APLIKASI HASIL UJI KLINIK

7/31/2019 APLIKASI HASIL UJI KLINIK

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APLIKASI HASIL UJI KLINIK

Ruben Dharmawan

Laboratorium Parasitologi danMikologi FKUNS


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Clinical Scenario

You are the attending physician on duty when apoor 45 year old man presents to theemergency room of a general hospital in the

Philippines. He has experienced severe chestpain for two hours, associated with clammyperspiration. Physical examination reveals ablood pressure of 110/70 mmHg, a heart rateof 92, a normal 1st heart sound and clearlungs. An electrocardiogram discloses 3mmST segment elevation in the inferior leads.


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As intravenous lines are placed, and the patientis prepared for admission to the coronary

care unit, you consider whether you shouldoffer this patient a thrombolytic agent.Though your response is that the

impecunious patient cannot afford thetreatment, you ponder the right course ofaction in a richer patient. As your duty endsthat night, you resolve to prepare for the next

patient admitted for an acute myocardialinfarction (MI), by retrieving the bestevidence on the use of thrombolytics.


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Biologic Issues

1.Are there pathophysiologicdifferences in the illness under study

that may lead to a diminished treatmentresponse?

2.Are there patient differences thatmay diminish the treatment response?


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Social and Economic Issues

1.Are there important differences inpatient compliance that may diminish

the treatment response?

2.Are there important differences in

provider compliance that may diminishthe treatment response?


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Epidemiologic Issues

1.Do my patients have co-morbidconditions that significantly alter the

potential benefits and risks of thetreatment?


untreated patients' risk of adverseoutcomes that might alter the efficiencyof treatment?


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1.Are there pathophysiologic differences in the

illness under study that may lead to a

diminished treatment response?

a. Divergence in pathogenetic mechanisms.

Contoh : Orang Negro responsif terhadapdiuretik tetapi tidak responsif terhadap beta-

blocker.

b. Biologic Differences in the causative agent.Contoh : Malaria dengan variasi resistensi

terhadap obat.


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2.Are there patient differences that may

diminish the treatment response?a. Differences in drug metabolism.

Slow metabolizers vs rapid

metabolizers.Hepatic N-acetyl transferase tinggipada orang Asia sehingga kadar

isoniazid, hydralazine danprocainamide.

G-6-PDH terhadap sulfonamide.


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b. Differences in immune response.

Hemophilus influenza vaccine has alower efficacy in Alaskan natives than innon-native populations.

c. Environmental factors.

Thyroid dysfunction differs in low

versus high iodine environments.


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patient compliance that may diminishthe treatment response?

a. Resource limitations in a particularsetting.

b. Less obvious attitudinal or behavioralidiosyncrasies.

patient compliance.


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provider compliance that may diminishthe treatment response?

Meliputi perlengkapan dan peralatandiagnostik, monitoring, interventionserta ketrampilan ahli medis/teknisi.

Contoh : walaupun rheumatic atrialfibrillation cukup banyak ditemukan dinegara2 Asia, hanya sedikitlaboratorium mampu melakukan testitrasi dosis warfarin.


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b. Competing etiologies of outcome.

Di Filipina di suatu RS angka kematiansetelah pemberian streptokinase padaAMI tinggi karena ternyata banyakpenderita disertai pneumonia withsepsis.

Infark berat sering disertai atrialfibrilasi, bila diberi antikoagulan(warfarin) akan memperolehkeuntungan ganda.


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untreated patients' risk of adverseoutcomes that might alter the efficiencyof treatment?

NNT = Number Needed to Treat

RR = Relative Risk

RRR = Relative Risk ReductionARR = Absolute Risk Reduction


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NNT = jumlah pasien yang perlu diobatiagar terdapat 1 efek samping =treatments efficiency = kebalikan dari

ARR.

Resiko tanpa terapi = 20%

RRR 10% maka resiko jadi 18%

Tiap 100 pasien ada pencegahan 2 (2%)

Maka NNT = 100/2 = 50Jika Resiko tanpa terapi 10%, RRR tetapi

10% maka NNT 100.


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Contoh :

Age standardized mortality rate for CHDdi Jepang = 40/100.000

North Ireland = 414/100.000

10 x penurunan insidens menyebabkan10 x kenaikan NNT obat pencegahkematian akibat CHD 10 kalipenurunan efisiensi pengobatan

Reconsideration of applying the resultsof a trial to low risk patients.


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DISCUSSION

RESOLUTION


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TERIMA

KASIH

Documents

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