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Вмешательства для профилактики рецидивов рожи и целлюлита

Appendices

Appendix 1. CENTRAL (Cochrane Library) search strategy

#1 MeSH descriptor: [Cellulitis] explode all trees
#2 MeSH descriptor: [Erysipelas] explode all trees
#3 MeSH descriptor: [Soft Tissue Infections] explode all trees
#4 MeSH descriptor: [Impetigo] explode all trees
#5 MeSH descriptor: [Staphylococcus] explode all trees
#6 MeSH descriptor: [Streptococcus] explode all trees
#7 MeSH descriptor: [Skin] explode all trees
#8 (cellulitis or erysipelas or impetigo or "soft tissue infection" or "soft tissue infections"):ti,ab,kw
#9 staphylococc* or streptococc*:ti,ab,kw AND skin:ti,ab,kw
#10 #5 or #6
#11 #7 and #10
#12 #1 or #2 or #3 or #4 or #8 or #9 or #11

Appendix 2. MEDLINE (Ovid) search strategy

1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. placebo.ab.
5. clinical trials as topic.sh.
6. randomly.ab.
7. trial.ti.
8. 1 or 2 or 3 or 4 or 5 or 6 or 7
9. (animals not (humans and animals)).sh.
10. 8 not 9
11. exp Erysipelas/ or erysipelas.ti,ab.
12. exp Cellulitis/ or cellulitis.ti,ab.
13. impetigo.ti,ab. or exp *Impetigo/
14. exp *Soft Tissue Infections/
15. Ignis sacer.ti,ab.
16. holy fire.ti,ab.
17. st anthony's fire.ti,ab.
18. exp *Staphylococcus/ or staphylococc$.ti,ab.
19. exp *Streptococcus/ or streptococc$.ti,ab.
20. 18 or 19
21. exp *Skin/
22. 20 and 21
23. 11 or 12 or 13 or 14 or 15 or 16 or 17 or 22
24. 10 and 23

[Lines 1‐10: Cochrane Highly Sensitive Search Strategy for identifying randomized trials in MEDLINE: sensitivity‐ and precision‐maximizing version (2008 revision)]

Appendix 3. EMBASE (Ovid) search strategy

1. exp Erysipelas/ or erysipelas.ti,ab.
2. exp Cellulitis/ or cellulitis.ti,ab.
3. impetigo.ti,ab. or exp *Impetigo/
4. Ignis sacer.ti,ab.
5. holy fire.ti,ab.
6. st anthony's fire.ti,ab.
7. exp *Staphylococcus/ or staphylococc$.ti,ab.
8. exp *Streptococcus/ or streptococc$.ti,ab.
9. 7 or 8
10. exp *Skin/
11. 9 and 10
12. exp *soft tissue infection/
13. 1 or 2 or 3 or 4 or 5 or 6 or 11 or 12
14. random$.mp.
15. factorial$.mp.
16. (crossover$ or cross‐over$).mp.
17. placebo$.mp. or PLACEBO/
18. (doubl$ adj blind$).mp.
19. (singl$ adj blind$).mp.
20. (assign$ or allocat$).mp.
21. volunteer$.mp. or VOLUNTEER/
22. Crossover Procedure/
23. Double Blind Procedure/
24. Randomized Controlled Trial/
25. Single Blind Procedure/
26. 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25
27. 13 and 26

Appendix 4. LILACS search strategy

(cellulitis or erysipelas or celulitis or "flemon difuso" or erisipela)

In LILACS we searched using the above terms and the Controlled clinical trials topic‐specific query filter.

Study selection flow diagram.
Figuras y tablas -
Figure 1

Study selection flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 1 Recurrence of cellulitis.
Figuras y tablas -
Analysis 1.1

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 1 Recurrence of cellulitis.

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 2 Incidence rate of recurrence of cellulitis.
Figuras y tablas -
Analysis 1.2

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 2 Incidence rate of recurrence of cellulitis.

