靳三针疗法治疗围绝经期失眠的临床研究
摘要
目的：
本课题采用临床随机对照研究的方法,观察靳三针疗法治疗围绝经期失眠的临床疗效,对比靳三针疗法和艾司唑仑片对睡眠障碍、抑郁程度的改善情况,探讨治疗围绝经期失眠的优化方案。方法：
收集2013年2月-2014年2月期间在本人工作单位及广州中医药大学第一附属医院针灸科就诊的符合病例筛选标准的90例围绝经期失眠症患者。采用随机化方法,按1：1对照原则分为治疗组、对照组,每组45例。治疗组采用靳三针疗法治疗,电针郁三针、定神针组穴,均两侧取穴。每周周一、周三、周五治疗一次。对照组采用口服艾司唑仑片治疗,每次lmg,每日睡前服用。治疗4周为1个疗程。治疗前、治疗1周后、治疗4周后填写观察表。使用匹兹堡睡眠质量指数(PSQI)评分量表、汉密尔顿抑郁量表(HAMD)和国际统一睡眠效率值进行评定并观察临床疗效。用SPSS18.0软件进行统计分析。
结果：
本研究共观察病人101位,其中共有合格受试者90例,11例为未完成临床研究病例或中途退出病例。有门诊病人及住院病人,年龄分布由45至55岁,均为女性,病程1月-2年,其中治疗组45例,平均50.04±2.67岁；平均病程13.36±7.47月；匹兹堡睡眠质量指数总分14.13±2.63分。对照组45例,平均50.42±2.96岁；平均病程13.51±7.76月；匹兹堡睡眠质量指数总分14.14±2.60分。
从患者基线特征的可比性分析中显示,两组基线特点具备可比性。
治疗后,分别观察各项指标,两组治疗后有效率治疗组为93.33%；对照组为86.67%,经统计学比较有统计学差异(P<0.05)。对PSQI评分板块的观察,靳三针疗法在改善睡眠质量、睡眠效率,减轻睡眠障碍、日间功能障碍方面优于对照组(P<0.05),在缩短入睡时间、延长睡眠时间方面效果与对照组相近,无统计学差异(P>0.05)。对PSQI总分分析,靳三针疗法的短期(1周)疗效与对照组无统计学差异(P>0.05),长期疗效(4周)与对照组有统计学差异,疗效优于对照组(P<0.05)。对HAMD汉密尔顿抑郁量表的观察,靳三针疗法能改善抑郁状态,调整心境,在评分上优于对照组(P<0.05)。
在安全性检测中,两组患者均未出现严重不良反应,表明两种治疗方法安全可靠。
综合以上临床研究结果,初步证明了采用靳三针疗法治疗围绝经期失眠,不仅有效缓解症状,并可改善抑郁程度,同时安全可靠。结论：
使用靳三针疗法治疗围绝经期失眠有明确的临床疗效,在PSQI总分及改善睡眠质量、睡眠效率,减少睡眠障碍、日间功能障碍方面优于对照组。短期(1周)疗效与对照组相近,长期疗效(4周)优于对照组。此外靳三针疗法在改善抑郁程度、调整心境上优于对照组。且该方法副作用小,安全、可靠、不产生药物依赖,值得临床推广。
Objective
This research intends to evaluate the effectiveness of treating Menopausal insomnia with Jin three needle therapy. We used randomized controlled clinical trial to compare Jin three needle therapy and Estazolam Tablet's effectiveness of sleeping disorders and depression. We hope to propose an optimization solution for Menopausal insomnia.
Methods
Research objects are90patients who were diagnosed as Menopausal insomnia in the clinic I work for and the First Affiliated Hospital of Guangzhou University of TCM's acupuncture department from February2013to February2014. The patients who met inclusion standards were randomly divided into the treatment group and the control group according to1:1comparison principle, both45cases. The treatment group is treated by Jin three needle therapy. We used electro-acupuncture on Melancholy three needle points and Stabilizing shen points at both sides. Treatments were done3times a week on Monday, Wednesday and Friday. The control group was treated by Estazolam tablet lmg daily bedtime.4weeks for a course of treatment. Records were made before,1week and4week after the treatment. We evaluated their improvement and the clinical efficacy according to The Pittsburgh Sleep Quality Index (PSQI), Hamilton's depression scale (HAMD), and Unified international sleep efficiency value. Statistical analysis was performed using SPSS18.0software.
