A Pilot Study for Randomized Controlled Trial on the Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma

Pheochromocytoma and paraganglioma (PPGL) are rare neuroendocrine tumors originating from catecholamine producing chromaffin cells in the adrenal medulla and extra-adrenal paraganglia. The overall age-standardized incidence rate is 0.18 per 100,000 person-years in Korea.
The definitive treatment of PPGL is surgical excision of tumor. However, surgery is associated with a high risk of perioperative hemodynamic instability (HI). To avoid perioperative HI in patients diagnosed with PPGL, preoperative management including routine use of alpha blockade and volume expansion has been advocated by several guidelines.
While unstable hypertension and tachycardia should be controlled in patients with PPGL, there is controversial that all patients diagnosed with PPGL should undergo preoperative pharmacological treatment, especially alpha blockade. The most important risk of preoperative alpha blockade use is perioperative hypotension.
A recent study reported that patients diagnosed with PPGL postoperatively may have no further higher risk of intraoperative hypertension than those diagnosed preoperatively despite insufficient preoperatively management of PPGL.
Therefore, it is a very important to study the relationship between HI and preoperative alpha blockade in normotensive patients diagnosed with PPGL. The aim this study is to analyze the effect and safety of omitting preoperative alpha-adrenergic blockade for normotensive pheochromocytoma through a prospective randomized controlled trial. The patients is divided into two groups. The patients in control group take a phenoxybenzamine at least 2 to 5 weeks before surgery. The patients in case group do not take a phenoxybenzamine.
Primary outcome is to evaluate the percentage of time during surgery with systolic blood pressure more than 160mmHg or average blood pressure less than 60mmHg. And secondary outcomes are to evaluate hemodynamic instability in preoperative ward and postoperative ward.

开始日期2023-01-18

申办/合作机构

Seoul National University Hospital

NCT01379898 / Completed临床4期IIT

Pheochromocytoma Randomised Study Comparing Adrenoreceptor Inhibiting Agents for Preoperative Treatment

Rationale: The optimal preoperative medical management for patients with a pheochromocytoma is currently unknown. In particular, there is no agreement with respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist to be administered before surgical resection of a pheochromocytoma. We hypothesized that the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and alfa2-antagonist phenoxybenzamine.
Objective: comparing effects of preoperative treatment with either phenoxybenzamine or doxazosin on intraoperative hemodynamic control in patients undergoing surgical resection of a pheochromocytoma.
Study design: Randomised controlled open-label trial.
Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign pheochromocytoma.
Intervention: Patients are randomised to receive oral treatment with either phenoxybenzamine or doxazosin preoperatively.
Main study parameters/endpoints: The main study parameter is defined as the percentage of intraoperative time that blood pressure is outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin.
In this multicenter trial, we compare the effects of two commonly used drugs in patients being medically prepared for resection of a benign pheochromocytoma. Participants are not subjected to an experimental treatment of any kind, as we merely aim to describe in detail the perioperative course in general and, in particular, the intraoperative hemodynamic control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A routine diagnostic work-up for pheochromocytoma will be performed in all participants. One extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and participants need to record their symptoms in a diary. In addition, patients who are pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the nursing staff. The final site visit is planned at 30 days after surgery, in line with current practice.

开始日期2011-12-01

申办/合作机构

University Medical Center Groningen

[+13]

CTRI/2011/09/002019 / Recruiting临床4期

Comparative study of pre-operative blockade using Phenoxybenzamine vs. Prazosin efficacy ( intra- and post-operative hemodynamic changes) and safety profile in Pheochromocytoma

