Cutaneous leishmaniasis (CL) caused by Leishmania donovani is an endemic vector-borne disease in Sri Lanka. Over 2,500 cases have been reported since 2000 and the number of CL cases has dramatically increased annually. Total 57 clinically suspected CL patients attending the dermatology clinic in Anuradhapura Teaching Hospital were recruited from January to June 2015. Slit skin smears and skin biopsies were taken from each of the subjects. Clinical and epidemiological data were obtained using interviewer administered questionnaire. Forty-three (75.4%) patients among 57 were confirmed positive for L. donovani. The majority of infected patients was males (P=0.005), and the most affected age group was 21–40 years. Soldiers in security forces, farmers, and housewives were identified as high risk groups. The presence of scrub jungles around the residence or places of occupation (P=0.003), the presence of sandflies (P=0.021), and working outsides more than 6 hr per day (P=0.001) were significantly associated with CL. The number of lesions ranged from 1–3, and the majority (76%) of the patients had a single lesion. Upper and lower extremities were the prominent places of lesions, while the wet type of lesions were more prevalent in females (P=0.022). A nodular-ulcerative type lesion was common in both sexes. The presence of sandflies, scrub jungles, and outdoor activities contributed to spread of Leishmania parasites in an endemic pattern. Implementation of vector control programs together with health education with regard to transmission and prevention of CL are necessary to control the spread of this infection.
causes cutaneous leishmaniasis (CL) in Sri Lanka. Standard treatment is multiple, painful doses of intralesional sodium stibogluconate (IL-SSG). Treatment failures are increasingly reported, hence the need to investigate alternatives. Efficacy, safety, and cost-effectiveness of thermotherapy were assessed for the first time for . CL. A single blinded noninferiority randomized controlled trial was conducted on new laboratory-confirmed CL patients with single lesions ( = 213). Selected patients were randomly assigned to 1) test group ( = 98; single session of radiofrequency-induced heat therapy (RFHT) given at 50°C for 30 seconds) and 2) control group ( = 115; 1-3 mL IL-SSG given weekly, until cure/10 doses). Patients were followed-up fortnightly for 12 weeks to assess clinical cure. Cost of treatment was assessed using scenario building technique. Cure rates by 8, 10, and 12 weeks in RFHT group were 46.5%, 56.5%, and 65.9% as opposed to 28%, 40.8%, and 59.4% in IL-SSG group, with no major adverse events. Cure rate by RFHT was significantly higher at 8 weeks ( = 0.009, odds ratio [OR]: 2.236, confidence interval [CI]: 1.217-4.108) and 10 weeks ( = 0.035, OR: 1.881, CI: 1.044-3.388), but comparable thereafter. Cost of RFHT was 7 times less (USD = 1.54/patient) than IL-SSG (USD = 11.09/patient). A single application of RFHT is safe, cost-effective, and convenient, compared with multiple doses of IL-SSG in the treatment of CL. Therefore, RFHT would be considered noninferior as per trial outcome when compared with standard IL-SSG therapy with multiple benefits for the patient and the national health care system.
BackgroundCytokines play a vital role in the host immune response to infection by initiating the healing process and/or accelerating the progression of the disease in cutaneous leishmaniasis (CL). Very little evidence is available on cytokine profiles and their regulatory function in CL patients in Sri Lanka. The aim of this study was to determine the cytokine expression pattern of IFN-γ, IL-4, IL-11 and IL-12p40 in CL patients and in healthy volunteers. Patients with suspected CL lesions attending to the Dermatology Clinic at the Anuradhapura Teaching Hospital were included in the study. Reverse transcription real time polymerase chain reaction (real-time RT-PCR) was performed to determine the relative expression level of target cytokines. Expression levels were quantified by 2- ∆∆CT equation.ResultsThe expression of cytokines IFN-γ, IL-4, IL-11 and IL-12p40 were significantly higher in CL patients compared to healthy volunteers (p < 0.05). There was a significant association between the expression of IFN-γ and the duration of the lesion (p = 0.021). Wet CL lesions showed significantly higher expression of IL-4, IL-11 and IL-12p40 (p = 0.039, 0.018 and 0.021 respectively) compared to dry lesions. Papulo-nodular lesions showed significantly high expression of IFN-γ (p = 0.023). However, cytokine expression was not significantly associated with the number, size and the locations of lesions.ConclusionsThe expression levels of all cytokines tested in the present study were significantly (p < 0.05) high in CL patients. Th1 response (IFN-γ and IL-12p40) had higher expression levels compared to Th2 (IL-4) and IL-11 in CL patients.
Treatment failure to intralesional sodium stibogluconate (IL-SSG) is a health challenge for cutaneous leishmaniasis (CL) in Sri Lanka. A randomized controlled proof of principle clinical trial, with two arms (viz., radio frequency–induced heat therapy [RFHT] by a ThermoMed™ device and thermotherapy by a handheld exothermic crystallization thermotherapy for CL [HECT-CL] device) was conducted on 40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020. Intention-to-treat cure rates were calculated at day 90 (initial cure rate) and at day 180 (final cure rate) posttreatment. Radio frequency–induced heat therapy group: the initial cure rate was 100% (20/20) and the final cure rate was 95% (19/20), with one patient relapsing. The HECT-CL group: both the initial and final cure rates were 80% (16/20), with no relapses and one excluded from the trial. In February 2020 (1.6–3 years posttreatment), 27 traceable patients (RFHT = 16, HECT-CL = 11) remained healed. Second-degree burns were observed with RFHT in 65% (13/20), with HECT-CL in 15% (3/20), which completely resolved subsequently. The cure rates between the two treatment groups were comparable (P = 0.15). Radio frequency–induced heat therapy consumed less time and required only a single hospital visit. Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG. This study is the first proof that thermotherapy is an efficacious and safe treatment for CL patients in Sri Lanka, complicated by treatment failure to IL-SSG.
Background: The quality of life in many patients is affected by skin lesions. Cutaneous leishmaniasis (CL), the commonest form of leishmaniasis is no exception. In Sri Lanka CL is an emerging parasitological condition with over 3000 cases within the last decade. Lesions are often seen on exposed parts of the body which may cause social stigma and hence a study was done to assess the changes in quality of life of CL patients. Method: A total of 294 patients (200 civilians and 94 army personnel) answered a previously validated Sinhala self- administered Dermatology Life Quality Index (DLQI) questionnaire and an interviewer administered questionnaire. Results: The majority of the civilian population 47% had no effect on their quality of life due to CL lesions, 33.5% were affected in a small way,12.5% were affected moderately, 6.5 % suffered in a large way and on 0.5% or one patient was extremely affected due a large ulcerative lesion being on the face. The effect on quality of life was negligible in the majority of army patients as well (35.1%-no effect, 31.9%-small effect), with a few patients affected moderately and very largely (22.3 % and 10.6%) respectively. The most affected domain in patients was symptoms and feeling 1.27±1.400 (mean±SD) and the least was the relationships domain 0.27±0.625. Conclusion: CL does not seem to affect the quality of life in the majority of Sri Lankan patients as compared to CL in other parts of the world or other skin diseases.
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