中药归脾汤加减干预心脾两虚型癌因性失眠的临床疗效研究

Clinical Effect of Guipi Decoction on Insomnia Caused by Cancer with Deficiency of Heart and Spleen

目的 探讨中药归脾汤加减干预心脾两虚型癌因性失眠的临床疗效。方法 采用随机对照试验模式,纳入符合标准的心脾两虚型癌因性失眠(CRI)患者60例。受试者随机分为两组,试验组:口服汤剂归脾汤,随症加减,每日1剂、100 ml,一日2次;对照组:予以地西泮片5 mg口服,每晚1次。总疗程4周,停药后随访2周。基于匹兹堡睡眠质量指数(PSQI),中医证候评分以及疗效综合评价进行观察。结果 治疗4周后和随访2周,两组PSQ1和中医证候评分比较均有统计学意义(P<0.01),说明中药归脾汤加减治疗CRI,与西药常规治疗比较改善PSQ1评分、中医证候方面有疗效优势。两组患者治疗4周后,试验组失眠疗效评价,总有效率90.00%;对照组总有效率86.67%,无统计学意义(P>0.05)。试验组中医证候总有效率96.67%;对照组总有效率83.33%,有统计学意义(P<0.05)。这说明试验组在改善中医证候方面优于对照组。结论 与西医常规治疗比较,中药归脾汤加减干预心脾两虚型CRI可降低中医证候积分、PSQI评分,明显缓解患者失眠症状,值得临床推广。

Objective To evaluate the advantages of Guipi Decoction in the treatment of insomnia caused by cancer with deficiency of heart and spleen.Methods 60 patients with carcinomatous insomnia(CRI)with heart and spleen deficiency were included in the randomized controlled trial mode.The subjects were randomly divided into two groups:experimental group(n=30):Oral decoction guipi Decoction,increased or decreased with symptoms,1 dose,100 ml,twice a day;Control group(n=30):diazepam tablet 5 mg orally,once a night.Continuous treatment for 4 weeks,followed up for 2 weeks after drug withdrawal.The observation indexes were Pittsburgh sleep Quality Index(PSQI),TCM syndrome score and comprehensive efficacy evaluation.Results After 4 weeks of treatment and 2 weeks of follow-up,the comparison of PSQ1 and TCM syndrome score between the two groups was statistically significant(P0.05).The total effective rate of TCM syndromes in experimental group was 96.67%;The total effective rate of control group was 83.33%,which was statistically significant(P<0.05).This shows that the experimental group is superior to the control group in improving TCM syndrome.Conclusion Compared with conventional western medicine,guipi Decoction can reduce TCM syndrome score and PSQI score of CRI with heart and spleen deficiency,and significantly relieve insomnia symptoms of patients,which is worthy of clinical promotion.