Results
Our research observed101patients,90of them are eligible subjects,11of them did not enter the clinical study or quit the research. Our subjects included outpatient and inpatient, age45-55years old. All of them were female, their course of disease last for1month to2years, in which the treatment group of45patients, with an average age of50.04±2.67; average duration of13.36±7.47months.
The treatment group had45cases, at average of50.04±2.67years old, Their average duration is13.36±7.47months, Pittsburgh sleep quality index score of14.13±2.63points. While the control group had45cases, at average of50.42±2.96years old, Their average duration is13.51±7.76months, Pittsburgh sleep quality index score of14.14±2.60points.
Comparable analysis of baseline characteristics of patients shows that two groups of baseline characteristics have comparability.
After the treatment, We compared the scores. The efficiency of treatment group is93.33%while the control group is86.67%, with statistical significant difference (P<0.05). We compared every factor and total score of PSQI, Jin three needle therapy score better in improving sleeping quality, sleeping latency, and reducing sleep disorders and daytime dysfunction than the control group (P<0.05). But in other factors they have no statistical difference (P>0.05). Jin three needle therapy scores similar to the control group in total score of PSQI in one week (P>0.05), but scores better after4weeks treatment (P<0.05).According to the score of Hamilton's depression scale(HAMD) Jin three needle therapy is better than the control group in improving depressive state and improving mood (P<0.05)
In the safety detection, patients in both two groups did not occurred serious adverse reaction, which suggests two methods are both safe and reliable.
According to above clinical research, it was preliminary proved that Jin three needle therapy is not only effective in the treatment for Menopausal insomnia, and can improve the degree of depression, at the same time, safe and reliable.
Conelusion
Use Jin three needle therapy to treat menopausal transition insomnia has definite clinical effect. Jin three needle therapy was significantly better than the control group in improving sleep quality, sleep efficiency, reducing the sleep disorders and daytime dysfunction. In the aspect of Short term efficacy (1week), Jin three needle therapy was similar to the control group, but in the aspect of long term efficacy (4weeks), its curative effect was significantly better. Moreover, Jin three needle therapy was better in improving the degree of depression and anxiety. Furthermore, it has less side effects and does not produce drug dependence, which is safe and reliable that worth clinical promotion.
本课题采用临床随机对照研究的方法,观察靳三针疗法治疗围绝经期失眠的临床疗效,对比靳三针疗法和艾司唑仑片对睡眠障碍、抑郁程度的改善情况,探讨治疗围绝经期失眠的优化方案。方法：
收集2013年2月-2014年2月期间在本人工作单位及广州中医药大学第一附属医院针灸科就诊的符合病例筛选标准的90例围绝经期失眠症患者。采用随机化方法,按1：1对照原则分为治疗组、对照组,每组45例。治疗组采用靳三针疗法治疗,电针郁三针、定神针组穴,均两侧取穴。每周周一、周三、周五治疗一次。对照组采用口服艾司唑仑片治疗,每次lmg,每日睡前服用。治疗4周为1个疗程。治疗前、治疗1周后、治疗4周后填写观察表。使用匹兹堡睡眠质量指数(PSQI)评分量表、汉密尔顿抑郁量表(HAMD)和国际统一睡眠效率值进行评定并观察临床疗效。用SPSS18.0软件进行统计分析。
结果：
本研究共观察病人101位,其中共有合格受试者90例,11例为未完成临床研究病例或中途退出病例。有门诊病人及住院病人,年龄分布由45至55岁,均为女性,病程1月-2年,其中治疗组45例,平均50.04±2.67岁；平均病程13.36±7.47月；匹兹堡睡眠质量指数总分14.13±2.63分。对照组45例,平均50.42±2.96岁；平均病程13.51±7.76月；匹兹堡睡眠质量指数总分14.14±2.60分。
从患者基线特征的可比性分析中显示,两组基线特点具备可比性。
治疗后,分别观察各项指标,两组治疗后有效率治疗组为93.33%；对照组为86.67%,经统计学比较有统计学差异(P<0.05)。对PSQI评分板块的观察,靳三针疗法在改善睡眠质量、睡眠效率,减轻睡眠障碍、日间功能障碍方面优于对照组(P<0.05),在缩短入睡时间、延长睡眠时间方面效果与对照组相近,无统计学差异(P>0.05)。对PSQI总分分析,靳三针疗法的短期(1周)疗效与对照组无统计学差异(P>0.05),长期疗效(4周)与对照组有统计学差异,疗效优于对照组(P<0.05)。对HAMD汉密尔顿抑郁量表的观察,靳三针疗法能改善抑郁状态,调整心境,在评分上优于对照组(P<0.05)。
在安全性检测中,两组患者均未出现严重不良反应,表明两种治疗方法安全可靠。
综合以上临床研究结果,初步证明了采用靳三针疗法治疗围绝经期失眠,不仅有效缓解症状,并可改善抑郁程度,同时安全可靠。结论：
使用靳三针疗法治疗围绝经期失眠有明确的临床疗效,在PSQI总分及改善睡眠质量、睡眠效率,减少睡眠障碍、日间功能障碍方面优于对照组。短期(1周)疗效与对照组相近,长期疗效(4周)优于对照组。此外靳三针疗法在改善抑郁程度、调整心境上优于对照组。且该方法副作用小,安全、可靠、不产生药物依赖,值得临床推广。
Objective
This research intends to evaluate the effectiveness of treating Menopausal insomnia with Jin three needle therapy. We used randomized controlled clinical trial to compare Jin three needle therapy and Estazolam Tablet's effectiveness of sleeping disorders and depression. We hope to propose an optimization solution for Menopausal insomnia.
