甲泼尼龙预防高危患者经皮肾镜取石术后尿脓毒症的随机对照研究

目的 探讨甲泼尼龙(METH)预处理对高危患者经皮肾镜取石术(PCNL)后尿脓毒症发生的影响.方法 前瞻性选择80例接受PCNL且具有尿脓毒症高危因素的患者,采用按性别分层的随机序列分为METH组(n=40)和对照组(n=40).全身麻醉诱导后,在手术操作前METH组患者静脉推注METH 40 mg,而对照组患者静脉推...     

Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial

Context  Postoperative pulmonary complications (PPCs) after coronary artery bypass graft (CABG) surgery are a major source of morbidity and mortality, and increase length of hospital stay and resource utilization. The prehospitalization period before CABG surgery may be used to improve a patient's pulmonary condition. The efficacy of preoperative inspiratory muscle training (IMT) in reducing the incidence of PPCs in high-risk patients undergoing CABG surgery has not yet been determined. Objective  To evaluate the prophylactic efficacy of preoperative IMT on the incidence of PPCs in high-risk patients scheduled for elective CABG surgery. Design, Setting, and Patients  A single-blind, randomized clinical trial conducted at the University Medical Center Utrecht, Utrecht, the Netherlands, with enrollment between July 2002 and August 2005. Of 655 patients referred for elective CABG surgery, 299 (45.6%) met criteria for high risk of developing PPCs, of whom 279 were enrolled and followed up until discharge from hospital. Intervention  Patients were randomly assigned to receive either preoperative IMT (n = 140) or usual care (n = 139). Both groups received the same postoperative physical therapy. Main Outcome Measures  Incidence of PPCs, especially pneumonia, and duration of postoperative hospitalization. Results  Both groups were comparable at baseline. After CABG surgery, PPCs were present in 25 (18.0%) of 139 patients in the IMT group and 48 (35.0%) of 137 patients in the usual care group (odds ratio [OR], 0.52; 95% confidence interval [CI], 0.30-0.92). Pneumonia occurred in 9 (6.5%) of 139 patients in the IMT group and in 22 (16.1%) of 137 patients in the usual care group (OR, 0.40; 95% CI, 0.19-0.84). Median duration of postoperative hospitalization was 7 days (range, 5-41 days) in the IMT group vs 8 days (range, 6-70 days) in the usual care group by Mann-Whitney U statistic (z = –2.42; P = .02). Conclusion  Preoperative IMT reduced the incidence of PPCs and duration of postoperative hospitalization in patients at high risk of developing a pulmonary complication undergoing CABG surgery. Trial Registration  isrctn.org Identifier: ISRCTN17691887      

Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial

Context  Although chronic Helicobacter pylori infection is associated with gastric cancer, the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown. Objective  To determine whether treatment of H pylori infection reduces the incidence of gastric cancer. Design, Setting, and Participants  Prospective, randomized, placebo-controlled, population-based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province, China, recruited in July 1994 and followed up until January 2002. A total of 988 participants did not have precancerous lesions (gastric atrophy, intestinal metaplasia, or gastric dysplasia) on study entry. Intervention  Patients were randomly assigned to receive H pylori eradication treatment: a 2-week course of omeprazole, 20 mg, a combination product of amoxicillin and clavulanate potassium, 750 mg, and metronidazole, 400 mg, all twice daily (n = 817); or placebo (n = 813). Main Outcome Measures  The primary outcome measure was incidence of gastric cancer during follow-up, compared between H pylori eradication and placebo groups. The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions, compared between the 2 groups. Results  Among the 18 new cases of gastric cancers that developed, no overall reduction was observed in participants who received H pylori eradication treatment (n = 7) compared with those who did not (n = 11) (P = .33). In a subgroup of patients with no precancerous lesions on presentation, no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo (0 vs 6; P = .02). Smoking (hazard ratio [HR], 6.2; 95% confidence interval [CI], 2.3-16.5; P<.001) and older age (HR, 1.10; 95% CI, 1.05-1.15; P<.001) were independent risk factors for the development of gastric cancer in this cohort. Conclusions  We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a high-risk region of China. In the subgroup of H pylori carriers without precancerous lesions, eradication of H pylori significantly decreased the development of gastric cancer. Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted.      

