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"Dihidroartemisinin-piperakuin (DHA-PPQ) telah digunakan secara global sebagai terapi kombinasi standar pada pengobatan malaria vivaks di Indonesia. Efikasi dan keamanan obat ini banyak dilaporkan, namun data efek samping obat terhadap jantung masih sangat terbatas. Salah satu efek samping yang patut diwaspadai adalah pemanjangan repolarisasi ventrikel yang dapat menyebabkan berkembangnya aritmia ventrikuler yang dikenal sebagai Torsade de Pointes (TdP).Pengukuran interval QT telah dijadikan standar untuk mengukur waktu repolarisasi ventrikel. Interval QT juga mewakili waktu yang dibutuhkan untuk depolarisasi dan repolarisasi ventrikel sehingga tidak selalu bisa dijadikan indikator akurat pada kelainan repolarisasi. Saat ini pengukuran interval QT digunakan sebagai standar utama penilaian efek samping obat terhadap jantung, namun menurut pemikiran sebagian ahli, pengukuran interval JT lebih akurat untuk mengukur waktu repolarisasi ventrikel, karena tidak terpengaruh oleh variabilitas durasi kompleks QRS. Interval QT dan JT dipengaruhi oleh frekuensi denyut jantung, maka dalam penelitian ini digunakan dua formula yang sudah dikoreksi terhadap frekuensi denyut jantung, yaitu formula Bazett (QTcB, JTcB) dan Fridericia (QTcF, JTcF).Penelitian before-after ini bertujuan untuk mengetahui perbedaan nilai rerata interval QTc dan JTc penderita malaria vivaks sebelum dan sesudah pemberian DHA-PPQ. Penelitian ini dilakukan pada penderita malaria vivaks yang juga diberikan primakuin (PQ) untuk mencegah kekambuhan, sehingga juga dilakukan pengukuran interval QTc dan JTc sebelum dan sesudah pemberian PQ.Subyek yang masuk dalam kriteria seleksi pada pemberian DHA-PPQ berjumlah 24 subyek, sedangkan pada pemberian PQ sebanyak 14 subyek. Pengukuran interval QT dan JT dilakukan pada data rekaman EKG penelitian utama ?Safety, tolerability, and efficacy of artesunat-pyonaridine or dihydroartemisinin-piperaquine in combination with primaquine as radical cure for P. Vivax in Indonesian Soldiers? tahun 2010.Hasil penelitian menunjukkan terdapat pemanjangan rerata interval QTcF dibandingkan baseline yang bermakna secara statistik di D3 setelah pemberian DHA-PPQ. Pemanjangan sebesar 14,42 milidetik terjadi di D3 predose dan 20,53 milidetik di D3 postdose, sedangkan rerata pemanjangan interval JTcF yang bermakna setelah pemberian DHA-PPQ, didapatkan sebesar 13,43 milidetik di D3 postdose.Hasil penelitian pada pemberian PQ terdapat perbedaan nilai rerata interval QTcB dibandingkan baseline sebesar 19,42 milidetik. Nilai median interval QTcB di D42 predose dan D42 postdose, masing-masing sebesar 402,69 milidetik dan 399,73 milidetik, sedangkan nilai median QTcB D29 predose sebagai baseline 380,31 milidetik, dan perbedaan tersebut bermakna secara statistik. Untuk rerata pemanjangan interval JTcF dibandingkan baseline diperoleh sebesar 16,50 milidetik di D42 postdose dan secara statistik bermakna.

