银杏二萜内酯葡胺注射液治疗动脉粥样硬化性血栓性脑梗死恢复期(痰瘀阻络证)Ⅲ期临床试验

Phase Ⅲ clinical trial of Diterpene Ginkgolides Meglumine Injection for syndrome of stagnant phlegm blocking collaterals in convalescence of atherosclerotic thrombotic cerebral infarction

目的 确证评价银杏二萜内酯葡胺注射液治疗卒中恢复期之痰瘀阻络证的有效性与安全性，尤其是改善语言、运动功能的临床疗效。方法 采用分层区组随机（416例动脉粥样硬化性血栓性脑梗死患者按3∶1随机分为试验组和对照组）、盲法、舒血宁注射液阳性药平行对照、多中心临床研究的试验方法。银杏二萜内酯葡胺注射液25 mg（5 mL/支），或舒血宁注射液1支（5 mL），均加于生理盐水250 mL中静脉滴注，1次/d。首次滴注时控制滴速10～15滴/min。疗程为14 d。结果 试验组与对照组治疗前后神经功能缺损程度总评分减少率的变化两组间比较差异有统计学意义（P＝0.000 1），试验组优于对照组。两组患者生活能力状态评分变化组间比较差异无统计学意义。脑梗综合疗效，试验组总有效率85.39%，对照组总有效率73.27%，两组比较差异有统计学意义（P＝0.000 1）。中医证候疗效，试验组总有效率62.99%、对照组40.59%，两组比较差异有统计学意义（P＝0.000 1）。单项神经功能指标肩臂运动、手运动、下肢运动、步行能力及中医证候上肢不遂、下肢不遂、口舌喎斜、言謇或失语、感觉减退或缺失、头晕目眩、痰多而黏及异常舌脉差异有统计学意义，试验组均优于对照组。结论 银杏二萜内酯葡胺注射液对动脉粥样硬化性血栓性脑梗死恢复期痰瘀阻络证的治疗安全、有效。同时提示银杏二萜内酯葡胺注射液在改善卒中神经功能缺损总评分、神经功能指标、中医证候总积分及上肢不遂、口舌喎斜、头晕目眩、痰多而黏、苔白腻、脉弦滑等指标，具有一定的优势。

Objective To evaluate the efficacy and safety of Diterpene Ginkgolides Meglumine Injection （DGMI） in the treatment of recovered stroke with syndrome of stagnant phlegm blocking collaterals, especially the clinical efficacy in improving the function of language and movements. Methods The clinical trial was carried out by the methods of stratification and randomization （416 cases of patients with atherosclerotic thrombotic cerebral infarction （ATCI） were randomly divided into experimental and control groups by the ratio of 3：1）, blindness, and positive parallel control of Shuxuening Injection （SI）, and multi-center clinical study. DGMI （25 mg, 5 mL/amp） or SI （5 mL/amp） was diluted into 250 mL physiological saline, iv drip, once daily for 14 d. The dropping speed must be controlled as 10—15 drops/min for the first infusion. Results There was statistical difference （P = 0.000 1） for the variations of inducing rate of the defect extent of nervous functions before and after the treatment in the experimental and control groups. The experimental group was superior to the control group. There was no statistical difference for the variation of scales of the patient living ability in the two groups （P 〉 0.05）. For the comprehensive efficacy of cerebral infarction, the total effective rates were 85.39% and 73.27% in the experimental and control groups, respectively, with statistical difference （P = 0.000 1）. For the efficacy of syndrome of traditional Chinese medicine （TCM）, the total effective rates were 62.99% and 40.59% in the experimental and control groups, respectively, with the statistical difference （P = 0.000 1）. For the single indicator of nervous functions, such as arm movements, hand movements, extremity movements ,walking, as well as the syndromes of TCM, such as upper limb disable, lower limb disable, deviated tongue, aphasia, abate or deficiency of feeling, dizziness, more and turbid phlegm, abnormal tongue and pulse manifestation, the experimental group was superior to the control group with statistified difference. Conclusion It is safe and effective for DGMI in the treatment of the syndrome of stagnant phlegm blocking collaterals in convalescence of ATCI. Meanwhile, it is also manifested that DGMI has the certain superiorities in the fields, such as improving the total score of nervous function deficiency for the patients with stroke, the nervous function, the total score of TCM syndromes, including upper limb disable, deviated tongue, dizziness, more and turbid phlegm, white coat of tongue, abnormal pulse, etc.