- ABSTRACT.
- INTRODUCTION
- MATERIALS AND METHODS
- Study area/setting/study unit.
- Study subject.
- Kala-azar case definition.
- Inclusion and exclusion criteria.
- Study design, sampling technique, and data collection.
- Study duration.
- Sample size.
- Operational definition of treatment outcomes.
- Data collection procedures and quality assurance.
- Data entry, management, and statistical analysis.
- RESULTS
- DISCUSSION
- CONCLUSION
- LIMITATIONS
- ACKNOWLEDGMENTS
- REFERENCES
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Ranjan A, Sur D, Singh VP, Siddiqui NA, Manna B, Lal CS, Sinha PK, Kishore K, Bhattacharya SK, 2005. Risk factors for Indian kala-azar. Am J Trop Med Hyg 73: 74–78.
-
2.
World Health Organization, 2021. Ending the Neglect to Attain the Sustainable Development Goals: A Road Map for Neglected Tropical Diseases 2021–2030. Geneva, Switzerland: WHO.
-
3.
Bora D, 1999. Epidemiology of visceral leishmaniasis in India. Natl Med J India 12: 62–68.
-
4.
Bern C, et al., 2005. Risk factors for kala-azar in Bangladesh. Emerg Infect Dis 11: 655–662.
-
5.
Rabi Das VN, Siddiqui NA, Pandey K, Lal CS, Sinha SK, Bimal S, Topno RK, Singh SK, Kumar S, Das P, 2019. The usefulness of trained field workers in diagnosis of post-kala-azar dermal leishmaniasis (PKDL) and clinico-epidemiological profile in highly endemic areas of Bihar. Trans R Soc Trop Med Hyg 113: 332–340.
-
6.
Alvar J, Aparicio P, Aseffa A, Den Boer M, Cañavate C, Dedet JP, Gradoni L, Ter Horst R, López-Vélez R, Moreno J, 2008. The relationship between leishmaniasis and AIDS: The second 10 years. Clin Microbiol Rev 21: 334–359.
-
7.
Hurissa Z, Gebre-Silassie S, Hailu W, Tefera T, Lalloo DG, Cuevas LE, Hailu A, 2010. Clinical characteristics and treatment outcome of patients with visceral leishmaniasis and HIV co-infection in northwest Ethiopia. Trop Med Int Health 15: 848–855.
-
8.
Tang Z, et al., 2017. Effects of high CD4 cell counts on death and attrition among HIV patients receiving antiretroviral treatment: An observational cohort study. Sci Rep 7: 3129.
-
9.
Burza S, et al., 2014. Visceral leishmaniasis and HIV co-infection in Bihar, India: Long-term effectiveness and treatment outcomes with liposomal amphotericin B (AmBisome). PLoS Negl Trop Dis 8: e3053.
-
10.
Ministry of Health & Family Welfare, Government of India, 2017. Accelerated Plan for Kala-Azar Elimination: Directorate, National Vector Borne Diseases Control Programme. New-Delhi, India: Ministry of Health & Family Welfare, Government of India.
-
11.
Operational Guidelines on Kala-azar (Visceral Leishmaniasis) Elimination in India – 2015. National Vector Borne Disease Control Programme. Available at: https://ncvbdc.mohfw.gov.in/Doc/opertional-guideline-KA-2015.pdf. Accessed September 16, 2023.
-
12.
Shargie EB, Lindtjørn B, 2005. DOTS improves treatment outcomes and service coverage for tuberculosis in South Ethiopia: A retrospective trend analysis. BMC Public Health 5: 62.
-
13.
Berhe G, Enquselassie F, Aseffa A, 2012. Treatment outcome of smear positive pulmonary tuberculosis patients in Tigray Region, northern Ethiopia. BMC Public Health 12: 537.
-
14.
Yassin MA, Datiko DG, Shargie EB, 2006. Ten-year experiences of the tuberculosis control programme in the southern region of Ethiopia. Int J Tuberc Lung Dis 10: 1166–1171.
-
15.
Endris M, Moges F, Belyhun Y, Woldehana E, Esmae A, Unakal C, 2014. Treatment outcome of tuberculosis patients at Enfraz Health Center, northwest Ethiopia: A five-year retrospective study. Tuberc Res Treat 2014: 726193.
-
16.
Burza S, Sinha PK, Mahajan R, Sanz MK, Lima MA, Mitra G, Verma N, Das P, 2014. Post kala-azar dermal leishmaniasis following treatment with 20 mg/kg liposomal amphotericin B (AmBisome) for primary visceral leishmaniasis in Bihar, India. PLoS Negl Trop Dis 8: e2611.
