Efficacy of Nasal Administration of Bikangfu in the Treatment of Chronic Rhinosinusitis in Children
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摘要: 目的 探讨鼻康复鼻腔透药治疗儿童慢性鼻窦炎的临床疗效。方法 168例慢性鼻窦炎患儿随机分为观察组和对照组, 每组84例, 观察组给予鼻康复鼻腔透药疗法, 对照组给予通窍鼻炎颗粒+欧龙马滴剂口服, 疗程均为4周。观察2组患儿治疗前后的VAS评分、中医鼻渊症状与体征积分、鼻窦CT Lund-Mackay评分等的变化, 检测2组患儿治疗前后鼻腔分泌物及血清炎性因子前列腺素D2(PGD2)、白细胞三烯C4(LTC4)、白细胞介素(IL-17、IL-33)、嗜酸性粒细胞阳离子蛋白(ECP)、免疫球蛋白(IgE)的含量。结果 治疗后, 2组患儿VAS评分、中医症状及体征积分、鼻窦CT的Lund-Mackay评分较治疗前均明显下降(P < 0.05, P < 0.01), 观察组优于对照组(P < 0.05, P < 0.01)。观察组总有效率优于对照组(P < 0.01)。2组患儿血清及鼻分泌液中PGD2、LTC4、IL-17、IL-33、ECP、IgE水平较治疗前均降低(P < 0.05, P < 0.01), 观察组优于对照组(P < 0.05, P < 0.01)。2组治疗过程均未见明显不良反应。结论 鼻康复鼻腔透药疗法可有效改善慢性鼻窦炎患儿临床症状, 且无不良反应发生, 其作用机制可能与调节血清及鼻分泌物中的炎性因子水平有关。Abstract: OBJECTIVE To investigate the clinical efficacy of nasal administration of Bikangfu in the treatment of chronic rhinosinusitis in children.METHODS A total of 168 children with chronic rhinosinusitis were randomly divided into observation group and control group, 84 cases in each group. The observation group was given nasal administration of Bikangfu therapy, the control group was given Tongqiao Biyan granules combined with Sinupret drops orally. The course of treatment was four weeks. The changes of visual analog scale (VAS) symptom score, symptoms and signs scores of rhinosinusitis in traditional Chinese medicine, Lund-Mackay score of nasal sinus CT were observed in patients treated before and after treatment. The levels of nasal secretions and serum inflammatory factors including prostaglandin D2 (PGD2), leukotriene C4 (LTC4), interleukins (IL-17, IL-33), eosinophil cationic protein (ECP), and immunoglobulin (IgE) were measured before and after treatment in the two groups.RESULTS After treatment, the VAS score, traditional Chinese medicine symptoms and signs scores, and Lund-Mackay score of nasal sinus CT in the two groups were decreased significantly compared with those before treatment (P < 0.05, P < 0.01), while the results in the observation group were better than those the control group (P < 0.05, P < 0.01). The total effective rate after treatment was better in the observation group than that in the control group (P < 0.01). In addition, the levels of PGD2, LTC4, IL-17, IL-33, ECP, and IgE in the serum and nasal secretions in both groups were lower than those before treatment (P < 0.05, P < 0.01), while the results in the observation group were better than those in the control group (P < 0.05, P < 0.01). Besides, there was no obvious adverse reaction occurred in the two groups after treatment.CONCLUSION With no adverse reaction, nasal administration of Bikangfu therapy can effectively reduce the clinical symptoms of children with chronic rhinosinusitis. Its mechanism of action may be related to the regulation of inflammatory factors in serum and nasal secretions.
