证据

本页包含特色内容的快照,内容强调了探讨关键临床问题的证据,包括不确定性领域。敬请参阅主要专题参考文献列表,了解支持该专题的所有信息源详情。

BMJ Best Practice 临床实践证据表单

Evidence table logo

对于特定临床问题,通过 GRADE 和 BMJ Best Practice 临床实践有效性评级,证据表提供了导航简单的分层证据。通过表单底部链接,可获取专题正文相关证据评分,为临床问题提供更多参考。查阅证据表单,获取更多信息。

该表单为 Cochrane Clinical Answer 针对上述重要临床问题所报道的分析总结。


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for key outcomes.


人群: Adults with severe or very severe COPD experiencing exacerbations

干预: Systemic corticosteroids for seven days or fewer

比较: Systemic corticosteroids for longer than seven days

结局效能(BMJ 评价)?证据可信度(GRADE)?

Treatment failure (10–14 days)

No statistically significant difference

Moderate

Relapse (14–180 days)

No statistically significant difference

Moderate

Time to re‐exacerbation

No statistically significant difference

GRADE assessment not performed for this outcome

FEV1 % predicted: 6 days

No statistically significant difference

GRADE assessment not performed for this outcome

FEV1 % predicted: 30 days

No statistically significant difference

GRADE assessment not performed for this outcome

Dyspnea

No statistically significant difference

GRADE assessment not performed for this outcome

Quality of life: 6 days

No statistically significant difference

GRADE assessment not performed for this outcome

Quality of life: 30 days

No statistically significant difference

Moderate

Duration of hospital stay

No statistically significant difference

Moderate

Adverse effects: hyperglycemia

No statistically significant difference

Moderate

Adverse effects: hypertension

No statistically significant difference

GRADE assessment not performed for this outcome

Adverse effects: other ᵃ

No statistically significant difference

Low

注意

The Cochrane Clinical Answer (CCA) noted that the number of participants included in the meta-analyses for the primary outcomes of treatment failure and relapse may be too small (450 and 478 participants) to detect differences between treatment groups.

The Cochrane review which underpins the CCA noted that one large study carried most of the weight in the meta-analysis, and was therefore responsible for the confidence in the conclusion that shorter courses of oral corticosteroids (for five days) can be used as treatment for COPD exacerbation as they seem to be equally effective as longer courses.

The Cochrane review which underpins this CCA noted that the reviewed studies did not include people with mild or moderate COPD and future studies are required in this patient group.

The Cochrane review also reported two outcomes not included in the CCA (mortality: no statistically significant difference between treatment groups, moderate GRADE rating; lung function (end of treatment; FEV1; 10–14 days]: no statistically significant difference between treatment groups, very low GRADE rating).

ᵃ Other adverse effects included gastrointestinal tract bleeding, symptomatic gastrointestinal reflux, symptoms of congestive heart failure or ischemic heart disease, sleep disturbance, fractures, and depression.

Эта таблица с доказательными данными относится к следующему разделу (разделам):

Эта таблица представляет собой итоговый анализ, представленный в систематическом обзоре, который фокусируется на обозначенном выше важном клиническом вопросе.


Confidence in the evidence is high or moderate to high where GRADE has been performed and there is no difference in effectiveness between the intervention and comparison for key outcomes.


Население: Adults with COPD

Вмешательство: Oral vitamin D supplementation

Сравнение: Oral placebo

Клинические исходыЭффективность (рейтинг BMJ)?Уровень доказательности (СТЕПЕНЬ)?

Moderate or severe exacerbations: overall

No statistically significant difference

High

Moderate or severe exacerbations: baseline 25(OH)D <25 nmol/L

Favors intervention

Moderate

Moderate or severe exacerbations: baseline 25(OH)D ≥25 nmol/L

No statistically significant difference

High

Proportion with ≥1 severe exacerbation

No statistically significant difference

High

Proportion with ≥1 serious adverse event

No statistically significant difference

High

Примечание

This systematic review reported that in the study population as a whole, vitamin D did not influence the rate of moderate or severe COPD exacerbations when compared with placebo.

