World journal of gastrointestinal surgery · 2025
Impact of teduglutide on pediatric short bowel syndrome: A systematic review and trial sequential meta-analysis.
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Jiao Pan, Zhang Zhong-Jing, Jiang Ying, Zhou Jun, Deng Ke-Heng, Zhu Wen-Xiang, Zhao Xiang-You, Guo Zhao-Kun
Аннотация
BACKGROUND: Pediatric short bowel syndrome (SBS) poses management challenges, and teduglutide is a potential therapy. However, comprehensive data on its pediatric safety are lacking.
AIM: To evaluate the impact of teduglutide on infection and gastrointestinal adverse events in pediatric SBS patients via systematic review and meta-analysis.
METHODS: Following PRISMA 2009 guidelines and PROSPERO registration, we searched PubMed, Web of Science, and EMBASE for randomized controlled trials (RCTs) (pediatric SBS patients ≤ 18 years; teduglutide vs placebo/standard care). Two reviewers screened studies, extracted data, and assessed bias (ROB2). Meta-analyses used RevMan 5.4 (Mantel-Haenszel method, random-effects if I 2 ≠ 0). Trial sequential analysis and GRADE were applied.
RESULTS: Three RCTs involving 115 pediatric patients were included. Pooled analysis revealed no statistically significant differences between the teduglutide and control groups for the primary outcome of infection events [RR = 0.83; (95%CI: 0.44-1.56); P = 0.57; I 2 = 0%; 2 studies, n = 55]. Similarly, no significant differences were found for secondary outcomes: Upper respiratory tract infection [RR = 0.68; (95%CI: 0.32-1.47); P = 0.33; I 2 = 0%], catheter site infection [RR = 1.86; (95%CI: 0.23-14.78); P = 0.56; I 2 = 0%], vomiting [RR = 1.35; (95%CI: 0.10-18.23); P = 0.82; I 2 = 72%], abdominal pain [RR = 2.47; (95%CI: 0.50-12.16); P = 0.27; I 2 = 0%], nausea [RR = 1.31; (95%CI: 0.24-7.22); P = 0.75; I 2 = 0%], diarrhea [RR = 1.02; (95%CI: 0.23-4.43); P = 0.98; I 2 = 0%], and abdominal distension [RR = 1.49; (95%CI: 0.18-12.35); P = 0.71; I 2 = 0%]. The overall certainty of evidence assessed by GRADE was moderate.
CONCLUSION: Teduglutide does not increase infection or gastrointestinal adverse event risk in pediatric SBS, but small sample sizes limit conclusions. Larger studies are needed.
AIM: To evaluate the impact of teduglutide on infection and gastrointestinal adverse events in pediatric SBS patients via systematic review and meta-analysis.
METHODS: Following PRISMA 2009 guidelines and PROSPERO registration, we searched PubMed, Web of Science, and EMBASE for randomized controlled trials (RCTs) (pediatric SBS patients ≤ 18 years; teduglutide vs placebo/standard care). Two reviewers screened studies, extracted data, and assessed bias (ROB2). Meta-analyses used RevMan 5.4 (Mantel-Haenszel method, random-effects if I 2 ≠ 0). Trial sequential analysis and GRADE were applied.
RESULTS: Three RCTs involving 115 pediatric patients were included. Pooled analysis revealed no statistically significant differences between the teduglutide and control groups for the primary outcome of infection events [RR = 0.83; (95%CI: 0.44-1.56); P = 0.57; I 2 = 0%; 2 studies, n = 55]. Similarly, no significant differences were found for secondary outcomes: Upper respiratory tract infection [RR = 0.68; (95%CI: 0.32-1.47); P = 0.33; I 2 = 0%], catheter site infection [RR = 1.86; (95%CI: 0.23-14.78); P = 0.56; I 2 = 0%], vomiting [RR = 1.35; (95%CI: 0.10-18.23); P = 0.82; I 2 = 72%], abdominal pain [RR = 2.47; (95%CI: 0.50-12.16); P = 0.27; I 2 = 0%], nausea [RR = 1.31; (95%CI: 0.24-7.22); P = 0.75; I 2 = 0%], diarrhea [RR = 1.02; (95%CI: 0.23-4.43); P = 0.98; I 2 = 0%], and abdominal distension [RR = 1.49; (95%CI: 0.18-12.35); P = 0.71; I 2 = 0%]. The overall certainty of evidence assessed by GRADE was moderate.
CONCLUSION: Teduglutide does not increase infection or gastrointestinal adverse event risk in pediatric SBS, but small sample sizes limit conclusions. Larger studies are needed.