袁晓蕾++叶青++袁灿兴++周洁
摘要：目的 觀察滋肾平颤颗粒治疗帕金森病非运动症状临床疗效。方法 采用随机、双盲、安慰剂平行对照设计方法，将124例帕金森病患者随机分为治疗组与对照组各62例。尚未服用西药者暂缓应用西药，直接予中药治疗，已服用西药者在原药物剂量及用法的基础上加服中药。治疗组予滋肾平颤颗粒，对照组予安慰剂颗粒，每次1袋，每日2次，早晚冲服。2组疗程均为12周。观察帕金森病评定量表（UPDRS）中Ⅱ～Ⅲ量表、自主神经症状量表（SCOPA-AUT）、帕金森病睡眠量表（PDSS）评分及左旋多巴用量变化。结果 与本组治疗前比较，2组治疗4、8、12周UPDRSⅡ及UPDRSⅢ评分差异无统计学意义（P>0.05）。2组治疗后UPDRSⅡ、UPDRSⅢ评分差异无统计学意义（P>0.05）。治疗组治疗后SCOPA-AUT疗效明显高于对照组；治疗后2组SCOPA-AUT评分中便秘、流涎、夜尿多、多汗比较差异有统计学意义（P<0.05）。与本组治疗前比较，治疗组治疗8、12周PDSS评分明显升高（P<0.05）；治疗4、8、12周，治疗组PDSS评分明显高于对照组（P<0.01）。2组治疗前后PDSS分项差值比较，治疗组在延长入睡时间，减少夜尿症、噩梦、幻觉方面疗效优于对照组（P<0.05）。治疗12周，对照组左旋多巴用量明显增加，治疗组用量明显低于同期对照组（P<0.05）。结论 滋肾平颤颗粒可以改善PD患者自主神经功能障碍，提高患者睡眠质量，减少左旋多巴用量。
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
DOI：10.3969/j.issn.1005-5304.2017.09.007
中图分类号：R277.725 文献标识码：A 文章编号：1005-5304（2017）09-0025-05
Clinical Study on Treatment of Non-motor Symptoms of Parkinson Disease by Zishen Pingchan Granules YUAN Xiao-lei， YE Qing， YUAN Can-xing， ZHOU Jie （Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， Shanghai 200032， China）
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 Ⅲ scores 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
