奥西洛德司他治疗库欣综合征的有效性和安全性:系统回顾与元分析》。

Lakshmi Nagendra, Deep Dutta, Nishant Raizada, Vineet Surana, Chitra Selvan, Saptarshi Bhattacharya
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引用次数: 0

摘要

目前还没有荟萃分析全面分析和总结奥西洛德司他这种新型 11β- 羟化酶(细胞色素 P450 家族 11 亚家族 B 成员 1 [CYP11B1])和 18- 羟化酶(醛固酮合成酶,CYP11B2)双重抑制剂在治疗库欣综合征(CS)方面的疗效和安全性。为了填补这一知识空白,我们进行了这项荟萃分析。我们在电子数据库中搜索了涉及在干预组中接受奥昔洛司他治疗的库欣综合征患者的随机对照试验(RCT)。主要结果是评估尿游离皮质醇 (UFC) 水平的变化。次要结果是评估皮质醇水平、雄激素水平、矿质皮质激素水平和不良事件的变化。从初步筛选出的 109 篇文章中,对涉及 144 名患者的 2 项 RCT 的数据进行了分析。经过 8-12 周的治疗后,与安慰剂相比,接受奥利司他治疗的患者达到正常 24 小时 UFC 的几率更高。[比值比 (OR) 21.94 (95% CI: 8.53-56.43);P < 0.00001;I2 = 0%]。不良事件[OR 1.35(95% CI:0.52-3.53);P = 0.54;I2 = 0%;低异质性(LH);高证据确定性(HCE)]、严重不良事件(SAE)[OR 1.32(95% CI:0.30-5.79);P = 0.72;I2 = 0%;LH;HCE]、肾上腺功能不全[OR 5.38(95% CI:0.91-31.78);P = 0.06;I2 = 0%;LH;HCE]、头痛[OR 0.98(95% CI:0.35-2.76);P = 0.97;I2 = 0%;LH;HCE]、雄激素过多[OR 3.68(95% CI:0.59-22.80); P = 0.16; I2 = 0%; LH; HCE]和死亡[OR 0.32 (95% CI: 0.01-8.00); P = 0.48; I2 = 0%; LH; HCE]在各组间具有可比性。与安慰剂相比,奥西洛前列素组的恶心[OR 4.25 (95% CI: 1.26-14.30); P = 0.02; I2 = 0%; LH]和关节痛[OR 6.54 (95% CI: 1.64-26.13); P = 0.008; I2 = 0%; LH; HCE]发生率明显更高。奥西洛前列素对CS具有良好的疗效和安全性,在48周的使用过程中耐受性良好。
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Efficacy and Safety of Osilodrostat in Managing Cushing's Syndrome: A Systematic Review and Meta-Analysis.

No meta-analysis has holistically analysed and summarized the efficacy and safety of osilodrostat, a novel dual 11β-hydroxylase (cytochrome P450 family 11 subfamily B member 1 [CYP11B1]) and 18-hydroxylase (aldosterone synthase, CYP11B2) inhibitor in managing Cushing's syndrome (CS). We undertook this meta-analysis to address this knowledge gap. Electronic databases were searched for randomized controlled trials (RCTs) involving patients with CS receiving osilodrostat in the intervention arm. The primary outcome was to evaluate changes in urine free cortisol (UFC) levels. Secondary outcomes were to evaluate alterations in cortisol levels, androgen levels, mineralocorticoid levels, and adverse events. From initially screened 109 articles, data from 2 RCTs involving 144 patients was analysed. After 8-12 weeks of therapy, the odds of achieving a normal 24-hour UFC was higher in patients receiving oslidrostat as compared to placebo. [odds ratio (OR) 21.94 (95% CI: 8.53-56.43); P < 0.00001; I2 = 0%]. The occurrence of adverse events [OR 1.35 (95% CI: 0.52-3.53); P = 0.54; I2 = 0%; low heterogeneity (LH); High certainty of evidence (HCE)], serious adverse events (SAEs) [OR 1.32 (95% CI: 0.30-5.79); P = 0.72; I2 = 0%; LH; HCE], adrenal insufficiency [OR 5.38 (95% CI: 0.91-31.78); P = 0.06; I2 = 0%; LH; HCE], headache [OR 0.98 (95% CI: 0.35-2.76); P = 0.97; I2 = 0%; LH; HCE], hyperandrogenism [OR 3.68 (95% CI: 0.59-22.80); P = 0.16; I2 = 0%; LH; HCE] and deaths [OR 0.32 (95% CI: 0.01-8.00); P = 0.48; I2 = 0%; LH; HCE] was comparable among the groups. The occurrence of nausea [OR 4.25 (95% CI: 1.26-14.30); P = 0.02; I2 = 0%; LH] and arthralgia [OR 6.54 (95% CI: 1.64-26.13); P = 0.008; I2 = 0%; LH; HCE] was significantly higher in the osilodrostat group as compared to placebo. Osilodrostat has good efficacy and safety in CS and was well tolerated over 48 weeks of use.

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来源期刊
Indian Journal of Endocrinology and Metabolism
Indian Journal of Endocrinology and Metabolism Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
2.10
自引率
0.00%
发文量
75
期刊介绍: The Indian Journal of Endocrinology and Metabolism (IJEM) aims to function as the global face of Indian endocrinology research. It aims to act as a bridge between global and national advances in this field. The journal publishes thought-provoking editorials, comprehensive reviews, cutting-edge original research, focused brief communications and insightful letters to editor. The journal encourages authors to submit articles addressing aspects of science related to Endocrinology and Metabolism in particular Diabetology. Articles related to Clinical and Tropical endocrinology are especially encouraged. Sub-topic based Supplements are published regularly. This allows the journal to highlight issues relevant to Endocrine practitioners working in India as well as other countries. IJEM is free access in the true sense of the word, (it charges neither authors nor readers) and this enhances its global appeal.
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