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Dihydroartemisinin-piperaquin (DHA-PPQ) has been used globally as standard combination therapies for vivax malaria treatment in Indonesia. There are accumulating reports of efficacy and safety for these drugs. However, data on cardiotoxicity are limited. One of the side effects that must be put into caution is the prolongation of ventricular repolarization which can lead to the development of ventricular arrhythmia known as Torsade de Pointes (TdP).QT interval has been the standard measurement of ventricular repolarization. However, it includes both depolarization and repolarization time, and may not always be an accurate indicator for repolarization abnormalities. Recently, many experts suggest that JT interval could be a more accurate measurement of ventricular repolarization since the variability of QRS complex duration does not affect it. QT and JT intervals are affected by heart rate, so both of them have to be corrected for the heart rate using two formulas, i.e.: Bazett (QTcB, JTcB) and Fridericia (QTcF, JTcF) formulas.This study used ?before and after? design and was aimed to find out whether there was a significant difference of QTc and JTc interval of vivax malaria patients pre and post DHA-PPQ dose. Since our patients were also given primaquine (PQ) the differences of QTc and JTc interval of vivax malaria patients pre and post PQ were also explored.The ECG record of 24 DHA-PPQ and 14 PQ treated subjects taken from ?Safety, tolerability, and efficacy of artesunat-pyonaridine or dihydroartemisinin-piperaquine in combination with Primaquine as radical cure for P. Vivax in Indonesian Soldiers? study in the 2010 year, were analyzed.The results showed significant QTcF prolongations of 14.42 ms predose and 20.53 ms postdose on D3 DHA-PPQ treatment compared to the baseline value, D1, whereas prolongations of JT interval were 13.43 ms found on D3 postdose.The results after given PQ showed mean difference of QTcB compared to the baseline value was 19.42 ms and the values of QTcB interval median were 402.69 ms and 399.73 ms for D42 predose and D42 postdose, respectively, compared to the baseline value 380.31 ms for D29 predose, and which was statistically significant. The result for JTcF interval after given PQ, showed mean difference of prolongations compared to the baseline value was 16.50 ms, statistically significant."

"ABSTRAK Latar belakangKematian akibat sepsis dan syok septik pada pasien rawatan Intensive Care Unit (ICU) yaitu 20-30%. Pemberian antibiotik empirik yang tepat merupakan salah satu langkah awal yang sangat penting. Amikasin merupakan salah satu antibiotik terpilih untuk tata laksana sepsis di ICU RSUPN dr. Cipto Mangunkusumo (RSCM). Saat ini belum pernah dilakukan penelitian mengenai ketercapaian kadar terapi amikasin dengan menggunakan dosis standar amikasin pada pasien sepsis dewasa di ICU RSCM, sehingga studi ini menjadi penelitian pertama di Indonesia.Penelitian ini bertujuan untuk mengetahui ketercapaian kadar amikasin optimal pada pasien ICU RSCM.MetodeData dikumpulkan secara potong lintang melalui observasi terhadap hasil pemeriksaan kadar plasma amikasin, pengukuran minimum inhibitory concentration (MIC) dan perhitungan rasio Cmax/MIC pada pasien sepsis di ICU RSCM periode Mei-September tahun 2015.Hasil penelitianProporsi pasien sepsis dengan kadar amikasin optimal ialah sebesar 57% (4/7). Kadar puncak amikasin yang dapat dicapai dengan dosis 1000 mg sekali sehari tanpa menghiraukan berat badan ialah median 86,4 (43,5-238) µg/mL. Pada penelitian ini ditemukan 87% pasien dengan kadar puncak amikasin di atas 64 µg/mL, meskipun amikasin 1000 mg tersebut lebih rendah dari dosis yang dianjurkan untuk sepsis (25 mg/kgBB). Sebagian besar (78,3 %) subyek pada kenyataannya menerima dosis 15-25 mg/kgBB, dengan pemberian 1000 mg amikasin tanpa memperhatikan berat badan. Bakteri yang banyak ditemukan dari hasil kultur pasien sepsis di ICU RSCM, yaitu K. pneumoniae, A. baumanii, P. aeruginosa dan