Daily oral pamidronate in women and men with osteoporosis: a 3-year randomized placebo-controlled clinical trial with a 2-year open extension.

The efficacy and safety of oral pamidronate was examined in a double-blind, placebo-controlled trial in women and men with established osteoporosis. Seventy-eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS-BMD) and of the femoral neck (FN-BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14-0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo-treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis.     

Cabergoline treatment in men with psychogenic erectile dysfunction: a randomized, double-blind, placebo-controlled study

The effectiveness of cabergoline in 50 men with psychogenic erectile dysfunction was investigated in a 4-month, randomized, placebo-controlled, double-blind study with validated psychological tests, and prolactin, follicle-stimulating hormone, luteinizing hormone and testosterone serum levels. Cabergoline treatment was well-tolerated and resulted in normalization of hormone levels in most cases. In the cabergoline-treated group, significant interactions between prolactin and testosterone serum concentrations were observed. Erectile function improved significantly. Sexual desire, orgasmic function, and the patient's and his partner's sexual satisfaction were also enhanced. Cabergoline may be an effective and safe alternative agent for men with psychogenic ED.     

利塞膦酸盐抗男性骨质疏松性骨折的效应

目的系统评价利塞膦酸盐对男性骨质疏松的抗骨折效应。方法通过Medline数据库、EMBASE数据库、Cochrane图书馆和中国生物医学文献数据库检索1980-01至2006-12有关利塞膦酸盐与安慰剂治疗男性骨质疏松患者的随机对照试验。随访大于12个月,提供骨折发生率的文献纳入研究。分析入选文献的方法学质量,提取资料,用RevMan4.2软件进行荟萃分析。结果3篇文献符合纳入标准,包括780例男性骨质疏松患者。荟萃分析结果显示利塞膦酸盐可降低69%的椎体骨折风险(RR=0.31,95%CI:0.16,0.60)和58%的非椎体骨折风险(RR=0.42,95%CI:0.23,0.78)。结论利塞膦酸盐对男性骨质疏松症患者可提供良好的抗骨折效应。     

Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study

Summary  

In this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated.     

Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience

Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year, placebo-controlled vertebral fracture study in osteoporotic women for an additional 2 years; women who entered the extension study continued to receive 5 mg risedronate or placebo according to the original randomization, with maintenance of blinding. End points included vertebral and nonvertebral fracture assessments, bone mineral density measurements, and changes in biochemical markers of bone turnover. A total of 265 women (placebo, 130; 5 mg risedronate, 135) entered the study extension and 220 (83%) completed the additional 2 years. Fracture results observed in the study extension were consistent with those observed in the first 3 years. The risk of new vertebral fractures was significantly reduced with risedronate treatment in years 4 and 5 by 59% (95% confidence interval, 19 to 79%, P = 0.01) compared with a 49% reduction in the first 3 years. Rapid and significant decreases in markers of bone turnover observed in the first 3 years were similarly maintained in the next 2 years of treatment. Increases in spine and hip bone mineral density that occurred in the risedronate group during the first 3 years were maintained or increased with a further 2 years of treatment. The mean increase from baseline in lumbar spine BMD over 5 years was 9.3% (P < 0.001). This study demonstrates that the effects of risedronate over 3 years on vertebral fracture and BMD are maintained with a further 2 years of treatment.     

Long-term treatment with darifenacin for overactive bladder: results of a 2-year, open-label extension study