Methods
Research objects are90patients who were diagnosed as Menopausal insomnia in the clinic I work for and the First Affiliated Hospital of Guangzhou University of TCM's acupuncture department from February2013to February2014. The patients who met inclusion standards were randomly divided into the treatment group and the control group according to1:1comparison principle, both45cases. The treatment group is treated by Jin three needle therapy. We used electro-acupuncture on Melancholy three needle points and Stabilizing shen points at both sides. Treatments were done3times a week on Monday, Wednesday and Friday. The control group was treated by Estazolam tablet lmg daily bedtime.4weeks for a course of treatment. Records were made before,1week and4week after the treatment. We evaluated their improvement and the clinical efficacy according to The Pittsburgh Sleep Quality Index (PSQI), Hamilton's depression scale (HAMD), and Unified international sleep efficiency value. Statistical analysis was performed using SPSS18.0software.
Results
Our research observed101patients,90of them are eligible subjects,11of them did not enter the clinical study or quit the research. Our subjects included outpatient and inpatient, age45-55years old. All of them were female, their course of disease last for1month to2years, in which the treatment group of45patients, with an average age of50.04±2.67; average duration of13.36±7.47months.
The treatment group had45cases, at average of50.04±2.67years old, Their average duration is13.36±7.47months, Pittsburgh sleep quality index score of14.13±2.63points. While the control group had45cases, at average of50.42±2.96years old, Their average duration is13.51±7.76months, Pittsburgh sleep quality index score of14.14±2.60points.
Comparable analysis of baseline characteristics of patients shows that two groups of baseline characteristics have comparability.
After the treatment, We compared the scores. The efficiency of treatment group is93.33%while the control group is86.67%, with statistical significant difference (P<0.05). We compared every factor and total score of PSQI, Jin three needle therapy score better in improving sleeping quality, sleeping latency, and reducing sleep disorders and daytime dysfunction than the control group (P<0.05). But in other factors they have no statistical difference (P>0.05). Jin three needle therapy scores similar to the control group in total score of PSQI in one week (P>0.05), but scores better after4weeks treatment (P<0.05).According to the score of Hamilton's depression scale(HAMD) Jin three needle therapy is better than the control group in improving depressive state and improving mood (P<0.05)
In the safety detection, patients in both two groups did not occurred serious adverse reaction, which suggests two methods are both safe and reliable.
According to above clinical research, it was preliminary proved that Jin three needle therapy is not only effective in the treatment for Menopausal insomnia, and can improve the degree of depression, at the same time, safe and reliable.
Conelusion
Use Jin three needle therapy to treat menopausal transition insomnia has definite clinical effect. Jin three needle therapy was significantly better than the control group in improving sleep quality, sleep efficiency, reducing the sleep disorders and daytime dysfunction. In the aspect of Short term efficacy (1week), Jin three needle therapy was similar to the control group, but in the aspect of long term efficacy (4weeks), its curative effect was significantly better. Moreover, Jin three needle therapy was better in improving the degree of depression and anxiety. Furthermore, it has less side effects and does not produce drug dependence, which is safe and reliable that worth clinical promotion.
引文
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