缺血性脑卒中中高血糖的治疗:一个随机前瞻性试验

高血糖可能加重急性脑梗死的脑损害（Stroke，2008，39：384）。该研究探讨急性脑梗死期间，相比常规治疗方法，静脉应用胰岛素积极纠正高血糖治疗的可行性及耐受性。方法：本试验为随机、多中心、双盲的前瞻性研究，入选对象为在24h内的新发脑梗死，基线血糖≥8．3mmol／L（≥150mg／dL），国立卫生研究院脑卒中评分（NIHSS）为3～22分的病人。

缺血性脑卒中中高血糖的治疗:一个随机前瞻性试验

高血糖可能加重急性脑梗死的脑损害。该研究探讨急性脑梗死期间，相比常规治疗方法，静脉应用胰岛素积极纠正高血糖治疗的可行性及耐受性。方法：本试验为随机、多中心、双盲始点的前瞻性研究，入选对象为脑梗死发病24h内，基线血糖≥8．3mmol／L（≥150mg／dL），国立卫生研究院脑卒中评分（NIHSS）为3～22分的病人。

纳美芬改善大面积脑梗死预后:随机对照前瞻性临床试验方案

背景:大脑中动脉主干梗死会造成大面积脑梗死,临床上常采用溶栓、降纤、血管扩张以及手术等方法进行治疗,但这些方法对患者预后的疗效存在争议。纳美芬是一种特异性吗啡受体阻断剂,具有神经保护作用。但是目前尚无其治疗大面积脑梗死有效性的临床研究。目的:以常规治疗为对照,观察纳美芬对大脑中动脉主干脑梗死患者的神经功能恢复作用。方法:随机对照前瞻性试验选取中国吉林大学第一医院收治的大脑中动脉主干梗死患者236例,随机分为对照组(n=116)和纳美芬组(n=120)。对照组采取常规治疗方法,纳美芬组在常规治疗基础上连续10 d静脉注射盐酸纳美芬注射液。试验以治疗结束后10 d时有效率作为主要评价指标。次要评价指标为:(1)治疗结束后10 d时的美国国立卫生院神经功能缺损评分;治疗前和治疗后10 d时的格拉斯哥昏迷评分;(3)治疗前和治疗5,10 d时对血清基质金属蛋白酶9水平;(4)治疗前和治疗10 d时头部行磁共振灌注成像检查结果。试验方案已在中国临床试验注册中心注册,注册号为Chi CTR-IOR-17013871。结果与结论:已完成的预试验结果显示,与对照组相比,治疗后纳美芬组患者美国国立卫生院神经功能缺损评分明显降低,治疗有效率增加,格拉斯哥昏迷评分明显升高,血清基质金属蛋白酶9水平下降,头部磁共振灌注病灶侧脑血流量和脑血容量明显增加,对比剂平均通过时间显著缩短。试验将为纳美芬联合常规治疗大面积脑梗死提供试验证据,为改善大面积脑梗死预后提供试验数据支持。

急性心肌梗塞二级预防的大系列前瞻性随机对照临床试验

近年来国际上先后组织了数百个大规模多中心前瞻性临床试验,所获结果因其科学位和普遍性,对临床工作具有重大指导意义。现综述急性心肌梗塞(AMI)二级预防的国际性大系列前瞻性随机化对照临床试验结果如下。1 抗心律失常药物的应用 为了评价用抗心律失常药物抑制AMI后无或轻度症状性室性心律失常能否降低病死率,著名的CAST选用了经CAPS筛选出的药物:高效的恩卡胺(Encainide)、氟卡胺(Flecainide)和中效的乙吗噻嗪(Moricizine)。