OBJECTIVE: To examine, in a 2-year, non-comparative, open-label extension study, the safety, tolerability and efficacy of darifenacin controlled-release (CR) 7.5/15 mg once daily in patients with overactive bladder (OAB) who completed two 12-week randomized, double-blind, placebo-controlled 'feeder' studies. PATIENTS AND METHODS: Patients entering the extension received darifenacin 7.5 mg once daily for 2 weeks, after which a voluntary increase in dose to 15 mg was permitted. Thereafter, patients could adjust the dose (either 7.5 or 15 mg). Safety and tolerability were assessed from adverse events (AEs) and discontinuations. Efficacy was determined using various endpoints. RESULTS: In all, 716 patients entered the extension (mean age 57.3 years; 85.1% women) and 475 (66.3%) completed it (1089.9 patient-years of exposure). Darifenacin was well tolerated with no significant safety concerns. The most commonly reported AEs were dry mouth and constipation (all-causality rates 23.3% and 20.9%, respectively), leading to discontinuation in 1.3% and 2.4% of patients, respectively. Constipation infrequently required intervention, and analysis of bowel-habit questionnaires revealed that the reporting of constipation was related to minor changes in bowel habit rather than true constipation. The efficacy of darifenacin was maintained, including significant improvements in the number of incontinence episodes/week (median change -84.4% at 2 years, P < 0.001 vs feeder-study baseline). After 2 years, > 40% of patients achieved a > or = 90% reduction in incontinence episodes/week. CONCLUSION: In the first published 2-year, open-label study of a CR antimuscarinic agent, darifenacin 7.5/15 mg once daily had a favourable safety, tolerability and efficacy profile during the long-term treatment of OAB. As such, darifenacin represents a valuable therapeutic option for OAB.     

随机双盲安慰剂对照研究全膝关节置换中使用氨甲环酸的有效性和安全性

[目的]前瞻性评估全膝关节置换术(TKA)中使用氨甲环酸(tranexamic acid,TNA)的有效性和安全性。[方法]2011年4月²012年4月,选择90例行单侧TKA术患者,随机分为TNA组(n=45)和安慰剂组(n=45)。TNA组,在松止血带前15min静脉给予15 mg/kg剂量的TNA;安慰剂组给予等量的生理盐水。记录两组术中失血量,术后12 h引流量,总引流量,隐性失血量,总失血量,输血量,输血人数,术后第1、3、5 d血红蛋白,红细胞压积,血小板,D-二聚体,下肢瘀斑人数,术后1周下肢彩超检查有无深静脉血栓(DVT),并对两组患者资料进行比较。[结果]TNA组失访6例,最终39例患者进入统计分析;对照组失访7例,最终38例患者进入统计分析。两组患者在年龄、身高、体重、MBI、性别、合并疾病数量、术前VAS评分、KSS评分、术前Hgb、Hct及D-二聚体值差异均无统计学意义(P>0.05),具有可比性。两组患者术后12 h引流量、总引流量、隐性失血量及总失血量差异均有统计学意义(P<0.05);两组术后24 h D-二聚体值差异有统计学意义(P<0.05);两组患者Hgb在术后第3 d达最低值,且差异有统计学意义(P<0.05),而术后第1、5 d Hgb差异无统计学意义(P>0.05);TNA组和对照组分别有3例(共1 200 ml)和4例(共1 400 ml)患者接受异体输血,差异无统计学意义(P>0.05)。TNA组和对照组下肢远端DVT分别有4例和3例,发生率差异无统计学意义(P>0.05)。TNA组和对照组下肢发现瘀斑分别有1例和7例,差异有统计学意义(P<0.05)。[结论]TKA中在松止血带前15 min静脉使用15 mg/kg剂量的TNA,能够减少TKA术后失血量,而不增加DVT的风险。     

Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial

Basiliximab, a high-affinity chimeric monoclonal antibody, is effective in reducing acute rejection episodes in renal allograft recipients. We assessed the ability of this antibody to similarly improve the outcome in liver transplant recipients. Adult recipients of a primary cadaveric liver transplant were randomized to treatment, stratified by hepatitis C virus (HCV) seropositivity. Patients were administered 40 mg of basiliximab (n = 188) or placebo (n = 193) as two 20-mg bolus injections days 0 and 4, plus cyclosporine and steroids. Primary efficacy variables were biopsy-confirmed acute rejection and its composite end point, including death or graft loss, and were assessed at 6 and 12 months and by HCV cohort. Because of differential efficacy responses between HCV-positive and HCV-negative cohorts, an additional analysis incorporating HCV recurrence as a component of treatment failure, termed problem-free transplant, was introduced. Safety and tolerability were monitored over the 12 months of the study. All 381 patients were assessable, and no meaningful differences in background characteristics were apparent between treatment groups. Biopsy-confirmed acute rejection rates 6 months after transplantation were 35.1% in the basiliximab group versus 43.5% in the placebo group. For death, graft loss, or first biopsy-confirmed acute rejection, rates were 44.1% versus 52.8%, respectively. The reduction in rejection episodes was concentrated in the HCV-negative cohort (14.5% relative to placebo; P = .034), with a much smaller difference (2.9%) in the HCV-positive cohort. For HCV-positive patients, problem-free transplant was shown at 12 months in 26.6% of the basiliximab group versus 11.6% in the placebo group (P = .020) and for all patients at 12 months in 39.7% of the basiliximab group versus 30.1% in the placebo group (P = .035). The incidence of infection and other adverse events was similar across the two treatment groups. There were 56 deaths (25 deaths, basiliximab group; 31 deaths, placebo group) over the 12-month study. The intravenous bolus injection was well tolerated. Immunoprophylaxis with 40 mg of basiliximab, in combination with cyclosporine and steroids, reduces the incidence of acute rejection episodes with no clinically relevant safety or tolerability concerns. The influence of HCV recurrence on efficacy results can be accounted for in future trials by using the concept of problem-free transplant, incorporating recurrence as a component of treatment failure. (Liver Transpl 2002;8:132-142.)     

利塞膦酸钠胶囊防治绝经后骨质疏松症的随机、双盲、安慰剂平行对照、多中心临床研究

目的评价利塞膦酸钠胶囊防治绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的疗效及安全性。方法240名受试者随机等分入利塞膦酸钠组(A组)和安慰剂组(B组)。A组给予利塞膦酸钠胶囊+碳酸钙D3咀嚼片,B组给予安慰剂+碳酸钙D3咀嚼片,整个试验疗程为12个月。在治疗前、用药后6月末及12月末随访,通过对腰椎2～4骨密度(bone mineral density,BMD)、髋部BMD的测量及骨代谢生化指标:血骨钙素(osteocalcin,OCN)和尿Ⅰ型胶原氨基末端肽/肌酐(urine cross-linked N-telopeptide of collagen typeⅠ/creatine,NTX/Cr)的检测,对有效性进行评估;在治疗前、3月末、6月末和12月末随访,通过对一般体征、心电图、血常规、尿常规、肝功能、肾功能的观察对安全性进行评估。结果治疗结束后,腰椎2～4BMD变化率A组增高8.28%±13.79%,B组增高4.09%±14.60%,组间有统计学差异(P0.05);髋部BMD变化率A组增高8.49%±15.58%,B组增高6.84%±18.34%,组间无统计学差异(P0.05)。血OCNA组下降2.94±4.73ng/ml,B组下降0.53±3.90ng/ml,组间比较有统计学差异(P0.01);尿NTX/CrA组下降9.38±65.93nMBCE/mMCR,B组升高3.59±59.86nMBCE/mMCR,组间比较有统计学差异(P0.05)。治疗期间,A组发生新骨折8例,发生率7.84%;B组6例,发生率5.76%,组间差别无统计学意义(P0.05)。试验过程中未发生与药物有关的严重不良事件。结论利塞膦酸钠胶囊能够有效提高绝经后骨质疏松症妇女的骨密度,抑制骨吸收,降低骨转换,不良反应少,用于防治PMOP安全有效。     

Safety and efficacy of tamsulosin in the treatment of painful ejaculation: a randomized, double-blind, placebo-controlled study

