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目的 :评价新药脑脉泰胶囊治疗中医辨证属于气虚血淤证和风痰淤血痹阻脉络证的脑血栓形成临床疗效。方法 :采用双盲双模拟平行随机分组将 5 36例脑血栓形成患者分为治疗组 2 14例 ,对照组 2 12例 ,治疗组给予脑脉泰胶囊Ⅰ号加安慰剂口服 ,对照组给予偏瘫复原丸加安慰剂口服 ;另设开放试验组 110例 ,给予脑脉泰胶囊Ⅰ号口服 ,疗程均为 2 8d。结果 :治疗组加开放试验组总显效率 34.88% (113/ 32 4 ) ,总有效率 83.95 %(2 72 / 32 4 ) ;中医证候疗效总显效率 5 5 .2 4 % (179/ 32 4 ) ,总有效率 88.2 7% (2 86 / 32 4 ) ,均明显优于对照组 (P <0 .0 1)。安全性检测表明脑脉泰胶囊对心、肝、肾及周围血象无毒副作用。结论 :脑脉泰胶囊是治疗脑血栓形成安全有效的药物
Objective: To evaluate the clinical efficacy of the new drug Naimai Tai Capsule in the treatment of cerebral thrombosis, which belongs to the syndrome of qi stagnation and blood stasis syndrome and phlegm and blood stasis syndrome. Methods: A total of 526 patients with cerebral thrombosis were divided into treatment group (n = 214) and control group (n = 12) by double-blind, double-dummy parallel randomized cohort.The patients in treatment group were treated with Naomaitai capsule I and placebo orally. Restoration pills and placebo were taken orally; another open test group was given 110 cases and given Naomaitai Capsule No. I orally for 28 days. Results: The total effective rate was 34.88% (113/32 4), the total effective rate was 83.95% (2 72/32 4) in the treatment group and the open trial group. The total effective rate of TCM syndromes was 54.24% (179/32) 4). The total effective rate was 88.27% (2 86/32 4), which was significantly better than that of the control group (P <0.01). Safety tests show that Naomaitai capsules on the heart, liver, kidney and peripheral blood no toxic side effects. Conclusion: Naomaitai Capsule is a safe and effective treatment for cerebral thrombosis