E. coli. Rentang nilai MIC untuk patogen tersebut berturut-turut yaitu 0,75 - >256 µg/mL, 0,75 - >256 µg/mL, 1,5 - >256 µg/mL dan 0,75 - 16) µg/mL. Sebanyak 84% isolat K. pneumoniae masih sensitif terhadap amikasin, diikuti oleh 63% untuk A. baumanii, 47% P. aeruginosa dan 100% untuk E. coli.KesimpulanOptimalitas amikasin terhadap bakteri Gram negatif penyebab sepsis bergantung kadar puncak dan MIC bakteri. Kadar puncak plasma amikasin yang dicapai dengan dosis 1000 mg sekali sehari sangat bervariasi. Pemberian amikasin dengan dosis per kgBB dapat dipertimbangkan. Kepekaan beberapa bakteri Gram negatif terhadap amikasin mulai menurun dengan rentang MIC yang cukup lebar. Pengukuran ketercapaian kadar optimal dalam terapi definitif dapat dilakukan untuk meningkatkan keberhasilan terapi.ABSTRACT BackgroundThe mortality caused by sepsis and septic shock in the Intensive Care Unit (ICU) is 20-50%. The important first step to reduce this conditions is to give the right empirical antibiotics. Amikacin is one of the antibiotics of choice for the sepsis and septic shock in ICU of Cipto Mangunkusumo (CM) Hospital. Studies on the amikacin plasma level in adult patients being given amikacin in ICU RSCM has never been done.The objective of this study is to explore the plasma level of amikacin in septic patients in CM Hospital.MethodsThis was a cross sectional study. Data on plasma amikacin level, microbiological culture, measurement of minimum inhibitory concentration (MIC), and amikacin optimal level in septic patients admitted to ICU of RSCM during May-September 2015.ResultsThe proportion of septic patients that achieve amikacin optimal level was 57% (4/7). Peak amikacin level that can be reached with 1 gram per day dose was 86,4 (43,5-238) g/mL. Although amikacin was given less than recommended dose for sepsis (25 mg/body weight), 87% patients was found to have peak amikacin level > 64 µg/mL. Most (78.3%) of the patients received amikacin with dose range 15-25 mg/kgBW, in which patients was given 1000 mg of amikacin regardless of the body weight. The organisms commonly identified from the microbiological culture septic in patients in ICU of RSCM were K. pneumoniae, A. baumanii, P. aeruginosa, and E. coli. The MIC for these pathogen were 0.75 - >256 µg/mL, 0.75 - >256 µg/mL, 1.5 - >256 µg/mL and 0.75 ? 16 µg/mL, respectively. Most (84%) of K. pneumoniae isolates was still sensitive to amikacin, while 63% A. baumanii isolate, 47% of P. aeruginosa, and 100% of E. coli were sensitive to amikacin.ConclusionsAmikacin?s efficacy to eradicate Gram negative microorganism causing sepsis depend on peak level and MIC of the microorganism. By giving 1000 mg dose per day of amikacin, highly variable peak plasma concentration of the drug was observed. Therefore, amikacin dosing based on weight might be useful to reduce the wide variation. In this study, we found that sensitivity of some Gram negative pathogen are decreasing, with wide range of MIC. Evaluation of optimal level for definitive therapy might be useful to reach more successful treatment.;BackgroundThe mortality caused by sepsis and septic shock in the Intensive Care Unit (ICU) is 20-50%. The important first step to reduce this conditions is to give the right empirical antibiotics. Amikacin is one of the antibiotics of choice for the sepsis and septic shock in ICU of Cipto Mangunkusumo (CM) Hospital. Studies on the amikacin plasma level in adult patients being given amikacin in ICU RSCM has never been done.The objective of this study is to explore the plasma level of amikacin in septic patients in CM Hospital.MethodsThis was a cross sectional study. Data on plasma amikacin level, microbiological culture, measurement of minimum inhibitory concentration (MIC), and amikacin optimal level in septic patients admitted to ICU of RSCM during May-September 2015.ResultsThe proportion of septic patients that achieve amikacin optimal level was 57% (4/7). Peak amikacin level that can be reached with 1 gram per day dose was 86,4 (43,5-238) g/mL. Although amikacin was given less than recommended dose for sepsis (25 mg/body weight), 87% patients was found to have peak amikacin level > 64 µg/mL. Most (78.3%) of the patients received amikacin with dose range 15-25 mg/kgBW, in which patients was given 1000 mg of amikacin regardless of the body weight. The organisms commonly identified from the microbiological culture septic in patients in ICU of RSCM were K. pneumoniae, A. baumanii, P. aeruginosa, and E. coli. The MIC for these pathogen were 0.75 - >256 µg/mL, 0.75 - >256 µg/mL, 1.5 - >256 µg/mL and 0.75 ? 