A randomized, prospective, double-blind study of the efficacy of dexpanthenol nasal spray on the postoperative treatment of patients with chronic rhinosinusitis after endoscopic sinus surgery.

OBJECTIVE: To assess the efficacy of dexpanthenol nasal spray compared with normal saline spray in the postoperative treatment of patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS). MATERIALS AND METHOD: A prospective, randomized controlled study was conducted in CRS patients who underwent ESS. The enrolled patients had never been operated intranasally. These patients received either dexpanthenol or normal saline nasal spray intranasally four times a day for six weeks post-operatively. RESULTS: Fifty CRS patients were recruited in the present study. Age ranged from 23 to 63 years (means 43.4 +/- 11.2 years). Forty-four percent of patients were diagnosed as CRS without nasal polyps (NP) (CRSs NP) and 56% were CRS with NP (CRSw NP). Twenty-five cases were randomly assigned to use dexpanthenol nasal spray whereas the other 25 cases used normal saline nasal spray. The preoperative severity of CRS, determined by the computerized tomography (CT) scan scoring system of Lund-McKay was 13.9 +/- 6.2 in the dexpanthenol group and 13.6 +/- 6.9 in the normal saline group, which were not statistically different (p > 0.05). The endoscopic scoring was 10.2 +/- 2 in the dexpanthenol group and 10.7 +/- 3 in the normal saline group, which were not statistically different (p > 0.05). The mucociliary transit time improvement (time difference between pre- and post-treatment by nasal spray) was 8.4 +/- 3.3 minutes in the dexpanthenol group and 1.7 +/- 1.2 minutes in the normal saline group, which were statistically different (p < 0.05). CONCLUSION: The majority of the postoperative symptom scores and all of the endoscopic scores of the dexpanthenol group were not statistically different from those of the normal saline group. However, dexpanthenol nasal spray has superior efficacy compared with normal saline nasal spray on improvement of mucociliary clearance and nasal discharge in the postoperative care of CRS patients after ESS.

Acoustic rhinometry of Asian noses.

BACKGROUND: Each ethnic group has different nasal cavity geometries. The reference value of the minimal cross-sectional area (MCA) and the nasal volume (NV) is mandatory for rhinologic evaluation in regular practice and for research. This study was designed to study the normal value of acoustic rhinometry (AR) in Asian subjects in comparison with other ethnic groups. METHODS: AR was performed in 135 healthy Thai subjects. Subjects were divided into two groups: group I, with normal anterior rhinoscopic appearance; group II included subjects with asymptomatic, slightly deviated nasal septa. RESULTS: The mean of the MCA was 0.61 +/- 0.60 cm2 before decongestion and 0.64 +/- 0.14 cm2 after decongestion. The mean distance from the nostril to the point of MCA (D) was 1.66 +/- 0.59 cm before decongestion and 1.41 +/- 0.74 cm after decongestion. The mean of the NV measured between 0 and 4 cm was 3.66 +/- 0.67 cm3 before decongestion and 4.18 +/- 0.75 cm3 after decongestion. Before decongestion, there were no significant differences in the mean of the MCA, D, and NV between group I and group II subjects; however, there were significant differences in mean MCA and NV after decongestion. There were no differences in the parameters between male and female subjects before decongestion, except for the D, but after decongestion the mean values of the MCA, D, and NV were significantly higher in male subjects compared with female subjects. CONCLUSION: The results of this study can be used as a reference value for Asian ethnicities. Thai subjects had measurements comparable with those of the European study and somewhat different from the study in black populations.

Quality of life assessment in Thai patients with allergic rhinoconjunctivitis using the SF-36 questionnaire (Thai version).

The health related quality of life (QOL) of patients with allergic rhinitis and/or conjunctivitis (ARc) as measured by the SF-36 questionnaire, has been shown to be impaired in a similar way to that of asthmatic patients in France and several other countries. We used the SF-36 questionnaire (Thai version) to evaluate the QOL of Thai ARc patients compared to healthy subjects. The SF-36 questionnaire (Thai version) consists of 36 items covering 8 dimensions and one health transition report question. Higher scores indicated better QOL. The internal consistency reliability of the questionnaire was analysed using Cronbach's alpha-coefficient. A total of 705 healthy persons and 900 ARc patients were included in this study. The mean difference of the scores between healthy and ARc groups in each dimension showed higher scores in the healthy group. This difference was statistically significant (p < 0.05 and p < 0.001) for all dimensions, except for the Social Functioning dimension. The internal reliability of the SF-36 questionnaire was confirmed by Cronbach's alpha-coefficient which was above 0.7 for seven of the dimensions; the exception was the Social Functioning dimension. Men were shown to have higher scores than women in several dimensions. In conclusion, this study has confirmed that the SF-36 questionnaire is sensitive enough to discriminate ARc patients from healthy persons with high reliability. QOL of ARc patients was significantly more impaired than healthy persons and hypertensive patients in several dimensions. These findings were similar to reports from other countries using the same instruments. Therefore the SF-36 questionnaire (Thai version) can be a useful tool in evaluating the impact of ARc on a patient's QOL and the improvement in QOL after therapeutic intervention in Thai patients.

