A.

Analisis Jurnal
a. Analisis PICO: Problem / Patient Intervention Pria, 58tahun, Tuberkulosis(KasusBaru) OAT KombinasiDosisTetap (KDT) oral (Isoniazide, Rifampicin, Pyrazinamide, Ethambutol) Comparison Outcome OAT yang dipisahdengandosis yang samaseperti KDT Apakahpemberian OAT yang dipisahlebihefektifdaripada OAT KDT untukpengobatanpasientuberkulosis?

b. Keywords: pulmonary tuberculosis; randomised trial; Fixed-dose combination; smear conversion; acceptability

c. Teknikpencarian Medline With Full Text

( http://web.ebscohost.com/ehost/search/advanced?sid=13a1a01e-6f604ce3-809a-cb7443bf74ca%40sessionmgr104&vid=2&hid=112 )

d. Jurnal yang didapat

Comparison of a four-drug xed-dose combination regimen with a single tablet regimen in smear-positive pulmonary tuberculosis Penulis :

Bartacek, D. Schtt, B. Panosch, M. Borek,

Namadantahunterbitjurnal

The International Journal of Tuberculosis and Lung Disease, 13(6):760766 2009 The Union

e. Validitas

Penjelasan, Pertanyaan Jawab LokasiPenjelasanditemukan, danPotonganKalimat yang Dimaksud This randomised, open, multicentre, multinational study was conducted in 26 centres and included 1a. Apakahalokasipasienterhadapterapi / perlakuandilakukansecara random? Ya 1159 patients with smearpositive PTB(Pulmonary TuBerculosis).

Ditemukan di : Design Penelitian This randomised, open, multicentre, multinational study was conducted in 26 centres and included 1159 patients with smearpositive PTB.

Ditemukan di : Design Penelitian

An open rather than a doubleblind study was chosen, as one 1b. Apakahrandomisasidilakukantersembunyi? Tidak objective was to compare patients acceptance of the dose regimens relative to the size of the tablets, the number of tablets and problems of swallowing. A double-dummy design involving placebo tablets would have increased the number of tablets to be swallowed by each patient to an intolerable amount, thereby reducing treatment acceptability and overall adherence and masking possible differences.

Ditemukan di : Study treatments

An open rather than a doubleblind study was chosen, as one objective was to compare patients acceptance of the dose regimens relative to the size of the tablets, the number of tablets and problems of 1c. Apakahantarasubyekpenelitiandanpenelitiblindterhadapterapi / perlakuan yang akandiberikan? Tidak swallowing. A double-dummy design involving placebo tablets would have increased the number of tablets to be swallowed by each patient to an intolerable amount, thereby reducing treatment acceptability and overall adherence and masking possible differences.

Ditemukan di : Study treatments A sensitivity analysis was performed, imputing all missing data in the ITT population as failures and in the follow-up ITTcc and PP populations as relapses. All 2a. Apakahsemuasubyek yang ikutsertadalampenelitiandiperhitungkandalamhasil / kesimpulan? (Apakahpengamatannyacukuplengkap?) Ya subjects randomised into the study who received at least one dose of medication and who had at least one element of post-baseline safety information were considered evaluable for safety analysis.

Ditemukan di : Patient populations A total of 1159 patients were enrolled between January 2003 and October 2004 (Egypt 200, 2b. Apakahpengamatan yang dilakukancukuppanjang? Tidak India 289, Pakistan 180, the Philippines 199, Thailand 291).

Ditemukan di : Patient

demographics

Eficacy recording was based on bacteriological response rate (sputum smear conversion rate) as determined by microscopy on two smears. Standardised procedures for sputum smear collection, storage and transport, preparation and acidfast staining were used in accordance with WHO recommendations.Conversion rates were measured at 2, 4 and 6 months of treatment, and at the 9- and 12-month visits after the initiation of treatment. Ditemukan di : Efcacy and patient assessments The mean daily doses of INH, PZA and EMB administered during the initiation phase in the 4-FDC group were significantly lower than those administered in the ST group; RMP doses were similar in both groups (Table 2).

2c. Apakahsubyekdianalisispadakelompok di manasubyektersebutdikelompokkandalamrandomisasi?

Ya

Sputum smear conversion rates at month 2, at EOT (primary endpoint) and relapse rates at follow-up demonstrated across all study populations the noninferiority of the 4-FDC formulation compared with the separate tablets (Table 3).

Patient satisfaction with regard to problems reported on

swallowing the tablets, convenience of the number of tablets and acceptability of taste is shown in Table 4.

A total of 1122 patients were evaluable for safety assessment, and 246 patients reported at least one AE. The number of patients with AEs and the total number of AEs were comparable in both groups. The total number of drug-related AEs was higher in the 4-FDC group, because general disorders were reported more often in the 4-FDC group (P < 0.001; Table 5).

Ditemukan di : Result Although HIV infection was not one of the exclusion criteria for the study, only six HIVpositive patients (one in the 4-FDC group, five in the ST group) were included by investigators. The disposition of patients at 3a. Selainperlakuan yang dieksperimenkan, apakahsubyekdiperlakukansama? Ya EOT and follow-up is shown in the Figure. There were no significant differences between the groups with regard to the reasons for exclusion from ITTcc and PP analysis.

Ditemukan di : Patient demographics Patients were randomised (1:1) to open treatment with 3b. Apakahkelompokdalampenelitiansamapadaawalpenelitian? Ya either Rimstar (HRZE 75/150/400/275 mg per tablet) daily for 2 months (initiation phase)

followed by Rimactazid (H/R 75/150 mg) daily for 4 months (continuation phase, test group), or single preparations of H, R, Z and E daily (initiation phase) followed by single preparations of H and R (continuation phase, control group).

Ditemukan di : Study treatments