北京生物醫(yī)學(xué)工程

羧甲基化棉短絨止血紗布的生物相容性研究

Biocompatibility ofcarboxymethylated cotton linters hemostatic gauze

作者：柳小軍劉康博劉振師月周靜徐玉茵王海濤田源

單位：河南省醫(yī)療器械檢驗(yàn)所（國(guó)家藥監(jiān)局醫(yī)用生物防護(hù)及植入器械質(zhì)量評(píng)價(jià)重點(diǎn)實(shí)驗(yàn)室）（鄭州  450003）;南陽(yáng)市久康醫(yī)療器械有限公司（河南南陽(yáng)473125） <p>通訊作者：王海濤，正高級(jí)工程師，E-mail:[email protected]</p>

關(guān)鍵詞：止血紗布；羧甲基化棉短絨；毒性反應(yīng)；凝血；生物相容性

分類號(hào)：R318. 08

出版年·卷·期（頁(yè)碼）：2022·41·5（500-505）

摘要：

目的研究羧甲基化棉短絨止血紗布的生物相容性，評(píng)價(jià)其生物安全性。方法進(jìn)行皮內(nèi)反應(yīng)試驗(yàn)、皮膚致敏試驗(yàn)、急性全身毒性試驗(yàn)、溶血試驗(yàn)、體外凝血指標(biāo)試驗(yàn)和體外血栓形成試驗(yàn)，通過(guò)檢測(cè)皮內(nèi)反應(yīng)記分、皮膚致敏反應(yīng)等級(jí)、毒性反應(yīng)、溶血率、體外凝血指標(biāo)和纖維蛋白原含量等指標(biāo)分析羧甲基化棉短絨止血紗布的生物相容性。結(jié)果羧甲基化棉短絨止血紗布無(wú)潛在的動(dòng)物皮內(nèi)刺激作用、無(wú)皮膚致敏性和無(wú)急性全身毒性反應(yīng)；溶血率符合要求；實(shí)驗(yàn)組紗布在凝血試驗(yàn)中凝血酶原時(shí)間（prothrombin time，PT)和活化部分凝血活酶時(shí)間（activated partial thromboplastin time，APTT)與體外血栓形成試驗(yàn)中纖維蛋白原含量雖與對(duì)照組相比有顯著性差異（P＜0.05），但與對(duì)照組的相對(duì)百分比均在85%～115%之間。結(jié)論羧甲基化棉短絨止血紗布具有良好的生物相容性，符合國(guó)家相關(guān)標(biāo)準(zhǔn)要求，為其在臨床創(chuàng)面止血中的安全應(yīng)用提供參考。

Objective To evaluate the biological safety of carboxymethylated cotton linters hemostatic gauze by studying its biocompatibility. MethodsIntradermal reaction test, skin sensitization test，acute systemic toxicity test, hemolysis test, blood coagulation index test and thrombosis test in vitro were examined andthe biocompatibility of carboxymethylated cotton linter hemostatic gauze was analyzed by intradermal rank score, skin sensitization reaction degree and toxicity reaction, hemolysis rate, in vitro coagulation indexes and fibrinogen content. Results The carboxymethylated cotton linters hemostatic gauze had no potential indermal irritation, no skin sensitization and no acute systemic toxicityandthe hemolysis rate met the requirements. There were significant difference about prothrombin time (PT) and activated partial thromboplastin time (APTT) in the coagulation test and the fibrinogen contentin vitro thrombosis test between experimental and control group(P<0.05), but the relative percentages ofexperimental group was between 85% and 115% compared with the control group. Conclusion The carboxymethylated cotton lintershemostatic gauze in this study has good biocompatibility and conforms to relevant national standards, which provides reference for its safe application in clinical wound hemostasis.

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