病机与证候并重的阴阳分治法治疗早醒型失眠的临床研究
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摘要
研究目的
本研究采用临床随机对照试验方案,探讨病机与证候并重的阴阳分治法治疗早醒型失眠的临床疗效,为病机与证候并重的阴阳分治法的确立提供科学依据。研究方法
本研究是以早醒型失眠患者为研究对象的随机对照临床试验,共纳入病例160例。研究依据sas8.2软件制作的随机化方案,将纳入的病例随机分为试验组和对照组。试验组患者于早卯时(7时)服用“早醒寤方”；晚酉时(19时)服用“早醒寐方”；睡前1小时温水足浴20分钟；同时配合以针灸治疗方案。对照组予口服艾司唑仑治疗。疗程为2周。睡眠评估采用Epworth困倦量表、匹兹堡睡眠质量指数评定量表(PSQI).所纳入的病例分别于治疗前、治疗第7天、疗程结束时(第14天)各测评1次。治疗结束后,应用Access软件建立数据库。参照《中药新药临床研究指导原则》评定其临床疗效。并以自拟昼不精指数作为反映患者日间觉醒状态的指标,自拟夜不暝指数作为反映患者夜间睡眠质量的评价指标,应用SPSS17.0软件,采取相应统计学方法进行统计分析,以明确试验结果。研究结果
本研究的病例来源为北京市社区中医药服务科技支撑示范项目下的课题一《基于社区医疗的失眠中医综合辨治法对早醒型失眠“昼不精、夜不瞑”的影响》所纳入的病例。本研究共入选病例160例,其中试验组女性62例,男性18例,最小年龄31岁,最大年龄80岁,平均年龄57.66±12.488岁,病程最短者6周,病程最长者为30年,平均病程3.95±6.202年；对照组女性55例,男性25例,年龄最小者29岁,最大者79岁,平均年龄59.79±12.986岁。对照组病程最短者为4周,病程最长者30年,平均病程为3.79±6.093年。
根据患者入组时基线资料的统计学分析,得出试验组与对照组在治疗前的年龄、性别、病程、睡眠时间、受教育程度、睡眠药物服用史、PSQI量表总分及各因子积分、Epworth量表评分、自拟昼不精指数和夜不暝指数评分间均具有可比性。研究结果显示试验组在7天和14天的临床有效率分别是68.75%和83.75%,对照组在7天和14天临床有效率分别是73.75%和77.5%。两组近期的临床疗效相近,但远期的临床疗效试验组较优。虽然两组的治疗均能改善患者的日间功能状态和夜间睡眠质量,但试验组结果明显优于对照组。且试验组具有在近期明显改善患者“夜不暝”状态的同时持续稳定的改善患者“昼不精,夜不瞑”的状态的特点。
结论
(1)病机与证候并重的阴阳分治法指导下的中医治疗组在改善患者日间觉醒状态、夜间睡眠状况以及远期临床疗效方面明显优于西医对照组。病机与证候并重的阴阳分治法能够有效的帮助失眠患者恢复“昼精而夜瞑”的生理状态。
(2)病机与证候并重的阴阳分治法治疗早醒型失眠的方案成熟,理论基础明确,临床疗效肯定,方法简便易行,是治疗失眠的有效方法。
Objective
In this study, randomized controlled clinical trial is applied to evaluate the clinical efficacy of the therapy based on difference between the treatment of yin and yang on early awakening type of insomnia. And the clinical trial is designed to provide a scientific basis for the therapy based on difference between the treatment of yin and yang
Method
In this study, a total of160cases were included. The randomized protocol produced by SAS8.2software was used. The patients suffering from early awakening type of insomnia were randomly assigned to the treatment group and control group. Patients of treatment group, including80cases, took the polyjuice potion named "zao xing wu fang", at7a. m, polyjuice potion named "zao xing mei fang", at7p. m. and20minutes warm water foot bath before going to bed. Besides, the patients from treatment group recieved the acupuncture treatment. Patients of control group, which also include80cases, took the estazolam therapy. The duration of treatment lasted2weeks. Patients in both groups were measured at the beginning、7days and the end of treatment (14days). The content of assessment included clinical efficacy, the daytime energy situation index and the nocturnal sleep situation index. The results were analysed by the SPSS17.0statistical software.
