中国中医药信息杂志2017，Vol.24Issue(9)：25-29,5.DOI:10.3969/j.issn.1005-5304.2017.09.007
滋肾平颤颗粒治疗帕金森病非运动症状临床研究
Clinical Study on Treatment of Non-motor Symptoms of Parkinson Disease by Zishen Pingchan Granules
摘要
Abstract
Objective To observe the clinical efficacy of Zishen Pingchan Granules in treating non-motor symptoms (NMS) of Parkinson disease (PD). Methods A randomized, double-blind, placebo-controlled trial was used. 124 patients with PD were randomly divided into the treatment group (n=62) and the control group (n=62). Patients not yet taking Western medicine were suspended the application of Western medicine, receiving direct TCM treatment. Patients who had already taken Western medicine were added TCM on the basis of original medicine dosage and method. The treatment group was given Zishen Pingchan Granules, while the control group was treated with placebo granule, once a bag, twice a day. The treatment lasted for 12 weeks. The clinical efficacy was assessed by using unified PD rating scale (UPDRSⅡ–Ⅲ), the scale for outcomes in PD for autonomic symptoms (SCOPA-AUT), Parkinson disease sleep scale (PDSS) and dosage of levodopa. Results The UPDRSⅡ and UPDRS Ⅲscores of the treatment group and the control group after 4, 8, and 12 week of treatment had no difference at each time point compared with before treatment (P>0.05). There was no statistical significance in scores of UPDRSⅡ and UPDRSⅢ after treatment (P>0.05). Efficacy of SCOPA-AUT in treatment group after treatment was significantly better than the control group; There was statistical significance in constipation, salivation, nocturia and sweating in SCOPA-AUT between the two groups after treatment (P<0.05). Compared with before treatment, PDSS scores in treatment group after 8 and 12 weeks of treatment increased significantly (P<0.05). After 4, 8, and 12 weeks of treatment, PDSS scores in treatment group were much higher than control group (P<0.01). By comparing PDSS score in the two groups before and after treatment, it showed that treatment group had better efficacy in extending the time to sleep, reducing nocturia, nightmares, and hallucinations (P<0.05). After 12 weeks of treatment, dosage of levodopa in control group increased significantly, which treatment group was much lower than the control group (P<0.05). Conclusion Zishen Pingchan Granules can improve the autonomic dysfunctionin and sleep quality of PD patients, and can significantly reduce the dosage of levodopa.关键词
滋肾平颤颗粒/帕金森病/随机双盲试验/非运动症状/左旋多巴剂量Key words
Zishen Pingchan Granules/Parkinson disease/randomized double-blind trial/non-motor symptoms/dosage of levodopa分类
医药卫生引用本文复制引用
袁晓蕾,叶青,袁灿兴,周洁..滋肾平颤颗粒治疗帕金森病非运动症状临床研究[J].中国中医药信息杂志,2017,24(9):25-29,5.基金项目
上海市科委重大项目(15401970100) （15401970100）
国家自然科学基金面上项目(81673726) （81673726）
国家中医临床基地龙医学者-育苗计划(LYTD-34) （LYTD-34）
上海市科委中医引导项目(17401934600) （17401934600）
