Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial

OBJECTIVES: To compare the efficacy and safety of two alpha1a/alpha1d adrenoceptor (AR) antagonists with different affinity for the alpha1AR subtypes, tamsulosin and naftopidil, in the treatment of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Patients with BPH were randomized to receive either tamsulosin or naftopidil. The primary efficacy variables were the changes in the total International Prostate Symptom Score (IPSS), maximum flow rate on free uroflowmetry, and residual urine volume. The secondary efficacy variables were average flow rate, changes in the IPSS storage score, IPSS voiding score, and quality-of-life (QoL) Index score, from baseline to endpoint (12 weeks). Data on all randomized patients were included in the safety analyses for adverse effects and changes in blood pressure. RESULTS: Of the 185 patients enrolled data for 144 who were eligible for inclusion in the efficacy analysis were analysed (75 from the tamsulosin and 69 from the naftopidil group). There was no significant difference in any variable at baseline between the groups. There were statistically significant improvements for all primary and secondary variables in both groups, except for residual urine in the tamsulosin group. However, there was no significant intergroup difference in the improvement of any efficacy variable between the groups. The adverse effects were comparable, with no significant differences in systolic and diastolic blood pressure after treatment in both groups. CONCLUSIONS: This study suggests that naftopidil is as effective and safe as tamsulosin. Both drugs were effective in improving storage and voiding symptoms. However, there was no difference in clinical efficacy or adverse effects between the alpha1 AR antagonists with different affinity to alpha1 subtypes, alpha1a and alpha1d.     

无管化经皮肾镜取石术可行性和安全性及疗效的随机对照研究

目的 通过随机对照临床试验,研究无管化PCNL的可行性、安全件和疗效. 方法 2010年5-8月行PCNL患者,术中取石完毕,随机数字法将患者随机分为试验组(无管化PCNL,即只留置双J管,不留置肾造瘘管)与对照组(传统PCNL,留置双J管及肾造瘘管).排除标准:严重出血需输血者;明显结石残留需行二期碎石取石i者;重度肾积水,肾实质厚度＜5 mm者;肾盂穿刺液为脓件者;合并输尿管狭窄或肾盂输尿管连接处狭窄;集合系统严重穿孔者.共50例患者被纳入研究,试验组和对照组各25例,两组患者的年龄、性别、结石大小差异均正统计学意义(P＞0.05).所有手术均由一位医生主刀.评价指标包括术后疼痛、Hb下降量、输血率、发热发生率、肾周血肿发生率、住院时间等. 结果 术后第1天试验组疼痛视觉模拟评分(VAS)为2.24,对照组为5.04(P＜0.01);试验组术后平均住院时间3.04 d,对照组6.88 d,两组差异有统计学意义(P＜0.01);两组术后Hb下降量、结石清除率差异无统计学意义(P＞0.05).两组输血率(1/25与3/25,P＞0.05)、肾周血肿发生率(6/27与7/27,P＞0.05)、发热发生率(3/25与4/25,P＞0.05)比较差异亦无统计学意义.两组患者术后穿刺通道部位均无漏尿发生. 结论 无管化PCNL安全,能显著减轻患者术后疼痛不适,缩短住院时间,且不增加出血、漏尿等并发症发生率,但需恰当掌握其适应证,对术中大出血、肾积脓、输尿管梗阻、集合系统严重穿孔、结石残留需二期手术者禁用.     

REXEEDTM系列高通量透析器疗效和安全性的临床随机对照试验

目的 评价REXEEDTM系列高通量透析器的疗效和安全性。 方法 研究对象为上海两家医院规律性血液透析（血透）患者72例。采用随机化交叉设计,采用REXEEDTM不同膜面积（1.5 m2和2.1 m2）15AC、15UC、21AC、21UC透析器（试验组）以及APS-15U、BIO-HX100透析器（对照组）,分别按2个3×3拉丁方进行透析治疗。检测透析器尿素、肌酐、磷、β2微球蛋白清除率,尿素、肌酐下降比率及治疗前后安全性指标。观察及记录不良反应。 结果 试验组15AC、15UC透析器的尿素、肌酐清除率均显著大于对照组APS-15U[分别为（222.07±18.74） ml/min、（220.23±26.26） ml/min比（199.56±14.21） ml/min;（176.73±16.41） ml/min、（175.22±25.94） ml/min比 （165.42±14.68） ml/min,均P < 0.05]。两组间磷和β2微球蛋白清除率差异均无统计学意义。21AC、21UC透析器尿素、肌酐、β2微球蛋白清除率均显著大于对照组BIO-HX100[分别为（230.59±15.24） ml/min、（233.96±7.06） ml/min比（203.43±36.66） ml/min;（183.50±25.90） ml/min、（181.05±23.94） ml/min比（166.25±29.82） ml/min;（111.77±53.42） ml/min、（125.54±51.99） ml/min比（42.39±4.81） ml/min,均P < 0.05]。两组间磷清除率差异无统计学意义。试验组4种透析器尿素下降比率均大于89%,治疗前后安全性监测指标均无明显变化。不良反应和不良事件少而程度轻,无严重不良反应。 结论 REXEEDTM-AC、UC系列高通量透析器临床使用安全有效。     

