氯霉素联合重组人酸性成纤维细胞生长因子治疗外伤性鼓膜穿孔的临床观察

Clinical Observation of Chloramphenicol Combined with Recombinant Human Acidic Fibroblast Growth Factor in the Treatment of Traumatic Perforation of Tympanic Membrane

目的:观察氯霉素联合重组人酸性成纤维细胞生长因子(rhaFGF)治疗外伤性鼓膜穿孔的疗效和安全性。方法:82例外伤性鼓膜穿孔患者随机分为观察组(41例)和对照组(41例)。在常规处理的基础上,对照组患者使用12.5%氯霉素注射液浸润棉片贴补鼓膜穿孔处,第2天起每日1次滴加12.5%氯霉素注射液1滴;观察组患者使用12.5%氯霉素注射液+外用rhaFGF浸润棉片贴补鼓膜穿孔处,第2天起每日1次滴加rhaFGF 1滴。两组均每7 d取出棉片1次,观察情况并重复上述治疗。治疗60 d后观察两组患者的临床疗效、感染率、再手术情况,治疗前后气导听阈、骨导听阈及不良反应发生情况。结果:观察组患者总有效率(78.05%)显著高于对照组(60.98%),再手术率及不良反应发生率均显著低于对照组,差异均有统计学意义(P<0.05);两组患者感染率比较,差异无统计学意义(P>0.05)。治疗后,两组患者气导听阈均显著低于同组治疗前,差异均有统计学意义(P<0.05),但两组间比较差异无统计学意义(P>0.05);两组患者治疗前后骨导听阈比较,差异均无统计学意义(P>0.05)。结论:氯霉素联合rhaFGF治疗外伤性鼓膜穿孔的疗效和安全性均较好,可显著降低再手术率。

OBJECTIVE： To observe therapeutic efficacy and safety of chloramphenicol combined with recombinant human acidic fibroblast growth factor （rhaFGF） in the treatment of traumatic perforation of tympanic membrane （TPTM）. METHODS ： A total of 82 TPTM patients were randomly divided into observation group （41 cases） and control group （41 cases）. On the basis of routine treatment, the patients in the control group were covered with cotton sheets infiltrated with 12.5% Chloramphenicol injec- tion, and 1 drop of 12.5% Chloramphenicol injection, once a day, since 2nd day. Observation group was covered with cotton sheets infiltrated with 12.5% chloramphenicol injection＋rhaFGF for external use, and 1 drop of rhaFGF, once a day, since 2nd day. Cotton sheets were removed every 7 days in 2 groups. After 60 days of treatment, clinical efficacies, infection rate and reoperation were observed in 2 groups, and air conduction threshold, bone conduction threshold and the occurrence of ADR were also observed before and after treatment. RESULTS： The total response rate of observation group was 78.05%, which was higher than 60.98% of control group （P〈0.05）. The reoperation rate and the incidence of ADR in observation group were significantly lower than control group, with statistical significance （P〈0.05）. There was no statistical significance in the infection rate between 2 groups （P〉 0.05）. After treatment, air conduction threshold of 2 groups were significantly lower than before treatment, with statistical significance （P〈0.05） ; but there was no statistical significance between 2 groups （P〉0.05）. There was no statistical significance in bone conduction threshold between 2 groups （P〉0.05）. CONCLUSIONS： Chloramphenicol combined with rhaFGF is effective and safe in the treatment of TPTM, and can significantly reduce the rate of reoperation.