Hemostatic effect and biocompatibility of RT-Q medical biomembrane / 中国组织工程研究

ABSTRACT

BACKGROUND: RT-Q medical biomembrane, the novel copolymer synthesized from lactic acid and hyaluronic acid, not only possesses the advantages of hyaluronic acid, such as multiple biological functions, excellent flexibility and biocompatibility, but also has the merits of polylactic acid fragments to be easily processed and transformed to membrane when encountering water. OBJECTIVE: To investigate the hemostatic effect of RT-Q medical biomembrane in rat external jugular vein hemorrhage model, and to evaluate its histocompatibility by locally applying it to rat muscle. DESIGN: Randomized controlled animal trial.SETTING: Department of Pharmacology, Department of Pharmacognosy, West China School of Pharmacy, Sichuan University.MATERIALS 130 male Wistar rats aged 6 weeks, weighing 170-210 g, were selected. Eighty rats were used for evaluation of hemostatic effect, and the other fifty were used in biocompatibility experiment. Animal intervention met the animal ethical standard. RT-Q aerosol composed of DL-lactic acid and hyaluronic acid, α-cyanoacrylate, acetone (solvent), freon (propellant) and excipient aerosol composed of acetone and freon (propellant) (Batch number 20050311) were provided by Department of Pharmaceutics, West China School of Pharmacy, Sichuan University.α-cyanoacrylate medical adhesive(SUNCON medical adhesive) (Batch number 20050930) was produced by Beijing Suncon Medical Adhesive Science and Technology Development Co., Ltd. METHODS: Haemostatic effect Eighty male rats were randomly divided into four groups, served as RT-Q, SUNCON (positive control), excipient group and non-treatment group (negative control), twenty in each group. After anesthesia was induced, external jugular vein of rats was exposed, and an approximately 0.6 cm incision was made to create hemorrhage. The bleeding areas were blotted by antiseptic gauze. After removing the gauze, the bleeding surfaces were immediately treated with RT-Q aerosol in the RT-Q group, excipient aerosol in the excipient group, 0.15 mL SUNCON medical adhesive in the SUNCON group, or no agent in non-treatment group, respectively. Then, injury surfaces were covered by gauze. In the non-treatment group, bleeding was left to naturally stop. Bleeding time and blood loss (gauze weight after hemostasia - that before hemostasia) were determined. Local histocompatibility Rats were divided into A and B groups. Incision was made in rat post-leg muscle after anesthesia was induced. Left bleeding surfaces were treated with excipient aerosol, and right bleeding surfaces were treated with RT-Q aerosol in group A (n=30). The same incision as the group A was made, but no intervention was performed in the group B (n=20). Tissues were possessed and HE-stained for pathological observation under light microscope at days 1, 2, 3, 4, 5, 6, 7, 15, 23, 30 after the surgery. Effect of biomembrane on wound healing, degradation and toxicity to tissues surrounding injuries were observed. MAIN OUTCOME MEASURES: Bleeding time and blood loss in hemostatic experiment; wound healing, biodegradation and toxicity to tissues surrounding injuries in local histocompatibility experiment. RESULTS: 130 rats were involved in the result analysis. Histopathologic examination showed RT-Q membrane had no effect of promoting or delaying wound healing. Membrane formed by RT-Q aerosol began to degrade on the 15th day, absorbed completely during 3-4 weeks, and had no toxicity to surrounding tissues. Bleeding time and blood loss were reduced in the RT-Q group than in the non-treatment group and the excipient group (P < 0.01). There was no significant difference between the RT-Q group and the SUNCON group (P > 0.05).CONCLUSION: RT-Q medical biomembrane as α-cyanoacrylate medical adhesive has significant hemostatic effects on topical bleeding, and possesses good histocompatibility.