Clinical Evaluation of The Radiopharmaceutical 99mTc-Ethambutol to Diagnose Pulmonary and Extra-pulmonary Tuberculosis – Case Series

Isi Artikel Utama

Wirabrata I Gede Made
Achmad Hussein Sundawa Kartamihardja
Syamsudin Abdillah
Yusi Anggriani
Hendig Winarno

Abstrak

Infectious tuberculosis disease is caused by Mycobacterium tuberculosis and can infect the lungs as well as other organs (extrapulmonary). Advanced diagnosis of TB disease using nuclear medicine methods involves the use of the radiopharmaceutical 99mTc-ethambutol. This study aims to clinically evaluate 99mTc-ethambutol for diagnosing both pulmonary and extrapulmonary TB. Research methodology is clinical scientific research based on the disciplines of nuclear medicine and nuclear pharmacy in marketing surveillance of new drugs. The research period was in 2023, conducted at multiple centers across three hospitals with a sample of 22 serial post-marketing surveillance cases. The examination results for TB in the subjects using the ethambutol patch test showed positive results in 40.9% and negative results in 59.1%. Comparative tests of the ethambutol patch test against treatment outcomes using X-ray methods yielded positive results in 40.9% and negative results in 59.1%, and using culture methods yielded positive results in 27.3% and negative results in 72.7%. The comparative results of TB examinations using the three methods showed the same results and were compared with treatment outcomes, with 6 subjects testing positive for TB, 13 subjects testing negative for TB, and 3 subjects with positive results being cases of extrapulmonary TB. All subjects diagnosed with TB underwent treatment. The measurements of the ethambutol patch test method using scintigraphy showed a sensitivity of 100%, specificity of 100%, and accuracy of 100%. The study concluded that the clinical evaluation of 99mTc-ethambutol can be used to diagnose both pulmonary and extrapulmonary TB. No drug side effects or subject complaints were found before or after the injection of 99mTc-ethambutol. Recommended to continue clinical evaluation with a larger number of subjects.

