[Correlation between severity of gastroesophageal reflux cough and degree of gastroesophageal reflux disease].

Objective: To explore the correlation between the severity of gastroesophageal reflux cough and degree of gastroesophageal reflux. Methods: A cross-sectional investigation was carried out. Data of 174 cases of chronic cough were collected in Children's Hospital of Fuzhou from March 2009 to December 2016. The esophageal 24 hours pH value dynamic monitoring was used to detect gastric acid reflux index. Cases with abnomal results were divided into mild, moderate and severe groups according to severity of reflux and that of day and night cough symptoms, respectively. They were also divided into infant (1-3 years old), preschool (4-6 years old), and school age (>7 years old) groups according to age. Comparative analysis between groups by chi-square test and rank sum test were performed. Correlation analysis was used to analyze the correlation between cough severity and gastroesophageal reflux index. Results: A total of 174 patients with chronic cough, including 115 males and 59 females, aged from 1 to 15 years with an average age of (8.5±2.3) years, and (1.6±0.8) years of disease duration were enrolled. Among them, 129 cases (74.1%) were positive for esophageal reflux test and 45 cases (25.9%) with no obvious pathological gastroesophageal reflux. Patients with positive esophageal reflux test were divided into severe (n=37, 28.7%), moderate (n=23, 17.8%), and mild (n=69, 53.5%). There was no significant difference in the distribution of gastroesophageal reflux in each age group. (The proportions of mild, moderate and severe reflux in infants were 45.0% (9/20), 25.0% (5/20), and 30.0% (6/20), respectively. The proportions of mild, moderate and severe reflux in preschool children were 53.3% (32/60), 16.7% (10/60), 30.0% (18/60), respectively. The proportions of mild, moderate and severe reflux in school age children were 57.1% (28/49), 16.3% (8/49), 26.5% (13/49), respectively χ(2)=1.204, P=0.877). There was no correlation between age group and gastroesophageal reflux (r=-0.065, P=0.489).The severity of nighttime cough was positively correlated with percentages of distal esophagus pH≤4 in time, recumbent pH≤4 in time, and DeMeester score<14.72 (r=0.689, 0.621, and 0.707 respectively, all P<0.05). There was no statistically significant correlation between the severity of nighttime cough symptoms and percentage of standing pH≤4 in time (r=0.113, P>0.05). There were no statistically significant correlation between the severity of daytime cough and all gastroesophageal reflux markers (all P>0.05). Conclusion: The severity of nocturnal symptoms of gastroesophageal reflux cough is related to the degree of gastroesophageal reflux, to which clinical pediatricians should pay attention.

Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety.

BACKGROUND: The optimal strategy of maintenance therapy for patients with mCRC is controversial. This study was to evaluate the efficacy and safety of maintenance therapy with capecitabine versus observation following inductive chemotherapy in patients with metastatic colorectal cancer. PATIENTS AND METHODS: In this randomized, open-label, multicenter, phase III trial, patients who received 18-24 weeks of induction chemotherapy with XELOX or FOLFOX and achieved disease control were randomly assigned centrally (1:1) to receive maintenance therapy of capecitabine or only observation until disease progression. The primary end point was progression-free survival (PFS) from randomization; the secondary end points included overall survival (OS), PFS from induction treatment (PFS2) and safety. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02027363. RESULTS: Between 30 July 2010 and 15 September 2013, 274 patients were enrolled in the study from 11 sites in China and randomly assigned to maintenance group (n = 136) or observation group (n = 138). Clinicopathological characteristics were balanced in two groups. The median follow-up time from randomization was 29.0 months [interquartile range (IQR) 21-36 months]. The primary end point of PFS was statistically significantly longer in capecitabine maintenance group than in observation group {6.43 [95% confidence interval (CI) 5.26-7.71] versus 3.43 (2.83-4.16) months, HR 0.54 (0.42-0.70), P < 0.001}. The median OS of capecitabine maintenance group was longer than that of observation group, but not statistically significant [25.63 (22.46-27.80) versus 23.30 (19.68-26.92) months; HR 0.85 (0.64-1.11), P = 0.2247]. Similar safety profiles were observed in both arms. The most common grade 3 or 4 toxicities in capecitabine maintenance group versus observation group were neutropenia, hand-foot syndrome, and mucositis. CONCLUSIONS: Maintenance therapy with a single agent of capecitabine can be considered an appropriate option following the induction of XELOX or FOLFOX in mCRC patients with acceptable toxicities. CLINICAL TRIALS NUMBER: NCT02027363.