胚胎移植当天进行针灸治疗显著改善不孕妇女的妊娠结局:一项前瞻性随机试验

Objective: To evaluate the effect of acupuncture on reproductive outcome in patients treated with IVF/intracytoplasmic sperm injection (ICSI). One group of patients received acupuncture on the day of ET, another group on ET day and again 2 days later (i.e., closer to implantation day), and both groups were compared with a control group that did not receive acupuncture. Design: Prospective, randomized trial. Setting: Private fertility center. Patient(s): During the study period all patients receiving IVF or ICSI treatment were offered participation in the study. On the day of oocyte retrieval, patients were randomly allocated (with sealed envelopes) to receive acupuncture on the day of ET (ACU 1 group, n = 95), on that day and again 2 days later (ACU 2 group, n = 91), or no acupuncture (control group, n = 87). Intervention(s): Acupuncture was performed immediately before and after ET (ACU 1 and 2 groups), with each session lasting 25 minutes; and one 25- minute session was performed 2 days later in the ACU 2 group. Main Outcome Measure(s): Clinical pregnancy and ongoing pregnancy rates in the three groups. Result(s): Clinical and ongoing pregnancy rates were significantly higher in the ACU 1 group as compared with controls (37 of 95 [39% ] vs. 21 of 87 [26% ] and 34 of 95 [36% ] vs. 19 of 87 [22% ]). The clinical and ongoing pregnancy rates in the ACU 2 group (36% and 26% ) were higher than in controls, but the difference did not reach statistical difference. Conclusion(s): Acupuncture on the day of ET significantly improves the reproductive outcome of IVF/ICSI, compared with no acupuncture. Repeating acupuncture on ET day + 2 provided no additional beneficial effect.

将卵巢反应弱的妇女其胚胎移植时间由第3天改为第2天的有效性:前瞻性随机试验

Objective: To compare the outcome of day 2 and day 3 embryo transfers in women demonstrating poor ovarian response. Design: Prospective randomized clinical trial. Setting: Private assisted reproductive technology center. Patient(s): Two hundred eighty-one women demonstrating poor ovarian response to controlled ovarian hyperstimulation. Intervention(s): Women who were poor responders were randomly allocated to day 2 or day 3 embryo transfer following oocyte retrieval. Main Outcome Measure(s): Implantation rates and pregnancy rates per oocyte retrieval and embryo transfer. Result(s): The clinical pregnancy rates per oocyte retrieval (37.2% vs. 21.4% , respectively; P < .05) and per embryo transfer (38.9% vs. 24.1% , respectively; P < .05) were significantly higher in the day 2 embryo transfer group compared with day 3. On the other hand, implantation rates were not different between groups (23.9% vs. 17.2% , respectively; P = .08). Conclusion(s): Our results demonstrated that trans-fering embryos on day 2 could provide an alternative to the management of poor responder patients.

辛伐他汀可改善多囊卵巢综合征妇女的生化指标:前瞻性随机试验结果

Objective: To test the hypothesis that statins improve hyperandrogenemia in women with polycystic ovary syndrome (PCOS).Design: Prospective, randomized trial.Setting: Academic medical center.Patient(s): Forty- eight women with PCOS.Intervention(s): Subjects were randomized to a statin group (simvastatin, 20 mg daily plus oral contraceptive pill [OCP]; n = 24) or an OCP group (OCP alone; n = 24).Main Outcome Measure(s): Serum T.Result(s): Baseline parameters of both groups were comparable.After 12 weeks of treatment, serum T levels declined by 41% in the statin group and by 14% in the OCP group.In the statin group, there was a greater decrease of LH (43% decrease vs.9% in the OCP group) and a greater decline of LH/FSH ratio (44% vs.12% ).In the statin group, total cholesterol declined by 10% and low- density lipoprotein (LDL) by 24% .In the OCP group, total cholesterol increased by 8% , and LDL was unchanged.Conclusion(s): This is the first study demonstrating that statin decreases T levels and normalizes gonadotropin levels in women with PCOS.Statin therapy might offer a novel approach, providing endocrine and cardiovascular benefits.

