研究破血逐瘀法治疗脑出血超早期的临床疗效和安全性。

选择2019年1月至2020年6月廉江市人民医院脑卒中科收治的80例满足入组条件的急性脑出血患者作为研究对象，随机分为观察组和对照组，每组40例。观察组采用西医治疗+中药（原方）治疗，对照组采用一般西医治疗+中药安慰剂（原方安慰剂）治疗，在发病入院时、发病后24 h及第3、7、14天各复查1次头颅CT。记录各组患者发病24 h内血肿扩大率、第1周内患者每天的意识变化（GCS评分），以及14 d内的病死率。采用ELISA检测不同治疗方法下患者治疗前和治疗后第3、10天的炎症指标变化；同时，应用改良Rankin量表（mRs）、神经功能缺损评估（NIHSS）评分、生活能力评估[Barthel指数（BI指数）]、社会功能活动问卷（FAQ）评估患者治疗后第90天的临床预后情况。

观察组和对照组患者的血肿扩大率、不良反应发生率、14 d内病死率差异无统计学意义（P>0.05），超急性期应用破血逐瘀药未明显增加安全风险。相较于对照组，观察组患者治疗后第7天时GCS评分更高，NIHSS评分更低，差异有统计学意义（P<0.05）。观察组患者治疗后第90天的BI指数高于对照组、FAQ评分低于对照组，差异有统计学意义（P<0.05）。2组患者治疗前的炎症指标肿瘤坏死因子α（TNF-α）和白细胞介素-1β（IL-1β）差异均无统计学意义（P>0.05），但观察组患者在水肿高峰期（第3天）和高峰期后（第10天）的TNF-α和IL-1β水平低于对照组，差异有统计学意义（P<0.05）。

脑出血患者超早期应用破血逐瘀法治疗不会明显增加安全风险，有助于控制炎症反应和改善意识和神经功能恢复，并一定程度提高了患者的临床预后。

To study the clinical efficacy and safety of the method of breaking blood and driving blood stasis in the treatment of cerebral hemorrhage at super early stage.

Eighty patients with acute cerebral hemorrhage who met the inclusion criteria in Stroke Centre of Lianjiang People’s Hospital from January 2019 to June 2020 were selected as subjects and randomly divided into observation group and control group with 40 patients in each group. The observation group was treated with western medicine plus traditional Chinese medicine (original prescription), while the control group was treated with general western medicine plus traditional Chinese medicine placebo (original prescription). Skull CT was performed once at admission, 24 h, 3 d, 7 d, and 14 d after the onset of the disease. The percentage of hematoma enlargement within 24 h after the onset of the disease, the daily change in patients’ consciousness (GCS score) during the first week, and the mortality within 14 d were recorded in each group. ELISA was used to detect the changes of inflammatory indexes before treatment, on the 3^rd day after treatment, and on the 10^th day after treatment. At the same time, improved Rankin scale (mRs), evaluation of neurological deficits (NIHSS), life ability assessment (BI index), and social function activity questionnaire (FAQ) were used to evaluate the clinical prognosis of patients in each group at the 90^th day after treatment.

There were no statistically significant differences between the observation group and the control group in the rate of hematoma enlargement, incidence of adverse reactions, and mortality within 14 d (P>0.05), the application of blood-breaking and blood-stasis removing drugs in the hyperacute stage did not significantly increase the safety risk. Compared with the control group, patients in the observation group had higher GCS scores and lower NIHSS scores on day 7 after treatment, and the difference was statistically significant (P<0.05). On the 90^th day after treatment, BI and FAQ score of patients in the observation group were higher than those in the control group, and the difference was statistically significant (P<0.05). There were no statistically significant differences in the inflammatory markers tumor necrosis factor α (TNF-α) and interleukin-1β (IL-1β) between the two groups before treatment (P>0.05), but the levels of TNF-α and IL-1β in the observation group were lower than those in the control group at the peak of edema (day 3) and after peak edema (day 10), and the differences were statistically significant (P<0.05).

The super-early treatment of cerebral hemorrhage with the method of breaking blood and driving blood stasis will not significantly increase the safety risk, which is helpful to control the inflammatory response and improve the recovery of consciousness and nerve function, and improve the clinical prognosis of patients to a certain extent.