Results
These patients suffering from early awakening type of insomnia came from the project of community service technology to support demonstration projects in Beijing. The treatment group includes18cases of male patients and62cases of female patients. The youngest in the treatment group is31years old, and the oldest is80years, the mean age is57.66±12.488years old. The shortest duration of insomnia is6weeks, and the longest disease duration is30years, the mean disease duration is3.95±6.202years. In the control group, there includes25male patients and55female patients. The youngest is29years old and the oldest is79years old, the mean age is59.79±12.986years old, the shortest disease duration is4weeks, and the longest is30years, the mean disease duration is3.79±6.093years.
According to statistical analysis, the general information of the treatment group and the control group before the treatment, including gender, age, educational level, duration of sleep time, each item and total score of PSQI, the Epworth Sleepiness Scale, the daytime energy situation index and the nocturnal sleep situation index, is indifference (P>0.05). The results show that the clinical efficacy of the treatment group is68.75%and83.75%, respectively in the treatment course of7days and14days. And that of the control group is73.75%and77.5%respectively.The short-term clinical efficacy of the two groups is similar, while the long-term efficacy of the treatment group is better. The treatment of the both groups can improve the situation of patients in status of daytime function and nocturnal sleep quality, while the efficacy of the treatment group is significantly better efficacy than the control group.
Conclusion
(1) The therapy based on difference between the treatment of yin and yang is better than western medicine therapy in improving in the status of daytime function, the nocturnal sleep quality and the long-term clinical efficacy for the early awakening type of insomnia.
(2) With clear clinical and theoretical basis, the therapy based on difference between the treatment of yin and yang has a positive clinical effect. Thus it is an effective method for the treatment of insomnia.
本研究采用临床随机对照试验方案,探讨病机与证候并重的阴阳分治法治疗早醒型失眠的临床疗效,为病机与证候并重的阴阳分治法的确立提供科学依据。研究方法
本研究是以早醒型失眠患者为研究对象的随机对照临床试验,共纳入病例160例。研究依据sas8.2软件制作的随机化方案,将纳入的病例随机分为试验组和对照组。试验组患者于早卯时(7时)服用“早醒寤方”；晚酉时(19时)服用“早醒寐方”；睡前1小时温水足浴20分钟；同时配合以针灸治疗方案。对照组予口服艾司唑仑治疗。疗程为2周。睡眠评估采用Epworth困倦量表、匹兹堡睡眠质量指数评定量表(PSQI).所纳入的病例分别于治疗前、治疗第7天、疗程结束时(第14天)各测评1次。治疗结束后,应用Access软件建立数据库。参照《中药新药临床研究指导原则》评定其临床疗效。并以自拟昼不精指数作为反映患者日间觉醒状态的指标,自拟夜不暝指数作为反映患者夜间睡眠质量的评价指标,应用SPSS17.0软件,采取相应统计学方法进行统计分析,以明确试验结果。研究结果
本研究的病例来源为北京市社区中医药服务科技支撑示范项目下的课题一《基于社区医疗的失眠中医综合辨治法对早醒型失眠“昼不精、夜不瞑”的影响》所纳入的病例。本研究共入选病例160例,其中试验组女性62例,男性18例,最小年龄31岁,最大年龄80岁,平均年龄57.66±12.488岁,病程最短者6周,病程最长者为30年,平均病程3.95±6.202年；对照组女性55例,男性25例,年龄最小者29岁,最大者79岁,平均年龄59.79±12.986岁。对照组病程最短者为4周,病程最长者30年,平均病程为3.79±6.093年。
根据患者入组时基线资料的统计学分析,得出试验组与对照组在治疗前的年龄、性别、病程、睡眠时间、受教育程度、睡眠药物服用史、PSQI量表总分及各因子积分、Epworth量表评分、自拟昼不精指数和夜不暝指数评分间均具有可比性。研究结果显示试验组在7天和14天的临床有效率分别是68.75%和83.75%,对照组在7天和14天临床有效率分别是73.75%和77.5%。两组近期的临床疗效相近,但远期的临床疗效试验组较优。虽然两组的治疗均能改善患者的日间功能状态和夜间睡眠质量,但试验组结果明显优于对照组。且试验组具有在近期明显改善患者“夜不暝”状态的同时持续稳定的改善患者“昼不精,夜不瞑”的状态的特点。
结论
(1)病机与证候并重的阴阳分治法指导下的中医治疗组在改善患者日间觉醒状态、夜间睡眠状况以及远期临床疗效方面明显优于西医对照组。病机与证候并重的阴阳分治法能够有效的帮助失眠患者恢复“昼精而夜瞑”的生理状态。
(2)病机与证候并重的阴阳分治法治疗早醒型失眠的方案成熟,理论基础明确,临床疗效肯定,方法简便易行,是治疗失眠的有效方法。
Objective
