目的 探討腦康泰膠囊聯(lián)合普拉克索治療早期帕金森病的臨床效果。方法 選取2019年4月—2021年10月北京市和平里醫(yī)院收治的136例早期帕金森病患者，采用隨機(jī)數(shù)字表法將所有患者平均分為對照組和治療組，每組各68例。對照組口服鹽酸普拉克索片，起始劑量0.125 mg/次，3次/d，隨后根據(jù)患者耐受情況逐漸增加劑量，每周加量1次，每次日劑量增加0.375 mg，有效劑量為0.50～0.75 mg/次，3次/d，最大日劑量為4.5 mg。治療組在對照組基礎(chǔ)上口服腦康泰膠囊，3粒/次，3次/d。兩組療程均為12周。觀察兩組的臨床療效，比較治療前后兩組國際運(yùn)動障礙學(xué)會帕金森病綜合評定量表（MDS-UPDRS）中各部分（Ⅰ、Ⅱ、Ⅲ、Ⅳ）評分及其總分、帕金森病睡眠評估量表中文版（PDSS-CV）總分、39項帕金森病生活質(zhì)量問卷（PDQ-39）總分及血清白細(xì)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。并統(tǒng)計兩組不良反應(yīng)情況。結(jié)果 治療后，治療組有效率是94.12%，較對照組82.35%顯著提高（P＜0.05）。治療后，兩組MDS-UPDRS中各部分（Ⅰ、Ⅱ、Ⅲ、Ⅳ）評分及其總分比治療前均顯著降低（P＜0.05）；且均以治療組下降更顯著（P＜0.05）。治療后，兩組PDSS-CV總分比治療前均顯著升高，PDQ-39總分比治療前均顯著降低（P＜0.05）；且均以治療組改善更顯著（P＜0.05）。治療后，兩組血清IL-1β、IL-17水平均顯著低于治療前，血清SOD、Glu和GABA水平均顯著高于治療前（P＜0.05）；且治療后，治療組血清IL-1β、IL-17水平比對照組均顯著更低，血清SOD、Glu和GABA水平比對照組均顯著更高（P＜0.05）。治療后，治療組患者不良反應(yīng)發(fā)生率是14.71%，比對照組29.41%顯著降低（P＜0.05）。結(jié)論 腦康泰膠囊聯(lián)合普拉克索治療早期帕金森病的整體療效滿意，可安全有效地改善患者睡眠狀況，并能進(jìn)一步抑制血清IL-1β和IL-17表達(dá)水平、增強(qiáng)體內(nèi)SOD活性及提高血清Glu、GABA水平，從而對患者生活質(zhì)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

北京市東城區(qū)科技計劃項目(S20190707001)