To explore the the clincial efficacy and safety of butylphthalide soft capsules combined with dual anti-platelet therapy (DAPT) in the treatment of non-disabling ischemic cerebrovascular events (NICE).

The patients with NICE admitted to the hospital were enrolled as the research objects. According to random number table method, they were divided into treatment group and control group. Control group was treated with DAPT (aspirin enteric-coated tablets 100 mg·d^-1+ clopidogrel bisulfate tablets 75 mg·d^-1), while treatment group was treated with butylphthalide soft capsules 0.6 g·d^-1 on basis of control group for 1 month. The clinical curative effect, incidence of recurrent cerebral infarction within 6 months of follow-up, levels of NLR family Pyrin domain containing protein 3 (NLRP3) inflammasome, homocysteine (Hcy) and interleukin (IL)-6, plasma viscosity, whole blood high-shear viscosity, low-shear viscosity and hematocrit were compared between the two groups, and the safety was evaluated.

Among the 130 patients in this study, there were 120 cases included finally after excluding 10 cases not meeting the inclusion criteria. According to random number table method, they were divided into treatment group and control group, and there was no case lost to follow-up in the study process. After treatment, total response rate in treatment group was 93.33% (56 cases /60 cases) which was statistically significantly higher than that in control group [80.00% (48 cases /60 cases), P<0.05]. After treatment, scores of National Institutes of Health stroke scale (NIHSS) in treatment group and control group were (1.10±0.12) and (1.85±0.21) points, scores of modified Rankin scale (mRS) were (1.10±0.12) and (1.82±0.19) points, scores of activity of daily living (ADL) were (68.97±6.96) and (60.11±6.12) points, levels of NLRP3 inflammasome were (1.40±0.16) and (1.96±0.21) μg·L^-1, IL-6 levels were (24.15±2.57) and (31.27±3.35) pg·mL^-1, Hcy levels were (20.18±2.13) and (27.78±3.14) μmol·L^-1, plasma viscosity were (1.59±0.16) and (1.81±0.19) mPa·s^-1, whole blood high-shear viscosity were (4.01±0.41) and (4.78±0.50) mPa·s^-1, whole blood low-shear viscosity were (10.42±1.15) and (11.87±1.20) mPa·s^-1, and hematocrit were (0.25±0.03) and (0.33±0.04) L·L^-1, there were statistically significant differences in the above indexes between the two groups (all P<0.05). After 6 months of follow-up, incidence of recurrent cerebral infarction in treatment group was 8.33% (5 cases /60 cases) which was statistically significantly lower than that in control group [23.33% (14 cases / 60 cases), P<0.05]. The main adverse drug reactions in treatment group were subcutaneous ecchymosis 1 case (1.67%), nausea 1 case (1.67%) and gastrointestinal discomfort 3 cases (5.00%), while which in control group were subcutaneous ecchymosis 2 cases (3.33%), nausea 2 cases (3.33%), vomiting 1 case (1.67%) and gastrointestinal discomfort 2 cases (3.33%). There was no significant difference in total incidence of adverse drug reactions between treatment group and control group (8.33% vs 11.67%, P>0.05).

Curative effect of butylphthalide soft capsule combined with DAPT is good in NICE patients, which can reduce level of NLRP3 inflammasome, improve blood circulation, reduce incidence of recurrent cerebral infarction and will not increase adverse drug reactions.