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[摘要]
目的 以灵芝口服液为对照评价灵芪加口服液治疗失眠症(心脾两虚证)临床应用的有效性和安全性。方法 将188例失眠症(心脾两虚证)患者随机分为两组,治疗组141例、对照组47例;治疗组实施灵芪加口服液治疗,对照组实施灵芝口服液治疗,两组均治疗4周。比较两组匹茨堡睡眠质量指数量表(PSQI)评分改善情况、疾病综合疗效、中医证候疗效及不良反应。结果 两组治疗后匹茨堡睡眠质量指数量表(PSQI)评分均低于治疗前,组内比较差异均有统计学意义(P < 0.05);两组间比较采用秩和检验,差异无统计学意义(P=0.9598)。疾病综合疗效:治疗组愈显率47.52%,总有效率75.18%;对照组愈显率27.66%,总有效率59.57%。两组愈显率治疗组优于对照组(χ2=5.6864,P=0.0171),两组总有效率治疗组优于对照组(χ2=4.1916,P=0.0406)。中医证候疗效:治疗组愈显率48.23%;对照组愈显率27.66%,两组愈显率比较,治疗组优于对照组(χ2=6.0808,P=0.0137)。"失眠"、"倦怠乏力"、"精神不振"、"食欲不振"单项症状,治疗组优于对照组,差异有统计学意义(P < 0.05)。结论 灵芪加口服液治疗失眠症(心脾两虚证)疗效确切,临床服用安全,具有较好的临床应用前景。
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[Abstract]
Objective Ganoderma lucidum liquid to control evaluation spirit stilbene plus oral liquid in the treatment of insomnia (Syndrome of deficiency of both heart and spleen) subjects the efficacy and safety of clinical application. Methods 188 subjects of insomnia (Syndrome of deficiency of both heart and spleen) subjects patients were randomly divided into two groups, 141 subjects were enrolled in the treatment group, 47 subjects were were enrolled in the control group; Treatment group were treated with spirit stilbene plus oral liquid, control group were treated with ganoderma oral liquid. Results This study the two groups after treatment of Pittsburgh sleep quality index scale (PSQI) score is lower than before treatment, compare differences in the group had statistical significance (P < 0.05), the comparison between the two groups using rank and inspection, there was no statistically significant difference (P=0.959 8). Comprehensive disease curative effect:the treatment group 52 subjects were recovered, 15 subjects were markedly effective, 39 subjects were effective, 35 subjects were invalid, markedly effective rate was 47.52%, total effective rate was 75.18%. Control group 8 subjects were recovered, 5 subjects were markedly effective, 15 subjects were effective, 19 subjects were invalid, markedly effective rate was 27.66%, total effective rate was 59.57%. Two group markedly effective rate of treatment group is better than that of control group (chi-square=5.6864, P=0.017 1), two group total effective rate of treatment group is better than the control group (chi-square=4.191 6, P=0.046 0). Syndromes curative effect:the treatment group clinical 12 subjects were recovered, 56 subjects were markedly effective, 51 subjects were effectively, 22 is invalid, the markedly effective rate was 48.23%. Control group clinical recovery 0, 13 subjects were markedly effective, 24 subjects were effectively, 10 subjects were invalid, the markedly effective rate was 27.66%. Markedly effective rate in both groups, the treatment group is better than that control group (chi-square=6.080 8, P=0.013 7). "Insomnia", "languid", "depressed", "poor appetite" individual symptoms, the treatment group is better than that of control group (P < 0.05). Conclusion Stilbene plus oral liquid shows defined efficacy and safety treatment of patients with insomnia (Syndrome of deficiency of both heart and spleen). Therefore, in the clinical treatment of insomnia, which makes its clinical application promising good clinical application prospects.
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