Clinical Study on the Treatment of Patients with Secretory Otitis Media after Novel Coronavirus Infection with Erlong Zhifei Decoction
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摘要:
目的 观察耳聋治肺汤联合西药治疗新型冠状病毒感染后分泌性中耳炎患者的临床疗效及对血清炎症因子的影响。 方法 选择符合纳入标准的新型冠状病毒感染后分泌性中耳炎患者100例, 随机分为对照组和治疗组各50例。对照组予阿奇霉素胶囊和桉柠蒎肠溶软胶囊口服治疗, 治疗组在对照组治疗基础上加服耳聋治肺汤, 疗程均为2周。观察2组患者治疗前后中医证候积分、临床疗效、血清炎症因子[白介素-1β(IL-1β)、白介素-18(IL-18)]、胱天蛋白酶1(Caspase-1)水平以及安全性指标的变化情况。 结果 治疗后, 2组中医证候积分均明显下降(P<0. 01), 且治疗组在改善耳内闷胀感、耳鸣、鼻塞、头痛、鼓膜状况和总积分方面优于对照组(P<0. 05);治疗组中医临床疗效优于对照组(P<0.05); 2组IL-1β、IL-18及Caspase-1水平均明显降低(P<0. 01), 其中在降低IL-18、Caspase-1水平方面治疗组优于对照组(P<0.05)。治疗期间2组患者均未出现明显不良反应。 结论 耳聋治肺汤联合西药治疗能改善新型冠状病毒感染后分泌性中耳炎患者症状，减轻炎症因子对中耳组织的损伤及咽鼓管管腔黏膜肿胀。 Abstract:OBJECTIVE To observe the clinical efficacy of Erlong Zhifei Decoction combined with western medicine in the treatment of patients with secretory otitis media after novel coronavirus infection and its influence on inflammatory cytokines. METHODS A total of 100 patients with secretory otitis media after novel coronavirus infection who met the inclusion criteria were selected and randomly divided into a control group and a treatment group with 50 cases each. The control group was treated with azithromycin capsules and eucalyptus acid enteric coated soft capsules orally, and the treatment group was given TCM pieces, Erlong Zhifei Decoction, on the basis of the control group. The course of treatment for both groups was 2 weeks. TCM syndrome scores, clinical efficacy, cytokines [Interleukin-1β (IL-1β) and Interleukin-18 (IL-18)], Caspase-1 activity and safety indicators were observed before and after treatment. RESULTS After treatment, the scores of TCM syndromes in the two groups were significantly decreased (P<0.01), and the treatment group was better than the control group in terms of improving the sensation of tightness and swelling in the ear, tinnitus, nasal congestion, headache, tympanic membrane examination and total score (P<0.05); the TCM clinical curative effect of the treatment group was better than that of the control group (P<0.05); the levels of IL-1β, IL-18 and Caspase-1 activity in the two groups were significantly reduced (P<0.01), among which the reduction in the level of IL-18 and Caspase-1 activity in the treatment group was better than that in the control group (P<0.05). During the treatment, no obvious adverse reaction occurred in the two groups of patients. CONCLUSION Erlong Zhifei Decoction combined with western medicine can relieve the symptoms of patients with secretory otitis media after novel coronavirus infection, and reduce the damage of inflammatory cytokines to middle ear tissue and the swelling of eustachian tube lumen mucosa. -
表 1 中医证候积分评分标准
Table 1. Evaluation standard of TCM syndrome score
症状和体征 0分 1分 2分 3分 耳内胀闷感 无 偶有 时有缓解 持续存在 听力下降 无 偶有, 不影响正常对面交谈 需对方大声, 才能对面交谈 严重影响听力, 对面交谈困难 耳痛 无 偶有 时发时止 痛如针刺, 痛连头项 耳鸣 无 偶有, 夜晚安静时明显 时有缓解, 心烦 心烦, 不缓解, 听力减退 鼻塞 无 有堵塞感，声重 鼻塞时有时无 鼻塞持续不解 流涕 无 偶有流涕 时流清涕 持续流涕 头痛 无 轻微头痛，时作时止 头痛较重，持续不止 头痛重，不能坚持工作 鼓膜检查 无 稍浑浊, 鼓室积液1/3以下 浑浊, 鼓室积液1/3以上 浑浊, 鼓室积液1/2以上 
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表 2 2组患者治疗前后中医证候积分比较(x±s, n=50)
Table 2. Comparison of TCM syndrome scores before and after treatment between the two groups of patients(x±s, n=50)
组别 时间 耳内闷胀感 听力下降 耳痛 耳鸣 鼻塞 治疗组 治疗前 2.20±0.72 1.17±0.83 0.57±0.67 0.93±0.82 0.66±0.92 治疗后 0.59±0.55**# 0.49±0.76** 0.06±0.25** 0.20±0.48**# 0.19±0.42 **# 对照组 治疗前 2.17±0.58 1.33±0.84 0.67±0.82 0.90±0.54 0.75±0.99 治疗后 0.97±0.54** 0.43±0.54** 0.09±0.29** 0.47±0.55** 0.31±0.67** 组别 时间 流涕 头痛 鼓膜检查 总积分 治疗组 治疗前 0.50±0.84 0.71±0.92 1.53±0.81 9.25±2.41 治疗后 0.24±0.67** 0.26±0.44**# 0.23±0.50**# 2.47±1.95**# 对照组 治疗前 0.45±0.79 0.62±0.77 1.80±0.75 9.84±2.13 治疗后 0.20±0.42** 0.33±0.60** 0.60±0.43** 3.17±1.82** 注: 组内比较, **P<0.01;组间比较, #P<0.05。
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表 3 2组患者中医临床疗效比较(n=50)
Table 3. Comparison of TCM clinical curative effect between the two groups(n=50)
组别 治愈 显效 有效 无效 有效率/% 治疗组 25 17 4 4 92.00# 对照组 21 14 3 12 76.00 注: 组间比较, χ2=4.762, #P<0.05。
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表 4 2组患者治疗前后血清IL-1β、IL-18和Caspase-1水平比较(x±s, pg·mL-1，n=50)
Table 4. Comparison of serum IL-1β, IL-18, Caspase-1 levels between the two groups of patients before and after treatment(x±s, pg·mL-1, n=50)
组别 时间 IL-1β IL-18 Caspase-1 治疗组 治疗前 20.12±5.16 278.40±72.38 17.65±1.86 治疗后 11.76±7.83** 80.43±0.54**# 15.87±1.34**# 对照组 治疗前 21.46±3.29 253.16±64.39 19.28±1.61 治疗后 13.58±6.90** 94.79±36.14** 18.19±2.45** 注: 组内比较, **P<0.01;组间比较, #P<0.05。
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