目的：观察穴位敷贴联合药物治疗对抑郁症的疗效和安全性，尤其是对患者失眠症状的改善程度。方法：将162例抑郁症患者随机分成研究组(n=86)和对照组(n=76)，研究组接受穴位敷贴治疗联合抗抑郁药物治疗，对照组接受抗抑郁药物治疗，治疗持续6周，基线及治疗第1，2，6周末用同时用汉密尔顿抑郁量表(Hamilton Depression scales，HAMD-17)以及汉密尔顿焦虑量表(Hamilton Anxiety Scale，HAMA)评定患者的抑郁和焦虑严重程度，用匹兹堡睡眠质量指数(Pittsburgh Sleep Quality Index，PSQI)评定患者的失眠严重程度，同时用副反应量表(Treatment Emergent Symptom Scale，TESS)和实验室检查评估治疗安全性。结果：治疗6周末研究组和对照组的HAMD评分分别为8.62±2.90，10.14±3.38，均较治疗前显著下降，研究组显著低于对照组，差异有统计学意义(t=3.0805，P=0.0024)；同样治疗6周末研究组和对照组的HAMA评分分别为6.93±2.19，10.30±3.55，均较治疗前显著下降，研究组显著低于对照组，差异有统计学意义(t=7.3614，P<0.001)；治疗6周末研究组和对照组的PSQI评分分别为5.23±1.90，8.14±3.11，均较治疗前显著下降，且研究组显著低于对照组，差异有统计学意义(t=7.2771，P<0.001)。研究组皮肤瘙痒显著多于对照组，失眠显著少于对照组，其他方面没有显著差异。结论：穴位敷贴联合抗抑郁药治疗对抑郁症安全有效，同时可以显著改善患者的失眠症状。
Effect of acupoint combined with anti-depressants on insomnia in depression patients
Objective: To observe the efficacy and safety of acupoint application combined with anti-depressants on insomnia in depression patients and its role in improving insomnia syndrome. Methods: A total of 162 depression patients were divided into a research group (n=86) and in the control group (n=76) randomly. The research group was treated with acupoint application combined with anti-depressants and the control group was treated with anti-depressants alone. The trial lasted 6 weeks. Hamilton Depression scales (HAMD) and Hamilton Anxiety scales (HAMA) were applied to evaluate the depression and anxiety status on the baseline and 1st, 2ed, 6th after the treatment respectively. The insomnia severity and efficacy were evaluated with Pittsburgh Sleep Quality Index (PSQI) at the same time and the safety was evaluated by Treatment Emergent Symptom Scale (TESS) and laboratory examination. Results: The HAMD scores of both groups were 8.62±2.90 and 10.14±3.38, the scores in the research group was lower than that in the control group (t=3.0805, P=0.0024). The HAMA scores of both groups were 6.93±2.19 and 10.30±3.55 which declined significantly when compared with before treatment, the scores of the research group was lower than that in the control group (t=7.3614, P<0.001). The PSQI scores of both groups were 5.23±1.90 and 8.14±3.11, which declined significantly when compared with before treatment, the scores in the research group was lower than that in the control group (t=7.2771, P<0.001). The incidence of pruritus in the research group is higher than that in the control group but the incidence of insomnia is much lower. Conclusion: Acupoint application combined with anti-depressants demonstrated to be effective and safe in the treatment of depression, and more superior in improving insomnia syndrome than anti-depressants alone.