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[1] Indonesian Ministry of Health, “National Guidelines for Tuberculosis Management Medical Services”, pp. 9-28, 66-90, 92-117, 122-124, 2020.
[2] World Health Organization, “Global TB Report 2021”, ISBN 978-92-4-003702-1 (electronic version), Access: 23 April 2022.
[3] Regulation of the Minister of Health of the Republic of Indonesia Number 21 of 2020 Concering “The Strategic Plan of The Ministry of Health for 2020-2024”, 2020.
[4] Food and Drug Monitoring Agency, “Efficacy and Safety Evaluation Results of the Lyophilized Ethambutol Powder Injection Kit”, Jakarta, 2020.
[5] Agus, “Ethambutol Dry Kit Clinic Document”, National Atomic Energy Agency, Radioisotope and Radiopharmaceutical Technology Center, Indonesia, 2018.
[6] A.H. Kartamihardja, Y. Kurniawati, R. Gunawan, “Diagnostic Value of 99mTc-Ethambutol Scintigraphy In Tuberculosis: Compared To Microbiological And Histopathological Tests”, Journal, 2017.
[7] Anna R., Witarti, Mujinah, Jakaria, Dede K., Widyastuti W., “Preparation of the Radiopharmaceutical 99mTc-Ethambutol for Tuberculosis Detection”, Proceedings of the National Seminar on Chemical Engineering, Indonesia, 2019.
[8] Singh N., Bhatnagar A., “Clinical Evaluation of Efficacy of 99mTc-Ethambutol in Tubercular Lesion Imaging”, Journal Tuberculosis Resistent Treatment, pp 1-9, 2010.
[9] Jeffrey S., Abrams, James H, Doroshow, “Clinical Trial”, Article, National Cancer Insitutes, Behtesda, Page 1-5, 2020.
[10] Verma. J., Bhatnagar A., Sen S., Singh A. K., dan Bose M., “Radio-labelling of Ethambutol with Technetium-99m and Its Evaluation for Detection of Tuberculosis”, World Journal of Nuclear Medicine, Volume 4 (1): 00. 35-46, 2005.
[11] Nanny Kartini Oekar, Kustiwa, “Development of 99mTc-Ethambutol Labeled Compound for Tuberculosis Diagnostics, Physico-Chemical and Microbiological Characteristics”, Indonesian Journal of Nuclear Science and Technology, Vol. 8. No. 1. pp 17-27, 2007.
[12] Hayakawa T., Hatsukawa Y., Tanimori T., “95gTc and 96gTc As Alternatives To Medical Radioisotope 99mTc”, Journal. Heliyon, Elsevier, e00497, Kyoto Univesrity, Japan, 2017.
[13] Juwita R., Sugiharti., Sumpena Y., Eka M., and Kartini S. N., “Biological Evaluation of 99mTC-Ethambutol for Early Detection of Tuberculosis Infection in Animal Model”, Indonesia Journal Phamacy, Vol. 20, No. 2, pp 55-61, 2009.
[14] Sheskin, D. J., “Handbook of Parametric and Nonparametric Statsistical Procedures”, CHAPMAN and HALL/CRC, 2004.
[15] Astuti, C. C., “Correlation analysis to determine the close relationship between student activity and final learning outcomes”, Journal of Information and Computer Technology Education, Pg. 1-7, 2013.
[16] Diah, Lisa Herawati L., A.H. Kartamihardja, “The Role of Techentium-99m-Ethambutol Scintigraphy in The Management of Spinal Tuberculosis”, World Journal of Nuclear Medicine, Vol. 18, pp 13-17, 2019.
[17] Primadhi, Raden Adri. Kartamihardja, Achmad Hussein Sundawa. Subclinical Ankle Joint Tuberculous Arthritis - The Role of Scintigraphy: A case series. World Journal of Orthopedics. 2023.
[18] Karimollah, Hajian-Tilaki, “Sampel Size Estimation In Diagnostic Test Studies of Biomedical Informatics”, Journal of Biomedical Informatics, Elsevier, Page 193-204, 2014.
[19] Desita D., Budi W. S., Gunawan G. Biodistribution of the radiopharmaceutical 99mTc DTPA in renographic examination. Youngster Physics Journal. Vol. 6 No. 2. Pg. 157-165. Diponogoro University. RSUP Dr. Kariadi. Semarang, Indonesia, 2017.
[20] Metello Luis F., “99mTc-Technetium Shortage: Old Problems Asking for New Solution”, Journal of Medical Imaging and Radiation Sciences 46, pp 256-261, Elsevier, University of Coimbra, Portugal. 2015.
[21] Prayudi Santoso, Basuki Hidayat, Chica Pratiwi, etc., “The role of 99mTc-Ethambutol Scintigraphy to Diagnose Pulmonary Tuberculosis, The Journal of Infection In Developing Countries, pp 226-230, 2022.
[22] Behera D., “Textbook of Pulmonary Medicine” (edisi ke-2nd ed.), New Delhi: Jaypee Brothers Medical Pub., pp. 457. ISBN 978-81-8448-749-7, 2010.
[23] Robert G. et al, “The Role of 99mTC-MIBI Scientigraphy in The Management of Patients with Pulmonary Tuberculosis”, Eur. Rev. Med. Phamacol. Sci. Vol. 16, pp 622-629, 2012.
[24] Barozi, Rusmini; Kartawiguna, Daniel, “Radiology Nuclear Medicine and Radiotherapy”, Graha Ilmu, Indonesia, pp 1-7, 15-21, 93-104, 2015.
[25] Nurlaila Z,“Marking of Mibi (Methoxy Isobutyl Isonitrile) with Technetium-99m as a Cardiac Perfusion Scan Radiopharmaceutical. Labeling Of Mibi (Metoxy Isobutyl Isonitryl) With Technetium-99m As A Perfusion Myocardiac Imaging Radiopharmaceutical”, Publication, Bandung, Indonesia, 2017.
[26] Qi Sun, Jiyuan Li, Zexuan Ding, Zhibo Liu, “Radiopharmaceutical Heat Anti-Tumor Immunity”, Theranostics, PubMed Central, National Library of Medicine, 13(2): pp. 767-786, 2023.
[27] Hidayati N. R., Hidayat B., “Application of 99mTc Radioisotope In Diagnostic Procedures and Internal Radiation Dose Estimation”, Conference Proceedings, International Conference on Nuclear Enerfy Technologies and Sciences, 2016.
[28] Nanny K., Widyasari Eva M., Isabel E., “Physico-Chemical Characteristics of the Radiopharmaceutical 99mTc-Human Serum Albumin (HAS)-Nanosphere”, Indonesian Journal of Nuclear Science and Technology, Vol. IX. No. 1 pp. 35-44, Center for Nuclear Materials Technology and Radiometry, Indonesia, 2010.
[29] Wangsaatmadja H. and Kartini N., “Pharmacokinetic Profile of the Radiopharmaceutical Ethambutol Labeled with Technicium-99m as a Tuberculosis Scan Preparation”’ Indonesian Pharmacy Journal, Vol. 5.No. 4. pp. 188-194, 2011.
[30] Dartois V., “The Path of Anti-Tuberculosis Drugs: From Blood To Lessions To Mycobacterial Cells”, Nat. Rev. Microbiol., Vol. 12. No. 3. pp 159-167, 2014.