Development of a health-related quality of life questionnaire for Thai patients with rhinoconjunctivitis.

The objective of this study was to develop a disease-specific questionnaire for patients with rhinoconjunctivitis. All patients were recruited at the Out-Patient Clinic at Siriraj Hospital. Related topics were gathered from several sources, and a list of 63 items was produced. In phase I, the first version of the questionnaire was completed by 363 patients. Forty-eight items were identified by clinical impact analysis during the item removal process, two more questions were then added, giving a total of 50. Two hundred and forty-three patients completed the second version questionnaire in phase II. The average time taken to complete the questionnaire was 6.38 minutes. The item removal process in phase II was achieved by a multi-step process. There were 36 items in the third version questionnaire which consisted of six dimensions and two independent items as follows: symptoms (17 items), physical functioning (3 items), role limitations (3 items), sleep (3 items), social functioning (3 items), emotions (5 items), general health (1 item), and absenteeism (1 item). The scores of each item ranged from 1 to 5; a lower score indicating a better quality of life. Data from the selected 36 items was extracted to test the validity and reliability of the final version. The floor and ceiling effects of the scores for each dimension were low. Multitrait multi-item analysis was conducted to examine construct validity. The scaling success of convergent and divergent validity was 100% and 94%, respectively. Internal consistency determined by Cronbach's alpha coefficient, was satisfactory (0.79-0.87). The study indicates that the questionnaire is suitable for use in clinical settings. While the test results are encouraging, further work needs to be done on the test-retest reliability and on responsiveness.

An open label, randomized comparative study of levofloxacin and amoxicillin/clavulanic acid in the treatment of purulent sinusitis in adult Thai patients.

The objective of the study was to compare the clinical efficacy and bacteriological response of levofloxacin and amoxicillin/clavulanic acid (co-amoxiclav) in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily (LEV group) or co-amoxiclav 625 mg three times a day (COA group) for 14 days. Thirty four patients were in the LEV group and 26 patients were in the COA group. The mean total symptom score was significantly decreased after treatment and was comparable between both groups. Radiological improvement was 61.8% in the LEV group (41.2% resolution, 20.6% improvement) and 61.5% in the COA group (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the LEV group and 20 patients (76.9%) in the COA group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa. There were no significant changes in vital sign measurements or hemato-biochemical parameters at the end of treatment as compared to baseline values, in both groups. Adverse events were found in 8.8% of patient in the LEV group and in 7.7% of patients in the COA group. Adverse events included nausea, abdominal pain, and diarrhea. All the adverse events in both groups were mild and resolved spontaneously. This study demonstrated that levofloxacin 300 mg orally once daily was as effective and safe as amoxicillin/clavulanic acid 625 mg three times a day in the treatment of maxillary sinusitis, either acute or acute exacerbation. Both drugs showed bacteriological efficacy that was not significantly different. The once daily dosage regimen is more applicable, convenience and has better compliance.

An open-label, prospective study of an oral polyvalent bacterial lysate (Luivac) in the treatment of recurrent respiratory tract infections in Thai patients.

An open-label, non-comparative study was performed in the Department of Otolaryngology, Siriraj Hospital, Bangkok, Thailand, to assess the safety, tolerability, acceptability and efficacy of an oral polyvalent bacterial lysate (Luivac) in the treatment of recurrent respiratory tract infections (RTIs) in Thai patients. Thirty-three patients were included in this study, 18 males and 15 females, with a mean age of 34.0 +/- 14.7 years. The mean number of RTIs during the 12-month period preceding the study was 9.5 per patient. During the study each patient received one tablet of Luivac daily for 28 days followed by a treatment-free period of 28 days. This was followed with another 28 days on Luivac, after which there was a 28-day treatment-free follow-up period. This study lasted 4 months with five scheduled patient visits (V1-V5). Laboratory studies were done at baseline (V1) and after treatment (V4), which included complete blood count and serum immunoglobulins (IgA, IgE, IgG and IgM). The incidence of all adverse events was 15.2% and no case was related to the studied drug. There were no clinical relevant changes in laboratory parameters after treatment. The reduction rate of RTIs per month at the end of the study period was 63.5% when compared to the average RTIs rate per month during the 12 months preceding the study. A comparison of the first study period (V1-V3) and the second study period (V3-V5) showed a reduction in duration of RTIs (23.1%), in the clinical infection score (17.5%), in the number of antibiotics used (2.1%), in the number of symptomatic treatments (3.5%), and in the number of days absent from school or work (50.0%). Overall tolerability and acceptability were assessed as very good and good in 96.8% of the patients. This study suggests that oral polyvalent bacterial lysate (Luivac) was safe and also showed a tendency to be effective in preventing RTIs in Thai patients with or without risk factors for recurrent RTIs. Other clinical advantages were reduction in the severity and duration of infection as well as in reduction of the cost of treatment and the number of days absent from school or work.

