BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastroint...BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.展开更多
目的评价应用Bristol大便分型量表(BSFS)指导不同肠道准备方案后对提升整体人群肠道准备质量的效果,及2 L+2 L聚乙二醇电解质溶液(PEG-ES)作为Bristol大便性状1型及2型患者个性化方案的效果及耐受性。方法采用前瞻性研究方法,将拟行结...目的评价应用Bristol大便分型量表(BSFS)指导不同肠道准备方案后对提升整体人群肠道准备质量的效果,及2 L+2 L聚乙二醇电解质溶液(PEG-ES)作为Bristol大便性状1型及2型患者个性化方案的效果及耐受性。方法采用前瞻性研究方法,将拟行结肠镜检查的患者随机分为A、B两组,使用BSFS分辨出两组中Bristol大便性状1型、2型患者及3~7型患者并记录,其中A组中Bristol大便性状1型、2型患者肠道准备方案为2 L+2 L PEG-ES,3~7型患者为2 L PEG-ES方案;B组全部患者肠道准备方案均为2 L PEG-ES。结果本研究共纳入310例门诊患者,A组中肠道准备成功率、Boston肠道准备评分量表(BBPS)评分、息肉发现率、盲肠插管率均高于B组(P<0.05);A组中Bristol大便分型1型及2型患者的排便次数多于B组(P<0.05),但两组中该类人群的不良反应发生率及重复准备意愿无明显差异(P>0.05)。结论应用BSFS分辨出具有肠道准备不足风险的患者,通过指导个性化肠道准备方案,可使整体人群的肠道准备质量得到有效提升;同时,2 L+2 L PEG-ES方案作为该类患者的个性化肠道准备方案具有良好的清肠效果及耐受性。展开更多
目的分析大便性状分型对结肠镜检查患者肠道准备失败的预测价值及肠道准备失败的危险因素,构建并验证风险预测模型。方法该研究为前瞻性队列研究,采用便利抽样法,选取2022年6月—12月在江苏省某三级甲等医院消化内科就诊及住院的结肠镜...目的分析大便性状分型对结肠镜检查患者肠道准备失败的预测价值及肠道准备失败的危险因素,构建并验证风险预测模型。方法该研究为前瞻性队列研究,采用便利抽样法,选取2022年6月—12月在江苏省某三级甲等医院消化内科就诊及住院的结肠镜检查患者作为建模队列,采用一般情况调查表、Bristol大便性状量表(Bristol Stool Form Scale,BSFS)收集相关资料,并根据肠道准备质量将患者分为肠道准备成功组和肠道准备失败组。采用最佳截断值法确定BSFS的最佳截断值,通过单因素和Logistic回归分析肠道准备失败的危险因素,并构建列线图风险预测模型。将2023年1月-2月在同一所医院行结肠镜检查的患者作为验模队列,进行模型的外部验证。结果最终建模队列纳入569例患者,验模队列纳入212例,肠道准备失败发生率分别为19.0%和19.8%。经Logistic回归分析后构建的风险预测模型公式为P=-2.209+0.619×住院患者+0.635×年龄≥65岁-0.710×有结肠镜检查史+2.031×BSFS分型为1~2型。该模型受试者操作特征曲线下面积为0.751,灵敏度为54.6%,特异度为85.9%,最佳截断值为0.225,肠道准备失败的风险值为80分。Hosmer-Lemeshow检验结果显示,χ^(2)=4.429,P=0.351。模型外部验证中,受试者操作特征曲线下面积为0.775,提示模型具有较好的拟合效果和较高的预测价值。结论结肠镜检查患者肠道准备失败发生率较高,年龄≥65岁、住院、无结肠镜检查史以及BSFS分型为1~2型的患者更易发生肠道准备失败。该研究构建的风险预测模型具有良好的预测性能,可为护理人员快速判别患者肠道准备失败风险提供依据。展开更多
Objective:To verify the effectiveness of acupuncture for diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:Sixty-five patients with IBS-D were randomized into an acupuncture group(33 cases)and a sham-acupun...Objective:To verify the effectiveness of acupuncture for diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:Sixty-five patients with IBS-D were randomized into an acupuncture group(33 cases)and a sham-acupuncture group(32 cases).In the acupuncture group,Tiānshū(天枢ST25),Zhōngwǎn(中脘CV12),Zúsānlǐ(足三里ST36),Shàngjùxū(上巨虚ST37),Gōngsūn(公孙SP4),Fēnglóng(丰隆ST40),Zhāngmén(章门LR13)and Yīnlíngquán(阴陵泉SP9)were selected and stimulated with routine acupuncture technique,once every two days,3 times weekly,for 8 weeks consecutively,24 times in total.In the shamacupuncture group,the sham-acupoints were selected,0.5 cun or 1 cun superior,inferior,lateral or medial to the corresponding points separately.The blunt-tip needles were used to stimulate only the skin surface of each point.The treatment frequency and courses were the same as the acupuncture group.Before treatment,in 4 weeks of treatment,after treatment and in follow-up,the changes in the score of IBS symptom severity scale(IBS-SSS),Bristol stool form scale and defecation satisfaction were observed in the patients of two groups.After treatment,the effectiveness was assessed in the two groups.Results:In 4 weeks of treatment,after treatment and in follow-up,IBS-SSS score,Bristol stool form scale and defecation satisfaction were all lower than those before treatment in either group(all P<0.01).Bristol stool form scale in the acupuncture group was lower than that in the sham-acupuncture group in4 weeks of treatment,after treatment and in follow-up,while,IBS-SSS score and defecation satisfaction were lower than the sham-acupuncture group in follow-up(all P<0.05).Conclusion:Acupuncture can effectively relieve diarrhea and improves defecation satisfaction in the patients with IBS-D.展开更多
文摘BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.