七氟醚预处理在二尖瓣置换手术的心肌保护作用:一项随机对照研究及lncRNA分析

目的 探讨七氟醚(sevoflurane)预处理对体外循环下行二尖瓣膜置换患者的心脏保护作用及其机制.方法 纳入我院心脏外科2017年5-11月收治的40例接受二尖瓣置换手术的患者(17例男性和23例女性),平均年龄48岁,BMI:(22.7-2.6) kg/m2.根据随机数字表法将患者分为七氟醚预处理(SEV)组和对照(CON)组(n=20),SEV组患者体外循环前接受七氟醚持续吸入维持麻醉,而CON组采用丙泊酚维持麻醉.采集术前、术后2、24 h血液,检测cTnI浓度;心脏彩超评估术前、术后24h左室缩短分数和射血分数,记录ICU停留时间及住院时间;分别在体外循环开始前取得两组患者取心房肌标本(n=5),进行lncRNA测序和分析.结果 SEV组患者:术后2h[0.58 (0.33,0.90) ng/mL vs 1.06(0.55、2.16) ng/mL,P＜0.05]和24 h[0.66(0.38、1.02) ng/mL vs 1.09 (0.72、1.54) ng/mL,P＜0.05]的cTnI浓度均显著低于CON组;术后24h左室缩短分数值[(39.8±3.3)％ vs(33.9±2.8)％,P＜0.05)和左室射血分数[(70.5±4.0)％ vs(62.7±4.2)％,P＜0.05]显著高于CON组;ICU停留时间[(68±18)h vs(83 ±26)h,P＜0.05]显著短于CON组.两组患者的住院时间差异无统计学意义(P＞0.05).lncRNA分析出73个上调和95个下调基因,结果提示心肌细胞凋亡相关的IncRNA通路可能参与七氟醚心脏保护.结论 体外循环前七氟醚预处理对行二尖瓣置换手术的患者具有早期心肌保护作用;心肌细胞凋亡相关lncRNA通路可能是七氟醚预处理心肌保护的潜在作用靶点.     

血塞通注射液对腹腔镜胃癌手术患者凝血功能影响的随机对照研究

目的：观察血塞通注射液对腹腔镜胃癌手术患者凝血功能的影响,并探讨其可能机制。方法：将腹腔镜胃癌手术患者50例随机分为对照组和血塞通组（预防组）,每组25例。对照组术后予常规抗感染和补液治疗,预防组在抗感染和补液治疗基础上于术后第1天起给予血塞通注射液400mg加5％葡萄糖注射液250mL,静脉滴注,1次/d,连续给药6d。于术前、术后即刻及术后3、5、7d采用凝固法检测患者凝血酶原时间（prothrombin time,PT）、活化部分凝血活酶时间（activated partial thromboplastin time,APTT）和纤维蛋白原（fibrinogen,FIB）,采用国际标准化比值（international normalized ratio,INR）法计算凝血酶原INR,采用酶联免疫吸附双抗体夹心法定量测定血浆D-二聚体（Ddimer,D—D）含量,并于术后第7天运用深静脉造影观察两组术后下肢深静脉血栓的发生情况。结果：术前两组患者PT、APTT、INR、FIB和D—D比较,差异无统计学意义,具有可比性;术后两组患者APTT和INR均无明显变化。术后3d,两组患者PT均缩短（P〈0．05）,但两组比较,差异无统计学意义;随着术后时间的延长,对照组PT进一步缩短（P〈0．05）,而预防组变化不明显,与对照组比较,差异有统计学意义（P〈0．05）。术后即刻两组患者FIB和D—D均升高（P〈0．05）,两组间差异无统计学意义。随着术后时间的延长,对照组FIB和D—D逐步升高（P〈0．05）;而预防组术后3dD—D亦升高（P〈0．05）,但与术后即刻比较,差异无统计学意义,其术后5、7dD—D水平则持续下降（P〈0．05）。术后第7天预防组下肢深静脉血栓发生率显著低于对照组。结论：腹腔镜胃癌手术可使患者血液呈高凝状态,增加术后血栓发生的风险,而血塞通注射液可有效改善腹腔镜胃癌手术所致血液高凝状态,降低术后血栓发生的风险。     

术前肾功能不全心脏病患者围术期处理

为评价术前肾功能不全心脏病患者的围术期处理,我们回顾性总结了从2001年1月到2002年1月26例伴肾功能不全行心脏手术患者的治疗经验.通过分析明确这些患者术前肾功能不全的病因并给予积极治疗,术中和术后以相应的治疗措施改善肾灌注,使得本组患者术后仅有4例死亡,而死亡原因均为肾功能衰竭,院内死亡率为14.5％.所以我们认为,对这类患者围术期应采取积极的措施以防止术后出现肾功能衰竭.     

