브리디온 주, sugammadex, renal dosing, 신장애 용량

 

 

rocuronium과 vecuronium의 신경근차단 역전을 위한 약제로 sugammadex, 브리디온 주가 있다.

아래 포스팅에서처럼 두 약제모두 renal elimination 되므로 신부전시 clearance의 증가가 예상된다. 뿐만 아니라 이 약제의 역전제인 sugammadex 역시 renal dosing이 필요한 약제이다.

 

gimi-drug.tistory.com/162

gimi-drug.tistory.com/140

 

 

 sugammadex_신기능에 따른 용량 조절

 

 

<국내 허가사항>

<Lexicomp 상 half-life>

Effective(정상)	Mild renal impairment	Moderate renal impairment	Severe renal impairment
~2 hr	4 hr	6 hr	19 hr

 

<Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment>

 

Background

- sugammadex는 주로 신장을 통해 배설됨

-  중증의 신부전 ICU 환자를 대상으로 sugammades 자체의 투석력(dialysability)와 sugammadex-rocuronium complex의 투석력 확인을 목적으로 함

 

Methods

- TEE(transoesophageal echocardiography)를 위해 마취를 하는 중증의 신부전 환자 6명을 대상으로 하였다.

- 모든 환자가 0.6 mg/kg rocuronium을 투여 받은 15분 뒤, sugammadex 4.0 mg/kg을 투여받았다.

- 연구기간동안 2명의 환자가 총 2번의 투석을 받았고 4명의 환자가 총 4번의 투석을 받았다. 투석은 6시간 동안 지속되었다.(범위 : 4.9-8 시간)

 

 Dialysis was performed using a sustained low-efficiency daily dialysis (SLEDD) technique. This method uses a high-flux dialysis membrane, but keeps the flow of blood and dialysate low. The Fresenius 4008H haemodialyser (Fresenius Medical Care AG, Bad Homburg, Germany) was used, with an FX 600 haemodiafilter standard helixone membrane (surface 1.5 m2). The ultrafiltration coefficient of the FX 600 membrane was 52 ml h−1 mm Hg−1. Unfractionated heparin, activated clotting time adjusted (120–150 s), was used for anticoagulation.

 

- 환자의 plasma와 dialysate에서 투석 전, 투석 중, 투석 후의 각각의 rocuronium과 rocuronium-sugammadex 농도를 측정하였다.

 

Results

Overlay plots of concentrations in plasma entering the dialyser and leaving the dialyser  vs  time for the sequential dialysis episodes. Each single line represents the measurements of one patient. Solid circles: first dialysis episode; open circles: second dialysis episode; solid triangles: third dialysis episode; and solid squares: fourth dialysis episode. Concentrations pertain to total sugammadex and total rocuronium. Time 0, start of dialysis.

Conclusions

In conclusion, in this study, sugammadex and the sugammadex–rocuronium complex were effectively removed from the body by haemodialysis using a high-flux dialysis method. Reversal of deep NMB by sugammadex appeared to be slower in these ICU patients with severe renal insufficiency than previously observed in surgical patients. Additional safety data are considered necessary to support the recommendation for the use of sugammadex in patients with severe renal impairment.

 

한계 : 일반적으로 고려되는 CRRT나 HD가 아닌 SLEDD 방식의 투석인 점

 

 

 

reference:

1) lexicomp

2) KIMS

3) 의약품안전나라

4) Cammu, G., et al. "Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment." British journal of anaesthesia 109.3 (2012): 382-390.