Naoxueshu Oral Liquid Promotes Hematoma Absorption and Relieves Neurological Symptoms in Chronic Subdural Hematoma Patients: A Prospective, Single-Arm, Self-Controlled Study.

Abstract

Objective: To investigate the potential of Naoxueshu Oral Liquid (NXS) to promote hematoma absorption in patients with chronic subdural hematoma (CSDH).

Methods: From September 2020 to August 2023, 60 patients with CSDH confirmed by computed tomography (CT) scan were enrolled in this prospective clinical trial. All patients received NXS at a dose of 10 mL thrice daily for 90 d. The outcomes included changes in maximal hematoma thickness (MHT), scores of Markwalder Grading Scale-Glasgow Coma Scale (MGS-GCS) and Barthel Index (BI) on days 30, 60, 90, and 180 from baseline, as well as the relapse rate by day 180. For subgroup analysis, patients aged over 60 years were divided into an elderly group (60-74 years) and an oldest-old group (> 75 years) to evaluate the effect of NXS in older individuals. Safety was also assessed during the study.

Results: All participants were included in the full analysis set (FAS) according to the modified intention-to-treat principle. On day 90, MHT significantly decreased from 16.00 [interquartile range [(IQR) 12.00-24.60] mm to 3.75 (IQR 0-10.00) mm (P<0.01), with complete hematoma absorption observed in 30% (18/60) of patients. MGS-GCS scores on days 90 and 180 and BI on day 180 significantly improved compared with baseline (P<0.05 or P<0.01). The relapse rate on day 180 was 1.5% (1/60) in the FAS. Both subgroups showed significant within-group improvements in MHT, MGS-GCS, and BI (P<0.01). Intergroup differences were noted in MHT, BI, and MGS-GCS at specific time points (P<0.05 or P<0.01). No treatment-related adverse events were reported.

Conclusions: NXS may promote hematoma absorption and improve neurological impairment in patients with CSDH. These findings suggest that NXS represents a potentially effective treatment for CSDH. (Trial registration No. ChiCTR2400090565).