However, subgroup analyses showed that vitamin D supplementation decreased moderate or severe COPD exacerbations in patients with baseline 25-hydroxyvitamin D levels <25 nmol/l but not in those with baseline levels ≥25 nmol/.

Эта таблица с доказательными данными относится к следующему разделу (разделам):

Эта таблица представляет собой итоговый анализ, представленный в систематическом обзоре, который фокусируется на обозначенном выше важном клиническом вопросе.


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for key outcomes.


Население: People with acute COPD exacerbations

Вмешательство: Procalcitonin-guided protocol

Сравнение: Standard therapy

Клинические исходыЭффективность (рейтинг BMJ)?Уровень доказательности (СТЕПЕНЬ)?

Length of antibiotic treatment (6 RCTs)

Favors intervention ᵃ

Moderate

Length of hospital stay (9 RCTs)

No statistically significant difference ᵇ

Low

Treatment failure (7 RCTs)

No statistically significant difference

Low

All-cause mortality (9 RCTs)

No statistically significant difference ᶜ

Low

Respiratory-related mortality (3 RCTs)

No statistically significant difference

Moderate

All-cause re-admission (4 RCTs)

No statistically significant difference

Low

Respiratory-related re-admission (4 RCTs)

No statistically significant difference

Low

Nota

This systematic review reported that procalcitonin-guided protocols have limited value in determining the use of antibiotics in acute exacerbations of COPD, and that procalcitonin should not be used in the intensive care unit (ICU) setting to guide antibacterial prescribing in these patients.

The systematic review also reported results from observational studies, in which effectiveness was the same as the RCTs and GRADE was reported as very low, except for length of hospital stay, for which GRADE was reported as low.

ᵃ Results showed that procalcitonin-guided protocols reduced the overall duration of antibiotic treatment by two days. However, a sensitivity analysis excluding studies with ≥1 high risk-of-bias item (except blinding for outcome assessment), or those with converted outcome value, found no significant difference between treatment groups.

ᵇ Subgroup analysis of patients in an ICU setting found a significantly longer length of hospital stay in the procalcitonin group compared with the standard therapy group (MD = 4.03 days [95% CI 0.74 to 7.32 days], p = 0.02).

ᶜ The reviewers reported that for the two studies conducted in an ICU setting, the mortality rates in the procalcitonin group were higher than the standard therapy group, although this difference was not statistically significant.

Esta tabla de evidencias está relacionada con la/s sección/es siguiente/s:

Esta tabla es un resumen del análisis que figura en una directriz (respaldada por una revisión sistemática) que se centra en la importante cuestión clínica arriba citada.


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes.


Población: Adults with acute exacerbations of COPD

Intervención: Antibiotics

Comparación: Placebo

ResultadoEficacia (clasificación BMJ)?Confianza en las evidencias (GRADE)?

Clinical cure at end of intervention ᵃ

Favors intervention

Moderate

Clinical failure rate ᵇ

Favors intervention

Moderate

Adverse events

No statistically significant difference

GRADE not reported for this outcome

Las recomendaciones que figuran en la directriz fuente

The AAFP recommends that clinicians prescribe systemic antibiotics for adults with acute exacerbation of COPD to improve clinical cure and reduce clinical failure (weak recommendation; moderate quality of evidence). Choice of antibiotic should be based on local resistance patterns, affordability, and patient history and preferences because there is insufficient evidence to support a preferential recommendation.

Nota

The guideline group noted that there were no statistically significant differences in other outcomes of interest, including mortality and quality of life. Outcomes of interest were defined as patient-oriented clinical outcomes. However, it is unclear which other outcomes of interest were reported in the included studies.

The guideline group also noted that, although they found studies of one antibiotic versus another and different dosages of antibiotics, there was “insufficient evidence to estimate an effect on most of the outcomes of interest”. No studies were identified for routes of administration of antibiotics in this population.

