孔圣枕中丹配方颗粒治疗心肾阴虚证肿瘤相关失眠疗效观察

Kongsheng Zhenzhong dispensing granule on tumor-related insomnia patients with deficiency in heart and kidney

目的综合评价经典名方孔圣枕中丹(配方颗粒)对心肾阴虚证肿瘤相关失眠的治疗效果,为临床推广应用提供依据。方法将符合诊断标准的肿瘤相关失眠患者随机分为治疗组与对照组,治疗组应用孔圣枕中丹免煎颗粒,每日早、晚餐后30 min各服1袋;对照组仅常规西药舒乐安定治疗失眠,每晚口服1 mg;28 d为1疗程。选择国际通用的匹兹堡睡眠质量指数量表(PSQI)、中医证候量表为观察指标,分别在治疗前、治疗第14天、治疗第28天记录2组病例PSQI评分、临床证候与单项症状变化,并以SPSS 18.0统计软件分析睡眠质量、中医证候疗效。结果与对照组比较,孔圣枕中丹颗粒治疗肿瘤相关失眠,在第14、28天,能够明显改善患者PSQI、中医证候积分,与对照组比较,经t检验,具有统计学意义,治疗组优于对照组(P<0.001);治疗组睡眠疗效优于对照组,经卡方检验,有统计学意义(P<0.001);治疗组中医证候疗效优于对照组(P<0.001)。第14、28天与第1天以及第14天与第28天PSQI各单项积分比较,除第14天与第28天睡眠P>0.05,其余各项比较,均具有统计学意义(P<0.001)。结论孔圣枕中丹颗粒治疗肿瘤相关失眠有确切疗效,值得临床推广应用。

Objective To evaluate comprehensively therapeutic effect of Kongsheng Zhenzhong Pill（ dispensing granule）（ KSZZ）,a classic TCM herbal formula,on tumor-relater insomnia patients with TCM pattern of deficiency in heart and kidney,so as to provide foundation for clinical application. Methods Sixty tumor-related insomnia patients with deficiency in heart and kidney who were conformed to the diagnostic criteria were randomly divided into control group and treatment group（ each n = 30）. Patients in treatment group took orally KSZZ twice daily,one pack 30 minutes after breakfast and dinner,and those in treatment group took orally estazolam at dose of 1 mg at night,for consecutive 28 days. Pittsburgh sleep quality index scale（ PSQI） and TCM Pattern Integral were used before treatment,on Day 1,Day14 and Day 28 after treatment,so as to record PSQI score,TCM clinical pattern and change of single symptom. Then the quality of sleep and TCM pattern curative efficacy were calculated by using SPSS 18. 0 software. Results Compared with the control group,PSQI scores and TCM pattern integral decreased significantly（ P 〈0. 001）. The curative efficacy of KSZZ on insomnia or TCM pattern was high-er than that of estazolam（ P〈 0. 001）. The scoring of individual symptoms on Day 14 or Day 28 were lower obviously than those on Day 1（ P〈 0. 001）,except sleep efficiency on Day 14 and Day 28（ P〈0. 05）. Conclusion The curative effect of KSZZ on improving sleep quality of tumor-related insomnia patients has been proved,and KSZZ could be worthy of wide clinical application.