Marjan Mokhtare, Maryam Fathi, Amir M Sadeghian, Mohammad-Javad Sotoudeheian, Abolfazl Namazi
{"title":"中度至重度腹泻为主的肠易激综合征患者短期服用利福昔明 2200 毫克/天对腹部症状的疗效及其对生活质量的影响的试验性研究》。","authors":"Marjan Mokhtare, Maryam Fathi, Amir M Sadeghian, Mohammad-Javad Sotoudeheian, Abolfazl Namazi","doi":"10.1007/s40261-024-01403-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>Rifaximin is used to treat diarrhea-predominant irritable bowel syndrome (IBS-D). However, determining the most effective regimen remains a challenge. This study aimed to evaluate the effectiveness and safety of a 10-day high-dose course of rifaximin (2200 mg/day) and its effects on both abdominal symptoms and quality of life (QOL) in patients with IBS-D.</p><p><strong>Method: </strong>Adult patients with moderate to severe IBS-D (Rome IV) and fecal urgency and bloating were prescribed rifaximin 1100 mg twice daily for 10 days. Demographic information, the IBS Symptom Severity Index (IBS-SSI) score (using a 7-point Likert scale), and Bristol Stool Scale (BSS) score were recorded at baseline, day 10, and 4 weeks after treatment cessation. IBS Symptom Severity Score (IBS-SSS) and IBS-QOL scores were recorded at baseline and day 10. Any drug adverse effects were recorded.</p><p><strong>Results: </strong>In total, 39 patients completed the study. Average scores for all abdominal symptoms and BSS showed significant improvement at day 10 and 4 weeks after treatment cessation (all p < 0.001). A significant improvement was seen in IBS-SSS and overall IBS-QOL score at day 10 (p < 0.001), with the highest improvement (31%) in interference with activity. Moreover, composite improvement rates were 38.64% for all abdominal symptoms, together with BSS < 5, bi-composite (66.67% for abdominal pain + bloating; 61.54% for abdominal pain + urgency), and 56.41% for tri-composite (abdominal pain + bloating + urgency) symptoms. Notably, no serious adverse effects were reported, and the adherence rate was 94.9%.</p><p><strong>Conclusions: </strong>Abdominal symptoms and overall QOL, especially in social and work dimensions, significantly improved in patients with moderate to severe IBS-D following a regimen of rifaximin 2200 mg/day, which was well tolerated.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"839-847"},"PeriodicalIF":2.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Pilot Study of the Effectiveness of a Short Course of Rifaximin 2200 mg/day on Abdominal Symptoms and its Effects on Quality of Life in Patients with Moderate to Severe Diarrhea-Predominant Irritable Bowel Syndrome.\",\"authors\":\"Marjan Mokhtare, Maryam Fathi, Amir M Sadeghian, Mohammad-Javad Sotoudeheian, Abolfazl Namazi\",\"doi\":\"10.1007/s40261-024-01403-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>Rifaximin is used to treat diarrhea-predominant irritable bowel syndrome (IBS-D). However, determining the most effective regimen remains a challenge. This study aimed to evaluate the effectiveness and safety of a 10-day high-dose course of rifaximin (2200 mg/day) and its effects on both abdominal symptoms and quality of life (QOL) in patients with IBS-D.</p><p><strong>Method: </strong>Adult patients with moderate to severe IBS-D (Rome IV) and fecal urgency and bloating were prescribed rifaximin 1100 mg twice daily for 10 days. Demographic information, the IBS Symptom Severity Index (IBS-SSI) score (using a 7-point Likert scale), and Bristol Stool Scale (BSS) score were recorded at baseline, day 10, and 4 weeks after treatment cessation. IBS Symptom Severity Score (IBS-SSS) and IBS-QOL scores were recorded at baseline and day 10. Any drug adverse effects were recorded.</p><p><strong>Results: </strong>In total, 39 patients completed the study. Average scores for all abdominal symptoms and BSS showed significant improvement at day 10 and 4 weeks after treatment cessation (all p < 0.001). A significant improvement was seen in IBS-SSS and overall IBS-QOL score at day 10 (p < 0.001), with the highest improvement (31%) in interference with activity. Moreover, composite improvement rates were 38.64% for all abdominal symptoms, together with BSS < 5, bi-composite (66.67% for abdominal pain + bloating; 61.54% for abdominal pain + urgency), and 56.41% for tri-composite (abdominal pain + bloating + urgency) symptoms. Notably, no serious adverse effects were reported, and the adherence rate was 94.9%.</p><p><strong>Conclusions: </strong>Abdominal symptoms and overall QOL, especially in social and work dimensions, significantly improved in patients with moderate to severe IBS-D following a regimen of rifaximin 2200 mg/day, which was well tolerated.</p>\",\"PeriodicalId\":10402,\"journal\":{\"name\":\"Clinical Drug Investigation\",\"volume\":\" \",\"pages\":\"839-847\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Drug Investigation\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40261-024-01403-w\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/30 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Drug Investigation","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40261-024-01403-w","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/30 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
A Pilot Study of the Effectiveness of a Short Course of Rifaximin 2200 mg/day on Abdominal Symptoms and its Effects on Quality of Life in Patients with Moderate to Severe Diarrhea-Predominant Irritable Bowel Syndrome.
Background and objective: Rifaximin is used to treat diarrhea-predominant irritable bowel syndrome (IBS-D). However, determining the most effective regimen remains a challenge. This study aimed to evaluate the effectiveness and safety of a 10-day high-dose course of rifaximin (2200 mg/day) and its effects on both abdominal symptoms and quality of life (QOL) in patients with IBS-D.
Method: Adult patients with moderate to severe IBS-D (Rome IV) and fecal urgency and bloating were prescribed rifaximin 1100 mg twice daily for 10 days. Demographic information, the IBS Symptom Severity Index (IBS-SSI) score (using a 7-point Likert scale), and Bristol Stool Scale (BSS) score were recorded at baseline, day 10, and 4 weeks after treatment cessation. IBS Symptom Severity Score (IBS-SSS) and IBS-QOL scores were recorded at baseline and day 10. Any drug adverse effects were recorded.
Results: In total, 39 patients completed the study. Average scores for all abdominal symptoms and BSS showed significant improvement at day 10 and 4 weeks after treatment cessation (all p < 0.001). A significant improvement was seen in IBS-SSS and overall IBS-QOL score at day 10 (p < 0.001), with the highest improvement (31%) in interference with activity. Moreover, composite improvement rates were 38.64% for all abdominal symptoms, together with BSS < 5, bi-composite (66.67% for abdominal pain + bloating; 61.54% for abdominal pain + urgency), and 56.41% for tri-composite (abdominal pain + bloating + urgency) symptoms. Notably, no serious adverse effects were reported, and the adherence rate was 94.9%.
Conclusions: Abdominal symptoms and overall QOL, especially in social and work dimensions, significantly improved in patients with moderate to severe IBS-D following a regimen of rifaximin 2200 mg/day, which was well tolerated.
期刊介绍:
Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes:
-Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs.
-Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice.
-Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed.
-Studies focusing on the application of drug delivery technology in healthcare.
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