ᵃ Clinical cure was defined as the complete improvement of clinical signs and symptoms following treatment. Three RCTs (633 participants) were included in the clinical cure analysis. One study randomized 223 patients to doxycycline or placebo for seven days in addition to corticosteroids. A second study randomized 100 patients to receive a fluoroquinolone or amoxicillin compared with placebo for 10 days. The third study randomized 310 patients to receive amoxicillin or placebo.

ᵇ Clinical failure, the main outcome of interest, was defined as “the lack of a significant improvement of clinical signs and symptoms and/or the requirement for additional or alternate treatment for an acute exacerbation event”.

Esta tabla de evidencias está relacionada con la/s sección/es siguiente/s:

Esta tabla es un resumen del análisis reportado en una Respuesta Clínica Cochrane que se centra en la pregunta clínica más importante antes mencionada.


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes.


Población: People with acute hypercapnic respiratory failure due to chronic obstructive pulmonary disease exacerbation

Intervención: NIV plus usual care

Comparación: Usual care alone (combinations of pharmacologic therapies)

ResultadoEficacia (clasificación BMJ)?Confianza en las evidencias (GRADE)?

Mortality (where reported, duration of follow‐up to intensive care unit [ICU] or hospital discharge)

Favors intervention

Moderate

Need for endotracheal intubation (where reported, duration of follow‐up 3 days to 30 days, ICU discharge, or hospital discharge)

Favors intervention

Moderate

Symptom scores (1 hour to 3 days)

No statistically significant difference

GRADE assessment not performed for this outcome

Duration of ICU stay

No statistically significant difference

GRADE assessment not performed for this outcome

Duration of hospital stay

Favors intervention

Moderate

Treatment intolerance

Favors comparison

GRADE assessment not performed for this outcome

Partial pressure of carbon dioxide (PaCO2; 1 hour postintervention)

No statistically significant difference

GRADE assessment not performed for this outcome

Partial pressure of oxygen (PaO2; 1 hour postintervention)

Favors intervention

GRADE assessment not performed for this outcome

Complications of treatment: NIV-related

See note ᵃ

GRADE assessment not performed for this outcome

Complications of treatment: NonNIV-related

Occurs more commonly with usual care alone compared with NIV plus usual care (favors intervention)

GRADE assessment not performed for this outcome

Nota

ᵃ 30% of people in the NIV plus usual care group had complications specifically related to NIV (not experienced in the usual care alone groups). See Cochrane Clinical Answer (CCA) for more details.

Esta tabela de evidências está relacionada às seguintes seções:

Esta tabela é um sumário da análise relatada em uma Resposta Clínica Cochrane que enfoca a importante questão clínica acima.


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes.


População: People with a clinical diagnosis of COPD (FEV1/FVC <70%) with a history of smoking

Intervenção: Action plan (written guidance detailing self‐initiated interventions such as changing medication regime or visiting a GP or hospital) in response to changes that may suggest the start of an acute exacerbation of COPD ᵃ

Comparação: Usual care (no access to the action plan)

DesfechoEficácia (classificação do BMJ)?Confiança na evidência (GRADE)?

Hospitalizations for COPD/100 patient years (follow‐up: 12 months)

No statistically significant difference

Moderate

At least 1 hospital admission (follow‐up: 12 months)

Favors intervention

Moderate

Hospitalizations & emergency visits for COPD/100 patient years

Favors intervention

High

Courses of oral corticosteroids: 12 months

Favors intervention

Moderate

Courses of antibiotics: 12 months

Favors intervention

Moderate

FEV1 % predicted: 6 months

No statistically significant difference

GRADE assessment not performed for this outcome

FEV1 % predicted: 12 months

No statistically significant difference

GRADE assessment not performed for this outcome

Quality of life measured by St George's Respiratory Questionnaire (SGRQ) overall score: 6–12 months

Favors intervention

Moderate

Mortality (all cause): 12 months

No statistically significant difference

Moderate

Примечание

ᵃ Accompanied by a single short educational component along with ongoing support directed at use of the action plan, but without a comprehensive self‐management program.

