The Influence Of Controlled-release Formulations In Maxillary Sinus In The Prognosis Of Chronic Sinusitis

ObjectiveWeight average molecular weight of50OOOg mol-1of polylactic acid (polylactic acid, PLA) as the carrier, mixed with a certain percentage of erythromycin(erythromycin, EM) and prednisone acetate(prednisone acetate, PNA) prepared erythromycin controlled release formulations. Use windowing of inferior nasal meatus under nasal endoscope of0°and30°to implant Erythromycin Sustained Release Preparation into windowed maxillary sinus. Then compare the clinical effect and cure result with traditional sinus operation under nasal endoscope.MethodSelected71cases of otorhinolaryngological department hospitalized patients of Qianfoshan Hospital consistent with<<chronic rhinitis-nasal sinusitis diagnosis and treatment guidelines>>, these patients were nonresponders after conservative treatment and twice maxillary sinus punctures (2008, Nanchang).Informed patients of the study purpose and methods, and signed informed consents with them, then divided these patients into experimental and control groups randomly according to treatment order. All patients were carried out inferior nasal meatus fenestrations in the tetracaine topical anesthesia and1%lido caine infiltration anesthesia at0°and30°angle under nasal endoscopy, and the window size was1cm×2cm,then unilateral implanted2pieces of Erythromycin Sustained Release Preparation,but didn’t open ethmoid or frontal sinus if somebody mergered ethmoid sinus inflammation or frontal sinusitis.The control group adopted uncinate process resection and the opening of maxillarysinus,opened anterior ethmoid and frontal sinus at the same time if mergered anterior ethmoid sinus inflammation or frontal sinusitis. Experimental group used calcium oxalate gauze to tamponade the inferior meatus while the control group tamponaded the entire surgical cavity using calcium oxalate gauze or the expansion of the sponge if necessary at the end of surgery.Experimental group were not systemic application of antibiotics while the control group used of antibiotics after surgery, including intravenous application of4days and oral were3d. Removed the nasal packing materials gradually postoperative1-2days, then clean up the crusts and secretions in the surgical cavity every day and processed nasal cavity thoroughly under intranasal endoscopic prior to discharge, collected nasal secretions after3d,6d,9d,12d,15d,18d,21d respectively and determined of the average drug content using ultraviolet spectrophotometry. Assessed the effect of surgery after3months and conduct the relevant questionnaire.ResultsErythromycin preparation of controlled release preparation method is feasible and good drug release property.Reference to<<chronic rhinitis-nasal sinusitis diagnosis and treatment guidelines>>(2008, Nanchang) to prepare。 In the release time of21days,the effective drug concentration (Erythromycin4mg/L, prednisone acetate50ng/ml)of erythromycin controlled release formulations has antibacterial effectsin,greater than21days,because the drug concentration has been reduced, inhibition is greatly reduced but still has a strong antibacterial effect.The criteria for grading is based on the Lund-Kennedy Endoscopic mucosal morphology scoring system.The differences between experimental group and control group patients have no statistical significance in the rate of nasal edema, rhinorrhea, and crusting (Zc, respectively0.682,1.324,1.962, P>0.05), But there is significant difference in the scar postoperative(Zc:3.556, P<0.05), which prove that implanting erythromycin controlled release formulations into the maxillary sinus through the inferior meatus window to treatment of chronic rhinitis-nasal sinusitis compared with the traditional sinus surgery, postoperative nasal mucosa edema, nasal discharge and crusting the system has no significant difference, but significantly better than traditional methods in postoperative pain, surgical scars, adhesions, recurrence, dressing change frequency and hospitalization costs.ConclusionPreparation of erythromycin controlled release formulations is feasible and the drug release property is stable. Compared to the traditional operation for curing Chronic sinusitis, our method can reduce patients’pain, frequency of dressing change and shorten length of stay. And the rate of adhesion of nasal cavity and relapse after operation is very low. So the total fee can be less. Besides, the application of Erythromycin Sustained Release Preparation can reduce or halt oral and vein ways of medication use, then decrease the systemic side effects. Erythromycin Sustained Release Preparation is safe and reliable, worthy of clinically adoption.