培元通滞汤治疗帕金森病伴抑郁和睡眠障碍的临床研究

Clinical Study on Treatment of Parkinson′s Disease with Depression and Sleep Disorder by Peiyuan Tongzhi Decoction

目的观察培元通滞汤治疗帕金森病伴抑郁和睡眠障碍的临床效果。方法收集黄世敬教授2017年5月至2020年5月在中国中医科学院广安门医院及广安门医院南区门诊治疗的71例匹兹堡睡眠质量指数量表(PSQI)评分>5分、汉密尔顿抑郁量表(HAMD)评分>8分的帕金森病患者,依据随机数字表法分为对照组(35例)和观察组(36例)。对照组常规给予多巴丝肼片口服,每次125 mg,每日3次;观察组在对照组基础上给予培元通滞汤治疗,每日1剂,分早晚2次温开水冲服。两组疗程均为3个月。比较两组治疗前后PSQI、HAMD、统一帕金森病评定量表(UPDRS)的变化情况,以及不良反应发生率。结果治疗前,两组PSQI、HAMD及UPDRS评分比较差异无统计学意义(P>0.05)。治疗后,两组PSQI、HAMD及UPDRS评分均低于治疗前(P<0.05或P<0.01),且观察组PSQI、HAMD及UPDRS评分低于对照组[(7.7±2.9)分比(11.4±2.8)分、(15.6±4.0)分比(18.6±2.6)分、(63.7±17.0)分比(72.3±15.3)分](P<0.05或P<0.01)。两组总不良反应发生率比较差异无统计学意义(P>0.05)。结论培元通滞汤能够有效改善帕金森病伴抑郁和睡眠障碍患者的抑郁和睡眠障碍症状,且安全性较高。

Objective To observe the clinical effect of Peiyuan Tongzhi decoction on Parkinson′s disease with depression and insomnia.Methods A total of 71 patients with Parkinson′s disease with Pittsburgh sleep quality index(PSQI)score>5 and Hamilton depression scale(HAMD)score>8 treated by Professor Huang Shijing in Guang′anmen Hospital and South Branch of Guang′anmen Hospital,China Academy of Chinese Medical Sciences from May 2017 to May 2020 were collected and divided into a control group(35 cases)and an observation group(36 cases)according to random number table method.The control group was given levodopa and benserazide hydrochloride tablets 125 mg per time,3 times a day.On the basis of the control group′s treatment,the observation group was treated with Peiyuan Tongzhi decoction,1 dose a day,divided into two times in the morning and evening mixed with warm water.The treatment course was 3 month for both groups.After 3 month of treatment,the changes of PSQI,HAMD and UPDRS scores and the incidence of adverse reactions were compared between the two groups.Results There were no significant differences in PSQI,HAMD and UPDRS scores between the two groups before treatment(P>0.05).After treatment,PSQI,HAMD and UPDRS scores in the two groups decreased compared with before treatment(P<0.05 or P<0.01),and PSQI,HAMD and UPDRS scores in the observation group decreased more significantly than the control group[(7.7±2.9)vs(11.4±2.8),(15.6±4.0)vs(18.6±2.6),(63.7±17.0)vs(72.3±15.3)](P<0.05 or P<0.01).There was no significant difference in the incidence of total adverse reactions between the two groups(P>0.05).Conclusion Peiyuan Tongzhi decoction can effectively improve the symptoms of depression and insomnia in patients with Parkinson′s disease,and has high safety.