文摘目的评价应用Bristol大便分型量表(BSFS)指导不同肠道准备方案后对提升整体人群肠道准备质量的效果,及2 L+2 L聚乙二醇电解质溶液(PEG-ES)作为Bristol大便性状1型及2型患者个性化方案的效果及耐受性。方法采用前瞻性研究方法,将拟行结肠镜检查的患者随机分为A、B两组,使用BSFS分辨出两组中Bristol大便性状1型、2型患者及3~7型患者并记录,其中A组中Bristol大便性状1型、2型患者肠道准备方案为2 L+2 L PEG-ES,3~7型患者为2 L PEG-ES方案;B组全部患者肠道准备方案均为2 L PEG-ES。结果本研究共纳入310例门诊患者,A组中肠道准备成功率、Boston肠道准备评分量表(BBPS)评分、息肉发现率、盲肠插管率均高于B组(P<0.05);A组中Bristol大便分型1型及2型患者的排便次数多于B组(P<0.05),但两组中该类人群的不良反应发生率及重复准备意愿无明显差异(P>0.05)。结论应用BSFS分辨出具有肠道准备不足风险的患者,通过指导个性化肠道准备方案,可使整体人群的肠道准备质量得到有效提升;同时,2 L+2 L PEG-ES方案作为该类患者的个性化肠道准备方案具有良好的清肠效果及耐受性。
文摘目的分析大便性状分型对结肠镜检查患者肠道准备失败的预测价值及肠道准备失败的危险因素,构建并验证风险预测模型。方法该研究为前瞻性队列研究,采用便利抽样法,选取2022年6月—12月在江苏省某三级甲等医院消化内科就诊及住院的结肠镜检查患者作为建模队列,采用一般情况调查表、Bristol大便性状量表(Bristol Stool Form Scale,BSFS)收集相关资料,并根据肠道准备质量将患者分为肠道准备成功组和肠道准备失败组。采用最佳截断值法确定BSFS的最佳截断值,通过单因素和Logistic回归分析肠道准备失败的危险因素,并构建列线图风险预测模型。将2023年1月-2月在同一所医院行结肠镜检查的患者作为验模队列,进行模型的外部验证。结果最终建模队列纳入569例患者,验模队列纳入212例,肠道准备失败发生率分别为19.0%和19.8%。经Logistic回归分析后构建的风险预测模型公式为P=-2.209+0.619×住院患者+0.635×年龄≥65岁-0.710×有结肠镜检查史+2.031×BSFS分型为1~2型。该模型受试者操作特征曲线下面积为0.751,灵敏度为54.6%,特异度为85.9%,最佳截断值为0.225,肠道准备失败的风险值为80分。Hosmer-Lemeshow检验结果显示,χ^(2)=4.429,P=0.351。模型外部验证中,受试者操作特征曲线下面积为0.775,提示模型具有较好的拟合效果和较高的预测价值。结论结肠镜检查患者肠道准备失败发生率较高,年龄≥65岁、住院、无结肠镜检查史以及BSFS分型为1~2型的患者更易发生肠道准备失败。该研究构建的风险预测模型具有良好的预测性能,可为护理人员快速判别患者肠道准备失败风险提供依据。
基金Supported by Evaluation of the clinical effect of acupuncture on diarrhea-type irritable bowel syndrome:2017S382。
文摘Objective:To verify the effectiveness of acupuncture for diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:Sixty-five patients with IBS-D were randomized into an acupuncture group(33 cases)and a sham-acupuncture group(32 cases).In the acupuncture group,Tiānshū(天枢ST25),Zhōngwǎn(中脘CV12),Zúsānlǐ(足三里ST36),Shàngjùxū(上巨虚ST37),Gōngsūn(公孙SP4),Fēnglóng(丰隆ST40),Zhāngmén(章门LR13)and Yīnlíngquán(阴陵泉SP9)were selected and stimulated with routine acupuncture technique,once every two days,3 times weekly,for 8 weeks consecutively,24 times in total.In the shamacupuncture group,the sham-acupoints were selected,0.5 cun or 1 cun superior,inferior,lateral or medial to the corresponding points separately.The blunt-tip needles were used to stimulate only the skin surface of each point.The treatment frequency and courses were the same as the acupuncture group.Before treatment,in 4 weeks of treatment,after treatment and in follow-up,the changes in the score of IBS symptom severity scale(IBS-SSS),Bristol stool form scale and defecation satisfaction were observed in the patients of two groups.After treatment,the effectiveness was assessed in the two groups.Results:In 4 weeks of treatment,after treatment and in follow-up,IBS-SSS score,Bristol stool form scale and defecation satisfaction were all lower than those before treatment in either group(all P<0.01).Bristol stool form scale in the acupuncture group was lower than that in the sham-acupuncture group in4 weeks of treatment,after treatment and in follow-up,while,IBS-SSS score and defecation satisfaction were lower than the sham-acupuncture group in follow-up(all P<0.05).Conclusion:Acupuncture can effectively relieve diarrhea and improves defecation satisfaction in the patients with IBS-D.
