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"Pada pengobatan Tuberkulosis Resistan Obat (TB RO), ada kemungkinan pasien mengalami Kejadian Tidak Diinginkan (KTD). KTD serius dapat menyebabkan kematian, keadaan yang mengancam yang jiwa, kecacatan permanen, dan memerlukan perawatan di rumah sakit. Maka dari itu, setiap fasilitas kesehatan TB RO perlu mencatat dan melaporkan KTD Serius. Tujuan dari tugas khusus ini adalah untuk mencatat dan menganalisis KTD Serius pada pasien TB RO di Rumah Sakit Universitas Indonesia pada periode Juli – November 2022. KTD Serius pada pasien TB RO dilihat dari Catatan Perkembangan Pasien Terintegrasi (CPPT) pada sistem AFYA Rumah Sakit Universitas Indonesia. Kemudian KTD serius dicatat ke dalam Formulir Pelaporan KTD Serius dan dianalisis. Hasil menunjukkan bahwa ditemukan 8 pasien TB RO yang mengalami KTD serius dan 3 pasien diantaranya mengalami KTD serius sebanyak 2 kali sehingga total ada 11 laporan KTD serius. KTD serius yang ditemukan pada pasien antara lain sesak napas (72,7%), mual muntah (36,4%), nyeri (36,4%), gangguan pencernaan (18,2%), demam (18,2%), batuk darah (9%), dan ruam gatal (9%). Kesimpulannya adalah terdapat sebanyak 11 laporan KTD serius pada pasien TB RO dan KTD serius yang paling banyak ditemukan pada pasien adalah sesak napas.

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In the treatment of drug-resistant Tuberculosis (DR TB), there is a possibility that the patient will experience an adverse event. Serious adverse events can cause death, life-threatening conditions, permanent disability, and hospitalization. Therefore, every DR TB health facility needs to record and report serious adverse events. The purpose of this special assignment was to record and analyze serious adverse events in DR TB patients at the Universitas Indonesia Hospital in the period July – November 2022. Serious adverse events in DR TB patients can be seen from the integrated patient progress record in the Universitas Indonesia Hospital AFYA system. Then the serious adverse event was recorded on the serious adverse event reporting form and analyzed. The results showed that there were 8 DR TB patients who had serious adverse events, and 3 of them had two serious adverse events, for a total of 11 serious adverse events reported. Serious adverse events found in patients included shortness of breath (72.7%), nausea, vomiting (36.4%), pain (36.4%), digestive disorders (18.2%), fever (18.2%), coughing up blood (9%), and an itchy rash (9%). In conclusion, there were 11 reports of serious adverse events in DR TB patients, and the most common serious adverse event found in patients was shortness of breath."

"Latar belakang: Kompleksitas pengobatan TB RO berupa durasi pengobatan yang panjang, penggunaan beberapa obat lini kedua, toksisitas obat, dan interaksi obat akibat multidrug use dapat menyebabkan efek samping pengobatan pada pasien. Hal ini dapat mengurangi efektivitas pengobatan dan memengaruhi luaran pengobatan TB RO. Tujuan: Untuk melihat efek samping obat/kejadian tidak diinginkan terhadap luaran pengobatan TB RO.Metode: Penelitian observasional dengan desain kohort retrospektif ini dilakukan di RSUP Persahabatan, Jakarta. Sumber data adalah data sekunder dari sistem informasi tuberkulosis (SITB) yang melibatkan pasien TB RO yang menjalani pengobatan di tahun 2021 – 2023. Metode sampling berupa total sampling. Analisis data bivariat antara KTD dengan luaran pengobatan TB RO berupa Cox regresi dan uji Log-Rank, yang kemudian dilanjutkan dengan analisis multivariat menggunakan Extended Cox Regresi.Hasil: Dari 583 subjek yang diikutsertakan dalam penelitian ini, insidens luaran pengobatan tidak berhasil sebanyak 40,65%. Sebanyak 12,69% pasien mengalami efek samping berat. Sebagian besar efek samping terjadi pada fase intensif pengobatan TB RO (43,57%). Jenis efek samping yang paling sering dialami pada pasien adalah gangguan gastrointestinal (79,25%), gangguan muskuloskeletal (58,32%), dan gangguan saraf (49,40%). Efek samping berupa KTD berat/serius tidak memiliki asosiasi yang signifikan terhadap terjadinya pengobatan tidak berhasil berdasarkan hasil analisis Cox regresi bivariat (HR=0,823; 95% CI: 0,558-1,216; p=0,329) dan analisis multivariat Extended Cox regresi (setelah dikontrol oleh variabel kovariat). Probabilitas survival antara kelompok dengan KTD berat dan kelompok non-KTD berat tidak berbeda bermakna. Kesimpulan: pemantauan efek samping selama pengobatan TB RO berlangsung merupakan hal yang penting untuk menunjang keberhasilan pengobatan.

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Background: The complexity of treating drug-resistant tuberculosis (DR TB) involves prolonged treatment duration, the use of several second-line drugs, drug toxicity, and drug interactions due to multidrug use, which can lead to adverse drug reactions in patients. These issues can reduce treatment effectiveness and affect treatment outcomes for DR TB.

Objective: To investigate the impact of adverse drug reactions/adverse events on DR TB treatment outcomes.

Methods: This observational study utilized a retrospective cohort design conducted at RSUP Persahabatan, Jakarta. The data source was secondary data from the tuberculosis information system (SITB) involving DR TB patients who underwent treatment between 2021 and 2023. The sampling method was total sampling. Bivariate data analysis between adverse events and TB RO treatment outcomes involved Cox regression and Log Rank tests, followed by multivariate analysis using Extended Cox Regression.

Results: Among the 583 subjects included in this study, the incidence of unsuccessful treatment outcomes was 40.65%. Severe adverse drug reactions were experienced by 12.69% of patients. Most adverse reactions occurred during the intensive phase of TB RO treatment (43.57%). The most common types of adverse reactions experienced by patients were gastrointestinal disorders (79.25%), musculoskeletal disorders (58.32%), and neurological disorders (49.40%). Severe/serious adverse reactions did not have a significant association with unsuccessful treatment outcomes based on the results of the bivariate Cox regression analysis (HR=0.823; 95% CI: 0.558-1.216; p=0.329) and the multivariate Extended Cox regression analysis (after adjusting for covariate variables). The survival probability between the group with severe adverse reactions and the non- severe adverse reactions group did not differ significantly.

Conclusion: Monitoring adverse drug reactions during DR TB treatment is crucial to support the success of the treatment."