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, controll...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.展开更多
Background: Lipoma is a very rare benign tumour of upper aero-digestive tract with less than 115 cases described in the English-literature. They account for approximately 1% of benign tumours of the larynx and oro/hyp...Background: Lipoma is a very rare benign tumour of upper aero-digestive tract with less than 115 cases described in the English-literature. They account for approximately 1% of benign tumours of the larynx and oro/hypopharynx. The symptoms are variable including progressive horseness, dysphagia and even severe dyspnea which can sometimes be life-threatening. The clinical presentation of lipoma is important particularly during the induction of general anesthesia, for they can cause unpredictable airway obstruction. Surgery is the treatment of choice which includes endoscopic techniques, microscopic laryngeal surgery and external surgical approach (cervicotomy). However, a standard surgical management for large lipomas of the epiglottis has not been present yet. In this article, we present a case report of a huge lipoma of the epiglottis successfully treated with tracheotomy and external surgical approach—cervicotomy with hyoidthyroidpexy without sacrificing any laryngeal structure. Case Presentation: We present a case of a 54-year-old female with a huge lipoma on the lingual surface of the epiglottis that extends upwards to the level of the left aryepiglottic fold narrowing the pyriform sinus, making impossible for our anesthesiologist the glottic visualization and the orotracheal intubation. Following a tracheotomy, the endoscopic and microscopic surgery approach was inadequate to manipulate the epiglottic lipoma. Instead, we performed macroscopic external surgery (cervicotomy with hyoidthyroidpexy) in which the epiglottic lipoma was pulled into the endolaryngeal window with forceps and then dissected from the surrounding tissues “in toto”. Conclusion: Despite epiglottic lipomas are rare and benign, they are important because of being potential cause of laryngeal obstruction. Surgery is the treatment of choice and different procedures are able to manage it. The external surgery approach—cervicotomy with hyoidthyroidpexy after tracheotomy enabled the huge lipoma to be extirpated without leaving any remnants or causing excessive laryngeal damage.展开更多
基金Supported by Heber Biotec,Havana(for providing products and reagents)and the Ministry of Public Health of Cuba(for hospital facilities and general medical care of patients)
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.
文摘Background: Lipoma is a very rare benign tumour of upper aero-digestive tract with less than 115 cases described in the English-literature. They account for approximately 1% of benign tumours of the larynx and oro/hypopharynx. The symptoms are variable including progressive horseness, dysphagia and even severe dyspnea which can sometimes be life-threatening. The clinical presentation of lipoma is important particularly during the induction of general anesthesia, for they can cause unpredictable airway obstruction. Surgery is the treatment of choice which includes endoscopic techniques, microscopic laryngeal surgery and external surgical approach (cervicotomy). However, a standard surgical management for large lipomas of the epiglottis has not been present yet. In this article, we present a case report of a huge lipoma of the epiglottis successfully treated with tracheotomy and external surgical approach—cervicotomy with hyoidthyroidpexy without sacrificing any laryngeal structure. Case Presentation: We present a case of a 54-year-old female with a huge lipoma on the lingual surface of the epiglottis that extends upwards to the level of the left aryepiglottic fold narrowing the pyriform sinus, making impossible for our anesthesiologist the glottic visualization and the orotracheal intubation. Following a tracheotomy, the endoscopic and microscopic surgery approach was inadequate to manipulate the epiglottic lipoma. Instead, we performed macroscopic external surgery (cervicotomy with hyoidthyroidpexy) in which the epiglottic lipoma was pulled into the endolaryngeal window with forceps and then dissected from the surrounding tissues “in toto”. Conclusion: Despite epiglottic lipomas are rare and benign, they are important because of being potential cause of laryngeal obstruction. Surgery is the treatment of choice and different procedures are able to manage it. The external surgery approach—cervicotomy with hyoidthyroidpexy after tracheotomy enabled the huge lipoma to be extirpated without leaving any remnants or causing excessive laryngeal damage.
