NCT00338793已完成不适用
A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy
Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Presented with clinical features suggesting pleural tuberculosis;
- •Had not previously received treatment or prophylaxis for tuberculosis;
- •Had not recently received treatment with glucocorticoids;
- •Were not pregnant or breast-feeding.
排除标准
- •Failed to complete the screening procedures;
- •Were seropositive for HIV
- •Tuberculous meningitis;
- •Had risk factors for serious steroid-related adverse events (a history of diabetes or positive urine glucose, a history or clinical finding of hypertension, or a history of peptic ulcer disease or mental illness);
- •Standard doses of antituberculosis drugs could not be used (as in participants with concurrent liver disease)
- •Psychiatric illness;
- •Alcoholism.
结局指标
主要结局
Death
Presence of pleural thickening
Pulmonary function at completion of treatment
Adverse drug effects
次要结局
- Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
- Reabsorption of pleural effusion
- Failure rate at the end of treatment
研究者
研究点 (1)
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