Эта таблица с доказательными данными относится к следующему разделу (разделам):

Эта таблица представляет собой итоговый анализ, представленный в руководстве (подкрепленный систематическим обзором), которое фокусируется на обозначенном выше важном клиническом вопросе.


Confidence in the evidence is very low or low where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes. However, this is uncertain and new evidence could change this in the future.


Население: Adults with acute exacerbations of COPD

Вмешательство: Systemic corticosteroids

Сравнение: Placebo

Клинические исходыЭффективность (рейтинг BMJ)?Уровень доказательности (СТЕПЕНЬ)?

Clinical failure rate ᵃ

Favors intervention

Low

Adverse events

No statistically significant difference

GRADE not reported for this outcome

Рекомендации, изложенные в исходном руководстве

The AAFP recommends that clinicians prescribe corticosteroids for adults with acute exacerbation of COPD to reduce clinical failure (weak recommendation; low quality of evidence). There is insufficient evidence to guide the dose, route of administration, or duration of treatment.

Примечание

The guideline group noted that there were no statistically significant differences in other outcomes of interest, including mortality and rehospitalization. It is unclear which other outcomes of interest were reported in the included studies.

The evidence to inform the route of administration (oral; inhaled; intravenous) of corticosteroids in adults with acute exacerbation of COPD was insufficient. No significant difference in outcomes was observed in three studies which evaluated different durations of systemic corticosteroids (3 days vs. 10 days; 5 days vs. 14 days; and 2 weeks vs. 8 weeks) in the inpatient setting. The guideline group also noted that a large observational study published subsequent to the guideline search also found that shorter courses of corticosteroid were noninferior to longer courses, and longer courses were associated with a small increase in pneumonia-associated hospitalization and mortality.

ᵃ Clinical failure, the main outcome of interest, was defined as “the lack of a significant improvement of clinical signs and symptoms and/or the requirement for additional or alternate treatment for an acute exacerbation event”.

Эта таблица с доказательными данными относится к следующему разделу (разделам):

Эта таблица представляет собой резюме анализа, представленного в Кокрановском клиническом обзоре, который фокусируется на вышеупомянутом важном клиническом вопросе.


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes.


Население: People admitted to hospital or to the ICU with exacerbations of COPD

Вмешательство: Oral or intravenous antibiotics for minimum of 2 days ᵃ

Сравнение: Placebo

Клинические исходыЭффективность (рейтинг BMJ)?Уровень доказательности (СТЕПЕНЬ)?

Treatment failure up to 4 weeks: inpatients ᵇ

Favors intervention

GRADE assessment not performed for this outcome

Treatment failure up to 4 weeks: ICU patients ᶜ

Favors intervention

Moderate

All‐cause mortality: inpatients

No statistically significant difference

Moderate

All‐cause mortality: ICU patients ᶜ

Favors intervention

Moderate

Duration of hospital stay (days): inpatients

No statistically significant difference

High

Duration of hospital stay (days): ICU ᶜ

Favors intervention

Moderate

Improvement in dyspnea measured at the end of the study period: inpatients

No statistically significant difference

GRADE assessment not performed for this outcome

Health‐related quality of life or functional status measures: inpatients

No statistically significant difference

GRADE assessment not performed for this outcome

Days off work: inpatients

Favors intervention

GRADE assessment not performed for this outcome

Overall adverse events

No statistically significant difference

Moderate

Примечание

The Cochrane review which the CCA is based upon also noted continued uncertainty around the treatment effectiveness of antibiotics for treatment failure, mortality, re-exacerbations, or health-related quality of life in those people with acute exacerbation of COPD, since results are heterogenous and associated with some risk of bias.

It also stated that factors such as patient preferences, resistance of bacteria to antibiotics, and cost are important when making recommendations or treatment decisions. There is also a need for research into clinical signs and biomarkers which can help identify patients who would benefit the most from antibiotic treatment.