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 3 Time to next episode of cellulitis.
Figuras y tablas -
Analysis 1.3

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 3 Time to next episode of cellulitis.

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 4 Hospitalisation.
Figuras y tablas -
Analysis 1.4

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 4 Hospitalisation.

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 5 Any adverse reactions.
Figuras y tablas -
Analysis 1.5

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 5 Any adverse reactions.

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 6 Mortality.
Figuras y tablas -
Analysis 1.6

Comparison 1 Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis, Outcome 6 Mortality.

Comparison 2 Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis, Outcome 1 Recurrence of cellulitis.
Figuras y tablas -
Analysis 2.1

Comparison 2 Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis, Outcome 1 Recurrence of cellulitis.

Comparison 2 Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis, Outcome 2 Incidence rate of recurrence of cellulitis.
Figuras y tablas -
Analysis 2.2

Comparison 2 Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis, Outcome 2 Incidence rate of recurrence of cellulitis.

Comparison 2 Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis, Outcome 3 Time to next episode of cellulitis.
Figuras y tablas -
Analysis 2.3

Comparison 2 Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis, Outcome 3 Time to next episode of cellulitis.

Comparison 3 Antibiotic prophylaxis versus no treatment/placebo, overall, Outcome 1 Recurrence of cellulitis.
Figuras y tablas -
Analysis 3.1

Comparison 3 Antibiotic prophylaxis versus no treatment/placebo, overall, Outcome 1 Recurrence of cellulitis.

Comparison 3 Antibiotic prophylaxis versus no treatment/placebo, overall, Outcome 2 Incidence rate of recurrence of cellulitis.
Figuras y tablas -
Analysis 3.2

Comparison 3 Antibiotic prophylaxis versus no treatment/placebo, overall, Outcome 2 Incidence rate of recurrence of cellulitis.

Summary of findings for the main comparison. Antibiotic prophylaxis compared to no treatment/placebo for the prevention of recurrent erysipelas and cellulitis

Antibiotic prophylaxis compared to no treatment/placebo for the prevention of recurrent erysipelas and cellulitis ‐ on prophylaxis

Patient or population: People with recurrent erysipelas or cellulitis
Intervention: Antibiotic prophylaxis
Comparison: No treatment/Placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

no treatment/placebo

Antibiotic prophylaxis

Recurrence of cellulitis

Study population

RR 0.31
(0.13 to 0.72)

513
(5 RCTs)

⊕⊕⊕⊝
MODERATE 1

Number needed to treat for 1 additional beneficial outcome (NNTB) is 6

316 per 1000

98 per 1000
(41 to 227)

Incidence rate of cellulitis

Study population

RR 0.44 (0.22 to 0.89)

473

(4 RCTs)

⊕⊕⊕⊝
MODERATE 1

43 fewer episodes of cellulitis per 1000 person‐months in treatment group

(from 8 fewer to 60 fewer)

Time to next episode of cellulitis

Not estimable

HR 0.51
(0.34 to 0.78)

437
(3 RCTs)

⊕⊕⊕⊝
MODERATE 1

Hospitalisation

Study population

RR 0.77
(0.37 to 1.57)

429
(3 RCTs)

⊕⊕⊝⊝
LOW 2

74 per 1000

57 per 1000
(27 to 116)

Any adverse reactions

Study population

RR 0.87
(0.58 to 1.30)

469
(4 RCTs)

⊕⊕⊝⊝
LOW 3

287 per 1000

250 per 1000
(166 to 373)

Quality of life

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: risk ratio; HR: hazard ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1We downgraded by one level because of imprecision due to the low number of events and the small sample size (optimal information size ‐ OIS).

2 We downgraded by two levels because of imprecision due to the low number of events and the small sample size (OIS) and the 95% confidence interval overlapping the line of no effect and ranging from benefit to harm.

3We downgraded by two levels because of imprecision due to the considerable low number of events and the small sample size (OIS).

