【作者】 许世峯；

【导师】 许能贵；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2011， 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,观察针刺加药物治疗心脾两虚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2010年3月至2010年10月期间在台湾许世峯中医诊所就诊的符合病例筛选标准的60例失眠症患者。采用单盲随机化方法,按1：1对照原则分为针刺加药物治疗组、中药对照组。10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。用EPIDATA3.1软件建立数据库,用SPSS15.0软件进行统计分析。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用χ2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism4.03完成。结果本研究共观察60例失眠症患者,中医辨证均为心脾两虚型失眠证。其中针刺加药物组30例,男13例,女17例；年龄19-69岁,平均38.6±12.5岁；病程2月～18年,平均6.2±3.6年；匹兹堡睡眠质量指数总分14.1±3.0分。中药对照组30例,男18例,女12例；年龄21-68岁,平均37.1±10.0岁；病程1月～16年,平均4.9±2.8岁；匹兹堡睡眠质量指数总分12.6±2.8分。患者基线特征的可比性分析中,针刺加药物组与中药组年龄、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,说明两组患者基线特征具有可比性。治疗1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。说明针刺加药物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,电针刺加药物组在睡眠时间、日间功能、睡眠质量、睡眠障碍评定方面优于中药组,其余各成分两组疗效相近。在临床疗效方面,针刺加药物组30例患者,痊愈17例,显效9例,有效3例,无效1例,总有效率96.6%；中药组30例患者,痊愈10例,显效7例,有效7例,无效6例,总有效率80.0%。两组临床疗效与总有效率的比较,差异均有统计意义。而针刺加药物组的总有效率较对照组高,可见,经针刺加药物治疗后,失眠症患者的临床症状明显改善,效果显著。针刺加药物治疗失眠症疗效优于对照组。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,表明该药临床应用安全。综合以上临床研究结果,初步证明了采用针刺加药物的方法治疗失眠症,可有效提高其临床疗效且安全可靠。结论针刺加中药治疗心脾两虚型失眠症有明显的临床疗效,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】 ObjectiveThis research adopts clinical epidemiological,clinical research methodological and mathematical statistical methods. This randomized controlled clinical trial intends to discuss the clinical curative effect and safety of insomnia treatment objectively with Acupuncture plus Chinese Herbal Medicine Therapy.MethodsResearch objects are patients who met the case selection criteria of insomnia and were treated from March 2010 to October 2010 in Xu Shifeng’s Chinese Medicine Clinic in Taiwan. Randomized single-blind method is adopted to group patients at the rate of 1:1 into the Acupuncture plus Chinese Herbal Medicine Group and the Chinese Herbal Medicine Group.10 days make one period of treatment and observe one treatment period in total. Adopt Pittsburgh PSQI to evaluate and observe its clinical curative effect. Use EPIDATA 3.1 software to set up a database and analyze with SPSS 15.0. The measurement data is expressed by mean±tandard deviation (x±S) and the numeration data by constituent ratio (%). The interclass comparison of the measurement data is expressed by the t-test (t’test or rank sum test for heterogeneity of variance), the self AP comparison by pair t test or Wilcoxon pair rank sum test. The interclass comparison of classified data is expressed by theχ2 test and the interclass comparison of ranked data by Wilcoxon rank sum test. Statistical graphics were produced by software Graph Pad Prism 4.03.Results60 insomnia patients are observed in this research of type of heart-spleen deficiency in Chinese Medicine syndrome differentiation, including 30 in the Acupuncture plus Chinese Herbal Medicine Group:male 13, female 17, between 19 and 69 years old, average age of 38.6±12.5 years old, disease course of 2 months-18 years, average disease course of 6.2±3.6 years, the Pittsburg PSQI of 14.1±3.0; 30 cases in the Chinese Herbal Medicine Group:male 18, female 12, aged 21-68 years old, an average age of 37.1±10.0 years old, the disease course 1 month-16 years, the average disease course 4.9±2.8 years, the Pittsburg PSQI of 12.6±2.8.In comparing the baseline features of patients, there’s no statistical significant difference in two groups’age, gender, disease course, Pittsburg PSQI index total score before treatment which indicates that the baseline data of two groups are comparable.After one treatment period, there’s significant difference in the in-class comparison and self AP comparison of the curative effect of principal research indexes and PSQI factors. These indicate that Acupuncture plus Chinese Herbal Medicine Group and the Chinese Herbal Medicine Group can both improve patients’hours of sleep, sleep latency, daytime function, sleep quality, sleep efficiency and sleep disorder, etc. The interclass comparison shows that the Acupuncture plus Chinese Herbal Medicine Group is superior to the Chinese Herbal Medicine group in factors of hours of sleep, daytime function, sleep quality and sleep disorder, but they have similar curative effects in other factors.In clinical efficacy, among the 30 patients in the Acupuncture plus Chinese Herbal Medicine Group, full recovery:17 cases, excellence:9 cases, utility: 3 cases, inefficacy:1 case, the total effective rate:96.6%; among the 30 patients in the Chinese Herbal Medicine Group:full recovery:10 cases, excellence:7 cases, utility:7 cases, inefficacy:6 cases, the total effective rate:80.0%. Comparing two groups’clinical curative effect and the total effective shows statistically significant differences. And the Acupuncture plus Chinese Herbal Medicine Group is superior to the Chinese Herbal Medicine Group in total effective rate. Acupuncture plus Chinese Herbal Medicine can effectively improve the clinical symptoms of insomnia patients and it’s better than the Control Group.Safety test indicated no abnormal changes occur to those with normal blood, urine, stool, liver and kidney function and electrocardiogram results which indicate that this therapy has clinical application security. With the above clinical research results taken into consideration, this thesis preliminary confirms that Acupuncture plus Chinese Herbal Medicine Therapy can improve the clinical efficacy of insomnia treatment and it’s safe and reliable.ConclusionAcupuncture plus Chinese Herbal Medicine has obvious clinical curative effect in the treatment of insomnia of heart-spleen deficiency type. It can improve sleep quality, shorten the sleep latency, extend sleep time, enhance sleep efficiency, alleviate sleep disorders and improve the daytime function. It’s superior to the Chinese Herbal Medicine Group in improving the sleep time, alleviating sleep disorders, enhancing sleep quality and daytime function. It has little side effect and it’s safe, reliable, simple and effective.更多还原