A Study of Liver Function Tests in Patients Receiving Four Drugs Regimen in Initial Two Months as Antitubercular Drugs

Biochemical monitoring of liver function is essential because Anti Tubercular Therapy (ATT) induced hepatotoxicity can cause permanent injury to liver and death. This cross-sectional comparative study was conducted in department of Biochemistry of Chittagong Medical College during the period of July 2009- Jun 2010 to determine the association of Anti-TB treatment to alter the liver function in patients of intensive phase of tuberculosis taking Four Fixed Dose Combination of Isoniazid, Rifampicin, Pyrazinamide and Ethambutol. A total of 100 subjects were enrolled in this study. They were divided into two groups. Group A (case) was diagnosed case of tuberculosis and had taken anti TB drugs (four Fixed dose combination) at least for fifteen days and group B (control) was consisting of normal subjects. Serum ALT, AST, Bilirubin and prothrombin time were measured. It was found, that out of 70 subjects 20% had increased level of serum ALT, 17.1% had increased level of serum AST, 20% had increased level of serum bilirubin and only 2.9% had increased level of prothrombin time in case group. Finally, determination of liver functions in patients receiving Anti TB therapy (in intensive phase) should be done irrespective of presence or absence of established risk factors, to minimize not only the incidence but also the morbidity and mortality. JCMCTA 2012 ; 23 (2): 27-29

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Association between Compliance Level on Fixed-Dose Combination Antiretroviral Drug and CD4 Level among HIV Patients

Childhood Stunting, Wasting, and Obesity, as the Critical Global Health Issues: Forging Cross-Sectoral Solutions ◽

10.26911/the7thicph.02.03 ◽

2020 ◽

Author(s):

Fadhil Ilham Mustafa ◽

◽

Nurfitri Bustamam ◽

Andri Pramesyanti ◽

◽

...

Keyword(s):

Significant Relationship ◽

Fixed Dose Combination ◽

Hiv Care ◽

Fixed Dose ◽

People Living With Hiv ◽

Hiv Patients ◽

Drug Induced ◽

Cross Sectional ◽

Dose Combination ◽

Hiv Aids

Background: People living with HIV / AIDS (PLWHA) have weak immune systems and are prone to infection. Therefore, PLWHA must take antiretroviral (ARV) to maintain their immunity. This study aimed to determine the relationship between the level of adherence to taking ARV fixed-dose combination (FDC) drugs and CD4 levels of HIV patients. Subjects and Method: This was a cross-sectional study conducted at Pengayoman Cipinang Hospital, Indonesia, in 2018. Total of 91 HIV patient over 17 years of age, had or had received FDC ARV therapy for at least 1 year, and did not experience drug-induced hepatitis were enrolled in this study. The dependent variable was CD4 level. The independent variable was level of adherence to taking ARV fixed-dose combination (FDC). The data were taken from the Voluntary Counseling and Testing Poli Pengayoman Cipinang Hospital. This study used secondary data from the Overview of HIV Care and ARV Therapy. The data were analyzed using Chi-square. Results: A total of 65.93% HIV patients had a good level of medication adherence and 79.12% had an increase of CD4 levels. There was a significant relationship between adherence to taking FDC ARV drugs and CD4 levels (OR = 6.50; 95% CI = 2.15 to 19.62; p<0.001), and it was statistically significant. Conclusion: There is a significant relationship between the level of adherence to taking FDC ARV drugs and CD4 levels. Therefore, patients must receive education and support to improve adherence to taking ARV drugs. Keywords: antiretroviral, CD4, fixed-dose combination, adherence to taking medication, people with HIV / AIDS Correspondence: Fadhil Ilham Mustafa. Faculty of Medicine, Universitas Pembangunan Nasional Veteran, Jakarta. Jl. RS Fatmawati, Pondok Labu, South Jakarta. Email: [email protected]. Mobile: 081283681755. DOI: https://doi.org/10.26911/the7thicph.02.03