开始日期2011-09-27

申办/合作机构

Sanjay Gandhi Post Graduate Institute of Medical Sciences

100 项与盐酸酚苄明相关的临床结果

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100 项与盐酸酚苄明相关的转化医学

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100 项与盐酸酚苄明相关的专利（医药）

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5,080

项与盐酸酚苄明相关的文献（医药）

2024-06-26·Sexual Medicine Reviews

A comprehensive history of injection therapy for erectile dysfunction, 1982-2023

Review

作者: Goldstein, Irwin ; Lewis, Ronald ; Virag, Ronald ; Porst, Hartmut

AbstractIntroductionAlthough oral phosphodiesterase 5 inhibitors represent a first choice and long-term option for about half of all patients with erectile dysfunction (ED), self-injection therapy with vasoactive drugs remains a viable alternative for all those who are not reacting or cannot tolerate oral drug therapy. This current injection therapy has an interesting history beginning in 1982.ObjectivesTo provide a comprehensive history of self-injection therapy from the very beginnings in 1982 by contemporary witnesses and some members of the International Society for Sexual Medicine’s History Committee, a complete history of injection therapy is prepared from eyewitness accounts and review of the published literature on the subject, as well as an update of the current status of self-injection therapy.MethodsPublished data on injection therapy, as a diagnostic and therapeutic tool for ED, were reviewed thoroughly by PubMed and Medline research from 1982 until June 2023. Early pioneers and witnesses added firsthand details to this historical review. Therapeutic reports of injection therapy were reviewed, and results of side effects and complications were thoroughly reviewed.ResultsThe pioneers of the first hours were Ronal Virag (1982) for papaverine, Giles Brindley (1983) for cavernosal alpha-blockade (phentolamine and phenoxybenzamine), Adrian Zorgniotti (1985) for papaverine/phentolamine, and Ganesan Adaikan and N. Ishii (1986) for prostaglandin E1. Moxisylyte (thymoxamine) was originally marketed but later withdrawn. The most common side effect is priapism, with the greatest risk of this from papaverine, which has modified its use for therapy. Currently, prostaglandin E1 and trimixes continue to be the agents of choice for diagnostic and therapeutic use in ED. A recent agent is a mixture of a vasoactive intestinal polypeptide (aviptadil) and phentolamine.ConclusionsAfter 40 years, self-injection therapy represents the medication with the highest efficacy and reliability rates and remains a viable option for many couples with ED. The history of this therapy is rich.

2024-02-23·JCEM Case Reports

Small Incidental Pheochromocytoma Presenting With Normal or Borderline High 24-hour Urine Fractionated Metanephrines

作者: Yeo, Chin Pin ; Kwek, Kevin Jun Hong ; Kon, Yin Chian ; Ho, Bernard Chi Sern

AbstractA 73-year-old man was found to have a 2-cm lipid-poor right adrenal incidentaloma on computed tomography imaging for hematuria. Twenty-four-hour urine metanephrine was 1.1-fold elevated, then normal on repeat measurement. Paired with the second urine collection, plasma metanephrine measured by liquid chromatography tandem mass spectrometry after a 30-minute supine rest was 3.3-fold elevated. Plasma normetanephrine was 1.2-fold elevated. The 24-hour urine catecholamines and normetanephrine, measured twice, were normal. He received low-dose phenoxybenzamine and underwent successful resection of right pheochromocytoma. Postoperatively, both plasma metanephrine and normetanephrine levels normalized, using an age-appropriate upper reference limit for plasma normetanephrine. Patients who harbor small lipid-poor adrenal incidentalomas have a relatively high risk (>5%) of having pheochromocytoma, indistinguishable from adenomas or carcinomas on computed tomography scan. In such cases when 24-hour urine fractionated metanephrines are normal, plasma free metanephrines measured by liquid chromatography tandem mass spectrometry under optimal sampling conditions that are 2-fold or more elevated confirm the diagnosis of pheochromocytoma. Preoperative alpha blockade followed by surgical resection is then appropriate, rather than continued monitoring with repeat urine measurements.

2023-12-01·Veterinary and Comparative Oncology

Risk factors influencing death prior to discharge in 302 dogs undergoing unilateral adrenalectomy for treatment of primary adrenal gland tumours

Article

作者: Selmic, Laura E ; Wustefeld-Janssens, Brandan G ; Dornbusch, Josephine A ; Souza, Carlos H ; Traverson, Marine ; Amsellem, Pierre ; Williams, Elroy ; Piegols, Hunter J ; Stephens, Julie A ; Liptak, Julius M ; Cray, Megan T ; Abrams, Brittany E ; Skinner, Owen T ; Murphy, Christina ; Lapsley, Janis M

AbstractAdrenalectomies for canine adrenal tumours are associated with peri‐operative morbidity and mortality. Objectives of this study included assessing the prognostic value of tumour‐ or surgery‐related variables in predicting peri‐operative mortality and overall survival in dogs undergoing adrenalectomies for primary adrenal tumours as well as pre‐treatment with phenoxybenzamine on survival to discharge with pheochromocytomas specifically. A multi‐institutional retrospective cohort study was performed across nine institutions. Electronic medical record searches identified 302 dogs which met the inclusion criteria. Data collected included dog‐related, tumour‐related, treatment‐related, surgery‐related, and outcome variables. Univariate and multivariable logistic regression and cox proportional hazards models were used to identify variables associated with death prior to discharge and tumour‐related survival. Overall, 87% of dogs survived to discharge with a tumour‐related survival time of 3.96 years. Post‐operative complications were reported in 25%. Increased surgical time (p = 0.002) and pre‐surgical medical treatment other than phenoxybenzamine (p = 0.024) were significantly associated with increased peri‐operative mortality while ureteronephrectomy (p = 0.021), post‐operative pancreatitis (p = 0.025), and post‐operative aspiration pneumonia (p < 0.001) were significantly associated with decreased overall survival. Phenoxybenzamine pretreatment had no effect on peri‐operative mortality. Thirty‐seven of 45 (82%) dogs with pheochromocytomas not pretreated survived to discharge, and 50 of 59 (85%) dogs with pheochromocytomas pretreated with phenoxybenzamine survived to discharge (p = 0.730). This study provides information on risk factors for death prior to discharge and tumour‐related survival that may help guide clinical management and owner expectations. In addition, the study findings challenge the previously reported benefit of phenoxybenzamine for pretreatment of dogs undergoing adrenalectomies for pheochromocytomas.

项与盐酸酚苄明相关的新闻（医药）

2022-12-13

·米内网

【瞩目】科伦发威！进攻10亿大品种

精彩内容12月12日，CDE官网显示，科伦药业以仿制4类报产的盐酸乌拉地尔注射液获得承办受理。盐酸乌拉地尔注射液为静脉降压药，2021年在中国公立医疗机构终端销售额突破10亿元。乌拉地尔是一种选择性α1受体阻滞剂，具有外周和中枢双重降压作用。盐酸乌拉地尔注射液主要适用于高血压危象以及控制围手术期高血压，在临床上应用甚广，是急诊室常备急救药品之一。米内网数据显示，2021年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端乌拉地尔注射剂销售规模接近15亿元，同比增长14.64%。其中，盐酸乌拉地尔注射液销售额首次突破10亿元，同比增长18.61%。中国公立医疗机构终端盐酸乌拉地尔注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局目前，国内已上市的乌拉地尔制剂包括盐酸乌拉地尔注射液、注射用盐酸乌拉地尔、乌拉地尔注射液、乌拉地尔缓释片、乌拉地尔缓释胶囊、乌拉地尔葡萄糖注射液、乌拉地尔氯化钠注射液。科伦药业获批上市的高血压用药来源：米内网新版数据库在高血压用药领域，科伦药业累计已有10个品种获批上市，包括阿替洛尔片、注射用呋塞米、盐酸酚苄明片、注射用硝普钠、盐酸拉贝洛尔片、替米沙坦片、替米沙坦胶囊、尼群地平片、尼莫地平片、尼莫地平注射液。数据来源：米内网数据库、CDE注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

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100 项与盐酸酚苄明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00507	盐酸酚苄明	C04AX02	DB00925

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
外周血管痉挛性疾病	中国	苏州弘森药业股份有限公司	1987-01-01
尿潴留	中国	苏州弘森药业股份有限公司	1987-01-01
高血压	美国	Concordia Pharmaceuticals, Inc.	1953-01-26
嗜铬细胞瘤	美国	Concordia Pharmaceuticals, Inc.	1953-01-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00620945 (CTgov)	N/A	先天性心脏缺损	87	Phenoxybenzamine (Phenoxybenzamine Treatment)	網鏇製鑰繭鏇窪壓艱願(憲鹽窪衊選壓顧餘繭願) = 獵簾淵願窪積襯齋鹹製蓋齋觸艱夢鏇憲鑰憲餘 (夢齋構鏇繭製範鹽憲網, 鹽鏇膚遞鏇衊築窪構襯 ~ 淵襯遞夢簾壓蓋願憲願) 更多	-	2017-11-20
NCT00620945 (CTgov)	N/A	先天性心脏缺损	87	Phenoxybenzamine (Phenoxybenzamine)	蓋鏇鬱廠膚艱構鹽憲顧(齋鹽憲醖繭簾遞艱鑰壓) = 積壓鹹蓋鏇鏇簾顧鏇壓願鏇繭憲網顧遞顧簾蓋 (窪鹽願憲壓壓鬱簾壓顧, 觸鹽網鹹簾積蓋鹹簾積 ~ 顧糧廠廠齋憲鑰鹹壓觸) 更多	-	2017-11-20
NCT00569855 (CTgov)	临床2期	心脏病	785	phenoxybenzamine	鏇壓憲選糧簾廠夢範築(鬱觸繭積鬱衊餘範觸網) = 觸憲範夢夢衊選鏇獵糧鏇範鏇製簾積遞衊醖淵 (醖夢餘糧鹽壓鬱醖築簾, 遞鑰構鑰鹹壓繭繭遞觸 ~ 鏇鹹遞鏇衊糧蓋築餘製) 更多	-	2011-03-01