脑心多泰胶囊治疗缺血性中风恢复期肝阳上亢、瘀血阻络证临床研究

[目的]评价脑心多泰胶囊治疗缺血性中风恢复期肝阳上亢、瘀血阻络证的有效性和安全性,并探索量效关系。[方法]随机双盲、单模拟、带有基础治疗的安慰剂(零剂量)阴性平行对照、多中心临床研究。[结果]脑心多泰胶囊高、低剂量组对中风患者的神经功能缺损疗效、中医证候疗效及患者病残程度、Barthel指数均有明显改善,两组与安慰剂对照有显著差异,试验中高低剂量组均未发现有不良反应。[结论]脑心多泰胶囊对治疗缺血性中风恢复期肝阳上亢、瘀血阻络证确有较好疗效,使用安全。推荐临床剂量为60mg/d。

Effect of Naoxin Duotai capsule in treating syndrome of excessive rising of liver-yang and obstruction of collaterals with blood stasis in the recovery stage of Ischemia Stroke

[Objective] To evaluate the effectiveness and safety of Naoxin(brain and heart) Duotai capsule(NXDT) in treating the syndrome of excessive rising of liver-yang and obstruction of collaterals with blood stasis in the recovery stage of ischemia stroke and explore the dose-effect relationship. [Methods] A multiple-center research of randomly and double-blind design, single simulation, negative control of basic treatment with placebo(zero dose) was carried out. [Results] The high and low dosage of NXDT may obviously improve the neurologic impairment, TCM syndrome and Barthel indexes. The adverse effect wasn't existed in the high and low dosage of NXDT group. [Conclusions] The Naoxin Duotai capsule has a better safety and curative effect in treating the syndrome of excessive rising of liver-yang and obstruction of collaterals with blood stasis in patients with ischemia stroke in recovery stage. The recommended clinical dosage is 60 mg daily.