PMID- 29443750
OWN - NLM
STAT- MEDLINE
DCOM- 20180222
LR  - 20221207
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 7
DP  - 2018 Feb
TI  - Effect and safety of roflumilast for chronic obstructive pulmonary disease in 
      Chinese patients.
PG  - e9864
LID - 10.1097/MD.0000000000009864 [doi]
LID - e9864
AB  - BACKGROUND: This trial aimed to evaluate the efficacy and safety of roflumilast 
      for treating Chinese patients with chronic obstructive pulmonary disease (COPD). 
      METHODS: A total of 120 patients with COPD were recruited and were randomly 
      divided into 2 groups (an intervention group and a placebo group) at a 1:1 ratio. 
      Patients received either roflumilast or placebo 500 mug once daily for a total of 
      12 months. The primary outcome was lung function, measured by the change from 
      baseline of forced expiratory volume in 1 second (FEV1), FVC = forced vital 
      capacity (FVC), and FEF25-75%. The secondary outcome measurements included the 
      quality of life, measured with the St. George's Respiratory Questionnaire (SGRQ). 
      All outcomes were measured at the end of 12-month treatment and 3-month follow-up 
      after the treatment. In addition, adverse events (AEs) were also recorded during 
      the treatment period. RESULTS: FEV1, FVC, FEF25-75%, and SGRQ were significantly 
      better in the intervention group than those in the placebo group at the end of 
      12-month treatment and 3-month follow up after treatment. Moreover, AEs were much 
      higher with roflumilast than placebo in this study. CONCLUSIONS: The findings 
      suggest that roflumilast has promising effect to improve lung function in Chinese 
      population with COPD.
FAU - Liu, Dong-Yang
AU  - Liu DY
AD  - Department of Respiratory Medicine, The People's Hospital of Yan'an, Yan'an 
      Department of Respiratory Medicine, Xi'an Central Hospital, Xi'an Department of 
      Respiratory Medicine, Affiliated Hospital of Yan'an University, Yan'an, China.
FAU - Wang, Zhi-Guo
AU  - Wang ZG
FAU - Gao, Yuan
AU  - Gao Y
FAU - Zhang, Hui-Min
AU  - Zhang HM
FAU - Zhang, Yu-Xiang
AU  - Zhang YX
FAU - Wang, Xiao-Jun
AU  - Wang XJ
FAU - Peng, Dan
AU  - Peng D
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Aminopyridines)
RN  - 0 (Benzamides)
RN  - 0 (Cyclopropanes)
RN  - 0 (Phosphodiesterase 4 Inhibitors)
RN  - 0P6C6ZOP5U (Roflumilast)
SB  - IM
MH  - Aged
MH  - *Aminopyridines/administration & dosage/adverse effects
MH  - Asian People
MH  - *Benzamides/administration & dosage/adverse effects
MH  - Cyclopropanes/administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Monitoring
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Outcome and Process Assessment, Health Care
MH  - Phosphodiesterase 4 Inhibitors/administration & dosage/adverse effects
MH  - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug 
      therapy/ethnology/psychology
MH  - *Quality of Life
MH  - Respiratory Function Tests/methods
MH  - Surveys and Questionnaires
PMC - PMC5839818
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2018/02/15 06:00
MHDA- 2018/02/23 06:00
PMCR- 2018/02/16
CRDT- 2018/02/15 06:00
PHST- 2018/02/15 06:00 [entrez]
PHST- 2018/02/15 06:00 [pubmed]
PHST- 2018/02/23 06:00 [medline]
PHST- 2018/02/16 00:00 [pmc-release]
AID - 00005792-201802160-00024 [pii]
AID - MD-D-17-07485 [pii]
AID - 10.1097/MD.0000000000009864 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Feb;97(7):e9864. doi: 10.1097/MD.0000000000009864.