使用活性沙丁胺醇、安慰剂和假针灸或无干预措施来治疗哮喘
2011/08/31
摘要
背景：在对哮喘患者进行的前瞻性试验研究中，很难区分患者对安慰剂的反应以及无任何干预下的自然病理变化。我们比较了支气管扩张剂、两种安慰治疗和无干预措施对哮喘转归的影响。
方法：在一项双盲、交叉试验中，我们将46名哮喘患者随机分为下列各组：沙丁胺醇吸入治疗组、安慰剂吸入治疗组、假针灸组和无干预组。采用区组设计，在4次连续就诊时（间隔3~7天），随机给予上述4种措施中的一种，该做法重复2次（对于每位患者共计12次就诊）。每次就诊时，在2 h内反复进行肺活量检测。检测第1秒内最大用力呼气量（FEV1），记录患者自我主诉的改善评分。
结果：在完成本研究的39名患者中，沙丁胺醇治疗组患者的FEV1增加20%，其他三组患者的FEV1增加约为7%(P<0.001)。然而，患者主诉的干预后病情改善情况，在沙丁胺醇组（50%改善）、安慰剂吸入组（45%）和假针灸组（46%）之间无显著差异，但上述3组患者的主观改善显著高于未干预组（21%）(P<0.001)。
结论：虽然沙丁胺醇，而不是2个安慰措施，能改善哮喘患者的FEV1，但沙丁胺醇对自我主诉的哮喘转归无进一步的优势。对于哮喘患者，安慰剂效应在临床上具有重要作用，有时能与活性药物治疗相当。然而，从临床治疗和研究设计的观点，患者自我主诉的结果并不可靠。因此，在评价患者主诉的转归时，有必要评价对哮喘未进行干预治疗时的反应。
（林江涛 审校）
N Engl J Med. 2011 Jul 14;365(2):119-26.
Active albuterol or placebo, sham acupuncture, or no intervention in asthma.
Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, Israel E, Kaptchuk TJ.
Source
Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02115, USA. mwechsler@partners.org
Abstract
BACKGROUND: In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma.
METHODS: In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV(1)) was measured, and patients’ self-reported improvement ratings were recorded.
RESULTS: Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV(1), as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001).
CONCLUSIONS: Although albuterol, but not the two placebo interventions, improved FEV(1) in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes.
N Engl J Med. 2011 Jul 14;365(2):119-26.
背景：在对哮喘患者进行的前瞻性试验研究中，很难区分患者对安慰剂的反应以及无任何干预下的自然病理变化。我们比较了支气管扩张剂、两种安慰治疗和无干预措施对哮喘转归的影响。
方法：在一项双盲、交叉试验中，我们将46名哮喘患者随机分为下列各组：沙丁胺醇吸入治疗组、安慰剂吸入治疗组、假针灸组和无干预组。采用区组设计，在4次连续就诊时（间隔3~7天），随机给予上述4种措施中的一种，该做法重复2次（对于每位患者共计12次就诊）。每次就诊时，在2 h内反复进行肺活量检测。检测第1秒内最大用力呼气量（FEV1），记录患者自我主诉的改善评分。
结果：在完成本研究的39名患者中，沙丁胺醇治疗组患者的FEV1增加20%，其他三组患者的FEV1增加约为7%(P<0.001)。然而，患者主诉的干预后病情改善情况，在沙丁胺醇组（50%改善）、安慰剂吸入组（45%）和假针灸组（46%）之间无显著差异，但上述3组患者的主观改善显著高于未干预组（21%）(P<0.001)。
结论：虽然沙丁胺醇，而不是2个安慰措施，能改善哮喘患者的FEV1，但沙丁胺醇对自我主诉的哮喘转归无进一步的优势。对于哮喘患者，安慰剂效应在临床上具有重要作用，有时能与活性药物治疗相当。然而，从临床治疗和研究设计的观点，患者自我主诉的结果并不可靠。因此，在评价患者主诉的转归时，有必要评价对哮喘未进行干预治疗时的反应。
（林江涛 审校）
N Engl J Med. 2011 Jul 14;365(2):119-26.
Active albuterol or placebo, sham acupuncture, or no intervention in asthma.
Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, Israel E, Kaptchuk TJ.
Source
Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02115, USA. mwechsler@partners.org
Abstract
BACKGROUND: In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma.
METHODS: In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV(1)) was measured, and patients’ self-reported improvement ratings were recorded.
RESULTS: Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV(1), as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001).
CONCLUSIONS: Although albuterol, but not the two placebo interventions, improved FEV(1) in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes.
N Engl J Med. 2011 Jul 14;365(2):119-26.
上一篇：
哮喘急性发作后早期和晚期采用丙酸氟替卡松/沙美特罗治疗的回顾性比较研究
下一篇：
氢氟烷-倍氯米松超细颗粒和大颗粒在哮喘控制中的作用：现实条件下的观察性研究
