Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries
Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries
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DOI：
10.1111/nmo.13714
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发表时间：
2019-12-01
影响因子：
3.5
通讯作者：
Pasricha, Pankaj J.
中科院分区：
文献类型：
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作者：
Abell, Thomas L.;Yamada, Goro;Pasricha, Pankaj J.
背景 用于治疗胃轻瘫症状的胃电刺激（GES）存在争议。方法 我们研究了来自胃轻瘫临床研究联盟 (GpCRC) 观察性研究的 319 名特发性或糖尿病性胃轻瘫症状患者：238 名未接受 GES，81 名接受 GES。我们使用基线和 48 周之间 GCSI 总分和恶心/呕吐分量表的变化来评估 GES 的效果。我们使用倾向评分方法来控制比较组之间患者特征的不平衡。主要结果 GES 患者临床情况更差（严重程度为 40%，非 GES 患者为 18%；P < .001）； PAGI-QOL 更差（2.2 对比 2.6；P = .003）； GCSI 总分更差（3.5 与 2.8；P < .001）。我们观察到 GES 与非 GES 的 48 周 GCSI 总分有所改善：改善 >= 1 分（RR = 1.63；95% CI = (1.14, 2.33)；P = .01），并且与入组相比发生变化（差异 = -0.5 (-0.8, -0.3)；P < .001）。当调整患者特征时，症状评分较小且不具有统计学意义：改善> = 1分（RR = 1.29（0.88，1.90）；P = .20），与入组相比发生变化（差异= -0.3（-0.6，0.0）；P = .07）。在各个项目中，恶心改善了 >= 1 分（RR = 1.31 (1.03, 1.67)；P = .04）。 GCSI 评分 >= 3.0 的患者往往比评分 < 3.0 的患者改善更多。 （调整后 P = 0.02）。结论和推论 这项针对胃轻瘫患者的多中心研究发现，GES 患者的胃轻瘫症状显着改善。考虑到患者特征的不平衡，只有恶心仍然很严重。基线症状较严重的患者在 GES 后改善较多。需要更大的患者样本来全面评估症状反应并确定可能对 GES 做出反应的患者。
Background Gastric electrical stimulation (GES) for treating gastroparesis symptoms is controversial. Methods We studied 319 idiopathic or diabetic gastroparesis symptom patients from the Gastroparesis Clinical Research Consortium (GpCRC) observational studies: 238 without GES and 81 with GES. We assessed the effects of GES using change in GCSI total score and nausea/vomiting subscales between baseline and 48 weeks. We used propensity score methods to control for imbalances in patient characteristics between comparison groups. Key Results GES patients were clinically worse (40% severe vs. 18% for non-GES; P < .001); worse PAGI-QOL (2.2. vs. 2.6; P = .003); and worse GCSI total scores (3.5 vs. 2.8; P < .001). We observed improvements in 48-week GCSI total scores for GES vs. non-GES: improvement by >= 1-point (RR = 1.63; 95% CI = (1.14, 2.33); P = .01) and change from enrollment (difference = -0.5 (-0.8, -0.3); P < .001). When adjusting for patient characteristics, symptom scores were smaller and not statistically significant: improvement by >= 1-point (RR = 1.29 (0.88, 1.90); P = .20) and change from the enrollment (difference = -0.3 (-0.6, 0.0); P = .07). Of the individual items, the nausea improved by >= 1 point (RR = 1.31 (1.03, 1.67); P = .04). Patients with GCSI score >= 3.0 tended to improve more than those with score < 3.0. (Adjusted P = 0.02). Conclusions and Inferences This multicenter study of gastroparesis patients found significant improvements in gastroparesis symptoms among GES patients. Accounting for imbalances in patient characteristics, only nausea remained significant. Patients with greater symptoms at baseline improved more after GES. A much larger sample of patients is needed to fully evaluate symptomatic responses and to identify patients likely to respond to GES.