【作者】 陈俊如；

【导师】 庄礼兴；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2010， 博士

【摘要】 目的本课题采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,观察电针四关穴为主治疗肝郁化火型失眠症的临床疗效并对其安全性进行客观评价。方法收集2008年10月至2009年12月期间在台湾易元堂中医诊所就诊的符合病例筛选标准的60例失眠症患者。采用随机化方法,按1：1对照原则分为电针组、中药组,电针组采用电针四关穴治疗,隔日一次,10次为一疗程,观察1个疗程。对照组采用口服丹栀逍遥丸(中药服法疗程)治疗,每次6-9g,一日二次。20日为一疗程,观察1个疗程。采用匹兹堡睡眠质量指数(PSQI)评分量表进行评定并观察其临床疗效。结果本研究共观察60例失眠症患者,中医辨证均为肝郁化火证。其中电针组30例,男13例,女17例；年龄19-69岁,平均38.61±12.57岁；病程2月-18年,平均6.23±3.65年；匹兹堡睡眠质量指数总分14.16±3.08分。中药组30例,男18例,女12例；年龄21-68岁,平均37.14±10.09岁；病程1月-16年,平均4.98±2.85岁；匹兹堡睡眠质量指数总分12.68±2.88分。患者基线特征的可比性分析中,电针组与中药组年龄、性别、病程、治疗前匹兹堡睡眠质量指数总分比较,差异均无统计意义(P>0.05),说明两组患者基线特征具有可比性。治疗1个疗程后,主要研究指标疗效,在PSQI各成分方面,经组内比较,两组自身前后对比差异均有统计意义(P<0.05)。说明电针组和中药组均能有效改善患者的睡眠时间、入睡时间、日间功能、睡眠质量、睡眠效率、睡眠障碍等情况。经组间比较,电针组在睡眠时间、日间功能、睡眠质量、睡眠障碍评定方面优于中药组。其他指标两组疗效相当。在临床疗效方面,电针组30例患者,痊愈16例,显效10例,有效3例,无效1例,总有效率96.67%：中药组30例患者,痊愈7例,显效7例,有效7例,无效9例,总有效率70.0%。两组临床疗效与总有效率的比较,差异均有统计意义(P<0.05)。可见,经电针治疗后,失眠症患者的临床症状明显改善,效果显著。电针治疗失眠症疗效优于中药组。安全性检测表明,治疗前血、尿、大便常规、肝肾功能、心电图正常者,治疗后未见异常改变,表明电针四关穴临床应用安全。综合以上临床研究结果,初步证明了采用电针四关穴的方法治疗失眠症,可有效提高其临床疗效且安全可靠。结论应用“电针四关穴”治疗失眠有明显的临床疗效,具有提高患者睡眠质量、缩短患者入睡时间、延长睡眠时间、提高睡眠效率、缓解睡眠障碍和改善日间功能的作用,在改善睡眠时间、缓解睡眠障碍、提高睡眠质量和日间功能方面上优于中药组。且该法副作用小,具有安全、可靠、简单、有效的特点。更多还原

【Abstract】 ObjectiveThe study utilizes clinical epidemiologic, research and statistical analytic methods to observe the safety and therapeutic effect of using electro-acupuncture on the siguan acupoints in treating insomnia of the stagnation of the liver qi with pathogenic heat syndrome.MethodA total of 60 insomnia patients who qualified the experimental criteria were gathered during the period of October to December of 2008 at the Yiyuan Tang TCM Clinic in Taiwan. They were randomly divided at a 1:1 ratio into electro-acupuncture group and herbal group. The previous used electro-acupuncture on the siguan acupoints once every 2 days,10 days was equivalent to 1 course of treatment; they were observed for 1 course of treatment. The latter group was prescribed herbal intake of danzhi xiaoya(?) wan,6-9g twice every day; the group was observed for once course of treatment for 10 days. Clinical effectiveness was observed and assessed via the Pittsburg Sleep Quality Index (PSQI).ResultsThe study observed a total of 60 insomnia patients diagnosed with stagnation of liver qi with pathogenic heat syndrome. The electro-acupuncture group consisted of 30 patients:13 males and 17 females, age ranged from 19 to 69 years old with an average of 38.61±12.57 years, the course of illness ranged from 2 months to 18 years, with an average of 6.23±3.65 years, the average PSQI score was 14.16±3.08. The herbal group also consisted of 30 patients:18 males and 12 females, age ranging from 21 to 68 years old with an average of 37.14±10.09 years, the course of illness ranged from 1 month to 16 years with an average of 4.98±2.85 years, and the average PSQI score was 12.68±2.88.With respect to the basic indices of the two groups, including gender, age, course of illness and PSQI score before treatment, were comparable and showed no statistical significance.After one course of treatment, the PSQI score improved in both groups and the differences were statistically significant (p<0.05), which indicated that both electro-acupuncture and herbal intake were effective in treating insomnia of the observed TCM syndrome in terms of sleep duration, sleep latency, daytime dysfunction, sleep quality, habitual sleep efficiency, and sleep disturbances. In group comparison, the electro-acupuncture group was more effective in improving sleep time, daytime dysfunction, sleep quality, and sleep disturbances than the herbal group; the groups showed similar results in other indices.In terms of clinical effectiveness, of the 30 patients in the electro-acupuncture group,16 patients were clinical recovered,10 were very effective,3 were effective, and 1 was ineffective; the total effective rate was 96.67%. As for the 30 patients in the herbal group,7 patients were clinical recovered,7 were very effective,7 were effective and 9 were ineffective; the total effective rate was 70.0%. The group differences in both clinical effectiveness and total effective rate were statistically significant (p<0.05). The total effective rate in the electro-acupuncture group was higher than that of the herbal group; patients in the electro-acupuncture group showed more improvements. Thus, electro-acupuncture treatment was more effective than herbal intake.Safety assessment was performed by taking blood work, urine and stool samples and electrocardiogram before and after treatment. No abnormal lab readings were found after treatment, which indicated that electro-acupuncture on the siguan acupoints resulted in no adverse effect in the experiment.ConclusionsUsing electro-acupuncture on the siguan acupoints to treat insomnia was clinically effective, improving patients’sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances and daytime dysfunction. The treatment was more effective in improving sleep time, sleep disturbances, sleep quality and daytime dysfunction than simply herbal intake. No adverse effect was resulted; the method was both safe and effective.更多还原