We evaluate the efficacy and safety of tamsulosin a selective alpha(1A)-receptor antagonist in patients with painful ejaculation (PE) as a sole entity. A total of 118 men with PE were included in the study. Patients were randomly assigned to receive 0.4 mg oral daily tamsulosin (group 1, n=59) or placebo (group 2, n=59), during a 6-week period for each agent. Pretreatment evaluation included history and physical examination, International Index of Erectile Function (IIEF) and a visual analog scale (VAS) for pain. The efficacy of two treatments was assessed every 2 weeks during treatment, and at the end of the study using responses to IIEF, VAS evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. In all, 104 patients (88%) completed the whole treatment schedule. Pain resolved in 16 and 13% of the patients treated with tamsulosin and placebo, respectively (P=0.1). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 12 and 10 at 6-week treatment in groups 1 and 2, respectively (P=0.08). The VAS after tamsulosin and placebo decreased from 5.7 and 5.8 to 5.1 and 5.5, respectively (P=0.1). The mean weekly intercourse episodes increased from pretreatment values of 1.8 and 1.6 to 1.9 and 1.7, for tamsulosin and placebo, respectively (P=0.08). Mean number of adverse events was 11 for tamsulosin and 5 for placebo (P<0.05). Tamsulosin is no better than placebo in improvement of PE as a sole entity.     

前列安栓治疗慢性前列腺炎的安全性和有效性:随机双盲安慰剂对照试验

目的　评价前列安栓治疗各型慢性前列腺炎的安全性、有效性和依从性。　方法　多中心随机双盲安慰剂对照研究。 12 5例慢性前列腺炎患者根据美国国立卫生院 (NIH)前列腺炎分型标准分型后随机分为治疗组和对照组 ,治疗组 (6 5例 )前列安栓 1粒 ,对照组 (6 0例 )安慰剂 1粒 ,肛内用药每晚 1次 ,疗程 1个月。以NIH慢性前列腺炎症状评分 (NIH CPSI)和前列腺按摩液 (EPS)白细胞计数为疗效评价指标。　结果　试验结束时 ,12 4例可评价病例中Ⅱ型 4 8例 (38.7% ) ,Ⅲa型 4 5例 (36 .3% ) ,Ⅲb型 31例 (2 5 .0 % )。治疗组NIH CPSI总分用药前后分别为 (2 5 .4 5± 5 .82 )和 (15 .0 8± 7.84 )分 ,平均降低 10 .37分 ,症状程度评分用药前后分别为 (16 .76± 4 .0 7)和 (9.4 2± 5 .38)分 ,平均降低 7.34分 ;对照组NIH CPSI总分用药前后分别为 (2 2 .87± 5 .79)和 (16 .2 2± 6 .2 3)分 ,平均降低 6 .6 5分 ,症状程度评分用药前后分别为 (15 .2 7± 3.86 )和 (10 .5 5± 4 .2 9)分 ,平均降低 4 .72分 ;治疗组NIH CPSI总分与症状程度评分的下降幅度均较对照组更明显 (P <0 .0 1)。治疗组总显效率2 8.1% (18/ 6 4 ) ,总有效率 71.9% (4 6 / 6 4 ) ,对照组总显效率 13.3% (8/ 6 0 ) ,总有效率 4 1.7% (2 5 / 6 0 )     

Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data

Summary

This study showed that risedronate 150-mg once a month provides similar efficacy and safety at 2 years compared with risedronate 5-mg daily for the treatment of postmenopausal osteoporosis. This adds to the range of risedronate dosing options and provides an alternative for patients who prefer once-a-month dosing.

Introduction

Risedronate is effective in the treatment of postmenopausal osteoporosis in oral daily, weekly, or on two consecutive days per month doses. This 2-year randomized, double-blind, multicenter study assesses the efficacy and safety of a single risedronate 150-mg once-a-month oral dose compared with the 5-mg daily regimen.

Methods

Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5-mg daily (n?=?642) or 150-mg once a month (n?=?650) for 2 years. Bone mineral density (BMD), bone turnover markers, new vertebral fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine BMD after 1 year.

