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| 1 | Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial(THERESA-3)显示文摘AIM: To compare the efficacy and safety of recombinant streptokinase(rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease.METHODS: A multicenter(14 sites), randomized(1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK(200000 IU) or 0.25% phenylephrine suppositories, which had different organoleptic characteristics. Treatment was administered by the rectal route, one unit every 6 h during 48 h for rSK, and up to a maximum of 5 d(20 suppositories) for phenylephrine. Evaluations were performed at 3, 5 and 10 d postinclusion. The main end-point was the 5th-day complete clinical response(disappearance of pain and edema, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too. RESULTS: 5thday complete response rates were 83/110(75.5%) and 36/110(32.7%) with rSK and phenylephrine suppositories, respectively. This 42.7% difference(95%CI: 30.5-54.2) was highly significant(P < 0.001). The advantage was detected since the early 3rdday evaluation(37.3% vs 6.4% for the rSK and active control groups, respectively; P < 0.001) and was kept even at the late 10thday assessment(83.6% vs 58.2% for rSK and phenylephrine, respectively; P < 0.001). Time for complete response was significantly shorter(P = 0.031; log-rank test) in the rSK group(median: 4.9 d; 95%CI: 4.8-5.0) with respect to the active control(median: 9.8 d; 95%CI: 9.8-10.0). Thrombectomy was necessary in 1/59 and 8/57 patients with baseline thrombosis in the rSK and phenylephrine groups, respectively(P = 0.016). There were no adverse events attributable to the experimental treatment. CONCLUSION: rSK suppositories showed a significant advantage over a widely used over-the-counter phen-ylephrine preparation for the treatment of acute hemorrhoidal illness, with an adequate safety profile. | Francisco Hernández-Bernal Georgina Castellanos-Sierra Carmen M Valenzuela-Silva Karem M Catasús-lvarez Roselin Valle-Cabrera Ana Aguilera-Barreto Pedro A López-Saura | 2014 | World Journal of Gastroenterology2014,20,6: | 4 |
| 2 | Recombinant streptokinase vs hydrocortisone suppositories in acute hemorrhoids:A randomized controlled trial显示文摘AIM: To compare the efficacy and safety of recombinant streptokinase(rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal disease.METHODS: 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 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 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 hemorrhoid classification) showed a statistically significant advantage for the rSK groups. Thrombectomy was necessary in4/251 and 14/133 patients with baseline thrombosis in the rSK and hydrocortisone acetate 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 hydrocortisone acetate preparation for the treatment of acute hemorrhoidal illness, as well as having an adequate safety profile. | 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 | 2015 | World Journal of Gastroenterology2015,21,23: | 2 |
| 3 | Effects of surgery, general anesthesia, and perioperative epidural analgesia on the immune function of patients with non-small cell lung cancer显示文摘 | Juan P. Cata Maria Bauer Telemate Sokari María F. Ramirez David Mason Gregory Plautz Andrea Kurz | 2013 | Journal of Clinical Anesthesia2013,,: | 2 |
| 4 | Neighborhoods of certain class of analytic functions with negative coefficients 显示文摘 | CATAS A | 2009 | Banach J Math Anal2009,,3: | 1 |
| 5 | Circadian rhythmicity of lymphocyte subpopulations and relationship with neuro-endocrine system显示文摘 | Mazzocolli G De Cata A Greco A | 2010 | J Biol Regul Homeost Agents2010,24,3: | 1 |
| 6 | Neuroendocfine alterations in lung cancer patients显示文摘 | Mazzoccoli G Carughi S De Cata A | 2003 | Neuro Endocrinol Lett2003,24,12: | 1 |
| 7 | Synchronous endometrioid carcinomas of the uterine corpus and ovary:alterations in the beta-catenin (CTNNB1) pathway are associated with Independent primary tumors and favorable prognosis显示文摘 | Irving J A Catasús L Gallardo A | | 0,,6: | 1 |
| 8 | Effects of surgery,gen- eral anesthesia,and perioperative epidural analgesia on the immune function of patients with non-small cell lung cancer显示文摘 | Cata JP Bauer M Sokari T et a/ | 2013 | J Clin Anesth2013,25,4: | 1 |
| 9 | Neighborhoods of a certain class of analytic functions with negative coefficients 显示文摘 | Catas A | 2009 | Banach J Math Anal2009,3,1: | 1 |
| 10 | lyst for Industrialization显示文摘 | Marco Da Rin and Thomas Hellmann Banks as a Cata | 2002 | Journal of Financial Intermediation2002,,11: | 1 |
| 11 | Altered time structure of neuro-endocrine-immune system function in lung cancer patients显示文摘 | Mazzoccoli G Vendemiale G De Cata A | 2010 | BMC Cancer2010,10,: | 1 |
| 12 | A genetically humanized mouse model for hepatitis C virus infection显示文摘 | Domer M Horwitz J A Robbins J B Barry W T Feng Q Mu K Jones C T Schoggins J W Cata | | 0,,7350: | 1 |
| 13 | Melatonin and cortisol serum levels in lung cancer patients at different stages of disease显示文摘 | Mazzoccoli G Carughi S De Cata A | 2005 | Med Sci Monit2005,11,6: | 1 |
| 14 | Brain na triuretic peptide enhances renal actions of furosemide and suppres ses {urosemide-indueed aldosterone activation in experimental heart {ailure显示文摘 | Cata Boerrigter G Costello Boerrigter LC et aI | 2004 | Circulation2004,109,16: | 1 |
| 15 | Serotonin transporter gene not associated with psychotic symtomatology of mood disorder显示文摘 | Serretti A Lattuada E Cata Lano A | 1999 | Psychiatry Res1999,86,: | 1 |
| 16 | Circadian rhythmicity of lymphocyte subpopulations and relationship with neuro-endocrine system显示文摘 | Mazzoccoli G De Cata A Greco A | 2010 | J Biol Regul Homeost Agents2010,24,3: | 1 |
| 17 | Neuroendocrine alterations in lung cancer patients 显示文摘 | Mazzoccoli G Carughi S De Cata A | 2003 | Neuroendocrinol Lett2003,24,12: | 1 |
| 18 | Fatal rupture of an inflammatory arterial aneurysm in a patient with Wegener's granulomatosis 显示文摘 | Famularo G De Cata A Braeci M | 2004 | Scand J Rheumatol2004,33,: | 1 |
| 19 | Effects of surgery, general anesthesia, and perioperative epidural analgesia on the immune function of patients with non-small cell lung cancer显示文摘 | Juan P. Cata Maria Bauer Telemate Sokari María F. Ramirez David Mason Gregory Plautz Andrea Kurz | 2013 | Journal of Clinical Anesthesia2013,,: | 1 |