Effect of magnetic vs sham-magnetic insoles on plantar heel pain: a randomized controlled trial

Context  Despite anecdotal reports, rigorous scientific evidence of the effectiveness of magnetic insoles for the pain of plantar fasciitis is lacking. Objective  To determine whether magnetic insoles provide greater subjective improvement for treatment of plantar heel pain compared with identical nonmagnetized insoles. Design, Setting, and Participants  Randomized, double-blind, placebo-controlled trial conducted from February 12, 2001, to November 9, 2001, of a volunteer sample of 101 adults with diagnoses of plantar heel pain for at least 30 days from a multispecialty group practice clinic in Rochester, Minn. Daily pain diaries were kept for 8 weeks. Interventions  Cushioned insoles, with either active bipolar magnets or sham magnets, which were worn daily by the participants for 8 weeks. Main Outcome Measures  Reported average daily foot pain (by metered visual analog scale [VAS] and by categorical response of change from baseline) at 4 and 8 weeks, and impact of insoles on employment performance and enjoyment. Results  No significant between-group differences were found on any outcome variables studied when comparing active vs sham magnets. Both the nonmagnetic and magnetic groups reported significant improvements in morning foot pain intensity, with mean (SD) VAS scores improving from 6.9 (2.3) and 6.7 (2.0), respectively, at baseline to 3.9 (2.6) for each group at 8 weeks (P = .94). At 8 weeks, 33% of the nonmagnetic group and 35% of the magnetic group reported being all or mostly better (P = .78). At baseline, foot pain interfered moderately with participants' employment enjoyment (mean VAS, 4.2) and improved in both groups by 8 weeks (1.3 and 1.5, respectively; P = .68). Conclusion  Static bipolar magnets embedded in cushioned shoe insoles do not provide additional benefit for subjective plantar heel pain reduction when compared with nonmagnetic insoles.      

Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial

Laura M. Dember, MD; Gerald J. Beck, PhD; Michael Allon, MD; James A. Delmez, MD; Bradley S. Dixon, MD; Arthur Greenberg, MD; Jonathan Himmelfarb, MD; Miguel A. Vazquez, MD; Jennifer J. Gassman, PhD; Tom Greene, PhD; Milena K. Radeva, MS; Gregory L. Braden, MD; T. Alp Ikizler, MD; Michael V. Rocco, MD, MSCE; Ingemar J. Davidson, MD; James S. Kaufman, MD; Catherine M. Meyers, MD; John W. Kusek, PhD; Harold I. Feldman, MD, MSCE; for the Dialysis Access Consortium Study Group

JAMA. 2008;299(18):2164-2171.

Context  The arteriovenous fistula is the preferred type of vascular access for hemodialysis because of lower thrombosis and infection rates and lower health care expenditures compared with synthetic grafts or central venous catheters. Early failure of fistulas due to thrombosis or inadequate maturation is a barrier to increasing the prevalence of fistulas among patients treated with hemodialysis. Small, inconclusive trials have suggested that antiplatelet agents may reduce thrombosis of new fistulas.

Objective  To determine whether clopidogrel reduces early failure of hemodialysis fistulas.

Design, Setting, and Participants  Randomized, double-blind, placebo-controlled trial conducted at 9 US centers composed of academic and community nephrology practices in 2003-2007. Eight hundred seventy-seven participants with end-stage renal disease or advanced chronic kidney disease were followed up until 150 to 180 days after fistula creation or 30 days after initiation of dialysis, whichever occurred later.

Intervention  Participants were randomly assigned to receive clopidogrel (300-mg loading dose followed by daily dose of 75 mg; n = 441) or placebo (n = 436) for 6 weeks starting within 1 day after fistula creation.

Main Outcome Measures  The primary outcome was fistula thrombosis, determined by physical examination at 6 weeks. The secondary outcome was failure of the fistula to become suitable for dialysis. Suitability was defined as use of the fistula at a dialysis machine blood pump rate of 300 mL/min or more during 8 of 12 dialysis sessions.

