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目的探讨铁必复颗粒治疗有缺铁的感音神经性耳聋患者的临床疗效。方法收集感音神经性耳聋患者1 214例,检查血清铁蛋白,筛查出存在缺铁的患者217例,其中单侧耳聋患者54例,双侧163例,以听力较好耳为观察对象,完全随机分为两组,铁必复颗粒组109耳,西药对照组108耳,铁必复颗粒组接受铁必复颗粒冲服,西药对照组口服常规剂量新B1、敏使朗、弥可保等,两组患者均连续用药2个月以上。分别在用药前1~3 d,治疗1、2个月时测平均电测听阈值和血清铁蛋白,观察听力改变与血清铁蛋白变化是否相关。结果治疗1个月后铁必复颗粒组有78耳(71.6%)血清铁蛋白恢复正常值,2个月后共有97耳(89.0%)血清铁蛋白恢复正常值,对照组分别为11耳(10.2%)和15耳(13.9%),秩和检验两组有效率差异有统计学意义(P<0.001)。听力测试结果显示治疗2个月后铁必复颗粒组显效9耳,有效48耳,总有效率为52.3%;西药对照组108耳,显效2耳,有效22耳,总有效率为22.2%。铁必复颗粒组有效率高于西药对照组,经秩和检验两组总有效率差异有统计学意义(P<0.05)。铁必复颗粒组听阈提高与血清铁蛋白的上升呈正相关,西药对照组无相关性。结论部分感音神经性耳聋可能与缺铁有关,铁必复颗粒能有效改善人体内缺铁状况,有效改善缺铁并感音神经性耳聋患者的听力情况。
Objective To investigate the clinical efficacy of Tiebushen Granule in treating patients with sensorineural hearing loss due to iron deficiency. Methods A total of 1 214 patients with sensorineural hearing loss were enrolled in this study. Serum ferritin was detected and 217 patients with iron deficiency were screened out. Among them, 54 patients with unilateral deafness and 163 bilateral patients were examined with better hearing ability. Completely randomized into two groups, iron will be complex particles 109 ears, Western medicine control group 108 ears, iron will be complex particles to receive iron will be complex particles Chongfu, western medicine control group oral conventional dose of new B1, sensitive to Long, , Two groups of patients were continuous medication for more than 2 months. The electrocardiographic thresholds and serum ferritin were measured at 1 to 3 days before treatment and at 1 and 2 months respectively to observe whether the change of hearing was related to the change of serum ferritin. Results After 1 month of treatment, 78 cases (71.6%) of serum ferritin were restored to normal values in the iron-treated group, 97 cases (89.0%) returned to normal after 2 months, and 11 cases 10.2%) and 15 ears (13.9%). The difference between the two groups in rank sum test was statistically significant (P <0.001). The result of audition test showed that after 2 months of treatment, Tiebushui granule group had 9 ears markedly effective and 48 ears effective, with a total effective rate of 52.3%. In the control group of 108 cases of Western medicine, 2 ears markedly effective and 22 ears effective were achieved. The total effective rate was 22.2%. Tiebifu particles were more effective than the western medicine group, the rank sum test showed that the total effective rate difference was statistically significant (P <0.05). Tiebifu particles increased hearing threshold and elevated serum ferritin was positively correlated, western medicine control group no correlation. Conclusions Some sensorineural deafness may be related to iron deficiency. Tiebushu capsule can effectively improve the iron deficiency in the human body and effectively improve the hearing of patients with iron deficiency and sensorineural hearing loss.