The efficacy and safety of Dl-3n-butylphthalide on progressive cerebral infarction: A randomized controlled STROBE study

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Abstract

Progressive cerebral infarction (PCI) is associated with high rates of mortality and disability. Many studies have shown that Dl-3n-butylphthalide (NBP) is effective against acute ischemic stroke. The administration of NBP can result in an increased number of capillaries in the ischemic region, promote the establishment of collateral circulation, protect the mitochondria, and narrow the infarction area, among other effects. In the present study, we evaluated the efficacy and safety of NBP for the treatment of PCI.

Between March 2008 and May 2012, we performed a randomized, double-blind placebo-controlled study including 304 inpatients with PCI. These patients were randomly assigned to the test (152 cases) and control groups (152 cases). The test group received 200 mg of NBP soft capsules orally, 15 minutes before each meal, 3 times daily. The control group received 200 mg of placebo soft capsules orally, 15 minutes before each meal, 3 times daily. Treatment was administered during 21 days. The National Institute of Health Stroke Scale (NIHSS) score was assessed before the treatment and on days 7, 14, 21, and 30 after treatment. The Barthel index (BI) was assessed on the same days and on day 90.

In the test group, the NIHSS scores on days 7, 14, 21, and 30 were 14.75 ± 4.85, 11.62 ± 3.49, 8.87 ± 5.17, and 6.38 ± 4.93, respectively. In the control group, they were 16.08 ± 3.76, 13.28 ± 5.02, 11.05 ± 4.25, and 8.43 ± 5.41 (P < .05), respectively. The BI on days 7, 14, 21, 30, and 90 were 51.57 ± 15.11, 61.21 ± 16.39, 70.48 ± 18.21, 76.41 ± 19.02, and 81.10 ± 15.52 for the test group and 46.79 ± 18.42, 55.93 ± 19.12, 64.84 ± 17.67, 70.65 ± 18.54, and 76.54 ± 17.05 for the control group (P < .05), respectively. Adverse events were elevation of alanine aminotransferase and aspartate aminotransferase (P > .05).

NBP was useful to improve the outcome of patients with PCI and decreased their disability for activities of daily living. NBP was an efficacious and safe treatment for PCI.

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