Results  Enrollment was stopped after 877 participants were randomized based on a stopping rule for intervention efficacy. Fistula thrombosis occurred in 53 (12.2%) participants assigned to clopidogrel compared with 84 (19.5%) participants assigned to placebo (relative risk, 0.63; 95% confidence interval, 0.46-0.97; P = .018). Failure to attain suitability for dialysis did not differ between the clopidogrel and placebo groups (61.8% vs 59.5%, respectively; relative risk, 1.05; 95% confidence interval, 0.94-1.17; P = .40).

Conclusion  Clopidogrel reduces the frequency of early thrombosis of new arteriovenous fistulas but does not increase the proportion of fistulas that become suitable for dialysis.

Trial Registration  clinicaltrials.gov Identifier: NCT00067119

     

Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial

CONTEXT: Incidence of end-stage renal disease due to hypertension has increased in recent decades, but the optimal strategy for treatment of hypertension to prevent renal failure is unknown, especially among African Americans. OBJECTIVE: To compare the effects of an angiotensin-converting enzyme (ACE) inhibitor (ramipril), a dihydropyridine calcium channel blocker (amlodipine), and a beta-blocker (metoprolol) on hypertensive renal disease progression. DESIGN, SETTING, AND PARTICIPANTS: Interim analysis of a randomized, double-blind, 3 x 2 factorial trial conducted in 1094 African Americans aged 18 to 70 years with hypertensive renal disease (glomerular filtration rate [GFR] of 20-65 mL/min per 1.73 m(2)) enrolled between February 1995 and September 1998. This report compares the ramipril and amlodipine groups following discontinuation of the amlodipine intervention in September 2000. INTERVENTIONS: Participants were randomly assigned to receive amlodipine, 5 to 10 mg/d (n = 217), ramipril, 2.5 to 10 mg/d (n = 436), or metoprolol, 50 to 200 mg/d (n = 441), with other agents added to achieve 1 of 2 blood pressure goals. MAIN OUTCOME MEASURES: The primary outcome measure was the rate of change in GFR; the main secondary outcome was a composite index of the clinical end points of reduction in GFR of more than 50% or 25 mL/min per 1.73 m(2), end-stage renal disease, or death. RESULTS: Among participants with a urinary protein to creatinine ratio of >0.22 (corresponding approximately to proteinuria of more than 300 mg/d), the ramipril group had a 36% (2.02 [SE, 0.74] mL/min per 1.73 m(2)/y) slower mean decline in GFR over 3 years (P =.006) and a 48% reduced risk of the clinical end points vs the amlodipine group (95% confidence interval [CI], 20%-66%). In the entire cohort, there was no significant difference in mean GFR decline from baseline to 3 years between treatment groups (P =.38). However, compared with the amlodipine group, after adjustment for baseline covariates the ramipril group had a 38% reduced risk of clinical end points (95% CI, 13%-56%), a 36% slower mean decline in GFR after 3 months (P =.002), and less proteinuria (P<.001). CONCLUSION: Ramipril, compared with amlodipine, retards renal disease progression in patients with hypertensive renal disease and proteinuria and may offer benefit to patients without proteinuria.     

十一酸睾酮改善维持性血液透析男性患者性生活质量的随机对照试验

目的了解十一酸睾酮（TU）在改善维持性血液透析男性患者性生活质量方面的作用及其安全性和耐受性。方法70例血清睾酮低于260ng／dl的维持性血透男性患者随机（随机数字表法）分为观察组和对照组,观察组除了常规血透外加用口服TU（安特尔）80mg／早、40mg／晚,2周后改为40mg早晚两次,疗程6个月;对照组仅常规血透,检测血清性激素水平（FSH、LH、E2、PRL、P、T）变化及IIEF-5评分变化。结果观察组经TU治疗后T（273．72±86．52）ng／dl高于对照组（212．36±69．10）ng／dl（P〈0．05）,IIEF评分优于对照组,雌性激素水平、排尿困难、下肢水肿、血PSA两组均无差异（P〉0．05）。结论TU能明显改善维持性血液透析男性患者性生活质量,具有良好的安全性和耐受性。     

