中医“三调”综合疗法联合普拉克索治疗不安腿综合征临床研究

Clinical Efficacy of "Three Adjustment comprehensive Therapy" Combined with Pramipexole in Treatment of Restless Legs Syndrome

目的:观察中医"三调"(调营卫、调气血、调三焦)综合疗法联合西药普拉克索片治疗不安腿综合征的临床疗效。方法:将50例符合纳入标准的患者随机分为对照组和治疗组,每组25例。对照组口服普拉克索片治疗,治疗组在对照组治疗基础上加用自拟中药(白芍30 g,桂枝10 g,党参15 g,当归20 g,丹参30 g,红花15 g,伸筋草30 g,鸡血藤30 g,柴胡12 g,黄芩15 g,合欢皮30 g,炒酸枣仁20 g,炙甘草10 g。)及针刺治疗,针刺腧穴:膻中、中脘、气海、外关、足三里、血海。两组患者均治疗2个月。治疗后比较两组患者的临床疗效,并对治疗前后患者的病情严重程度、生活质量评价、睡眠质量评价、焦虑和抑郁情况评价进行比较。结果:治疗组25例中,治愈15例,显效6例,有效3例,无效1例,有效率为96.0%;对照组25例中,治愈6例,显效10例,有效5例,无效4例,有效率为84.0%,两组比较,差异有统计学意义(P<0.01)。两组患者均能显著降低患者国际不安腿综合征量表(international lrestless legs team rating scale,IRLS)评分,提高不宁腿综合征生活质量问卷(RLS-Quality of Life,RLSQoL)评分,差异均有统计学意义(P<0.01)。治疗后两组患者均能显著降低入睡后清醒时间、微觉醒指数、睡眠分期转换次数、醒转次数,且治疗组显著优于对照组,差异均有统计学意义(P<0.01)。两组患者的BAI评分和BDI评分均能显著降低,两组比较,差异均有统计学意义(P<0.01)。结论:中医"三调"(调营卫、调气血、调三焦)综合疗法联合西药普拉克索片治疗能更好地改善患者的临床症状、提高患者生活质量、改善患者整体睡眠质量、提高患者睡眠的连续性和稳定性,改善患者的焦虑与抑郁症状,调整患者的精神心理状态。

Objective： To observe the clinical curative effect of traditional Chinese medicine ＂ Three Adjustment Comprehensive Therapy＂（ adjusting Ying and Wei,adjusting Qi and Blood and adjusting Triple burners） combined with western medicine Pramipexole in treatment of restless leg syndrome. Methods： Fifty patients who met the criteria were randomly divided into control group and treatment group（ n = 25）. The control group was treated with oral administration of pramipexole. The treatment group was treated with Chinese medicine functioning in adjusting Ying and Wei,adjusting Qi and Blood and adjusting Triple burners（ White peony root 30 g,Guizhi 10 g,Codonopsis 15 g,Angelica 20 g,Salvia 30 g,Safflower 15 g,30 g,Bupleurum 12 g,Scutellaria 15 g,Acacia 30 g,Fried jujube kerne 20 g,Prepared Liquorice Root 10 g）. In addition,acupuncture treatment was used in the treatment grouop. The acupuncture points are： Shan zhong,zhong wan,Qi hai,Wai guan,Zu sanli and Xuehai. Both groups were treated for 2 months. After treatment,the clinical efficacy,the severity of the patients before and after treatment,quality of life evaluation,sleep quality evaluation,anxiety and depression of both groups were compared. Results： In the treatment group of 25 cases,15 cases were cured,6 cases were markedly effective,3 cases were effective and 1 case was ineffective,with the effective rate being 96. 0%. In the control group of 25 cases,6 cases were cured,10 cases were markedly effective,5 cases were effective and 4 cases were ineffective,with the effective rate being 84. 0%. There was significant differences between the two groups（ P〈0. 01）. The RLS-Quality of Life scores were significantly higher in the two groups was significantly higher than those of the patients（ P〈0. 01）. After treatment,the two groups of patients can significantly reduce the awake time after sleep,micro arousal index,sleep staging frequency,wake frequency,and the treatment group was significantly better than the control group,the difference was statistically significant（ P〈0. 01）. The BAI score and BDI score of both groups were significantly lower in the two groups,the difference between the both groups was statistically significant（ P〈0. 01）. Conclusion： The combination of traditional Chinese medicine ＂ Three Adjustment Comprehensive Therapy＂（ adjusting Ying and Wei,adjusting Qi and Blood and adjusting Triple burners） combined with western medicine Pramipexole can significantly improve the clinical symptoms,improve the quality of life of patients,improve the overall sleep quality,improve patients＇ sleep continuity and stability,relieve the patient＇s anxiety and depression symptoms and adjust patients＇ mental state.