消化道振动胶囊对功能性便秘患者疗效及生活质量影响  

The effect of gastrointestinal vibration capsules on functional constipation patients and quality of life

作　　者：朱春洋 范一宏[1] 吕宾[1] Zhu Chunyang

机构地区：[1]浙江中医药大学附属第一医院(浙江省中医院),310060

出　　处：《浙江临床医学》2023年第3期327-329,共3页Zhejiang Clinical Medical Journal

基　　金：国家自然科学基金资助项目(81473506);浙江省中医药管理局科研基金资助项目(2019ZA056,2022ZB129,2021ZA057)。

摘　　要：目的探讨新型振动胶囊治疗慢性功能性便秘的有效性及安全性。方法选取就诊于本院消化科门诊的14例慢性功能性便秘患者,随机分为观察组与对照组,并分别接受振动胶囊及安慰剂治疗,每周2次。研究阶段分为2周基础期,6周双盲、安慰剂对照治疗阶段及4周随访阶段。通过比较两组患者的周均自发排便次数(SBM)、周均完全自发排便次数(CSBM)以评价振动胶囊的临床疗效;便秘患者生活质量评分问卷(PAC-QOL)、便秘患者症状评分问卷(PAC-SYM)以评价生活质量变化;通过记录不良事件发生、实验室安全指标及生命体征以评价其安全性。结果观察组共入组7例(其中2例脱落,脱落原因为外地随访不便);对照组有7例纳入统计。治疗6周后,观察组周均SBM次数较治疗前显著提高(P<0.05);观察组周均CSBM次数显著高于对照组(P<0.05),且观察组周均CSBM次数较治疗前显著提高(P<0.05)。治疗后周均CSBM较基线增加≥1患者4例(80.0%),周均CSBM≥3患者1例(20.0%),两组相比差异均无统计学意义(P均>0.05)。治疗6周后观察组PAC-SYM评分显著低于对照组(P<0.05),且观察组治疗后PAC-SYM评分较基线显著降低(P<0.05),尤其粪便症状评分改善较为明显(P<0.05);两组PAC-QOL评分组间及治疗前后均无明显差异(P>0.05),但观察组治疗后躯体不适评分与满意度评分较基线显著下降(P<0.05)。结论消化道振动胶囊能够显著改善功能性便秘患者的便秘症状,提高生活质量,且具有较好的安全性。Objective To explore the efficacy and safety of vibrating capsule in the treatment of chronic functional constipation.Methods Fourteen patients with chronic functional constipation were randomly divided into the experimental group and the control group,treating with vibrating capsule or placebo twice a week.The trial process included basic period for two weeks,double-blind treatment period for six weeks and followup period for four weeks.The efficacy of vibrating capsule treatment was evaluated by comparison of the patients of two groups in the spontaneous bowel movements(SBM),complete spontaneous bowel movements(CSBM),scores of Patient Assessment of Constipation-Symptoms(PAC-SYM)and Patient Assessment of Constipation Quality of Life(PAC-QOL).The safety was evaluated by the incidence of adverse events,laboratory indicators and vitals.Results Two patients were lost to follow-up.In the end,five patients were enrolled in the experimental group and seven patients were enrolled in the control group.After the sixth week of treatment,the average SBM in one week of experimental group was significantly higher than that before the treatment(P<0.05).The average CSBM in the test group was significantly higher than that in the control group(P<0.05)and was significantly higher than that before the treatment(P<0.05).After the treatment,there were four patients(80.0%)whose weekly average CSBM increased≥1 compared with baseline,and one patient(20.0%)whose weekly average CSBM increased≥3.There was no significant difference between the two groups(P>0.05).At the sixth week of the treatment,the PAC-SYM score of the experimental group was significantly lower than that of the control group(P<0.05),and the PAC-SYM score of the experimental group was significantly lower than that of the baseline(P<0.05),and the fecal symptom score was significantly improved.There was no significant difference in PAC-QOL scores between the two groups(P>0.05),but the scores of physical discomfort and satisfaction of the experimental group after treatme

关 键 词：振动胶囊 功能性便秘 完全自发排便 生活质量 

分 类 号：R473.5[医药卫生—护理学]