Efficacy and safety of the compound Chinese medicine SaiLuoTong in vascular dementia: A randomized clinical trial.
Efficacy and safety of the compound Chinese medicine SaiLuoTong in vascular dementia: A randomized clinical trial.
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中药复方赛络通治疗血管性痴呆的疗效和安全性随机临床试验
DOI：
10.1016/j.trci.2018.02.004
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Gauthier S
中科院分区：
文献类型：
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作者：
Jia J;Wei C;Chen S;Li F;Tang Y;Qin W;Shi L;Gong M;Xu H;Li F;He J;Song H;Yang S;Zhou A;Wang F;Zuo X;Chu C;Liang J;Jia L;Gauthier S
目前还没有获得许可的药物可用于治疗血管性痴呆（VaD）。患者被随机分配到实验组（A组和B组分别给予赛罗通360 mg或240 mg，持续52周）或安慰剂组（C组仅给予赛罗通360 mg和240 mg，分别从第27周至第52周）。325例患者纳入最终分析。第26周时，A组与C组的VaD评估量表-认知子量表评分的差异为2.67（95%置信区间，1.54 - 3.81），B组与C组的差异为2.48（1.34 - 3.62）（均P <0.0001）。然而，在第52周时，在VaD评估量表-认知子量表（P = .062）上未观察到组间差异，因为从第27周开始，安慰剂组中出现了新的疗效。本研究提示，复方丹参对VaD有较好的治疗作用，是治疗VaD的较好选择。
No licensed medications are available to treat vascular dementia (VaD). Patients were randomly assigned to experimental groups (SaiLuoTong [SLT] 360 or 240 mg for groups A and B for 52 weeks, respectively) or placebo group (SLT 360 mg and 240 mg for group C only from weeks 27 to 52, respectively). Three hundred twenty-five patients were included in final analysis. At week 26, the difference in VaD Assessment Scale–cognitive subscale scores was 2.67 (95% confidence interval, 1.54 to 3.81) for groups A versus C, and 2.48 (1.34 to 3.62) for groups B versus C (both P < .0001). However, at week 52, no difference was observed among the groups on the VaD Assessment Scale–cognitive subscale (P = .062) because of the emerging efficacy of SLT in placebo beginning at week 27. This study suggests that SLT is effective for treatment of VaD, and this compound Chinese medicine may represent a better choice to treat VaD.