摘要
目的探讨苏合香丸联合氢溴酸加兰他敏对脑卒中后认知障碍(PSCI)患者的临床疗效。方法采取前瞻性研究,选取2024年1月至2025年4月上海市杨浦区市东医院收治的PSCI患者136例,按随机数字表法分为观察组(苏合香丸联合氢溴酸加兰他敏治疗,68例)和对照组(氢溴酸加兰他敏治疗,68例)。比较对照组和观察组的临床疗效,治疗前及治疗12周后的血清炎症因子水平、神经功能缺损程度、药物安全性、认知功能和生活能力。结果治疗12周后,对照组和观察组美国国立卫生研究院卒中量表(NIHSS)评分较治疗前降低(P<0.001),且观察组NIHSS评分(4.76±1.56)分低于对照组(6.04±1.89)分(t=4.312,P<0.001)。治疗12周后,对照组和观察组简易精神状态检查量表(MMSE)、日常生活能力量表(ADL)及蒙特利尔认知评估量表(MoCA)评分均较治疗前提高(P<0.001),且观察组MMSE、ADL、MoCA评分[分别为(25.93±2.08)分、(70.96±9.12)分、(31.59±5.75)分]均高于对照组[分别为(23.74±1.91)分、(64.87±7.83)分、(27.04±5.18)分](t=6.389、4.176、4.844,均P<0.05)。治疗12周后,观察组总有效率高于对照组[92.65%(63/68)vs 79.41%(54/68),χ^(2)=4.955,P<0.05]。治疗12周后,对照组和观察组血清白细胞介素6(IL-6)和C反应蛋白(CRP)水平均较治疗前降低(P<0.001),且观察组IL-6、CRP[分别为(123.65±13.69)ng/L、(5.04±1.22)mg/L]均低于对照组[分别为(149.87±14.82)ng/L、(6.26±1.68)mg/L](t=10.719、4.815,均P<0.001)。对照组和观察组不良反应总发生率差异无统计学意义[7.35%(5/68)vs 14.71%(10/68),χ^(2)=1.873,P>0.05]。结论苏合香丸联合氢溴酸加兰他敏治疗方案可显著改善PSCI患者的神经功能及认知能力,提高其生活质量和临床疗效,有效抑制炎症反应,且安全性良好。
Objective To investigate the clinical efficacy of Suhexiang pill combined with galantamine hydrobromide in treating post-stroke cognitive impairment(PSCI).Methods A total of 136 PSCI patients admitted to Shidong Hospital of Shanghai Yangpu District from January 2024 to April 2025 were enrolled in this prospective study.They were randomly assigned to the observation group(68 cases treated with Suhexiang pill combined with galantamine hydrobromide)and the control group(68 cases treated with galantamine hydrobromide alone).The clinical efficacy,serum inflammatory cytokine levels,neurological deficit severity,drug safety,cognitive function,and daily living ability before treatment and after 12 weeks of intervention were compared between the two groups.Results After 12 weeks of treatment,the National Institutes of Health Stroke Scale scores in the control group and the observation group decreased significantly compared with baseline(both P<0.001),and the score in the observation group(4.76±1.56)was lower than that in the control group(6.04±1.89)(t=4.312,P<0.001).After 12 weeks of treatment,the scores of the Mini-Mental State Examination,Activities of Daily Living,and Montreal Cognitive Assessment in the control group and the observation group showed significant improvement compared to those before treatment(all P<0.001).The above indicators in the observation group((25.93±2.08)points,(70.96±9.12)points,(31.59±5.75)points)were higher than those in the control group((23.74±1.91)points,(64.87±7.83)points,(27.04±5.18)points)(t=6.389,4.176,4.844,all P<0.05).After 12 weeks of treatment,the total effective rate in the observation group was higher than that in the control group(92.65%(63/68)vs 79.41%(54/68),χ^(2)=4.955,P<0.05).Serum interleukin-6(IL-6)and C-reactive protein(CRP)levels were significantly reduced in the control group and the observation group compared to those before treatment(all P<0.001).Specifically,the observation group showed lower IL-6(123.65±13.69)ng/L and CRP(5.04±1.22)mg/L levels than the control group((149.87±14.82)ng/L and(6.26±1.68)mg/L)(t=10.719,4.815,both P<0.001).There was no statistically significant difference in the incidence of adverse reactions between the two groups(7.35%(5/68)vs 14.71%(10/68),χ^(2)=1.873,P>0.05).Conclusion The combination of Suhexiang pill and galantamine hydrobromide in the treatment of PSCI can significantly improve patients’neurological function and cognitive abilities,enhance their quality of life and clinical efficacy,effectively inhibit inflammatory responses,and demonstrate good safety.
作者
王林琳
庄婵娟
李沂轩
孙丽颖
王必莲
WANG Linlin;ZHUANG Chanjuan;LI Yixuan;SUN Liying;WANG Bilian(Department of Intensive Care Medicine,Shidong Hospital of Shanghai Yangpu District,Shanghai 200438,China;Department of General Practice,Wujiao Community Health Service Center of Yangpu District,Shanghai 200433,China;Department of Dermatology,Shidong Hospital of Shanghai Yangpu District,Shanghai 200438,China)
出处
《中国药物应用与监测》
2025年第9期1584-1588,共5页
Chinese Journal of Drug Application and Monitoring
关键词
苏合香丸
氢溴酸加兰他敏
脑卒中
认知障碍
临床疗效
Suhexiang pill
galantamine hydrobromide
stroke
cognitive impairment
clinical efficacy