Background Individual studies have suggested the utility of fractional exhaled nitric oxide (F eno ) measurement in detecting cough-variant asthma (CVA) and eosinophilic bronchitis (EB) in patients ...with chronic cough. Objective We sought to obtain summary estimates of diagnostic test accuracy of F eno measurement in predicting CVA, EB, or both in adults with chronic cough. Methods Electronic databases were searched for studies published until January 2016, without language restriction. Cross-sectional studies that reported the diagnostic accuracy of F eno measurement for detecting CVA or EB were included. Risk of bias was assessed with Quality Assessment of Diagnostic Accuracy Studies 2. Random effects meta-analyses were performed to obtain summary estimates of the diagnostic accuracy of F eno measurement. Results A total of 15 studies involving 2187 adults with chronic cough were identified. F eno measurement had a moderate diagnostic accuracy in predicting CVA in patients with chronic cough, showing the summary area under the curve to be 0.87 (95% CI, 0.83-0.89). Specificity was higher and more consistent than sensitivity (0.85 95% CI, 0.81-0.88 and 0.72 95% CI, 0.61-0.81, respectively). However, in the nonasthmatic population with chronic cough, the diagnostic accuracy to predict EB was found to be relatively lower (summary area under the curve, 0.81 95% CI, 0.77-0.84), and specificity was inconsistent. Conclusions The present meta-analyses indicated the diagnostic potential of F eno measurement as a rule-in test for detecting CVA in adult patients with chronic cough. However, F eno measurement may not be useful to predict EB in nonasthmatic subjects with chronic cough. These findings warrant further studies to validate the roles of F eno measurement in clinical practice of patients with chronic cough.
Exposure to allergens or irritants in the workplace may affect asthma control and the quality of life (QoL) of patients with asthma.
To examine the prevalence and characteristics of work-related ...asthma (WRA) in adult patients with severe asthma.
We analyzed data from the Korean Severe Asthma Registry (KoSAR), which is a nationwide multicenter observational study on severe asthma in Korea. Severe asthma was defined according to the American Thoracic Society (ATS) and the European Respiratory Society (ERS) guidelines. WRA was identified on the basis of asthma symptom aggravation at the workplace, as indicated by responses to a structured questionnaire. We compared the demographic and clinical characteristics and QoL between adult patients with severe asthma and WRA and those without WRA.
Among 364 patients with severe asthma who were employed at the time of enrollment, 65 (17.9%) had WRA. There were no significant differences in age, sex, obesity, or smoking history between the WRA and non-WRA groups. However, individuals with WRA exhibited a higher prevalence of anxiety (7.7% vs 2.4%, P = 0.046) and depression (12.3% vs 3.7%, P = 0.010) than those without. The levels of asthma control, lung function, and frequency of asthma exacerbations were similar between the two groups, but patients with WRA reported lower QoL, as determined by the Quality of Life Questionnaire for Adult Korean Asthmatics (56.6 ± 14.6 vs. 63.5 ± 13.9, P < 0.001).
Patients with severe asthma and WRA are more likely to experience anxiety and depression and have lower QoL than those without WRA.
Tiotropium, a long-acting muscarinic antagonist, is recommended for add-on therapy to inhaled corticosteroids (ICS)-long-acting beta 2 agonists (LABA) for severe asthma. However, real-world studies ...on the predictors of response to tiotropium are limited. We investigated the real-world use of tiotropium in asthmatic adult patients in Korea and we identified predictors of positive response to tiotropium add-on.
We performed a multicenter, retrospective, cohort study using data from the Cohort for Reality and Evolution of Adult Asthma in Korea (COREA). We enrolled asthmatic participants who took ICS-LABA with at least 2 consecutive lung function tests at 3-month intervals. We compared tiotropium users and non-users, as well as tiotropium responders and non-responders to predict positive responses to tiotropium, defined as 1) increase in forced expiratory volume in 1 s (FEV1) ≥ 10% or 100 mL; and 2) increase in asthma control test (ACT) score ≥3 after 3 months of treatment.
The study included 413 tiotropium users and 1756 tiotropium non-users. Tiotropium users had low baseline lung function and high exacerbation rate, suggesting more severe asthma. Clinical predictors for positive response to tiotropium add-on were 1) positive bronchodilator response (BDR) odds ratio (OR) = 6.8, 95% confidence interval (CI): 1.6–47.4, P = 0.021 for FEV1 responders; 2) doctor-diagnosed asthma-chronic obstructive pulmonary disease overlap (ACO) OR = 12.6, 95% CI: 1.8–161.5, P = 0.024, and 3) initial ACT score <20 OR = 24.1, 95% CI: 5.45–158.8, P < 0.001 for ACT responders. FEV1 responders also showed a longer exacerbation-free period than those with no FEV1 increase (P = 0.014), yielding a hazard ratio for the first asthma exacerbation of 0.5 (95% CI: 0.3–0.9, P = 0.016).
