Oral ivermectin is an alternative therapy for human scabies infection due to its ease of administration and good safety profile. However, there is no definitive consensus on the optimal dosing regimen.. To describe the treatment of human scabies with different dosages of oral ivermectin and the possible adverse events.. A second, or even a third dose, was administered in cases of treatment failure..
A complete clinical response was achieved by all of the patients. Within the first 72 h after the administration of oral ivermectin, new cutaneous lesions were observed in eleven patients Cutaneous biopsies showed signs of subacute eczema. The eruption was treated with topical corticosteroids and emollient therapy. There was no other new drug administration or a history of irritants. There was no history of atopic diathesis except for one patient..
Oral ivermectin is an effective therapy for the treatment of human scabies. However, the appearance of eczematous cutaneous lesions induced by oral ivermectin has not previously been reported in the literature. Dermatologists should be aware of this possible adverse event.. Describir el tratamiento de escabiosis en humanos con diferentes dosis de ivermectina oral y sus posibles efectos adversos. Todos los pacientes tuvieron respuesta clinica al tratamiento.
Ivermectina oral es una terapia eficaz en el tratamiento de escabiosis humana. Traditionally, ivermectin has been extensively used to control and treat onchocerciasis, a disease caused by the filarial worm Onchocerca volvulus.
However, it has also been demonstrated to act strongly against a wide variety of insects, nematodes, and acarine parasites, including lice and scabies. Oral ivermectin has been recommended as a systemic alternative to topical scabicides due to its ease of administration, convenience, safety and favourable side effect profile.
It has the additional advantage of alleviating the problems of noncompliance, misuse, and inadequate application associated with topical therapy.
The majority of side effects reported in onchocerciasis and other filarial diseases are minor and rare. These side effects include mild gastrointestinal upset, abdominal pain, asthenia, somnolence, dizziness, pruritus and rare biochemical abnormalities such as hypertransaminasaemia and leukopenia. We describe 23 patients with human scabies treated with oral ivermectin.
We emphasize the development of an eczematous eruption in 11 of these patients, a finding not previously reported in the literature. With the corresponding authorization, and after the signed informed consent by the patients, the medication was supplied, out of indication, by the Madrid Community Health Department.
The diagnosis of scabies was based on typical clinical features and was confirmed microscopically by the demonstration of mites, eggs or faecal pellets scybala in skin scrapings. The severity of the disease was recorded as mild less than 11 lesions , moderate 11—49 lesions , severe 50 or more lesions or crusted Norwegian.
The intensity of pruritus was determined with a visual analogue scale 0— At baseline, clinical data were recorded, and a complete physical and dermatologic examination was performed. Patients were evaluated each 2 weeks after the first dose of ivermectin was administered and a physical examination including the collection of skin scrapings were repeated. A third dose of ivermectin was administered at the end of the fourth week to the second dose non-responders.
Complete resolution of the infection was considered as the absence of clinical evidence of scabies and a lack of positive signs of scabies in skin scrapings two weeks after ivermectin administration. No topical or any other systemic scabicide treatment was provided within thirty days of treatment initiation or during the study. Ivermectin was administered orally as 6-mg tablets. The total dose ranged from 12 to 30 mg, depending on patient body weight. Patients in both groups were evaluated clinically and microbiologically every two weeks until the scabies infection completely resolved.
The last visit was made three months after the last ivermectin dose. The severity of the lesions, the intensity of pruritus and the possible appearance of side effects were recorded at each visit. Haematological and biochemical analyses were performed two weeks after each ivermectin dose. The study included 23 patients 15 males and 8 females; mean age of Mild scabies was present in one patient, moderate in twelve, severe in nine, and the remaining patient presented with crusted scabies.
The mean intensity of pruritus was 7. None of the patients had a history of scabies infection. Summary of distribution, treatment and evolution of ivermectin-induced subacute eczema. Three months after the last dose of ivermectin, there was no evidence of disease in nine patients. One patient was lost to regular follow-up. No patient required a second ivermectin oral dose.
The patients fulfilled the criteria for complete resolution after four 12 patients or six weeks a year-old immunocompetent woman with psychiatric disturbances who was diagnosed with crusted scabies. Throughout the treatment, the complementary tests showed no changes in relation to baseline findings. Ivermectin was well-tolerated, and no severe side effects were reported at any of the follow-up visits. Within twenty-four to seventy-two hours after the administration of oral ivermectin, eleven patients The skin eruptions appeared after receiving the first oral ivermectin dose in 9 patients, after receiving the second dose in 1 patient, and after both the first and second dose in 1 patient.
