血府逐瘀汤加减方治疗不宁腿综合征的临床研究  

Modified Xuefu Zhuyu Decoction Treated Patients with Restless Legs Syndrome

作　　者：李海聪[1] 杨毅玲[2] 李求兵[1] 杨学青[1] 田心[1] 王朋 刘颖[1] 王烁[1] 杨晓亮 LI Hai-cong;YANG Yi-ling;LI Qiu-bing;YANG Xue-qing;TIAN Xin;WANG Peng;LIU Ying;WANG Shuo;YANG Xiao-liang(The Fourth Department of Health and Medical Care, China-Japan Friendship Hospital, Beijing (100029);Faculty of Diagnostics, Basic College, Beijing University of Traditional Chinese Medicine, Beijing (100029);Taiyanggong Health Service Center, Chaoyang District, Beijing (100029))

机构地区：[1]国家卫健委中日友好医院保健四部,北京100029 [2]北京中医药大学基础医学院诊断教研室,北京100029 [3]北京市朝阳区太阳宫卫生服务中心,北京100029

出　　处：《中国中西医结合杂志》2019年第6期661-667,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：中日友好医院院级科研基金资助项目(No.2010-MS-37)

摘　　要：目的观察血府逐瘀汤加减方治疗不宁腿综合征患者的临床疗效。方法根据计算机制定的随机号将不宁腿综合征患者234例随机分为治疗组(119例)和对照组(115例),分别采用中药血府逐瘀汤加减方与西药盐酸普拉克索治疗,疗程4周,观察两组治疗前及治疗后第1、2、3、4周末不同时间点国际不宁腿综合征自评量表(IRLSSG)、匹茨堡睡眠质量指数量表(PSQI)、汉密尔顿焦虑量表(HAMA)、17项汉密尔顿抑郁量表(HAMD17)、健康状况问卷(SF-36)、治疗药物副作用量表(TESS)等评分的变化,以判断两者的临床疗效。结果治疗组总有效率为81.3%(87/107),优于对照组67.3%(70/104,P<0.05)。在第4周末时,治疗组IRLSSG评分显著低于对照组(P<0.01),PSQI因子的睡眠质量、入睡时间、睡眠时间、催眠药物、日间功能评分及总分均较对照组显著改善(P<0.05,P<0.01),HAMA评分显著低于对照组(P<0.01)。两组治疗后HAMD17评分比较差异无统计学意义(P>0.05),治疗组于第4周末时其生理机能(PF)、生理职能(RP)、躯体疼痛(BP)、总体健康(GH)、生命活力(VT)、社会功能(SF)、情感职能(RE)、精神健康(MH)评分和总分均较治疗前显著升高(P<0.05,P<0.01),且其PF、BP、VT和SF的评分较对照组升高更加显著(P<0.05),但两组总分比较差异无统计学意义(P>0.05)。结论血府逐瘀汤加减方治疗不宁腿综合征有较好的临床疗效,同时能改善不宁腿综合征患者的睡眠、焦虑、抑郁和生活质量。Objective To study the efficacy of Modified Xuefu Zhuyu Decoction(MXFZYD) in treating patients with restless legs syndrome(RLS). Methods Totally 234 RLS patients randomized by computer were assigned to two groups, 119 in the treated group(treated with MXFZYD according to syndrome differentiation), and 115 in the control group treated with pramipexole. Changes of scores rated by International RLS Study Group(IRLSSG) Scale, Pittsburgh sleep quality index(PSQI), Hamilton Anxiety Rating Scale(HAMA), Hamilton Depression Scale-17(HAMD17), Short Form 36 Health Survey Questionnaire(SF-36), and Treatment Emergent Symptom Scale(TESS) were observed before and after treatment in order to compare the efficacies of MXFZYD and pramipexole. Results The total effective rate of the treatment group on treating RLS was 81.3 %(87/107), better than that of the control group [(67.3%,70/104);P<0.05]. At the end of the 4th week, the IRLSSG score in the treatment group was significantly lower than that of the control group(P<0.01). The scores of sleep quality, sleep latency, sleep duration, medication use, daily function, and the overall score of PSQI factors in the treatment group were significantly more improved, as compared with those of the control group(P<0.05, P<0.01). The patients′ HAMA score was significantly lower in the treatment group than that of the control group(P<0.01). The reduction of patients′ HAMD17 score was not statistically different between the two groups(P>0.05). At the end of the 4th week, the Physical Functioning(PF), Role-Physical(RP), Bodily Pain(BP), General Health(GH), vitality(VT), Social Functioning(SF), Role-Emotional(RE), Mental Health(MH), and the total score of the treatment group were all significantly higher than those before treatment(P<0.05, P<0.01), and their PF, BP, VT, and SF scores were significantly higher than those of the control group(P<0.05). But the total score between the two groups was not statistically significant(P>0.05). Conclusion MXFZYD had better efficacy in treating RLS, and i

关 键 词：血府逐瘀汤加减方 不宁腿综合征 睡眠障碍 焦虑 生活质量 

分 类 号：R277.7[医药卫生—中医学]