Zhongguo cuzhong zazhi (Sep 2022)
心血宁胶囊对伴高同型半胱氨酸水平缺血性卒中患者短期功能预后的影响 Effect of Xinxuening Capsule on Short-term Functional Outcome in Patients with Ischemic Stroke and High Homocysteine Level
Abstract
目的 分析心血宁胶囊改善伴有高Hcy水平（＞15 μmol/L）的缺血性卒中患者短期功能预后的效果。 方法 选取心血宁胶囊用于缺血性卒中伴高Hcy水平患者的有效性和安全性研究（研究周期2018年10月30日-2019年12月27日）中完成3个月药物治疗及随访的患者作为研究对象。根据研究用药的不同，将患者随机分成心血宁组（给予心血宁胶囊0.4克/粒、2粒/次、3次/日，叶酸片模拟剂2片/次、1次/日）、叶酸组（给予心血宁胶囊模拟剂2粒/次、3次/日，叶酸片0.4毫克/片、2片/次、1次/日）和安慰剂组（给予心血宁胶囊模拟剂2粒/次、3次/日，叶酸片模拟剂2片/次、1次/日），连续用药3个月。采用χ2趋势检验比较患者治疗3个月时mRS评分的变化情况。 结果 本研究纳入238例患者，平均年龄为64.49±12.48岁。其中，心血宁组患者79例，叶酸组患者86例，安慰剂组患者73例。治疗3个月时，心血宁组mRS 0～1分的比例为91.14%（72/79），叶酸组为80.23%（69/86），安慰剂组为80.82%（59/73）。趋势检验结果显示，叶酸组与安慰剂组相比mRS评分没有趋势关系（P=0.89），心血宁组与安慰剂组相比mRS评分有下降趋势（P=0.04），心血宁组与叶酸组相比mRS评分有下降趋势（P=0.03）。 结论 对于伴有高Hcy水平的缺血性卒中患者，使用心血宁胶囊治疗可能改善患者3个月功能预后。 Abstract: Objective To investigate the effect of xinxuening capsule on short-term functional outcome among patients with ischemic stroke and high homocysteine level (>15 μmol/L). Methods This study included the patients who were treated with drugs and followed up for 3 months from the “Efficacy and safety of xinxuening capsule in the treatment of patients with ischemic stroke and high homocysteine level: a randomized, double-blind, controlled clinical trial (from October 30, 2018 to December 27, 2019)”. The patients were divided into 3 groups according to the taking medications: xinxuening group (xinxuening capsule 0.4 g/capsule, 2 capsules/time, 3 times/d, folic acid tablet analog agent 2 tablets/time, 1 time/d), folic acid group (xinxuening capsule analog agent 2 capsules/time, 3 times/d, folic acid tablet 0.4 mg/tablet, 2 tablets/time, 1 time/d), and placebo group (xinxuening capsule analog agent 2 capsules/time, 3 times/day, folic acid tablet analog agent 2 tablets/time, 1 time/d). The patients taken the medications continuously for 3 months. The chi-squared trend test was used to evaluate the 90-day functional outcome (mRS) of the three groups. Results A total of 238 patients were included in this study, with a mean age of 64.49±12.48 years. Among them, there were 79 patients in xinxuening group, 86 patients in folic acid group, and 73 patients in placebo group. The proportion of patients with a mRS of 0-1 at 90 days was 91.14% (72/79) in xinxuening group, 80.23% (69/86) in folic acid group, and 80.82% (59/73) in placebo group. There was no significant trend in mRS between folic acid group and placebo group (P=0.89), while a decreased trend was observed in xinxuening group compared to placebo group (P=0.04), and also a decreased trend in xinxuening group compared to folic acid group (P=0.03). Conclusions Xinxuening capsule could improve 90-day functional outcome among patients with ischemic stroke and high homocysteine level.
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