Plasmin® (rongshuan jiaonans) is a medicine from China - which has gone through a high technology of biochemical extraction - that has thrombolitic effect, fibrinolytic effect, anticoagulant, antiplatelet and anti-inflamation effect. The purpose of this study was to evaluate Plasmin® in acute ischemic stroke patients in a randomized, double-blind, placebo-controlled trial using some assessments of functional outcome and vascular as well as labarotary parameter such as Barthel Index (BI) and Modified Rankin Scale (MRS), mini mental state examination (MMSE), transcranial Doppler’s (TCD) performance, and measurement of blood analysis including fibrinogen level, INR, platelet aggregation, total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride level. An 84-day randomized double-blind placebo-controlled study was conducted. Participants were recruited from six academic hospitals that had been diagnosed as ischaemic stroke for the first time after 2 hours and before 2 weeks of onset. Patients were randomly assigned to plasmin® or placebo control (1:1 ratio). Sixty patients of ichaemic stroke who fulfilled inclusion criteria were enrolled in the study over 84 days period, with 44 participants completing the study (21 plasmin and 23 placebo). The increasing of BI score at 84th day compare to 14th day was significantly more in plasmin group than in placebo. Eighteen participants (85.7%) of plasmin showed improvement in MRS score, while in placebo group only 12 participants (52.2%) showed improvement (p =0.018). Motor strength of upper extremity was seen improving significantly in plasmin after 14 days of treatment compare to placebo, while lower extremity was significantly improved after 28 days of treatment. Administration of plasmin® in the acute ischaemic stroke patient between 2 hours and 2 weeks of onset showed significant improvement in motor strength, BI score, and MRS score. Further study with larger number of participants is recommended to confirm the benefit of plasmin® in management of acute ischaemic stroke.
|Journal||Journal of the Indonesian Medical Association : Majalah Kedokteran Indonesia|
|Publication status||Published - 2009|