目的：评价调督安神法针灸治疗原发性失眠的临床疗效及安全性。方法：本研究采用患者随机对照试验设计，将72例原发性失眠患者按1∶1比例分为治疗组和对照组。治疗组以调督安神法为治疗原则进行针灸治疗，要求得气，取穴百会、神庭、印堂、神门、安眠、三阴交；对照组为假针灸治疗，假针灸针不刺破皮肤，取穴同治疗组。两组每次均治疗30 min，每周3次，连续治疗4周。分别在治疗前、治疗2周、治疗4周以及治疗结束后2周、4周随访时对患者进行失眠严重程度指数(ISI)、焦虑自评量表（SAS）以及抑郁自评量表（SDS）的评估，观察并记录针灸的不良反应。结果：治疗组完成32例，脱落4例；对照组完成30例，脱落6例。与治疗前相比，两组的ISI评分在治疗后及随访时有显著性差异（P＜0.01）；与对照组相比，治疗组在治疗4周、治疗结束后2周、4周随访时评分差异有统计学意义（P＜0.05），但在治疗2周时差异无统计学意义（P＞0.05）。与对照组相比，治疗组的SAS及SDS评分在治疗4周、治疗结束后2周、4周随访时有显著性差异（P＜0.01，P＜0.05），但在治疗2周时差异无统计学意义（P＞0.05)。两组针灸疗法不良事件发生率比较，差异无统计学意义（P＞0.05）。结论：调督安神法针灸方案治疗原发性失眠临床疗效显著，安全性高。

This study was aimed to evaluate the efficacy and safety of acupuncture based on regulating Du meridian and calming mind in the treatment of primary insomnia. A patient-blinded, randomized controlled trial was designed. A total of 72 primary insomnia patients were randomly divided into the treatment group and the control group. Patients in the treatment group received acupuncture with deqi sensation at DU- 20 Baihui, DU- 24 Shenting, EX Yintang, HT- 7 Shenmen, EX Anmian and SP-6 Sanyinjiao. Patients in the control group received sham acupuncture without needle insertion at the same acupoints. All sessions of acupuncture treatment were conducted for 30 minutes each time, 3 times a week, for 4 consecutive weeks. The insomnia severity index (ISI), anxiety self-rating scale (SAS) and depression selfrating scale (SDS) were measured before treatment, 2-week treatment, 4-week treatment, 2 weeks and 4 weeks after treatment. Adverse reactions of acupuncture treatment were also recorded. The results showed that the treatment group completed 32 cases, 4 cases off; the control group completed 30 cases, 6 cases off. Compared with those before treatment, the ISI scores of both groups were significantly different after treatment and at follow-up (P < 0.01). Compared with the control group, there was statistical difference in the treatment group at 4-week treatment, 2 weeks and 4 weeks after treatment (P < 0.05). However, there was no statistical significance at 2-week treatment (P > 0.05). Compared with the control group, there were significant differences on SAS and SDS scores of the treatment group at 4-week treatment, 2 weeks and 4 weeks after treatment (P < 0.01, P < 0.05). However, there was no statistical significance at 2- week treatment (P > 0.05). There was no statistical significance on the comparison of adverse reactions of acupuncture treatment between two groups (P > 0.05). It was concluded that acupuncture treatment based on regulating Du meridian and calming mind was an effective and safe therapy for primary insomnia treatment.

国家科学技术部973 计划项目（2009CB522900）:灸法的基本作用原理与应用研究规律，负责人：吴焕淦；国家科学技术部973 计划项目（2015CB554500）：基于临床的灸法作用机理研究，负责人：吴焕淦；上海市卫计委中医药科研基金项目（2010L036A）：原发性失眠针刺优化方案及影响疗效共性技术的临床评价，负责人：徐世芬。