1. Co-construction Collaborative Innovation Center for Respiratory Disease Diagnosis and Treatment & Chinese Medicine Development of Henan Province/Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, China
2. Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China
3. Department of Respiratory Diseases, The Third Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450004, China
4. Liaoning University of Traditional Chinese Medicine, Shenyang 110847, China
5. Department of Respiratory Diseases, Shangcheng County Traditional Chinese Medicine Hospital, Shangcheng 465300, China
6. Department of Respiratory Diseases, Hopeshine Minsheng Hospital of Xinzheng, Xinzheng 451100,China
7. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Pl, Liverpool L3 5QA, UK
8. Department of Epidemiology and Health Statistics, School of Public Health, Xi’an Jiaotong University Health Science Center, Xi’an 710049, China
Corresponding author:
li_js8@163.com
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History+
Received
Accepted
Published Online
2025-10-18
2026-01-08
2026-07-21
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Abstract
Persistent pure ground-glass nodules (pGGNs) are one of the main imaging manifestations of early-stage lung cancer. However, there is a lack of effective treatment methods except surgical resection. To assess the effectiveness of YiFei SanJie Formula (YFSJF) on pGGNs, we conducted a multicenter prospective cohort study. This study was conducted in 4 centers in China. The clinical efficacy difference between the YFSJF group and non-YFSJF treatment was compared during the 2-year follow-up. The primary outcome was growth rate. The secondary outcomes included regression rate, volume of pGGN, maximum diameter of pGGN in axial plane, mean CT attenuation of pGGN in axial plane.From January 2021 to December 2022, 63 patients dropped out. Ultimately, 717 patients (91.9%) were included in the final analysis. After 2-year follow-up, pGGNs growth was observed in 27 patients (7.2%) in the YFSJF group, compared to 48 patients (14%) in the non-YFSJF (OR, 0.48; 95% CI, 0.29–0.79; P = 0.004). pGGNs regression was observed in 27 patients (7.2%) in the YFSJF group, compared to 13 patients (3.8%) in the non-YFSJF (OR, 2.31; 95% CI, 1.15–4.65; P = 0.019). In the multivariable analysis, the YFSJF group had a significant effect on the volume change of pGGNs compared with the non-YFSJF group (P < 0.001). However, maximum diameter and mean CT attenuation did not significantly differ between the two groups (P > 0.05). Conclusions: During the 2-year follow-up period, YFSJF may have a certain effect on pGGNs, which can delay the growth of pGGNs and improve the regression.
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