The results of this study suggest that tiotropium add-on for uncontrolled asthma with ICS-LABA would be more effective in patients with positive BDR or ACO. Additionally, an increase in FEV1 following tiotropium may predict a lower risk of asthma exacerbation.
Objectives The object of this study was to introduce the KORean Observational study Network for Arthritis (KORONA) registry with an emphasis on the design of the Korean rheumatoid arthritis (RA) ...national database, as well as to provide an overview of the RA patients who are currently registered in KORONA. Methods The KORONA was established in July 2009 by the Clinical Research Center for Rheumatoid Arthritis (CRCRA) in South Korea. KORONA is based on a prospective protocol and standard, defined data collection instruments. Demographic and clinical features, laboratory and radiologic data, health-related outcomes, treatment side effects, resource utilization, and health behaviors of the RA cohort patients are recorded in a database. Results A total of 23 institutions, which are about 38% of the rheumatologic departments at tertiary academic hospitals across South Korea, are part of KORONA. The quality control of data collection and management has been performed through annual monitoring and auditing, staff training, and providing standard operation protocol by the executive committee of CRCRA. As of 31 December 2010, 4721 patients with established RA were included in KORONA, because an annual survey had started to be performed in July 2010. Conclusions KORONA is the first nationwide Korean RA-specific cohort and it will provide valuable “real-world” information for Korean RA patients.
Background Pattern hair loss (PHL) can be classified into several patterns. Currently, the Hamilton–Norwood classification system for men and the Ludwig grade system for women are commonly used ...to describe patterns of hair loss. However, these pre-existing classifications have some limitations. Objective To establish an acceptable, universal, and accurate standard of both male and female pattern hair loss and to report its use in determining the incidence of PHL. Methods We developed a new classification system (BASP classification) and then applied this system to classify the types of PHL. The BASP classification was based on observed patterns of hair loss. The basic (BA) types represent the shape of the anterior hairline, and the specific types (SP) represent the density of hair on distinct areas (frontal and vertex). There are four basic types (L, M, C, and U) and two specific types (F and V). The final type is decided by the combination of the assigned basic and specific types. Between November 2004 and June 2005, 2213 Korean subjects, comprised of 1768 males and 445 females, were classified according to the BASP classification at 13 university dermatologic centers nationwide throughout South Korea, as a multicenter study of the Korean Hair Research Society. Results For both sexes, the majority of patients enrolled in the study were in the third and fourth decade of life (65.1% of males and 56.68% of females). In males, the older group as well as the younger group in the study were more likely to have little recession of the frontal hairline (classified as type M1∼2) and diffuse thinning over the top of scalp (type F1∼2). The women in the study developed typical female PHL. Limitations The subjects of our study were mostly outpatients and some inpatients who complained about hair loss, not the general population of Korea. Conclusion The BASP classification is a new stepwise, systematic, and universal classification system for PHL, regardless of sex.
A nomogram is a predictive statistical model that generates the continuous probability of a clinical event such as death or recurrence. The aim of the study was to construct a nomogram to predict ...5-year overall survival after postoperative radiation therapy for stage IB to IIA cervical cancer.
The clinical data from 1702 patients with early-stage cervical cancer, treated at 10 participating hospitals from 1990 to 2011, were reviewed to develop a prediction nomogram based on the Cox proportional hazards model. Demographic, clinical, and pathologic variables were included and analyzed to formulate the nomogram. The discrimination and calibration power of the model was measured using a concordance index (c-index) and calibration curve.
The median follow-up period for surviving patients was 75.6 months, and the 5-year overall survival probability was 87.1%. The final model was constructed using the following variables: age, number of positive pelvic lymph nodes, parametrial invasion, lymphovascular invasion, and the use of concurrent chemotherapy. The nomogram predicted the 5-year overall survival with a c-index of 0.69, which was superior to the predictive power of the International Federation of Gynecology and Obstetrics (FIGO) staging system (c-index of 0.54).
A survival-predicting nomogram that offers an accurate level of prediction and discrimination was developed based on a large multi-center study. The model may be more useful than the FIGO staging system for counseling individual patients regarding prognosis.
Background Recently, placement of fully covered self-expandable metal stents (FCSEMSs) has been proposed as an alternative treatment for the management of benign biliary strictures. However, the ...major limitations of FCSEMSs are frequent migration and removal complications. Objective We conducted this study to compare the antimigration effects, complication rates, and short-term efficacy of 2 FCSEMSs with either an anchoring flap (AF) or a flared end (FE) at the proximal end of the stent. Design A multicenter, prospective comparative pilot study. Setting Two tertiary referral centers. Patients A total of 43 patients with benign biliary stricture who were candidates for placement of FCSEMSs were assigned to the AF (n = 22) or the FE group (n = 21). Interventions Predefined duration of placement and removal of FCSEMSs. Results After a median period of placement of 6 months (interquartile range 4-6), no patients in the AF group and 33% of patients (7 of 21, 1 in proximal and 6 in distal) in the FE group had stent migration ( P = .004). The removal rate of the FCSEMSs was 100% in both groups (per protocol, n = 22 in the AF group and n = 17 in the FE group). Immediate improvement of biliary stricture was 91% (20/22, per protocol) in the AF group and 88% (15/17, per protocol) in the FE group. All stents were removed without difficulty. Limitations Short-term follow-up after the removal of FCSEMSs. Conclusions With regard to the antimigration effect of FCSEMSs for benign biliary stricture, the AF design may be superior to the FE. For up to 6 months, both FCSEMSs can be endoscopically removed without complications. (Clinical trial registration number: NCT00945516 .)