减轻全视网膜光凝固术疼痛的前瞻性随机试验研究

Purpose:To evaluate the efficacy of pain relief by oral diazepam,acetaminophen,mefenamic acid,intramuscular ketorolac tromethamine,and peribulbar anaesthesia in panretinal photocoagulation(PRP).Methods:A total of 220 patients with proliferative diabetic retinopathy requiring PRP treatment were enrolled in this study.Before laser treatment,the patients were allocated randomly to one of eight groups:group 1:diazepam(n=22),group 2:acetaminophen(n=21),group 3:mefenamic acid(n=21),group 4:diazepam and acetaminophen(n=22),group 5:diazepam and mefenamic acid(n=22),group 6:peribulbar anaesthesia with lidocaine(n=23),group 7:intramuscular injection of ketorolac tromethamine(n=22),group 8:placebo(n=67).Pain after the laser treatment was assessed by a verbal descriptive scale.Blood pressure and heart rate were measured before and after laser treatment.Results:Patients receiving peribulbar anaesthesia had a significantly lower pain score than the control group(P=0.0001).Additionally,the peribulbar anaesthesia-treated group had the significantly least PRP-associated rise in either systolic(P=0.043)or diastolic blood pressure rates(P=0.030).There were no significant differences in pain score using other anesthetic agents when compared with the control group.There were no significant changes in heart rate after PRP treatment.Conclusion:Peribulbar anaesthesia is effective in reducing pain and blood pressure increase after PRP treatment.Oral diazepam,mefenamic acid,and acetaminophen(either alone or in combination with each other)are not effective in preventing PRP treatment-associated pain.Intramuscular injection of ketorolac tromethamine is also not effective in reducing PRP-associated pain.

多巴酚丁胺与米力农对准备心脏移植患者的效果比较——前瞻性随机试验

儿茶酚胺类药(多巴酚丁胺,Dobutamine)或磷酸二酯酶抑制药(米力农,Milrinone)常作强心药使用于心脏移植患者,但两者中的选择一向只凭医院或个人的喜恶。目前对其药效和费用尚无前瞻性的随机研究。

关于现代胚胎移植导管与妊娠结局的前瞻性随机试验

Objective: Embryo transfer (ET) is the final crucial step in IVF treatment. The type of catheter used can affect the pregnancy rate (PR). In this prospective, randomized trial we compared the clinical PR between the Wallace and the Cook K-Jet embryo transfer catheters. Design: Prospective, randomized clinical trial. Setting: A National Health Service Assisted Reproduction Unit. Patient(s): One hundred fifty women undergoing a fresh ET. Age more than 40 years, a high basal FSH, a previous difficult ET, or more than six previous ETs were the exclusion criteria. Intervention(s): Women undergoing a fresh ET were randomized at the time of ET to either the Cook K-Jet or Wallace embryo transfer catheter. The randomization was stratified according to age and the number of previous ETs. Main Outcome Measure(s): Clinical PR. Result(s): There was no significant difference in the clinical PR between the Wallace and the Cook catheters (22/75 [29.3%] and 23/75 [30.6%], relative risk [RR]: 0.96 [95%confidence interval 0.58-1.58]). Conclusion(s): There is no significant difference in the PRs achieved by modern, soft, double-lumen ET catheters.

辅助孵化对卵母细胞单精子显微注射结局的影响:一项前瞻性随机临床试验及妊娠追踪观察

Objective: To evaluate the overall effect of assisted hatching (AH) on the implantation, pregnancy, and live birth rates in women undergoing intracytoplasmic sperm injection (ICSI)- cycles; and to determine the effect of AH on the cytogenetic outcome (chromosomal constitution) of pregnancy.Design: Prospective, randomized study.Setting: Academic research environment.Patient(s): A total of 172 couples were enrolled in the study.Intervention(s): Assisted hatching was carried out on day- 3 ICSI embryos.Main Outcome Measure(s): Implantation, clinical pregnancy, and live birth rates; cytogenetic analysis of abortuses and umbilical cord blood samples from newborns.Result(s): Biochemical, clinical, and ongoing pregnancy rates were not significantly different between the AH and control groups.The implantation rate was higher in the AH group than in the control group (16% vs.8% ), especially in women aged ≥ 35 years.Postnatal umbilical cord blood samples were collected and cytogenetically analyzed from 39 live births (20 from the AH group, 19 from the control group).Two abnormal karyotypes were found (one AH, one control).There were seven spontaneous losses during the study interval.Six of the abortuses underwent cytogenetic study (five AH, one control), and four were found to have an abnormal karyotype (three AH, one control). Conclusion: We found that AH improves implantation rates of ICSI cycles and seems to be most effective in women aged ≥ 35 years.A larger sample size is needed to determine whether AH improves the take- home- baby rate.Assisted hatching did not affect the rate of chromosomal abnormalities in live births in this study.

