摘要
目的探讨舒洛地特治疗高危动脉粥样硬化性脑卒中的早期疗效及安全性。方法采用前瞻性研究。纳入2020年9月至2023年9月芜湖市第一人民医院收治的高危动脉粥样硬化性脑卒中患者150例,采用随机数字表法分为治疗组(76例)和对照组(74例)。对照组患者按照现行指南接受危险因素控制、抗血小板聚集、降脂、血压和血糖管理及康复等标准治疗。治疗组在对照组标准治疗的基础上加用舒洛地特注射液,600 LSU/d,静脉注射15 d。所有患者在随访结束时继续接受标准治疗方案。对比对照组和治疗组患者出院及发病90 d时神经功能评分[包括美国国立卫生研究院卒中量表(NIHSS)评分和改良Rankin量表(mRS)评分],出院时早期卒中进展率、早期神经功能恶化率,发病90 d良好预后率、卒中复发率、血管狭窄率、出血事件发生率及全因死亡率。结果治疗组患者出院时NIHSS评分及mRS评分[(2.97±2.25)分、(1.69±1.07)分]均低于对照组[(4.91±3.67)分、(2.24±1.04)分],差异有统计学意义(t=15.07、10.12,均P<0.05)。发病90 d时,治疗组患者的NIHSS评分、mRS评分[(2.57±1.91)分、(1.56±1.06)分]低于对照组[分别为(3.50±2.68)分、(2.07±0.98)分],差异有统计学意义(t=5.915、9.211,均P<0.05)。出院时治疗组患者的早期卒中进展率及早期神经功能恶化率分别为7.89%(6/76)和10.53%(8/76),低于对照组[21.62%(16/74)、22.97%(17/74)],差异有统计学意义(χ^(2)=3.334、4.182,均P<0.05)。治疗组患者的出院时出血事件发生率为9.21%(7/76),90 d时出血事件发生率为17.11%(13/76),全因死亡率为1.32%(1/76),与对照组[出院时出血事件发生率为8.11%(6/74)、90 d时出血事件发生率为13.51%(10/74)、全因死亡率为2.70%(2/74)]比较,差异无统计学意义(χ^(2)=0.735、0.373、0.368,均P>0.05)。治疗组患者的90 d时良好预后率为80.26%(61/76),高于对照组[62.16%(46/74)],差异有统计学意义(χ^(2)=6.180,P<0.05)。对照组和治疗组患者发病90 d时卒中复发率、入院时和发病90 d时血管狭窄率比较,差异均无统计学意义(均P>0.05)。结论舒洛地特能够降低高危动脉粥样硬化性脑卒中患者早期卒中进展率及早期神经功能恶化率,改善出院时及90 d时神经功能评分,提高患者90 d时良好预后率,具有较好的安全性。
Objective To explore the early efficacy and safety of sulodexide in the treatment of patients with highrisk atherosclerotic stroke.Methods A total of 150 high-risk atherosclerotic stroke patients admitted to the First People’s Hospital of Wuhu from September 2020 to September 2023 were enrolled in this prospective study.They were randomly assigned to the treatment group(n=76)and the control group(n=74)using a random number table method.The control group received standard treatment as per current guidelines,including risk factor management,antiplatelet therapy,lipid-lowering,blood pressure and blood glucose control,and rehabilitation.The treatment group received sulodexide injection at a dose of 600 LSU/day via intravenous infusion for 15 days,in addition to the standard regimen given to the control group.All patients continued with the standard treatment protocol until the end of follow-up.The neurological function scores of patients in the control group and the treatment group at discharge and 90 days after onset(including National Institutes of Health Stroke Scale(NIHSS)scores and modified Rankin Scale(mRS)scores)at discharge and 90 days after onset,as well as the early stroke progression rate and early neurological deterioration rate at discharge,the good prognosis rate,stroke recurrence rate,vascular stenosis rate,bleeding event occurrence rate and all-cause mortality rate at 90 days after onset were compared between the control group and the treatment group.Results At discharge,the NIHSS and mRS scores of the treatment group((2.97±2.25)points and(1.69±1.07)points,respectively)were significantly lower than those of the control group((4.91±3.67)points and(2.24±1.04)points,respectively)(t=15.07,10.12,both P<0.05).At 90 days after onset,the NIHSS and mRS scores of the treatment group((2.57±1.91)points and(1.56±1.06)points,respectively)were significantly lower than those of the control group((3.50±2.68)points and(2.07±0.98)points,respectively)(t=5.915,9.211,both P<0.05).The early stroke progression rate and early neurological deterioration rate in the treatment group were 7.89%(6/76)and 10.53%(8/76),respectively,lower than those in the control group(21.62%(16/74)vs 22.97%(17/74)),and the differences were statistically significant(χ^(2)=3.334,4.182,both P<0.05).At discharge,the bleeding events rate in the treatment group was 9.21%(7/76),increasing to 17.11%(13/76)at 90 days,and the all-cause mortality rate was 1.32%(1/76).And no statistically significant differences were observed compared with the control group(bleeding event rates:8.11%(6/74)at discharge and 13.51%(10/74)at 90 days;mortality:2.70%(2/74))(χ^(2)=0.735,0.373 and 0.368,all P>0.05).The good prognosis rate at 90 days in the treatment group was 80.26%(61/76),significantly higher than that in the control group(62.16%(46/74)),with a statistically significant difference(χ^(2)=6.180,P<0.05).There were no statistically significant differences between the two groups in stroke recurrence rates at 90 days or in vascular stenosis rates at admission and 90 days post-onset(all P>0.05).Conclusion Sulodexide can reduce the early stroke progression rate and early neurological deterioration rate in patients with high-risk atherosclerotic stroke,improve neurological function scores at discharge and 90 days,and improve the good prognosis rate of patients at 90 days,with good safety.
作者
何敏
张强
陈后勤
崔凡
HE Min;ZHANG Qiang;CHEN Houqin;CUI Fan(Department of Neurology,The First People’s Hospital of Wuhu,Wuhu 241000,China;Department of Orthopaedics,The First People’s Hospital of Wuhu,Wuhu 241000,China;Department of Clinical Laboratory,The First People’s Hospital of Wuhu,Wuhu 241000,China)
出处
《中国药物应用与监测》
2025年第9期1502-1506,共5页
Chinese Journal of Drug Application and Monitoring
基金
安徽省科学技术厅项目(201907d07050010)
芜湖市第一人民医院科研项目(2020WYY0221)。