-
17.
World Health Organization, 2003. Introduction to Drug Utilization Research. Available at: https://atcddd.fhi.no/filearchive/publications/drug_utilization_research.pdf. Accessed September 10, 2023.
-
18.
Amante TD, Ahemed TA, 2015. Risk factors for unsuccessful tuberculosis treatment outcome (failure, default and death) in public health institutions, eastern Ethiopia. Pan Afr Med J 20: 247.
-
19.
Grzybowski S, Enarson D, 1978. The fate of cases of pulmonary tuberculosis under various treatment programmes. Bull Int Union Tuberc 53: 70–75.
-
20.
Mekonnen D, Derbie A, Desalegn E, 2015. TB/HIV co-infections and associated factors among patients on directly observed treatment short course in northeastern Ethiopia: A 4 years retrospective study. BMC Res Notes 8: 666.
-
21.
Tesfahuneygn G, Medhin G, Legesse M, 2015. Adherence to anti-tuberculosis treatment and treatment outcomes among tuberculosis patients in Alamata District, northeast Ethiopia. BMC Res Notes 8: 503.
-
22.
Muñoz-Sellart M, Cuevas LE, Tumato M, Merid Y, Yassin MA, 2010. Factors associated with poor tuberculosis treatment outcome in the southern region of Ethiopia. Int J Tuberc Lung Dis 14: 973–979.
-
23.
Welay GM, Alene KA, Dachew BA, 2017. Visceral leishmaniasis treatment outcome and its determinants in northwest Ethiopia. Epidemiol Health 39: e2017001.
-
24.
Tekalign S, et al., 2020. Clinical features and treatment outcomes of visceral leishmaniasis patients admitted to three centres in Oromia, Ethiopia. J Infect Dev Ctries 14: 42S–47S.
-
25.
Sinha PK, et al., 2006. Visceral leishmaniasis (kala-azar): The Bihar (India) perspective. J Infect 53: 60–64.
-
26.
Perry D, Dixon K, Garlapati R, Gendernalik A, Poché D, Poche R, 2013. Indian visceral leishmaniasis prevalence and associated risk factors in the Saran District of Bihar, India, from 2009 to July of 2011. Am J Trop Med Hyg 88: 778–784.
-
27.
Das A, Karthick M, Dwivedi S, Banerjee I, Mahapatra T, Srikantiah S, Chaudhuri I, 2016. Epidemiologic correlates of mortality among symptomatic visceral leishmaniasis cases: Findings from situation assessment in high endemic foci in India. PloS Negl Trop Dis 10: e0005150.
-
28.
Lucero E, Collin SM, Gomes S, Akter F, Asad A, Das AK, Ritmeijer K, 2015. Effectiveness and safety of short course liposomal amphotericin B (AmBisome) as first line treatment for visceral leishmaniasis in Bangladesh. PLoS Negl Trop Dis 9: e0003699.
-
29.
Sundar S, Singh A, Agrawal N, Chakravarty J, 2019. Effectiveness of single-dose liposomal amphotericin B in visceral leishmaniasis in Bihar. Am J Trop Med Hyg 101: 795–798.
-
30.
Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, 2003. Single-dose liposomal amphotericin b in the treatment of visceral leishmaniasis in India: A multicenter study. Clin Infect Dis 37: 800–804.
-
31.
Tamiru A, Tigabu B, Yifru S, Diro E, Hailu A, 2016. Safety and efficacy of liposomal amphotericin B for treatment of complicated visceral leishmaniasis in patients without HIV, north-west Ethiopia. BMC Infect Dis 16: 548.
-
32.
Salih NA, et al., 2014. Liposomal amphotericin B for complicated visceral leishmaniasis (kala-azar) in eastern Sudan: How effective is treatment for this neglected disease? Trop Med Int Health 19: 146–152.
-
33.
Goyal V, et al., 2019. Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. PLo S Negl Trop Dis 13: e0007726.
-
34.
Rabi Das VN, et al., 2021. Improved kala-azar case management through implementation of health facility-based sentinel sites surveillance system in Bihar, India. PLoS Negl Trop Dis 15: e0009598.
-
35.
Rabi Das VN, Ranjan A, Pandey K, Singh D, Verma N, Das S, Lal CS, Sinha NK, Verma RB, Siddiqui NA, Das P, 2012. Clinical epidemiologic profile of a cohort of post–kala-azar dermal leishmaniasis patients in Bihar, India. Am J Trop Med Hyg 86: 959–961.
-
36.
