Stabil coronariabetegség kezelésére alkalmazott trimetazidin prolong hatásosságának vizsgálata. Multicentrikus, prospektív, obszervációs, nyílt klinikai vizsgálat, ONECAPS-vizsgálat = Effectiveness of trimetazidine prolong in stable coronary artery disease. Multicenter, prospective, observational study, ONECAPS study
Bibliographic record
Abstract
Absztrakt: Bevezetes: A stabil angina pectorisban a kezeles hatekonysaga mind nemzetkozi, mind hazai viszonylatban keveset vizsgalt terulet. Celkitűzes: A hazai ONECAPS-vizsgalat soran a trimetazidin prolong hatasat ertekeltuk kronikus, stabil anginas betegeknel. Modszer: A 3 honapos multicentrikus, prospektiv, beavatkozassal nem jaro, obszervacios vizsgalatba 2160 bevalasztott betegből 1701 beteg vett kompletten reszt a vizsgalatban (atlageletkor 68 ev, 60 ev alatt 17%, angina kezdete 7,8 ± 6,7 ev). A betegek igen nagy szamban voltak hypertoniasak (93,4%) es hyperlipidaemiasak (81%). Beta-blokkolot 88% kapott, 49% kalciumantagonistat, 90% ACE-gatlot, 77% statint, de ivabradint csak 5%, es a betegek 50,5%-a volt trimetazidin-MR-kezelesen a vizsgalat előtt. A betegek bevalasztas utan egy honapos es harom honapos viziten vettek reszt. Eredmenyek: A viziteken a napi egyszeri 80 mg trimetazidin prolong hatasara bekovetkező heti anginaszam-valtozas szignifikans volt (2,55-rol 0,41-ra csokkent, p<0,0001). A Kanadai Cardiovascularis Tarsasag (CCS) ajanlasa szerinti osztalyokban is szignifikans valtozas allt be. Az enyhe angina szazalekos előfordulasa nőtt, mig a sulyosabbak csokkentek (CCS I.-ben 40,37%-rol 66,81%-ra emelkedett, CCS II.-ben 49,89%-rol 30,59%-ra csokkent, CCS III.-ban 9,17%-rol 2%-ra csokkent, mig a legsulyosabb CCS IV.-ben 0,56%-rol 0%-ra csokkent). A viziteken vizsgalt vernyomas es pulzus is csokkent (137/83 Hgmm-ről 130/80 Hgmm-re, p<0,0001, illetve 74/min-ről 71/min-re, p<0,0001). Kovetkeztetesek: Stabil angina pectorisban a beteg anginas panaszai gyakran megmaradnak a gyogyszeres kezeles mellett is. A trimetazidin prolong hatasara mar rovid tavon is szignifikansan csokken a heti anginak szama, sulyossaga. E kedvező hatasok a trimetazidin kozvetlen antiischaemias hatasan tul a prolong gyogyszerforma napi egyszeri adagolasaval es az adherencia javulasaval magyarazhatok. Orv Hetil. 2018; 159(38): 1549–1555. | Abstract: Introduction: The effectiveness of the manegement of stable coronary artery disease among outpatients is not well known. Aim: The aim of the study was to evaluate the effect of daily once trimetazidine prolong 80 mg on the angina number and severity (Canadian Cardiovascular Society class). Method: This multicenter, prospective, observational, 3-month clinical study included 2160 patients, but only 1701 patients completed the study. The patients’ mean age was 68 years (17% under 60 years). The start of angina was 7.8 ± 6.7 years. Hypertension (93.4%) and hypercholesterolemia (81%) were very common. Results: The patients were well treated with beta-blocking agents (88%), calcium antagonists (49%), angiotensin-converting enzym inhibitors (90%) and statin (77%) but only 5% received ivabradine and 50.5% was treated with trimetazidine MR. The patients attended 3 visits (inclusion, 1 month, 3 month). During the 3-month period, the weekly angina number of all patients treated with trimetazidine prolong 80 mg decreased from 2.55 to 0.41 (p<0.0001). A favorable effect was observed in CCS grading: CCS I. from 40.37% to 66.81%, CCS II. from 49.89% to 30.59%, CCS III. from 9.17% to 2% and CCS IV. from 0.56% to 0%. The mean office measured blood pressure decreased from 137/83 mmHg to 130/80 mmHg and the heart rate from 74 bpm to 71 bpm. Conclusions: In the real-life, in the stable coronary artery disease the angina remains despite the medical treatment. Once a day administered trimetazidine prolong 80 mg significantly reduced the weekly number of angina and the severity, too. These beneficial effects mediated not only by antiischemic effect but also by increased medication adherence. Orv Hetil. 2018; 159(38): 1549–1555.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".