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生长抑素类似物对多囊肝病患者肝体积和生活质量的影响:一项随机对照试验的荟萃分析。

The effects of somatostatin analogues on liver volume and quality of life in polycystic liver disease: a meta-analysis of randomized controlled trials.

机构信息

Division of Nephrology, Department of Scienze Mediche e Chirurgiche Avanzate, University of Campania "Luigi Vanvitelli", Via M. Longo 50, 80138, Naples, Italy.

Department of Public Health, Chair of Nephrology, University Federico II of Naples, Naples, Italy.

出版信息

Sci Rep. 2021 Dec 6;11(1):23500. doi: 10.1038/s41598-021-02812-z.

Abstract

A clear evidence on the benefits of somatostatin analogues (SA) on liver outcome in patients affected by polycystic liver disease is still lacking. We performed a meta-analysis of RCTs and a trial sequential analysis (TSA) evaluating the effects of SA in adult patients with polycystic liver disease on change in liver volume. As secondary outcome, we evaluated the effects on quality of life as measured by SF36-questionnaire. Six RCTs were selected with an overall sample size of 332 adult patients with polycystic liver disease (mean age: 46 years). Mean liver volume at baseline was 3289 ml in SA group and 3089 ml in placebo group. Overall, unstandardized mean difference in liver volume was - 176 ml (95%CI, - 406, 54; p < 0.133). Heterogeneity was low (I:0%, p < 0.992). However, we performed a moderator analysis and we found that a higher eGFR significantly correlates to a more pronounced effect of SA on liver volume reduction (p = 0.036). Cumulative Z-curve in TSA did not reach either significance and futility boundaries or required information size. Three RCTs have evaluated Quality of life parameters measured by SF36-QOL questionnaire for a total of 124 patients; no significant difference was found on the effect of SA on QOL parameters when compared with placebo. The present meta-analysis revealed a potential effect of SA on reduction of liver volume and quality of life parameters, but results did not reach a statistical significance. These data could be explained by the need of further studies, as demonstrated through TSA, to reach an adequate sample size to confirm the beneficial outcomes of SAs treatment.

摘要

在患有多囊肝病的患者中,生长抑素类似物 (SA) 对肝脏结局的益处仍缺乏明确证据。我们进行了一项荟萃分析和试验序贯分析 (TSA),评估了 SA 对多囊肝病成年患者肝脏体积变化的影响。作为次要结局,我们评估了 SA 对 SF36 问卷测量的生活质量的影响。共纳入 6 项 RCT,总样本量为 332 例患有多囊肝病的成年患者(平均年龄:46 岁)。SA 组和安慰剂组的基线肝体积分别为 3289ml 和 3089ml。总体而言,肝体积的未标准化均数差值为 -176ml(95%CI,-406,54;p<0.133)。异质性低(I:0%,p<0.992)。然而,我们进行了一项调节分析,发现较高的 eGFR 与 SA 对肝体积减少的影响更为显著显著相关(p=0.036)。TSA 中的累积 Z 曲线未达到显著或无效边界,也未达到所需信息大小。3 项 RCT 评估了 SF36-QOL 问卷测量的生活质量参数,共有 124 例患者;与安慰剂相比,SA 对 QOL 参数的影响没有显著差异。本荟萃分析显示 SA 可能对减少肝脏体积和生活质量参数有一定的作用,但结果未达到统计学意义。这些数据可以通过 TSA 来解释,需要进一步的研究来达到足够的样本量,以确认 SAs 治疗的有益结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdb1/8648823/5a57f52a0be9/41598_2021_2812_Fig1_HTML.jpg

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