肝活检后复原的体位的前瞻性随机试验:体位真的重要吗?

Goals: The goal of this study was to compare three commonly practiced post-liver biopsy recovery postures with respect to pain levels and overall patient acceptability. Background: Percutaneous liver biopsy is a valuable procedure used in the diagnosis, prognosis, and treatment of liver diseases. No standardized recovery posture exists, and no studies have been performed to compare these different recovery techniques. Study: Ninety adult patients were randomized into three arms of the study: right-side (R), supine (S), and combination (C) groups. A validated Visual Analogue Scale (VAS) was given to patients to grade the pain and discomfort experienced during recovery intervals as well as to grade the overall acceptability of the biopsy experience. Results: Immediately following liver biopsy, more pain was experienced by patients randomized to R with a mean VAS score of 26.5 of 100, compared with 14.2 (P = 0.026) and 12.1 (P = 0.009) for C and S groups, respectively. At the end of recovery, there was no difference among the three groups. The mean acceptability score was 89.2 of 100 for C versus 94.5 for S (P = 0.047) and 94.8 for R (P = 0.046). Conclusion: This study is the first to examine differing post-liver biopsy techniques. When three commonly practiced recovery positions, C, R, and S, are compared, C was the least acceptable position. Patients should be placed in position R or S during recovery.

开放式胶囊显示小肠通畅程度:一项前瞻性临床试验?

Background and study aims: At many centers wireless capsule endoscopy (WCE) without prior radiographic examination to rule out relevant strictures is considered to be contraindicated in suspected obstructive small- bowel disease. However, the accuracy of radiography in this situation has often been questioned. The purpose of this prospective study was to investigate the feasibility and safety of the recently developed patency capsule, and its predictive value regarding the clinical relevance of radiographic small- bowel strictures. Patients and methods: 22 patients with suspected obstructive small- bowel disease and/or radiological evidence of small- bowel strictures underwent a patency capsule examination. Intact passage, patient experience of pain, and capsule disintegration were correlated with radiographic findings, clinical variables, and outcome. Results: 13 patients passed an intact capsule without complaints, despite radiographically observed small- bowel stenosis; the subsequent video capsule examination was uneventful in all. In nine patients either intact passage was painful or the capsule disintegrated; in one of these, impaction of an intact capsule led to an ileus and emergency surgery. The type of capsule passage did not correlate with radiographic presence of a stricture, underlying diagnosis, or previous surgery. There was a statistically significant correlation between outcome (surgery performed or recommended) and occurrence of painful capsule passage and disintegration (P≤ 0.05). Conclusions: Painless egestion of an intact patency capsule indicates safety of WCE. Patients without obstructive symptoms require neither small- bowel radiography nor a patency capsule study prior to WCE. Disintegration of the patency capsule or painful passage seems to be associated with a clinically relevant small- bowel stricture and with a high probability of surgery.

体外受精中多囊卵巢综合征患者的二甲双胍治疗:一项前瞻性随机试验

In the present study, we investigated the impact of metformin therapy on in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes in patients with polycystic ovary syndrome (PCOS). Metformin does not lead to any improvement in IVF/ICSI outcomes among patients with PCOS.

