Yang Jian, Liu Chan, Li Jianxiong, Chen Xianqiu, Wang Beibei, Zhang Jing, Wang Haifeng, Zhao Deping, Zhou Yiming, Cai Haomin, Xu Jin-Fu, Liang Shuo
Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Institute of Respiratory Medicine, Tongji University School of Medicine, Shanghai, China.
Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
BMC Infect Dis. 2025 Jul 3;25(1):895. doi: 10.1186/s12879-025-11267-w.
Surgical resection is considered the most effective therapeutic method for pulmonary aspergilloma (PA), while the necessity of postoperative antifungal therapy remains controversial. Previous studies have several shortcomings such as retrospective design and inadequate follow-up durations. In this study, we aim to address these evidence gaps by evaluating the effects of postoperative antifungal therapy on both Aspergillus infection recurrence and drug-related side effects.
We conducted a prospective, randomized, controlled, single-center clinical trial. Eligible patients with PA who underwent surgical resection at our institute were enrolled and randomly assigned to receive either a 3-month course of voriconazole (VRZ) tablet postoperatively or symptomatic treatment alone. Participants were evaluated for Aspergillus infection recurrence and drug-related side effects every 3 months for 2 years. Ultimately, 36 patients in the VRZ group and 14 patients in the control group were included in the analysis, with balanced baseline characteristics between groups.
After a median follow-up of 27 months, no recurrence of Aspergillus infection was observed in either group. Symptomatic improvements (e.g., hemoptysis and white sputum) were comparable between groups. Although serum IgG level significantly increased by 2.22 g/L after VRZ treatment (p < 0.001), other parameters indicating immune activity (CD4%, CD8%, CD4/CD8 ratio, IgA, IgM and Aspergillus-specific IgG) and pulmonary function showed no significant intergroup differences at the final follow-up. Regarding safety, VRZ intervention was associated with a significant increase in aspartate aminotransferase level (20.9 ± 6.2 U/L to 26.5 ± 7.8 U/L, p = 0.023). Hypokalemia incidence was numerically higher in the VRZ group (21.4% vs. 0, p = 0.530), though not statistically significant.
Our findings demonstrated that postoperative antifungal therapy did not reduce Aspergillus recurrence rate but posed potential safety risks. For immunocompetent patients undergoing complete resection without intraoperative fungal spillage, routine postoperative antifungal agents are not recommended.
Chinese Clinical Trial Registry Number: ChiCTR1800019990, registration date: December 11th, 2018.
手术切除被认为是治疗肺曲菌球（PA）最有效的方法，而术后抗真菌治疗的必要性仍存在争议。以往的研究存在一些缺点，如回顾性设计和随访时间不足。在本研究中，我们旨在通过评估术后抗真菌治疗对曲霉菌感染复发和药物相关副作用的影响来填补这些证据空白。
我们进行了一项前瞻性、随机、对照、单中心临床试验。纳入在我院接受手术切除的符合条件的PA患者，并随机分配接受术后3个月的伏立康唑（VRZ）片剂治疗或仅进行对症治疗。参与者在2年的时间里每3个月接受一次曲霉菌感染复发和药物相关副作用的评估。最终，VRZ组36例患者和对照组14例患者纳入分析，两组基线特征均衡。
中位随访27个月后，两组均未观察到曲霉菌感染复发。两组症状改善情况（如咯血和白痰）相当。虽然VRZ治疗后血清IgG水平显著升高2.22g/L（p<0.001），但在最终随访时，其他表明免疫活性的参数（CD4%、CD8%、CD4/CD8比值、IgA、IgM和曲霉菌特异性IgG）和肺功能在组间无显著差异。关于安全性，VRZ干预与天冬氨酸转氨酶水平显著升高有关（20.9±6.2U/L至26.5±7.8U/L，p=0.023）。VRZ组低钾血症发生率在数值上更高（21.4%对0，p=0.530），但无统计学意义。
我们的研究结果表明，术后抗真菌治疗并未降低曲霉菌复发率，但存在潜在的安全风险。对于免疫功能正常、接受完整切除且术中无真菌溢出的患者，不建议常规使用术后抗真菌药物。
中国临床试验注册中心编号：ChiCTR1800019990，注册日期：2018年12月11日。
