[Cyclosporine microemulsion C2 monitoring in Chinese adult liver transplant recipients: a preliminary randomized control trial].
OBJECTIVE
To evaluate the safety and reliability of cyclosporine microemulsion (CsA-ME) C(2) monitoring and to determine the target level of C(2) in Chinese adult liver transplant recipients.


METHODS
53 Chinese adult liver transplant recipients were randomly divided into three groups (group C(0), n = 17; group high level C(2), n = 18; group low level C(2), n = 18). Blood chemistry reflecting heart, liver and renal function and CsA level were examined at certain interval during follow-up. The change of immune status and episodes of rejection were also observed closely.


RESULTS
The group low level C(2) had the lowest CsA oral dose (2.51 +/- 0.37 mg/kg/d), and had significant difference compared with the other groups (P < 0.01). The best liver, heart and renal function was observed in group low level C(2). The CD(4)(+)/CD(8)(+) ratio of group low level C(2) was 1.04 +/- 0.68, which had no significant difference with C(0) group. The rejection incidence of the three groups had no significant difference. group low level C(2) had highest clinical benefit ratio (72.22%), while the clinical benefit of group high level C(2) is the lowest (11.11%).


CONCLUSIONS
With rational target level, C(2) monitoring can show us the proper oral dose of CsA which can decrease the side effects remarkably without rejection episodes increasing. The target level of C(2) in Chinese adult liver transplant recipients might be: 600-800 ng/ml 1 to 6 months posttransplant, 400-600 ng/ml 7-12 months posttransplant.
Chen
Geng
G
Hepatobiliary Surgery Institute of Chinese People's Liberation Army, South-West Hospital, Third Military Medical University, Chongqing 400038, China.
He
Yu
Y
Wang
Huai-zhi
HZ
Lu
Qian
Q
Yang
Shi-zhong
SZ
Yang
Zhan-yu
ZY
Dong
Jia-hong
JH
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D016903:Drug Monitoring; D004655:Emulsions; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D016031:Liver Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D014184:Transplantation, Homologous
D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine