[Cost-effectiveness analysis of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in treatment of chronic rhinosinusitis].

This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS). The randomized controlled trial(RCT) of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS was searched against EMbase, PubMed, Cochrane Library, CNKI, VIP, SinoMed, and Wanfang. The efficacy, nasal mucociliary transport time, and safety of the therapy above in the treatment of CRS were analyzed with single-group rate and Meta-analysis, and the economy and sensitivity were evaluated from the perspective of payer. A total of 9 RCTs were included, including 1 145 patients. Meta-analysis showed that compared with Triamcinolone Acetonide Nasal Spray alone, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS patients increased the effective rate(RR=1.17, 95%CI[1.11, 1.24], P<0.000 01) and shortened the nasal mucociliary transport time(MD=-3.32, 95%CI[-5.86,-0.78], P=0.01), there was no significant difference in the incidence of adverse reactions between the two groups. The incremental cost-effectiveness analysis showed that the treatment costs of the control group and the observation group were 44.15 yuan and 1 044.96 yuan, respectively. In the Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray treatment group, 75.48 yuan was spent to improve the effective rate of CRS by 1%. The one-way sensitivity analysis indicated the days of treatment, the RR of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray, the price of unit preparation of Biyuan Tongqiao Granules, and the effective rate of Triamcinolone Acetonide Nasal Spray alone had great influence on the incremental cost-effectiveness ratio. In conclusion, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray improves the therapeutic effect on CRS. The probabilistic sensitivity analysis showed that when the willingness to pay was greater than 7 920 yuan(less than 0.1 of GDP per capita 8 098 yuan), the combined therapy was economically superior to the control. Due to the limited number of articles published, it is necessary to carry out a real-world clinical trial of Biyuan Tongqiao Gra-nules and Triamcinolone Acetonide Nasal Spray in the treatment of CRS, so as to compare the cost-effectiveness of Biyuan Tongqiao Granules and Triamcinolone Acetonide Nasal Spray.

Saline nasal irrigation and gargling in COVID-19: a multidisciplinary review of effects on viral load, mucosal dynamics, and patient outcomes.

With unrelenting SARS-CoV-2 variants, additional COVID-19 mitigation strategies are needed. Oral and nasal saline irrigation (SI) is a traditional approach for respiratory infections/diseases. As a multidisciplinary network with expertise/experience with saline, we conducted a narrative review to examine mechanisms of action and clinical outcomes associated with nasal SI, gargling, spray, or nebulization in COVID-19. SI was found to reduce SARS-CoV-2 nasopharyngeal loads and hasten viral clearance. Other mechanisms may involve inhibition of viral replication, bioaerosol reduction, improved mucociliary clearance, modulation of ENaC, and neutrophil responses. Prophylaxis was documented adjunctive to personal protective equipment. COVID-19 patients experienced significant symptom relief, while overall data suggest lower hospitalization risk. We found no harm and hence recommend SI use, as safe, inexpensive, and easy-to-use hygiene measure, complementary to hand washing or mask-wearing. In view of mainly small studies, large well-controlled or surveillance studies can help to further validate the outcomes and to implement its use.

A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the efficacy and safety of zolmitriptan nasal spray for the acute treatment of migraine in patients aged 6 to 11 years, with an open-label extension.