Comparison of the safety and efficacy of one-shot and telescopic metal dilatation in percutaneous nephrolithotomy: a randomized controlled trial

Minimizing X-ray exposure during percutaneous nephrolithotomy (PCNL) is challenging. Using the single semirigid dilator, also called “one-shot” or “one-stage” is a good alternative to routine telescopic metal dilators to reduce X-ray exposure. Our aim was to compare the single semirigid one-shot dilator with a telescopic metal dilator in PCNL. The intraoperative status was evaluated in 100 consecutive patients randomly assigned to two equal groups undergoing PCNL either with the one-shot (group A) or telescopic technique (group B). No significant difference in stone burden and location existed between the groups (P > 0.05). The mean age of group A and group B was 44.8 ± 15 and 45.6 ± 14 years, respectively (P = 0.78). The mean operation time was 51.14 ± 40.85 min in group A and 57.00 ± 38.85 min in group B (P = 0.46). The mean X-ray exposure time was 41.2 ± 17 and 48.4 ± 15 s in group A and group B, respectively (P = 0.03). The stone-free rate was 94 % (n = 47) in group A and 84 % (n = 42) in group B (P = 0.10). The mean hemoglobin drop was 1.26 ± 0.09 and 1.44 ± 0.11 g/dl in group A and group B, respectively (P = 0.09). The one-shot technique is feasible, safe, and well tolerated in patients undergoing PCNL. In addition to lack of complications, the method also provides less radiation exposure for urologists and nursing teams.     

Bar-coding surgical sponges to improve safety: a randomized controlled trial

OBJECTIVE: A randomized, controlled trial was performed to evaluate a computer-assisted method for counting sponges using a bar-code system. BACKGROUND: Retained sponges are a rare and preventable problem but persist in surgery despite standardized protocols for counting. Technology that improves detection of counting errors could reduce risk to surgical patients. METHODS: We performed a randomized controlled trial comparing a bar-coded sponge system with a traditional counting protocol in 300 general surgery operations. Observers monitored sponge and instrument counts and recorded all incidents of miscounted or misplaced sponges. Surgeons and operating room staff completed postoperative and end-of-study surveys evaluating the bar-code system. RESULTS: The bar-code system detected significantly more counting discrepancies than the traditional protocol (32 vs.13 discrepancies, P = 0.007). These discrepancies involved both misplaced sponges (21 vs. 12 sponges, P = 0.17) and miscounted sponges (11 vs. 1 sponge, P = 0.007). The system introduced new technical difficulties (2.04 per 1000 sponges) and increased the time spent counting sponges (5.3 vs. 2.4 minutes, P < 0.0001). In postoperative surveys, there was no difference in surgical teams' confidence that all sponges were accounted for, but they rated the counting process and team performance lower in operations randomized to the bar-code arm. By the end of the study, however, most providers found the system easy to use, felt confident in its ability to track sponges, and reported a positive effect on the counting process. CONCLUSIONS: Use of automated counting using bar-coded surgical sponges improved detection of miscounted and misplaced sponges and was well tolerated by surgical staff members.     

A pilot study for a randomized controlled trial comparing the efficacy, safety and cost-effectiveness of surgical treatments of the prostate

