Abstract: Background　Multiple randomized controlled trials have showed that acupuncture has good clinical efficacy in the treatment of anxiety，but related real-world study evidence is lacking so far.Objective　To explore the clinical efficacy of acupuncture in the treatment of mild anxiety based on a real-world study.Methods　A total of 276 patients with mild anxiety were selected from the Affiliated Hospital of Henan Academy of Chinese Medicine，and were first divided into acupuncture group（n=149）and non-acupuncture group（n=127）according to the prevalence of acupuncture treatment，and then the groups were matched by a 1:1 propensity score matching methodology，yielding 75 pairs.Comparison was conducted between the two groups for clinical efficacy，Hamilton Anxiety Rating Scale（HAMA）score and total score of Pittsburgh Sleep Quality Index（PSQI）before treatment and 6 and 8 weeks after treatment.Results　Pre-matching overall response rate of acupuncture group and non-acupuncture group was 91%（136/149）and 82%（104/127），respectively，showing a significant difference（P<0.05）. Furthermore，post-matching overall response rates of acupuncture and non-acupuncture groups〔97%（73/75）vs 87%（65/75）〕still had a significant difference（P<0.05）.There was significant interaction between treatment time and method on pre- and post-matching HAMA score or total score of PSQI（P<0.05）.The main effect of treatment time and method was significant on pre- and post-matching HAMA score（P<0.05）.The main effect of treatment time and method was significant on pre- and post-matching total score of PSQI（P<0.05）.Compared to non-acupuncture group，acupuncture group had lower HAMA score after 8 weeks of treatment，as well as lower total score of PSQI after 6 and 8 weeks of treatment either before or after matching（P<0.05）.Conclusion　Our real-world evidence suggests that acupuncture may be effective in reducing the severity of mild anxiety and improving the quality of life in mild anxiety patients，with high safety and feasibility.

Key words: Anxiety disorders, Acupuncture therapy, Real-world study, Propensity score, Treatment outcome

摘要： 背景　多项随机对照试验表明针刺治疗焦虑症具有较好的临床疗效，但目前尚缺乏真实世界研究证据。目的　基于真实世界研究探讨针刺治疗焦虑症的临床疗效。方法　选取2016年9月—2018年9月河南省中医药研究院附属医院收治的轻度焦虑症患者276例，先根据住院期间针刺治疗情况分为针刺组149例和非针刺组127例，再根据倾向性评分值及1∶1匹配原则进行配对，最终75对病例匹配成功。比较匹配前后两组患者临床疗效，治疗前及治疗6、8周汉密尔顿焦虑量表（HAMA）评分、匹兹堡睡眠质量指数（PSQI）总分。结果　匹配前针刺组、非针刺组患者总有效率分别为91%（136/149）、82%（104/127），匹配后针刺组、非针刺组患者总有效率分别为97%（73/75）、87%（65/75）；匹配前、后两组患者总有效率比较，差异有统计学意义（P<0.05）。时间与方法在匹配前、后HAMA评分及PSQI总分上存在交互作用（P<0.05）；时间和方法在匹配前、后HAMA评分及PSQI总分上主效应显著（P<0.05）；匹配前、后针刺组患者治疗8周HAMA评分及治疗6、8周PSQI总分均低于非针刺组（P<0.05）。结论　基于真实世界的证据表明针刺治疗轻度焦虑症有效，可减轻患者焦虑程度，改善患者睡眠质量，且安全、可行。

关键词: 焦虑症, 针刺疗法, 真实世界研究, 倾向性评分, 治疗结果