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งานนำเสนอกำลังจะดาวน์โหลด โปรดรอ

I NTERACTION BETWEEN PARACETAMOL AND WARFARIN IN PATIENTS : A DOUBLE - BLIND, PLACEBO - CONTROLLED, RANDOMIZED STUDY นสภ. มารุตต์ตรีอินทองรหัส47210463.

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งานนำเสนอเรื่อง: "I NTERACTION BETWEEN PARACETAMOL AND WARFARIN IN PATIENTS : A DOUBLE - BLIND, PLACEBO - CONTROLLED, RANDOMIZED STUDY นสภ. มารุตต์ตรีอินทองรหัส47210463."— ใบสำเนางานนำเสนอ:

1 I NTERACTION BETWEEN PARACETAMOL AND WARFARIN IN PATIENTS : A DOUBLE - BLIND, PLACEBO - CONTROLLED, RANDOMIZED STUDY นสภ. มารุตต์ตรีอินทองรหัส นสภ. ชฎาพรพรมปัญญารหัส แหล่งฝึก : โรงพยาบาลเชียงรายประชานุเคราะห์

2 O BJECTIVE Main assess the effect of paracetamol on the INR in patients receiving a stable regimen of warfarin

3 O BJECTIVE Secondary +investigate the mechanism +evaluate a correlation between INR variation and paracetamol intake +determine a min. duration of paracetamol administration which does not cause significant INR variations +identify early variations in clotting factor activities

4 PATIENTS 20 outpatients, both sex, 18+ years Target INR 2-3 On stable warfarin > 1 m (2-9 mg/day) No recent or ongoing diseases The intake of concomitant Tx as well as medication known to affect INR values allowed on condition that dosages were kept constant throughout the trial

5 S TUDY DESIGN Single-center, double-blind,placebo- controlled, randomized and crossover study 20 pts 10: placebo 14 d 10: paracetamol 4 g* 14 d Wash-out period 14 d Paracetamol 4 g 14 d Placebo 14 d *Doliprane®, 500 mg capsule

6 Run-in periodVerify stability anticoagulant treatment D 0 (before 1 st medication intake) Physical examine and blood sample taken at hospital D 2, 4, 7, 9, 11 and 14 Visit at home - examine signs of hemorrhage and thrombosis -ask about possible lapses from the protocol Ex. changing any OTC or prescription drugs -counting the returned empty blister packs and the unused paracetamol and placebo capsules -evaluate alcohol consumption and dietary intake of food containing vit.K S TUDY DESIGN ( CONT.)

7 Intra-individual variability of INR = 0.3 (previous studies) => INR increase > 0.5 was significant and related to an interaction between paracetamol and warfarin If 2 successive INR values were >3.5, warfarin was to be discontinued then restarted at the same dose as before If INR remained outside the target range during the wash-out period, the warfarin regimen was readjusted and the pt entered the 2 nd study period after stabilization on the new dose

8 R ESULT Mean age: 62±19 years (range years) 19 (10 women and 9 men) completed the study 1 pt withdrew her consent for personal reason after 4 days in the 1 st period and 1 pt had a serious protocol deviation => excluded from final analysis No bleeding events The paracetamol regimen was stop in 4 pts and 1 pt in placebo administration because of increases in 2 consecutive INR values

9 R ESULT ( CONT.) 1 pt had a serious non-drug-related adverse event (hospitalization for a sinoatrial block) and discontinued the trial on day 4 of the 2 nd period

10 R ESULT ( CONT.) No significant variations in INR were observed during the placebo period Paracetamol therapy significant rise in mean INR was observe within 2 day Continued to increase until day 7 and remained significant enhanced until the end of the Tx period In each pt, the mean INR peak was significantly higher in the paracetamol period than in the placebo period

11 R ESULT ( CONT.) The mean absolute AUC of factor II,VII and X chandes from baseline were significantly greater during the paracetamol period than during the placebo period No significant variation in factor V levels

12 C ONCLUTION Mean INR rose rapidly after the start of patacetamol and significantly increase within 1 week of paracetamol intake Paracetamol intake were signigicant reduction in the vitamin K-dependent clotting factor II, VII, and X

13 เหตุผลที่ไม่เห็นด้วยกับ ข้อมูลดังกล่าว

14 รูปแบบการศึกษา จำนวนของผู้ป่วยในการศึกษา ขนาดยา การตรวจติดตาม การประเมินความร่วมมือการใช้ยาตามสั่ง ความแปลผันของ INR

15 เกณฑ์การคัดเข้า/คัดออก จากการศึกษา ความคงที่ของ INR การรับประทานยาอื่นร่วมด้วย

16 ลักษณะต่างๆ ของกลุ่มศึกษา ช่วงอายุ โรคร่วมอื่นๆ ยาอื่นๆที่ได้รับ/สมุนไพร

17 Thank You & Questions


ดาวน์โหลด ppt I NTERACTION BETWEEN PARACETAMOL AND WARFARIN IN PATIENTS : A DOUBLE - BLIND, PLACEBO - CONTROLLED, RANDOMIZED STUDY นสภ. มารุตต์ตรีอินทองรหัส47210463.

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