (RA), yet the predictors to its response remains unclear. A two-stage trial was designed to identify and verify the baseline symptomatic predictors of this therapy. 167 patients with active RA were enrolled with a 24-week TwHF based therapy treatment and the symptomatic predictors were identified in an open trial; then in a randomized clinical trial (RCT) for verification, 218 RA patients were enrolled and classified into predictor positive (P+) and predictor negative (P−) group, and were randomly assigned to accept the TwHF based therapy and Methotrexate and Sulfasalazine combination therapy (M&S) for 24 weeks, respectively. Five predictors were identified (diuresis, excessive sweating, night sweats for positive; and yellow tongue-coating, thermalgia in the joints for negative). In the RCT, The ACR 20 responses were 82.61% in TwHF/P+ group, significantly higher than that in TwHF/P− group (P = 0.0001) and in M&S/P+ group (P < 0.05), but not higher than in M&S/P− group. Similar results were yielded in ACR 50 yet not in ACR 70 response. No significant differences were detected in safety profiles among groups. The identified predictors enable the TwHF based therapy more efficiently in treating RA subpopulations.
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影响因子：
6.1
作者：
Harnly JM;Harrington PB;Botros LL;Jablonski J;Chang C;Bergana MM;Wehling P;Downey G;Potts AR;Moore JC
通讯作者：
Moore JC
影响因子：
--
作者：
Hudler P;Kocevar N;Komel R
通讯作者：
Komel R
影响因子：
5.7
作者：
He, Yiting;Lu, Aiping;Tsang, Ian
通讯作者：
Tsang, Ian
影响因子：
2.9
作者：
Ito M;Ibi T;Sahashi K;Ichihara M;Ito M;Ohno K
通讯作者：
Ohno K
影响因子：
3.4
作者：
He, Yiting;Lu, Aiping;Lu, Cheng
通讯作者：
Lu, Cheng