OBJECTIVE: To assess the numbers of men in outpatients and subsequently undergoing transurethral resection of the prostate (TURP) who were referred during 1993-94 and 1996-97, thereby assessing the feasibility of a subsequent study of treatment efficacy in men with bladder outlet obstruction secondary to benign prostatic hyperplasia, prospectively randomized to the surgical treatment options, i.e. TURP, laser ablation of the prostate, transurethral needle ablation and T3 thermotherapy, to investigate treatment outcome, cost-efficacy and cost-benefit. PATIENTS AND METHODS: All patients considered and consenting for prostate surgery were reviewed prospectively with a view to inclusion in the proposed trial. The diagnosis was based on two estimates of flow rate from voids of >150 mL and from symptoms assessed using the International Prostate Symptom Score. All patients had TURP explained by a urological surgeon and nursing staff, and subsequently had further consultation with research staff. RESULTS: Patients seen in clinic as new referrals increased by 11% between the periods assessed, although the numbers undergoing TURP decreased by 19%. Of the 383 patients screened, who were on the waiting list for TURP, only 13 elected to enter the trial. Of the 383 men, 267 (67%) ultimately had prostate surgery, with 39 (10%) electing to continue with watchful waiting and 34 (9%) continuing with pharmacotherapy. CONCLUSION: Although more men with benign prostatic disease and lower urinary tract symptoms are being seen in clinics, the reduced proportion of patients continuing to surgical intervention will lead to increasing difficulty in carrying out randomized controlled clinical trials assessing surgical options. With ever more therapeutic options available, patients find it difficult to make decisions in both the clinical situation and when asked to enter a trial. Fully informed decisions by both the surgeon and the patient will only be possible when objective data are available from trials that investigate outcome, cost-efficacy and cost-benefit. This study suggests that when presented with more information and counselling, fewer men decide to undergo prostate surgery for symptomatic BPH.     

前列安栓治疗慢性前列腺炎:多中心双盲随机安慰剂对照试验

目的　评估前列安栓治疗慢性前列腺炎各种疼痛和不适感等症状的有效性、安全性和依从性。　方法　安慰剂对照随机双盲试验。 72例慢性前列腺炎患者随机分为两组。治疗组 36例 ,每晚前列安栓 1粒纳肛 ,连续 1个月 ;对照组 36例 ,安慰剂治疗 1个月。根据前列腺按摩液 (EPS)和美国国立卫生院 (NIH)前列腺炎症状评分评估疗效。　结果　治疗组痊愈 1例 (2 .8% ) ,显效 7例(2 0 .0 % ) ,有效 16例 (45 .7% ) ,总显效率 2 2 .8% ,总有效率 6 8.6 %。对照组无痊愈病例 ,显效 2例(5 .7% ) ,有效 8例 (2 2 .8% ) ,总显效率 5 .7% ,总有效率 2 8.6 %。两组各有 1例在治疗 2周内退出试验。两组相比 ,总有效率和总显效率差别均有显著性意义 (P <0 .0 5 ) ;不良反应发生率差别无显著性意义 (P >0 .0 5 )。　结论　前列安栓治疗慢性前列腺炎安全、有效 ,患者依从性较好     

直肠粘膜保护剂治疗痔急性发作的临床研究

目的研究含直肠粘膜保护剂的肛门栓剂治疗痔急性发作的有效性及安全性。方法对123例患者采用随机、双盲对照的方法进行研究。研究组使用含直肠粘膜保护剂的肛门栓剂，对照组使用无粘膜保护成分的栓剂。结果（1）开盲后研究组60例，对照组63例。2组均未出现全身不良反应。（2）在治疗48h后，研究组疼痛、出血及瘙痒的减轻程度已明显优于对照组(P＜0.05)。（3）治疗7d后，研究组的疼痛、出血、水肿、糜烂和瘙痒的减轻程度也优于对照组(P＜0.05）。结论含直肠粘膜保护剂的肛门栓剂对痔发作有明显的疗效，未见到明显副作用。     

Fine catheter peritoneal cytology for the acute abdomen: a randomized, controlled trial

A randomized, controlled clinical trial, of sequential design, was undertaken to determine whether fine catheter aspiration cytology of the peritoneal cavity, using the percentage of neutrophils in the sample as the main test marker, reduces errors about urgent laparotomy in patients admitted to a surgical unit with acute abdominal pain. One hundred and forty-four patients with acute abdominal pain were studied. Of these, 26 were excluded because the test was unlikely to be useful and 20 did not consent. Conventional clinical assessment was undertaken and then the subjects were randomly allocated to have a peritoneal cytology test or not. After the test result was made available, the surgeon(s) decided whether to operate or continue conservative treatment. The correct decision was later ascertained by a blinded clinical referee. With the entry of the 98th patient the difference between the groups achieved the 5% significance level. The groups were well-matched in regard to demographic and other variables. The decision about urgent laparotomy was incorrect in only 8.2% of the test patients, compared with 28.6% of the others. It is concluded that fine catheter aspiration cytology of the peritoneal cavity is likely to reduce the numbers of unnecessary or delayed laparotomies when used in most patients admitted with acute abdominal pain.     

