Abstract
BackgroundIn recent years, the incidence of pulmonary aspergilloma has increased. The harm of aspergilloma is life-threatening massive hemoptysis, and the conventional treatment is surgical treatment. However, whether the antifungal treatment after surgery is required and the course of treatment before and after surgery are still unclear.MethodsIn this study, patients with pulmonary aspergilloma confirmed pathologically after surgery will be selected as subjects to conduct a single-center, randomized, parallel grouping, prospective, 2-year clinical study. Through regular visits, the recurrence of aspergillus infection, quality of life, lung function indicators, safety of antifungal therapy and other indicators were recorded to evaluate the recurrence risk of aspergillus infection and safety of antifungal agents. Cox proportional risk regression model was used to analyze the influencing factors of antifungal therapy on aspergillus infection recurrence after aspergillus bulbectomy. Cox multiple regression model was used for optimal model fitting, and regression coefficient (β), relative risk (RR) and 95% confidence interval of RR were calculated.DiscussionThe study will explore whether antifungal therapy could improve the quality of life, reduce the recurrence of aspergillus infection, and ultimately improve the prognosis of patients with aspergilloma. The study results will provide high-quality evidence-based medical evidence for the formulation, revision and optimization of international and domestic clinical guidelines and expert consensus on chronic aspergillus lung disease, effectively improve the clinical treatment effect of aspergilloma, and form the latest concept of diagnosis and treatment of aspergilloma.Trial registration: The trial was registered on the Chinese Clinical Trial Registry website (https://www.chictr.org.cn/showprojen.aspx?proj=33231). Registration number: ChiCTR1800019990.
Highlights
In recent years, the incidence of pulmonary aspergilloma has increased
As for the acute and long-term prognosis of patients with pulmonary aspergilloma treated by surgery, studies [5] showed that the overall survival rate at 2, 5 and 10 years was 86.6%, 79.4% and 79.4%, respectively, and the disease-free survival rates were 86.6%, 72.6% and 72.6%, respectively
This study was designed to evaluate the difference in recurrence risk of aspergillus infection and safety of antifungal agents in patients with pathologically confirmed aspergilloma after surgery in a single-center, randomized, parallel grouping, prospective, 2-year clinical study
Summary
Study design and setting The study was a single-center, prospective, non-blind, randomized, 24-month parallel controlled trial. Exclusion criteria (1) Patients with a severe disease other than the lung that, in the investigator’s judgment, would put the subject at risk for participating in the study or affect the results of the study and the subject’s ability to participate in the study. If one of the following situations occurs, the principal investigator shall comprehensively judge whether to exclude the subject based on the degree of completion of the test and the reasons for withdrawal, and make relevant explanations: 1. The Investigator has the right to discontinue the subject’s participation in the study if: the investigator must carefully evaluate the discontinued subject, take active treatment, and record this procedure in detail in the original notebook. The investigator may determine at any time during the study whether or not the subject should continue the clinical trial based on medical judgment
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