Surgery vs orthosis vs watchful waiting for hallux valgus: a randomized controlled trial

CONTEXT: Hallux valgus is a common foot deformation in adults, but evidence for effectiveness of surgical and conservative treatments for this condition is limited. OBJECTIVE: To compare the effectiveness of surgical and orthotic treatment with no treatment in patients with hallux valgus. DESIGN AND SETTING: Randomized controlled trial conducted in 4 general community hospitals in Finland in 1997-1998, with a follow-up period of 12 months. PARTICIPANTS: Two hundred nine consecutive patients (mean age, 48 years; 93% women) with a painful bunion and a hallux valgus angle 35 degrees or less. INTERVENTIONS: Patients were randomly assigned to surgery (distal chevron osteotomy; n = 71), orthosis (n = 69), or a 1-year waiting list (control group, n = 69). MAIN OUTCOME MEASURES: Pain intensity during walking on a visual analog scale (0-100), patient assessment of global improvement, number of painful days, cosmetic disturbance, footwear problems, functional status, and treatment satisfaction, compared among treatment groups. RESULTS: Follow-up rates at 6 and 12 months were 99% and 98%, respectively. At 6 months, pain intensity decreased more in the surgical group than in the control group (adjusted mean differences, -20 [95% confidence interval (CI), -28 to -12]) and more in orthosis than in the control groups (adjusted mean difference, -14 [95% CI, -22 to -6. At 1 year, pain intensity decreased more in the surgical than in the control groups (adjusted mean difference, -19 [95% CI, -28 to -10]) and more than in the surgical and orthosis groups (adjusted mean difference, -14 [95% CI, -22 to -5]). At 1 year, 83%, 46%, and 24% in the surgery, orthosis, and control groups, respectively, thought they had improved compared with baseline (number needed to treat), 1.7 between surgical and control groups). Number of painful days, cosmetic disturbance, and footwear problems were least and functional status and satisfaction with treatment were best in the surgical group. CONCLUSIONS: Surgical osteotomy is an effective treatment for painful hallux valgus. Orthoses provide short-term symptomatic relief.     

氢氯噻嗪治疗儿童夜尿症的随机对照研究

目的：探讨氢氯噻嗪治疗夜尿症的有效性。方法：前瞻性纳入2010年1月～2010年9月我院夜尿症患儿100例,实际纳入病例95例,将其分为实验组（47例）和对照组（48例）。实验组服用氢氯噻嗪,对照组服用安慰剂。评估夜尿症的缓解情况及药物不良反应,并比较两组间的差异。结果：所有纳入患者均对药物有较好的耐受性。氢氯噻嗪和安慰剂均能明显缓解夜尿症的发生（57.4%vs 33.3%）,差异具有统计学意义（P=0.018）,但氢氯噻嗪降低夜尿症频率缓解程度50%以上者较安慰剂效果更明显（48.1%vs 12.5%）,差异具有统计学意义（P=0.018）。结论：氢氯噻嗪能安全而有效地缓解儿童夜尿症,但是在以后的研究和临床中其临床效果仍有待于进一步证实。     

