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中华脑科疾病与康复杂志(电子版) ›› 2024, Vol. 14 ›› Issue (03) : 140 -145. doi: 10.3877/cma.j.issn.2095-123X.2024.03.003

临床研究

舒脑欣滴丸对脑小血管病患者客观睡眠和炎症标志物的影响
张轩1, 冯明2, 王倩3, 薛蓉1,()   
  1. 1. 300308 天津,天津医科大学总医院空港医院神经内科
    2. 300100 天津市中西医结合医院神经外科
    3. 300250 天津市第三中心医院分院神经内科
  • 收稿日期:2023-10-23 出版日期:2024-06-15
  • 通信作者: 薛蓉

Effect of Shunaoxin Dropping Pills on objective sleep parameters and inflammatory markers in patients with cerebral small vessel disease

Xuan Zhang1, Ming Feng2, Qian Wang3, Rong Xue1,()   

  1. 1. Department of Neurology, Tianjin Medical University General Hospital Airport Site, Tianjin 300308, China
    2. Department of Neurosurgery, Tianjin Hospital of ITCWN, Tianjin 300100, China
    3. Department of Neurology, Tianjin Third Central Hospital Branch Courts, Tianjin 300250, China
  • Received:2023-10-23 Published:2024-06-15
  • Corresponding author: Rong Xue
  • Supported by:
    Tianjin Science and Technology Project(17ZXMFSY00180)
引用本文:

张轩, 冯明, 王倩, 薛蓉. 舒脑欣滴丸对脑小血管病患者客观睡眠和炎症标志物的影响[J]. 中华脑科疾病与康复杂志(电子版), 2024, 14(03): 140-145.

Xuan Zhang, Ming Feng, Qian Wang, Rong Xue. Effect of Shunaoxin Dropping Pills on objective sleep parameters and inflammatory markers in patients with cerebral small vessel disease[J]. Chinese Journal of Brain Diseases and Rehabilitation(Electronic Edition), 2024, 14(03): 140-145.

目的

评价舒脑欣滴丸对脑小血管病(CSVD)患者的客观睡眠和炎症标志物的影响。

方法

选择2020年6月至2022年9月于天津医科大学总医院空港医院神经内科及天津市中西医结合医院神经外科就诊的104例CSVD患者,按照随机数字表法分为对照组和舒脑欣治疗组。对照组给予常规治疗,舒脑欣治疗组在常规治疗的基础上给予舒脑欣滴丸口服。采用便携式睡眠监测仪评估2组患者治疗前和治疗3个月后的客观睡眠参数,使用酶联免疫吸附试验方法检测2组患者治疗前和治疗3个月后的血浆C-反应蛋白(CRP)、白介素-6(IL-6)、可溶性P选择素、可溶性血管细胞黏附分子1(sVCAM-1)、细胞间黏附分子(ICAM-1)含量。

结果

对照组脱落1例,有效例数54例,舒脑欣治疗组脱落2例,有效例数47例。与对照组相比,舒脑欣治疗组治疗后与治疗前的入睡潜伏期差值减少,睡眠效率差值增加,血浆sVCAM-1水平差值减少,差异具有统计学意义(P<0.05);总睡眠时间差值、快速眼动期睡眠占比差值、稳定睡眠占比差值、不稳定睡眠占比差值、觉醒总次数差值、血浆CRP差值、IL-6差值、可溶性P选择素差值及ICAM-1水平差值比较,差异无统计学意义(P>0.05)。舒脑欣治疗组治疗前后睡眠效率的变化与血浆sVCAM-1水平的变化呈负相关(r=-0.419,P=0.003)。

结论

在常规抗血小板、调脂和控制脑血病危险因素治疗的基础上,连续服用舒脑欣滴丸3个月可缩短CSVD患者的入睡潜伏期,提高睡眠效率,减轻血管内皮炎症,而且睡眠效率提高与血管内皮炎症的改善相关。

Objective

To evaluate the effect of Shunaoxin Dropping Pills on objective sleep parameters and inflammatory markers in patients with cerebral small vessel disease (CSVD).

Methods

One hundred and four patients with CSVD from Neurology Department of Tianjin Medical University General Hospital and Neurosurgery Department of Tianjin Hospital of ITCWN were collected from June 2020 to September 2022. They were randomly divided into two groups according to the random number table: the control group which received normalization therapy and the Shunaoxin treatment group which received Shunaoxin Dropping Pills and normalization therapy. The objective sleep parameters were evaluated by the portable sleep monitor. The plasma levels of C-reactive protein (CRP), interleukin-6 (IL-6), soluble P-selectin, soluble vascular cell adhesion molecule-1 (sVCAM-1), intercellular adhesion molecule-1 (ICAM-1) were measured by enzyme linked immunosorbent assay. The above evaluations were performed at baseline and after therapy of 3 months.