16 µg/mL, respectively. Most (84%) of K. pneumoniae isolates was still sensitive to amikacin, while 63% A. baumanii isolate, 47% of P. aeruginosa, and 100% of E. coli were sensitive to amikacin.ConclusionsAmikacin?s efficacy to eradicate Gram negative microorganism causing sepsis depend on peak level and MIC of the microorganism. By giving 1000 mg dose per day of amikacin, highly variable peak plasma concentration of the drug was observed. Therefore, amikacin dosing based on weight might be useful to reduce the wide variation. In this study, we found that sensitivity of some Gram negative pathogen are decreasing, with wide range of MIC. Evaluation of optimal level for definitive therapy might be useful to reach more successful treatment.;BackgroundThe mortality caused by sepsis and septic shock in the Intensive Care Unit (ICU) is 20-50%. The important first step to reduce this conditions is to give the right empirical antibiotics. Amikacin is one of the antibiotics of choice for the sepsis and septic shock in ICU of Cipto Mangunkusumo (CM) Hospital. Studies on the amikacin plasma level in adult patients being given amikacin in ICU RSCM has never been done.The objective of this study is to explore the plasma level of amikacin in septic patients in CM Hospital.MethodsThis was a cross sectional study. Data on plasma amikacin level, microbiological culture, measurement of minimum inhibitory concentration (MIC), and amikacin optimal level in septic patients admitted to ICU of RSCM during May-September 2015.ResultsThe proportion of septic patients that achieve amikacin optimal level was 57% (4/7). Peak amikacin level that can be reached with 1 gram per day dose was 86,4 (43,5-238) g/mL. Although amikacin was given less than recommended dose for sepsis (25 mg/body weight), 87% patients was found to have peak amikacin level > 64 µg/mL. Most (78.3%) of the patients received amikacin with dose range 15-25 mg/kgBW, in which patients was given 1000 mg of amikacin regardless of the body weight. The organisms commonly identified from the microbiological culture septic in patients in ICU of RSCM were K. pneumoniae, A. baumanii, P. aeruginosa, and E. coli. The MIC for these pathogen were 0.75 - >256 µg/mL, 0.75 - >256 µg/mL, 1.5 - >256 µg/mL and 0.75 ? 16 µg/mL, respectively. Most (84%) of K. pneumoniae isolates was still sensitive to amikacin, while 63% A. baumanii isolate, 47% of P. aeruginosa, and 100% of E. coli were sensitive to amikacin.ConclusionsAmikacin?s efficacy to eradicate Gram negative microorganism causing sepsis depend on peak level and MIC of the microorganism. By giving 1000 mg dose per day of amikacin, highly variable peak plasma concentration of the drug was observed. Therefore, amikacin dosing based on weight might be useful to reduce the wide variation. In this study, we found that sensitivity of some Gram negative pathogen are decreasing, with wide range of MIC. Evaluation of optimal level for definitive therapy might be useful to reach more successful treatment."

