OBJECTIVE: To investigate the effects of Ningmitai capsule combined with sertraline on patients with premature ejaculation(PE) and an increased anterior-posterior diameter(APD) of the seminal vesicles(SVs).METHODS: Si...OBJECTIVE: To investigate the effects of Ningmitai capsule combined with sertraline on patients with premature ejaculation(PE) and an increased anterior-posterior diameter(APD) of the seminal vesicles(SVs).METHODS: Sixty men with acquired PE were enrolled and randomly divided into two groups. The combined group was treated with Ningmitai capsule and sertraline, while the control group was treated with sertraline alone. Main outcomes were measured using the premature ejaculation diagnostic tool(PEDT), APD of SVs, and Clinical Global Impression of Change questionnaire and compared before and after 3 months of treatment.RESULTS: Comparing after treatment with before treatment outcomes within each group, the PEDT score was significantly reduced in the combined group(12.1 ± 2.5 vs 8.6 ± 3.2, P < 0.001, respectively) and control group(12.9 ± 2.6 vs 10.3 ± 1.6, P <0.001, respectively). Furthermore, the PEDT score after treatment was significantly lower in the combined compared with control group(8.6 ± 3.2 vs10.3 ± 1.6, P = 0.011, respectively). The APD of SVs in the combined group was significantly decreased after treatment [(10.8 ± 2.4) vs(12.9 ± 2.2) mm, P =0.001], while the APD of SVs in the control group was equivalent before and after treatment. The treatment response rate was not significantly higher in the combined compared with control group.CONCLUSION: These results indicated that the effect of Ningmitai capsule combined with sertraline was better than that of sertraline alone for the treatment of PE patients exhibiting an increased APD of SVs. The therapeutic effect found for the combined treatment may be due to antibacterial and anti-inflammatory activity reported for Ningmitai capsule,and may suggest that seminal vesiculitis is a potential pathophysiological factor in acquired PE.展开更多
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
基金Supported by a Grant from the National Key Basic Research Program of China(No.2013CB945204)a Research and Development Project for Young Doctors in Reproductive Medicine from the Chinese Medical Association Specialized Fund for Clinical Medical Research(No.16020380654)
文摘OBJECTIVE: To investigate the effects of Ningmitai capsule combined with sertraline on patients with premature ejaculation(PE) and an increased anterior-posterior diameter(APD) of the seminal vesicles(SVs).METHODS: Sixty men with acquired PE were enrolled and randomly divided into two groups. The combined group was treated with Ningmitai capsule and sertraline, while the control group was treated with sertraline alone. Main outcomes were measured using the premature ejaculation diagnostic tool(PEDT), APD of SVs, and Clinical Global Impression of Change questionnaire and compared before and after 3 months of treatment.RESULTS: Comparing after treatment with before treatment outcomes within each group, the PEDT score was significantly reduced in the combined group(12.1 ± 2.5 vs 8.6 ± 3.2, P < 0.001, respectively) and control group(12.9 ± 2.6 vs 10.3 ± 1.6, P <0.001, respectively). Furthermore, the PEDT score after treatment was significantly lower in the combined compared with control group(8.6 ± 3.2 vs10.3 ± 1.6, P = 0.011, respectively). The APD of SVs in the combined group was significantly decreased after treatment [(10.8 ± 2.4) vs(12.9 ± 2.2) mm, P =0.001], while the APD of SVs in the control group was equivalent before and after treatment. The treatment response rate was not significantly higher in the combined compared with control group.CONCLUSION: These results indicated that the effect of Ningmitai capsule combined with sertraline was better than that of sertraline alone for the treatment of PE patients exhibiting an increased APD of SVs. The therapeutic effect found for the combined treatment may be due to antibacterial and anti-inflammatory activity reported for Ningmitai capsule,and may suggest that seminal vesiculitis is a potential pathophysiological factor in acquired PE.
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.
