摘要
【目的】观察孔圣枕中丹加味方治疗心肾两虚型失眠的临床疗效和安全性。【方法】将70例心肾两虚型失眠患者随机分为治疗组和对照组,每组各35例。治疗组给予孔圣枕中丹加味方口服治疗,对照组给予佐匹克隆片口服治疗,疗程为4周。观察2组患者治疗前、治疗2周后和治疗4周后匹兹堡睡眠质量指数(PSQI)评分、中医证候积分的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)临床疗效方面:治疗4周后,治疗组的总有效率为88.57%(31/35),对照组为62.86%(22/35),组间比较,治疗组的疗效有优于对照组趋势,但差异无统计学意义(P>0.05)。(2)睡眠质量方面:治疗2周和4周后,2组患者的PSQI评分均较治疗前降低,差异均有统计学意义(P<0.05),但组间比较,差异均无统计学意义(P>0.05)。(3)中医证候方面:治疗2周和4周后,治疗组的中医证候积分均较治疗前明显降低(P<0.05),而对照组的中医证候积分较治疗前有降低趋势,但差异均无统计学意义(P>0.05);组间比较,治疗组在治疗2周和4周后对中医证候积分的降低作用均明显优于对照组,差异均有统计学意义(P<0.05或P<0.01)。(4)安全性方面:治疗过程中,治疗组无明显不适;对照组出现2例头晕,3例口干口苦,未予停药或特殊处理。【结论】孔圣枕中丹加味方治疗心肾两虚型失眠疗效确切,可有效改善患者的睡眠质量和中医证候,且具有较高的安全性。
Objective To observe the clinical efficacy and safety of modified Kongsheng Zhenzhongdan Decoction in treating patients with heart-kidney deficiency type of insomnia. Methods Seventy patients with heart-kidney deficiency type of insomnia were randomly divided into the treatment group and the control group,with 35 cases in each group. The treatment group was given oral administration of modified Kongsheng Zhenzhongdan Decoction,while the control group was given oral administration of Zopiclone Tablets. Both groups were treated for 4 weeks.The changes in the Pittsburgh Sleep Quality Index(PSQI)scores and traditional Chinese medicine(TCM)syndrome scores in the two groups were observed before treatment and after 2 and 4 weeks of treatment. Moreover, the clinical efficacy and safety of the two groups were evaluated. Results(1)After 4 weeks of treatment,the overall effective rate of the treatment group was 88.57%(31/35)and that of the control group was 62.86%(22/35). The intergroup comparison showed that the efficacy of the treatment group tended to be superior to that of the control group,but the difference was not statistically significant(P>0.05).(2)After 2 and 4 weeks of treatment,the PSQI scores for sleep quality in both groups were decreased compared with those before treatment, and the differences were statistically significant(P<0.05). However,there was no statistical significance between the two groups after treatment(P>0.05).(3)After 2 and 4 weeks of treatment,the TCM syndrome scores of the treatment group were significantly decreased compared with those before treatment(P<0.05), while the TCM syndrome scores of the control group tended to be lower than those before treatment,but the difference was not statistically significant(P>0.05). The intergroup comparison showed that the treatment group had stronger effect on decreasing TCM syndrome scores than the control group after 2 and 4 weeks of treatment,and the differences were statistically significant(P<0.05 or P<0.01).(4)During treatment,there was no significant discomforts in the treatment group;in the control group,there were 2 cases of dizziness and 3 cases of dry mouth and bitter mouth,which needed no discontinuation or special treatment. Conclusion The modified Kongsheng Zhenzhongdan Decoction exerts certain effect in treating patients with heart-kidney deficiency type of insomnia. It is effective and safe on improving patients’ sleep quality and TCM syndrome.
作者
陈玉玲
王晨曦
裴清华
郑琴
CHEN Yu-Ling;WANG Chen-Xi;PEI Qing-Hua;ZHENG Qin(The Third School of Clinical Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;Department of Encephalopathy,the Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《广州中医药大学学报》
CAS
2023年第4期833-837,共5页
Journal of Guangzhou University of Traditional Chinese Medicine
基金
北京市科委首都特色临床应用项目(编号:Z171100001017227)
中央高校基本科研业务费专项基金资助项目(编号:2015-JYBJSMS138)。
关键词
孔圣枕中丹加味方
失眠
心肾两虚
匹兹堡睡眠质量指数(PSQI)评分
中医证候积分
modified Kongsheng Zhenzhongdan Decoction
insomnia
heart-kidney deficiency
Pittsburgh Sleep Quality Index(PSQI)scores
traditional Chinese medicine(TCM)syndrome scores
作者简介
陈玉玲(1996-),女,硕士研究生,E-mail:chyling10@163.com;共同第一作者:王晨曦(1994-),女,硕士研究生,E-mail:1369886144@qq.com;通信作者:裴清华(1973-),女(朝鲜族),教授,主任医师,硕士研究生导师,E-mail:peiqinghua333@126.com。
