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難治性てんかん重積状態の治療におけるプロポフォールとチオペンタールナトリウムの比較

Appendices

Appendix 1. Cochrane Epilepsy Group Specialized Register search strategy

#1 status epilepticus

#2 MeSH DESCRIPTOR Status Epilepticus Explode All

#3 #1 OR #2

#4 thiopental OR thiopentone

#5 MeSH DESCRIPTOR Barbiturates Explode All

#6 MeSH DESCRIPTOR Thiopental Explode All

#7 #4 OR #5 OR #6

#8 MeSH DESCRIPTOR Propofol Explode All

#9 propofol

#10 #8 OR #9

#11 #3 AND #7 AND #10

#12 #11 AND > 26/03/2015:CRSCREATED AND INREGISTER

Appendix 2. CENTRAL via Cochrane Register of Studies Online (CRSO) search strategy

#1 MESH DESCRIPTOR Propofol EXPLODE ALL TREES

#2 anepol OR diprivan OR disoprivan OR disoprofol OR fresofol OR hypro OR lipuro OR plofed OR profol OR propofil OR propofol OR propofol2 OR propofol9 OR propofola OR propofolalfentanil OR propofolanasthesie OR propofoland OR propofolanestesi OR propofolapplikationssysteme OR propofolbased OR propofold OR propofoldosierungen OR propofole OR propofoleinsatz OR propofolem OR propofolfentanyl OR propofolformulierungen OR propofolgpi OR propofolis OR propofolketamine OR propofolom OR propofolon OR propofolondansetron OR propofolparavertebral OR propofolremifentanil OR propofols OR propofolsedierung OR propofolsufentanil OR propofolthiopentone OR propofolum OR propofolun OR propofolverbrauch OR propofolvs OR propofolzielkonzentration OR propovan OR propoven OR provive OR recofol

#3 #1 OR #2

#4 MESH DESCRIPTOR Thiopental EXPLODE ALL TREES

#5 penthiobarbital OR pentothal OR thiopental OR thiopentalem OR thiopentalor OR thiopentalum OR thiopentone OR tiopental OR tiopentale OR trapanal

#6 MESH DESCRIPTOR Barbiturates EXPLODE ALL TREES

#7 #4 OR #5 OR #6

#8 MESH DESCRIPTOR Status Epilepticus EXPLODE ALL TREES

#9 (Status Epilepticus):TI,AB,KY

#10 #8 OR #9

#11 #3 AND #7 AND #10

#12 26/03/2015 TO 16/08/2016:CD

#13 #11 AND #12

Appendix 3. MEDLINE search strategy

This strategy is based on the Cochrane Highly Sensitive Search Strategy for identifying randomised trials published in Lefebvre 2011.

1. (randomized controlled trial or controlled clinical trial or pragmatic clinical trial).pt. or (randomi?ed or placebo or randomly).ab.

2. clinical trials as topic.sh.

3. trial.ti.

4. 1 or 2 or 3

5. exp animals/ not humans.sh.

6. 4 not 5

7. exp Status Epilepticus/

8. status epilepticus.tw.

9. 7 or 8

10. exp Thiopental/

11. exp Barbiturates/

12. (thiopental or thiopentone).tw.

13. 10 or 11 or 12

14. exp Propofol/

15. propofol.tw.

16. 14 or 15

17. 13 and 16

18. 6 and 9 and 17

19. limit 18 to ed=20150326‐20160816

20. remove duplicates from 19

Appendix 4. ClinicalTrials.gov search strategy

propofol | epilepsy | received on or after 03/26/2015

Appendix 5. South Asian Database of Controlled Clinical Trials search strategy

Keywords: propofol And thiopent Or Title: propofol And thiopent Or Abstract: propofol And thiopent

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

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

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Study flow diagram.
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Figure 2

Study flow diagram.

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Comparison 1 Propofol versus thiopental sodium, Outcome 1 Total control of seizures.
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Analysis 1.1

Comparison 1 Propofol versus thiopental sodium, Outcome 1 Total control of seizures.

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Comparison 1 Propofol versus thiopental sodium, Outcome 2 In‐hospital mortality.
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Analysis 1.2

Comparison 1 Propofol versus thiopental sodium, Outcome 2 In‐hospital mortality.