苦参素对维持性血液透析患者微炎症状态的影响：随机对照试验

背景：维持性血液透析（maintenance hemodialysis,MHD）患者体内普遍存在微炎症状态。它严重影响MHD患者长期生存率,改善MHD患者微炎症状态具有重要意义。 目的：观察苦参素对MHD患者微炎症状态的影响,探讨苦参素对MHD患者微炎症的治疗作用。 设计、场所、对象和干预措施：选择2008年6～9月在武汉市第一医院血液净化中心进行规律性维持血液透析治疗的60例慢性肾衰竭患者,随机分为治疗组和对照组,每组各30例。治疗组给予苦参素胶囊0．4g口服,1次／d,连续服用3个月,对照组不用药。 主要结局指标：检测治疗前及治疗3个月后血清超敏C反应蛋白（high-sensitivity C-reactive protein,hs-CRP）、白细胞介素1β（interleukin-1β,IL—1β）、肿瘤坏死因子α（tumor necrosis factor—α,TNF—α）、血清白蛋白（albumin,Alb）、血清前白蛋白（pre-albumin,PAB）、总胆固醇（total cholesterol,TC）和三酰甘油（triglyceride,TG）浓度。 结果：治疗组3例服药后当天出现胃痛,其中2例退出,1例经停药观察后症状消失,继续服药后胃痛未再次出现。治疗组2例服药第2天出现皮疹,经停药观察后症状消失,继续服药后未再次出现皮疹。其他患者均未发现不良反应,共58例完成观察。与治疗前比较,治疗组治疗后hs-CRP、IL-1β和TNF-α水平降低（P〈0.01）,Alb,PAB、TC及TG水平升高（P〈0．01）,与对照组比较,差异亦有统计学意义（P〈0．01,P〈0．05）。结论：苦参素能够改善MHD患者的微炎症状态。     

中药复方肺泰胶囊维持治疗对中晚期非小细胞肺癌生存质量的影响：随机对照试验

背景：近年关于已完成治疗周期的瘤灶稳定的非小细胞肺癌（non-small-cell lung cancer,NSCLC）患者的维持治疗问题,引起医学界普遍兴趣。开展中医药在中晚期恶性肿瘤维持治疗领域的研究可能是目前综合治疗措施有益的补充。目的：观察中药复方肺泰胶囊维持治疗对NSCLC患者生存质量的影响,并评价其安全性。设计、场所、受试者和干预措施：按标准入选南京军区福州总医院中晚期NSCLC患者62例,按信封法随机分为治疗组和对照组,每组各31例。治疗组给予肺泰胶囊维持治疗,对照组不给予任何干预。两组患者均定期随访。主要结局指标：定期评估临床证候疗效、体力状况、生存质量和安全性。组间临床特征、症状缓解率、体力状况和生活质量评分分别采用方差分析、非参数检验和协方差分析进行统计。安全性评价采用描述性统计。结果：入组62例,治疗组和对照组各1例出组,可评价疗效病例60例。治疗前两组基线资料分布均衡（P〉0.05）。治疗组治疗后临床证候评估以及体力状况改善率分别提高了36.6%（Z=-2.632,P=0.008）和26.7%（Z=-2.182,P=0.029）,两指标间存在显著正相关（r=0.917,P〈0.001）;治疗组生活质量得以改善,治疗期间未见明显药物相关的不良反应。结论：中药复方肺泰胶囊维持治疗可改善中晚期非小细胞肺癌患者的生存质量。     

Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial

Context  Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes. Objective  To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control. Design, Setting, and Participants  Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI >30 and <40) with recently diagnosed (<2 years) type 2 diabetes. Interventions  Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care. Main Outcome Measures  Remission of type 2 diabetes (fasting glucose level <126 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA_1c] value <6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat. Results  Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up. Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval, 2.2-14.0). Surgical and conventional-therapy groups lost a mean (SD) of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P < .001). Remission of type 2 diabetes was related to weight loss (R² = 0.46, P < .001) and lower baseline HbA_1c levels (combined R² = 0.52, P < .001). There were no serious complications in either group. Conclusions  Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss. These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed. Trial Registration  actr.org Identifier: ACTRN012605000159651      

Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial

Context  Laboratory evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer disease (AD), along with epidemiological evidence, suggests that nonsteroidal anti-inflammatory drugs (NSAIDs) may favorably influence the course of the disease. Objective  To determine whether treatment with a selective cyclooxygenase (COX) -2 inhibitor (rofecoxib) or a traditional nonselective NSAID (naproxen) slows cognitive decline in patients with mild-to-moderate AD. Design  Multicenter, randomized, double-blind, placebo-controlled, parallel group trial, with 1-year exposure to study medications. Setting  Forty ambulatory treatment centers affiliated with the Alzheimer's Disease Cooperative Study consortium. Participants  Participants with mild-to-moderate AD (Mini-Mental State Examination score of 13-26) were recruited from December 1999 to November 2000 using clinic populations, referrals from community physicians, and local advertising. Stable use of cholinesterase inhibitors, estrogen, low-dose aspirin, and vitamin E was allowed. Participants with inflammatory diseases that might respond to the study medications were excluded. Of 474 participants screened, 351 were enrolled. Interventions  Once-daily rofecoxib, 25 mg, or twice-daily naproxen sodium, 220 mg, or placebo. Main Outcome Measures  The primary outcome measure was the 1-year change in the Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) subscale score. Secondary outcome measures included the Clinical Dementia Rating scale sum-of-boxes, the Neuropsychiatric Inventory, the Quality of Life-AD, and the time to attainment of significant end points (4-point decline from baseline ADAS-Cog score, 1-step worsening on the global Clinical Dementia Rating scale, 15-point decline on the ADCS activities of daily living inventory, institutionalization, or death). Results  The 1-year mean (SD) change in ADAS-Cog scores in participants treated with naproxen (5.8 [8.0]) or rofecoxib (7.6 [7.7]) was not significantly different from the change in participants treated with placebo (5.7 [8.2]). Results of secondary analyses showed no consistent benefit of either treatment. Fatigue, dizziness, and hypertension were more commonly reported in the active drug groups, and more serious adverse events were found in the active treatment group than in the placebo group. Conclusion  The results of this study indicate that rofecoxib or low-dose naproxen does not slow cognitive decline in patients with mild-to-moderate AD.      

Effect of hysterectomy vs medical treatment on health-related quality of life and sexual functioning: the medicine or surgery (Ms) randomized trial

Context  Although a quarter of US women undergo elective hysterectomy before menopause, controlled trials that evaluate the benefits and harms are lacking. Objective  To compare the effect of hysterectomy vs expanded medical treatment on health-related quality of life. Design, Setting, and Participants  A multicenter, randomized controlled trial (August 1997–December 2000) of 63 premenopausal women, aged 30 to 50 years, with abnormal uterine bleeding for a median of 4 years who were dissatisfied with medical treatments, including medroxyprogesterone acetate. The participants, who were patients at gynecology clinics and affiliated practices of 4 US academic medical centers, were followed up for 2 years. Interventions  Participants were randomly assigned to undergo hysterectomy or expanded medical treatment with estrogen and/or progesterone and/or a prostaglandin synthetase inhibitor. The hysterectomy route and medical regimen were determined by the participating gynecologist. Main Outcome Measures  The primary outcome was mental health measured by the Mental Component Summary (MCS) of the 36-Item Short-Form Health Survey (SF-36). Secondary outcomes included physical health measured by the Physical Component Summary (PCS), symptom resolution and satisfaction, body image, and sexual functioning, as well as other aspects of mental health and general health perceptions. Results  At 6 months, women in the hysterectomy group had greater improvement in MCS scores than women in the medicine group (8 vs 2, P = .04). They also had greater improvement in symptom resolution (75 vs 29, P<.001), symptom satisfaction (44 vs 7, P<.001), interference with sex (41 vs 22, P = .003), sexual desire (21 vs 3, P = .01), health distress (33 vs 13, P = .009), sleep problems (13 vs 1, P = .03), overall health (12 vs 2, P = .006), and satisfaction with health (31 vs 14, P = .01). By the end of the study, 17 (53%) of the women in the medicine group had requested and received hysterectomy, and these women reported improvements in quality-of-life outcomes during the 2 years that were similar to those reported by women randomized to the hysterectomy group. Women who continued medical treatment also reported some improvements (P<.001 for within-group change in many outcomes), with the result that most differences between randomized groups at the end of the study were no longer statistically significant in the intention-to-treat analysis. Conclusions  Among women with abnormal uterine bleeding and dissatisfaction with medroxyprogesterone, hysterectomy was superior to expanded medical treatment for improving health-related quality-of-life after 6 months. With longer follow-up, half the women randomized to medicine elected to undergo hysterectomy, with similar and lasting quality-of-life improvements; those who continued medical treatment also reported some improvements.      

