TA的每日心情 | 2020-9-29 11:20 |
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Rifaximin appears safe, effective for treating SIBO
利福昔明安全、有效治疗小肠细菌过度生长
Rifaximin appeared safe and effective for the treatment of small intestinal bacterial overgrowth in adults, according to the results of a systematic review and meta-analysis.
根据系统综述和荟萃分析结果显示,利福昔明可以安全、有效治疗成人小肠细菌过度生长(SIBO)。
However, investigators noted that available studies are of generally poor quality, and that randomized controlled trials are needed to confirm these findings and optimize rifaximin regimens for SIBO.
然而,研究人员指出现有研究的质量普遍较差,需要随机对照试验来证实这些发现并优化利福昔明治疗SIBO的治疗方案。
“Rifaximin fulfills all the characteristics set by Dupont and Ericsson for the ideal antimicrobial that should be used for the treatment of gastrointestinal infections (including dysbiosis and SIBO),” the researchers wrote. “As a consequence, over the past decades, rifaximin has been largely used to treat SIBO even if there is currently a lack of a critical summary of evidence.”
“利福昔明满足Dupont和Ericsson设定的用于治疗胃肠道感染(包括微生态失调和SIBO)理想抗微生物制剂的所有特性。”研究人员写到,“因此,在过去几十年里,利福昔明主要用于治疗SIBO,即使目前缺乏重要的循证总结。”
To assess the clinical effectiveness and safety of rifaximin for treating SIBO, they searched for randomized controlled trial and observational study data published up to March 12, 2015, and included 32 studies involving 1,331 patients in their analysis.
为了评估利福昔明治疗SIBO的临床有效性和安全性,研究人员搜索了截至2015年3月12日发表的随机对照试验和观察性研究数据,该荟萃分析共纳入32项研究,涉及1,331例患者。
They found that rifaximin led to an overall SIBO eradication rate of 70.8% (95% CI, 61.4-78.2) based on intention-to-treat (ITT) analysis of 26 studies, and 72.9% (95% CI, 65.5-79.8) based on per protocol (PP) analysis of all 32 studies.
研究人员发现,基于26项研究的意向治疗(ITT)分析,利福昔明治疗SIBO的总体根除率为70.8%(95%CI,61.4-78.2);基于所有32项研究的按方案(PP)分析,其总体根除率为72.9%(95%CI,65.5-79.8)。
A subset of studies in IBS patients showed the pooled SIBO eradication rate was 71.6% (95% CI, 56.7-84.4) based on ITT analysis and 75.4% (95% CI, 65-84.5) based on PP analysis.
一项肠易激综合征(IBS)患者的亚组研究显示,基于ITT分析的合并SIBO根除率为71.6%(95%CI,56.7-84.4),基于PP分析的合并SIBO根除率为75.4%(95%CI,65-84.5)。
Because there was significant heterogeneity among trials, the researchers performed meta-regression analysis, and found drug dose, study design and co-therapy were all independently associated with a higher eradication rate.
由于试验之间存在显着的异质性,研究人员进行了Meta回归分析。结果发现药物剂量、研究设计和联合治疗均是与更高的根除率相关的独立因素。
Regarding safety, the overall adverse event rate was 4.6% (95% CI, 2.3-7.5).
关于安全性,总不良事件发生率为4.6%(95%CI,2.3-7.5)。
Finally, a subset of 10 studies showed 67.7% (95% CI, 44.7-86.9) of SIBO patients experienced improvement or resolution of symptoms after eradication therapy.
最后,基于10项研究的亚组分析结果显示,67.7% (95% CI, 44.7-86.9)的SIBO患者在根除治疗后症状得到改善或消除。
“Concomitant administration of rifaximin with fibers (both soluble and insoluble), probiotics (Lactobacilli and Bifidobacteria), or mesalazine, three gut microbiota-directed therapies, consistently gave higher eradication rate,” the researchers noted.
研究人员指出:“利福昔明与纤维(可溶性和不溶性)、益生菌(乳杆菌和双歧杆菌)或美沙拉嗪——三种肠道微生物定向治疗,联合给药往往能提高根除率。
“Since the quality of the available studies is generally poor, well-designed, large RCTs ... are needed to substantiate these findings and to establish the optimal regimen ... of rifaximin to treat this increasingly common condition,” they concluded. – by Adam Leitenberger
他们总结说:“由于现有研究的质量普遍较差,需要设计良好、大规模的随机对照试验来证实这些发现,并建立利福昔明的最佳治疗方案,以治疗这种日益普遍的疾病。-Adam Leitenberger
Disclosures: Scarpignato reports he is a member of the speakers bureau and scientific advisory board for Alfa Wassermann, the manufacturer and marketer of rifaximin.
披露:Scarpignato报告说他是利福昔明制造商和营销商Alfa Wassermann公司的代言团队和科学顾问委员会成员。
原文链接:http://www.healio.com/gastroente ... e-for-treating-sibo
参考文献: [1]. Gatta, L. and C. Scarpignato, Systematic review with meta-analysis: rifaximin is effective and safe for the treatment of small intestine bacterial overgrowth. Aliment Pharmacol Ther, 2017. 45(5): p. 604-616. |
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