Results

Four hundred ninety-eight subjects in the daily group (77.6 %) and 513 subjects in the once-a-month group (78.9 %) completed the study. After 24 months, the mean percent change in lumbar spine BMD was 3.9 % (95 % confidence interval [CI], 3.43 to 4.42 %) and 4.2 % (95 % CI, 3.68 to 4.65 %) in the daily and once-a-month groups, respectively. The once-a-month regimen was determined to be non-inferior to the daily regimen. The mean percent changes in BMD at the hip were similar in both dose groups, as were changes in biochemical markers of bone turnover. The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the two treatment groups.

Conclusions

After 2 years, treatment with risedronate 150-mg once a month provided similar efficacy and tolerability to daily dosing and provides an alternative for patients who prefer once-a-month oral dosing.     

No effect of risedronate on femoral periprosthetic bone loss following total hip arthroplasty: A 4-year follow-up of 61 patients in a double-blind,randomized placebo-controlled trial

Background and purpose

We have previously shown that during the first 2 years after total hip arthroplasty (THA), periprosthetic bone resorption can be prevented by 6 months of risedronate therapy. This follow-up study investigated this effect at 4 years.

Patients and methods

A single-center, double-blind, randomized placebo-controlled trial was carried out from 2006 to 2010 in 73 patients with osteoarthritis of the hip who were scheduled to undergo THA. The patients were randomly assigned to receive either 35 mg risedronate or placebo orally, once a week, for 6 months postoperatively. The primary outcome was the percentage change in bone mineral density (BMD) in Gruen zones 1 and 7 in the proximal part of the femur at follow-up. Secondary outcomes included migration of the femoral stem and clinical outcome scores.

Results

61 of the 73 patients participated in this 4-year (3.9- to 4.1-year) follow-up study. BMD was similar in the risedronate group (n = 30) and the placebo group (n = 31). The mean difference was −1.8% in zone 1 and 0.5% in zone 7. Migration of the femoral stem, the clinical outcome, and the frequency of adverse events were similar in the 2 groups.

Interpretation

Although risedronate prevents periprosthetic bone loss postoperatively, a decrease in periprosthetic BMD accelerates when therapy is discontinued, and no effect is seen at 4 years. We do not recommend the use of risedronate following THA for osteoarthritis of the hip.Adaptive bone remodeling around the femoral stem following total hip arthroplasty (THA) results in regional loss of bone mass, especially in proximal parts of the femur—most of which takes place within the first postoperative year (Bodén et al. 2006, Sköldenberg et al. 2006). Periprosthetic bone loss may predispose to periprosthetic fracture, aseptic loosening, and difficulties at revision surgery (Lindahl 2007, Streit et al. 2011, Sköldenberg et al. 2014).The bisphosphonate (BP) risedronate has been used successfully to prevent osteoporotic fractures, mainly in the hip and vertebrae, by inhibiting osteoclast activity (McClung et al. 2001). In recent years, the possible use of BPs to prevent or ameliorate periprosthetic adaptive bone resorption, osteolysis, and implant migration has been investigated thoroughly in animal models and humans. The short-term results of several studies showing the effects of postoperative BP treatment in reducing periprosthetic bone loss up to a year after the arthroplasty have already been published (Venesmaa et al. 2001, Wilkinson et al. 2001, Hennigs et al. 2002, Wilkinson et al. 2005, Arabmotlagh et al. 2006).We have previously found that risedronate given once a week for 6 months after THA reduces periprosthetic bone resorption around an uncemented femoral stem in the first and second postoperative year (Sköldenberg et al. 2011). We now report the 4-year outcome in the same cohort.     

Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study

Aim:To assess the efficacy and safety of tadalafil in comparison to a placebo,when taken on demand for 12 weeksby East/Southeast Asian men with erectile dysfunction(ED).Methods:This multicenter,randomized,double-blind,parallel group,placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August2002 and February 2003.Men more than 18 years of age with mild to severe ED of various etiologies were randomizedto receive a placebo or 20 mg of tadalafil taken as needed(maximum once daily).Efficacy assessments included theInternational Index of Erectile Function,the Sexual Encounter Profile diary and Global Assessment Questions.Results:Tadalafil significantly improved erectile function as compared to the placebo(P<0.001).At the endpoint,the pa-tients receiving 20 mg of tadalafil reported a greater mean per patient percentage of successful intercourse attempts(Sexual Encounter Profile question 3:70.9% compared to 33.5% in the placebo)and a greater proportion of improvederections(Global Assessment Question:86.2% compared to 30.1%).Most(≥3%)treatment emergent adverseevents were mild or moderate.The most common treatment emergent adverse events were headache,back pain,dizziness and dyspepsia.Conclusion:Tadalafil was an effective and well-tolerated treatment for ED in East andSoutheast Asian men.(Asian J Androl 2006 Nov;8:685-692)     

Safety and efficacy of citalopram in the treatment of premature ejaculation: a double-blind placebo-controlled, fixed dose, randomized study

We evaluate the efficacy and safety of citalopram, a potent and highly selective serotonin reuptake inhibitor (SSRI) antidepressant, in patients with premature ejaculation (PE). In total, 58 potent men with PE were included in the study. Patients were randomly assigned to receive 20 mg oral daily citalopram (group 1, n = 29) or placebo (group 2, n = 29), during a 12-week period for each agent. Pretreatment evaluation included history and physical examination, intravaginal ejaculatory latency time (IVELT) evaluation, International Index of Erectile Function (IIEF) and Meares-Stamey test. The efficacy of two treatments was assessed every 2 weeks during treatment, at the end of study and in 3- and 6-month follow-up after cessation of treatment, using responses to IIEF, IVELT evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. The trial was completed by 51 (88%) men. Analysis revealed a difference in the evolution of IVELT delay over time (P < 0.001). The IVELT after citalopram and placebo gradually increased from 32 and 28 s to approximately 268 and 38 s, respectively. The mean weekly intercourse episodes increased from pretreatment values of 1.3 and 1.2 to 2.4 and 1.4, for citalopram and placebo, respectively (P < 0.05). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 16 and 10 at 12-week treatment in groups 1 and 2, respectively (P < 0.05). Mean IVELT in group 1 was 210 and 198 s at 3- and 6-month follow-up, while in group 2 it was 27 and 25 s (P < 0.001), respectively. At 3- and six-month intercourse satisfaction domain values of IIEF were 15 and 14 in group 1 and 10 and 10 (P < 0.05) in group 2, respectively. Group 1 patients reported a significantly higher number of intercourse episodes per week (P < 0.05). Mean number of adverse events was 12 for citalopram and 4 for placebo (P < 0.05). In conclusion, these results indicate that citalopram has significantly better results in terms of IVELT and intercourse satisfaction versus placebo. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in PE and to prolong the efficacy.     

Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter,randomized, double-blind,placebo-controlled crossover trial

BackgroundTo evaluate the efficacy and safety of aildenafil citrate in the treatment of erectile dysfunction (ED) in Chinese population.MethodsA multicenter, randomized, double-blind, placebo-controlled, double-cycle crossover trial was conducted in three medical centers. Male patients with mild to moderate ED were randomized into two groups and received either aildenafil citrate or placebos, followed by a crossover administration after a 7-day washout. The primary outcome was the duration of penile rigidity over 60% measured by RigiScan^® Plus. Main secondary outcomes were the duration of penile rigidity over 80% and erectile hardness score (EHS).ResultsA total of 60 patients with mild to moderate ED were enrolled in the study and 57 of them completed the trial (30 in the aildenafil group and 27 in the placebo group). The median duration of penile tip rigidity over 60% was 4.25 (0.00, 19.00) min in the aildenafil group, as compared with 0.50 (0.00, 2.75) min in the placebo group (P<0.001). The median duration of penile base rigidity over 60% was 3.25 (0.00, 12.50) min in the aildenafil group, as compared with 0.00 (0.00, 2.50) min in the placebo group (P<0.001). The duration of penile base rigidity over 80% was significantly increased in the aildenafil group versus the placebo group (P=0.002). The EHS was significantly improved in the aildenafil group (P<0.001). No severe adverse events associated with aildenafil citrate occurred in both groups.ConclusionsThese results suggested that aildenafil citrate was efficient and well-tolerated in the treatment of Chinese men with mild to moderate ED.Trial RegistrationChinese Clinical Trial Registry ChiCTR1900026025.     

