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Objective:To review the historical evolution and current situation of approval system for marketing application of new chemical pharmaceuticals in China to provide reference for the establishment of more perfect approval system. Methods: Through clearing up the historical evolution of approval regulations for marketing application and combining with the current approval system,the development track of the regulatory system from the vulgar administration gradually transferring to the scientific management was ana-lyzed comprehensively. Results and Conclusion: The dividend of current approval system has appeared, meanwhile, the constantly improving process will lay the foundation for setting up the regulatory system conforming to the situation of China and in line with inter-national standards.
RESUMEN
OBJECTIVE@#To observe the clinical treatment effectiveness of Clarithromycin combined with nasal glucocorticoids for chronic rhinosinusitis (CRS).@*METHOD@#Clarithromycin was 0.25 g a day (the first two weeks was 0.25 g twice a day) and topical Triamcinolone Acetonide Acetate nasal spray was (220 microg/d) once a day. Fifty-six patients were enrolled in our research. Twenty-six patients of CRS without nasal polyps was treated for 12 to 28 weeks (average 16.62 weeks). Thirty patients of CRS with nasal polyps was treated for 12 to 33 weeks (average 20.03 weeks) after polypectomy. The patients' symptom were evaluated through Sino-Nasal Outcome Test 20 (SNOT-20) scale. Meanwhile sinus CT were evaluated by Lund-Mackey system before and after operation.@*RESULT@#The score of CT scan was significantly decreased to 2.83 +/- 1.86 (t = 11.41, P < 0.01) in the CRS with nasal polyps group and to 2.43 +/- 1.91 (t = 12.86, P < 0.01) in the CRS without nasal polyps group after treatment. Recovery rate of CRS with nasal polyps group was 43.3% and of CRS without nasal polyps group was 50.0% with CT images. The self assessments of treatment efficiency was coincident with CT image in the two groups.@*CONCLUSION@#The treatment with Long term use of low dosage oral macrolide Clarithromycin combined with nasal steroid on CRS was efficacy. Polypectomy ,large dose antibiotic and steroid used in intraoperative period could significant improve the treatment efficiency of CRS with nasal polyps.