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KADAR SERUM GLUTAMIC OXALOACETAT TRANSAMINASE DAN SERUM GLUTAMIC PYRUVIC TRANSAMINASE PADA PASIEN TUBERKULOSIS PARU SELAMA DUA BULAN BERJALANNYA PEMBERIAN OBAT ANTI TUBERKULOSIS KOMBINASI DOSIS TETAP

e-CliniC ◽

10.35790/ecl.2.3.2014.6068 ◽

2014 ◽

Vol 2 (3) ◽

Author(s):

Ayu R. Pribadini Nelwan ◽

Stella Palar ◽

Julia C. M. Lombo

Keyword(s):

Pulmonary Tuberculosis ◽

Serum Levels ◽

Fixed Dose Combination ◽

World Health ◽

Fixed Dose ◽

Glutamic Pyruvic Transaminase ◽

Cross Sectional ◽

The World ◽

Dose Combination ◽

Health Organization

Abstract: Tuberculosis (TB) is still a health problem around the world. According to statistics of the World Health Organization (WHO) showed that Indonesia’s ranking were down from third to fifth in the world. However there are also challenges in the treatment of tuberculosis worldwide and in Indonesia, like treatment failure, dropping out of treatment, and inappropriate treatment. This study aimed to compare the serum levels of SGOT (AST) and SGPT (ALT) in patients with pulmonary TB during two months administration of OAT KDT. This study was a cross sectional analytic study using secondary data and blood sample from patients with pulmonary TB. The samples in this study was patients with pulmonary tuberculosis, pulmonary tuberculosis first category, pulmonary tuberculosis BTA smear (+), pulmonary tuberculosis with controlled hypertension, pulmonary tuberculosis suspected MDR, pulmonary tuberculosis with secondary infections, pulmonary tuberculosis on treatment, and pulmonary tuberculosis which dropping put of treatment. The analysis of data changes on SGOT levels before and after administration of Anti-Tuberculosis Drugs (OAT) shows that the value of zcount: 2,223 >ztable: 1,645 with a significance value of p= 0,026 < 0,05. This indicates that there is an effect of the Anti Tuberculosis Drugs (OAT) fixed-dose combination toward SGOT levels. The analysis of data changes on SGPT levels before and after administration of Anti-Tuberculosis Drugs (OAT) shows that the value of zcount: 2,045 >ztable: 1,645 with a significance value of p= 0,041 < 0,05. This indicates that there is an effect of the Anti Tuberculosis Drugs (OAT) fixed-dose combination toward SGPT levels. There are a significant correlation between serum levels of glutamic oxaloacetat transaminase and glutamic pyruvic transaminase in patients with pulmonary tuberculosis during two months administration of anti-tuberculosis medication with a fixed-dose combination and an increasing levels of SGOT and SGPT in pulmonary tuberculosis patients. Abstrak: Penyakit Tuberkulosis (TB) masih merupakan masalah kesehatan di dunia. Menurut data statistik World Health Organization (WHO) menunjukkan Indonesia turun dari peringkat tiga menjadi peringkat kelima dunia. Namun masih terdapat pula tantangan dalam pengobatan TB di dunia dan Indonesia, antara lain kegagalan pengobatan, putus pengobatan, dan pengobatan yang tidak tepat. Penelitian ini ditujukan untuk mengetahui perbandingan kadar serum SGOT dan SGPT pada pasien TB Paru selama dua bulan pemberian OAT KDT. Penelitian ini merupakan penelitian analitik cross sectional dengan menggunakan data sekunder dan pengambilan sampel darah pada pasien TB Paru. Pada penelitian ini sampel yang digunakan adalah penderita TB Paru, TB Paru kategori 1, TB paru BTA (+), TB Paru dengan Hipertensi terkontrol, TB paru suspek MDR, TB Paru dengan infeksi sekunder, TB paru on treatment, dan TB paru putus obat. Hasil analisis data perubahan kadar SGOT sebelum dan setelah diberikan Obat Anti Tuberkulosis menunjukkan bahwa nilai zhitung: 2,223 >ztabel : 1,645 dengan nilai signifikansi p= 0,026 < 0,05. Hal ini menunjukkan bahwa terdapat pengaruh pemberian Obat Anti Tuberkulosis (OAT) kombinasi dosis tetap terhadap kadar SGOT. Hasil analisis data perubahan kadar SGPT sebelum dan setelah diberikan Obat Anti Tuberkulosis menunjukkan bahwa nilai zhitung: 2,045 >ztabel : 1,645 dengan nilai signifikansi p= 0,041 < 0,05. Hal ini menunjukkan bahwa terdapat pengaruh pemberian Obat Anti Tuberkulosis (OAT) kombinasi dosis tetap terhadap kadar SGPT. Terdapat hubungan yang signifikan antara kadar serum glutamic oxaloacetic transaminase dan serum glutamic pyruvic transaminase pada pasien tuberkulosis paru selama dua bulan berjalannya pemberian obat anti tuberkulosis kombinasi dosis tetap dan terdapat peningkatan kadar SGOT dan SGPT pada pasien tuberkulosis paru.