"ABSTRAKLatar Belakang: Gagal jantung merupakan salah satu masalah kesehatan global dengan angka yang meningkat setiap tahunnya. Pengobatan gagal jantung melibatkan berbagai golongan obat, salah satunya adalah digoksin sebagai komponen terapi tertua pada gagal jantung. Penggunaan digoksin masih kontroversial karena selain batas terapeutik sempit, terdapat berbagai faktor yang dapat meningkatkan risiko terjadinya intoksikasi.Tujuan: Menganalisis kejadian intoksikasi, rehospitalisasi, dan kesintasan dalam setahun pada pasien gagal jantung yang mendapat digoksin.Metode: Studi analitik observasional dengan desain potong lintang dilakukan di Rumah Sakit Pusat Jantung dan Pembuluh Darah Harapan Kita pada bulan Januari 2017 hingga Desember 2018. Pasien gagal jantung yang mendapatkan terapi digoksin dan diperiksa kadar digoksin serum diikutsertakan dalam penelitian. Intoksikasi didefinisikan sebagai peningkatan kadar digoksin serum ≥ 2 ng/ml disertai dengan perubahan EKG tipikal intoksikasi dan minimal satu gejala non-kardiak. Dilakukan analisis terhadap faktor-faktor risiko pada pasien dan gejala intoksikasi menggunakan uji X2, sedangkan angka kesintasan dan rehospitalisasi dalam setahun dianalisis dengan rumus Kaplan Meyer.Hasil: Sebanyak 195 subyek penelitian yang terdiri dari 22 (11,3%) subyek dengan kadar digoksin subterapeutik, 43 (22,1%) subyek dengan kadar terapeutik, 70 (35,9%) subyek dengan kadar supraterapeutik dan 60 (30,8%) subyek dengan kadar toksik diikutsertakan dalam studi ini. Didapatkan sebanyak 32 (16,4%) subyek mengalami intoksikasi. Insufisiensi renal merupakan faktor risiko yang sangat memengaruhi kejadian intoksikasi digoksin, dengan risiko sebesar 2,5 kali (p=0,016; RR=2,484). Angka rehospitalisasi pada pasien gagal jantung yang mendapat dan tidak mendapat digoksin adalah sebesar 11,8% dan 29,2% (p=0,085). Angka kesintasan dalam setahun pada pasien gagal jantung yang mendapat digoksin di RS JPDHK tahun 2017-2018 adalah 300 hari (259 hari pada yang mengalami intoksikasi, dan 307 hari pada yang tidak mengalami intoksikasi).Kesimpulan: Proporsi intoksikasi digoksin pasien gagal jantung pada penelitian ini adalah 16,4%. Insufisiensi renal merupakan faktor risiko yang memengaruhi kejadian intoksikasi digoksin. Terdapat kecendrungan pengurangan rehospitalisasi pada pasien yang mendapat digoksin.

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ABSTRACTBackground: Heart failure is one of the most prevalent global health problems with increasing number every year. Treatment of heart failure involves various classes of drugs, one of which is digoxin as the oldest therapy for heart failure. The use of digoxin is still controversial because of a narrow therapeutic limit, there are various factors that can increases the risk of intoxication.Objective: To analyze digoxin intoxication, rate of rehospitalization as well as one-year survival in patients with heart failure who were prescribed digoxin.Methods: An observational analytic study with a cross-sectional design was conducted at the Harapan Kita National Cardiovascular Center from January 2017 to December 2018. Heart failure patients who received digoxin therapy and had been examined for serum digoxin levels were included in the study. Intoxication was defined as having increased serum digoxin level exceeding 2 ng/ml along with electrocardiogram changes and a minimum of one non-cardiac symptomsRisk factors of intoxication were analyzed by Chi-square test, and one year survival was analyzed with Kaplan Meyer method.Results: A total of 195 study subjects consisting of 22 (11,3%) subjects with subtherapeutic digoxin levels, 43 (22,1%) were therapeutic, and 70 (35,9%) supratherapeutic and 60 (30,8%) toxic digoxin level were included in the study. There were 32 (16.4%) subjects having digoxin intoxication in this study. Renal insufficiency was revield as significant influencing factor of digoxin intoxication with 2.5 fold increasing risk. Overall, one-year survival of heart failure patients receiving digoxin was 300 days (259 days in non-intoxication group and 307 days in intoxication group). One-year rehospitalization was 11,8% in patients who received digoxin, and 29,2% in those without digoxin (p=0.085).Conclusion: The proportion of digoxin intoxication in heart failure patient is 16,4%. Renal insufficiency was reviled as significant influencing factor of intoxication. There was a tendency of reduced hospitalization in those who received digoxin."

