Department of Pediatrics, Sapienza University of Rome, Rome, Italy.
Aliment Pharmacol Ther. 2012 May;35(9):1010-26. doi: 10.1111/j.1365-2036.2012.05055.x. Epub 2012 Mar 8.
Because of the decrease in the Helicobacter pylori eradication rate after standard triple therapy with a proton pump inhibitor and two antibiotics, bismuth-based therapy has recently been recommended as alternate first-line regimen in children.
To comprehensively review the clinical, pharmacologic and microbiologic properties of bismuth salts, and to summarise the evidence for the therapeutic efficacy of bismuth-based therapy for H. pylori eradication in children.
Bibliographical searches were performed in MEDLINE. Results on the efficacy of bismuth-containing regimens on H. pylori eradication were combined using the inverse variance method.
Bismuth monotherapy showed a very low efficacy. Overall, the mean eradication rate with bismuth-based dual therapy was 68% (95% CI, 60-76%) (intention-to-treat analysis-ITT) and 73% (95% CI, 64-81%) (per protocol-PP). In case series, the overall percentages of children with successful eradication for triple therapy containing bismuth were 82% (95% CI, 76-88%) and 86% (95% CI, 80-92%) according to ITT and PP respectively. In comparative studies, H. pylori eradication rates ranged between 69% and 85% according to ITT and between 74% and 96% PP. Side effects included dark stools, urine discoloration, black tongue, burning tongue, and marked darkness of the gums.
The evidence in favour of bismuth compounds for treating infected children is still not clear. Well-designed, randomised, multi-centre studies of H. pylori eradication trials in children comparing bismuth-based triple therapy with the best available recommended first-line therapies are needed. The evidence obtained from audited case series that produce an eradication rate of >95% on PP analysis should also be considered.
由于质子泵抑制剂和两种抗生素的标准三联疗法后幽门螺杆菌根除率下降，铋剂治疗最近被推荐为儿童的替代一线方案。
全面综述铋盐的临床、药理和微生物学特性，并总结铋剂治疗儿童幽门螺杆菌根除的疗效证据。
在 MEDLINE 中进行文献检索。采用逆方差法合并铋剂方案对幽门螺杆菌根除疗效的研究结果。
铋单药治疗疗效很低。总体而言，铋剂双联疗法的根除率平均为 68%（95%CI，60-76%）（意向治疗分析-ITT）和 73%（95%CI，64-81%）（按方案分析-PP）。在病例系列研究中，三联疗法中含铋的儿童成功根除率的总体百分比分别为 ITT 为 82%（95%CI，76-88%）和 PP 为 86%（95%CI，80-92%）。在对照研究中，ITT 根除率为 69%-85%，PP 根除率为 74%-96%。副作用包括黑便、尿色改变、黑舌、灼舌和牙龈明显变黑。
支持铋化合物治疗感染儿童的证据仍不明确。需要设计良好、随机、多中心的儿童幽门螺杆菌根除试验，比较铋剂三联疗法与最佳推荐一线疗法。也应考虑经过审核的病例系列研究提供的证据，这些研究在按方案分析中产生了>95%的根除率。
