ABSTRACT
Objective::To observe the clinical efficacy of modified therapy of Qingxintang combined Zhenzhongdan in the treatment of cardionephric disharmony type insomnia. Method::A total 100 cases were randomly divided into control group and treatment group according to the random number table method on the basis of the inclusion order, with 50 cases in each group.The control group was given esazolam, 1.0 mg·d-1 before bedtime.The observation group was treated with Qingxintang and Zhenzhongdan, 1 dose per day, 2 times per day, for 6 days continuously, and rested for a day.The course of treatment was both 8 weeks.Pittsburgh sleep quality index (PSQI) score was compared between the two groups before and after treatment.The polysomnography monitor for [awakening time (AWT), total sleep time (TST), sleep maintenance rate (SE), sleep latency (SL), rapid eye movement sleep latency (RL), awakening times (AT)] was used to monitor sleep progress.The monoamine neurotransmitters [5-hydroxyindoleacetic acid (5-HIAA), 5-hydroxy-tryptamine (5-HT), norepinephrine (NE) and β-endorphin (β-EP)] were measured.The clinical efficacy was observed in two groups after treatment for 30 d, and the incidence of adverse reactions was researched during the study. Result::Totally 7 cases were lost during the study.The total effective rate in the observation group was 89.6% (43/48), which was higher than 71.1% (32/45) in the control group (P<0.05). The PSQI score in treatment group was significantly, which was lower than that in control group (P<0.05). TST, SE, RL in treatment group were higher than those in control group (P<0.05), while AWT, SL, AT were lower than those in control group (P<0.05). The 5-HIAA, 5-HT and β-EP levels in treatment group were higher than those in control group (P<0.05), whereas the NE levels were lower than those in control group (P<0.05). The incidence of adverse reactions was 22.2% (10/45) in control group, and no significant adverse reactions were observed in treatment group. Conclusion::Qingxintang and Zhenzhongdan could obviously alleviate clinical symptoms of cardionephric disharmony type insomnia, and monoamine neurotransmitters, with a low incidence of adverse reactions, and thus is worthy of clinical promotion and application.