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FIXED-DOSE COMBINATION VERSUS SEPARATE ANTITUBERCULOSIS FORMULATIONS IN PULMONARY TUBERCULOSIS PATIENTS: EVALUATION OF EFFECTIVENESS AND SAFETY

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2018.v10s1.46 ◽

2018 ◽

Vol 10 (1) ◽

pp. 208

Author(s):

Rimenda Sitepu ◽

Purwantyastuti Ascobat ◽

Flora Ekasari ◽

Insti Instiaty

Keyword(s):

Treatment Phase ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Sputum Smear ◽

Chi Square ◽

Extended Phase ◽

Intensive Phase ◽

First Category ◽

Sputum Conversion ◽

Dose Combination

Objective: This study aimed to compare the effectiveness and safety of fixed dose combination (FDC) versus separate (separate formulation [SF])antituberculosis (TB) formulations in patients with bacteriologically confirmed pulmonary TB.Methods: Data were collected retrospectively from patient records, which included all newly diagnosed bacteriologically confirmed pulmonaryTB patients treated with first category FDC or SF between January 2014 and January 2017 at the Dr. Esnawan Antariksa Hospital. The efficacy ofthe formulations was determined according to acid-fast bacilli (AFB) sputum smear conversion at the end of the intensive phase (month 2), after6 months of therapy, and after the extended treatment phase (month 3). Adverse drug reactions (ADRs) during treatments were recorded as safetyoutcomes. Chi-square tests were used to analyze the differences between the groups.Results: On comparing patients treated with FDC (n=33) and SF (n=30), rates of sputum conversions did not differ significantly after 2 months(83.3% vs. 78.7%, p=0.693) and the intensive phase was extended by 1 month for patients with conversion failures at this time point. One of sevenpatients in the FDC group did not achieve sputum conversion during the extended phase and was recorded as a medication failure. At the end ofcontinuation phase, all other subjects achieved sputum conversion. The overall frequencies of ADRs were not significantly higher in the FDC groupthan that in the SF group (36.4% vs. 23.3%, p=0.260).Conclusion: No differences in effectiveness and safety profiles were identified between first category FDC and separate anti TB formulations.

