Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.
The Key Laboratory of Development Biology, College of Life Sciences, Jinggangshan University, Ji'an, China.
Neurol Sci. 2022 Mar;43(3):1885-1891. doi: 10.1007/s10072-021-05582-8. Epub 2021 Sep 16.
To evaluate the efficacy and safety outcome and related risk factors of Naoxueshu in the treatment of acute SICH.
Two hundred twenty patients were enrolled in this study. Diagnosis of SICH was based on neuroimaging. All the patients received regular treatment and Naoxueshu oral liquid 10 ml 3 times a day for 14 consecutive days. Surgical intervention was conducted as needed. Efficacy and safety outcomes were evaluated.
Hematoma volume decreased significantly 7 days after Naoxueshu treatment (from 27.3 ± 20.0 to 15.1 ± 15.1 ml, P < 0.0001), and it decreased further in 14-day result (6.9 ± 10.4 ml, P < 0.0001). Patients' neurological function was improved remarkably with NIHSS scores from baseline 13 points to 7-day 7 points (P < 0.0001) and 14-day 4 points (P < 0.0001). Cerebral edema was relieved only 14 days after Naoxueshu treatment (from 3 to 2 points, P < 0.0001). No clinically significant change was found in 7-day and 14-day safety results. Female sex was related independently to large 7-day hematoma volume and worse 7-day NIHSS score while it would not affect patients' 14-day outcomes. Rare cause of SICH (B = 17.4, P = 0.009) alone was related to large 14-day hematoma volume. Worse baseline NIHSS score (B = 0.3, P = 0.003) and early use of Naoxueshu (B = 2.9, P = 0.005) were related to worse 7-day and14-day neurological function.
Naoxueshu oral liquid could relieve hematoma volume and cerebral edema safely; meanwhile, it could improve patients' neurological function. Sex, cause of SICH, and time from onset to receive Naoxueshu should be taken into consideration in the treatment of SICH.
评估醒脑舒口服液治疗急性 SICH 的疗效和安全性结局及其相关风险因素。
本研究纳入 220 例患者。SICH 的诊断基于神经影像学。所有患者均接受常规治疗和醒脑舒口服液，每日 3 次，每次 10 ml，连续 14 天。根据需要进行手术干预。评估疗效和安全性结局。
醒脑舒口服液治疗 7 天后血肿体积显著减少（从 27.3±20.0 毫升减少至 15.1±15.1 毫升，P<0.0001），14 天结果进一步减少（6.9±10.4 毫升，P<0.0001）。患者的神经功能显著改善，NIHSS 评分从基线的 13 分降至 7 天的 7 分（P<0.0001）和 14 天的 4 分（P<0.0001）。醒脑舒口服液治疗 14 天后脑水肿得到缓解（从 3 分降至 2 分，P<0.0001）。7 天和 14 天的安全性结果无明显变化。女性性别与较大的 7 天血肿体积和更差的 7 天 NIHSS 评分独立相关，但不会影响患者的 14 天结局。SICH 的罕见病因（B=17.4，P=0.009）单独与较大的 14 天血肿体积相关。更差的基线 NIHSS 评分（B=0.3，P=0.003）和早期使用醒脑舒口服液（B=2.9，P=0.005）与更差的 7 天和 14 天神经功能相关。
醒脑舒口服液能安全地减轻血肿体积和脑水肿，同时改善患者的神经功能。在治疗 SICH 时，应考虑性别、SICH 病因和发病后开始使用醒脑舒口服液的时间。
