目的:观察中药方剂敛肾枫心汤治疗运动神经元病患者流涎过多和夜尿次数增多的疗效。
方法:招募2014年6月—2016年11月在上海中医药大学附属曙光医院神经内科门诊就诊或接受住院治疗的符合病例选择标准的52例运动神经元病患者,随机分入敛肾枫心汤治疗组(26例,在西医常规治疗的基础上接受敛肾枫心汤口服治疗)和西医常规治疗组(26例),共治疗6周。测量治疗前后夜间活动量、一昼夜(24 h)流涎总量、夜尿次数和肌萎缩侧索硬化功能量表评分。
结果:治疗前2组患者的夜间活动量、一昼夜(24 h)流涎总量、夜尿次数和肌萎缩侧索硬化功能量表评分的差异均无统计学意义(P值均>0.05)。治疗期间,敛肾枫心汤治疗组和西医常规治疗组分别有4例和5例患者脱落或失访。敛肾枫心汤治疗组患者治疗后的夜间活动量、一昼夜(24 h)流涎总量和夜尿次数均较治疗前显著减少(P值均<0.05)。西医常规治疗组治疗前后的夜间活动量、一昼夜(24 h)流涎总量和夜尿次数均无显著变化(P值均>0.05)。2组患者治疗前后肌萎缩侧索硬化功能量表评分均无显著变化(P值均>0.05)。2组患者均未见明显的肝肾功能损害等不良反应。
结论:具有补肾敛涩功能的中药方剂敛肾枫心汤能够明显改善运动神经元病患者的流涎过多和夜尿次数增多症状。
Abstract
Objective: To investigate the efficacy of Lianshen Fengxin Decoction, a formula of Traditional Chinese Medicine, in treatment of excessive salivation and frequent urination overnight in patients with motor neuron disease (MND).
Methods: Fifty-two eligible patients with MND suffering with excessive salivation and frequent urination overnight who were outpatients or inpatients from Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine between June, 2014 and November, 2016 were recruited in this study. The patients were randomly divided into two groups: Lianshen Fengxin Decoction group (n = 26, receiving routine Western medicine in combination with Lianshen Fengxin Decoction for 6 weeks) and routine Western medicine group (n = 26, only receiving routine Western medicine for 6 weeks). The overnight activity, quantity of salivation (24 h) and frequency of urination overnight as the primary measurements, and the score of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) as the secondary mesurement were used to evaluate the clinical efficacy of Lianshen Fengxin Decoction.
Results: There were no significant differences in overnight activity, quantity of salivation (24 h), frequency of urination overnight and ALSFRS score before treatment between two groups (all P > 0.05). At the end of 6-week treatment, there were 4 patients and 5 patients dropped out or lost to follow-up in Lianshen Fengxin Decoction group and routine Western medicine group, respectively. The overnight activity, quantity of salivation (24 h) and the frequency of urination overnight were significantly decreased after treatment as compared with those before treatment in Lianshen Fengxin Decoction group (all P < 0.05), but there were no significant changes observed in routine Western medicine group (all P > 0.05). The ALSFRS score in two groups had no significant changes after treatment (both P > 0.05). No obvious liver and renal dysfunctions were observed in two groups.
Conclusion: Traditional Chinese Medicine formula—Lianshen Fengxin Decoction, which has the function of tonifying the kidney and the astringent effect, can obviously decrease the quantity of salivation and frequency of urination overnight in patients with MND.
关键词
运动神经元病 /
肌萎缩侧索硬化 /
流涎 /
夜尿 /
敛肾枫心汤 /
体动描记术
Key words
Motor neuron disease /
Amyotrophic lateral sclerosis /
Sialorrhea /
Nocturia /
Lianshen Fengxin Decoction /
Actigraphy
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参考文献
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基金
国家自然科学基金面上项目(编号:81373619)