Rabi Das VN, Siddiqui NA, Pal B, Lal CS, Verma N, Kumar A, Verma RB, Kumar D, Das P, Pandey K, 2017. To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). PLoS One 12: e0174497.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 660 | 660 | 64 |
| Full Text Views | 64 | 64 | 16 |
| PDF Downloads | 77 | 77 | 18 |
Treatment Outcomes of Single-Dose Liposomal Amphotericin B–Treated Visceral Leishmaniasis Patients and Factors Affecting Outcome in Bihar, India
Niyamat Ali Siddiqui
niyamatalisiddiqui@yahoo.com
Niyamat Ali Siddiqui
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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Mohd. Zahid Ansari
Mohd. Zahid Ansari
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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Sanjay Kumar Sinha
Sanjay Kumar Sinha
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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Biplab Pal
Biplab Pal
Department of Pharmacology, School of Pharmaceutical Science, Lovely Professional University, Phagwara, India;
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Ashish Kumar Singh
Ashish Kumar Singh
Department of Microbiology, School of Sciences, RK University, Rajkot, India
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Subhankar Kumar Singh
Subhankar Kumar Singh
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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Roshan Kamal Topno
Roshan Kamal Topno
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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Vidya Nand Rabi Das
Vidya Nand Rabi Das
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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Krishna Pandey
Krishna Pandey
Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;
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ABSTRACT.
An assessment of the treatment outcomes of single-dose liposomal amphotericin B, implemented in 2010, had not been conducted until this study. This prospective cross-sectional study encompassed 527 cases, comprising 470 (89%) cases of visceral leishmaniasis (VL) and 57 (11%) cases of post–kala-azar dermal leishmaniasis (PKDL). The male proportion was higher (55% for VL), and the mean (±SD) age was 39.2 (±33.9) years. Among VL cases (426) treated with single-dose liposomal amphotericin B, 402 cases were cured at the 6-month follow-up, resulting in a cure rate of 95%, whereas fewer than 1% (0.9%) experienced unsuccessful outcomes and 4.1% faced relapse. A statistically highly significant difference in treatment outcomes (successful versus unsuccessful) was observed between males and females (P = 0.0005). Males had higher odds of successful outcomes compared with females, with an odds ratio of 5.03 (95% CI: 1.84–13.74). Those aged ≤23 years had higher odds of successful outcomes than unsuccessful outcomes, with an odds ratio of 6.82 (95% CI: 2.29–20.33). Patients with PKDL had a mean (±SD) age of 28.5 (±10.6) years, with 63% being male. Among the 57 PKDL cases, 21 (37%) had been treated with single-dose liposomal amphotericin B, whereas others had received alternative drugs. The median duration of PKDL development for single-dose liposomal amphotericin B was significantly shorter (14.5 months), with a statistically significant difference (P <0.001) compared with other drugs. The current treatment strategy necessitates continuous close monitoring and reviews to ensure consistent and improved outcomes.
Author Notes
Disclosures: The study received approval from the ICMR-RMRIMS (Rajendra Memorial Research Institute of Medical Sciences) Ethics Committee and the Scientific Advisory Committee, Patna. Written informed consent was obtained from all selected health facilities and adult participants during door-to-door visits. For participants under 18 years old who were able to read, written assent was obtained following written consent from their parent or guardian. All study data were anonymized before analysis, and confidentiality was maintained in accordance with the principles of the Declaration of Helsinki (as amended in Tokyo, Hong Kong, and Somerset West, South Africa).
Current contact information: Niyamat Ali Siddiqui, Mohd. Zahid Ansari, Sanjay Kumar Sinha, Subhankar Kumar Singh, Roshan Kamal Topno, Vidya Nand Rabi Das, and Krishna Pandey, Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India, E-mails: niyamatalisiddiqui@yahoo.com, zahidstatistics@gmail.com, sinhask70@yahoo.com, sksrmri@yahoo.com, roshanktopno@yahoo.co.in, drvnrdas@yahoo.com, and drkrishnapandey@yahoo.com. Biplab Pal, Department of Pharmacology, School of Pharmaceutical Science, Lovely Professional University, Phagwara, India, E-mail: biplab2006pal@gmail.com. Ashish Kumar Singh, Department of Microbiology, School of Sciences, RK University, Rajkot, India, E-mail: ashish.drug.research@gmail.com.
- ABSTRACT.
- INTRODUCTION
- MATERIALS AND METHODS
- Study area/setting/study unit.
- Study subject.
- Kala-azar case definition.
- Inclusion and exclusion criteria.
- Study design, sampling technique, and data collection.
- Study duration.
- Sample size.