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Comparison 1 Propofol versus thiopental sodium, Outcome 3 Adverse events.
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Analysis 1.3

Comparison 1 Propofol versus thiopental sodium, Outcome 3 Adverse events.

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Study

Propofol group

Thiopentone sodium group

Rossetti 2011

Median: 4 days

Median: 17 days

Rossetti 2011

Range: 2 to 28 days

Range: 5 to 70 days

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Analysis 1.4

Comparison 1 Propofol versus thiopental sodium, Outcome 4 Duration of mechanical ventilation.

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Comparison 1 Propofol versus thiopental sodium, Outcome 5 Long‐term outcomes.
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Analysis 1.5

Comparison 1 Propofol versus thiopental sodium, Outcome 5 Long‐term outcomes.

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Summary of findings for the main comparison. Propofol compared to Thiopental sodium for the treatment of refractory status epilepticus

Propofol compared to Thiopental sodium for the treatment of refractory status epilepticus

Patient or population: patients with the treatment of refractory status epilepticus
Settings: Hospital based
Intervention: Propofol
Comparison: Thiopental sodium

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Thiopental sodium

Propofol

Total control of seizures

Study population

RR 1.5
(0.4 to 5.61)

21
(1 study)

⊕⊕⊝⊝
low1,2

286 per 1000

429 per 1000
(114 to 1000)

In‐hospital mortality

Study population

RR 1.5
(0.19 to 11.93)

21
(1 study)

⊕⊕⊝⊝
low1,2

143 per 1000

214 per 1000
(27 to 1000)

Length of intensive care unit (ICU) stay

Not reported

Not reported

NA

NA

NA

*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;

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.

1 Single blinded study: we downgraded one level for risk of bias
2 Wide confidence intervals crossing the line of "no effect" were noted; we downgraded one level for imprecision

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Summary of findings for the main comparison. Propofol compared to Thiopental sodium for the treatment of refractory status epilepticus
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Table 1. Overview of study populations

Study ID

Interventions

Screened (n)

Randomised (n)

Safety analysis (n)

ITT (n)

Finishing study (n)

[%] of randomised participants
finishing study

Rossetti 2011

I1 Propofol

I2 Barbiturate (thiopental (n = 7) and pentobarbital (n = 3))

I1 14

I2 10

I1 14

I2 10

I1 14

I2 10

I1 14

I2 10

I1 14

I2 9

I1 100

I2 90

I1: intervention 1; I2: intervention 2; ITT: intention‐to‐treat; n: number.
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Table 1. Overview of study populations
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Table 2. Adverse effects

Characteristic

Rossetti 2011

I1

I2

Propofol

Thiopental

Participants who died (n)

Epilepsy‐related

I1 Propofol

I2 Thiopental

0

0

Participants who died (n)

All causes

I1 Propofol

I2 Thiopental

3

1

Adverse events (n)

I1 Propofol

I2 Thiopental

14

11

Serious adverse events (n)

I1 Propofol

I2 Thiopental

1

1

Duration of ICU stay

Not reported

Duration of mechanical ventilation (median (range))

I1 Propofol

I2 Thiopental

17 days (5 to 70 days)

4 days (2 to 28 days)

Duration of hospitalisation

Not reported

Neurological deficits

Not reported

Cognitive deficits

Not reported

Haematological toxicity

Not reported

Liver toxicity

Not reported

Hypersensitivity or drug allergy

Not reported

Bronchopneumonia

Not reported

Other side effects

Not reported

I1: intervention 1; I2: intervention 2; ICU: intensive care unit; n: number.
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Table 2. Adverse effects
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Comparison 1. Propofol versus thiopental sodium

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total control of seizures Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 In‐hospital mortality Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Infection

1

21

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.35, 1.41]

3.2 Hypotension

1

21

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.38, 2.00]

3.3 Other serious complications

1

21

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.04, 6.86]

4 Duration of mechanical ventilation Show forest plot

Other data

No numeric data

5 Long‐term outcomes Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Figuras y tablas -
Comparison 1. Propofol versus thiopental sodium
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