舒马曲坦鼻腔喷雾治疗青少年偏头痛患者：一项随机、双盲、安慰剂对照的急性期研究

目的：比较舒马曲坦鼻腔喷雾（NS）（5mg和20mg）与安慰剂在青少年偏头痛患者急性期治疗中的有效性和耐受性。背景：当前，在美国尚无曲普坦类药物被批准应用于治疗青少年偏头痛患者（年龄12～17岁）。在先前的一项包括510例青少年患者的随机、安慰剂对照的研究中，5mg、10mg和20mg的舒马曲坦NS具有很好的耐受性。然而，在2h时20mg舒马曲坦使头痛缓解的主要疗效分析显示无统计学意义（P=0．059）。进行第2项研究以评估舒马曲坦NS在该人群中的疗效。方法：这是一项随机（1：1：1）、安慰剂对照、双盲、平行分组的研究，共纳入738例偏头痛病史≥6个月（有或无先兆）和呈自愈的中重度偏头痛单次发作（伴或不伴有先兆）青年患者（平均年龄14岁）。主要终点是1h时患者的头痛缓解和1～24h内持续缓解。研究同时对疼痛缓解率、有或无相关症状、头痛复发和使用补救药物治疗进行评估，根据不良事件（AEs）和生命体征对耐受性进行评估。结果：在用药后30min（42％vs33％，P=0．046）和2h（68％vs58％，P=0．025）时，舒马曲坦20mg NS较安慰剂能更明显地缓解头痛，但在1h时（61％vs52％，P=0．087）或1～24h内的头痛持续缓解（P=0．061）无统计学意义。舒马曲坦20mg NS与安慰剂间几项次要疗效终点（包括2～24h内的持续缓解）的比较显示有显著差异（P〈0．05）。一般而言，     

依昔舒林治疗散发的腺瘤性息肉病时疗效与毒性并存：一项随机、双盲、安慰剂对照的剂量反应性研究

背景与目的：进行一项为期12个月的Ⅲ期多中心随机、双盲、安慰剂对照的剂量反应性研究。依昔舒林可通过诱导细胞凋亡而抑制肿瘤的生长，该文拟对依昔舒林能否诱发散发腺瘤性息肉的消退进行研究。患者与方法：依据结肠镜检查结果，选取左侧息肉（3～10mm）标记，测量但不切除，并进行为期12个月的多中心、随机、双盲、安慰剂对照、剂量反应性Ⅲ期临床研究，患者随机分组，每日分别接受200mg、400mg依昔舒林或安慰剂治疗，服药6个月后通过乙状结肠镜检查进行随访，并于治疗后12个月结肠镜检查时切除所有残余息肉，初级治疗效果变量依息肉基线期大小而有所不同。结果：共纳入281例患者并随机分组。符合意向治疗分析（ITT）标准者155例（55％），符合疗效评估分析标准者114例（41％），即患者接受了治疗12个月时的结肠镜检查。     

重症急性坏死性胰腺炎的早期抗生素治疗：一项随机、双盲、安慰剂对照研究

本研究主要目的是通过预防性静脉应用美罗培南在阻止／延缓胰腺或周围组织感染方面的疗效。此外，还评估了预防性美罗培南用药在手术清创的要求、总体病死率和死亡时间等方面的作用。     

金刚烷胺治疗吉兰-巴霄综合征患者的疲劳：一项随机、双盲、安慰剂对照的交叉试验

目的：疲劳是免疫介导的多发性神经病变患者的主要症状。尽管吉兰-巴雷综合征（GBS）患者的身体状况可获得明显好转，但许多患者的日常和社交活动仍然受限，并且患者的生活质量下降。本试验对金刚烷胺治疗GBS相关严重疲劳的疗效进行研究。方法：在治疗前2周内，对所有患者进行监测。只有严重疲劳患者[根据疲劳严重程度量表（FSS）的平均评分≥5．0分进行定义]随机纳入本项双盲、安慰剂对照的交叉试验。主要预后指标是FSS的疲劳评分至少提高1分。次要预后指标包括疲劳影响、焦虑和抑郁、残疾和生活质量。结果：共80例GBS患者纳入本试验，对其中的74例进行分析。疲劳在研究前期即显示出下降（P=0．05），可能与患者得到的关注增加有关。主要和次要预后指标之间无显著性差异。结论：金刚烷胺治疗并不优于安慰剂。由于疲劳仍然是患者的主要症状，强烈推荐进行其他研究以评估新的治疗方法。     