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Key words:
- Bikangfu /
- nasal administration /
- rhinosinusitis in children /
- chronic rhinosinusitis /
- clinical study
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表 1 儿童慢性鼻窦炎的西医诊断标准
项目 临床表现 临床症状 主要症状 咳嗽、鼻塞、头痛、流涕 伴随症状 嗅觉减退、听力下降、行为异常 体征 主要体征 下鼻甲充血、肥大, 鼻腔、中鼻道可见黏(脓)性分泌物, 咽后壁淋巴组织增生, 并可见黏(脓)性分泌物 伴随体征 腺样体和(或)扁桃体增生肥大, 分泌性中耳炎的体征 影像学检查 上颌窦、额窦、前组筛窦黏膜见炎性改变 表 2 2组患儿治疗前后VAS评分比较(x±s)
组别 例数 治疗前 治疗后 对照组 65 39.61±5.27 16.81±1.84** 观察组 67 38.92±5.96 5.74±0.46**## 注: 组内比较, **P < 0.01;组间比较, ##P < 0.01。 表 3 2组患儿治疗前后中医鼻渊症状及体征积分比较(x±s)
组别 时间 鼻塞 流涕 咳嗽 头痛 嗅觉减退 总评分 对照组 治疗前 7.49±1.44 8.81±1.52 7.23±1.31 4.18±0.75 3.95±0.79 31.66±5.81 (n=65) 治疗后 3.56±0.32** 4.13±0.53** 3.97±0.37** 1.15±0.13** 1.54±0.16** 14.35±1.51** 观察组 治疗前 7.62±1.52 9.31±1.67 6.54±1.18 4.25±0.76 3.75±0.65 31.47±5.78 (n=67) 治疗后 0.95±0.07**## 0.53±0.04**## 0.47±0.05**## 0.28±0.04**## 0.92±0.11**# 3.15±0.31**## 注: 组内比较, **P < 0.01;组间比较, #P < 0.05, ##P < 0.01。 表 4 2组患儿临床疗效比较
组别 例数 治愈 显效 有效 无效 总有效率/% 对照组 65 25 14 9 17 73.8 观察组 67 50 8 6 3 95.5## 注: 组间比较, χ2=12.058, ##P < 0.01。 表 5 2组患儿治疗前后血清炎性因子水平比较(x±s, ng·L-1)
组别 时间 例数 PGD2 LTC4 IL-17 IL-33 对照组 治疗前 65 32.19±5.84 27.56±5.18 478.29±33.52 389.15±22.94 治疗后 65 20.87±3.49* 15.77±3.92* 317.25±28.55* 319.54±19.14* 观察组 治疗前 67 31.54±5.18 29.39±5.14 451.95±40.67 382.13±20.56 治疗后 67 12.38±3.92**# 9.15±3.19**# 210.98±20.85**## 135.63±11.93**## 注: 组内比较, *P < 0.05, **P < 0.01;组间比较, #P < 0.05, ##P < 0.01。 表 6 2组患儿治疗前后鼻分泌液炎性因子水平比较(x±s, ng·L-1)
组别 时间 例数 PGD2 LTC4 IL-17 IL-33 对照组 治疗前 65 18.96±2.27 14.28±1.08 359.26±23.85 221.35±13.78 治疗后 65 11.68±1.61* 9.54±0.92* 287.95±23.91* 187.77±12.83* 观察组 治疗前 67 17.85±2.56 12.73±1.96 359.28±25.67 219.95±13.54 治疗后 67 3.82±0.56**## 2.94±0.64**## 115.96±17.88**## 95.38±8.12**## 注: 组内比较, *P < 0.05, **P < 0.01;组间比较, ##P < 0.01。 表 7 2组患儿治疗前后血清及鼻分泌液ECP及IgE表达水平比较(x±s)
组别 时间 例数 血清 鼻分泌液 ECP/(μg·L -1) IgE/(kU·L -1) ECP/(μg·L -1) IgE/(kU·L -1) 对照组 治疗前 65 13.35±2.25 16.81±2.18 25.89±3.88 37.18±5.58 治疗后 65 8.98±1.24* 8.54±1.78* 17.54±3.16* 29.15±3.42* 观察组 治疗前 67 15.89±2.57 17.18±2.16 23.54±3.56 38.16±5.74 治疗后 67 6.04±1.08**# 3.58±2.17**## 10.18±3.95**# 16.75±4.12**## 注: 组内比较, *P < 0.05, **P < 0.01;组间比较, #P < 0.05, ##P < 0.01。 -