In this study, randomized controlled clinical trial is applied to evaluate the clinical efficacy of the therapy based on difference between the treatment of yin and yang on early awakening type of insomnia. And the clinical trial is designed to provide a scientific basis for the therapy based on difference between the treatment of yin and yang
Method
In this study, a total of160cases were included. The randomized protocol produced by SAS8.2software was used. The patients suffering from early awakening type of insomnia were randomly assigned to the treatment group and control group. Patients of treatment group, including80cases, took the polyjuice potion named "zao xing wu fang", at7a. m, polyjuice potion named "zao xing mei fang", at7p. m. and20minutes warm water foot bath before going to bed. Besides, the patients from treatment group recieved the acupuncture treatment. Patients of control group, which also include80cases, took the estazolam therapy. The duration of treatment lasted2weeks. Patients in both groups were measured at the beginning、7days and the end of treatment (14days). The content of assessment included clinical efficacy, the daytime energy situation index and the nocturnal sleep situation index. The results were analysed by the SPSS17.0statistical software.
Results
These patients suffering from early awakening type of insomnia came from the project of community service technology to support demonstration projects in Beijing. The treatment group includes18cases of male patients and62cases of female patients. The youngest in the treatment group is31years old, and the oldest is80years, the mean age is57.66±12.488years old. The shortest duration of insomnia is6weeks, and the longest disease duration is30years, the mean disease duration is3.95±6.202years. In the control group, there includes25male patients and55female patients. The youngest is29years old and the oldest is79years old, the mean age is59.79±12.986years old, the shortest disease duration is4weeks, and the longest is30years, the mean disease duration is3.79±6.093years.
According to statistical analysis, the general information of the treatment group and the control group before the treatment, including gender, age, educational level, duration of sleep time, each item and total score of PSQI, the Epworth Sleepiness Scale, the daytime energy situation index and the nocturnal sleep situation index, is indifference (P>0.05). The results show that the clinical efficacy of the treatment group is68.75%and83.75%, respectively in the treatment course of7days and14days. And that of the control group is73.75%and77.5%respectively.The short-term clinical efficacy of the two groups is similar, while the long-term efficacy of the treatment group is better. The treatment of the both groups can improve the situation of patients in status of daytime function and nocturnal sleep quality, while the efficacy of the treatment group is significantly better efficacy than the control group.
Conclusion
(1) The therapy based on difference between the treatment of yin and yang is better than western medicine therapy in improving in the status of daytime function, the nocturnal sleep quality and the long-term clinical efficacy for the early awakening type of insomnia.
(2) With clear clinical and theoretical basis, the therapy based on difference between the treatment of yin and yang has a positive clinical effect. Thus it is an effective method for the treatment of insomnia.
引文
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