The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP.
The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP. During the observation, study visits will occur at the end of each month. During the 1-year follow-up period which is lasting 6 months after the treatment, all participants will be required to check the various efficacy indicators.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
GM-CSF will be given subcutaneously according to the rule in different groups.
using double lumen endotracheal tube (DLT) to selectively lavage one lung
Shanghai Pulmonary Hospital
Shanghai, China
RECRUITINGImprovements in double pulmonary diffuse lesions （Chest CT score ）
Time frame: 6 months
Clinical symptoms observation: shod of breath, cough (according to each score standard）
Time frame: 6 months
Granulocyte Macrophage Colony Stimulating Factor(GM-CSF) Antibody titer change
Time frame: 6 months
Improvements in pulmonary function
Pulmonary function tests include residual volume/total lung capacity(RV/TLC), forced vital capacity(FVC), forced expiratory volume in one second/forced vital capacity(FEV1/FVC), diffusing capacity of carbon monoxide(DLCO).
Time frame: 6 months
Improvements in arterial blood gas, including alveolar-arterial oxygen difference(A-aDO2), partial pressure of oxygen(PaO2), partial pressure of carbon dioxide in artery(PaCO2), arterial oxygen saturation(SaO2).
Time frame: 6 months
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