[1] HASTAN D, FOKKENS WJ, BACHERT C, et al. Chronic rhinosinusitis in Europe: An underestimated disease. A GA2LEN study[J]. Allergy, 2011, 66(9): 1216-1223. doi: 10.1111/j.1398-9995.2011.02646.x [2] 张铁松, 石浩, 林建云, 等. 云南昆明地区儿童鼻窦炎发病情况调查[J]. 临床耳鼻咽喉头颈外科杂志, 2010, 24(5): 207-208. https://www.cnki.com.cn/Article/CJFDTOTAL-LCEH201005008.htm [3] FOKKENS WJ, LUND VJ, HOPKINS C, et al. European position paper on rhinosinusitis and nasal polyps 2020[J]. Rhinology, 2020, 58(s29): 1-464. [4] 敬尚林, 林楠, 陈继昌. 儿童鼻-鼻窦炎诊疗规范化探讨[J]. 山东大学耳鼻喉眼学报, 2014, 28(5): 91-94, 98. https://www.cnki.com.cn/Article/CJFDTOTAL-SDYU201405029.htm [5] 李勇. 儿童鼻窦炎的诊治: 困难、挑战与对策[J]. 山东大学耳鼻喉眼学报, 2019, 33(6): 1-7. https://www.cnki.com.cn/Article/CJFDTOTAL-SDYU201906001.htm [6] 李华斌, 曹玉洁. 儿童鼻窦炎的临床诊疗进展[J]. 山东大学耳鼻喉眼学报, 2019, 33(6): 16-19. https://www.cnki.com.cn/Article/CJFDTOTAL-SDYU201906004.htm [7] 陶泽璋, 陈始明. 儿童慢性鼻-鼻窦炎的精准化诊疗[J]. 临床耳鼻咽喉头颈外科杂志, 2018, 32(21): 1610-1613. https://www.cnki.com.cn/Article/CJFDTOTAL-LCEH201821002.htm [8] 许庚. 小剂量长期大环内酯药物用于慢性鼻-鼻窦炎的治疗[J]. 中华耳鼻咽喉头颈外科杂志, 2013, 48(2): 102-104. doi: 10.3760/cma.j.issn.1673-0860.2013.02.007 [9] GIGER R, PASCHE P, CHESEAUX C, et al. Comparison of once-versus twice-daily use of beclomethasone dipropionate aqueous nasal spray in the treatment of allergic and non-allergic chronic rhinosinusitis[J]. Eur Arch Otorhinolaryngol, 2003, 260(3): 135-140. doi: 10.1007/s00405-002-0543-1 [10] 李敏, 姚斌峰, 金庆江, 等. 慢性鼻-鼻窦炎中医外治法研究进展[J]. 四川中医, 2019, 37(7): 220-222. https://www.cnki.com.cn/Article/CJFDTOTAL-SCZY201907080.htm [11] 熊子云. 不同中医辨证分型慢性鼻-鼻窦炎患者鼻内窥镜术后中医药治疗效果分析[J]. 检验医学与临床, 2019, 16(12): 1732-1734. doi: 10.3969/j.issn.1672-9455.2019.12.031 [12] 蔡纪堂, 王俊杰, 王慧敏. 鼻康复治疗变应性鼻炎临床研究[J]. 中医学报, 2016, 31(8): 1209-1211. https://www.cnki.com.cn/Article/CJFDTOTAL-HNZK201608039.htm [13] 中华耳鼻咽喉头颈外科杂志编辑委员会, 中华医学会耳鼻咽喉头颈外科学分会小儿学组、鼻科学组. 儿童鼻-鼻窦炎诊断和治疗建议(2012年, 昆明)[J]. 中华耳鼻咽喉头颈外科杂志, 2013, 48(3): 177-179. doi: 10.3760/cma.j.issn.1673-0860.2013.03.001 [14] 刘蓬. 中医耳鼻咽喉科学[M]. 北京: 中国中医药出版社, 2016: 111-114. [15] LIM M, LEW-GOR S, DARBY Y, et al. The relationship between subjective assessment instruments in chronic rhinosinusitis[J]. Rhinology, 2007, 45(2): 144-147. http://www.seorl.net/wp-content/uploads/2015/09/Anexo-2-The-relationship-between-subjective-assessment-instruments-in-chronic-rhinosinusitis.pdf [16] 叶艺贤. 多层螺旋CT在慢性鼻窦炎鼻息肉患者嗅觉评估及预后判断中的应用价值[J]. 