益精方治疗弱精子症的临床随机对照研究

目的:观察益精方治疗弱精子症的临床疗效。方法:450例患者以信封法随机分为治疗组(益精方组)300例和对照组(五子衍宗丸+左卡尼汀口服液组)150例,经精液常规检查诊为弱精子症,治疗组服用益精方,每天1剂,温水冲服,分2次服用,对照组服用五子衍宗丸+左卡尼汀口服液,五子衍宗丸9 g,口服,每日2次,左卡尼汀口服液,10 ml,口服,每日2次,均治疗3个月,于治疗前及治疗后的第1个月(第27~33天)、2个月(第57~63天)和3个月(第87~93天)分别检测患者的精液常规,比较治疗前后精子浓度、前向运动精子百分率(PR)、精子总活力(PR+NP)等精液参数的变化。结果:两组患者治疗前精液常规检查结果无显著差异(P0.05)。治疗组治疗1、2、3个月时,精子浓度分别为49.66±10.91、55.21±11.46、74.90±13.07(×10~6/ml),PR分别为23.81±2.56、26.12±2.34、32.17±1.62(%),PR+NP分别为34.17±3.43、36.59±3.36、47.08±2.97(%),精液体积分别为3.15±1.06、3.12±0.90、3.27±0.78(ml),液化时间分别为31.68±3.14、30.38±3.44、30.86±2.42(min),组内比较显示,治疗后精子浓度、PR、PR+NP较治疗前差异显著(P0.001),精液体积、液化时间差异不明显(P0.05)。对照组治疗1、2、3个月时,精子浓度分别为40.53±8.32、47.51±12.73、56.14±11.98(×10~6/ml),PR分别为25.17±2.64、27.23±2.25、31.89±2.27(%),PR+NP分别为33.89±2.26、37.38±4.79、40.35±3.06(%),精液体积分别为3.16±1.78、3.15±0.96、3.12±0.65(ml),液化时间分别为29.36±4.25、28.21±3.26、28.33±3.59(min),组内比较显示,治疗后精子浓度、PR、PR+NP较治疗前差异显著(P0.001),精液体积、液化时间差异不明显(P0.05)。组间比较显示,治疗组精子浓度及PR+NP增长率较对照组有显著差异(P0.001),PR增长率两组间差异不明显(P0.05)。结论:益精方可在生精周期多个阶段调控精子的发生,提高弱精子症患者的PR及PR+NP比例,是一种有效的治疗弱精子症的方剂。     

Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial

Background Context

The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown.

Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial

Background contextSystematic reviews of randomized controlled trials suggest that spinal manipulative therapy (SMT) is efficacious for care of cervicogenic headache (CGH). The effect of SMT dose on outcomes has not been studied.PurposeTo compare the efficacy of two doses of SMT and two doses of light massage (LM) for CGH.Patient sampleEighty patients with chronic CGH.Main outcome measuresModified Von Korff pain and disability scales for CGH and neck pain (minimum clinically important difference=10 on 100-point scale), number of headaches in the last 4 weeks, and medication use. Data were collected every 4 weeks for 24 weeks. The primary outcome was the CGH pain scale.MethodsParticipants were randomized to either 8 or 16 treatment sessions with either SMT or a minimal LM control. Patients were treated once or twice per week for 8 weeks. Adjusted mean differences (AMD) between groups were computed using generalized estimating equations for the longitudinal outcomes over all follow-up time points (profile) and using regression modeling for individual time points with baseline characteristics as covariates and with imputed missing data.ResultsFor the CGH pain scale, comparisons of 8 and 16 treatment sessions yielded small dose effects: |AMD|≤5.6. There was an advantage for SMT over the control: AMD=?8.1 (95% confidence interval=?13.3 to ?2.8) for the profile, ?10.3 (?18.5 to ?2.1) at 12 weeks, and ?9.8 (?18.7 to ?1.0) at 24 weeks. For the higher dose patients, the advantage was greater: AMD=?11.9 (?19.3 to ?4.6) for the profile, ?14.2 (?25.8 to ?2.6) at 12 weeks, and ?14.4 (?26.9 to ?2.0) at 24 weeks. Patients receiving SMT were also more likely to achieve a 50% improvement in pain scale: adjusted odds ratio=3.6 (1.6 to 8.1) for the profile, 3.1 (0.9 to 9.8) at 12 weeks, and 3.1 (0.9 to 10.3) at 24 weeks. Secondary outcomes showed similar trends favoring SMT. For SMT patients, the mean number of CGH was reduced by half.ConclusionsClinically important differences between SMT and a control intervention were observed favoring SMT. Dose effects tended to be small.