酸枣仁汤合黄连温胆汤治疗成人慢性失眠症及辅助苯二氮卓类药物撤药的作用: 一项多中心、前瞻性队列研究

Treatment of Adult Chronic Insomnia and the Effect of Assisting Benzodiazepine Withdrawl with a Combination of Suanzaoren Decoction and Huanglian Wendan Decoction: A Multicenter, Prospective Cohort Study

    摘要
  • 摘要:
      目的  观察酸枣仁汤合黄连温胆汤对成人慢性失眠症的疗效以及对镇静催眠药撤药的影响。
      方法  纳入187名慢性失眠症患者进行分析, 其中中医组102人, 西医组85人, 中医组予酸枣仁汤合黄连温胆汤治疗, 西医组在医生指导下服用苯二氮卓类镇静催眠药治疗。干预时间为1个月, 干预前和干预结束予匹兹堡睡眠质量指数(PSQI)评估, 并在干预结束后3个月和6个月进行随访。
      结果  2组患者基线资料无明显差异。干预结束后, 2组患者PSQI评分均有显著改善(P < 0.01), 中医组在睡眠质量、催眠药物及总分下降方面优于西医组(P < 0.01)。线性回归分析结果显示, 在控制混杂因素后, 中医组在2个不同的模型中回归系数分别是1.821和1.922, 前者具有统计学意义(P < 0.05)。筛选中医组基线服用镇静催眠药的患者, 与西医组比较镇静催眠药撤药的影响因素，3个月随访时中医组39例患者中有25例撤药, 西医组80例患者中17例撤药(χ2=19.25, P < 0.001);6个月随访时中医组39例患者中有23例撤药, 西医组79例患者中18例撤药(χ2=13.53, P < 0.001), 中医组撤药率明显高于西医组。进一步回归分析结果显示, 在调整混杂因素后, 组别结果显示西医组在3个月(OR=5.50, 95%CI: 2.30~13.72)和6个月(OR=6.43, 95%CI: 2.54~17.77)未撤药的比值明显高于中医组, 结果具有统计学差异(P < 0.05)。
      结论  酸枣仁汤合黄连温胆汤对慢性失眠症疗效明显, 并具有辅助镇静催眠药撤药的作用。

     

    Abstract:
      OBJECTIVE  To explore the efficacy of Sour Jujube Seed Decoction combined with Huanglian Wendan Decoction on adult chronic insomnia and its effect on hypnotic withdrawal.
      METHODS  187 patients with chronic insomnia were included for analysis, including 102 in the traditional Chinese medicine (TCM) group and 85 in the western medicine group. The TCM group was treated with Sour Jujube Seed Decoction combined with Huanglian Wendan Decoction, while the western medicine group was treated with benzodiazepine under the consideration of doctor. The intervention period was 1 month, with assessments using the Pittsburgh Sleep Quality Index (PSQI) conducted before and after the intervention. Follow-up evaluations were performed at 3 months and 6 months respectively after the intervention.
      RESULTS  There was no significant difference between the two groups at baseline. After the intervention, the PSQI scores of patients in both groups were significantly improved (P < 0.01). Among them, the TCM group was better than the western medicine group in the improvement of sleep quality and sleeping pills, total PSQI score reduction (P < 0.01). The results of linear regression analysis showed that after controlling for confounding factors, the regression coefficients of the TCM group in two different models were1.821 and 1.922 respectively, and the former was statistically significant (P < 0.05). By screening patients who took hypnotics at baseline in the TCM group and comparing them with those in the western medicine group, the influencing factors of hypnotic withdrawal were analyzed. During the 3-month follow-up, 25 out of 39 patients in the TCM group and 17 out of 80 patients in the western medicine group had hypnotic withdrawal (χ2= 19.25, P < 0.001); during the 6-month follow-up, 23 of the 39 patients in the TCM group and 18 of the 79 patients in the western medicine group had hypnotic withdrawal (χ2= 13.53, P < 0.001), the withdrawal rate of patients in the TCM group was significantly higher than that in the western medicine group. Further regression analysis showed that after adjusting for confounding factors, the results showed that the western medicine group had a significantly higher rate of not withdrawal than the TCM group at 3 months (OR=5.50, 95%CI: 2.30~13.72) and 6 months (OR=6.43, 95%CI: 2.54~17.77), and the results were statistically different (P < 0.05).
      CONCLUSION  Sour Jujube Seed Decoction combined with Huanglian Wendan Decoction is effective in treating adult chronic insomnia and assisting in hypnotic withdrawal.

     

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