[Analysis of the influence on the prognosis and safety of arginine in patients with severe trauma and burns--a multi-center randomized double blinded, placebo controlled, clinical trail in 86 patients].
OBJECTIVE
To observe the influence on prognosis and possible side-effects of arginine in


METHODS
Multi-center clinical trial, randomized double blinded patients with severe trauma and burns. and placebo control methods were employed in the study. Eighty-six patients with severe trauma and burns were randomly divided into control (C, n = 45) and arginine treatment (Arg, n = 41) groups. The patients in Arg group received arginine in dose of 0. 4 g x kg(-1) x d(-1) orally, while those in C group received same dose of placebo (tyrosine) for 7 days. All the patients in both groups were given diet with equal calories and equal nitrogen content. The changes in the wound healing time, hospital stay, and the incidence of side-effects of the medication in both groups of patients were observed and compared before and after the supplementation of arginine.


RESULTS
The wound healing time and hospital stay days of severe trauma patient in Arg group (n = 29) were 11. 1+/-2. 8 d and 19+/-6 d, which were all obviously shorter than those in C group (13. 2+/-5. 5 d, 22 +/-6 d, n =33, P <0.05). On the other hand, in severe burn patients there were no significant difference of the wound healing time (20+/-5 d vs 22+/-8 d, n = 12, P > 0. 05) and hospital stay days (28+/-6 d vs 29+/-8 d, n = 12, P >0. 05) between the Arg and C groups. In addition, in C and Arg groups, the occurrence of the side-effects were seldom (2. 44% vs 2. 22% , P = 1. 000) and it disappeared when the supplementation of drugs was stopped.


CONCLUSIONS
Oral feeding of arginine is beneficial in enhancing wound healing, reduction of hospital stay days in severe trauma patients and with little side-effects, but it is not beneficial to improve the prognosis of severe burn patients. Maybe this is due to inadequate number of case involved in the study.
Peng
Xi
X
Institute of Burn Research , State Key Laboratory of Trauma, Burns and Combined Injury , Southwest Hospital, the Third Military Medical University, Chongqing 400038, PR China. pxlrmm@163.com
Yi
Dong
D
Fan
Shi-zhi
SZ
Liao
Zhen-jiang
ZJ
Yao
Yuan-zhang
YZ
Cong
Tai-qian
TQ
Xiang
Jun
J
Wang
Zhi-yong
ZY
Meng
De-sheng
DS
You
Zhong-yi
ZY
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001120:Arginine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002056:Burns / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D014945:Wound Healing
D001120:Arginine