Tamsulosin and steroids for urolithiasis

坦索罗辛和类固醇治疗尿石症

• 批准号: 7214754
• 负责人: JEREMY BROWN
• 金额: $ 27.31万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7214754
• 关键词: Abdominal colic; Absence of pain sensation; Accident and Emergency department; Acute; Adverse effects; Affect; Age; Analgesics; Blinded; Calculi; Caring; Clinic; Clinical; Clinical Research; Consent; Cost Savings; Country; Diagnosis; Disease; Employment; European; Excision; Female; Gender; Goals; Incidence; Institution; Intervention; Kidney; Kidney Calculi; Length; Lithotripsy; Location; Medical; Mission; Monitor; Narcotics; National Institute of Diabetes and Digestive and Kidney Diseases; Numbers; Operative Surgical Procedures; Oral; Outcome; Outpatients; Pain; Pain-Free; Patients; Persons; Pharmaceutical Preparations; Placebos; Population; Population Study; Protocols documentation; Public Health; Randomized; Recovery; Recruitment Activity; Recurrence; Safety; Standards of Weights and Measures; Steroids; Subgroup; Therapeutic; Time; United States; Urology; Visit; Work; base; day; follow-up; improved; male; programs; size; tamsulosin; urolithiasis; urologic

DESCRIPTION (provided by applicant): Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients. Based on encouraging results from several small European clinical studies, we hypothesize that the administration of tamsulosin and/or a steroid to patients with symptomatic urolithiasis will enhance stone passage, and reduce both the time to recovery and the need for surgical intervention or lithotripsy. We will conduct a study by identifying and recruiting patients presenting with urolithiasis in the emergency departments of four institutions. A total of 302 consenting subjects will be randomly assigned to one of four groups: 1) tamsulosin for a maximum of 28 days and an oral steroid for a maximum of 10 days, 2) tamsulosin and placebo, 3) steroid and placebo, and 4) double placebo. In addition, both groups will receive standard analgesic therapy. The study team, which will be blinded to treatment status, will monitor each subject's clinical progress and outcome.The primary objectives of this study are: 1) to determine which protocol is the most effective, and 2) to evaluate the safety of the therapy. The secondary objective is to identify the most appropriate clinical subgroup(s) for treatment. If the therapeutic benefits observed in smaller clinical studies are replicated, administration of these medications should produce several benefits, including: a) a reduction in time to pain free recovery and hence a more rapid return to employment; b) decreased requirements for narcotic analgesia; c) less need for urological out-patient clinic follow-up; d) decreased need for surgical intervention or lithotripsy and e) substantial cost savings. If this therapy is beneficial, it will represent a major advance in the treatment of urolithiasis. This objective is a major stated goal of the NIDDK Clinical Urology Program, which has a stated mission to improve the treatment of urolithiasis. Kidney stones are a major public health issue, and one person in eight will be affected by the disease. If our hypothesis is verified, we will provide the first medical therapy ever for this disease. This therapy, if effective, will reduce the amount of time a patient is off work because of the pain from the disease, and may also reduce the need for expensive and time-consuming surgical treatments.

描述（由申请人提供）：尿石症是一种影响 12% 人口的疾病，并且其发病率正在上升。在美国，每年有超过 110 万人次因肾绞痛前往急诊室就诊。这种疾病极其痛苦，通常需要大量麻醉镇痛，并导致工作日损失。此外，多达 30% 的患者最终可能需要碎石术或手术切除结石。目前，除了镇痛之外，没有向患者提供任何医疗干预措施。基于几项小型欧洲临床研究的令人鼓舞的结果，我们假设对有症状的尿石症患者给予坦索罗辛和/或类固醇将促进结石排出，并减少恢复时间和手术干预或碎石术的需要。我们将通过识别和招募四个机构急诊科的患有尿石症的患者来进行一项研究。总共 302 名同意的受试者将被随机分配到四组之一：1) 坦索罗辛最多 28 天，口服类固醇最多 10 天，2) 坦索罗辛和安慰剂，3) 类固醇和安慰剂，4) ）双重安慰剂。此外，两组都将接受标准镇痛治疗。研究团队对治疗状态不知情，将监测每位受试者的临床进展和结果。本研究的主要目标是：1) 确定哪种方案最有效，2) 评估治疗的安全性。次要目标是确定最适合治疗的临床亚组。如果在较小规模的临床研究中观察到的治疗效果得到复制，那么使用这些药物应该会产生多种好处，包括： a) 缩短无痛恢复时间，从而更快地重返工作岗位； b) 减少麻醉镇痛的需求； c) 泌尿外科门诊随访需求较少； d) 减少手术干预或碎石术的需要，以及 e) 节省大量成本。如果这种疗法有效，将代表尿石症治疗的重大进步。这一目标是 NIDDK 临床泌尿外科项目的一个主要既定目标，该项目的既定使命是改善尿石症的治疗。肾结石是一个重大的公共卫生问题，八分之一的人会受到这种疾病的影响。如果我们的假设得到证实，我们将为这种疾病提供有史以来的第一种药物治疗。如果这种疗法有效，将减少患者因疾病疼痛而休息的时间，也可能减少昂贵且耗时的手术治疗的需要。