- Operational definition of treatment outcomes.
- Data collection procedures and quality assurance.
- Data entry, management, and statistical analysis.
- RESULTS
- DISCUSSION
- CONCLUSION
- LIMITATIONS
- ACKNOWLEDGMENTS
- REFERENCES
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Ranjan A, Sur D, Singh VP, Siddiqui NA, Manna B, Lal CS, Sinha PK, Kishore K, Bhattacharya SK, 2005. Risk factors for Indian kala-azar. Am J Trop Med Hyg 73: 74–78.
-
2.
World Health Organization, 2021. Ending the Neglect to Attain the Sustainable Development Goals: A Road Map for Neglected Tropical Diseases 2021–2030. Geneva, Switzerland: WHO.
-
3.
Bora D, 1999. Epidemiology of visceral leishmaniasis in India. Natl Med J India 12: 62–68.
-
4.
Bern C, et al., 2005. Risk factors for kala-azar in Bangladesh. Emerg Infect Dis 11: 655–662.
-
5.
Rabi Das VN, Siddiqui NA, Pandey K, Lal CS, Sinha SK, Bimal S, Topno RK, Singh SK, Kumar S, Das P, 2019. The usefulness of trained field workers in diagnosis of post-kala-azar dermal leishmaniasis (PKDL) and clinico-epidemiological profile in highly endemic areas of Bihar. Trans R Soc Trop Med Hyg 113: 332–340.
-
6.
Alvar J, Aparicio P, Aseffa A, Den Boer M, Cañavate C, Dedet JP, Gradoni L, Ter Horst R, López-Vélez R, Moreno J, 2008. The relationship between leishmaniasis and AIDS: The second 10 years. Clin Microbiol Rev 21: 334–359.
-
7.
Hurissa Z, Gebre-Silassie S, Hailu W, Tefera T, Lalloo DG, Cuevas LE, Hailu A, 2010. Clinical characteristics and treatment outcome of patients with visceral leishmaniasis and HIV co-infection in northwest Ethiopia. Trop Med Int Health 15: 848–855.
-
8.
Tang Z, et al., 2017. Effects of high CD4 cell counts on death and attrition among HIV patients receiving antiretroviral treatment: An observational cohort study. Sci Rep 7: 3129.
-
9.
Burza S, et al., 2014. Visceral leishmaniasis and HIV co-infection in Bihar, India: Long-term effectiveness and treatment outcomes with liposomal amphotericin B (AmBisome). PLoS Negl Trop Dis 8: e3053.
-
10.
Ministry of Health & Family Welfare, Government of India, 2017. Accelerated Plan for Kala-Azar Elimination: Directorate, National Vector Borne Diseases Control Programme. New-Delhi, India: Ministry of Health & Family Welfare, Government of India.
-
11.
Operational Guidelines on Kala-azar (Visceral Leishmaniasis) Elimination in India – 2015. National Vector Borne Disease Control Programme. Available at: https://ncvbdc.mohfw.gov.in/Doc/opertional-guideline-KA-2015.pdf. Accessed September 16, 2023.
-
12.
Shargie EB, Lindtjørn B, 2005. DOTS improves treatment outcomes and service coverage for tuberculosis in South Ethiopia: A retrospective trend analysis. BMC Public Health 5: 62.
-
13.
Berhe G, Enquselassie F, Aseffa A, 2012. Treatment outcome of smear positive pulmonary tuberculosis patients in Tigray Region, northern Ethiopia. BMC Public Health 12: 537.
-
14.
Yassin MA, Datiko DG, Shargie EB, 2006. Ten-year experiences of the tuberculosis control programme in the southern region of Ethiopia. Int J Tuberc Lung Dis 10: 1166–1171.
-
15.
Endris M, Moges F, Belyhun Y, Woldehana E, Esmae A, Unakal C, 2014. Treatment outcome of tuberculosis patients at Enfraz Health Center, northwest Ethiopia: A five-year retrospective study. Tuberc Res Treat 2014: 726193.
-
16.
Burza S, Sinha PK, Mahajan R, Sanz MK, Lima MA, Mitra G, Verma N, Das P, 2014. Post kala-azar dermal leishmaniasis following treatment with 20 mg/kg liposomal amphotericin B (AmBisome) for primary visceral leishmaniasis in Bihar, India. PLoS Negl Trop Dis 8: e2611.
-
17.
World Health Organization, 2003. Introduction to Drug Utilization Research. Available at: https://atcddd.fhi.no/filearchive/publications/drug_utilization_research.pdf. Accessed September 10, 2023.
-
18.
