Abstract: 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/m²; 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/m²; 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, χ² test, rank sum test, calibration χ² 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); χ²=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); calibration χ²=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.

Key words: Multiple sclerosis,  , Simiao , pills,  , Helper T cells 17,  , Regulating T cells

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/m²，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/m²，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、χ²检验、秩和检验、校正χ²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）；χ²=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χ²=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。

关键词: 多发性硬化病, 四妙丸, 辅助T细胞17, 调节T细胞