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Clinical audit on treatment of mucosal and multiple cutaneous leishmaniasis lesions with pentavalent systemic antimony.

Byline: Mansoor Dilnawaz, Khadim Hussain, Nasir Javed Malik, Liaquat Mahmood Khan, Hina Mazhar and Amanat Ali Soomro

Abstract

Background Cutaneous leishmaniasis is a parasitic disease spread by the female sandfly occurring throughout the Americas from Texas to Argentina, and in the Old World, particularly the Middle East and North Africa. The condition is diagnosed every year in travelers, immigrants, and military personnel. The treatment mainstay is pentavalent antimony (e.g., sodium stibogluconate). Not all patients require treatment; many lesions heal spontaneously. The treatment is usually indicated in mucosal, mucocutaneous and multiple active cutaneous lesions.

Methods 30 patients of cutaneous leishmaniasis were included from the dermatology ward. The method of data collection was retrospective. The basis of proposal was local guidelines. The audit type was process. The standard set was 100% patients with mucosal and multiple cutaneous leishmaniasis lesions should be treated with pentavalent systemic antimonials".

Results The result showed 100% compliance with our local guidelines in the analyzed cases.

Key words

Clinical audit, cutaneous leishmaniasis.

Introduction

Leishmaniasis is a major cause of illness and death and a top priority for the tropical disease program of WHO. Globally, there are an estimated 1.5-2 million new cases and 70,000 deaths each year, and 350 million people are at risk of infection and disease.1 In Pakistan the prevalence has been estimated at 2.7% in the North-Western part of the country with incidence at 4.6 cases/1000 persons/year over the last ten years.2 Pentavalent antimony compounds like meglumine antimoniate are the main therapeutic agents for various forms of leishmaniasis.1. In view of the usual need for parenteral administration, side effects profile and emergence of resistant strains, there has been an intensive search for alternative therapies for cutaneous leishmaniasis like certain azole antifungal drugs which have activity against leishmania.3,4

Methods

30 patients with mucosal and multiple lesions of cutaneous leishmaniasis were included from the dermatology ward. The method of data collection was Retrospective'. The basis of proposal was Local Guidelines'. The audit type was Process'. The sample source was Case-Notes' from the dermatology ward. The sample size was 30 cases. A data collection proforma was used. The collected data was analyzed according to the pre-set criteria and standards. The criteria were All patients with mucosal and multiple cutaneous leishmaniasis lesions should be treated with systemic antimonials".

Table 1 Sociodemographic data and clinical characteristics (n=30).

Variable###Result

Mean age###31 years

Gender

###Male###30 (100%)

###Female###0

Marital status

###Married###17 (56.6%)

###Unmarried###13 (43.4%)

Lesional status

###Mucosal###6 (20%)

###Scattered###19 (63.3%)

###Grouped###5 (16.6%)

The standard was 100% patients with mucosal and multiple cutaneous leishmaniasis lesions should be treated with systemic antimonials". The inclusion criteria included age 12 or more, both gender, active mucosal or skin lesions, no known allergies, side effects or co-morbidities especially related to systemic antimonials. The exclusion criteria included age less than 12, pregnancy and breastfeeding, known allergies or side effects to systemic antimonials and already substantially regressed lesions.

Results

The analysis of all the 30 records showed that 100% patients with mucosal and multiple cutaneous leishmaniasis lesions were treated with systemic antimonials. There was no contraindication or side effects in any of the treated patients.

This was in accordance with our local guidelines. The sociodemographic data and the clinical characteristics (Table 1) showed mean age of patients 31 years, males 100% (n=30), females 0% (n=0), married 56.6% (n=17), unmarried 43.4% (n=13), mucosal lesions 20% (n=6), scattered lesions 63.3% (n=19), grouped lesions 16.6 % (n=5) (Fig 3). The common sites involved included upper and lower limbs, lips, nose and ear. The recommendation was to continue with this good clinical practice. A re-audit is planned in 6-month time to see if this good practice is maintained.

The audit is summarized in Table 2.

Table 2 Audit summary.

Rationale###Evidence-based and correct treatment of mucosal and multiple cutaneous

###leishmaniasis lesions like any other medical condition is important.

