Torbay Hospital, South Devon NHS Foundation Trust, Torquay, UK.
Anaesthesia. 2012 Oct;67(10):1076-90. doi: 10.1111/j.1365-2044.2012.07232.x. Epub 2012 Jun 27.
The population sampling in randomised controlled trials by Fujii et al. have been shown to exhibit unusual distributions. This systematic review analysed the effectiveness of prophylactic antiemetics in trials by Fujii et al. compared with other authors. Granisetron was more effective in trials by Fujii et al., relative risk ratios (RRR (95% CI)): nausea 0.53 (0.42-0.67), p=0.00021; vomiting 0.60 (0.50-0.73), p=0.00094. Ramosetron was also more effective in studies by Fujii et al.: vomiting 0.60 (0.39-0.91), p=0.02; nausea or vomiting 0.71 (0.56-0.91); p=0.006. In comparison with granisetron, droperidol was less effective in trials by Fujii et al. than others: nausea 2.41 (1.72-3.36), p=2.5×10(-7); vomiting 1.73 (1.26-2.38), p=6.4×10(-4). Postoperative nausea and vomiting was less likely to trigger rescue antiemesis after granisetron and metoclopramide in studies by Fujii et al., 0.40 (0.27-0.60), p=9.7×10(-6). Triggered rates of rescue were not different in studies by others for droperidol, granisetron and metoclopramide, but were less common after granisetron than droperidol and metoclopramide in studies by Fujii et al., 0.50 (0.38-0.66), p=1.7×10(-6) and 0.47 (0.34-0.64), p=2.6×10(-6), respectively. There was no synergism between antiemetics in trials by other authors. In contrast, in studies by Fujii et al., postoperative nausea and vomiting was more likely if granisetron was administered alone: nausea 4.20 (1.94-9.08), p=2.6×10(-4) ; vomiting 4.50 (2.55-7.97), p=2.3×10(-7); nausea or vomiting 5.00 (2.84-8.81), p=2.5×10(-8). Similarly, droperidol was less effective in studies by Fujii et al. if administered alone: vomiting 2.76 (1.25-6.11), p=0.01; nausea or vomiting 2.96 (1.46-6.00), p=2.7×10(-3). The conclusion is that if, as recommended, data with unusual distributions are removed from meta-analysis and articles by Fujii et al. excluded, then the antiemetic effects of granisetron and ramosetron are greatly reduced; further, there is no evidence of synergism between antiemetics and indeed, some evidence of antagonism between antiemetic agents.
随机对照试验中的人群抽样由 Fujii 等人进行,结果显示分布异常。本系统评价分析了 Fujii 等人与其他作者进行的预防性止吐药试验的效果。与 Fujii 等人的研究相比,格拉司琼的相对风险比(RRR(95%CI)):恶心 0.53(0.42-0.67),p=0.00021;呕吐 0.60(0.50-0.73),p=0.00094。与 Fujii 等人的研究相比,雷莫司琼也更有效:呕吐 0.60(0.39-0.91),p=0.02;恶心或呕吐 0.71(0.56-0.91);p=0.006。与格拉司琼相比,氟哌利多在 Fujii 等人的试验中效果较差:恶心 2.41(1.72-3.36),p=2.5×10(-7);呕吐 1.73(1.26-2.38),p=6.4×10(-4)。与氟哌利多相比,格拉司琼和甲氧氯普胺在 Fujii 等人的研究中术后恶心和呕吐的可能性较小,0.40(0.27-0.60),p=9.7×10(-6)。在其他研究中,氟哌利多、格拉司琼和甲氧氯普胺的解救性止吐触发率没有差异,但在 Fujii 等人的研究中,格拉司琼的触发率低于氟哌利多和甲氧氯普胺,0.50(0.38-0.66),p=1.7×10(-6)和 0.47(0.34-0.64),p=2.6×10(-6),分别。其他作者的止吐药之间没有协同作用。相比之下,在 Fujii 等人的研究中,如果单独给予格拉司琼,则更有可能发生术后恶心和呕吐:恶心 4.20(1.94-9.08),p=2.6×10(-4);呕吐 4.50(2.55-7.97),p=2.3×10(-7);恶心或呕吐 5.00(2.84-8.81),p=2.5×10(-8)。同样,如果单独给予氟哌利多,氟哌利多在 Fujii 等人的研究中效果较差:呕吐 2.76(1.25-6.11),p=0.01;恶心或呕吐 2.96(1.46-6.00),p=2.7×10(-3)。结论是,如果按照建议将分布异常的数据从荟萃分析和 Fujii 等人的文章中删除,则格拉司琼和雷莫司琼的止吐作用会大大降低;此外,没有证据表明止吐药之间存在协同作用,实际上,一些证据表明止吐药之间存在拮抗作用。