MILD HYPERPARATHYROIDISM--A RANDOMIZED TRIAL OF SURGERY

轻度甲状旁腺功能亢进症——随机手术试验

• 批准号: 2016432
• 负责人: D SUDHAKER RAO
• 金额: $ 28.79万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-01-10 至 1998-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2016432
• 关键词: clinical trials; human subject; human therapy evaluation; hyperparathyroidism; medical complication; parathyroidectomy; prognosis

Since the introduction of multi-channel biochemical screening, there has been a four-fold increase in the incidence of primary hyperparathyroidism (PHPT), making it the third most common endocrine disorder. The clinical expression has changed, and most patients are now discovered accidentally, and lack either the complaints or the complications traditionally associated with this disease. Many different opinions have been expressed concerning the optimal management of such patients. However, the balance of risks and benefits of surgical intervention versus conservative follow-up can be determined only by a longterm multicenter randomized clinical trial. Thy hypothesis of interest in this trial is the null hypothesis that patients randomized to follow-up without surgery will have no more adverse effects than patients randomized to surgery. We propose to study a group of patients with mild asymptomatic PHPT and randomize them to surgery or no surgery. Eligible patients will have: (1) persistent hypercalcemia with mean values between 10.1 and 11.5 mg/dl without evidence of another cause; (2) absence of relevant symptoms or complications; (3) normal renal function; (4) normal bone density for age in forearm, spine, and hip; (5) absence of phalangeal subperiosteal resorption, vertebral compression fractures, or nephrolithiasis; and (6) no medical contraindication to surgery. One hundred such patients will be randomly assigned in blocks of 4-8 to standard surgical treatment or to conservative management, with stratification by sex. Both groups will be followed for a minimum of 36 and a maximum of 54 months, and compared with respect to rates of bone loss at each site, changes in renal function, incidence of fractures and nephrolithiasis, left ventricular function determined by Doppler Echocardiography, quality of life determined by SF-36 questionnaire, morbidity and mortality. Patients randomized to conservative management will be reevaluated every 6 months to ensure continued conformity to the entry and exclusion criteria. Additionally, this trial will serve as a feasibility study for a larger, longer term multicenter trial.

自从引入多通道生化筛查以来， 原发性甲状旁腺功能亢进的发病率增加了四倍 （PHPT），使其成为第三大最常见的内分泌疾病。 临床 表达发生了变化，大多数患者现在发现 意外地，没有抱怨或并发症 传统上与这种疾病有关。 许多不同的意见 这类患者的最佳治疗方法。 然而，手术干预的风险和受益的平衡 与保守随访相比，只能通过长期观察来确定 多中心随机临床试验。 本试验中您感兴趣的假设是零假设， 随机接受随访而不接受手术的患者将不再有 与随机接受手术的患者相比， 我们建议研究 一组患有轻度无症状PHPT的患者，并将其随机分配至 不管手术与否 合格患者将具有：（1）持续性 高钙血症，平均值在10.1和11.5 mg/dl之间， （2）无其他相关症状;或 并发症;（3）肾功能正常;（4）年龄骨密度正常 前臂、脊柱和髋部;（5）指骨骨膜下缺失 吸收、椎体压缩性骨折或肾结石;以及（6） 无手术禁忌症。 一百个这样的病人将 以4-8人为一组随机分配到标准手术治疗组，或 保守管理，按性别分层。 两组将 随访最短36个月，最长54个月，并进行比较 关于每个部位的骨丢失率，肾脏 功能，骨折和肾结石的发生率，左心室 多普勒超声心动图测定的功能，生活质量 通过SF-36问卷、发病率和死亡率确定。 患者 随机分配至保守治疗组，每6个月重新评估一次 确保继续符合入选和排除标准。 此外，这项试验将作为一个更大的可行性研究， 长期多中心试验。