We decided not to downgrade any of the outcomes for risk of bias as we decided it was not serious enough to affect the overall quality of the outcome.

Figuras y tablas -
Summary of findings for the main comparison. Antibiotic prophylaxis compared to no treatment/placebo for the prevention of recurrent erysipelas and cellulitis
Table 1. Glossary of terms

Medical term

Explanation

Ambulatory

Ambulatory is when the patient can walk and is not bedridden. When referring to medical care it means that it is being provided to patients that are not hospitalised (outpatients)

Block randomisation

A method of randomisation that ensures allocation of participants into roughly equal sizes of comparison groups

Clostridium difficile

A bacterium that causes inflammation of the colon (colitis), typically resulting in diarrhoea, and is strongly associated with the use of antibiotics

Comorbidity

The presence of one or more diseases or conditions other than those of primary interest

Contralateral

On the opposite side of the body (e.g. a repeat episode of leg cellulitis can recur in the same leg [see 'ipsilateral'] or the other, contralateral leg

Control event rate (CER)

The rate at which events of interest (i.e. episodes of cellulitis in our review) occur in the control group of the study

Diuretics

Commonly known as "water pills" these are drugs that help the body to eliminate unneeded water and salt through the urine

Epidemiology

The study of the health of populations and communities, not just particular individuals

Erythema

Redness of the skin caused by increased blood flow. Often a sign of inflammation or infection

Filariasis

A disease caused by infection with worms, usually in tropical and subtropical areas of the world. The worms reside in the lymphatic system of the affected person and interfere with the drainage of the lymph, subsequently causing a significant swelling of the involved limb

Filarial lymphoedema

see Filiariasis

Folliculitis

Inflammation of hair follicles

Furunculosis

Deep form of inflammation of the hair follicles resulting in lumps caused by the accumulation of pus (boils)

Gastrointestinal

Relating to the stomach and the intestines

Incidence rate/Incidence rate ratio

The number of new occurrences of events in a population divided by its time period at risk; Incidence rate ratio is the ratio of two incidence rates

Ipsilateral

On the same side of the body; as opposed to 'contralateral'

Mastectomy

Surgical removal of one or both breasts

Outpatient/Inpatient

Outpatient is a person that is being treated without being hospitalised overnight and visits the physician in the clinic, hospital or other facility; compared with an inpatient who requires an overnight stay in hospital for medical treatment

Person‐months

The sum of the number of months each participant in the trial has been under observation (treated/followed)

'Per protocol'/Intention‐to‐treat (ITT) analyses

'Per protocol' analysis compares participants in a study based on the treatment they actually took and includes only those patients who completed the treatment originally allocated, as opposed to intention‐to‐treat analysis that compares participants on the basis of their random assignment to groups (treatment or placebo), regardless of adherence to treatment

Prophylaxis

Preventive treatment for disease

Retrospective cohort study

An observational study in which a defined group of people (the cohort) is followed over time. A retrospective cohort study identifies persons from past medical records and follows them from the time of those records to the present

Sensitivity analysis

An analysis used to determine how sensitive the results of a study or systematic review are to changes in how it was done

Tinea pedis

Fungal infection of the foot (athlete's foot)

Tonsillectomy

Surgical removal of tonsils

Figuras y tablas -
Table 1. Glossary of terms
Table 2. Contact with investigators of included studies

Study

Way of communication

Date

Information provided

Notes

Chakroun 1994

email

12/2013

‐ Allocation concealment

‐ Participants follow‐up

‐ Criteria for diagnosis

‐ Adherence

‐ Adverse reactions

‐ Informed consent

‐ Ethical committee approval

‐ Source of funding

Full information was not available for all queries, but investigators responded to all of them

Kasseroller 1998

airmail, email, website

2013 ‐ 2014

Investigator did not reply to our queries

We also contacted a potential sponsor, not reported by the author, who confirmed their financial support for the conduct of this study (email correspondence with the head of medical‐scientific department of 'biosyn