OBJECTIVE: To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in patients aged 6 to 11 years. BACKGROUND: Triptans have demonstrated efficacy in adults, but pediatric studies of these agents have largely failed and there are few triptan options for these patients. Because lack of response to 1 triptan does not necessarily preclude response to an alternate triptan, additional triptan options for pediatric patients are desirable. METHODS: This Phase 3, randomized, double-blind, placebo-controlled, multicenter crossover trial with an open-label extension enrolled patients aged 6 to 11 years with a diagnosis of migraine for ≥6 months and ≥16 headache-free days/month (N = 373). After a run-in period to eliminate placebo responders, 186 patients were randomized within their body weight stratum to ZNS followed by matching placebo, or placebo followed by matching ZNS. Patients <50 kg who were randomly allocated to ZNS were randomized to 5:1 to ZNS 2.5 or 1.0 mg; those ≥50 kg were randomized 5:1 to ZNS 5.0 or 2.5 mg. Patients had 6 weeks to treat 1 moderate to severe migraine headache and then crossed over to the alternate arm, during which they had 6 weeks to treat a second migraine attack. Patients could participate in a subsequent 6-month outpatient open-label extension. The primary efficacy endpoint was pain-free status at 2 h in patients treated with the high dose from each stratum. RESULTS: The trial was terminated early due to slow enrollment. Three hundred patients (mean age, 9 years) entered the placebo run-in period and 186 entered the double-blind period. Pain-free status at 2 h postdose was achieved by 45/133 (33.8%) and 30/128 (23.4%) of patients who received high-dose ZNS and placebo, respectively (p = 0.0777; odds ratio [OR] 1.51; 95% confidence interval [CI] 0.96, 2.38). Several secondary endpoints achieved statistical significance. There were few treatment-related adverse events and none led to discontinuation. ZNS retained efficacy and demonstrated a consistent safety profile throughout the 6-month open-label extension. CONCLUSION: The effect of high-dose ZNS on the primary endpoint of pain-free status at 2 h did not achieve statistical significance. ZNS was safe and well tolerated in this pediatric population.

Single-Center-Single-Blinded Clinical Trial to Evaluate the Efficacy of a Nutraceutical Containing Boswellia Serrata, Bromelain, Zinc, Magnesium, Honey, Tyndallized Lactobacillus Acidophilus and Casei to Fight Upper Respiratory Tract Infection and Otitis Media.

Some nutraceuticals have been studied as supportive treatment for fighting upper respiratory tract infection and middle ear disease. Our study aims at evaluating the effect of a specific oral supplementation in the treatment of pediatric otits media. The subjects were randomly assigned by the physician (single-blinded study) to one of three groups: Control Group (CG), Treatment Group 1 (TG1), or Treatment Group 2 (TG2). Both TG were treated with Flogostop Duo (for 20 days-TG1 or 30 days-TG2) in combination with the standard treatment, while CG underwent standard treatment only. The standard treatment was nasal aerosol with Fluticasone and Mucolytic, and nasal washing with hypertonic solution. All patients were analyzed by otoscopy, impedance, fibroscopy, and pure auditory test at the baseline (T0), after 20 days (T1) and 35 days (T2). 120 children were included in the study, 40 in the CG, 40 in the TG1, and 40 in the TG2. Both TG1 and TG2 presented statistically significant differences with respect to controls in otoscopy, impedance, fibroscopy, and PTA at T2. The otoscopy improved at T2 with statistically significant value only in TG2. The impedance and fibroscopy improved at T1 both in TG1 and TG2 compared to CG. A statistically significant improvement was observed in TG2 at T2 in comparison to both CG and TG1. Statistically significant differences were observed in PTA at T2 only compared with controls. This study confirmed the efficacy of nutraceutical as supporting therapy in the upper respiratory tract infection in children. In particular, the supplement containing Boswellia serrata and Bromelain, which are molecules with strong anti-inflammatory and pain-control capacities, could add the benefit without the adverse effects which are related to NSAID use.

Virucidal Effect of Povidone Iodine on SARS-CoV-2 in Nasopharynx: An Open-label Randomized Clinical Trial.

To assess the virucidal effect of povidone iodine (PVP-I) on severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) located in the nasopharynx and suitable dose-formulation for nasal application were the purpose of this clinical trial. This single-center, open-label randomized clinical trial with a 7-arm parallel-group design was conducted in Dhaka Medical College (DMC) Hospital. A total of 189 reverse transcription-polymerase chain reaction (RT-PCR)-confirmed SARS CoV-2 positive cases aged 12-90 years with symptoms was sequentially enrolled following randomization. Nasopharyngeal clearance of SARS-CoV-2 was tested against PVP-I nasal irrigation (NI) at diluted concentrations of 0.4%, 0.5% and 0.6%, and PVP-I nasal spray (NS) at diluted concentrations of 0.5% and 0.6%. All groups were compared to the corresponding controls (distilled water). Written informed consent was ensured before participation. All procedures were conducted in after ethical clearance from the Ethical Review Board and in accordance with the Declaration of Helsinki. Viral clearance in a repeat RT-PCR (qualitative) was the primary outcome, and occurrence of any adverse event following administration of testing drug was considered as the secondary outcome. Analysis was performed using SPSS (Version 26). All cases were randomized into seven groups and each group consists of 27-patient. Mean age of the cases 43.98 ± 12.67 years (SD). All strength of NI were effective in nasopharyngeal clearance compared to the control (0.4%, p = 0.006; 0.5%, p < 0.001; and 0.6%, p = 0.018). Similarly, all strength of the NS is also effective than control (0.5%, p = < 0.001; and 0.6%, p ≤ 0.001). Highest nasopharyngeal clearance was observed in patients using 0.5% NI (n = 25, 92.6%, p = 0.018). Nasal irritation was the single most adverse event recorded in this trial and found in two patients using 0.4%, and 0.6% PVP-I NI, respectively. Both PVP-I NS and NI are effective for nasopharyngeal clearance in-vivo. However, further community trials are needed to repurpose these solutions as preventive agents against SARS-CoV2. Ethical clearance memo no ERC-DMC/ECC/2020/93. Trial registration NCT Identifier number NCT04549376. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-022-03106-0.

