复方倍他米松注射液耳后注射治疗突发性耳聋患者的临床研究

Clinical trial of postauricular injection of compound betamethasone injection in the treatment of patients with sudden deafness

目的观察复方倍他米松注射液治疗突发性耳聋患者的临床疗效及对经颅多普勒(TCD)参数、纤溶-凝血指标的影响。方法将突发性耳聋患者按队列法分为对照组和试验组。对照组在常规治疗的基础上,给予地塞米松磷酸钠静脉注射,连用10d;试验组在常规治疗的基础上,给予复方倍他米松耳后注射,每次0.8mg,隔日1次,共5次。比较2组患者的临床疗效、听力水平、血流动力学指标及实验室指标[同型半胱氨酸(Hcy)、血小板(PLT)计数],统计药物不良反应发生情况。结果试验组入组50例,对照组入组50例。治疗后,试验组和对照组的总有效率分别为94.00%(47例/50例)和80.00%(40例/50例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的听阈值在0.5kHz下分别为(42.48±5.65)和(50.64±6.92)dB,在1kHz下分别为(45.35±6.44)和(57.66±7.41)dB,在2kHz下分别为(48.67±5.58)和(60.24±8.31)dB,在4kHz下分别为(50.25±6.06)和(63.15±8.25)dB,在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的全血高切黏度分别为(4.18±0.58)和(4.99±0.76)mpa·s,全血低切黏度分别为(9.18±1.15)和(10.31±1.28)mpa·s,血浆黏度分别为(1.44±0.32)和(1.76±0.25)mpa·s,Hcy分别为(15.57±4.25)和(21.75±4.93)μmol·L^(-1),PLT分别为(198.72±21.41)×10^(9)·L^(-l)和(212.67±18.46)×10^(9)·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组均未见明显药物不良反应发生。结论复方倍他米松注射液耳后注射用于突发性耳聋患者的治疗,可改善患者的听力水平、提高临床疗效,还有助于改善血流动力学、降低血清Hcy水平,且安全性较好。

Objective To observe the efficacy of postauricular injection of compound betamethasone injection in the treatment of sudden deafness and its influence on transcranial doppler(TCD)parameters and fibrinolysis-coagulation indicators.Methods Patients with sudden deafness were divided into control group and treatment group according to cohort methed.The control group was given intravenous injection of dexamethasone sodium phosphate for 10 days on the basis of conventional treatment,and the treatment group was given postauricular injection of compound betamethasone injection 0.8 g for once every other day for 5 times in addition to conventional treatment.The clinical efficacy,hearing level,haemodynamics and laboratory indicators[homocysteine(Hcy),platelet(PLT)count] were compared between the two groups of patients,and the adverse drug reactions or complications were counted.Results There were 50 cases in treatment group and 50 cases in control group.After treatment,the total effective rates in treatment group and control group were 94.00%(47 cases/50 cases)and 80.00%(40 cases/50 cases),with significant difference(P<0.05).After treatment,the acoustic thresholds under 0.5 kHz,1 kHz,2 kHz and 4 kHz in treatment group were(42.48±5.65),(45.35±6.44),(48.67±5.58)and(50.25±6.06)dB,which in control group were(50.64±6.92),(57.66±7.41),(60.24±8.31)and(63.15±8.25)dB,all with significant difference(all P<0.05).After treatment,the whole blood high-shear viscosities in treatment group and control group were(4.18±0.58)and(4.99±0.76)mpa·s;the whole blood low-shear viscosities were(9.18±1.15)and(10.31±1.28)mpa·s;the plasma viscosities were(1.44±0.32)and(1.76±0.25)mpa·s;the Hcy levels in treatment group and control group were(15.57±4.25)and(21.75±4.93)μmol.L^(-1);PLT levels were(198.72±21.41)×10^(9).L^(-1)and(212.67±18.46)×10^(9).L^(-1)respectively,all with significant difference(all P<0.05).There were no obvious adverse drug reactions in treatment group and control group.Conclusion Postauricular injection of compound betamethasone injection can improve the hearing level and enhance the clinical efficacy in patients with sudden deafness,and it is helpful to improve haemodynamics and reduce serum Hcy level,with good safety.