Arzneimittel GmbH' from January 2015)

Kremer 1991

email and telephone

12/2013 and 1/2014

Data were not available and the investigator did not remember any details

Sjöblom 1993

email

12/2013

‐ Allocation concealment

‐ Participants follow‐up

‐ By whom cellulitis was diagnosed

‐ Adherence

‐ Source of funding

Full information was not available for all queries, but investigators responded to all of them

Thomas 2012

email

1/2014

‐ Episodes of recurrent cellulitis

per person‐months (incidence rate)

‐Time to next episode

‐ Adverse events by study arm

‐ Duration of hospitalisation

‐ Quality of life

Thomas 2013

email

1/2014

‐ Episodes of recurrent cellulitis

per person‐months (incidence rate)

‐ Quality of life

Hospitalisation and quality of life were not evaluated directly in this trial but were reported by indirect evaluation in Mason 2014

Figuras y tablas -
Table 2. Contact with investigators of included studies
Table 3. Clinical guidelines on antibiotic prophylaxis for the prevention of recurrent cellulitis

Guideline

Organisation

Recommended antibiotic

Duration of Px

No of episodes

to initiate Px

Adjunctive Tx

Quality of evidence †

BLS 2016

BLS

penicillin by mouth;

alternatives: cephalexin,

erythromycin, clarithromycin,

clindamycin, doxycycline

2 y; life‐long Px

if recurrence after Px stopped

2 ≥/y

skin care, decongestive Tx, antifungal Tx, alcohol

wipes; SIT

NS

ALA 2015

ALA

penicillin by mouth;

alternatives: cephalexin,

erythromycin, clindamycin

2 y; life‐long Px

if recurrence after

Px stopped

2 ≥/y

skin care, decongestive Tx, bacterial decolonisation Tx; SIT

NS

Stevens 2014

IDSA

penicillin by mouth/IM;

alternatives:erythromycin

as long as

RF persist

3 – 4 /y

skin care, Tx of oedema, weight reduction

antibiotic Px ‐weak, moderate ‡

duration of Px ‐ strong,

moderate ‡

skin care ‐ strong,

moderate ‡

Stevens 2005

penicillin by mouth/IM;

alternatives:erythromycin

NS

frequent

skin care, Tx of oedema

compression stockings,

diuretics; SIT

grade IIB §

ISL 2013

ISL

penicillin;

alternatives: broad spectrum

antibiotic

NS

repeat despite

physical Tx

skin care, antifungal Tx

NS

Esposito 2011

SIMIT and ISC

penicillin or macrolide

NS

recurrent

skin hygiene and

compression stockings

NS

Draijer 2008

NHG

penicillin by mouth/IM

1 ‐ 2 y

2 ≥/y

skin care, compression

stockings; SIT

NS

ILF 2006

ILF

penicillin by mouth;

alternatives:erythromycin,

clindamycin, clarithromycin

2 y; life‐long Px

if recurrence after

Px stopped

2 ≥/y

skin care, decongestive Tx,

antifungal Tx; SIT

NS

CREST 2005

CREST

penicillin or erythromycin by mouth

2 y

2 ≥/y

SIT may be preferable

weak and inconclusive

NICE 2005

NICE

a trial should be considered

NS

> 2/y

skin care, Tx of oedema,

compression stockings,

weight reduction

weak and inconclusive

Eron 2003

Other*

antibiotic may be needed;

type of antibiotic NS

long term

NS

skin care, Tx of oedema,

antifungal Tx; SIT

NS

SFD 2000

SFD

penicillin by mouth/IM;

alternatives: macrolide

prolonged,

probably indefinitely

several/poorly

controlled RF

skin care, Tx of oedema

NS

Duodecim 1999

FMSD

antibiotic should be considered;

type of antibiotic NS

long term

frequent

skin care

NS

† Assessement of quality of evidence as defined and graded by the authors of the document.