评估口服西地那非治疗严重肺动脉高压有效性的一项随机、安慰剂对照、双盲、交叉研究

背景:严重肺动脉高压(PAH)的治疗方法较少。近期,有几种新药被用于治疗PAH。西地那非是其中在非对照试验中表现出很有应用前景的一种药物。但对照试验几乎没有。在此项随机化、安慰剂对照试验中,评估了口服西地那非治疗特发性PAH和艾森曼格综合征继发PAH的有效性。方法:本试验是一项随机、双盲、安慰剂对照、交叉研究。以随机双盲方式分配20例患者(特发性PAH和艾森曼格综合征继发PAH患者各10例)接受安慰剂或西地那非治疗6周,经2周的洗脱期后,相互交叉。主要有效性终点为6m in步行试验距离的增加。次要终点是6周治疗后多普勒超声所测…     

Darbepoetin α对有症状性慢性心力衰竭伴贫血患者运动耐量的影响：一项随机、双盲、安慰剂对照试验

目的：本研究旨在观察darbepoetin α（一种红细胞生成刺激蛋白，ESP）能否改善有症状性慢性心力衰竭（CHF）伴贫血患者的运动耐量。背景：贫血在CHF患者中较为常见。方法：在此项多中心、随机、双盲、安慰剂对照研究中，伴有贫血（血红蛋白90～120g／L）的CHF患者接受安慰剂（n=22）或darbepoetind（n=19）皮下注射，初始剂量为0．75μg／kg，每2周1次，持续26周。主要终点是从基线到27周时以峰值耗氧量[ml／（min·kg体重）】测量的运动耐量的变化。其他终点包括：绝对峰值耗氧量、运动持续时间以及健康相关生活质量的变化。[第一段]     

应用5％咪喹莫特软膏单一治疗皮肤原位鳞状细胞癌（鲍温病）：一项随机、双盲、安慰剂对照试验

背景:作者设计了一项随机、双盲、安慰剂对照试验,以评价使用5%咪喹莫特软膏治疗皮肤原位鳞状细胞癌(SCC)的初步疗效及安全性。方法:将活检证实为皮肤原位SCC的31例患者随机分配至安慰剂组(n=16)或5%咪喹莫特软膏治疗组(n=15),1次/d,持续16周。在第28周时,对主要终点即皮肤原位     

一项针对重度持续性哮喘患者使用TNF-α阻断剂的随机双盲安慰剂对照研究

戈利木单抗（golimumab）是针对人TNF-α的单克隆抗体,其在重症哮喘中的治疗价值尚不明确。为了评价golimumab对于重度持续性哮喘患者的安全性及有效性,美国匹兹堡大学的Wenzel SE等人对此进行了研究,     

两种中药治疗上呼吸道感染的疗效评价：随机、双盲、安慰剂对照临床研究

目的 以安慰剂为对照,探讨两种中草药治疗急性上呼吸道感染疾病的疗效。 方法 两个随机、双盲、安慰剂对照的临床试验入选了香港地区327例诊断为上呼吸道感染的患者。这些患者由中医医师分类为两种不同的中医症候群,并分别随机接受中草药治疗或安慰剂治疗,疗程至多10d。以治疗的第4天和第7天时患者痊愈的比例作为主要终点,而症状痊愈所需的时间、由健康调查简表（SF-36）和中华生活质量量表（ChQOL）方法测量的生存质量评分以及临床不良反应作为次要终点。     

多奈哌齐治疗重度阿尔茨海默病患者：双盲、平行分组、安慰剂对照研究

背景:胆碱酯酶抑制剂多奈哌齐用于治疗轻中度阿尔茨海默病,关于其对重度痴呆患者的疗效因尚未进行评价故而不确定。本研究旨在确定多奈哌齐治疗重度阿尔茨海默病患者的疗效,重点探讨其对认知功能和日常生活活动能力的影响。方法:进行一项为期6个月的双盲、平行分组、安慰剂对照     

Nimodipine after resuscitation from out-of-hospital ventricular fibrillation. A placebo-controlled, double-blind, randomized trial

One hundred fifty-five consecutive patients resuscitated after out-of-hospital ventricular fibrillation by a physician-manned advanced life support unit were randomly assigned to receive nimodipine or placebo at a dosage of 10 micrograms/kg as an intravenous injection immediately after restoration of spontaneous circulation, followed by an infusion of 0.5 micrograms/kg per minute for 24 hours. No significant difference was found in the 1-year survival rate of nimodipine-treated (30 [40%] of 75 patients) and placebo-treated patients (29 [36%] of 80 patients). Recurrent ventricular fibrillation during the treatment occurred in one patient in the nimodipine group compared with 12 patients in the placebo group. In a post hoc analysis of patients with very long delays in advanced life support (more than 10 minutes), the 1-year survival rate was higher with nimodipine (eight [47%] of 17 patients) than with placebo (two [8%] of 26 patients). Nimodipine may be of benefit in patients with delayed resuscitation.     

