摘要
目的:观察芪蛭丹通络胶囊治疗非急性期缺血性中风气虚血瘀证的临床疗效及其安全性。方法:选择于2020年1月至2021年12月在玉林市中医医院脑病科住院且符合非急性期缺血性中风气虚血瘀证诊断的患者205例，按入院时间采用随机对照试验设计方法分为2组：治疗组103例，对照组102例。2组基础治疗相同，治疗组加用芪蛭丹通络胶囊，2组治疗时间均为3周。2组治疗前后开展功能评定，应用美国国立卫生研究院卒中量表（NIHSS）评价神经功能缺损，观察2组患者血液流变学生化指标变化，记录2组患者治疗效果。采用χ2检验比较2组疗效的差异，采用t检验比较2组间或组内治疗前后NIHSS评分和血液流变学生化指标的差异。结果:治疗组在治疗后其NIHSS评分低于对照组[（5.42±1.92）分vs（7.53±1.67）分]，差异具有统计学意义（t=8.395，P＜0.001），血液流变学生化指标均低于对照组[全血黏度（低切）：（10.85±1.19）mPa·a vs（12.25±1.53）mPa·a，全血黏度（高切）：（6.61±0.97）mPa·a vs（7.42±0.93）mPa·a，血浆黏度：（1.33±0.22）mPa·a vs（1.41±0.20）mPa·a]，差异具有统计学意义（t=7.344、6.150、2.615，P＜0.001、＜0.001、=0.010）；而治疗组总有效率高于对照组[86.41%（89/103）vs 74.51%（76/102）]，差异具有统计学意义（χ2=4.619，P=0.032）。2组患者治疗期间不良反应率为0。结论:芪蛭丹通络胶囊可有效改善非急性期气虚血瘀型缺血性中风患者的神经功能缺损情况，改善患者血液流变，且无明显不良反应。
Abstract
Objective:To evaluate the clinical efficacy and safety of Qizhidan Tongluo capsule in treating qi deficiency and blood stasis syndrome in patients with non-acute ischemic stroke.Methods:A total of 205 patients were admitted to the Department of Encephalopathy of Yulin Hospital of Traditional Chinese Medicine from January 2020 to December 2021 and qualified for the diagnosis of Qi deficiency and blood stasis syndrome of non-acute ischemic stroke. They were divided into two groups randomly, including 103 patients in the treatment group and the other 102 patients in the control group. The two groups received the same primary treatment. The treatment group was treated additionally with Qizhidan tongluo capsules for 3 weeks. Neurological deficit score, TCM syndrome score (syndrome manifestations), and hemorheology were used to evaluate the effect in the two groups before and after treatment. Chi-square test and t-test were used to compare the differences of categorical and continuous variables between the treatment and control groups, respectively.Results:NIHSS score in the treatment group was lower than that in the control group [(5.42±1.92) vs (7.53±1.67)], and the differences were statistically significant (t=8.395, P＜0.001); hemorheology was lower than that in the control group [whole blood viscosity (low cut): (10.85±1.19)mPa·a vs (12.25±1.53)mPa·a; whole blood viscosity (high cut): (6.61±0.97)mPa·a vs (7.42±0.93)mPa·a; plasma viscosity: (1.33±0.22)mPa·a vs (1.41±0.20)mPa·a], and the differences were statistically significant (t=7.344, 6.150, 2.615; P＜0.001, <0.001, =0.010]. The total effective rate of the treatment group was 86.41% (89/103), which was higher than that of the control group (74.51%, 76/102), and the differences were statistically significant (χ2=4.619, P=0.032). The adverse reaction rate during treatment in the two groups was 0.Conclusion:Qizhidan Tongluo capsules can effectively improve the neurological function and hemorheology in patients with non-acute ischemic stroke type of Qi deficiency and blood stasis without obvious adverse reactions.
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