Nasal Spray Formulations Based on Combined Hyalurosomes and Glycerosomes Loading Zingiber officinalis Extract as Green and Natural Strategy for the Treatment of Rhinitis and Rhinosinusitis.

A total green nanotechnological nasal spray has been manufactured and proposed as an alternative treatment of rhinitis and rhinosinusitis. It was obtained by combining the strengthening effect of liposomes on barrier function, the hydrating and lubricating properties of sodium hyaluronan and the anti-inflammatory and antioxidant activities of the extract of Zingiber officinalis. To this purpose, the extract was loaded in special phospholipid vesicles immobilized with hyaluronic acid (hyalurosomes), which were further enriched with glycerol in the water phase. Liposomes and glycerosomes were prepared as well and used as reference. Vesicles were oligolamellar and multicompartment, as confirmed by cryogenic transmission electron microscopy (cryo-TEM) observation, small in size (~140 nm) and negatively charged (~-23 mV). Spray characteristics were evaluated by using the Spraytec® and instant images, from which the plume angle was measured. The range of the droplet size distribution and the narrow spray angle obtained suggest a good nebulization and a possible local deposition in the nasal cavity. In vitro studies performed by using human keratinocytes confirmed the high biocompatibility of vesicles and their ability to effectively counteract oxidative damage on cells induced by hydrogen peroxide. The overall collected data suggest that our vesicles are suitable as nasal spray.

Review of the use of nasal and oral antiseptics during a global pandemic.

A review of nasal sprays and gargles with antiviral properties suggests that a number of commonly used antiseptics including povidone-iodine, Listerine®, iota-carrageenan and chlorhexidine should be studied in clinical trials to mitigate both the progression and transmission of SARS-CoV-2. Several of these antiseptics have demonstrated the ability to cut the viral load of SARS-CoV-2 by 3-4 log10 in 15-30 s in vitro. In addition, hypertonic saline targets viral replication by increasing hypochlorous acid inside the cell. A number of clinical trials are in process to study these interventions both for prevention of transmission, prophylaxis after exposure, and to diminish progression by reduction of viral load in the early stages of infection.

Nasally inhaled therapeutics and vaccination for COVID-19: Developments and challenges.

The nose is the initial site of viral infection, replication, and transmission in the human body. Nasally inhaled vaccines may act as a promising alternative for COVID-19 management in addition to intramuscular vaccination. In this review, the latest developments of nasal sprays either as repurposed or antiviral formulations were presented. Nasal vaccines based on traditional medicines, such as grapefruit seed extract, algae-isolated carrageenan, and Yogurt-fermenting Lactobacillus, are promising and under active investigations. Inherent challenges that hinder effective intranasal delivery were discussed in detail, which included nasal device issues and human nose physiological complexities. We examined factors related to nasal spray administration, including the nasal angiotensin I converting enzyme 2 (ACE2) locations as the delivery target, nasal devices, medication translocation after application, delivery methods, safety issues, and other nasal delivery options. The effects of human factors on nasal spray efficacy, such as nasal physiology, disease-induced physiological modifications, intersubject variability, and mucociliary clearance, were also examined. Finally, the potential impact of nasal vaccines on COVID-19 management in the developing world was discussed. It is concluded that effective delivery of nasal sprays to ACE2-rich regions is urgently needed, especially in the context that new variants may become unresponsive to current vaccines and more refractory to existing therapies.