癌症患者腹腔镜或传统结肠切除术后全身和腹膜的血管生成反应:一项前瞻性随机试验

PURPOSE: Angiogenesis is essential for wound healing. Vascular endothelial growth factor and endostatin are both endogenous angiogenic factors thought to be involved in the initiation and termination of angiogenesis. The aim of this study was to assess the local and systemic angiogenic profile in patients undergoing laparoscopic or open surgery for colon cancer. METHODS: Patients with primary colon carcinoma were prospectively randomized to curative laparoscopic (n = 12) or conventional (n = 14) resection. Vascular endothelial growth factor and endostatin levels in serum and wound fluid were investigated. RESULTS: In both groups vascular endothelial growth factor levels in wound fluid were significantly higher than postoperative serum levels, whereas endostatin levels in wound fluid were lower than serum levels and decreased progressively after surgery. The vascular endothelial growth factor levels in wound fluid measured at Day 4 were significantly higher in the laparoscopy group than in the laparotomy patients. CONCLUSIONS: Wound healing is associated with a strong local increase in pro angiogenic factors and a decrease in antiangiogenic factors. The investigation of locally produced factors offered greater insight into the process of angiogenesis during wound healing than could be acquired from the circulation.

纯切割电刀电流用于内镜下括约肌切开术与ERCP术后胰腺炎风险:一项前瞻性随机试验

Background: It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterotomy may reduce the risk of post-ERCP pancreatit is. The aim of this study was to determine whether pure-cut current reduces the risk of pancreatitis compared with blend current. Methods: Patients were randomly assigned to undergo sphincterotomy over a non-conductive guidewire with 30 W /sec pure-cut current or 30 W/sec blend-2 current by a blinded endoscopist. Serum amylase and lipase levels were determined 1 day before and within 24 hours after ERCP. Post-ERCP pancreatitis was the primary outcome of interest. Secondary outcomes were as follows: severity of immediate bleeding, as graded by a 3-po int scale from 1 (no bleeding) to 3 (injection or balloon tamponade therapy requ ired to stop bleeding) and evidence of delayed bleeding 24 hours after ERCP. Ana lyses were performed in intention-to treat fashion. Results: A total of 246 patients were randomized (116 pure-cut current, 130 blend current). There were no differences in baseline characteristics between the groups. The overall frequency of post-ERCP pancreatitis was 6.9%, with no significant difference in frequ ency between treatment arms (pure cut, 7.8%vs. blend, 6.1%; p = 0.62). The dif ference in rates of pancreatitis between the two groups was 1.7%: 95%CI[-4.8 %, 8.2%]. Six patients (2.4%) had delayed bleeding after ERCP, of which two required transfusion. There was a significant increase in minor bleeding episodes (grade 2) in the pure-cut group (p < 0.0001). Delayed episodes of bleeding were equal (n = 3) in each arm. Conclusions: The type of current used when performing endoscopic sphincterotomy does not appear to alter the risk of post-ERCP pan creatitis. The selection of electrosurgical current for biliary endoscopic sphin cterotomy should be based on endoscopist preference.

专业录像带教育患者的效应和新诊断为黑色素瘤患者的焦虑/抑郁水平:随机前瞻性临床试验

Objective:Little is known about the effects of videotape-based education on knowledge and anxiety levels among patients with melanoma. We sought to evaluate effects of a professionally produced videotape on the knowledge and distress levels among patients with newly diagnosed melanoma. Secondarily, we sought to compare these effects with those of a traditional clinic visit. Methods:We conducted a randomized controlled trial involving 217 patients. An intervention group underwent questionnaire-based testing of melanoma knowledge and anxiety/distress levels before and after viewing an educational videotape. A control group underwent similar testing before and after a clinic visit. Results:The videotape and clinical encounter significantly increased knowledge and decreased anxiety. Improvement in knowledge levels was significantly greater after viewing the videotape compared with the clinic visit, whereas anxiety levels decreased to a greater degree after the clinical encounter. Whether or not a synergistic relationship may exist between exposure to an educational videotape and a physician visit was not specifically evaluated in this study. Conclusion:Videotape-based education may be more effective than that provided by a clinic visit,where as the clinical encounter appears to be more effective in alleviating patient anxiety/distress.