In all of the cases, the eruptions were characterized by itchy, scaly erythematous eczematous plaques located on the trunk and extremities at the time of onset, but they were much more prominent in areas previously infected with scabies, particularly the interdigital folds.
Although the eruptions simulated an exacerbation of the disease they were clinically distinct Figs. The patients clearly distinguished the quality of pruritus as distinct from scabies.
Some patients also presented an accompanying xerosis. Scabietic burrows and nodules in volar surface of the wrists. Same patient as Figure 1. We performed a cutaneous biopsy in three patients showing similar histopathological findings characterized by parakeratosis, small droplets of plasma limited to the stratum of Malpighi and epidermal spongiosis. An inflammatory cellular infiltrate, mainly composed of lymphocytes and eosinophils, was present within the papillary and upper reticular dermis.
The spongiotic dermatitis findings were characteristic of subacute eczema Fig. Histological section haematoxylin and eosin stain showing a small plasma droplet and epidermal spongiosis characteristic of subacute eczema. No patient required an interruption of treatment with ivermectin. The skin eruptions were treated with topical diflucortolone valerate and emollient therapy and cleared within one week.
Ivermectin was inferior to permethrin in 3 RCTs and not statistically significantly different in 3 RCTs 4 comparisons, 2 from the same trial. Differences in treatment regimens and the length of follow-up may explain some of the heterogeneity in the results of the different studies.
Adverse events reported in people receiving oral ivermectin in RCTs for classical or uncomplicated scabies included aggravation of symptoms including pruritus , irritation, headache, nausea, pustular rash, cellulitis, abdominal pain and mild diarrhoea.
The trials were too small to assess serious but rare potential adverse effects. This evidence summary includes the results of 5 uncontrolled trials and case series with 4 or more participants with crusted scabies that reported cure rates or treatment failures.
More robust studies are needed to further evaluate the safety and efficacy of ivermectin for the treatment of crusted scabies. Because ivermectin is unlicensed in the UK, no costs could be obtained from standard published sources.
No data were identified that reported the extent to which ivermectin is currently being used to treat scabies in the UK. The summaries provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies. The summaries support decision-making on the use of an unlicensed or off-label medicine for an individual patient, where there are good clinical reasons for its use, usually when there is no licensed medicine for the condition requiring treatment, or the licensed medicine is not appropriate for that individual.
The strengths and weaknesses of the relevant evidence are critically reviewed within this summary, but this summary is not NICE guidance. Advice Information for the public Key points from the evidence Overview for healthcare professionals Relevance to NICE guidance programmes Intervention and alternatives Evidence review: efficacy Evidence review: safety Evidence review: economic issues Evidence strengths and limitations Summary for patients References Development of this evidence summary Appendix: Search strategy and evidence selection About 'Evidence summaries: unlicensed or off-label medicines'.
Download PDF. NICE interactive flowchart - Skin conditions. Next Key points from the evidence Summary Key points. Key points from the evidence The content of this evidence summary was up-to-date in March Minus Related Pages. The following medications for the treatment of scabies are available only by prescription. Permethrin is a synthetic pyrethroid similar to naturally occurring pyrethrins which are extracts from the chrysanthemum flower. Permethrin is safe and effective when used as directed.
Permethrin kills the scabies mite and eggs. Permethrin is the drug of choice for the treatment of scabies. Two or more applications, each about a week apart, may be necessary to eliminate all mites. Children aged 2 months or older can be treated with permethrin. Crotamiton is not FDA-approved for use in children. Frequent treatment failure has been reported with crotamiton.
Although FDA-approved for the treatment of scabies, lindane is not recommended as a first-line therapy. Overuse, misuse, or accidentally swallowing lindane can be toxic to the brain and other parts of the nervous system; its use should be restricted to patients who have failed treatment with or cannot tolerate other medications that pose less risk. Lindane should not be used to treat premature infants, persons with a seizure disorder, women who are pregnant or breast-feeding, persons who have very irritated skin or sores where the lindane will be applied, infants, children, the elderly, and persons who weigh less than pounds.
Evidence suggests that oral ivermectin may be a safe and effective treatment for scabies; however, ivermectin is not FDA-approved for this use. Oral ivermectin should be considered for patients who have failed treatment with or who cannot tolerate FDA-approved topical medications for the treatment of scabies. The safety of ivermectin in children weighing less than 15 kg and in pregnant women has not been established.
Note that although ivermectin guidelines recommend taking on an empty stomach, scabies experts recommend taking with a meal to increase bioavailability CITE NEJM Currie article.
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