Local Bacteriotherapy - a promising preventive tool in recurrent respiratory infections.

INTRODUCTION: Children with recurrent respiratory infections (RRI) represent a social issue for the economic burden and the negative family impact. Local Bacteriotherapy is an attractive therapeutic strategy that could be potentially effective in preventing infections. The current article remarks on the existing evidence of preventing RRI by Local Bacteriotherapy. AREAS COVERED: The literature search methodology was based on the articles cited by PubMed from 1980 to 2020. Respiratory infections include rhino-pharyngitis, otitis media, rhinosinusitis, pharyngo-tracheitis, bronchitis, and pneumonia. Several studies were performed to investigate the effects of Local Bacteriotherapy in children with RRI. Both intranasal and oral Local Bacteriotherapy were evaluated. The findings showed that Local Bacteriotherapy significantly reduced the number of RI episodes, their severity, the use of antibiotics, and school absences. EXPERT OPINION: Local Bacteriotherapy is a promising approach to RRI prevention and could be a profitable strategy to contrast infections in the future.

Histomorphological Study of a New Nasal Spray with Anti-inflammatory Properties Efficacy in Rabbits with Rhinosinusitis.

INTRODUCTION: The high world prevalence of rhinosinusitis (RS) initiates the ways of a favorable search for effective and safe medicines for its pathogenetic treatment. The important part of this process is the choice of the most comfortable dosage form, which will enhance therapeutic compliance and ensure the appropriate medicine efficacy and safety. AIM: To substantiate the efficacy of a new nasal spray with anti-inflammatory properties containing Enisamium Iodide (EI) at a concentration of 10 mg/mL by histomorphological study of the nasal cavity and paranasal sinuses mucosal in rabbits with experimental rhinosinusitis (ERS). METHODS: EI (nasal spray) was a test object. Sinupret® was a reference drug. ERS was induced in rabbits on the first day of the study by tamponade of the right half of the nasal cavity under general anesthesia. The study was performed using 24 rabbits (4 groups, 6 rabbits in each group). The histomorphological examination was performed on the 25th day of the study by the standard light microscopy methods. RESULTS: The histomorphological examination of EI 10 mg/mL (nasal spray) impact on RS in rabbits, which administered during 10 days intranasally, revealed the significant therapeutic effect presented by reduced inflammation signs in the epithelium of the nasal cavities and paranasal sinuses mucosal. Besides, the EI impact was not inferior to the reference drug Sinupret® in tablets. The study of the pharmacological properties of the EI (nasal spray) on ERS showed the high rate of onset of EI actions when used intranasally which was superior to the rate of actions of the reference drug Sinupret® (tablets) administered intragastrically. CONCLUSION: The EI (nasal spray) is a promising drug for a pathogenetic therapy of acute RS, which demands further pre-clinical and clinical studies aiming to substantiate its implementation to the clinical practice.

Rose geranium in sesame oil nasal spray: a treatment for nasal vestibulitis?

OBJECTIVES: As a rose geranium in sesame oil spray product has been anecdotally noted to improve nasal vestibulitis symptoms, this study was designed to assess whether patients with nasal vestibulitis associated with cancer-directed therapy experienced symptomatic improvements from it. METHODS: Patients with breast cancer, prescribed rose geranium nasal spray, were identified by looking at pharmacy records and patient diagnosis at Mayo Clinic Rochester. Patient medical information, as well as documentation of symptoms, were gleaned from medical charts. Questionnaires were sent to patients regarding their experiences. RESULTS: Of the 40 patients with breast cancer who were prescribed rose geranium nasal spray, 100% were receiving cancer-directed therapy: 58 % were receiving taxane chemotherapy; others received a variety of cytotoxic and targeted therapy treatments. Twenty patients who had used the spray product returned surveys. Patient-reported nasal symptoms included bleeding (90%), dryness (86%), pain (81%), scabbing (67%) and sores (52%); patients consistently reported symptoms at a higher proportion than did healthcare providers. All patients who used the rose geranium nasal spray reported symptomatic benefit; one reported a little benefit, 11 (55%) reported moderate benefit and eight (40%) reported dramatic or complete resolution of symptoms. The therapy was well tolerated in most patients. CONCLUSIONS: Rose geranium in sesame oil nasal spray appears to improve patient-reported nasal symptoms associated with cancer-directed therapy.

