Chavanet 1992.
Methods | A single‐centre trial with enrolment from June to December 1991. Location of study: France Loss to follow‐up: Amp Glucose 4/11 (36%) Amp Fat 0/11 (0%) Analysis: no ITT |
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Participants | Eligibility criteria: Patients who had oral candidiasis, 18 years and older, HIV positive Exclusion criteria: Esophagitis, oral Kaposi, hyperlipidaemia, known intolerance to amphotericin, pancreatitis, serum creatinine > 115 umol/l. Diagnosis confirmed using mycological analysis 22 patients enrolled Amphot‐glucose :11 Amphot‐fat : 11 |
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Interventions | Amphotericin deoxycholate dissolved in either:
5% glucose (amphotericin glucose) ‐ final concentration 1.6 g amphotericin / l or
parenteral fat emulsion (amphotericin fat emulsion) ‐ final concentration 2 g amphotericin / l Given as a 1 hour infusion of 1 mg/kg/day on four consecutive days. |
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Outcomes | Clinical scores of candidiasis ‐ 9 sites were inspected for the presence or absence of candidiasis which were examined for confluent, patchy or scattered lesions scored as 3,2 and 1 respectively. Evaluated the reduction in clinical score. Mycologic cure : culture from swab Clinical and biological tolerance Serum concentrations of amphotericin Adverse events: more frequent with glucose preparation. Chills and fever were most frequent side effect ‐ 66% vs 4%. Sweating and Nausea slightly less frequent in Fat emulsion group. |
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Notes | Ethics: Ethics approval obtained from local ethics committee, informed consent obtained from patients. Enrolment: June ‐ December 1991. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | "..patients were assigned randomly to one of the two treatment groups. Group selection was determined by sequential assignment from a table of random numbers.." |
Allocation concealment? | High risk | Sealed envelopes. Each envelope was opened immediately before the treatment was given. |
Blinding? All outcomes | High risk | No blinding was used. |
Incomplete outcome data addressed? All outcomes | Low risk | Reasons given for discontinuation of intervention |