目的 探讨脑康泰胶囊联合普拉克索治疗早期帕金森病的临床效果。方法 选取2019年4月—2021年10月北京市和平里医院收治的136例早期帕金森病患者，采用随机数字表法将所有患者平均分为对照组和治疗组，每组各68例。对照组口服盐酸普拉克索片，起始剂量0.125 mg/次，3次/d，随后根据患者耐受情况逐渐增加剂量，每周加量1次，每次日剂量增加0.375 mg，有效剂量为0.50～0.75 mg/次，3次/d，最大日剂量为4.5 mg。治疗组在对照组基础上口服脑康泰胶囊，3粒/次，3次/d。两组疗程均为12周。观察两组的临床疗效，比较治疗前后两组国际运动障碍学会帕金森病综合评定量表（MDS-UPDRS）中各部分（Ⅰ、Ⅱ、Ⅲ、Ⅳ）评分及其总分、帕金森病睡眠评估量表中文版（PDSS-CV）总分、39项帕金森病生活质量问卷（PDQ-39）总分及血清白细胞介素（IL）-1β、IL-17、超氧化物歧化酶（SOD）、谷氨酸（Glu）和γ氨基丁酸（GABA）水平。并统计两组不良反应情况。结果 治疗后，治疗组有效率是94.12%，较对照组82.35%显著提高（P＜0.05）。治疗后，两组MDS-UPDRS中各部分（Ⅰ、Ⅱ、Ⅲ、Ⅳ）评分及其总分比治疗前均显著降低（P＜0.05）；且均以治疗组下降更显著（P＜0.05）。治疗后，两组PDSS-CV总分比治疗前均显著升高，PDQ-39总分比治疗前均显著降低（P＜0.05）；且均以治疗组改善更显著（P＜0.05）。治疗后，两组血清IL-1β、IL-17水平均显著低于治疗前，血清SOD、Glu和GABA水平均显著高于治疗前（P＜0.05）；且治疗后，治疗组血清IL-1β、IL-17水平比对照组均显著更低，血清SOD、Glu和GABA水平比对照组均显著更高（P＜0.05）。治疗后，治疗组患者不良反应发生率是14.71%，比对照组29.41%显著降低（P＜0.05）。结论 脑康泰胶囊联合普拉克索治疗早期帕金森病的整体疗效满意，可安全有效地改善患者睡眠状况，并能进一步抑制血清IL-1β和IL-17表达水平、增强体内SOD活性及提高血清Glu、GABA水平，从而对患者生活质量及病情的改善具有重要作用。

Objective To investigate the clinical effect of Naokangtai Capsules combined with pramipexole in treatment of early Parkinson's disease. Methods A total of 136 patients with early Parkinson's disease admitted to Beijing Hepingli Hospital from April 2019 to October 2021 were randomly divided into control group and treatment group by random number table method, with 68 patients in each group. Patients in the control group were po administered with Pramipexole Dihydrochloride Tablets, the initial dosage was 0.125 mg/time, 3 times daily, and then the dosage was gradually increased according to the patient's tolerance, once a week, and each daily dosage was increased by 0.375 mg. The effective dosage was 0.50-0.75 mg/time, 3 times daily, and the maximum daily dosage was 4.5 mg. Patients in the treatment group were po administered with Naokangtai Capsules on the basis of the control group, 3 capsules/time, 3 times daily. The treatment course of both groups was 12 weeks. The clinical efficacy of the two groups was observed. The scores of various parts (Ⅰ, Ⅱ, Ⅲ, Ⅳ) of MDS-UPDRS, the total scores of Chinese version of Pd Sleep Assessment Scale (PDSS-CV), the total scores of 39 items of PD Quality of Life Questionnaire (PDQ-39) and serum interleukin-1β, IL-17, superoxide dismutase (SOD), glutamate (Glu) and GABA were compared before and after treatment,. The adverse reactions of the two groups were analyzed. Results After treatment, the effective rate in the treatment group was 94.12%, significantly higher than that in the control group (82.35%) (P < 0.05). After treatment, the scores of all parts of MDS-UPDRS (Ⅰ, Ⅱ, Ⅲ, Ⅳ) and their total scores in two groups were significantly decreased compared with before treatment (P < 0.05). The decrease was more significant in the treatment group (P < 0.05). After treatment, the total scores of PDSS-CV in both groups were significantly higher than before treatment, and the total scores of PDQ-39 were significantly lower than before treatment (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). After treatment, the levels of serum IL-1β and IL-17 in two groups were significantly lower than before treatment, and the levels of serum SOD, Glu and GABA were significantly higher than before treatment (P < 0.05). After treatment, the serum levels of IL-1β and IL-17 in the treatment group were significantly lower than those in the control group, and the serum levels of SOD, Glu and GABA were significantly higher than those in the control group (P < 0.05). After treatment, the incidence of adverse reactions in treatment group was 14.71%, significantly lower than 29.41% in control group (P < 0.05). Conclusion Naokangtai Capsules combined with pramipexole has satisfactory overall curative effect in the treatment of early Parkinson's disease, and can safely and effectively improve the sleep status of patients, and can further inhibit the expression levels of serum IL-1β and IL-17, enhance the activity of SOD in vivo and increase the serum Glu, GABA level, which plays an important role in the improvement of patients' quality of life and disease.

R971

北京市东城区科技计划项目(S20190707001)