‡ Strong recommendation, moderate quality ‐ desirable effects clearly outweigh undesirable effects; evidence from RCTs with important limitations or exceptionally strong evidence from unbiased observational studies; recommendation can apply to most patients in most circumstances and further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.

Weak recommendation, moderate quality ‐ desirable effects closely balanced with undesirable effects; evidence from RCTs with important limitations;recommendation may change when higher‐quality evidence becomes available; and further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.

§ Moderate evidence ‐ should generally be offered; II ‐ evidence from one well‐designed clinical trial.

Abbreviations

IM injections into the muscle (intramuscular)
No ‐ number
NS ‐ not specified
Px ‐ preventive treatment (prophylaxis)
RF‐ risk factors
SIT ‐ self‐initiated treatment
Tx ‐ treatment
y ‐ year/s

Medical organisations

BLS ‐ British Lymphology Society
ALA ‐ Australasian Lymphology Association
IDSA ‐ Infectious Diseases Society of America
ISL ‐ International Society of Lymphology
SIMIT ‐ Società Italiana di Malattie Infettive e Tropicali ‐ Italian Society of Infectious Diseases
ISC ‐ International Society of Chemotherapy
NHG ‐ Nederlands Huisartsen Genootschap ‐ The Dutch College of General Practitioners
ILF ‐ International Lymphoedema Framework
CREST ‐ Clinical Resources Efficiency Support Team (UK)
NICE ‐ National Institute for Health and Clinical Excellence (England)
SFD ‐ La Société Française de Dermatologie ‐ The French Society of Dermatology
MSD ‐ The Finnish Medical Society Duodecim

* 5 of 6 experts in this consensus paper were from North America; published in the Journal of the British Society for Antimicrobial Chemotherapy

Figuras y tablas -
Table 3. Clinical guidelines on antibiotic prophylaxis for the prevention of recurrent cellulitis
Comparison 1. Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrence of cellulitis Show forest plot

5

513

Risk Ratio (M‐H, Random, 95% CI)

0.31 [0.13, 0.72]

2 Incidence rate of recurrence of cellulitis Show forest plot

4

4375

Risk Ratio (M‐H, Random, 95% CI)

0.44 [0.22, 0.89]

3 Time to next episode of cellulitis Show forest plot

3

Hazard Ratio (Random, 95% CI)

0.51 [0.34, 0.78]

4 Hospitalisation Show forest plot

3

429

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.37, 1.57]

5 Any adverse reactions Show forest plot

4

469

Risk Ratio (M‐H, Random, 95% CI)

0.87 [0.58, 1.30]

5.1 Penicillin

3

437

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.60, 1.10]

5.2 Erythromycin

1

32

Risk Ratio (M‐H, Random, 95% CI)

7.0 [0.39, 125.44]

6 Mortality Show forest plot

3

437

Risk Ratio (M‐H, Random, 95% CI)

1.12 [0.32, 3.91]

Figuras y tablas -
Comparison 1. Antibiotic prophylaxis versus no treatment/placebo, on prophylaxis
Comparison 2. Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrence of cellulitis Show forest plot

2

287

Risk Ratio (M‐H, Random, 95% CI)

0.88 [0.59, 1.31]

2 Incidence rate of recurrence of cellulitis Show forest plot

2

4566

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.65, 1.36]

3 Time to next episode of cellulitis Show forest plot

2

Hazard Ratio (Random, 95% CI)

0.78 [0.39, 1.56]

Figuras y tablas -
Comparison 2. Antibiotic prophylaxis versus no treatment/placebo, post‐prophylaxis
Comparison 3. Antibiotic prophylaxis versus no treatment/placebo, overall

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrence of cellulitis Show forest plot

2

397

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.59, 0.95]

2 Incidence rate of recurrence of cellulitis Show forest plot

2

7854

Risk Ratio (M‐H, Random, 95% CI)

0.69 [0.56, 0.85]

Figuras y tablas -
Comparison 3. Antibiotic prophylaxis versus no treatment/placebo, overall