GM1注射液联合巴曲酶治疗突发性耳聋患者的疗效及安全性

Analysis of the Efficacy and Safety of GM1 Injection Combined with Batroxobin in the Treatment of Sudden Deafness Patients

目的 探讨突发性耳聋采取单唾液酸四己糖神经节苷脂钠(monosialotetrahexosylganglioside,GM1)注射液、巴曲酶联合治疗效果及其安全性的评估。方法 选取2018年1月至2022年12月间唐山职业技术学院附属医院162例突发性耳聋患者的临床资料进行回顾性分析,根据治疗方案分为对照组和观察组,对照组的81例采用巴曲酶治疗,观察组的81例采用GM1注射液联合巴曲酶治疗。比较2组疗效、症状恢复时间、治疗前后纯音听阈、炎性指标[白介素-10(interleukin-10,IL-10)、超敏-C反应蛋白(high sensitive C-reactive protein,hs-CRP)、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)]水平及安全性。结果 观察组总有效率92.59%高于对照组59.26%(P <0.05);观察组头晕消失、听力恢复正常及耳鸣消失时间均短于对照组(P <0.05);治疗7 d、14 d后观察组纯音听阈低于对照组(P <0.05);治疗后观察组血清IL-10水平高于对照组,hs-CRP、TNF-α水平低于对照组(P <0.05);观察组不良反应发生率11.11%与对照组9.88%相比,差异无统计学意义(P>0.05)。结论 GM1注射液联合巴曲酶治疗可有效控制突发性耳聋患者炎性反应、改善听力状况,加速康复进程,且疗效确切,具备一定安全性。

Objective To investigate the therapeutic efficacy and safety of the combination of monosialotetrahexosylganglioside( GM1) injection and Batroxobin in treating sudden deafness.Methods The clinical data of 162 patients with sudden deafness in Affiliated Hospital of Tangshan Vocational and Technical College between January 2018 and December 2022 were selected for retrospective analysis and grouped according to the treatment protocol,81 cases in the control group were treated with batroxobin and 81 cases in the observation group were treated with GM1 injection combined with batroxobin.The efficacy and symptom recovery time of the 2 groups were compared,as well as the levels of pure tone hearing threshold,inflammatory indexes [interleukin-10(IL-10),high sensitive C-reactive protein(hs-CRP),and tumor necrosis factor-α(TNF-α)] before and after treatment,and safety.Results The total effective rate of the observation group was 92.59%,which was higher than that of the control group(59.26%)(P < 0.05);the observation group had shorter time for dizziness to disappear,hearing to return to normal,and tinnitus to disappear than the control group(P < 0.05);pure tone hearing thresholds in the observation group were lower than those in the control group after 7 d and 14 d of treatment(P > 0.05);after treatment,the serum IL-10 level in the observation group was higher than that in the control group,while the levels of hs-CRP and TNF-α were lower than those in the control group(P < 0.05);the incidence of adverse reactions in the observation group was 11.11%,compared with 9.88% in the control group,the difference was not statistically significant( P > 0.05).Conclusion GM1 injection combined with batroxobin can effectively control the inflammatory response in patients with sudden deafness,improve hearing status,accelerate the recovery process,and has a certain degree of safety and efficacy.