TY - JOUR
T1 - Plasmin for Enhanced Improvement in Acute Ischaemic Stroke: A Multicentre Randomized Placebo-Controlled Trial
AU - Misbach, Jusuf
AU - Jannis, Jofizal
AU - Kustiowati, Endang
AU - Umbas, David Gunawan
AU - Nurimaba, Nurjaman
AU - Suratno,
AU - Kotambunan, Siwi
AU - Yamanie, Nizar
AU - Soertidewi, Lyna
AU - Octaviana, Fitri
AU - Khosama, Herlyani
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
M3 - Article
SN - 2654-3796
JO - Journal of the Indonesian Medical Association : Majalah Kedokteran Indonesia
JF - Journal of the Indonesian Medical Association : Majalah Kedokteran Indonesia
ER -