Effect of preoperative immunonutrition in patients undergoing hepatectomy; a randomized controlled trial

No consensus has been reached concerning the effects of preoperative immunonutrition in patients undergoing hepatectomy. We evaluated the effects of immunonutrition before hepatectomy on perioperative management. This study was performed as a randomized controlled trial. Patients expected to undergo segmentectomy or more extensive hepatectomy for liver tumors were randomized to immunonutrition (IM) and control (C) groups each consisting of 13 patients. The IM group was given 750 ml of IMPACT in addition to half-size hospital meals orally from 5 days before to the day before surgery, and the C group was given conventional hospital meals. The blood level of eicosapentaenoic acid was elevated preoperatively in all patients of the IM group. The white blood cell count and interleukin 6 levels, which are indices of postoperative inflammation, were significantly lower in the IM group. As regards liver function, postoperative increases in the aspartate aminotransferase and alanine aminotransaminase levels were slightly suppressed in the IM group. No significant difference was noted in postoperative complications or duration of postoperative hospital stay. In patients undergoing hepatectomy, preoperative immunonutrition reduced inflammation and protected against liver dysfunction.     

Use of continuous quality improvement to increase use of process measures in patients undergoing coronary artery bypass graft surgery: a randomized controlled trial

Context  A rigorous evaluation of continuous quality improvement (CQI) in medical practice has not been carried out on a national scale. Objective  To test whether low-intensity CQI interventions can be used to speed the national adoption of 2 coronary artery bypass graft (CABG) surgery process-of-care measures: preoperative -blockade therapy and internal mammary artery (IMA) grafting in patients 75 years or older. Design, Setting, and Participants  Three hundred fifty-nine academic and nonacademic hospitals (treating 267 917 patients using CABG surgery) participating in the Society of Thoracic Surgeons National Cardiac Database between January 2000 and July 2002 were randomized to a control arm or to 1 of 2 groups that used CQI interventions designed to increase use of the process-of-care measures. Intervention  Each intervention group received measure-specific information, including a call to action to a physician leader; educational products; and periodic longitudinal, nationally benchmarked, site-specific feedback. Main Outcome Measure  Differential incorporation of the targeted care processes into practice at the intervention sites vs the control sites, assessed by measuring preintervention (January-December 2000)/postintervention (January 2001-July 2002) site differences and by using a hierarchical patient-level analysis. Results  From January 2000 to July 2002, use of both process measures increased nationally (-blockade, 60.0%-65.6%; IMA grafting, 76.2%-82.8%). Use of -blockade increased significantly more at -blockade intervention sites (7.3% [SD, 12.8%]) vs control sites (3.6% [SD, 11.5%]) in the preintervention/postintervention (P = .04) and hierarchical analyses (P<.001). Use of IMA grafting also tended to increase at IMA intervention sites (8.7% [SD, 17.5%]) vs control sites (5.4% [SD,15.8%]) (P = .20 and P = .11 for preintervention/postintervention and hierarchical analyses, respectively). Both interventions tended to have more impact at lower-volume CABG sites (for interaction: P = .04 for -blockade; P = .02 for IMA grafting). Conclusions  A multifaceted, physician-led, low-intensity CQI effort can improve the adoption of care processes into national practice within the context of a medical specialty society infrastructure.      

