AIM: To c.mpare the effic.c. and safety of rec.mbinant streptokinase(rSK) vs hydroc.rtisone ac.tate-based suppositories in ac.te hemorrhoidal ***: A multic.nter(11 sites), randomized(1:1:1), open, c.ntrolled trial wit...
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AIM: To c.mpare the effic.c. and safety of rec.mbinant streptokinase(rSK) vs hydroc.rtisone ac.tate-based suppositories in ac.te hemorrhoidal ***: A multic.nter(11 sites), randomized(1:1:1), open, c.ntrolled trial with parallel groups was performed. All partic.pating patients gave their written,informed c.nsent. After inc.usion, patients with ac.te symptoms of hemorrhoids were c.ntrally randomized to rec.ive, as outpatients, by the rec.al route, suppositories of rSK 200000 IU of one unit every 8 h(first 3 units)and afterwards every 12 h until 8 administrations were c.mpleted(sc.edule A), one unit every 8 h until 6 units were c.mpleted(sc.edule B), or 25 mg hydroc.rtisone ac.tate onc. every 8 h up to a maximum of 24 administrations. Evaluations were performed at 3, 5,and 10 d post-inc.usion. The main end-point was the 5thday response(disappearanc. of pain and bleeding, and≥ 70% reduc.ion of the lesion size). Time to response and need for thrombec.omy were sec.ndary effic.c. variables. Adverse events were also ***: Groups were homogeneous with regards to demographic.and baseline c.arac.eristic.. Fifth day c.mplete response rates were 156/170(91.8%; 95%c.:87.3-96.2), 155/170(91.2%; 95%c.: 86.6%-95.7%),and 46/170(27.1%; 95%c.: 20.1%-34.0%) with rSK(sc.edule A and B) and hydroc.rtisone ac.tate suppositories, respec.ively. These 64.6% and 63.9%differenc.s(95%c.: 56.7%-72.2% and 55.7%-72.0%)were highly signific.nt(P c.ed sinc. the early 3rd day evaluation(68.8% and64.1% vs 7.1% for the rSK and ac.ive c.ntrol groups,respec.ively; P c.rtisone ac.tate, respec.ively;P c.: 2.9-3.1)for both rSK groups and 10 d(95%c.: 9.3-10.7) in the hydroc.rtisone ac.tate group. This differenc. was highly signific.nt(P < 0.001). All subgroup stratified analyses(with or without thrombosis and he
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