Bacteriotherapy for preventing recurrent upper respiratory infections in children: a real-world experience.

Background Recurrent upper respiratory infections (RURI) constitute a social problem for both their pharmaco-economic impact and the burden for the family. Bacteriotherapy could be an interesting preventive option. Objective The aim of this study was to evaluate the preventive effects of RURI in children. Design The study was designed as spontaneous, and was conducted in real-life seting. Globally, 80 children (40 males, mean age 5.26 (2.52) years) with RURI were enrolled. Children were treated with Streptococcus salivarius 24SMB and Streptococcus oralis 89a: nasal spray 2 puffs per nostril twice/day for a week for 3 monthly courses. Number of URI, and school and work absences were evaluated and compared with the past year. Results Bacteriotherapy significantly halved the mean number of URI episodes being 5.98 (2.30) in the past year and 2.75 (2.43) after the treatment (p<0.0001). Bacteriotherapy also induced an over 35% reduction both in the number of school days and in the number of working days missed per month from 4.50 (2.81) to 2.80 (3.42) and from 2.33 (2.36) to 1.48 (2.16) respectively (p<0.0001). Conclusions This and real-life study provides the first evidence that Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray could be effective in preventing RURI in children.

Folk prescription for treating rhinitis as a rare cause of childhood lead poisoning: a case series.

BACKGROUND: Folk prescriptions continue to be important sources of childhood lead poisoning. Nasal spray folk prescriptions for treating rhinitis has only been reported once previously as a cause of lead poisoning. CASE PRESENTATION: We identified three pediatric cases of severe lead poisoning caused by nasal spray folk medicines prescribed for treating rhinitis. The three patients had similar clinical manifestations including: severe abdominal pain, headache, pale appearance and fatigue. Liver function tests were abnormal. Blood lead levels (BLLs) of the three patients were 91 µg/dL, 91 µg/dL, and 105 µg/dL, respectively. After chelation BLLs decreased. The lead content of the three folk remedies as measured by inductively coupled plasma mass spectrometry (ICP-MS) were 14.8, 22.3, and 33.4%. All the symptoms resolved during a course of chelation therapy. There were no severe side effects of treatment. CONCLUSIONS: Nasal spray folk prescriptions for treating rhinitis may contain extremely high bio-accessible lead content and are potential sources of lead poisoning. Clinicians should be alert to this possibility especially in those children presenting with multisystem symptoms.

In vitro and preclinical assessment of an intranasal spray formulation of parathyroid hormone PTH 1-34 for the treatment of osteoporosis.

Osteoporosis treatment with PTH 1-34 injections significantly reduces the incidence of bone fracture. Potential further reductions in fracture rate should be observed through nasal spray delivery to address the poor compliance associated with patient dislike of repeated PTH 1-34 subcutaneous injections. In vitro human osteoblast-like Saos-2 cell intracellular cAMP levels were used to define PTH 1-34 nasal spray formulation bioactivity. The chemically synthesised PTH 1-34 had an EC50 of 0.76nM. Absorption enhancers polyethylene glycol (15)-hydroxystearate (Solutol® HS15), poloxamer 407, chitosan or sodium hyaluronate did not diminish the bioactivity of PTH 1-34 within an in vitro cell culture model (p >0.05). We also demonstrated the effectiveness of the transmucosal absorption enhancer Solutol® HS15 in a nasal spray formulation using a preclinical pharmacokinetic model. In Sprague-Dawley rats without the absorption enhancer the uptake of PTH 1-34 into the blood via intranasal delivery produced a Cmax of 2.1±0.5ng/ml compared to 13.7±1.6ng/ml with Solutol® HS15 enhancer (p=0.016) and a Cmax14.8±8ng/ml in subcutaneous injections. Together these data illustrate that the nasal spray formulation bioactivity in vitro is not affected by the nasal spray absorption enhancers investigated, and the Solutol® HS15 nasal spray formulation had an equivalent pharmacokinetic profile to subcutaneous injection in the rat model. The Solutol® HS15 formulation therefore demonstrated potential as a PTH 1-34 nasal spray formulation for the treatment of osteoporosis.