Abstract Purpose The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. ...Methods Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2). Findings Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were −2.0 (8.8) mm Hg in the L10 group, −6.7 (8.5) mm Hg in L10/V80 group, and −8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was −4.6 mm Hg (95% CI, −6.5 to −2.6; P < 0.001) in the L10/V80 group and −5.9 mm Hg (95% CI, −7.9 to −4.0, P < 0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were −5.6 (7.9)/−8.0 (12.0) mm Hg and −5.5 (7.0)/−8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups. Implications Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.
Little is known about the characteristics of anaphylaxis in Korea or even in Asia.
To evaluate the incidence of anaphylaxis and the clinical features of patients with anaphylaxis in a Korean tertiary ...care hospital.
We performed a retrospective review from January 1, 2000, through July 31, 2006, of 138 patients with anaphylaxis, including inpatients, outpatients, and emergency department visitors, in the Seoul National University Hospital.
Among 978,146 patients, 138 (0.014%) had anaphylaxis. Two cardiopulmonary resuscitations were performed and 1 death occurred. The total mortality rate of anaphylactic patients was 0.0001%. The causes of anaphylaxes were drug (35.3%), food (21.3%), food-dependent exercise-induced (13.2%), idiopathic (13.2%), insect stings (11.8%), exercise induced (2.9%), blood products (1.5%), and latex (0.7%). Radiocontrast media and buckwheat were the leading causes of drug and food anaphylaxis, respectively. The organs most frequently involved in the anaphylaxis were cutaneous (95.7%), cardiovascular (76.8%), and respiratory (74.6%). The most common manifestations were dyspnea (71.3%), urticaria (81.9%), and angioedema (69.4%). Three of 138 patients (2.2%) had biphasic reactions.
The incidence, mortality rate, and clinical features of Korean patients with anaphylaxis were similar to rates for patients from other countries, despite some differences in causative agents.
Abstract Background context There are limited data analyzing radiological and clinical factors for the functional outcomes of surgery for spinal metastasis. Also, there are few studies to investigate ...the relationship between the functional outcome and the patients' survival. Thus, analysis of both functional outcomes and the survival with their relationship in a possibly homogenous group of patients is worth being reported. Purpose To assess treatment outcomes of single-stage posterior decompression and stabilization (PDS) with or without corpectomy for thoracic vertebral metastases and to analyze factors affecting both the functional outcome and the patients' survival after the surgical intervention. Study design Retrospective observational study. Patient sample A consecutive series of 105 patients, who underwent the previously stated surgery for metastatic spinal cord compression (MSCC) of thoracic spine, were included and retrospectively analyzed. Outcome measures The postoperative functional outcomes were evaluated using visual analog scale and Frankel grade at postoperative 2 weeks, and all patients were followed for survival analysis. Methods An institutional database was searched to identify all patients who underwent single-stage PDS for thoracic metastatic spinal tumors between March 2002 and June 2010. Demographic data as well as preoperative and postoperative medical conditions were collected from medical records. Radiological findings were confirmed on electronic archive. Survival data were obtained either on medical records or with a reference to governmental cancer registry system. Results Postoperative pain improvement was more evident in patients receiving anterior column reconstruction and four or more levels of fixation (p=.02 and <0.01, respectively). Twenty-one patients (20%) showed improvement of the Frankel grade, and 10 of 21 Frankel C patients became ambulatory. The preoperative Karnofsky Performance Scale (≥70) and ambulatory status were significant predictors for the postoperative ambulatory function. After surgery, the median overall survival of the patients was 6.0 months. In the univariate analysis, the patient's age (younger than 60 years), type of primary cancer (ie, moderate and slow growth), no visceral metastases, less than three levels of spinal metastases, and postoperative adjuvant therapy were positively significant for the patients' survival (p<.05). In the multivariate analysis, limited (less than three levels) spinal metastases and postoperative adjuvant therapy were proven to significantly prolong the patient's survival (hazard ratios of 0.53 and 0.48, respectively, p<.05). Although the functional outcomes did not directly influence the patients' survival, the patients with better functional outcome showed increased chance of receiving postoperative adjuvant therapy (p<.01). Conclusions Single-stage PDS with or without corpectomy effectively improved the functional status of patients with MSCC of the thoracic spine and also afforded the patients to have more chances of postoperative adjuvant therapy, which was significant for patients' survival. Therefore, we suggest that the role of surgery in the management of MSCC could be not only a symptomatic palliation but also a strategy to prolong patients' survival.