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Operant Procedures for Assessing Behavioral Flexibility in Rats
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在轻度持久性喘中使用布索尼德的早期干预:一个随机的双盲试验
Romain A Pauwels1, Søren Pedersen, William W Busse
1Department of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium. romain.pauwels@rug.ac.be <romain.pauwels@rug.ac.be>
Lancet (London, England)
|April 4, 2003
概括
低剂量布索尼德显著降低了最近出现的轻度持久性喘中的严重喘恶化. 这种治疗也改善了喘控制和肺功能超过三年.
科学领域:
- 肺部病理学 肺部病理学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 吸入型葡萄糖皮质类固醇是持续性喘的标准.
- 在近期发作,轻度持续性喘的长期疗效仍未得到充分评估.
研究的目的:
- 为了评估布索尼德在轻度持续性最近发作的喘中产生的长期影响.
- 评估布索尼德对严重恶化和喘控制的影响.
主要方法:
- 随机,双盲,安慰剂对照试验涉及32个国家的7241名患者.
- 患者每天接受布迪索尼德 (400微克或200微克对于11岁以下的儿童) 或安慰剂3年.
- 主要结局:第一个严重喘相关事件发生的时间;治疗意图分析.
主要成果:
- 布西尼德显著减少了严重的喘恶化 (HR0.56,p<0.0001).
- 服用布索尼德的患者体验到更少的全身性皮质类固醇疗程和更多的无症状日.
- 布德索尼德改善了肺功能 (FEV1),并且无论基线参数如何,都显示出一致的效果.
- 在11岁以下的儿童中观察到轻微的增长减缓.
结论:
- 每天服用一次,低剂量布索尼德对最近出现的轻度持久性喘有效.
- 治疗降低了严重恶化的风险,并提高了整体喘控制.
- 儿童的潜在生长影响需要考虑.
相关概念视频
Blind Procedures
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...
Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

