摘要
目的:研究外用冻干重组人酸性成纤维细胞生长因子(商品名:艾夫吉夫,rhaFGF)对剖宫产术后切口愈合的影响,并初步探寻外用冻干重组人酸性成纤维细胞生长因子最佳的给药方式。方法:本研究采用开放性临床随机、对照试验设计,将2011年8月—2013年7月451例行剖宫产术并符合纳入标准的患者,根据住院病历号随机分为3组(安慰剂组、喷雾治疗组和冲洗治疗组),冲洗治疗组于皮肤缝合前采用溶于0.9%氯化钠注射液的外用冻干重组人酸性成纤维细胞生长因子冲洗创面,缝合后再将外用冻干重组人酸性成纤维细胞生长因子喷于创面或纱布;喷雾治疗组于切口缝合后同冲洗治疗组进行喷雾治疗;安慰剂组于缝合前用0.9%氯化钠注射液冲洗创面。随访并记录患者住院时间,观察患者切口愈合情况、应用TDP神灯护理情况等。结果:冲洗治疗组患者疗效与安慰剂组比较,各指标具有显著性差异;与喷雾治疗组比较,冲洗治疗组患者在切口愈合甲级(82.98%vs.52.52%,P=0.027)、乙级(16.31%vs.43.17%,P=0.033)、手术切口满意率(91.49%vs.74.82%,P=0.038)、瘢痕直径[(7.84±2.85)cm vs.(10.08±3.17)cm]方面均具有显著性差异。结论:外用冻干重组人酸性成纤维细胞生长因子可缩短患者术后切口愈合时间和住院时间,减少瘢痕面积,并且疼痛和瘙痒发生率较低,最佳的给药方式为术中冲洗联合术后喷雾。
OBJECTIVE:To study the efficacy of lyophilized recombinant human acidic fibroblast growth factor for external use(rhaFGF) for abdominal wound healing in patients after undergoing cesarean section and explore the best route of administration of rha-FGF.METHODS:An open-labelled randomized controlled trial was performed in which a total of 451 pregnant women undergoing cesarean section meeting including criteria were randomly assigned to placebo group,atomization group and rinse group).In the rinse group,rh-aFGF dissolved in 0.9% sodium chloride was used for rinsing of wound surface,then rh-aFGF was sprayed on the wound or gauze after suture of wound; in atomization group,rh-aFGF aerosol was applied on the wound after suture of wound; in the placebo group,the wound surface was rinsed with 0.9% sodium chloride injection.The length of hospital stay,wound healing time and application of TDP lamp were recorded during the follow-up.RESULTS:The differences between the rinse group and the placebo group in all the indexes were statistically significant; the differences between the rinse group and the aerosol therapy group in wound healing Grade A (82.98% vs.52.52%,P =0.027),wound healing Grade B (16.31% vs.43.17%,P =O.033),patient satisfaction on operative incision (91.49% vs.74.82%,P =0.038),scar diameter [(7.84 ±2.85) cm vs.(10.08 ±3.17) cm] were all statistically significant.CONCLUSION:Rha-FGF treatment resulted in shorter wound healing time and shorter length of hospital stay,deceased scar size,low incidence of pain and itching.The optimal route of administration of Rha-FGF is intraoperative rinse plus postoperative atomization.
出处
《中国医院用药评价与分析》
2014年第2期150-153,共4页
Evaluation and Analysis of Drug-use in Hospitals of China