Electroacupuncture for the prevention of postoperative gastrointestinal dysfunction in patients undergoing vascular surgery under general anesthesia： study protocol for a prospective practical randomized controlled trial

BACKGROUND： Postoperative gastrointestinal dysfunction（PGD） is one of the most common complications following major surgeries under general anesthesia（GA）. Despite ongoing research and new drug treatments, abdominal distension within 24 h postoperatively occurs in 8%–28% of all surgeries. We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan（PC6）, Zusanli（ST36） and Shangjuxu（ST37） bilaterally twice a day compared with sham-acupuncture treatment and standard treatment.METHODS AND DESIGN： This is a single-center, prospective practical randomized controlled trial. All groups will be given standard treatments. Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University, China, and divided into three groups. The experimental group will receive routine treatments and acupuncture at PC6, ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively. The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6, ST36 and ST37, which are 1 cun away from the real acupoints. The routine-treatment group will not receive electroacupuncture. The outcomes include the incidence of abdominal distention, abdominal circumference, the degree of abdominal distension, the fi rst time of fl atus and defecation, and hospitalization duration. DISCUSSION： The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. This study may also provide a standardized acupuncture treatment for reduction of PGD. TRIAL REGISTRATION： This study is registered with the Chinese Clinical Trial Registry： Chi CTR-TRC-13003649.     

Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial

Context  Sexual dysfunction is a common adverse effect of antidepressants that frequently results in treatment noncompliance. Objective  To assess the efficacy of sildenafil citrate in men with sexual dysfunction associated with the use of selective and nonselective serotonin reuptake inhibitor (SRI) antidepressants. Design, Setting, and Patients  Prospective, parallel-group, randomized, double-blind, placebo-controlled trial conducted between November 1, 2000, and January 1, 2001, at 3 US university medical centers among 90 male outpatients (mean [SD] age, 45 [8] years) with major depression in remission and sexual dysfunction associated with SRI antidepressant treatment. Intervention  Patients were randomly assigned to take sildenafil (n = 45) or placebo (n = 45) at a flexible dose starting at 50 mg and adjustable to 100 mg before sexual activity for 6 weeks. Main Outcome Measures  The primary outcome measure was score on the Clinical Global Impression-Sexual Function (CGI-SF); secondary measures were scores on the International Index of Erectile Function, Arizona Sexual Experience Scale, Massachusetts General Hospital-Sexual Functioning Questionnaire, and Hamilton Rating Scale for Depression (HAM-D). Results  Among the 90 randomized patients, 93% (83/89) of patients treated per protocol took at least 1 dose of study drug and 85% (76/89) completed week 6 end-point assessments with last observation carried forward analyses. At a CGI-SF score of 2 or lower, 54.5% (24/44) of sildenafil compared with 4.4% (2/45) of placebo patients were much or very much improved (P<.001). Erectile function, arousal, ejaculation, orgasm, and overall satisfaction domain measures improved significantly in sildenafil compared with placebo patients. Mean depression scores remained consistent with remission (HAM-D score 10) in both groups for the study duration. Conclusion  In our study, sildenafil effectively improved erectile function and other aspects of sexual function in men with sexual dysfunction associated with the use of SRI antidepressants. These improvements may allow patients to maintain adherence with effective antidepressant treatment.      

肺保护性通气在中老年脊柱俯卧位手术中的应用:随机对照试验

目的 肺保护性通气策略对中老年脊柱俯卧位手术人群呼吸循环的影响.方法 60例择期脊柱手术患者,随机分为常规通气对照组与肺保护性通气试验组,每组30例.对照组:VT:10 mL/kg(PBW),呼吸频率:10～12次/min;试验组:VT:6 mL/kg(PBW)+RMs+PEEP:5 cm H2O,呼吸频率:12～18次/min,每间隔30 min作1次RM.观察术前,入室后,改俯卧位前5 min,改俯卧位后30 min、lh、3h,术后第1天、第3天各相应时间点:心率(HR),平均动脉压(MAP),气道峰压(Ppeak),气道平台压(PPlat),动脉血气分析(PaO2/FiO2、SpO2、PaCO2)、白细胞计数(wBC),中性粒细胞百分比(NEUT％),血清C-反应蛋白(CRP),VAS疼痛评分,肺部并发症风险评分,临床肺部感染评分.结果 两组肺部并发症风险评分、HR、MAP、WBC、NEUT％、PaCO2组间比较无统计学差异(P＞0.05).与对照组相比,试验组在改俯卧位前5 min,改俯卧位后30 min、1h、3 h Ppeak和Pplat下降(P＜0.05),术后第1天氧合指数升高(P＜0.05),术后第1天、第3天CRP及临床肺部感染评分下降(P＜0.05).结论 肺保护性通气策略能够减少中老年脊柱俯卧位手术患者术中气压伤,降低肺部炎症反应,改善术后氧合功能,不会增加术中血液动力学不平稳事件及CO2储留的发生.     

