Pengaruh pemberian N-Asetilsistein intravena terhadap kadar C-Reactive protein pada penderita penyakit ginjal kronik stadium 5 yang menjalani Hemodialisis

KAMINDANG, Ernita, Prof.Dr.dr. H. Moch. Sja'bani, M.Med.Sc.,SpPD-KGH

2007 | Tesis | PPDS I Ilmu Penyakit Dalam

Latar Belakang: Inflamasi kronik direfleksi dengan peningkatan C-reactive protein (CRP). Peningkatan CRP pada pasien dialisis mengakibatkan peningkatan kematian, peningkatan kematian kardiovaskuler, peningkatan risiko hospitalisasi dan peningkatan tunika media intima. N-asetilsistein (NAC) salah satu antioksidan dapat menurunkan proses inflamasi dengan menghambat kemotaksis, agregasi dan aktivasi netrofil, menghambat aktivitas makrofag, menghambat leukocyte endothelial cell adhesion dan menghambat aktivasi nuclear factor kappa-B (NF-kB). Penelitian NAC yang dilakukan selama ini pada dosis kecil baik oral dan intravena. Penelitian NAC dosis tinggi pada pasien hemodialisis pernah dilaporkan sebelumnya. Penelitian untuk melihat efek antiinflamasi NAC dosis tinggi (5000 mg intravena) sekali seminggu selama 12 minggu pada pasien hemodialisis belum pernah dilaporkan. Penelitan ini merupakan bagian dari penelitian besar yang menilai efek NAC 5000 mg intravena sekali seminggu selama 12 minggu terhadap kualitas hidup pada pasien hemodialisis. Metode : Penelitian uji klinik acak buta ganda terkendali selama 12 minggu perlakuan pada bulan Mei-Juli 2006. Subyek penelitian adalah pasien PGK dengan hemodialisis rutin dirandomisasi blok dibagi menjadi kelompok NAC dan plasebo. Kelompok NAC diberikan NAC 5000 mg intravena dan kelompok plasebo diberikan NaCl 0,9% 500 cc sekali seminggu. Kadar CRP diperiksa awal, minggu ke-7 dan 13. Uji normalitas data dengan Kolmogorov Smirnov, rerata kadar CRP dianalisis Indepent sample t-test dan uji kemaknaan Mann Whitney U test. Hasil: Subyek penelitian 72 orang, 9 subyek drop out (6 kelompok plasebo dan 3 kel. NAC). Enam orang meninggal dunia (dari kel. Plasebo) dengan sebab akibat gempa bumi (2), kecelakaan (1) dan lain-lain/tidak sakit/tidak dirawat sebelumnya (3). Tidak terdapat perbedaan rerata kadar CRP pada minggu ke-1 (p=0,118), minggu ke-7 (p=0,756) dan minggu ke-13 (p=0,302). Juga perbedaan beda rerata kadar CRP pada minggu ke 1 dan 7 (p=0,371) serta minggu 1 dan 13 (p=0,701) tidak berbeda bermakna pada kedua kelompok. Simpulan: Tidak terdapat perbedaan rerata dan perbedaan beda rerata kadar CRP pada kedua kelompok.

Background. Chronic inflammation is indicated by an increase in C-reactive protein (CRP) level. An elevated CRP in dialysis patient caused an increase in mortality rate, mortality of cardiovascular mortality, risk of hospitalization and athroschlerosis. N-acetylcysteine (NAC) is one of antioxidant capable to decrease the inflammation process by suppressing neutrofil activity, macrophage activity, inhibiting leukocyte endothelial cell adhesion and inhibiting nuclear factor (NF)- κβ. Recent study on NAC used small dose either oral and intravenous. Study of high dose NAC in hemodialysis (HD) patients had also been reported. Study to evaluate anti-inflammatory effect of high dose NAC (intravenous 5000 mg) once a week for 12 weeks in HD patients is not yet reported. This study is a part of large study, which was proposed to evaluate its effect in improvement of quality of life (QoL) in HD patients. Method. A randomized double blind controlled clinical trial was conducted for 12 weeks from May to July 2006. A block randomization was done to group the HD patients into NAC and placebo group. NAC group received intravenous 5000 mg NAC weekly, and placebo group received 500 ml NaCl 0.9%. The level of CRP was measured before therapy, on week 7th and 13th. Normality data test was analyzed with Kolmogorov Smirnov test. Difference of mean of CRP level between two groups was analyzed by Independent t-test and Mann-Whitney U test. Results. There were 72 subjects, from which 9 patients were drop out (6 patients from placebo group and 3 from NAC group). Six subjects died (all were from placebo group). The reasons of drop out in placebo group were due to death, with causes of death of an earthquake (2), traffic accident (1), and unknown (3). While in NAC group, the causes of drop out were stopping from treatment with no reason, change to CAPD and loss sample. There was no difference of CRP level mean before therapy (p=0.118), week 7th (p=0.756) and week 13th (p=0.302). There was no significant on difference in the mean of difference of CRP level in week 1th and 7th (p=0.371) and in week 7th and 13th (p=0.701) between two groups. Conclusion. There were no difference in the mean of CRP and the mean of difference in the level of CRP between two groups.

Kata Kunci : N-asetilsistein, C-Reactive Protein, Hemodialisis, N-acetylcysteine, hemodialysis