Department of General Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
J Cardiovasc Pharmacol. 2012 Mar;59(3):215-21. doi: 10.1097/FJC.0b013e31823c0bed.
Medicinal treatment of vasospastic Raynaud phenomenon is limited to primarily vasodilator medicines.
To explore the possible beneficial effects and tolerability of 120 mg two times a day of Ginkgo Biloba special extract EGb 761 in patients suffering from Raynaud disease (RD) (primary Raynaud phenomenon).
In a placebo-controlled, double-blind, pilot study, 41 patients with RD were randomized to either the active treatment group (EGb 761, n = 21) or placebo group for 10 weeks, after an initial 2-week run-in phase. The primary efficacy variables were self-reported changes of the frequency, duration, and severity of vasospastic attacks between the placebo-controlled run-in phase and the end of the study.
Most of the patients were female, and both groups were perfectly matched with respect to demographic characteristics. The frequency of daily attacks reduced from 3.6 ± 2.3 to 2.4 ± 2.6 (-33%) in the EGb 761 group and from 2.9 ± 2.0 to 2.0 ± 1.8 (-31%) in the placebo group with no significant difference according to the ordinary least squares test (P = 0.3564). Furthermore, no significant differences were found with respect to the duration and severity of vasospastic attacks between the EGb 761 and placebo groups (P = 0.4392 and P = 0.7187, respectively). In all, 17 adverse events (AEs) were reported, 6 AEs from 5 patients in the EGb 761 group and 11 AEs from 8 patients in the placebo group. Serious AEs did not occur.
EGb 761 treatment showed an excellent safety profile in patients with RD but could not demonstrate a statistically significant reduction in clinically relevant symptoms compared with placebo.
治疗血管痉挛性雷诺现象的药物治疗仅限于主要的血管扩张药。
探讨银杏叶提取物 EGb 761 每天两次 120mg 对雷诺病（RD）（原发性雷诺现象）患者的可能有益效果和耐受性。
在一项安慰剂对照、双盲、初步研究中，41 例 RD 患者随机分为活性治疗组（EGb 761，n=21）或安慰剂组，进行 10 周治疗，在初始的 2 周导入期后。主要疗效变量为自报的血管痉挛发作频率、持续时间和严重程度在安慰剂对照导入期和研究结束之间的变化。
大多数患者为女性，两组在人口统计学特征方面完全匹配。EGb 761 组的每日发作频率从 3.6±2.3 减少到 2.4±2.6（减少 33%），安慰剂组从 2.9±2.0 减少到 2.0±1.8（减少 31%），根据普通最小二乘法检验无显著差异（P=0.3564）。此外，EGb 761 和安慰剂组之间的血管痉挛发作的持续时间和严重程度也没有显著差异（P=0.4392 和 P=0.7187）。共有 17 例不良事件（AE）报告，EGb 761 组有 5 例患者发生 6 例 AE，安慰剂组有 8 例患者发生 11 例 AE。未发生严重不良事件。
EGb 761 治疗 RD 患者具有良好的安全性，但与安慰剂相比，不能显示出在临床上相关症状方面的统计学显著减少。