医疗装备, 2019, 32(12): 100-101. doi: 10.3969/j.issn.1002-2376.2019.12.067 [17] KALCIOGLU MT, DURMAZ B, AKTAS E, et al. Bacteriology of chronic maxillary sinusitis and normal maxillary sinuses: Using culture and multiplex polymerase chain reaction[J]. Am J Rhinol, 2003, 17(3): 143-147. doi: 10.1177/194589240301700306 [18] KAY DJ, ROSENFELD RM. Quality of life for children with persistent sinonasal symptoms[J]. Otolaryngol Head Neck Surg, 2003, 128(1): 17-26. doi: 10.1067/mhn.2003.41 [19] JONES NS. Acute and chronic sinusitis in children[J]. Curr Opin Pulm Med, 2000, 6(3): 221-225. doi: 10.1097/00063198-200005000-00010 [20] 张革化, 李源. 儿童鼻窦炎[J]. 国外医学: 耳鼻咽喉科学分册, 2000, 24(2): 86-88. https://www.cnki.com.cn/Article/CJFDTOTAL-GWRB200002006.htm [21] 中国医师协会儿科医师分会儿童耳鼻咽喉专业委员会. 通窍鼻炎颗粒治疗儿童鼻炎及鼻-鼻窦炎临床应用专家共识[J]. 中国实用儿科杂志, 2020, 35(2): 88-92. https://www.cnki.com.cn/Article/CJFDTOTAL-ZSEK202002003.htm [22] 李春苗. 欧龙马滴剂联合微波理疗对小儿急性分泌性中耳炎的疗效[J]. 河南医学研究, 2020, 29(10): 1844-1846. doi: 10.3969/j.issn.1004-437X.2020.10.059 [23] 黄帝内经素问[M]. 北京: 人民卫生出版社, 2005: 74. [24] 灵枢经[M]. 北京: 人民卫生出版社, 2005: 52. [25] CHEN ZZ, GONG X, LU Y, et al. Enhancing effect of borneol and muscone on geniposide transport across the human nasal epithelial cell monolayer[J]. PLoS ONE, 2014, 9(7): e101414. doi: 10.1371/journal.pone.0101414 [26] 冯昕. 嗜酸性粒细胞在AERD患者PGD2产生中的作用及相关机制的研究[D]. 济南: 山东大学, 2016. [27] KOWALSKI ML, CIELAK M, PEREZ-NOVO CA, et al. Clinical and immunological determinants of severe/refractory asthma(SRA): Association with Staphylococcal superantigen-specific IgE antibodies[J]. Allergy, 2011, 66(1): 32-38. doi: 10.1111/j.1398-9995.2010.02379.x [28] 姜晓丹. Th17及其细胞因子在不同病理特征慢性鼻-鼻窦炎鼻息肉中作用机制的研究[D]. 长春: 吉林大学, 2011. [29] 东丽丽, 徐勇胜. IL-33与支气管哮喘的研究进展[J]. 国际儿科学杂志, 2017, 44(11): 765-768. doi: 10.3760/cma.j.issn.1673-4408.2017.11.009 [30] FINKELMAN FD, KHODOUN MV, STRAIT R. Human IgE-independent systemic anaphylaxis[J]. J Allergy Clin Immunol, 2016, 137(6): 1674-1680. http://www.sciencedirect.com/science/article/pii/s0091674916003821 [31] STEINKE JW, BORISH L. The role of allergy in chronic rhinosinusitis[J]. Immunol Allergy Clin N Am, 2004, 24(1): 45-57. doi: 10.1016/S0889-8561(03)00108-5 [32] 余文婷, 周玥, 檀慧芳, 等. 血液和鼻分泌物中嗜酸粒细胞和嗜酸粒细胞阳离子蛋白对变应性鼻炎的辅助诊断价值[J]. 临床耳鼻咽喉头颈外科杂志, 2019, 33(11): 1027-1030. https://www.cnki.com.cn/Article/CJFDTOTAL-LCEH201911006.htm