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

World Journal of Gastroenterology 2015年第23期21卷 7305-7312页

作者： Francisco Hernández-Bernal Georgina Castellanos-Sierra Carmen M Valenzuela-Silva Karem M Catasús-Alvarez Osmany Martínez-Serrano Odalys C Lazo-Diago Cimara H Bermúdez-Badell José R Causa-García Juan E Domínguez-Suárez Pedro A López-Saura 无 Clinical Research Direction Center for Genetic Engineering and Biotechnology Juan B.Zayas Hospital Ernesto Guevara Hospital Celia Sánchez Hospital Manzanillo Gustavo Aldereguía Hospital THERESA-4(Treatment of HEmorrhoids with REcombinant Streptokinase Application)Group of Investigators

AIM: To compare the efficacy and safety of recombinant streptokinase(rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal ***: A multicenter(11 sites), randomized(1:1:1), open, controlled trial with parallel groups was performed. All participating patients gave their written,informed consent. After inclusion, patients with acute symptoms of hemorrhoids 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 hydrocortisone acetate 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 5thday response(disappearance of pain and bleeding, and≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were also ***: 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 hydrocortisone acetate 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 3rd day evaluation(68.8% and64.1% 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% vs67.1% for rSK and hydrocortisone acetate, 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 hydrocortisone acetate group. This difference was highly significant(P < 0.001). All subgroup stratified analyses(with or without thrombosis and he

关键词： Streptokinase Suppository Hydrocortisoneacetate Thrombolysis Hemorrhoids randomizedclinical trial

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