Systematic Review of the Safety of Steroids for Chronic Sinusitis/Nasal Polyps and Allergic Rhinitis_Chinese Journal of Evidence-Based Medicine

Authors：

MENG Zhaoli ¹ , BAI Mei ² , LIANG Chuanyu ¹

1. Department of Otorhinolaryngology of West China Hospital; Sichuan University; Chengdu 610041; China2. Department of Otorhinolaryngology of Affiliated Third Hospital; Inner Mongolia Medical University; Neimonggu 014010;

Corresponding author：

Keywords：

Sinusitis; Nasal polyps; Allergic rhinitis; Adverse events; Systematic review

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Objective 　To evaluate the safety of intranasal use of beclomethasone dipropionate, budesonide, fluticasone propionate and mometasone for adults and children with chronic sinusitis/nasal polyps and allergic rhinitis.
Methods 　Randomized controlled trials were located. Study quality was evaluated by two researchers independently. RevMan 4.2 was used for meta-analysis.
Results 　Seven RCTs involving 826 patients were included. Compared with placebo, local use of fluticasone proprionate in adults showed no statistically significant trend to increase incidence of acute sinusitis (OR 16.87, 95% CI 0.87 to 301.62), but no significant difference was seen for epistaxis (OR 7.76, 95% CI 0.38 to 157.14): 1 trial, 60 patients. In another trial, no cases of nasal atrophy were reported in either fluticasone or placebo groups. No significant differences were seen between local use ofbudesonide and placebo in adults for dryness of nasal mucosa (OR 3.38, 95%CI 0.66 to 17.18) and epistaxis (OR 2.20, 95%CI 0.39 to 12.32): 1 trial, 193 participantions. No significant difference was seen between budesonide and pollinex for headache (OR 1.71, 95%CI 0.52 to 5.62). No differences were seen between placebo and fluticasone propionate in children for epistaxis (OR 0.85, 95%CI 0.20 to 3.66), headache (OR 0.25, 95%CI 0.02 to 2.83), plasma cortisol concentration (OR 1.56, 95%CI 0.06 to 38.69) and dryness of nasal mucosa (OR 4.76, 95%CI 0.25 to 89.54). Beclomethasone dipropionate in children showed no statistical differences for dryness of nasal mucosa (OR 0.51, 95%CI 0.14 to 1.87), epistaxis (OR 0.68, 95%CI 0.26 to 1.73) and rhinitis (OR 0.47, 95%CI 0.04 to 5.36). No decrease of plasma cortisol concentration was detected in either group. Mometasone and placebo showed no significant differences in children for epistaxis (OR 1.57, 95%CI 0.41 to 5.95), rhinitis (OR 0.33, 95%CI 0.01 to 8.22) or headache (OR 0.33, 95%CI 0.01 to 8.22). Decrease of plasma cortisol concentration was not detected.
Conclusions 　According to this systematic review, long term intranasal use of steroid for adults and children may be safe based on the two high quality, four moderate quality trials and one with b bias. High quality studies with larger sample sizes and in other languages are needed to provide ber evidence.

Citation： MENG Zhaoli,BAI Mei,LIANG Chuanyu. Systematic Review of the Safety of Steroids for Chronic Sinusitis/Nasal Polyps and Allergic Rhinitis. Chinese Journal of Evidence-Based Medicine, 2004, 04(8): 563-569. doi: Copy

1.	［1］Gu ZY, Gu RJ. Pharmacotherapy for allergic rhinitis [J].Chin J Otorhinolaryngol, 2000; 35 ( 1 ): 73 - 75.
2.	顾之燕,顾瑞金.变应性鼻炎的药物疗法[J].中华耳鼻咽喉科杂志,2000;35(1):73～75.
3.	［2］Kanai N, Denburg J, Jardana M. Nasal poly inflammation:effect of topical nasal steroid[J]. Am J Respir Crit Care Med,1994; 150(4): 1 094-1 100.
4.	［3］Juni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials[J]. BMJ, 2001; 323:42-46.
5.	［4］Grossman J, Banov C, Bronsky EA, Nathan RA, Pearman D, Winder JA, Rather PH, Mendelson L, Findlay SR, Kral KM, Field EA, Rogenes PR. Fluticasone propionate aqueous nasal spray is safe and effective for children with seasonal allergic rhinitis[J]. Pediatrics, 1993; 92(4): 594 -599.
6.	［5］Mostafa BE. Fluticasone propionate is associated with severe infection after endoscopic polypectomy [J]. Arch Otolaryngol Head Neck Surg, 1996; 122:729-731.
7.	［6］Skoner DP, Rachelefsky GS, Meltzer EO, Chervinsky P, Morris RM, SeltzerJM, Storms WW, Wood RS. Detection of growth suppression in children during treatment with intranasal beclomethasone dipropionate [J]. Pediatrics, 2000;105(2): 23 -29.
8.	［7］Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rookin A, Rosen JP, Ruff ME, Vanderwalker ML,Wanderer A, Damaraju CV, Nolop KB, Mesarina-Wicki B. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray[J]. Pediatrics, 2000; 105(2): 16 -22.
9.	［8］Baroody FM, Cheng CC, Moylan B, deTineo M, Haney L,Reed KD, Cook CK, Westlund RE, Sengupla E, Corey JP,Togias A, Naclerio RM. Absence of nasal mucosal atrophy with fluticasone aqueous nasal spray[J]. Arch Otolaryngol Head Surg, 2001; 127:193-199.
10.	［9］Juniper EF , Kline PA, R amsdale EH, Hargreave FE. Comparison of the efficacy and side effects of aqueous steroid nasal spray (budesonide) and allergic rhinoconjunctivitis [J]. Allergy Clin Immunol, 1990; 85(3): 606 -611.
11.	［10］Gastpar H, Acerich R, Petzold U, Dorow P, Enmann H,Gering R, Kochy HP, Philipp A, Renz W, Wendenburg G. Intranasal treament of perennial allergic rhinitis[J]. Drug Res,1993; 43(1): 475-479.
12.	［11］Kolssek JM, Peloquin L, Friedman WH. Diffuse nasal polyposis: postoperative long-term results after endoscopic sinus surgery and fronta lirrigation [J]. Otolarygnol Head Neck Surg,1997; 117(4): 355 -361.
13.	［12］Zhang L. The effect and mechanism of glucocorticosteroid for cure nasal polyp[J ]. Medical Journal Abroad (Otorhinolaryngology), 2000; 24(2): 73 -77.
14.	张罗.糖皮质激素治疗鼻息肉的疗效和机理[J].国外医学耳鼻咽喉科学分册,2000;24(2):73～77.

