重组表皮生长因子治疗外伤性鼓膜穿孔患者的临床研究  

Clinical trail of recombinant epidermal growth factor in the treatment of patients with traumatic tympanic membrane perforation

作　　者：王丹凤 吕建刚 孙岚 WANG Dan-feng;LU Jian-gang;SUN Lan(Department of Otolaryngology,Zhengzhou Hospital of Traditional Chinese Medicine,Zhengzhou 450000,Henan Province,China)

机构地区：[1]郑州市中医院耳鼻咽喉科,河南郑州450000

出　　处：《中国临床药理学杂志》2025年第5期641-645,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察耳内镜下重组表皮生长因子(rhEGF)凝胶加吸收性明胶海绵贴补治疗外伤性鼓膜穿孔的临床效果和安全性。方法将外伤性鼓膜穿孔患者按照队列法分为对照组和试验组。对照组患者给予克林霉素磷酸酯注射液0.9 g,静脉滴注,qd;试验组患者给予rhEGF凝胶(每次1滴,bid)联合耳内镜下吸收性明胶海绵贴补。2组患者均治疗1周。比较2组的临床疗效、炎症指标[白细胞计数(WBC)、C反应蛋白(CRP)]、听力状况和评价安全性。结果试验组和对照组分别入组43例和37例。治疗后,试验组和对照组的总有效率分别为95.35%(41例/43例)和78.38%(29例/37例),在统计学上差异有统计学意义(P<0.05)。试验组和对照组治疗后的WBC水平分别为(7.74±1.47)和(10.68±1.64)×10^(9)·L^(-1),CRP水平分别为(3.37±0.97)和(6.35±1.01)pg·mL^(-1),气导听阈分别为(25.64±2.13)和(29.68±2.24)dB HL,气骨导差分别为(6.54±1.24)和(12.36±2.47)dB,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有感染,对照组的药物不良反应主要有感染、再穿孔。试验组和对照组的药物不良反应发生率分别为4.65%(2例/43例)和10.81%(4例/37例),在统计学上差异无统计学意义(P>0.05)。结论rhEGF凝胶联合吸收性明胶海绵贴补治疗外伤性鼓膜穿孔患者的临床疗效比保守治疗更佳,药物不良反应发生率低,安全性高。Objective To observe the clinical efficacy and safety of recombinant epidermal growth factor(rhEGF)gel combined with gelatin sponge application under ear endoscopy in the treatment of traumatic tympanic membrane perforations.Methods Patients with traumatic tympanic membrane perforations were divided into control group and treatment group using cohort method.The control group received intravenous infusion of clindamycin phosphate injection(0.9 g,once daily).The treatment group received rhEGF gel(1 drop per dose,twice daily)combined with gelatin sponge application under ear endoscopy.Both groups received treatment for 1 week.The clinical efficacy,inflammatory markers[white blood cell count(WBC),C-reactive protein(CRP)],hearing status,and safety were compared between the two groups.Results A total of 37 patients in the control group and 43 patients in the treatment group were enrolled.The overall treatment efficacy in the treatment and control groups were 95.35%(41 cases/43 cases)and 78.38%(29 cases/37 cases),respectively,with statistically significant difference(P<0.05).After treatment,the WBC levels in the treatment and control groups were(7.74±1.47)and(10.68±1.64)×10·L^(-1),respectively;the CRP levels were(3.37±0.97)and(6.35±1.01)pg·mL^(-1),respectively;the air conduction hearing thresholds were(25.64±2.13)and(29.68±2.24)dB HL,respectively;and the air-bone conduction gap were(6.54±1.24)and(12.36±2.47)dB,respectively.The treatment group showed statistically significant differences in all these indicators compared to the control group(allP<0.05).The adverse drug reactions in the treatment group,the main adverse drug reaction was infection,while in the control group mainly included infection and re-perforation.The incidence of adverse drug reactions in the treatment and control groups were 4.65%(2 cases/43 cases)and10.81%(4 cases/37 cases),respectively,with no significant difference(P>0.05).Conclusion The clinical efficacy of treating patients with traumatic tympanic membrane perforation by combining rhEG

关 键 词：重组表皮生长因子凝胶 吸收性明胶海绵 耳内镜 外伤性鼓膜穿孔 临床疗效 

分 类 号：R97[医药卫生—药品]