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A Stability-Indicating High Performance Liquid Chromatographic Assay for the Simultaneous Determination of Pyridoxine, Ethionamide, and Moxifloxacin in Fixed Dose Combination Tablets

Chromatography Research International ◽

10.1155/2014/258125 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8

Author(s):

Munib-ur-Rehman ◽

Rabia Ismail Yousuf ◽

Muhammad Harris Shoaib

Keyword(s):

Mobile Phase ◽

High Performance ◽

Degradation Products ◽

Reversed Phase ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Combination Tablet ◽

Antitubercular Drugs ◽

Stability Indicating ◽

Dose Combination

Stability indicating reversed phase HPLC method was developed and validated for the simultaneous quantitation of antitubercular drugs, ethionamide (ETH), and moxifloxacin (MOX) with commonly coprescribed vitamin, pyridoxine (PYR) in tablet dosage form. The method was found rapid, precise and accurate. The separation was performed in Hibar 150-4.6, Purospher STAR, RP-18e (5 μm) column, using mobile phase A (0.03 M sodium citrate adjusted to pH 5 with glacial acetic acid) and mobile phase B (100% methanol), ran at variable proportions at flow rate of 1.0 mL/min. The detection was carried out at 320 nm. The method was observed linearly in the range of 2.5–17.5 μg/mL for PYR, 25–175 μg/mL for ETH, and 40–280 μg/mL for MOX with respective limits of detection/quantitation of 0.125 μg/mL/1.28 μg/mL, 0.25 μg/mL/2.56 μg/mL, and 0.35 μg/mL/3.65 μg/mL. The drugs were also subjected to oxidative, hydrolytic, photolytic, and thermal degradation; the degradation products showed interference with the detection of PYR, ETH, and MOX. The proposed method was observed to be effective to quantitate MOX (400 mg), ETH (250 mg), and PYR (25 mg) in fixed dose combination tablet formulation.

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Off-label prescription of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

10.21203/rs.3.rs-359408/v1 ◽

2021 ◽

Author(s):

Montserrat Viñas-Bastart ◽

Míriam Oms-Arias ◽

Àfrica Pedraza-Gutiérrez ◽

Irene Lizano-Díez ◽

Eduardo L. Mariño ◽

...

Keyword(s):

Health Care ◽

Primary Health Care ◽

Average Length ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Short Term Treatment ◽

Cross Sectional ◽

Off Label ◽

Primary Health ◽

Dose Combination

Abstract Background: The increase of consumption of the fixed-dose combination of tramadol/dexketoprofen in Spain and other countries is noteworthy. The authorised therapeutic indication is symptomatic short-term treatment of moderate to severe acute pain in adult patients.Objective: Describe the pattern of use of tramadol/dexketoprofen in the field of primary health care to examine potential off-label prescribing and warn about possible risks.Methods: A descriptive, cross-sectional and multicenter study carried out between March 2017 and March 2018. Total population were patients covered by the public health service in Catalonia, Spain, with an active prescription of tramadol/dexketoprofen on March 28, 2018. Target population were those patients who were prescribed tramadol/dexketoprofen over 20 day’s treatment.Results: There were 176 patients with active prescription of tramadol/dexketoprofen. All patients (100%) had a treatment duration exceeding 5 days and 72.7% (N=128) exceeding 20 days. The average length of treatment was 224±160.8 days. 35.1% of patients were treated with >2 medicines for pain concomitantly with tramadol/dexketoprofen.Conclusion: Tramadol/dexketoprofen fixed-dose combination in practice was used frequently off labelled according to the product characteristics and the literature reviewed. This study highlights potential harmful or ineffective effects of this combination since no adequate evidence exists about its off-label use.

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Knowledge, attitude and practice regarding use of fixed dose combination drugs among young prescribers a tertiary care teaching hospital in rural Bengal, India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20192601 ◽

2019 ◽

Vol 8 (7) ◽

pp. 1479

Author(s):

Ananya Mandal ◽

Sonai Mandal ◽

Somenath Das

Keyword(s):

Patient Compliance ◽

Synergistic Effects ◽

Tertiary Care ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Cross Sectional ◽

