CAJ | 학술논문

目的：观察中医辨证治疗阴虚火旺和心脾两虚型亚健康失眠的临床疗效。方法采用多中心、单盲、随机对照研究方法，将符合纳入标准的亚健康失眠受试者随机分为治疗组96例和对照组94例，分别给予中医辨证汤剂和乌灵胶囊口服1周为1个疗程，共4个疗程，每周复诊1次。比较两组治疗前后匹兹堡睡眠质量量表（PSQI）评分、临床医生总体印象（CGI）评分及WHO生活质量测定量表简明版（WHOQOL-BREF）评分以评估其临床疗效。结果两组治疗后PSQI评分明显改善，与治疗前比较，差异有统计学意义（P<0.01），但组间比较差异无统计学意义（P>0.05）。两组治疗4周及治疗结束后2周CGI分值较治疗前改善（P<0.01），组间比较差异有统计学意义[治疗4周：（2.15±0.97）分比（2.64±0.87）分；治疗结束后2周：（2.21±1.01）分比（2.83±0.89）分，P<0.01）]；治疗前后两组HOQOL-BREF评分在生理、心理、环境、社会关系4个领域均有升高（P<0.01）；组间比较只有心理领域分值差异有统计学意义[（14.02±2.01）分比（13.64±1.86）分，P<0.05]。结论基于中医辨证的中药汤剂干预对阴虚火旺和心脾两虚型亚健康失眠者的症状及生活质量均有明显改善，安全性和治疗效果良好，且在改善患者的心理状况及后期CGI评分方面优于中成药乌灵胶囊。
목적：관찰중의변증치료음허화왕화심비량허형아건강실면적림상료효。방법채용다중심、단맹、수궤대조연구방법，장부합납입표준적아건강실면수시자수궤분위치료조96례화대조조94례，분별급여중의변증탕제화오령효낭구복1주위1개료정，공4개료정，매주복진1차。비교량조치료전후필자보수면질량량표（PSQI）평분、림상의생총체인상（CGI）평분급WHO생활질량측정량표간명판（WHOQOL-BREF）평분이평고기림상료효。결과량조치료후PSQI평분명현개선，여치료전비교，차이유통계학의의（P<0.01），단조간비교차이무통계학의의（P>0.05）。량조치료4주급치료결속후2주CGI분치교치료전개선（P<0.01），조간비교차이유통계학의의[치료4주：（2.15±0.97）분비（2.64±0.87）분；치료결속후2주：（2.21±1.01）분비（2.83±0.89）분，P<0.01）]；치료전후량조HOQOL-BREF평분재생리、심리、배경、사회관계4개영역균유승고（P<0.01）；조간비교지유심리영역분치차이유통계학의의[（14.02±2.01）분비（13.64±1.86）분，P<0.05]。결론기우중의변증적중약탕제간예대음허화왕화심비량허형아건강실면자적증상급생활질량균유명현개선，안전성화치료효과량호，차재개선환자적심리상황급후기CGI평분방면우우중성약오령효낭。
Objective To observe the clinical efficacy of TCM treatment for sub-healthy people with insomnia differentiated to the pattern of Yin deficiency with effulgent fire and the pattern of the heart and spleen deficiency. Methods A multi-center, single-blind and randomized control trial was carried out. Subjects who were in sub-healthy state with insomnia and met the inclusion criteria were randomly divided into treatment group (n=96) and control group (n=94). Treatment group received TCM Decoction and control group was given Wuling capsule. One course of treatment was one week and there were total 4 courses. One subsequent visit was in every week. The Pittsburgh Sleep Quality Index(PSQI), Clinical Global Impression-Improvement(CGI) and the World Health Orga-nization Quality of Life-BREF(WHOQOL-BREF) of all subjects were assessed and compared before and after treat-ment for each group and between two groups to evaluate the effectiveness. Results The PSQI scores were im-proved after treatment in both groups(P<0.01) and no significant difference was found between two groups(P>0.05). The CGI during the course and at 2 weeks after treatment was improved in both groups as compared with that be-fore treatment (P<0.01), and a significant difference was noted between treatment group and control group (during the course: 2.15±0.97 vs 2.64±0.87; at 2 weeks after treatment: 2.21±1.01 vs 2.83±0.89; all P<0.01). After treat-ment, the scores of WHOQOL-BREF in the fields of physiology, psychology, environment, and social relations were all higher than those before treatment in both groups, but only the score of the psychological field was statistically different between treatment group and control group(14.02±2.01 vs 13.64±1.86, P<0.05). Conclusion The TCM in-terference for insomnia patients with differential patterns of Yin deficiency with effulgent fire and of the heart and spleen deficiency and their quality of life is effective, with satisfactory safety and compliance. TCM differential in-terference may be superior to Wuling capsules in aspects of improving patients' psychologic status and late CGI.