ᵃ Included studies ranging from 5 to 14 days duration of antibiotic/placebo treatment.

ᵇ The CCA noted that when reviewers focused on currently prescribed drugs in their analysis, there was no statistical significance between treatment groups for inpatients with severe exacerbations who were not admitted to ICU.

ᶜ Evidence for ICU patients was limited to one trial of 93 patients.

Эта таблица с доказательными данными относится к следующему разделу (разделам):

Эта таблица представляет собой резюме анализа, представленного в Кокрановском клиническом обзоре, который фокусируется на вышеупомянутом важном клиническом вопросе.


Confidence in the evidence is moderate or low to moderate where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for key outcomes.


Население: Selected adults presenting at emergency rooms with acute exacerbation of COPD ᵃ

Вмешательство: Hospital-at-home (regular home visits by trained respiratory nurse supported by hospital team)

Сравнение: Standard inpatient care

Клинические исходыЭффективность (рейтинг BMJ)?Уровень доказательности (СТЕПЕНЬ)?

Hospital re-admission (follow up: 1–6 months)

Favors intervention

Moderate

Mortality (follow up: 2–6 months)

No statistically significant difference

Moderate

FEV1

No statistically significant difference

Low

FVC

No statistically significant difference

GRADE assessment not performed for this outcome

Quality of life (follow up: at discharge)

See note ᵇ

Very Low

Satisfaction with care (follow up: 0–2 weeks after discharge; subgroup: patient satisfaction

No statistically significant difference

Low

Satisfaction with care (follow up: 0–2 weeks after discharge; subgroup: carer satisfaction)

No statistically significant difference

Very Low

Speed of exacerbation recovery, recurrent exacerbations

-

None of the studies identified by the review assessed these outcomes

Note

The Cochrane Clinical Answer (CCA) noted that patient characteristics varied across reviewed studies in terms of lung function and reasons for trial exclusion, affecting the generalizability of results. It also noted that the co-interventions given to participants varied across studies.

The Cochrane review which underpins this CCA noted that while the review showed that treatment with a hospital-at-home scheme is safe, acceptable, and as effective as inpatient care, the majority of patients will still continue to require hospital care for their exacerbation. They also highlighted that more studies are required to evaluate the cost-effectiveness of hospital-at-home schemes.

ᵃ The CCA noted that trials reported variable respiratory exclusion criteria (e.g., respiratory failure, pneumonia, pneumothorax, lung cancer, chest X‐ray changes, pulmonary embolism, hypoxia) and also that patients with acute/unstable co‐morbidities, reduced level of consciousness, and/or confusion were excluded by some trials.

ᵇ Results reported narratively. Three RCTs (332 participants) reported quality of life using the St George’s Respiratory Questionnaire. Results could not be combined since one study reported percentage improvement while the other two reported standard deviations. The latter showed no statistically significant difference between treatment groups.

This evidence table is related to the following section/s:

Cochrane Clinical Answers

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Cochrane Clinical Answers (CCAs) provide a readable, digestible, clinically focused entry point to rigorous research from Cochrane systematic reviews. They are designed to be actionable and to inform decision making at the point of care and have been added to relevant sections of the main Best Practice text.

  • How does longer corticosteroid treatment (>7 days) compare with shorter (≤7 days) in people with exacerbations of chronic obstructive pulmonary disease?
    Show me the answer
  • What is the impact of airway clearance techniques when treating acute exacerbations of COPD?
    Show me the answer
  • How do antibiotics compare with placebo in people admitted to hospital or to the intensive care unit with exacerbations of chronic obstructive pulmonary disease?
    Show me the answer
  • How does non-invasive ventilation compare with usual care in people with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease?
    Show me the answer
  • What are the effects of hospital-at-home in adults with acute exacerbations of chronic obstructive pulmonary disease?
    Show me the answer
  • What are the effects of action plans with limited patient education only in reducing exacerbations of chronic obstructive pulmonary disease?
    Show me the answer

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