"Pendahuluan: PGK merupakan penyakit yang sering memiliki beberapa komorbid sehingga perlu menggunakan berbagai terapi kombinasi obat. Oleh sebab itu, polifarmasi sering dilakukan dan salah satu konsekuensinya adalah terjadinya potensi interaksi obat (PIO). PIO dianggap sebagai masalah pengobatan yang dapat dicegah, namun dalam praktik klinis dapat mengakibatkan efek samping obat (ESO) atau reaksi obat yang merugikan. Hal tersebut tentu akan mempengaruhi klinis dan keberhasilan pengobatan serta keamanan penggunaan obat pada pasien PGK. Penelitian ini bertujuan untuk mengetahui pola peresepan pasien PGK dan pengaruhnya terhadap potensi interaksi dan efek samping obat yang dicurigai akibat interaksi obat. Metode: Penelitian ini merupakan penelitian non eksperimental dan pengambilan data dilakukan secara potong lintang pada pasien PGK rawat jalan stadium 3-5 pre-dialisis di rumah sakit Cipto Mangunkusumo (RSCM) dalam periode Januari 2019 sampai dengan Desember 2020. Data diambil dari electronic health record dan pusat rekam medis RSCM. Rujukan potensi interaksi obat menggunakan software Micromedex. Hasil: Terdapat 106 pasien yang memenuhi persyaratan dan diambil menjadi subjek penelitian. Hasil penelitian menunjukkan bahwa pada pasien PGK rawat jalan stadium 3- 5 pre-dialisis di RSCM tahun 2019-2020, terdapat 111 jenis obat yang diresepkan dan obat yang paling sering diresepkan adalah bisoprolol (36,5%). Proporsi pasien yang mendapatkan pengobatan dengan potensi interaksi obat adalah 76% (81 pasien), sedangkan proporsi pasien yang mengalami ESO yang dicurigai akibat interaksi obat adalah 28% (23 pasien) dari 81 pasien dengan PIO. ESO tersebut berupa hiperglikemi (17 pasien), hipertensi (1 pasien), hiperkalemi (1 pasien) dan hipotensi (1 pasien). Terdapat hubungan yang bermakna secara statistik antara variabel perancu yaitu, jumlah obat > 10, komorbid jantung dan DM dengan ESO yang dicurigai akibat interaksi obat (p<0.05). Hasil multivariat mendapatkan hanya komorbid jantung (gagal jantung dan penyakit jantung koroner) yang memiliki hubungan yang bermakna secara statistik dengan ESO yang dicurigai akibat interaksi obat (p = 0,03). Kesimpulan: Pada penelitian ini, sebanyak 76% pasien mendapatkan pengobatan dengan PIO. Sedangkan 28% pasien dari 81 pasien dengan PIO mengalami ESO yang dicurigai akibat interaksi obat. ESO yang paling banyak dialami adalah hiperglikemi. Komorbid jantung merupakan faktor risiko terjadinya ESO yang dicurigai akibat interaksi obat.

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Introduction: CKD often has several comorbidities so it is necessary to use various drug combination therapies. Therefore, it can lead to polypharmacy and one of its consequences is the occurrence of potential drug-drug interactions (DDI). DDI is considered a problem that can be prevented, but in clinical practice it can result in adverse drug reactions (ADR). This will certainly affect the clinical and treatment success as well as the safety of the drug use in CKD patients. This study was aimed to determine the prescribing pattern and its effect on potential DDI and ADR that are suspected due to DDI.

Methods: This was a non-experimental cross-sectional study, conducted on CKD outpatients stage 3-5 pre-dialysis at Cipto Mangunkusumo Hospital in the period January 2019 to December 2020. Data were taken from electronic health records and the hospital’s medical record. The Micromedex software was used as a reference for potential drug interactions.

Results: There were 106 patients who met the requirements and were taken as research subjects. The results showed that in CKD out-patients stage 3-5 pre-dialysis at RSCM in 2019-2020, there were 111 types of drugs prescribed and the most frequently prescribed drug was bisoprolol (36.5%). The proportion of patients who received treatment with a potential DDI was 76% (81 patients), while the proportion of patients who experienced ADR suspected due to DDI was 28% (23 patients) from 81 patients with suspected DDI. The ADRs were hyperglycemia (17 patients), hypertension (1 patient), hyperkalemia (1 patient) and hypotension (1 patient). There was a statistically significant association between the confounding variables, namely, number of drugs, cardiovascular disease and DM with ADR suspected due to DDI (p<0.05). Multivariate analysis found that only cardiovascular disease (congestive heart failure and coronary artery disease) had a statistically significant relationship with ADR suspected due to DDI (p = 0.03).

Conclusion: In this study, 76% of patients received treatment with potential DDI. Meanwhile, 23% from 81 patients patients with DDI experienced ADR suspected due to drug interactions. The most often occuring ADR is hyperglycemia. It was found that cardivascular comorbidity is a risk factor for having an ADR suspected cause by DDI."