“补肾安志方”治疗以“夜寐早寤”为主症的老年不寐临床研究

Clinical Research of‘Bushen Anzhi Formula’in Treatment of‘Late Sleep and Early Wake’of Senile Insomnia

目的:观察“补肾安志方”治疗“夜寐早寤”老年不寐患者的临床疗效。方法:收集符合诊断标准的患者60例,随机分为中药组和西药组,中药组30例,给予“补肾安志方”,每日1剂,早晚餐后分服;西药组30例,给予艾司唑仑片1 mg/d,每日1次,睡前口服,共治疗8周,疗程结束后继续随访4周。填写患者临床信息采集表,采用匹兹堡睡眠质量量表(PSQI)计分,并进行统计分析。结果:(1)治疗4周、8周后与基线比较,两组差异均有统计学意义(P<0.05);停药4周后中药组与基线比较,差异有统计学意义(P<0.01);停药4周后西药组与基线比较,差异无统计学意义(P>0.05)。(2)两组治疗前与治疗后组间比较,差异无统计学意义(P>0.05);两组治疗后与停药4周后患者的匹兹堡睡眠质量指数差值、整体疗效评价的组间比较,差异均有统计学意义(P<0.05)。(3)两组患者显效率、有效率比较,差异均有统计学意义(P<0.05)。结论:运用“补肾安志方”治疗“夜寐早寤”老年不寐患者效果优于艾司唑仑西药组,疗效确切,反弹率少,持续时间长。

Objective:To observe the clinical efficacy of‘Bushen Anzhi Formula’in the treatment of‘Late sleep and early wake’of senile insomnia.Methods:60 patients who met the diagnostic criteria were randomly divided into the Chinese medication group and the western medication group,with 30 patients in each group.The Chinese medication group was treated with‘Bushen Anzhi Formula’(one dose per day),and the Western medication group was treated with Estazolam Tablets(1mg daily before sleep).The course of treatment was 8 weeks.After the treatment was finished,the patients were followed up for 4 weeks.Patient clinical information form was filled,and Pittsburgh Sleep Quality Scale(PSQI)was used for statistical analysis.Results:Compared with baseline after 4 and 8 weeks of treatment,both groups had statistical differences(P<0.05).After 4 weeks of withdrawl,compared with baseline,the Chinese medication group had significant difference(P<0.01),and the western medicinal group had no statistical difference(P>0.05).There were no statistical differences between the two groups both before the treatment and after the treatment(P>0.05);the difference of both sleep quality index and overall efficacy evaluation after 4 weeks withdrawl had statistical differences(P<0.05).The two groups were significantly different in terms of significant efficiency and effective rate(P<0.05).Conclusion:The clinical effect of‘Bushen Anzhi Formula’is better than Estazolam in treatment of‘Late sleep and early wake’of senile insomnia with its more definite and longer-term effect,and less rebound rate.