Objective(s)###The aim of this audit was to see if the active mucosal and multiple

###cutaneous leishmaniasis lesions were being treated in accordance with our

###local guidelines

Project type###Process

Basis of proposal###Local guidelines

Criteria###The patients with active mucosal and multiple cutaneous leishmaniasis

###lesions should preferably be treated with systemic antimony

Standard(s)###100% patients with mucosal and multiple cutaneous leishmaniasis lesions

###should be treated with systemic antimony

Sample source###Case-records of patients admitted in the dermatology ward

Sample size###30 case-notes

Data collection/ analysis###Retrospective

Results###The result showed 100% compliance with our local guidelines

Recommendations/###The recommendation was to continue with this same good clinical practice

Areas for improvement###of treatment of leishmaniasis patients

Re-audit###6-months

Discussion

Many cutaneous leishmaniasis (CL) infections eventually resolve clinically without treatment, and not all patients who undergo treatment demonstrate elimination of parasitic infection.5. The benefits of treatment include accelerated healing of skin lesions6,7 reduced likelihood of recurrence (especially in the setting of subsequent immune compromise), diminished severity of skin scarring and attendant emotional concerns.8,9 The aim of CL treatment is clinical cure, not parasitologic cure. Treatment decisions must include consideration of individual risks and benefits, which can be complex given the large number of parasite species with variable clinical syndromes, complications, and rates of spontaneous resolution.

CL is a parasitic disease occurring throughout the Americas from Texas to Argentina, and in the Old World, particularly the Middle East and North Africa. It is spread by the female sandfly. The condition is diagnosed every year in travelers, immigrants, and military personnel. Physicians working for short periods in endemic areas often must make the diagnosis and should be aware of local disease patterns. When faced with a possible leishmanial skin lesion, a skin scraping with microscopic analysis is the best test. Punch biopsies with tissue-impression smears also can be diagnostic. Needle aspiration of tissue fluid from the margin of a lesion can yield fluid for culture to isolate the organism and identify the species. Immunologic tests are being developed, including a highly sensitive polymerase chain reaction test. The treatment mainstay is pentavalent antimony (e.g. sodium stibogluconate). Not all patients require treatment; many lesions heal spontaneously.

Antimonials have a high incidence of reversible adverse effects.10 In a military study,11 96 subjects with leishmaniasis (83 cases were cutaneous) were treated for 20 to 28 days and followed for one year. Side effects included body aches, arthralgia, fatigue, gastrointestinal upset, and elevation of amylase, lipase, and liver enzyme levels, leukopenia, anemia, and electrocardiographic abnormalities. Other medications used for treatment include amphotericin B, pentamidine, paromomycin, and antifungals. This disease must be considered in at-risk patients, and physicians should know the basics of diagnosis and where to go for more help.

References

1. Reithinger R, Dujardin JC, Louzir H et al. Cutaneous leishmaniasis. Lancet Infect Dis. 2007;7:581-96.

2. Ejaz A, Raza N, Din QU, Bux H. Outbreak of cutaneous leishmaniasis in Somniani, Balochistan implementation of preventive measures for deployed personnel of armed forces. J Pak Assoc Dermatol. 2008;18:220-5.

3. Saleem K, Rahman A. Comparison of oral itraconazole and intramuscular meglumine antimoniate in the treatment of cutaneous leishmaniasis. J Coll Physicians Surg Pak. 2007;17:713-6.

4. Emad M, Hayati F, Fallahzadeh MK, Namazi MR. Superior efcacy of oral uconazole 400 mg daily versus oral uconazole 200 mg daily in the treatment of cutaneous Leishmania major infection: a randomized clinical trial. J Am Acad Dermatol. 2011;64:606-8.

5. Mendonca MG, de Brito ME, Rodrigues EH et al. Persistence of leishmania parasites in scars after clinical cure of American cutaneous leishmaniasis: is there a sterile cure J Infect Dis. 2004;189:1018-23.

6. Unger A, O'Neal S, Machado PR et al. Association of treatment of American cutaneous leishmaniasis prior to ulcer development with high rate of failure in northeastern Brazil. Am J Trop Med Hyg. 2009;80:574-9.

7. Navin TR, Arana BA, Arana FE et al. Placebo-controlled clinical trial of sodium stibogluconate (Pentostam) versus ketoconazole for treating cutaneous leishmaniasis in Guatemala. J Infect Dis. 1992;165:528-34.

8. Weigel MM, Armijos RX, Racines RJ et al. Cutaneous leishmaniasis in subtropical Ecuador: popular perceptions, knowledge, and treatment. Bull Pan Am Health Organ. 1994;28:142-55.

9. Yanik M, Gurel MS, Simsek Z, Kati M. The psychological impact of cutaneous leishmaniasis. Clin Exp Dermatol. 2004;29:464-7.

10. Markle WH, Makhoul K. Cutaneous leishmaniasis: recognition and treatment. Am Fam Physician. 2004;69:1455-60.

11. Aronson NE, Wortmann GW, Johnson SC et al. Safety and efficacy of intravenous sodium stibogluconate in the treatment of leishmaniasis: recent U.S. military experience. Clin Infect Dis. 1998;27:1457-64.
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Publication:Journal of Pakistan Association of Dermatologists
Article Type:Report
Geographic Code:9PAKI
Date:Mar 31, 2015
Words:1448
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