Effect of Zuogui pill and Yougui pill on osteoporosis: a randomized controlled trial

OBJECTIVE

To evaluate the effect and safety of Zuogui pill and Yougui pill, classic Yin and Yang tonic formula (CYYTF), in the treatment of osteoporosis and the underlying mechanism.

Effect of Chinese herbs on immunoglobulin A nephropathy:a randomized controlled trial

OBJECTIVE: The accumulation of extracellular matrix (ECM) is one of the main causes of renal fibrosis. Emerging evidence suggests that the metabolic enzyme of ECM is associated with renal fibrosis. In this study, we applied randomly controlled trial to check the curative effect of Chinese herbs on patients with immunoglobulin A nephropathy (IgAN). METHODS: Twenty-six patients were randomly divided into group A (control group) treated with Western Medicine and group B (treatment group) treated with combination of Traditional Chinese Medicine (TCM) and Western Medicine. Blood and urine tests were done before treatment and after 8-week treatment. RESULTS: The levels of the main composition of ex- tracellular matrix (MC-ECM), the metabolic enzyme of ECM (ME-ECM) and some cytokines in group B decreased more obviously than those in group A after 8-week treatment. So did the level of 24-hour urine protein. However, Metal matrix protease (MMP)-2 and vascular endothelial growth factor in group B increased more obviously than those in group A after 8-week treatment. No effects on the renal function were found in both groups. CONCLUSION: Our study provided important information on using the combination of TCM with Western Medicine to inhibit the progression of renal fibrosis in patients with IgAN.     

Splinting vs surgery in the treatment of carpal tunnel syndrome: a randomized controlled trial

Context  Carpal tunnel syndrome (CTS) can be treated with nonsurgical or surgical options. However, there is no consensus on the most effective method of treatment. Objective  To compare the short-term and long-term efficacy of splinting and surgery for relieving the symptoms of CTS. Design, Setting, and Patients  A randomized controlled trial conducted from October 1998 to April 2000 at 13 neurological outpatient clinics in the Netherlands. A total of 176 patients with clinically and electrophysiologically confirmed idiopathic CTS were assigned to wrist splinting during the night for at least 6 weeks (89 patients) or open carpal tunnel release (87 patients); 147 patients (84%) completed the final follow-up assessment 18 months after randomization. Main Outcome Measures  General improvement, number of nights waking up due to symptoms, and severity of symptoms. Results  In the intention-to-treat analyses, surgery was more effective than splinting on all outcome measures. The success rates (based on general improvement) after 3 months were 80% for the surgery group (62/78 patients) vs 54% for the splinting group (46/86 patients), which is a difference of 26% (95% confidence interval [CI], 12%-40%; P<.001). After 18 months, the success rates increased to 90% for the surgery group (61/68 patients) vs 75% for the splinting group (59/79 patients), which is a difference of 15% (95% CI, 3%-27%; P = .02). However, by that time 41% of patients (32/79) in the splint group had also received the surgery treatment. Conclusion  Treatment with open carpal tunnel release surgery resulted in better outcomes than treatment with wrist splinting for patients with CTS.      

Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial

Context  Pancreatic cancer is an aggressive tumor associated with high mortality. Optimal pain control may improve quality of life (QOL) for these patients. Objective  To test the hypothesis that neurolytic celiac plexus block (NCPB) vs opioids alone improves pain relief, QOL, and survival in patients with unresectable pancreatic cancer. Design, Setting, and Patients  Double-blind, randomized clinical trial conducted at Mayo Clinic, Rochester, Minn. Enrolled (October 1997 and January 2001) were 100 eligible patients with unresectable pancreatic cancer experiencing pain. Patients were followed up for at least 1 year or until death. Intervention  Patients were randomly assigned to receive either NCPB or systemic analgesic therapy alone with a sham injection. All patients could receive additional opioids managed by a clinician blinded to the treatment assignment. Main Outcome Measures  Pain intensity (0-10 numerical rating scale), QOL, opioid consumption and related adverse effects, and survival time were assessed weekly by a blinded observer. Results  Mean (SD) baseline pain was 4.4 (1.7) for NCPB vs 4.1 (1.8) for opioids alone. The first week after randomization, pain intensity and QOL scores were improved (pain intensity, P.01 for both groups; QOL, P<.001 for both groups), with a larger decrease in pain for the NCPB group (P = .005). From repeated measures analysis, pain was also lower for NCPB over time (P = .01). However, opioid consumption (P = .93), frequency of opioid adverse effects (all P>.10), and QOL (P = .46) were not significantly different between groups. In the first 6 weeks, fewer NCPB patients reported moderate or severe pain (pain intensity rating of =" BORDER="0">5/10) vs opioid-only patients (14% vs 40%, P = .005). At 1 year, 16% of NCPB patients and 6% of opioid-only patients were alive. However, survival did not differ significantly between groups (P = .26, proportional hazards regression). Conclusion  Although NCPB improves pain relief in patients with pancreatic cancer vs optimized systemic analgesic therapy alone, it does not affect QOL or survival.      

Comparison of contamination between conventional three-way stopcock and needleless injection device: a randomized controlled trial.

BACKGROUND: Intraluminal contamination of catheter hubs has been recognized as the most frequent cause of catheter-related blood stream infections. We have investigated the efficacy of a new hub device, Planecta SC(R) (PNSC), in preventing endoluminal catheter contamination, compared to a conventional three-way stopcock. MATERIAL/METHODS: Adults patients requiring an intravascular catheter placement for at least 48 hours in intensive care units were randomly assigned to receive either the infusion device with the newly designed hub, PNSC (P group, n=89), or with a conventional three-way stopcock (C group, n=73). To evaluate intraluminal contamination, we examined the bacteria isolated in the inline bacterial filters which were attached to downstream of the injection ports. In addition to the clinical study, we conducted a bench study to investigate if use of protection caps or strict disinfection technique prevented intraluminal contamination with this new needleless connector. RESULTS: The incidence of bacterial contamination was not significantly different between the groups (P group 9/89 (10.1%) vs. C group 6/73 (8.2%), P=0.79). There was no correlation between the numbers of injections, duration of the use of the device or the microbial contamination rate. In the bench study, protection caps and disinfection technique significantly decreased microbial transfer from the hub to the fluid space. CONCLUSIONS: We concluded that the use of the new hub device did not reduce endoluminal bacterial contamination rate in comparison with that of a three way stopcock. Intraluminal bacterial contamination may be reduced by either strict disinfection technique or when a protection cap is use.     

Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial

Context  Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective  To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design  Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting  Ninety hospitals in Europe, Latin America, and Asia. Patients  A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. Intervention  Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685). Main Outcome Measures  The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non–Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results  In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, –0.22 mm; 95% CI, –0.26 to –0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, –3.60%; 95% CI, –5.12% to –2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73). Conclusion  In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. Clinical Trial Registration  ClinicalTrials.gov Identifier: NCT00235092      

腹及腹腔镜手术对腹膜纤溶系统影响的临床研究

目的探讨腹腔镜与开腹手术中腹膜纤维蛋白溶酶的变化。方法在腹腔镜与开腹手术前、后、立即，分别测量腹膜组织中组织型纤溶酶原激活物(t-PA)、纤溶酶原激活物抑制物(PAI-1)的浓度及t-PA的活性。结果腹膜组织t PA浓度在腹腔镜手术和传统腹部手术两组术中均下降，在传统腹部手术组下降更显著(P<0.05)，而腹膜组织PAI-1水平在腹腔镜手术组术前较高（P<0.05），在传统腹部手术组术中明显升高。手术后，两组PAI-1浓度无显著差异。t-PA活性在两组术前、后均无明显差异，但术中两组均显著下降(P<0.05) 。结论腹腔镜和传统腹部手术对腹膜的影响是相似的，腹腔镜手术最初腹膜组织中PAI-1浓度的升高是由于CO₂气腹造成的，并影响腹膜组织的修复。