Amante TD, Ahemed TA, 2015. Risk factors for unsuccessful tuberculosis treatment outcome (failure, default and death) in public health institutions, eastern Ethiopia. Pan Afr Med J 20: 247.
-
19.
Grzybowski S, Enarson D, 1978. The fate of cases of pulmonary tuberculosis under various treatment programmes. Bull Int Union Tuberc 53: 70–75.
-
20.
Mekonnen D, Derbie A, Desalegn E, 2015. TB/HIV co-infections and associated factors among patients on directly observed treatment short course in northeastern Ethiopia: A 4 years retrospective study. BMC Res Notes 8: 666.
-
21.
Tesfahuneygn G, Medhin G, Legesse M, 2015. Adherence to anti-tuberculosis treatment and treatment outcomes among tuberculosis patients in Alamata District, northeast Ethiopia. BMC Res Notes 8: 503.
-
22.
Muñoz-Sellart M, Cuevas LE, Tumato M, Merid Y, Yassin MA, 2010. Factors associated with poor tuberculosis treatment outcome in the southern region of Ethiopia. Int J Tuberc Lung Dis 14: 973–979.
-
23.
Welay GM, Alene KA, Dachew BA, 2017. Visceral leishmaniasis treatment outcome and its determinants in northwest Ethiopia. Epidemiol Health 39: e2017001.
-
24.
Tekalign S, et al., 2020. Clinical features and treatment outcomes of visceral leishmaniasis patients admitted to three centres in Oromia, Ethiopia. J Infect Dev Ctries 14: 42S–47S.
-
25.
Sinha PK, et al., 2006. Visceral leishmaniasis (kala-azar): The Bihar (India) perspective. J Infect 53: 60–64.
-
26.
Perry D, Dixon K, Garlapati R, Gendernalik A, Poché D, Poche R, 2013. Indian visceral leishmaniasis prevalence and associated risk factors in the Saran District of Bihar, India, from 2009 to July of 2011. Am J Trop Med Hyg 88: 778–784.
-
27.
Das A, Karthick M, Dwivedi S, Banerjee I, Mahapatra T, Srikantiah S, Chaudhuri I, 2016. Epidemiologic correlates of mortality among symptomatic visceral leishmaniasis cases: Findings from situation assessment in high endemic foci in India. PloS Negl Trop Dis 10: e0005150.
-
28.
Lucero E, Collin SM, Gomes S, Akter F, Asad A, Das AK, Ritmeijer K, 2015. Effectiveness and safety of short course liposomal amphotericin B (AmBisome) as first line treatment for visceral leishmaniasis in Bangladesh. PLoS Negl Trop Dis 9: e0003699.
-
29.
Sundar S, Singh A, Agrawal N, Chakravarty J, 2019. Effectiveness of single-dose liposomal amphotericin B in visceral leishmaniasis in Bihar. Am J Trop Med Hyg 101: 795–798.
-
30.
Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, 2003. Single-dose liposomal amphotericin b in the treatment of visceral leishmaniasis in India: A multicenter study. Clin Infect Dis 37: 800–804.
-
31.
Tamiru A, Tigabu B, Yifru S, Diro E, Hailu A, 2016. Safety and efficacy of liposomal amphotericin B for treatment of complicated visceral leishmaniasis in patients without HIV, north-west Ethiopia. BMC Infect Dis 16: 548.
-
32.
Salih NA, et al., 2014. Liposomal amphotericin B for complicated visceral leishmaniasis (kala-azar) in eastern Sudan: How effective is treatment for this neglected disease? Trop Med Int Health 19: 146–152.
-
33.
Goyal V, et al., 2019. Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. PLo S Negl Trop Dis 13: e0007726.
-
34.
Rabi Das VN, et al., 2021. Improved kala-azar case management through implementation of health facility-based sentinel sites surveillance system in Bihar, India. PLoS Negl Trop Dis 15: e0009598.
-
35.
Rabi Das VN, Ranjan A, Pandey K, Singh D, Verma N, Das S, Lal CS, Sinha NK, Verma RB, Siddiqui NA, Das P, 2012. Clinical epidemiologic profile of a cohort of post–kala-azar dermal leishmaniasis patients in Bihar, India. Am J Trop Med Hyg 86: 959–961.
-
36.
Rabi Das VN, Siddiqui NA, Pal B, Lal CS, Verma N, Kumar A, Verma RB, Kumar D, Das P, Pandey K, 2017. To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). PLoS One 12: e0174497.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 660 | 660 | 64 |
| Full Text Views | 64 | 64 | 16 |
| PDF Downloads | 77 | 77 | 18 |