To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase.
This study is based on a real world using a multicenter, randomized, double-blind, placebo-controlled trial.Based on a real-world multi-center, randomized, double-blind, placebo-controlled trial, this study will clinically observe patients with frequent acute exacerbations of chronic obstructive pulmonary disease in the stable phase.The study will evaluate the clinical efficacy and safety of Chinese medicine treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization and application of Chinese medicine therapy in chronic obstructive pulmonary disease.This study will scientifically evaluate the clinical efficacy and safety of TCM treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization of TCM evidence-based treatment in chronic obstructive pulmonary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
848
The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.
The number of acute exacerbations
The number of acute exacerbations
Time frame: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.
The number of AECOPD leading to hospitalization and death
Deaths due to AECOPD should be recorded in the study diary.
Time frame: Change from baseline the number of AECOPD leading to hospitalization and death at month 3, 6, 9 and 12.
Time of onset of the first AECOPD
the interval between the first medication and the first AECOPD (days).
Time frame: Immediately after the intervention
Severity of AECOPD
mild, moderate and severe
Time frame: Change from baseline severity of AECOPD at month 3, 6, 9and 12.
Duration of AECOPD
The duration of acute exacerbation is from the beginning of an acute exacerbation to the stabilization of the disease
Time frame: Change from baseline duration of AECOPD at month 3, 6, 9and 12.
Case fatality rate
including the case fatality rate of AECOPD and the all-cause case fatality rate
Time frame: Up to month 12
Lung function
FVC, FEV1, FEV1 % of the estimated value, FEV1/FVC were mainly used for evaluation
Time frame: Change from baseline lung function at month 3, 6, 9and 12.
Score for clinical signs and symptoms
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Formulate with reference to the "Guidelines for Clinical Research of New Chinese Medicines"Clinical scoring is weighted or assigned according to some of the main symptoms, signs, physiological parameters of patients, etc., so as to quantitatively evaluate the severity of the disease.The higher the score, the worse the state.
Time frame: Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.
6-minute walking distance (6MWD)
The 6-minute walking test standard published by ERS and ATS was adopted
Time frame: Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.
The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT)
The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT), with a score range of 0 to 40.The higher the score, the worse the state.
Time frame: Change from baseline the chronic obstructive pulmonary patient self-assessment test (CAT) at month 3, 6, 9and 12.
The MOS item short fromhealth survey(SF-36)
SF-36 Includes 8 dimensions: physical functioning, physical functioning, somatic pain, general health status, social functioning, emotional functioning, and mental health.The higher the score, the worse the state.
Time frame: Change from baseline SF-36 scale at month 3, 6, 9and 12.