Prophylactic sulfamethoxazole and trimethoprim in ventriculoperitoneal shunt surgery. A double-blind, randomized, placebo-controlled trial

We conducted a randomized, double-blind, placebo-controlled study during a 30-month period to determine whether sulfamethoxazole and trimethoprim would decrease the incidence of infections occurring after ventriculoperitoneal shunt surgery. Of the 120 patients who completed the study according to protocol, 55 received sulfamethoxazole and trimethoprim and 65 received placebo. The incidence of CSF infection in the group receiving sulfamethoxazole and trimethoprim (4/55) was similar to that in the control group (5/65). There was a trend toward earlier identification of infections in the sulfamethoxazole and trimethoprim group (mean, 24.5 days) compared with the control group (mean, 47 days). There was no difference between infected and uninfected patients with respect to frequency of purported risk factors for infection, including history of shunt infection, history of recent myelomeningocele repair, and type and duration of shunt surgery. The incidence of shunt malfunction was similar in uninfected patients receiving antibiotic prophylaxis (18/51) compared with that of patients receiving placebo (23/60). We did not find that the perioperative use of sulfamethoxazole and trimethoprim reduced the incidence of shunt infection or malfunction.     

Oropharyngeal decontamination decreases incidence of ventilator-associated pneumonia. A randomized, placebo-controlled, double-blind clinical trial

Secondary pneumonia in patients requiring mechanical ventilation has a high morbidity and mortality. Diagnosis is difficult and treatment failure common; therefore, preventive measures are important. In a double-blind, placebo-controlled trial, we evaluated selective decontamination of the oropharynx with polymyxin B sulfate, neomycin sulfate, and vancomycin hydrochloride (PNV) in 52 patients requiring mechanical ventilation during a 3- to 34-day period (mean, 10 days). Either PNV or placebo was administered six times daily in the oropharynx. During the first 12 days of intubation, tracheobronchial colonization by gram-negative bacteria and Staphylococcus aureus, as well as pneumonia, occurred less frequently in the PNV than in the placebo group (16% vs 78%; P less than .0001). Hospital mortality was not different, but systemic antibiotics were prescribed less often in the PNV group and no resistant microorganism emerged. In these critically ill patients, topical oropharyngeal antibiotic application lowered the rate of ventilator-associated pneumonia by a factor of 5, probably by interrupting the stomach-to-trachea route of infection, and decreased the requirement for intravenous antibiotics.     

人参皂苷联合强的松治疗系统性红斑狼疮的前瞻性随机双盲对照试验

背景：糖皮质激素治疗系统性红斑狼疮（systemic lupus erythematosus,SLE）的副作用一直是临床医生关注的焦点,我们的前期研究表明人参皂苷可以增强地塞米松的临床疗效。目的：探讨人参皂苷联合强的松对SLE中医证候积分和临床疗效的影响。设计、场所、对象和干预措施：所有病例均为上海长海医院风湿免疫科的门诊及住院SLE患者。采用随机、双盲、对照的方法,60例SLE患者在常规强的松治疗的基础上分别给予人参皂苷胶囊和安慰剂胶囊。疗程为3个月。主要结局指标：观察治疗前后SLE患者的中医证候积分和临床总体疗效。结果：治疗组28例,对照组27例纳入结果分析。治疗组总有效率为89.28%,与对照组总有效率66.67%相比,差异有统计学意义（P〈0.05）。两组中医证候积分均较治疗前下降（P〈0.01）,治疗组治疗前后中医证候积分差值与对照组比较,差异有统计学意义（P〈0.05）。治疗组的症状改善程度亦优于对照组（P〈0.05）。结论：人参皂苷联合强的松可以显著提高SLE的临床治疗有效率,更好地改善SLE患者的临床症状。     

Magnesium administration and dysrhythmias after cardiac surgery. A placebo-controlled, double-blind, randomized trial.