The effectiveness of topical colloidal silver in recalcitrant chronic rhinosinusitis: a randomized crossover control trial.

BACKGROUND: Recalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements. Colloidal silver (CS), a widely used naturopathic agent, has recently shown anti-biofilm properties both in vitro and within a rhinosinusitis animal model. To date, no trials involving humans have been published in world literature. The purpose of this study was to assess the efficacy of CS as a topical nasal spray in patients with refractory CRSsP. METHODS: A prospective cohort study was conducted using a convenience sample of 20 randomized patients with crossover methodology, comparing nasal sprays with CS versus saline. Patients sprayed twice daily for six weeks with the first intervention and then switched to the second for the next six weeks, with measurements made at baseline and each time point. Primary outcomes were changes in SNOT-22 and Lund-Kennedy (LK) endoscopic scores. All analysis was non-parametric and was conducted using STATA 14. RESULTS: Twenty-two patients were enrolled in the study with 20 completing the entire protocol. Mean 6-week change in SNOT-22 scores were -2.8 and 1.0 for saline and CS, respectively (p = 0.373). Similarly, mean 6-week change in LK scores were -1.4 and -1.1 for saline and CS, respectively (p = 0.794). Significant period effects were observed with the SNOT-22 score between the randomized groups. No participants experienced negative health effects directly attributable to the administration of intranasal CS. CONCLUSION: Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP. TRIAL REGISTRATION: NCT02403479 . Registered on March 1, 2015.

Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy.

PURPOSE: The aim of the current analysis was to evaluate the effectiveness and tolerability of rapid onset opioid in a cohort of head and neck cancer (HNC) patients affected by painful mucositis influencing swallowing function during RT ± ChT with definitive or adjuvant intent. METHODS: A retrospective analysis was conduct on HNC patients during RT ± ChT that received fentanyl pectin na sal spray (FPNS) for incidental BTP due to painful mucositis 13 min before the main meals. The period of observation has been 90 days starting from the beginning of RT ± ChT. RESULTS: Forty HNC patients with incidental BTP due to painful mucositis treated with FPNS were analyzed. The mean NRS of untreated episodes of BTP was 5.73 ± 1.54 decreasing to 2.25 ± 2.45 with FPNS (median dose 100 mcg). During the pain treatment, the number of meals increased from 2.08 ± 0.35 to 2.868 ± 0.4 (p = 0.000), and the BMI remained stable (from 25.086 ± 3.292 to 25.034 ± 3.090; p = 0.448). The 94.9% of patients was satisfied or very satisfied for the rapidity of the effect, and 97.4% for the easiness and convenience in the use. CONCLUSIONS: FPNS showed an acceptable safety activity profile in predictable BTP due to painful mucositis in HNC patients during RT ± ChT. FPNS was also effective in reducing the mucositis sequelae and allowing the completion of RT scheduled scheme. Moreover, patients declared satisfaction in terms of ease of use.

[Effect of saline nasal irrigation with different temperature on the clinical symptoms and the level of inflammatory factors in patients with allergic rhinitis].

Objective:To study the effect of nasal spray on the clinical symptoms and the level of inflammatory factors in patients with allergic rhinitis by salines with different temperature normal salines.Method:One hundred and twenty patients were divided into control group (n = 60) and experimental group (n = 60) randomly and all the patients were given specific immunotherapy. The patients in control group were treated with saline in 25 degrees for nasal douche, while the patients in the experimental group were treated with saline in 40 degrees. Clinical symptoms and inflammatory factors were compared between two groups.Result:In the experimental group, the total effective rate was 95.00%, while the control group was only 76.67%. The difference was statistically significant (P< 0.05). Before treatment, the symptoms scores of nasal congestion, runny nose, nasal itching, sneezing and other symptoms were similar in two groups (P>0.05). After treatment, nasal congestion and sneezing score in experimental group was lower than that in the control group (P< 0.05). The scores of runny nose and nasal itching score is similar in two groups (P> 0.05). Before treatment, the histamine and eosinophil cationic protein (ECP), leukotriene C4 and specific IgE inflammatory factor level were similar in two groups (P> 0.05). After treatment, histamine and leukotriene C4 levels in experimental group is lower than that in the control group (P< 0.05).Conclusion:Forty degrees saline nasal irrigation can reduce histamine and leukotriene C4 level in patient with allergic rhinitis, improving the symptoms of nasal congestion and sneezing.