Ear diseases and hearing in the Thai elderly population. Part I. A comparative study of the accuracy of diagnosis and treatment by general practitioners vs ENT specialists.

The prevalence of ear disease and hearing disability in elderly Thais in 14 urban communities around Siriraj Hospital was studied. The accuracy of diagnosis and treatment of common ear diseases and of screening for hearing loss in the elderly between general practitioners (GP) and Ear, Nose and Throat (ENT) specialists was also compared. Elderly people aged 60 years or more who had registered with the health care program had their ear and hearing check-up performed by GPs and ENT specialists from mobile team. Altogether, 980 subjects were included, 332 were males, 648 were females, (male:female ratio 1:2). Their ages ranged from 60-96 years with an average age of 68.5 years. The prevalence of ear disease diagnosed by ENT specialists was 16.3 per cent (95% CI = 14.0-18.6), 12.5 per cent was external ear disease and 2.7 per cent middle ear disease. The most common ear problem was impacted ear wax (8%), the second most common problem was otitis externa (4.3%). Compared with an ENT specialist, the ability of a GP to diagnose ear diseases had a sensitivity of 46.5 per cent and a specificity of 80.3 per cent, the positive predictive value of their diagnoses was 31.5 per cent. The efficacy of the treatment of ear diseases in 51 elderly people by GPs and in 63 elderly people by ENT specialists was statistically significantly different (p = 0.02). Hearing screening by the GP using whisper or the watch test performed in 650 elderly people revealed abnormal findings (could not hear) in 70 cases or 10.8 per cent. Hearing screening using pure tone audiometry in 980 elderly people showed abnormal hearing level in 508 cases (52.4%). 9.5 per cent of them had a bilateral moderate to severe degree of hearing impairment. There was no difference in the level of hearing impairment between males and females or between right and left ears. The prevalence of hearing loss increases with increasing age. Tympanometry performed by an acoustic impedance machine in 980 of the elderly showed a conductive hearing loss in 85 cases (9.1%). The authors conclude that the prevalence of ear disease in elderly people living in the urban community around Siriraj Hospital is quite high. Although the ear diseases commonly encountered were not serious, if left untreated they may lead to complication and decreased hearing. Therefore, the proficiency of GPs in the management of common ear diseases in every community should be regularly maintained. Hearing impairment is very prevalent and increases with age. Thus, screening for hearing loss using an audiometer and/or acoustic impedance is recommended for all senior citizens in their community at least once a year. Early detection of elderly persons who could benefit from a properly fitted hearing aid will certainly improve the quality of life and may prevent psychiatric and functional impairment of the Thai elderly population.

Ear diseases and hearing in the Thai elderly population. part II. A one year follow-up study.

The ear and hearing survey of the Thai elderly in 14 urban communities around Siriraj Hospital was repeated one year after the first survey in order to detect any changes. Altogether 556 elderly people came for follow-up examination, 191 were males, 365 were females, the average age was 68.2 years (60-88 years). Ear disease was diagnosed by ENT specialists in 80 cases which implied that the prevalence of ear disease was 14.4 per cent. This was not statistically significantly different from the prevalence of ear disease in the survey conducted in the previous year and although the elderly who had ear diseases in the first survey had already been treated, the prevalence did not decrease. Some elderly people only had ear diseases in this survey. Hearing evaluation by pure tone audiometry was performed in 549 elders. There were 12.4 per cent who had bilateral, moderate to severe hearing loss which was 2.9 per cent higher than in the previous survey. The hearing level had also deteriorated in 14.3 per cent of the elderly people. Tympanometry was performed in 556 cases and showed that 10.5 per cent had a conductive hearing loss. When audiometry and tympanometry of the same elderly people were evaluated together, 49.2 per cent of them had a sensorineural hearing loss, 3 per cent had a conductive hearing loss and 6.5 per cent had a conductive or mixed type hearing loss. When the results of audiometry were compared with the self identification/perception of their hearing reported by the elderly in the questionnaires, they were not reliable. In conclusion, a one-year follow-up study of the prevalence of ear disease and hearing impairment in the elderly showed that the prevalence of ear disease was still high and had not changed significantly. Concerning hearing impairment, not only had the prevalence increased, but also the severity of hearing loss. Therefore, the authors stress the need to implement the "Ear and Hearing Care" program for the elderly both in rural and urban communities at least once a year in order to improve quality of life of the elderly Thai people and to prevent complications of ear disease.