OBJECTIVE--To determine whether magnesium administration is effective in reducing postoperative morbidity and mortality after cardiac surgery. DESIGN--Randomized, double-blind, placebo-controlled trial. SETTING--A tertiary acute-care 500-bed university teaching hospital. PATIENTS--Over a 6-month period, 100 patients electively scheduled for cardiac surgery involving cardiopulmonary bypass were studied. INTERVENTIONS--Fifty patients were randomized to receive an intravenous infusion of magnesium chloride, 2 g, and 50 patients received placebo intraoperatively after the termination of cardiopulmonary bypass. RESULTS--Magnesium-treated patients had a significantly decreased frequency (P < .04) of postoperative ventricular dysrhythmias (eight [16%] of 50) compared with placebo-treated patients (17 [34%] of 50). Patients who were normomagnesemic postoperatively had new supraventricular dysrhythmias less frequently (P < .03) than patients who were hypomagnesemic postoperatively (eight [17%] of 48 vs 19 [37%] of 52). Compared with placebo-treated patients, magnesium-treated patients had significantly higher (P < .02) postoperative cardiac indices in the intensive care unit (2.8 +/- 0.1 vs 2.5 +/- 0.1 L/min per m2). Patients with postoperative total and ultrafilterable hypomagnesemia had postoperative ventricular dysrhythmias (P < .04) and required prolonged mechanical ventilatory support (P < .01) more frequently than patients without postoperative hypomagnesemia. CONCLUSIONS--Total and ultrafilterable hypomagnesemia are prevalent findings in cardiac surgery patients, and postoperative hypomagnesemia is strongly associated with clinically important morbidity. Magnesium administration decreased the frequency of postoperative ventricular dysrhythmias and increased the stroke volume and thereby cardiac index in the early postoperative period.     

Postcoital antimicrobial prophylaxis for recurrent urinary tract infection. A randomized, double-blind, placebo-controlled trial

We conducted a randomized, double-blind, placebo-controlled study to determine the efficacy of postcoital antibiotic prophylaxis in healthy young women prone to recurrent urinary tract infections. Sixteen patients were randomized to receive postcoital administration of a combination product of trimethoprim and sulfamethoxazole, while 11 received postcoital placebo. The treatment groups were similar with respect to age, parity, diaphragm use, history of lifetime urinary tract infections, frequency of intercourse, and number of lifetime sexual partners. In over 6 months of observation, postcoital administration of trimethoprim-sulfamethoxazole was highly effective in preventing recurrent urinary tract infections. Nine of 11 patients who took the placebo developed urinary tract infections (infection rate, 3.6 per patient-year), compared with only two of 16 patients who received postcoital trimethoprim-sulfamethoxazole (infection rate, 0.3 per patient-year). Postcoital administration of trimethoprim-sulfamethoxazole was effective in patients with both low (two or fewer times per week) and high (three or more times per week) intercourse frequencies. Side effects were few and compliance was excellent. We conclude that postcoital trimethoprim-sulfamethoxazole is a safe, effective, and inexpensive approach to management of recurrent urinary tract infections in young women.     

前列腺素E1乳膏治疗女性性唤起障碍的多中心随机双盲对照研究

目的：目前用于治疗女性性唤起障碍(FSAD)的药物尚属空白。通过多中心、随机、双盲、剂量组平行对照研究,评估前列腺素E1乳膏治疗FSAD的临床有效性及安全性,并确定临床有效治疗剂量。方法：受试者随机分配到4组,分别给予3种不同剂量（500 μg、700 μg、900 μg）的试验药物或安慰剂,于性活动前外涂在阴蒂及G点（阴道前壁5 cm处）。比较治疗前后的性唤起满意率、女性性功能问卷(FSFI)评分、女性性窘迫等级(FSDS)评分及其性活动的总体情况（GAQ）有效性指标。试验期间记录不良事件及实验室指标评价药物的安全性。结果：共400例受试者入组,374例进入疗效分析人群,387例进入安全性分析人群。4组的人口学特征及基线结果差异无统计学意义,4组（次序为安慰剂组,低、中、高剂量组）受试者的性唤起满意率与基线（治疗前）相比,分别提高了22.63%、36.67%、34.01%、44.29%（P<0.05）;安慰剂组与高剂量组相比差异有统计学意义（P<0.016 7）;FSFI评分在结束时比基线提高了14.68、20.71、21.69、22.89（P<0.05）;FSDS评分在结束时比基线降低了17.60、20.27、21.98、25.97（P<0.05）;GAQ改善情况4组间差异无统计学意义（P=0.054）。主要不良反应为局部刺激症状,未发现与药物有关的体格检查、血生化检查、心电图、宫颈细胞学检测（TCT）异常。结论：前列腺素E1乳膏治疗女性性唤起障碍有效,剂量为900 μg作用最佳,无明显全身副作用,不良反应以局部刺激症状为主。