Medical College ◽

Prescribing Practice ◽

Dose Combination ◽

Graduate Trainees

Background: Use of fixed dose combination (FDCs) is a double edged sword with scope for irrational prescribing on one hand and improved pharmacotherapy and patient compliance on the other hand. Irrational FDCs are being marketed aggressively and often young prescribers including Post Graduate Trainees fall prey to the lure of FDCs. This was a Knowledge-Attitude-Practice study regarding of FDC use among the resident doctors working at a tertiary care medical college of rural Bengal.Methods: This was a cross-sectional, questionnaire based study including 50 resident doctors who were asked to fill a 10-question questionnaire on FDCs anonymously.Results: Ninety two percent of the study participants were aware of the FDCs. The most commonly perceived advantages were better patient compliance and synergistic effects. Most (96%) cited problems of titrating dosages and problems of more side effects. Only 37.6% knew about the banned FDCs. Preferred FDCs among them were antibiotics (94%), cough syrups (80%) and NSAIDs (68%). Residents of dermatology, orthopaedics, surgery and medicine most commonly prescribed FDCs. Sources of knowledge regarding FDCs were CME (92%), medical representative (76%), colleagues (72%), internet (68%), journals (48%) and textbooks (36%).Conclusions: The study showed that most participants were aware of the FDCs and also aware of the problems with irrational FDC use. Knowledge regarding banned drugs was poor as was the rationality of such combinations. More CMEs and inter department group discussions could be conducted to improve awareness and FDC prescribing practice among young prescribers.

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Evaluasi Penggunaan Antiretroviral (ARV) Berdasarkan Indikator CD4 Pada Pasien HIV di RSPI Prof. Dr. Sulianti Saroso

The Indonesian Journal of Infectious Diseases ◽

10.32667/ijid.v5i2.85 ◽

2019 ◽

Vol 5 (2) ◽

pp. 21

Author(s):

Dina Mungki Febriani ◽

Stefanus Lukas ◽

Farida Murtiani

Keyword(s):

Human Immunodeficiency Virus ◽

Fixed Dose Combination ◽

Fixed Dose ◽

P Value ◽

Chi Square ◽

Cross Sectional ◽

Probability Sampling ◽

Immunodeficiency Virus ◽

Dose Combination ◽

Quota Sampling

Latar belakang: Kasus Human Immunodeficiency Virus (HIV) di Indonesia bahkan di dunia semakin meningkat setiap tahunnya. Obat Antiretriviral (ARV) merupakan pengobatan untuk kasus HIV yang dapat meningkatkan kualitas hidup ODHA walau tidak dapat menyembuhkan. Pemeriksaan CD4 merupakan salah satu indikatorpemantauan pasien untuk melihat keberhasilan penggunaan ARV. Tujuan dari penelitian ini adalah melakukan evaluasi pengobatan sebelum dan sesudah penggunaan ARV berdasarkan indikator CD4 pada pasien RS Prof. Dr. Sulianti Saroso di Jakarta Utara. Metode: desain penelitian cross sectional. Pengumpulan data dilakukan secara non probability sampling dengan teknik quota sampling sehingga diperoleh 42 pasien HIV yang berasal dari data rekam medis pasien. Hasil: analisa sosiodemografi sebagian besar usia 26–45 tahun 73,8%, jenis kelamin laki-laki 92,9%, pendidikan sarjana 69%, sudah bekerja 88,1% serta sudah menikah 76,2%. Berdasarkan kepatuhan dalam pengobatan diperoleh 78,6% patuh. Kombinasi obat yang paling banyak digunakan adalah TDF(300)+3TC(300)+EFV(600) dalam bentuk FDC (fixed-dose combination). Hasil Uji Wilcoxon menunjukan adanya perbedaan bermakna antara CD4 awal dengan CD4 akhir dengan p value 0,000 (p<0,05). Uji statistik dengan chi square didapatkan status pernikahan, kepatuhan, status pekerjaan dan status pendidikan menunjukan ada hubungan yang signifikan dengan perubahan CD4 (Pvalue <0,05) sedangkan usia, jenis kelamin, dan kombinasi obat tidak signifikan (Pvalue >0,05). Kesimpulan: ARV efektif menaikkan CD4 pada pasien HIV.

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