Fentanyl Pectin Nasal Spray Versus Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Comparative Study.

CONTEXT: Fentanyl products have shown superiority over oral opioids for the management of breakthrough cancer pain (BTcP). However, these studies did not use an appropriate patient selection, and drugs have been compared using a different rationale. OBJECTIVES: The aim of this randomized, crossover, controlled study was to compare the efficacy and safety of fentanyl pectin nasal spray (FPNS) and oral morphine (OM), given in doses proportional to opioid daily doses. METHODS: Cancer patients with pain receiving ≥60 mg of OM equivalents/day and presenting with ≤3 episodes of BTcP/day were included. Patients received, in a randomized, crossover manner, FPNS or OM at doses proportional to the daily opioid regimen in four consecutive episodes of BTcP. Pain intensity was measured before (T0), 15 (T15), and 30 minutes (T30) after study drugs. RESULTS: A total of 167 episodes were treated, 82 with FNPS and 85 with OM. A statistical difference in pain intensity between the two groups was observed at T15, but not at T30 (P = 0.018 and P = 0.204, respectively). In a greater number of episodes treated with FPNS, there was a pain decrease of ≥33% in comparison with OM after 15 and 30 minutes (76.5% vs. 32.8%, and 89% vs. 54.9%, respectively). Similar differences were found in the decrease in pain intensity of ≥50% after 15 and 30 minutes (52.3% vs. 11.4%, and 75% vs. 45.8%, respectively). The difference was highly significant at T15 (P < 0.0005). The mean (SD) pain difference at T15 of FPNS and OM were 3.24 (1.7) and 2.70 (1.2), respectively, whereas the mean (SD) SPIDs30 of FPNS and OM were 4.87 (1.7) and 4.54 (1.5), respectively. The difference was highly significant at T15 (P = 0.019). No severe adverse effects after study drug administration were observed. CONCLUSION: When used in doses proportional to the basal opioid regimen, FPNS showed a superior analgesic effect over OM for the management of BTcP. Only minor adverse effects were found with both medications.

Beclomethasone dipropionate hydrofluoroalkane for the treatment of allergic rhinitis.

Allergic rhinitis (AR) is a common respiratory disease, and its prevalence is increasing all over the world, both in adults and in children. Patients experience symptoms that may negatively impact on physical, social and psychological well-being. Hence, if left untreated, allergic rhinitis may significantly affect quality of life. Under current guidelines, intranasal corticosteroids are considered the most effective drugs and they are recommended as first-line therapy. Among the several corticosteroid intranasal sprays available, beclomethasone dipropionate is one of the most prescribed. Recently, new intranasal hydrofluoroalkane-propelled formulations with little or no impact on the ozone layer have been developed for the treatment of AR. The use of these devices might improve patients' adherence to treatment, avoiding some of the most common side effects associated with aqueous formulations. This review provides the most recent evidence for the efficacy and safety of beclomethasone dipropionate hydrofluoroalkane nasal aerosol in the treatment of allergic rhinitis.

Fentanyl pectin nasal spray as treatment for incident predictable breakthrough pain (BTP) in oral mucositis induced by chemoradiotherapy in head and neck cancer.

BACKGROUND: Painful mucositis is one of the most distressing toxicities of chemoradiotherapy (CRT) for head and neck cancer (HNC), with the characteristics of incidental predictable breakthrough pain (BTP) during swallowing. Fentanyl pectin nasal spray (FPNS) could be a good therapeutic option. METHODS: Patients were prospectively considered if receiving basal analgesic therapy with opiates for painful mucositis of grade ⩾4 on a numerical rating scale from 0 to 10. They were offered FPNS 100mcg before oral intake. When patients reached the effective dose, they evaluated the basal pain intensity before FPNS use and after 10, 20, 30 and 40min. RESULTS: Seventeen HNC patients were offered FPNS before oral intake, with 15 patients completing treatment. Mean reduction of incidental BTP intensity after FPNS was 3.1 points (range 1.2-5.8). Mean time elapsed since FPNS use and highest pain reduction was 26min. CONCLUSIONS: FPNS demonstrated activity against BTP when swallowing in HNC patients. These data should be considered as hypothesis-generating.