1. ［1］Gu ZY, Gu RJ. Pharmacotherapy for allergic rhinitis [J].Chin J Otorhinolaryngol, 2000; 35 ( 1 ): 73 - 75.
2. 顾之燕,顾瑞金.变应性鼻炎的药物疗法[J].中华耳鼻咽喉科杂志,2000;35(1):73～75.
3. ［2］Kanai N, Denburg J, Jardana M. Nasal poly inflammation:effect of topical nasal steroid[J]. Am J Respir Crit Care Med,1994; 150(4): 1 094-1 100.
4. ［3］Juni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials[J]. BMJ, 2001; 323:42-46.
5. ［4］Grossman J, Banov C, Bronsky EA, Nathan RA, Pearman D, Winder JA, Rather PH, Mendelson L, Findlay SR, Kral KM, Field EA, Rogenes PR. Fluticasone propionate aqueous nasal spray is safe and effective for children with seasonal allergic rhinitis[J]. Pediatrics, 1993; 92(4): 594 -599.
6. ［5］Mostafa BE. Fluticasone propionate is associated with severe infection after endoscopic polypectomy [J]. Arch Otolaryngol Head Neck Surg, 1996; 122:729-731.
7. ［6］Skoner DP, Rachelefsky GS, Meltzer EO, Chervinsky P, Morris RM, SeltzerJM, Storms WW, Wood RS. Detection of growth suppression in children during treatment with intranasal beclomethasone dipropionate [J]. Pediatrics, 2000;105(2): 23 -29.
8. ［7］Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rookin A, Rosen JP, Ruff ME, Vanderwalker ML,Wanderer A, Damaraju CV, Nolop KB, Mesarina-Wicki B. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray[J]. Pediatrics, 2000; 105(2): 16 -22.
9. ［8］Baroody FM, Cheng CC, Moylan B, deTineo M, Haney L,Reed KD, Cook CK, Westlund RE, Sengupla E, Corey JP,Togias A, Naclerio RM. Absence of nasal mucosal atrophy with fluticasone aqueous nasal spray[J]. Arch Otolaryngol Head Surg, 2001; 127:193-199.
10. ［9］Juniper EF , Kline PA, R amsdale EH, Hargreave FE. Comparison of the efficacy and side effects of aqueous steroid nasal spray (budesonide) and allergic rhinoconjunctivitis [J]. Allergy Clin Immunol, 1990; 85(3): 606 -611.
11. ［10］Gastpar H, Acerich R, Petzold U, Dorow P, Enmann H,Gering R, Kochy HP, Philipp A, Renz W, Wendenburg G. Intranasal treament of perennial allergic rhinitis[J]. Drug Res,1993; 43(1): 475-479.
12. ［11］Kolssek JM, Peloquin L, Friedman WH. Diffuse nasal polyposis: postoperative long-term results after endoscopic sinus surgery and fronta lirrigation [J]. Otolarygnol Head Neck Surg,1997; 117(4): 355 -361.
13. ［12］Zhang L. The effect and mechanism of glucocorticosteroid for cure nasal polyp[J ]. Medical Journal Abroad (Otorhinolaryngology), 2000; 24(2): 73 -77.
14. 张罗.糖皮质激素治疗鼻息肉的疗效和机理[J].国外医学耳鼻咽喉科学分册,2000;24(2):73～77.

Chinese Journal of Evidence-Based Medicine

Systematic Review of the Safety of Steroids for Chronic Sinusitis/Nasal Polyps and Allergic Rhinitis

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