电针深刺治疗严重功能性便秘有效性及安全性评价——随机对照盲法试验  

Efficacy and Safety of Deep Needling in the Treatment of Severe Functional Constipation:A Blind Randomized Controlled Trial

作　　者：张虹[1] 傅立新[2] ZHANG Hong;FU Lixin(Tianjin Haihe Hospital,Tianjin,300350;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine)

机构地区：[1]天津市海河医院,天津市300350 [2]天津中医药大学第一附属医院

出　　处：《中医杂志》2023年第3期260-268,共9页Journal of Traditional Chinese Medicine

基　　金：“十二五”国家科技支撑计划(2012BAI24B00)。

摘　　要：目的评价电针治疗严重功能性便秘(SFC)的有效性与安全性。方法将70例SFC患者随机分为电针组和假电针组各35例。电针组予电针深刺双侧天枢、腹结及上巨虚,假电针组予假电针浅刺双侧天枢旁、腹结旁及浅刺上巨虚旁,两组均每日治疗1次,前两周每周连续治疗5次,休息2天,后六周每周3次,隔日治疗1次,连续8周,共治疗28次。基线期2周内、治疗期8周内,患者每日自行记录当天24 h内的排便状况,包括每次完全自主排便(CSBM)次数,每次自主排便(SBM)次数,每次大便的布里斯托大便性状(BSFS)评分,每次排便时的困难程度评分,随访12周记录完全自主排便(CSBM)次数。以治疗期与基线期和随访期与基线期平均周CSBM次数差值,以及治疗期与基线期的平均周SBM评分差值为主要疗效指标,以治疗期与基线期的平均周BSFS评分差值、治疗期与基线期的平均周排便困难程度评分差值、治疗第4周末期与基线期末和治疗第8周末期与基线期末的便秘生存质量量表(PAC-QOL)评分差值、治疗期和随访期的通便药/其他辅助排便措施使用次数为次要疗效指标。记录两组严重不良事件和不良反应的发生情况,评价患者对电针方案的接受度。结果最终电针组34例、假电针组33例纳入统计分析。电针组治疗期和随访期平均周CSBM次数均较基线期显著增加(P<0.01),假电针组差异无统计学意义(P>0.05),电针组治疗期与基线期的平均周CSBM差值和随访期与基线期间平均周CSBM差值均显著高于假电针组(P<0.01);电针组治疗期平均周SBM次数均较基线期显著改善(P<0.01),假电针组平均周SBM次数亦较基线期增加(P<0.05),电针组治疗期与基线期平均周SBM次数差值优于假电针组(P<0.01)。电针组治疗期平均周BSFS评分、平均周排便困难程度评分、PAC-QOL评分均较基线期有明显改善(P<0.01),假电针组仅治疗第4周末PAC-QOL评分较基线期有改善Objective To evaluate the efficacy and safety of electroacupuncture for severe functional constipation(SFC).Methods Seventy SFC participants were randomly assigned into electroacupuncture(EA)group and the sham electroacupuncture(SEA)group,each with 35 cases.The EA group received the true-electroacupuncture with deep needling at bilateral Tianshu(ST 25),Fujie(SP 14)and Shangjuxu(ST 37),while the SEA group received light skin penetration at the corresponding sham acupoints with sham-electroacupuncture.The course was 8weeks with a total of 28 treatments,i.e.once a day,5 times per week with 2 days’rest in the first two weeks,and once every other day,3 times per week in the last six weeks.The study had the baseline period for 2 weeks,the treatment period for 8 weeks,and the follow-up period for 12 weeks.All participants recorded their daily defecation status within 24 hours every day,including the number of completely spontaneous bowel movements(CSBM),the number of spontaneous bowel movements(SBM),the Bristol Stool Form score(BSFS)of each stool,difficulty score of each defecation was recorded,as well as the number of completely voluntary defecation(CSBM)during the 12-week followup period.The primary outcome measures were the mean weekly CSBM difference between the treatment and baseline period,and the mean weekly SBM difference between the treatment and baseline period.The secondary outcome measures included the mean weekly BSFS score difference between the treatment and baseline period,the mean weekly defecation difficulty score difference between the treatment and baseline period,the PAC-QOL score difference between the end of the 4-week treatment and the end of the baseline period,as well as that between the end of 8-week treatment and end of baseline period,and also,the frequency of laxatives or other auxiliary defecation aids during the treatment and follow-up period.Meanwhile,the occurrence of serious adverse events or adverse reactions in both groups,the acceptance of electroacupuncture options were recorded.

关 键 词：严重功能性便秘 电针 深刺 单盲 随机对照试验 

分 类 号：R246.1[医药卫生—针灸推拿学]