Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease
Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease
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DOI：
10.1016/j.cgh.2015.12.049
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发表时间：
2016-07-01
影响因子：
12.6
通讯作者：
Ruggenenti, Piero
中科院分区：
文献类型：
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作者：
Pisani, Antonio;Sabbatini, Massimo;Ruggenenti, Piero
背景与目的：短期研究表明生长抑素类似物对多囊肾和肝病患者有效。我们在这些患者中评价了生长抑素抑制剂长效释放奥曲肽(奥曲肽LAR)与安慰剂的长期效果。方法：我们在意大利的一个中心对患有多囊肾和肝病的成年人(估计肾小球滤过率，40mL/min/1.73m(2)或更高)进行了对照研究。我们分析了27名患者的数据，这些患者被随机分配到每月服用奥曲肽LAR(40 mg，n=14)或安慰剂(n=13)的组，为期3年。主要结果是治疗3年后和治疗结束2年后通过磁共振成像测量的肝总体积(TLV)的绝对和百分比变化。结果：两组患者的基线特征相似。3年后，服用奥曲肽的患者TLV减少了130.2+/-133.2毫升(7.8%+/-7.4%)(P=.003)，而服用安慰剂的患者则增加了144.3+/-316.8毫升(6.1%+/-14.1%)。两组间的变化与基线有显著差异(P=0.004)。治疗结束两年后，服用奥曲肽的患者TLV较基线下降了14.4+/-138.4毫升(0.8%+/-9.7%)，而服用安慰剂的患者则增加了224.4+/-331.7毫升(11.0%+/-14.4%)。与基线相比，两组间的变化仍有显著差异(P=0.046)。TLV的下降在性别上是相似的；在基线TLV较大的受试者中，TLV的变化最大。无一例患者因副作用而停药。结论：在一项针对多囊肾和肝病患者的安慰剂对照研究中，奥曲肽LAR治疗3年可显著缩小肝脏体积；治疗结束后，缩小幅度可维持2年。奥曲肽对LAR耐受性良好。
BACKGROUND & AIMS: Short-term studies have shown that somatostatin analogues are effective in patients with polycystic kidney and liver disease. We evaluated the long-term effects of long-acting release octreotide (octreotide LAR), a somatostatin inhibitor, vs placebo in these patients.METHODS: We performed a controlled study of adults with polycystic kidney and liver disease (estimated glomerular filtration rate, 40 mL/min/1.73m(2) or more) at a single center in Italy. We analyzed data from 27 patients randomly assigned to groups given octreotide LAR (40 mg, n = 14) or placebo (n = 13) each month for 3 years. The primary outcome was absolute and percentage change in total liver volume (TLV), which was measured by magnetic resonance imaging at baseline, after 3 years of treatment, and then 2 years after treatment ended.RESULTS: Baseline characteristics were similar between groups. After 3 years, TLV decreased by 130.2 +/- 133.2 mL in patients given octreotide LAR (7.8% +/- 7.4%) (P = .003) but increased by 144.3 +/- 316.8 mL (6.1% +/- 14.1%) in patients given placebo. Change vs baseline differed significantly between groups (P = .004). Two years after treatment ended, TLV had decreased 14.4 +/- 138.4 mL (0.8% +/- 9.7%) from baseline in patients given octreotide LAR but increased by 224.4 +/- 331.7 mL (11.0% +/- 14.4%) in patients given placebo. Changes vs baseline still differed significantly between groups (P = .046). Decreases in TLV were similar in each sex; the change in TLV was greatest among subjects with larger baseline TLV. No patient withdrew because of side effects.CONCLUSIONS: In a placebo-controlled study of patients with polycystic kidney and liver disease, 3 years of treatment with octreotide LAR significantly reduced liver volume; reductions were maintained for 2 years after treatment ended. Octreotide LAR was well-tolerated.