摘要
目的观察四妙丸结合常规西医治疗多发性硬化病患者的效果。方法选取2022年4月至2024年6月西安中医脑病医院收治的86例多发性硬化病患者进行随机对照试验。采用随机数字表法将其分为对照组和观察组,各43例。对照组男16例,女27例,年龄(37.65±9.13)岁,体重指数(23.72±2.78)kg/m^(2),病程(4.28±1.07)年,发作次数(2.53±0.63)次,病灶部位:大脑半球18例、小脑9例、脑干13例、脊髓3例。观察组男14例,女29例,年龄(38.86±9.51)岁,体重指数(23.47±2.45)kg/m^(2),病程(4.16±1.04)年,发作次数(2.65±0.67)次,病灶部位:大脑半球17例、小脑10例、脑干12例、脊髓4例。对照组予以常规西医治疗,观察组予以四妙丸联合常规西医治疗,均治疗4周。比较两组临床疗效、不良反应发生率以及治疗前和治疗后神经功能、中医证候积分、免疫功能指标[辅助T细胞17(helper T cell 17,Th17)、调节T细胞(regulatory T cell,Treg),Th17/Treg]、炎症指标[白细胞介素(interleukin,IL)-17、IL-23、肿瘤坏死因子-α(tumor necrosis factor-alpha,TNF-α)]。统计学方法采用t检验、χ^(2)检验、秩和检验、校正χ^(2)检验、Fisher’s精确概率检验。结果治疗后,观察组扩展残疾状态量表评分、中医证候积分和Th17、Th17/Treg、IL-17、IL-23、TNF-α水平均低于对照组[(3.79±0.76)分比(4.51±0.92)分、(9.45±1.59)分比(11.27±1.88)分、(1.58±0.39)%比(1.82±0.46)%、0.79±0.21比1.05±0.26、(51.36±12.84)ng/L比(62.23±15.55)ng/L、(436.71±109.67)ng/L比(512.58±128.65)ng/L、(17.78±4.49)ng/L比(23.26±5.85)ng/L;t=3.891、4.766、2.566、5.018、3.476、2.894、4.794,均P<0.05],Treg水平高于对照组[(2.01±0.51)%比(1.73±0.43)%;t=2.701,P<0.05]。观察组总有效率高于对照组[95.24%(40/42)比78.05%(32/41);χ^(2)=4.822,P=0.028];观察组[14.29%(6/42)]与对照组[7.32%(3/41)]不良反应率比较,差异无统计学意义(校准χ^(2)=0.771,P=0.380)。结论四妙丸联合常规西医治疗多发性硬化病患者效果显著,可有效改善患者神经功能和临床症状,调节Th17/Treg细胞平衡,减轻炎症反应。
Objective To observe the effect of Simiao pills combined with conventional western medicine for patients with multiple sclerosis.Methods Eighty-six patients with multiple sclerosis treated at Xi'an Traditional Chinese Medicine Brain Disease Hospital from April 2022 to June 2024 were selected for the randomized controlled trial,and were divided into a control group and an observation group by the random number table method,with 43 cases in each group.There were 16 males and 27 females in the control group;they were(37.65±9.13)years old;their body mass index was(23.72±2.78)kg/m^(2);their disease course was(4.28±1.07)years;the attack frequency was 2.53±0.63;18 cases had lesions in the cerebral hemisphere,9 in the cerebellum,13 in the brainstem,and 3 in the spinal cord.There were 14 males and 29 females in the observation group;they were(38.86±9.51)years old;their body mass index was(23.47±2.45)kg/m^(2);their disease course was(4.16±1.04)years;the attack frequency was 2.65±0.67;17 cases had lesions in the cerebral hemisphere,10 in the cerebellum,12 in the brainstem,and 4 in the spinal cord.The control group took conventional western medicine,and the observation group Simiao pills and conventional western medicine,for 4 weeks.The clinical treatment efficacies,incidence rates of adverse reactions,and neurological function,traditional Chinese medicine symptom scores,levels of immune function indicators[helper T cell 17(Th17),regulatory T cell(Treg),and Th17/Treg],and levels of inflammatory indicators[interleukin(IL)-17,IL-23,and tumor necrosis factor-α(TNF-α)]before and after the treatment were compared between the two groups by t test,χ^(2)test,rank sum test,calibrationχ^(2)test,and Fisher's precision probability test.Results After the treatment,the score of the Expanded Disability Status Scale,traditional Chinese medicine syndrome score,and the levels of Th17,Th17/Treg,IL-17,IL-23,TNF-α,and Treg in the observation group were better than those in the control group[3.79±0.76 vs.4.51±0.92,9.45±1.59 vs.11.27±1.88,(1.58±0.39)%vs.(1.82±0.46)%,0.79±0.21 vs.1.05±0.26,(51.36±12.84)ng/L vs.(62.23±15.55)ng/L,(436.71±109.67)ng/L vs.(512.58±128.65)ng/L,(17.78±4.49)ng/L vs.(23.26±5.85)ng/L,and(2.01±0.51)%vs.(1.73±0.43)%;t=3.891,4.766,2.566,5.018,3.476,2.894,4.794,and 2.701;all P<0.05].The total effective rate of the observation group was higher than that of the control group[95.24%(40/42)vs.78.05%(32/41);χ^(2)=4.822;P=0.028].There was no statistical difference in the incidence rate of adverse reactions between the observation group and the control group[14.29%(6/42)vs.7.32%(3/41);calibrationχ^(2)=0.771;P=0.380].Conclusion Simiao pills combined with conventional western medicine in the treatment of patients with multiple sclerosis is effective,and can effectively improve their neurological function and clinical symptoms,regulate Th17/Treg cell balance,and alleviate inflammatory reactions.
作者
李玲
陈霄
聂伟
Li Ling;Chen Xiao;Nie Wei(Department of Geriatrics,Xi'an Traditional Chinese Medicine Brain Disease Hospital,Xi'an 710032,China;Nineth Department of Brain Diseases,Xi'an Traditional Chinese Medicine Brain Disease Hospital,Xi'an 710032,China;Fourth Department of Brain Diseases,Xi'an Traditional Chinese Medicine Brain Disease Hospital,Xi'an 710032,China)
出处
《国际医药卫生导报》
2025年第14期2450-2455,共6页
International Medicine and Health Guidance News
基金
陕西省高水平中医药重点建设项目(SX2YY2DXK-2021008)。
