Abstract: OBJECTIVE To systematically assess the clinical efficacy and safety of butylphthalide soft capsule for patients with progressive stroke. METHODS Databases including Cochrane library, Wan Fang data and CNKI and so on were searched to collect randomized controlled trials(RCTs) about butylphthalide for patients with progressive stroke from inception to December 2018. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Then, RevMan 5.3 software was used to perform meta-analysis. RESULTS Twenty-six RCTs involving 2 519 patients were included. Results of meta-analysis showed that the butylphthalide group were superior to those of the control group in the clinical efficacy rate(RR=1.23, 95%CI 1.17-1.29, P<0.000 01), The National Institutes of Health Stroke Scale score(MD=-3.01 95%CI-3.49——2.52, P<0.000 01), Chinese Stroke Scale score(MD=-3.39, 95%CI -4.70——2.08, P<0.000 01) and Barthel Index score(MD=9.84, 95%CI 6.06-13.62, P<0.000 01), and these differences were statistically significant, while there was no statistical difference between the two groups in the incidence of adverse events(RR=1.27, 95%CI 0.50-3.18, P=0.61). CONCLUSION Butylphthalide soft capsule can improve the neurological function for patients with progressive stroke without increasing the incidents of adverse events.