癃清片治疗慢性前列腺炎多中心双盲安慰剂对照试验研究

目的 评价癃清片治疗慢性前列腺炎的有效性和安全性.方法 多中心、随机、双盲、安慰剂对照临床设计.480例湿热兼瘀血型慢性前列腺炎患者按3:1的比例随机分为治疗组、安慰剂对照组.治疗组360例,口服癃清片,一次6片,每日2次.安慰剂对照组120例,服用安慰剂,一次6片,每日2次,疗程为4周.以美国国立卫生院前列腺炎症状评分(NIH-CPSI)、慢性前列腺炎中医证候评分作为主要疗效评价指标.结果 (1)治疗4周后,治疗组和对照组CPSI评分分别为(11.9±5.04)和(17.66±4.92),(P<0.05).治疗组和对照组治疗前后CPSI评分差值分别为(10.44±5.91)和(4.18±3.50),治疗组降幅大于对照组(P<0.05).治疗组在降低NIH-CPSI评分疗效优于对照组.(2)治疗4周后,治疗组和对照组中医证候评分分别为(9.87±3.95)和(14.43±4.14),治疗组低于对照组(P<0.05);治疗组和对照组治疗前后差值分别为(9.17±4.82)和(4.64±4.36),治疗组降幅大于对照组(P<0.05).(3)治疗组总有效率为82.4%,对照组为40.6%,总有效率治疗组优于对照组(P<0.05).(4)两组间不良事件发生率比较无差异(P>0.05).结论 癃清片治疗慢性前列腺炎安全、有效,值得在临床推广.     

Salvage of sildenafil failures with cabergoline: a randomized, double-blind, placebo-controlled study

To evaluate the safety and efficacy of cabergoline in men with erectile dysfunction (ED) who did not respond to sildenafil. Four hundred two sildenafil nonresponders aged from 21 to 59 years were included in the study. Patients were randomly divided into group 1, those who received 0.5-1 mg cabergoline weekly for 6 months and group 2, who received placebo for the same period. They underwent preliminary assessment, including medical and sexual history, self-administered International Index of Erectile Function (IIEF) and intravaginal ejaculatory latency time (IVELT) evaluation. Standard biochemistry and hematological laboratory tests, and measurement of serum testosterone and prolactin levels were also carried out. When indicated, other tests were used to establish the diagnosis of vasculogenic and neurogenic ED, including penile color duplex Doppler ultrasonography, pudendal nerve conduction test and impaired sensory-evoked potentials studies. The efficacy of two treatments was assessed every 2 weeks during treatment, at the end of the study, using responses to IIEF, IVELT evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. The trial was completed by 370 (92%) men. Positive clinical results were seen in 31.2% of patients in the cabergoline group compared with 7.1% of patients in the placebo group (P=0.04). The mean weekly intercourse episodes increased from pretreatment values of 1.4 and 1.2 to 2.2 and 1.4, for cabergoline and placebo, respectively (P=0.04). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 15 and 10 at 6-month treatment in groups 1 and 2, respectively (P=0.04). The IVELT after cabergoline and placebo gradually increased from 98 and 101 s to approximately 242 and 116 s, respectively (P=0.001). More drug-related adverse effects occurred in cabergoline group and 12 (5.9%) had to discontinue treatment (P=0.001). Cabergoline is moderately effective salvage therapy for sildenafil nonresponse. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in ED.