[The safety and efficacy of basiliximab as induction agent in preventing early acute rejection in Chinese cardiac transplantation receipts].
OBJECTIVE
To investigate the safety and efficacy of basiliximab as induction agent in preventing early acute rejection post heart transplantation.


METHODS
Basiliximab (20 mg, iv) was administered one hour before and 4 days post operation to patients (n = 47) underwent heart transplantation between June 2004 and Feb 2005 in our department. Intravenous methylprednisolone (500 mg at operation beginning and repeated immediately post operation, followed by 125 mg every 8 hours for the first day). Prednisone was then initiated at 1 mg.kg(-1).d(-1) tapered 10 mg every 3 days to 10 mg/d. Mycophenolate mofetil (MMF, 0.5 - 1.0 g twice daily) was also administered post intubation, oral Cyclosporine A (CsA, 3 to 6 mg.kg(-1).d(-1)) was prescribed after transplantation if serum creatinine was < 150 micromol/L. The dose of CsA was individually adjusted to achieve a target serum concentration of 180 - 300 ng/ml. Endomyocardial biopsies were performed 3 weeks (19.7 +/- 9.6) d post heart transplantation. Biopsy specimens were graded according to the standardized criteria of the International Society for Heart and Lung Transplantation (ISHLT). Echocardiograms were routinely performed weekly within the first 3 weeks post-operation.


RESULTS
All 47 consecutive patients [mean age (44.9 +/- 13.4) years, range 13 - 63 years, 38 men] survived the operation and the underlying diseases was idiopathic cardiomyopathy (42.5%), ischemic heart disease (25.5%), arrhythmogenic right ventricular cardiomyopathy (17.0%), hypertrophic cardiomyopathy (4.2%), heart tumor (4.25%), valve heart disease (2.1%), hypertensive cardiomyopathy (2.1%) and giant cell myocarditis (2.1%). There were 4 patients with pre-operation PRA > 10% and CDC was less than 5% in all patients. The grades of the acute rejection in biopsy specimens were as follow: Grade (G) 0 in 30 (63.8%), G IA in 11 (23.4%), G IB in 3 (6.3%) and GII in 3 (6.3%) patients. The average dose of MMF was (1.2 +/- 0.3) g/d. The initial time of receiving CsA was (3.4 +/- 2.1) day post operation. The average cumulative dose of CsA was (4.1 +/- 1.2) mg.kg(-1).d(-1) before endomyocardial biopsy. The average serum concentration of CsA was (237.0 +/- 76.2) ng/ml. Left ventricular ejection fraction assessed by echocardiogram was normal in all patients within the first 3 weeks. Five patients suffered from respiratory infections and recovered post antibiotic and symptomatic therapies.


CONCLUSIONS
Basiliximab as induction agent in combination with conventional triple immunosuppressive therapy is safe and effective in preventing acute rejection in Chinese cardiac transplantation receipts.
Huang
Jie
J
Cardiovascular Regeneration Laboratory, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100037, China.
Zheng
Zhe
Z
Hu
Sheng-Shou
SS
Song
Yun-Hu
YH
Yang
Yue-Jin
YJ
Zhu
Jun
J
Liu
Ping
P
Zhao
Hong
H
Li
Li-Huan
LH
Liu
Ming-Zheng
MZ
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D016027:Heart Transplantation / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D000911:Antibodies, Monoclonal; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab