Risk Assessment of Cutaneous Leishmaniasis and the Outcome of Therapy among Patients in Almaza Fever Hospital

INTRODUCTION

Leishmaniasis, a common parasitic infection being caused by kinetoplast protozoan parasites of the genus Leishmania, is considered a neglected infectious disease. It has posed significant health challenges in numerous tropical and subtropical areas globally. In 98 countries, this disease is prevalent and considered an endemic disease and poses a grave risk to roughly 310 million individuals residing in the affected regions [1].

This disease is a significant issue in developing and underdeveloped nations, especially in the Americas where it is widespread. The main risk factors, stemming from local social, economic, and environmental processes, greatly increase the population at risk of infection [2].

The medical complexity of leishmaniasis leads to a lack of comprehensive tools and guidelines for managing cases, whether for initial clinical suspicion, diagnoses, treatment or post-therapy follow-up. Existing resources are often limited to specific regions. As a result, leishmaniasis is not given due recognition or priority in public health policy, and its reported awareness does not accurately reflect its true impact [3].

Leishmaniasis is considered a zoonotic disease, with animal vectors being responsible for transmitting the parasites that cause the majority of its forms. However, there have been reports of some forms being transmitted directly between humans [4].

Due to the remote residence of the majority of affected patients and their poor access to health care services,leishmaniasis has still been considered as a hidden problem and underestimated [5]. There is currently a lack of cost-effective and easy-to-use medications for treating leishmaniasis. Leishmaniasis was not considered a direct threat to industrial countries until it appeared as a co-infection of HIV/AIDS [5].

Chemoprophylaxis or vaccination against various forms of leishmaniasis is not officially recognized or reliable. Regrettably, chemotherapy is still unsatisfactory in many aspects [6].

The current study is designed aiming to improve disease outcome and disease long term sequela via assessment of cutaneous Leishmaniasis therapy outcome among patients attending Almaza fever Hospital.

PATIENTS/MATERIALS AND METHODS

Following the declaration of Helsinki and after approval of Research Ethics Committee of Faculty of Medicine, Suez Canal University, this descriptive, cross-sectional study was conducted at Almaza Fever Hospital from December 2020 to December 2021 on 90 patients with cutaneous leishmaniasis diagnosed by clinical examination and direct smear biopsy among military groups in Egypt. Patients with definitive skin lesion according to clinical and laboratory data were included into the study. Patients were excluded from the study if they refused to share in the study. An informed written consent was a main prerequisite that was obtained from all recruited patients.

This study included control group of 20 healthy participants, age and sex matched with cases presented to the hospital. We included all patients with cutaneous leishmaniasis whom were presented to the hospital from December 2020 to December 2021.

The studied patients were subjected to the following:

1) Structured questionnaire: identifying the environmental factors favoring leishmaniasis spread. The questionnaire was formed of two main parts. First part: included demographic data as (age, sex, job, education level, stay length). Second part: included the description of living and working environment including land, building, and vegetation, and water collection, presence of insect-vector and animal-reservoir).

2) Present history of present illness (main complaint, lesion discovery, diagnosis, treatment type and duration, and outcome.

3) Clinical description of skin lesion features such as (type, size, site, number, complication).

4) Patients who were diagnosed with cutaneous leishmaniasiswere given sodium stibogluconate (Pentostam) (20 mg Sb/kg/day (maximum 850 mg) IV/IM for 20-28 days) or Cryotherapy sessions (cryotherapy was used every two weeks for maximum of three months. To reduce visits and simplify the follow up process, follow up examinations were scheduled during the same time of cryotherapy). Patients were allocated to which treatment according to feasibility of repeated visits for cryotherapy sessions.

5) Patients were followed up for incidence of adverse effects such as gastrointestinal upset, cardiac affection in form of ECG changes, headache, malaise, hepatotoxicity, coughing and retrosternal pain, fever, sweating, any spontaneous bleeding, skin rash, pain and thrombosis on intravenous administration, or painful intramuscular injection. Treatment failure was considered after 1 month of treatment without resolution of the cutaneous lesions. Failed cases were followed up after another one month for possibility of self-limited resolution and if no change was reported the same treatment was re-administered.

Statistical analysis was done using SPSS version 25 (SPSS Inc., Chicago, IL, USA). Quantitative data were presented as means ± SD while qualitative data were presented as numbers and percentages (%). Student t test was used to test significance of difference for quantitative variables and Chi Square was used to test significance of difference for qualitative variables. A probability value of p-value < 0.05 was considered statistically significant.

RESULTS

This study included 90 patients with cutaneous leishmaniasis among military groups in Egypt (Cases) and 20 healthy participants coming to hospital with their siblings (Controls). A total of 90 patients (Cases) and 20 controls participated in our study aged from 21 to 35 years and 20 to 39 years with mean age of 23.9± 4.5 years and 25.5± 5.6 years respectively with no significant difference. The BMI was ranging from 22 to 31 and 19 to 29 with a mean BMI 25.8± 2.5 and 23.7± 2.6 Kg/ m2 respectively with no significant difference. The most of our participants 97.8% and 95% were males and there were 2.2% and 5% females respectively with no significant difference. Regarding education, 77.8% and 75% was highly educated and 22.2% and 25% was primary and secondary educated respectively with no significant difference. There were 38.9% and 40% from rural areas while 61.1% and 60% from urban areas respectively with no significant difference. There were 7.8% and 10% had chronic diseases among them 2.2% and 5% diabetic, 4.5% and 5% hypertensive and 1.1% and 0 had cardiovascular diseases. While 92.2% and 90% had no chronic diseases respectively with no significant difference. There were 93.3% and 90% were military workers and 6.6% and 10% were non-military workers among cases and controls respectively with no significant difference. There were 42.2% and 40% non-smokers, 35.6% and 35% current smoker, and 22.2% and 25% Ex-smoker among cases and controls respectively with no significant difference. ( Table1)

Table 1. Sociodemographic data of patients:

                         BMI: Body Mass index, SD: standard deviations, n (%) number (percentage out of total)

Upon assessing the characteristics of the lesions among the cases, the lesions were disseminated among 72.2% while it was localized among 27.8%. The number of lesions was ranging from 1 to 25 lesions with the mean 5.5± 3.5. The size of lesions was ranging from 1 to 5 cm with mean 1.3± 0.6 cm. (Table2)

Table 2. Characteristics of the lesions among the participants:

                     N: total number of studied patients, SD: standard deviations, n (%) number (percentage out of total)

                    N.B: Quantitative data represented as mean± SD Qualitative data represented as frequency (percentage)

 The treatment used was cryo-therapy among 61.1% and Pentostam among 38.9%. (table 3)

Table 3: Treatment used among the participants:

                N: total number of study patients, n (%) number (percentage out of total)

Regarding treatment effects among the participants after first session of treatment, 92.2% had erythema, 95.6% had induration, 14.4% developed ulcer. After second session, 90% had erythema, 92.2% had induration, 15.6% developed ulcer. (table 4)

Table 4:Treatment effects after first and second session among the participants.

                N: total number of the studied cases, n (%) number (percentage out of total)

                N.B: Qualitative data represented as frequency (percentage)

Regarding outcome of treatment, there were 72.2% improved, 5.6% relapsed, 8.9% had treatment failure, 13.3% developed chronic infection. Discontinuation of treatment in these patients might be an explanation for this loss of efficacy. (table 5)

Table 5: Outcome of treatment among the treatment.

                N: total number of the studied cases, n (%) number (percentage out of total)

               N.B: Qualitative data represented as frequency (percentage)

Upon comparison the outcome of the two treatment modalities, there were 69.1% improved, 5.5% relapsed, 9.1% had treatment failure, 16.4% developed chronic infection among Cryo-therapy, while there were 77.1% improved, 5.7% relapsed, 6.7% had treatment failure, 8.6% developed chronic infection among pentostam group with no statistically significant difference. (table 6)

Table 6: Comparison of outcome between the two treatment modalities.

              n (%) number (percentage out of total)

             N.B: Qualitative data represented as frequency (percentage)

DISCUSSION