Recombinant streptokinase vs hydrocortisone suppositories in acute XXXX : A randomized controlled trial.

@entity1 @entity548 @entity7496 @entity158 @entity6713 @entity715
AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) vs @entity7496 -based suppositories in acute @entity6713 . METHODS: A multicenter (11 sites), randomized (1:1:1), open, controlled trial with parallel groups was performed. All participating @entity1 gave their written, informed consent. After inclusion, @entity1 with acute symptoms of @entity6713 were centrally randomized to receive, as outpatients, by the rectal route, suppositories of rSK 200000 IU of one unit every 8 h (first 3 units) and afterwards every 12 h until 8 administrations were completed (schedule A), one unit every 8 h until 6 units were completed (schedule B), or 25 mg @entity7496 once every 8 h up to a maximum of 24 administrations. Evaluations were performed at 3, 5, and 10 d post-inclusion. The main end-point was the 5(th)-day response (disappearance of @entity158 and @entity548 , and >=  70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were also evaluated. RESULTS: Groups were homogeneous with regards to demographic and baseline characteristics. Fifth day complete response rates were 156/170 (91.8%; 95%CI: 87.3-96.2), 155/170 (91.2%; 95%CI: 86.6%-95.7%), and 46/170 (27.1%; 95%CI: 20.1%-34.0%) with rSK (schedule A and B) and @entity7496 suppositories, respectively. These 64.6% and 63.9% differences (95%CI: 56.7%-72.2% and 55.7%-72.0%) were highly significant (P < 0.001). This advantage was detected since the early 3(rd) day evaluation (68.8% and 64.1% vs 7.1% for the rSK and active control groups, respectively; P < 0.001) and was maintained even at the late 10(th) day assessment (97.1% and 93.5% vs 67.1% for rSK and @entity7496 , respectively; P < 0.001). Time to response was 3 d (95%CI: 2.9-3.1) for both rSK groups and 10 d (95%CI: 9.3-10.7) in the @entity7496 group. This difference was highly significant (P < 0.001). All subgroup stratified analyses (with or without @entity715 and @entity6713 ) showed a statistically significant advantage for the rSK groups. Thrombectomy was necessary in 4/251 and 14/133 @entity1 with baseline @entity715 in the rSK and @entity7496 groups, respectively (P < 0.001). There were no adverse events attributable to the experimental treatment. CONCLUSION: rSK suppositories showed a significant advantage over a widely-used over-the-counter @entity7496 preparation for the treatment of acute @entity6713 , as well as having an adequate safety profile.
