目的 以靈芝口服液為對(duì)照評(píng)價(jià)靈芪加口服液治療失眠癥（心脾兩虛證）臨床應(yīng)用的有效性和安全性。方法 將188例失眠癥（心脾兩虛證）患者隨機(jī)分為兩組，治療組141例、對(duì)照組47例；治療組實(shí)施靈芪加口服液治療，對(duì)照組實(shí)施靈芝口服液治療，兩組均治療4周。比較兩組匹茨堡睡眠質(zhì)量指數(shù)量表（PSQI）評(píng)分改善情況、疾病綜合療效、中醫(yī)證候療效及不良反應(yīng)。結(jié)果 兩組治療后匹茨堡睡眠質(zhì)量指數(shù)量表（PSQI）評(píng)分均低于治療前，組內(nèi)比較差異均有統(tǒng)計(jì)學(xué)意義（P < 0.05）；兩組間比較采用秩和檢驗(yàn)，差異無(wú)統(tǒng)計(jì)學(xué)意義（P=0.9598）。疾病綜合療效：治療組愈顯率47.52%，總有效率75.18%；對(duì)照組愈顯率27.66%，總有效率59.57%。兩組愈顯率治療組優(yōu)于對(duì)照組（χ²=5.6864，P=0.0171），兩組總有效率治療組優(yōu)于對(duì)照組（χ²=4.1916，P=0.0406）。中醫(yī)證候療效：治療組愈顯率48.23%；對(duì)照組愈顯率27.66%，兩組愈顯率比較，治療組優(yōu)于對(duì)照組（χ²=6.0808，P=0.0137）。"失眠"、"倦怠乏力"、"精神不振"、"食欲不振"單項(xiàng)癥狀，治療組優(yōu)于對(duì)照組，差異有統(tǒng)計(jì)學(xué)意義（P < 0.05）。結(jié)論 靈芪加口服液治療失眠癥（心脾兩虛證）療效確切，臨床服用安全，具有較好的臨床應(yīng)用前景。

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.