Evaluation Of Role Of Platelet Rich Plasma In Treatment Of Patients Suffering From Atrophic Rhinitis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Degree of change in histopathological pattern of nasal mucosa
研究概览
简要总结
An interventional hospital based study will be undertaken from February 2021 to February 2023 in order to determine the efficacy of platelet rich plasma as a new modality for treatment of patients suffering from atrophic rhinitis in Sohag university hospital.
详细描述
- Random sample will be taken from patients presenting with atrophic rhinitis to ear, nose and throat outpatient clinic in Sohag University Hospital during the period extending from February 2021 to October 2022 (taking in consideration the follow up time of the last case which will take four months). Patients will be divided randomly into two groups. The division of patients subjected to treatment will be obtained by a random sequence of computer generated numbers. One group will be subjected to submucosal platelet-rich plasma (PRP) injection (study group) and the other group will be subjected to the usual conservative lines of treatment including nasal douchings, frequent local care and mucosal lubricants (control group).
All patients will be subjected to:
- Full history taking and clinical examination.
- Symptom score, sinonasal outcome test-25 (SNOT 25) will be noted at the beginning and after treatment.
- Diagnostic nasal endoscopy and the results will be noted under four objective variables; these will be noted and the scores at the beginning and the end of 12 weeks of therapy will be statistically compared in both groups; 1. Crusting (nil = 0, minimal=1, gross = 2) 2. Status of nasal mucosa (normal = 0, congested = 1, Pale Atrophic which often indicative of underlying squamous metaplasia =2) 3. Nature of secretions (thin = 0, thick = 1) 4. Condition of nasal cavity (normal size = 0, roomy (see nasopharynx) = 1)
- Routine Laboratory investigation: looking for iron deficiency anemia, thrombocytopenia.
- Baseline nasal biopsy and only those with histopathological features of atrophic rhinitis will be included in the study. Five subheadings for histopathology; Each variable was assigned a score of 0, 1 or 2 where 0 representing normal nasal mucosal features whereas 2 signifying extreme variation, the biopsy will be repeated after 12 weeks of treatment;
- Status of epithelium: respiratory epithelium (pseudo stratified columnar ciliated epithelium, squamous metaplasia (partial/total ± keratinization); Denuded or not
- Status of mucous (goblet) cells (Normal glands / ↓ number and size / Absence)
- Condition of blood vessels (Reduced vascularity or Dilated blood vessels / Periarteritis/ Endarteritis).
- Tunica propria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary atrophic rhinitis
- •patients with empty nose syndrome
排除标准
- •patients with secondary atrohic rhinitis except for those with empty nose syndrome
- •patients with bleeding disorders mainly platelet disorders
结局指标
主要结局
Degree of change in histopathological pattern of nasal mucosa
时间窗: 12 weeks after end of the procedure.
A nasal mucosal biopsy will be obtained in all cases. Five subheadings for histopathology; Each variable was assigned a score of 0, 1 or 2 where 0 representing normal nasal mucosal features, whereas 2 signifying extreme variation, 1. Status of epithelium: respiratory epithelium (pseudo stratified columnar ciliated epithelium, squamous metaplasia (partial/total ± keratinization); Denuded or not 2. Status of mucous cells (Normal glands / ↓ number and size / Absence) 3. Condition of blood vessels (Reduced vascularity or Dilated blood vessels / Periarteritis/ Endarteritis). 4. Tunica propria: Granulation tissue Presence of Chronic inflammatory cellular infiltrate Degree of Fibrosis Chronic inflammatory cellular infiltration with fibrosis Basement membrane (Normal / Ill-defined /Thickened) Seromucinus glands especially the serous component
Degree of change in patient satisfaction and quality of life
时间窗: 12 weeks after end of the procedure.
Symptom score, Sinonasal Outcome Test 25 (SNOT 25) will be noted .
次要结局
- Assess the nasal mucociliary function .(12 weeks after end of the procedure.)
研究者
Marwa Saad Badry Abaas
Evaluation Of Role Of Platelet Rich Plasma In Treatment Of Patients Suffering From Atrophic Rhinitis
Sohag University