柴胡疏肝散加味方治疗不宁腿综合征抑郁情绪的临床疗效及对炎症因子表达的影响

Clinical Observation of Flavored Chaihu Shugan Powder in Treating Restless Legs Syndrome with Depression and Its Effect on the Expression of Inflammatory Factors

【目的】研究柴胡疏肝散加味方治疗不宁腿综合征(restless legs syndrome,RLS)抑郁情绪的临床疗效。【方法】将64例肝郁血虚型RLS抑郁情绪患者随机分为对照组和观察组,每组各32例。对照组给予口服普拉克索缓释片治疗,观察组在对照组的基础上给予柴胡舒肝散加味方治疗,疗程为4周。观察2组患者治疗前后国际不宁腿综合征严重程度评定量表(IRLS)、24项汉密尔顿抑郁量表(HAMD-24)、匹兹堡睡眠质量指数(PSQI)、中医证候积分量表评分及血清白细胞介素6(IL-6)、C反应蛋白(CRP)、肿瘤坏死因子α(TNF-α)含量变化,以评估2组患者治疗后RLS严重程度、抑郁程度、睡眠质量及炎症因子表达水平。【结果】(1)治疗4周后,观察组的总有效率为93.75%(30/32),对照组为87.50%(28/32);组间比较(秩和检验),观察组的临床疗效明显优于对照组(P<0.05)。(2)治疗后,2组患者的IRLS、HAMD及PSQI评分均较治疗前明显降低(P<0.01),且观察组对IRLS、HAMD及PSQI评分的降低幅度均明显优于对照组(P<0.05)。(3)治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.01),且观察组对中医证候积分的降低幅度明显优于对照组(P<0.01)。(4)治疗后,2组患者的血清IL-6、CRP、TNF-α水平均较治疗前明显降低(P<0.01),且观察组对血清IL-6、CRP、TNF-α水平的降低幅度均明显优于对照组(P<0.01)。【结论】柴胡疏肝散加味方联合普拉克索缓释片治疗肝郁血虚型RLS抑郁情绪患者疗效确切,相比单纯口服普拉克索缓释片更有助于改善患者RLS的严重程度、抑郁程度及睡眠质量,有效抑制炎症因子表达,改善患者生活质量。

Objective To study the clinical efficacy of Flavored Chaihu Shugan Powder for the treatment of restless legs syndrome(RLS)with depressed emotion.Methods Sixty-four RLS patients with liver stagnation and blood deficiency type were randomly divided into the control group and the observation group,with 32 patients in each group.The control group was treated with oral administration of Pramipexole Sustained-Release Tablets,and the observation group was treated with Flavored Chaihu Shugan Powder on the basis of treatment for the control group.Both groups of patients were treated for 4 weeks.Before and after treatment,the two groups were observed in the changes of the scores of International Restless Legs Syndrome Severity Rating Scale(IRLS),24-item Hamilton Depression Scale(HAMD-24),Pittsburgh Sleep Quality Index(PSQI)and traditional Chinese medicine(TCM)syndrome,and serum levels of interleukin 6(IL-6),C-reactive protein(CRP),and tumor necrosis factor alpha(TNF-α),so as to assess the severity of RLS,depression degree,sleep quality and inflammatory factor expression levels after treatment.Results(1)After 4 weeks of treatment,the total effective rate of the observation group was 93.75%(30/32),and that of the control group was 87.50%(28/32).The intergroup comparison(tested by rank-sum test)showed that the clinical efficacy of the observation group was significantly superior to that of the control group(P<0.05).(2)After treatment,the IRLS,HAMD and PSQI scores of the patients in the two groups were significantly decreased compared with those before treatment(P<0.01),and the degree of decrease of IRLS,HAMD and PSQI scores in the observation group was significantly superior to that in the control group(P<0.05).(3)After treatment,the TCM syndrome scores of the two groups were significantly decreased compared with those before treatment(P<0.01),and the degree of decrease of TCM syndrome scores in the observation group was significantly superior to that in the control group(P<0.01).(4)After treatment,the serum IL-6,CRP,and TNF-αlevels of the two groups of patients were significantly reduced compared with those before treatment(P<0.01),and the degree of decrease of serum IL-6,CRP,and TNF-αlevels in the observation group was significantly superior to that in the control group(P<0.01).Conclusion The combination of Flavored Chaihu Shugan Powder and Pramipexole Sustained-Release Tablets exerts certain effect in treating RLS patients with liver stagnation and blood deficiency type,and the combined therapy is more helpful for improving the severity of RLS,depression degree and sleep quality of the patients,inhibiting the expression of inflammatory factors and improving the quality of life of the patients than Pramipexole Extended-Release Tablets alone.