体外循环过程中吸入七氟烷对婴幼儿心脏术后恢复过程影响的随机对照临床研究

目的 观察体外循环过程中吸入七氟烷对婴幼儿心脏手术后恢复过程及术后血清肌钙蛋白Ⅰ (cTnI)含量的影响.方法90例拟在体外循环下行根治手术的先天性心脏病患儿纳入本随机对照研究,随机分为七氟烷组(45例)和对照组(45例),七氟烷组在体外循环开始后通过氧合器吸入2％七氟烷,体外循环结束前停止吸入.对照组只给予空氧混合气.体外循环前后记录患儿血压,术后5个时间点(返回ICU即刻、ICU 3 h、ICU 6 h、ICU 12 h和ICU 24 h)取血样检测cTnI含量.术后恢复过程中其它参数如动脉血乳酸含量、血糖含量、呼吸机辅助呼吸时间、ICU 24 h尿量、ICU时间、术后正性肌力药物使用情况、术后住院时间、死亡和并发症发生情况同时记录.结果 两组患儿术前、术中各项参数无显著差异.七氟烷组患儿体外循环后动脉舒张压显著高于对照组(P =0.028).七氟烷组术后死亡1例,对照组术后因呼吸功能不全二次插管2例.七氟烷组呼吸机辅助呼吸时间显著低于对照组(P =0.0064).术后ICU时间、术后住院时间、术后24h内5个时间点血清cTnI含量、血乳酸含量和血糖含量两组比较无显著差异.结论 体外循环中吸入2％七氟烷在一定程度上有利于改善婴幼儿心脏手术后的恢复,对术后cTnI的血清含量无显著影响.     

Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial

Context  Antidepressant-associated sexual dysfunction is a common adverse effect that frequently results in premature medication treatment discontinuation and for which no treatment has demonstrated efficacy in women. Objective  To evaluate the efficacy of sildenafil for sexual dysfunction associated with selective and nonselective serotonin reuptake inhibitors (SRIs) in women. Design, Setting, and Participants  An 8-week prospective, parallel-group, randomized, double-blind, placebo-controlled clinical trial conducted between September 1, 2003, and January 1, 2007, at 7 US research centers that included 98 previously sexually functioning, premenopausal women (mean [SD] age 37.1 [6] years) whose major depression was remitted by SRIs but who were also experiencing sexual dysfunction. Intervention  Forty-nine patients were randomly assigned to take sildenafil or placebo at a flexible dose starting at 50 mg adjustable to 100 mg before sexual activity. Main Outcome Measures  The primary outcome measure was the mean difference in change from baseline to study end (ie, lower ordinal score) on the Clinical Global Impression sexual function scale. Secondary measures included the Female Sexual Function Questionnaire, the Arizona Sexual Experience scale-female version, the University of New Mexico Sexual Function Inventory-female version, a sexual activity event log, and the Hamilton Depression Rating scale. Hormone levels were also assessed. Results  In an intention-to-treat analysis, women treated with sildenafil had a mean Clinical Global Impression–sexual function score of 1.9 (95% confidence interval [CI], 1.6-2.3) compared with those taking placebo (1.1; 95% CI, 0.8-1.5), with a mean end point difference of 0.8 (95% CI, 0.6-1.0; P = .001). Assigning baseline values carried forward to the 22% of patients who prematurely discontinued resulted in a mean end point in the sexual function score of 1.5 (95% CI, 1.1-1.9) among women taking sildenafil compared with 0.9 (95% CI, 0.6-1.3) among women taking placebo with a mean end point difference of 0.6 (95% CI, 0.3-0.8; P = .03). Baseline endocrine levels were within normal limits and did not differ between groups. The mean (SD) Hamilton scores for depression remained consistent with remission in both groups (4.0 [3.6]; P = .90). Headache, flushing, and dyspepsia were reported frequently during treatment, but no patients withdrew because of serious adverse effects. Conclusion  In this study population, sildenafil treatment of sexual dysfunction in women taking SRIs was associated with a reduction in adverse sexual effects. Trial Registration  clinicaltrials.gov Identifier: NCT00375297      

Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial

Context  Reperfusion with percutaneous transluminal coronary intervention (PCI) is effective at improving outcomes in patients with acute ST-elevation myocardial infarction (STEMI). However, in patients without prompt reestablishment of brisk coronary flow and tissue perfusion, mortality remains high, providing an opportunity for novel treatments, including anti-inflammatory agents. Objective  To evaluate the effectiveness of pexelizumab, a humanized monoclonal antibody that binds the C5 component of complement, as an adjunct to PCI in improving 30-day mortality from STEMI. Design, Setting, and Patients  This trial was a prospective, multicenter, double-blind, placebo-controlled, phase 3 study of the intravenous administration of pexelizumab in conjunction with primary PCI in STEMI with prespecified high-risk electrocardiographic findings. The trial was intended to enroll 8500 patients, but in conjunction with the US Food and Drug Administration enrollment was modified to 5745 patients presenting from 296 hospitals in 17 countries from July 13, 2004, to May 11, 2006. Interventions  Two thousand eight hundred eighty-five patients were randomly assigned to receive placebo and 2860 to receive pexelizumab given as a 2-mg/kg intravenous bolus prior to PCI followed by 0.05-mg/kg per hour infusion over the subsequent 24 hours. Patients were randomized within 6 hours of symptom onset. Main Outcome Measures  The primary end point was all-cause mortality through day 30. Secondary end points were death through day 90 and the composite of death, cardiogenic shock, or congestive heart failure through days 30 and 90. Results  No difference in mortality through day 30 was observed between the pexelizumab and placebo treatment groups, with 116 patients (4.06%) and 113 patients (3.92%) who died in the respective groups (hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.80-1.35; log-rank P = .78). The composite end points of death, shock, or heart failure were also similar with 257 patients (8.99%) receiving pexelizumab and 265 patients (9.19%) receiving placebo at 30 days (HR, 0.98; 95% CI, 0.83-1.16; P = .81) and 293 patients (10.24%) receiving pexelizumab and 293 patients (10.16%) receiving placebo at 90 days (HR, 1.01; 95% CI, 0.86-1.19; P = .91). Conclusion  In this large clinical trial of patients treated with primary PCI for STEMI, mortality was low and unaffected by administration of pexelizumab. Trial Registration  clinicaltrials.gov Identifier: NCT00091637      

Acupuncture for patients with migraine: a randomized controlled trial

Context  Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. Objective  To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. Design, Setting, and Patients  Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany. Interventions  Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization. Main Outcome Measures  Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization. Results  Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, –0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group. Conclusion  Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.      

神经阻滞麻醉降低近端髓内钉治疗高龄股骨粗隆间骨折术后谵妄的随机对照研究

目的 探讨神经阻滞麻醉能否有效降低防旋型股骨近端髓内钉（proximal femoral nail antirotation, PFNA）内固定术后谵妄发生率。方法 采用临床随机对照试验方法,3个中心共100例股骨粗隆间骨折,计算机随机数法随机分为实验组和对照组,各50例。比较分析两组术前及术后3、7、14d的SF-36评分、Harris评分、CAM-ICU评价(confusion assessment method for the intensive careuint, CAM-ICU)和MMSE评分（mini mental state exam, MMSE）。结果 术前各组基线齐,各组无脱漏。术后组间并发症差异无统计学意义（P>0.05）。术后3d,谵妄发生率组间差异有统计学意义（P<0.05）,其余时间点无统计学意义（P>0.05）。术后3d,试验组Harris评分、SF-36评分、MMSE评分（38.1±6.2、55.6±8.9、26.7±2.4）均高于对照组（34.4±7.2、50.6±9.0、25.3±2.7,P<0.05）;术后7d,试验组的Harris评分、MMSE评分（40.9±6.3、29.1±1.6）高于对照组（37.0±7.4、28.3±1.9,P<0.05）;术后14d,试验组的Harris评分、SF-36评分（51.5±9.3、73.5±11.1）高于对照组（47.78±9.1、68.0±11.1,P<0.05）,而MMSE评分组间差异没有统计学意义（P>0.05）。CAM-ICU评价谵妄发生率和MMSE评分、SF-36评分相关性强（r分别为-0.814和-0.887,P<0.01）,术后3d谵妄发生率和术后3次随访Harris评分之间相关性弱（r分别为-0.152、-0.171和-0.040,P分别为0.130、0.089和0.692）。结论 神经阻滞麻醉能满足PFNA内固定手术要求,能有效降低术后谵妄的发生率,提高患者精神评分,加快患者术后康复,是PFNA内固定手术值得选择的麻醉方式。     

Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial

Context  The role of adjuvant therapy in resectable pancreatic cancer is still uncertain, and no recommended standard exists. Objective  To test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival by 6 months or more. Design, Setting, and Patients  Open, multicenter, randomized controlled phase 3 trial with stratification for resection, tumor, and node status. Conducted from July 1998 to December 2004 in the outpatient setting at 88 academic and community-based oncology centers in Germany and Austria. A total of 368 patients with gross complete (R0 or R1) resection of pancreatic cancer and no prior radiation or chemotherapy were enrolled into 2 groups. Intervention  Patients received adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks (n = 179), or observation ([control] n = 175). Main Outcome Measures  Primary end point was disease-free survival, and secondary end points were overall survival, toxicity, and quality of life. Survival analysis was based on all eligible patients (intention-to-treat). Results  More than 80% of patients had R0 resection. The median number of chemotherapy cycles in the gemcitabine group was 6 (range, 0-6). Grade 3 or 4 toxicities rarely occurred with no difference in quality of life (by Spitzer index) between groups. During median follow-up of 53 months, 133 patients (74%) in the gemcitabine group and 161 patients (92%) in the control group developed recurrent disease. Median disease-free survival was 13.4 months in the gemcitabine group (95% confidence interval, 11.4-15.3) and 6.9 months in the control group (95% confidence interval, 6.1-7.8; P<.001, log-rank). Estimated disease-free survival at 3 and 5 years was 23.5% and 16.5% in the gemcitabine group, and 7.5% and 5.5% in the control group, respectively. Subgroup analyses showed that the effect of gemcitabine on disease-free survival was significant in patients with either R0 or R1 resection. There was no difference in overall survival between the gemcitabine group (median, 22.1 months; 95% confidence interval, 18.4-25.8; estimated survival, 34% at 3 years and 22.5% at 5 years) and the control group (median, 20.2 months; 95% confidence interval, 17-23.4; estimated survival, 20.5% at 3 years and 11.5% at 5 years; P = .06, log-rank). Conclusions  Postoperative gemcitabine significantly delayed the development of recurrent disease after complete resection of pancreatic cancer compared with observation alone. These results support the use of gemcitabine as adjuvant chemotherapy in resectable carcinoma of the pancreas. Trial Registration  isrctn.org Identifier: ISRCTN34802808      

Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial

Context  Healthy lifestyle factors are associated with maintenance of erectile function in men. Objective  To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men. Design, Setting, and Patients  Randomized, single-blind trial of 110 obese men (body mass index 30) aged 35 to 55 years, without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF). The study was conducted from October 2000 to October 2003 at a university hospital in Italy. Interventions  The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise. Main Outcomes Measures  Erectile function score, levels of cholesterol and tryglycerides, circulating levels of interleukin 6, interleukin 8, and C-reactive protein, and endothelial function as assessed by vascular responses to L-arginine. Results  After 2 years, body mass index decreased more in the intervention group (from a mean [SD] of 36.9 [2.5] to 31.2 [2.1]) than in the control group (from 36.4 [2.3] to 35.7 [2.5]) (P<.001), as did serum concentrations of interleukin 6 (P = .03), and C-reactive protein (P = .02). The mean (SD) level of physical activity increased more in the intervention group (from 48 [10] to 195 [36] min/wk; P<.001) than in the control group (from 51 [9] to 84 [28] min/wk; P<.001). The mean (SD) IIEF score improved in the intervention group (from 13.9 [4.0] to 17 [5]; P<.001), but remained stable in the control group (from 13.5 [4.0] to 13.6 [4.1]; P = .89). Seventeen men in the intervention group and 3 in the control group (P = .001) reported an IIEF score of 22 or higher. In multivariate analyses, changes in body mass index (P = .02), physical activity (P = .02), and C-reactive protein (P = .03) were independently associated with changes in IIEF score. Conclusion  Lifestyle changes are associated with improvement in sexual function in about one third of obese men with erectile dysfunction at baseline.