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桉柠蒎肠溶软胶囊联合糠酸莫米松治疗慢性鼻炎的疗效观察
引用本文:骆平莉,殷婷.桉柠蒎肠溶软胶囊联合糠酸莫米松治疗慢性鼻炎的疗效观察[J].现代药物与临床,2020,35(7):1421-1425.
作者姓名:骆平莉  殷婷
作者单位:天津药物研究院生物技术中心, 天津 300462;天津药物研究院 释药技术与药代动力学国家重点实验室, 天津 300462
摘    要:目的探讨桉柠蒎肠溶软胶囊联合糠酸莫米松治疗慢性鼻炎的临床效果。方法选取2017年1月—2018年8月西安医学院第二附属医院收治的134例慢性鼻炎患者,随机分成对照组(n=67)和治疗组(n=67)。对照组给予糠酸莫米松鼻喷雾剂,鼻腔给药,每侧鼻孔2揿/次,1次/d。治疗组患者在对照组基础上口服桉柠蒎肠溶软胶囊,1粒/次,2次/d,于餐前0.5 h用凉开水整粒吞服。两组均连续治疗4周。比较两组临床疗效、治疗前后鼻部主要症状评分、鼻腔鼻窦结局测试-20(SNOT-20)评分、DIP内镜评分、总鼻阻力(TNR)值、鼻声反射参数鼻腔最小横截面积(NMCA)、0~5 cm鼻腔容积(0~5cmNCV)]值及鼻灌洗液炎症细胞计数变化及随访复发率。结果治疗组总有效率为95.5%显著高于对照组83.6%(P0.05)。两组治疗后鼻塞评分、鼻涕评分及SNOT-20总分均显著低于治疗前(P0.05),且治疗组下降更显著(P0.05)。与治疗前对比,两组治疗后DIP内镜评分系统中各项(炎症、分泌物、息肉/水肿)评分及其总分均显著降低(P0.05);但治疗后,治疗组以上DIP内镜评分均较对照组同期显著更低(P0.05)。两组治疗后TNR较治疗前均显著减小(P0.05),NMCA和0~5cmNCV则均显著增大(P0.05);且治疗组上述参数的改善效果均更显著(P0.05)。两组治疗后鼻灌洗液EOS和LYM计数均显著低于治疗前(P0.05),而治疗组鼻灌洗液以上炎症细胞计数均显著更少(P0.05)。随访6个月,治疗组复发率3.0%显著低于对照组14.9%(P0.05)。结论桉柠蒎肠溶软胶囊联合糠酸莫米松治疗慢性鼻炎的整体疗效显著,能明显缓解患者鼻部症状和体征,改善鼻腔通气功能,减轻鼻腔炎症反应,降低复发风险,具有一定的临床推广应用价值。

关 键 词:疫苗  新型冠状病毒  研究开发  安全性  有效性  评价  监管  系统工程
收稿时间:2020/6/15 0:00:00

Clinical study on Eucalyptus Carabinieri Enteric Soft Capsule combined with mometasone furoate in treatment of chronic rhinitis
LUO Ping-li,YIN Ting.Clinical study on Eucalyptus Carabinieri Enteric Soft Capsule combined with mometasone furoate in treatment of chronic rhinitis[J].Drugs & Clinic,2020,35(7):1421-1425.
Authors:LUO Ping-li  YIN Ting
Institution:Research Center of Bio-Technology, Tianjin Institute of Pharmaceutical Research, Tianjin 300462, China;State Key Laboratory of Drug Release Technology and Pharmacokinetics, Tianjin Pharmaceutical Research Institute, Tianjin 300462, China
Abstract:Objective To investigate the clinical effect of Eucalyptus Carabinieri Enteric Soft Capsule combined with mometasone furoate in treatment of chronic rhinitis. Methods 134 Patients with chronic rhinitis admitted to Second Affiliated Hospital of Xi''an Medical University from January 2017 to August 2018 were randomly divided into control group (n=67) and treatment group (n=67). The control group was treated by Mometasone Furoate Nasal Spray, 2 snouts/time for each nostril, once daily. The treatment group was po administered with Eucalyptus Carabinieri Enteric Soft Capsule with cold boiled water 0.5 h before meal on the basis of the control group, one tablet/time, twice daily. All patients were treated for 4 weeks. The clinical effects of the two groups were compared. The nasal main symptom score, nasal sinus outcome test -20(SNOT-20) score, DIP endoscopy score, total nasal resistance (TNR) value, nasal acoustic reflex parametersnasal minimum cross-sectional area (NMCA), nasal volume of 0-5 cm (0-5 cm NCV)] value, changes in inflammatory cell count in nasal lavage fluid and follow-up recurrence rate were compared before and after treatment. Results The total effective rate of the treatment group was 95.5%, significantly higher than that of the control group 83.6%, P<0.05. After treatment, nasal congestion score, nasal mucus score and SNOT-20 total score in both groups were significantly lower than before treatment (P<0.05), and the decline was more significant in the treatment group (P<0.05). Compared with before treatment, scores of various items (inflammation, secretions, polyps/edema) in the DIP endoscopic scoring system and their total scores were significantly reduced after treatment in both groups (P<0.05). However, after treatment, all the DIP endoscopic scores in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, TNR of both groups was significantly reduced compared with that before treatment (P<0.05), while NMCA and NCV of 0-5 cm were significantly increased (P<0.05). The improvement effect of the above parameters in the treatment group was more significant (P<0.05). After treatment, the EOS and LYM counts of nasal lavage fluid in both groups were significantly lower than before treatment (P<0.05), while the inflammatory cell counts above nasal lavage fluid in the treatment group were significantly lower (P<0.05). Follow-up for 6 months showed that the recurrence rate of 3.0% in the treatment group was significantly lower than that of 14.9% in the control group (P<0.05). Conclusion Eucalyptus Carabinieri Enteric Soft Capsule combined with mometasone furoate has overall effect in treatment of chronic rhinitis, and can significantly relieve patients'' nasal symptoms and signs, and also can improve nasal ventilation, reduce nasal inflammation and the risk of recurrence, which has a certain clinical application value.
Keywords:vaccine  SARS-CoV-2  research and development  safety  effectiveness  evaluation  regulation  systems engineering
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