【作者】 孙元杰； 刘岩； 刘保延； 周科华； 岳增辉； 章薇； 符文彬； 杨骏； 李宁； 何丽云； 臧志伟； 苏同生； 方剑乔； 丁玉龙； 秦宗实； 宋虎杰； 胡慧； 赵宏； 莫倩； 周婧； 吴佳霓； 刘晓旭； 王伟明； 庞然； 陈欢； 王馨璐； 刘志顺；

【Author】 Yuanjie Sun;Yan Liu;Baoyan Liu;Kehua Zhou;Zenghui Yue;Wei Zhang;Wenbin Fu;Jun Yang MD;Ning Li;Liyun He;Zhiwei Zang;Tongsheng Su;Jianqiao Fang;Yulong Ding;Zongshi Qin;Hujie Song;Hui Hu;Hong Zhao;Qian Mo;Jing Zhou;Jiani Wu;Xiaoxu Liu;Weiming Wang;Ran Pang;Huan Chen;Xinlu Wang;Zhishun Liu;Guang’anmen Hospital,China Academy of Chinese Medical Sciences;Key Laboratory of Chinese Internal Medicine of Ministry of Education,Dongzhimen Hospital,Beijing University of Chinese Medicine;ThedaCare Regional Medical Center–Appleton;Hengyang Hospital Affiliated to Hunan University of Chinese Medicine;The First Hospital of Hunan University of Chinese Medicine;Guangdong Provincial Hospital of Traditional Chinese Medicine;The First Affiliated Hospital of Anhui University of Chinese Medicine;West China Hospital of Sichuan University;China Academy of Chinese Medical Sciences;Yantai Hospital of Traditional Chinese Medicine;Shaanxi Provincial Hospital of Traditional Chinese Medicine;The Third Affiliated Hospital of Zhejiang Chinese Medical University;Beijing Fengtai Hospital of Integrated Traditional and Western Medicine;Xi’an TCM Brain Disease Hospital;Dongfang Hospital Beijing University of Chinese Medicine;Luohu District Hospital of Traditional Chinese Medicine;Guizhou University of Traditional Chinese Medicine;

【机构】 中国中医科学院广安门医院； 北京中医药大学东直门医院； 达卡尔地区医疗中心； 湖南中医药大学附属衡阳医院； 湖南中医药大学第一附属医院； 广东省中医院； 安徽中医药大学第一附属医院； 四川大学华西医院； 中国中医科学院中医临床基础医学研究所； 烟台市中医院； 陕西省中医医院； 浙江中医药大学第三附属医院； 北京丰台中西医结合医院； 西安中医脑病医院； 北京中医药大学东方医院； 深圳市罗湖区中医院； 贵州中医药大学；

【摘要】 背景:针刺治疗慢性前列腺炎/慢性盆底疼痛综合征(CP/CPPS)前景良好,但高质量证据不足。目的:评价针刺治疗CP/CPPS的远期疗效。设计:多中心、随机、假针刺对照临床研究(ClinicalTrials.gov:NCT03213938)。地点:十家中国三甲医院。受试者:中重度CP/CPPS患者。有无针刺治疗史的受试者均可纳入。干预:患者接受8周20次针刺或假针刺治疗,治疗结束后随访24周。评价:以应答率为主要结局指标,即第8周和第32周美国国立卫生研究院慢性前列腺炎症状积分指数中文版(The National Institute of Health Chronic Prostatitis Symptom Index, NIH-CPSI)总分较基线减少≥6分的受试者所占的百分比。两个时间点的组间差值均有统计学意义才能够证实针刺持续效应的存在。结果:本试验共纳入了440例(每组220例)受试者。8周治疗结束后,针刺组的应答率为60.6%(95%CI:53.7%,67.1%),假针组的应答率为36.8%(95%CI:30.4%,43.7%),两组的校正组间差值为21.6%(95%CI:12.8%,30.4%),校正OR值为2.6 (95%CI:1.8,4.0)(P<0.001)。第32周,针刺组应答率为61.5%(96%CI:54.5%, 68.1%),假针组的应答率为38.3%(95%CI:31.7%,45.4%),两组的校正组间差值为21.1%(95%CI:12.2%, 30.1%),校正OR值为2.6(95%CI:1.7, 3.9)(P<.001)。针刺组有20 (9.3%)例受试者发生不良事件,假针组有14(6.4%)例受试者发生不良事件。两组均没有严重不良事件发生。局限性:假针可能存在一定的生理效应。结论:相对于假针刺,8周20针次的治疗能够显著缓解中重度CP/CPPS受试者的症状,疗效在治疗结束后持续24周。更多还原

【Abstract】 Background:Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS),but high-quality evidence is scarce.Objective:To assess the long-term efficacy of acupuncture for CP/CPPS.Design:Multicenter,randomized,sham-controlled trial.(ClinicalTrials.gov:NCT03213938) Setting:Ten tertiary hospitals in China.Participants:Men with moderate to severe CP/CPPS,regardless of prior exposure to acupuncture.Intervention:Twenty sessions of acupuncture or sham acupuncture over 8 weeks,with 24-week follow-up after treatment.Measurements:The primary outcome was the proportion of responders,defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32.Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points.Results:A total of 440 men(220 in each group) were recruited.At week 8,the proportions of responders were 60.6%(95% CI,53.7% to 67.1%) in the acupuncture group and 36.8%(CI,30.4% to 43.7%) in the sham acupuncture group(adjusted difference,21.6 percentage points [CI,12.8 to 30.4 percentage points];adjusted odds ratio,2.6 [CI,1.8 to 4.0];P < 0.001).At week 32,the proportions were 61.5%(CI,54.5% to 68.1%) in the acupuncture group and 38.3%(CI,31.7% to 45.4%) in the sham acupuncture group(adjusted difference,21.1 percentage points [CI,12.2 to 30.1 percentage points];adjusted odds ratio,2.6 [CI,1.7 to 3.9];P < 0.001).Twenty(9.1%) and 14(6.4%) adverse events were reported in the acupuncture and sham acupuncture groups,respectively.No serious adverse events were reported.Limitation:Sham acupuncture might have had certain physiologic effects.Conclusion:Compared with sham therapy,20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS,with durable effects 24 weeks after treatment.更多还原