Results

As 1 patient dropped out, there were 54 available cases in the control group. As 2 patients dropped out, there were 47 available cases in the Shunaoxin treatment group. Compared with the control group, the Shunaoxin treatment group showed significant decreased D-value of sleep latency, increased D-value of sleep latency, and deceased D-value of plasma sVCAM-1 level after and before therapy (P<0.05); The D-values of total sleep time, rapid eye movement sleep proportion, stable sleep proportion, unstable sleep proportion, total number of awakenings, plasma CRP, IL-6, soluble P-selectin, and plasma ICAM-1 levels before and after treatment were not statistically significant (P>0.05). The changes of sleep efficiency were negatively correlated with the changes of plasma level of sVCAM-1 (r=-0.419, P=0.003) in the Shunaoxin treatment group.

Conclusion

Based on the normalization therapy with antiplatelet and lipid-regulating therapy, and treatment of cerebrovascular risk factors, therapy with Shunaoxin Dropping Pills for 3 months can decrease sleep latency and improve sleep efficiency, as well as alleviate the inflammation of vascular endothelium in the patients with CSVD. In addition, the increase of sleep efficiency was correlated with the decrease of vascular inflammation in the patients with CSVD.

表1 2组患者治疗前的临床资料比较
Tab.1 Comparison of clinical data before therapy between two groups
项目 舒脑欣治疗组(n=47) 对照组(n=54) χ2/t/Z P
年龄(岁,Mean±SD) 62.00±8.52 61.52±8.14 -0.290 0.772
男性[例(%)] 21(44.68) 21(38.89) 0.347 0.556
文化程度[例(%)]     1.184 0.757
小学 13(27.66) 13(24.07)    
初中 13(27.66) 16(29.63)    
高中/中专 7(14.89) 12(22.22)    
大专及以上 14(29.79) 13(24.07)    
BMI(kg/m2,Mean±SD) 24.01±2.93 23.86±3.48 -0.262 0.793
吸烟[例(%)] 18(38.30) 16(29.63) 0.846 0.358
高血压[例(%)] 34(72.34) 29(53.70) 3.719 0.054
糖尿病[例(%)] 16(34.04) 13(24.07) 1.220 0.269
血脂异常[例(%)] 27(57.45) 27(50.00) 0.560 0.454
冠心病[例(%)] 17(36.17) 15(27.78) 0.818 0.366
脑梗死[例(%)] 31(65.96) 32(59.26) 0.480 0.488
睡眠参数        
总睡眠时间[min,M(Q1,Q3)] 369.00(285.50,394.00) 362.25(324.00,397.88) -0.112 0.911
入睡潜伏期[min,M(Q1,Q3)] 31.00(22.50,53.50) 28.25(16.50,47.13) 1.287 0.198
睡眠效率占比[%,M(Q1,Q3)] 74.80(65.80,79.90) 78.20(73.30,82.85) -2.305 0.021
REM睡眠占比(%,Mean±SD) 22.83±2.71 22.76±2.58 -0.129 0.897
稳定睡眠占比[%,M(Q1,Q3)] 14.90(6.00,22.20) 19.45(13.75,27.15) -1.556 0.120
不稳定睡眠占比(%,Mean±SD) 60.05±13.29 56.69±12.12 -1.328 0.187
觉醒总次数[次,M(Q1,Q3)] 24.0(19.0,27.0) 23.0(16.0,30.0) 0.113 0.910
血浆炎症标志物        
CRP[mg/L,M(Q1,Q3)] 2.31(1.96,2.45) 2.33(2.05,2.65) -1.995 0.046
IL-6[ng/L,M(Q1,Q3)] 7.54(6.62,8.04) 6.58(6.24,7.61) 2.254 0.024
sP-selectin[μg/L,M(Q1,Q3)] 0.19(0.17,0.24) 0.26(0.24,0.31) -6.482 <0.001
sVCAM-1[mg/L,M(Q1,Q3)] 0.47(0.42,0.52) 0.44(0.41,0.51) 1.048 0.294
ICAM-1(μg/L,Mean±SD) 0.33±0.05 0.43±0.06 8.539 <0.001
表2 2组患者客观睡眠参数、血浆炎症标志物治疗前与治疗3个月后差值的比较
Tab.2 D-value of objective sleep parameters and plasma inflammatory markers at baseline and 3 months after therapy between two groups
表3 舒脑欣治疗组患者治疗前后客观睡眠参数与sVCAM-1水平的相关性分析
Tab.3 Correlation analysis between objective sleep parameters and sVCAM-1 level before and after treatment in the Shunaoxin treatment group
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