title: [Safety analysis of application of medical anti-adhesion modified chitosan in cardiac surgery].
abstract: OBJECTIVE
  To verify the application safety of medical anti-adhesion modified chitosan (Baifeimi) in cardiac surgery.
  
  
  METHODS
  From August to December 2010, 42 patients undergoing surgery for congenital heart disease, valvular heart disease or ischemic heart disease were selected and divided into testing (n = 22) and control (n = 20) groups. After complete intraoperative hemostasis, two sheets of anti-adhesion modified chitosan (Baifeimi) were placed on the surface of heart and vessels in the testing group and then chest was closed. And the control group underwent routine chest closing without an application of Baifeimi. The systemic and local reactions and drainage fluid were observed. The postoperative drainage fluid was subject to bacteria culture. Blood routines and laboratory tests at preoperation and Day 1 and Week 1 postoperation were performed to evaluate the changes of chemical, biological and immunological parameters.
  
  
  RESULTS
  There was no occurrence of systemic reaction, local inflammation or exudation.Wounds were healed at Phase I. The drainage fluid of pericardium and mediastina had no significant intergroup difference. Drainage was unobstructed in the testing group. A comparison of two groups revealed that the differences of aspartate aminotransferase ( (24 ± 17) vs (40 ± 22) U/L), preoperative and postoperative immunoglobulin A( (1.9 ± 0.7) vs (2.9 ± 1.4) g/L, (2.3 ± 0.9) vs (3.3 ± 1.5) g/L) were statistically significant (all P < 0.05). But the average values of both group stayed within a normal range without clinical significance while other indices had no significant difference. The bacteria cultures of all patients in the control group were negative.
  
  
  CONCLUSIONS
  Anti-adhesion modified chitosan is both convenient and safe for clinical application. The duration of cardiac surgery is not extended.No systemic or local adverse event is reported. There is no interference of hepatic, renal or immune functions.
authors.affiliation: Department of Cardiac Surgery, Anzhen Hospital, Capital Medical University, Beijing 100029, China.
authors.forename: Qing-yu
authors.initials: QY
authors.lastname: Kong
authors.forename: Li-qun
authors.initials: LQ
authors.lastname: Chi
authors.forename: Jian-qun
authors.initials: JQ
authors.lastname: Zhang
authors.forename: Zi-jie
authors.initials: ZJ
authors.lastname: Zhou
authors.forename: Yang
authors.initials: Y
authors.lastname: Lin
authors.forename: Ya-ping
authors.initials: YP
authors.lastname: Niu
authors.forename: Wei
authors.initials: W
authors.lastname: Xiao
authors.forename: Xin-liang
authors.initials: XL
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D002648:Child; D048271:Chitosan / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000267:Tissue Adhesions; D055815:Young Adult
chemical_list: D048271:Chitosan