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国外医学(老年医学分册) 1989年第4期 186-187页

作者：孙国山

人的记忆力随增龄而逐渐减退。作者对能否通过训练来减少或防止记忆力的减退,进行了研究。对象与方法在244名>60岁的志愿者中,随机挑选112人分为试验组和对照组。试验组每周训练2次,共4周。通过刺激基本记忆功能,围绕声

关键词：逐渐减退随机试验心理刺激心理学测验联想过程编花时间感训练课程持续时间初始数据

促进初级保健提供者加强预防性哮喘治疗的一项随机试验

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世界核心医学期刊文摘（儿科学分册） 2005年第10期1卷 39-40页

作者： Halterman J.S. McConnochie K.M. Conn K.M. 郭战宏 Departme nt of Pediatrics Golisano Children's Hosp. at Strong Box 777 601 Elmwood Ave Rochester NY 14642 United States Dr.

Background: Guidelines recommend preventive medications for all children with persistent asthma, yet young urban children often receive inadequate therapy. Th is may occur in part because primary care providers are unaware of the severity of their patients’symptoms. Objective: To determine whether systematic school- based asthma screening, coupled with primary care provider notification of asthm a severity, will prompt providers to take preventive medication action (prescribe a new preventive medication or change a current d ose). Design: Children aged 3 to 7 years with mild persistent to severe persiste nt asthma were identified at the start of the 2002-2003 school year in Rocheste r. Children were assigned randomly to a provider notification group (child’s pr imary care provider notified of asthma severity) or a control group (provider no t notified of severity). Primary care providers of children in the provider noti fication group were sent a facsimile indicating the child’s symptoms and recomm ending medication action based on national criteria. Interviewers blinded to the child’s group assignment called parents 3 to 6 months later to determine if pr eventive actions were taken. Results: Of 164 eligible children with mild persist ent or more severe asthma, 151 (92.1%) were enrolled. Children in the provider notification group were not more likely to receive a preventive medication actio n than were children in the control group (21.9%vs 26.0%; P=.57). Additional p reventive measures, including encouraging compliance with medications (33.3%vs 31.3%; P=.85), recommending environmental modifications (39.3%vs 42.4%; P=.86 ), and referrals for specialty care (6.6%vs 6.0%; P>.99), also did not differ between the provider notification and control groups. At the end of the study, 5 2.4%of children in both groups with no medication changes were still experienci ng persistent symptoms. Conclusions: School-based asthma screening identified m any symptomatic children in need of medication modification. Provider notifica

关键词：初级保健哮喘治疗持续性哮喘随机试验预防保健患儿症状药物治疗 Rochester 患儿父母依从性

医师教育和组织变革在慢性哮喘保健中的作用的一项多址随机试验:儿科哮喘保健患者转归研究队列II的成本效益分析

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世界核心医学期刊文摘（儿科学分册） 2005年第10期1卷 40-41页

作者： Sullivan S.D. Lee T.A. Blough D.K. 郭战宏 Pharmaceut. Outc omes Res./Plcy. P. Box 357630 University of Washington SeattleWA 98195-7630 United States Dr.

Background: A decision to implement innovative disease management intervention s in health plans often requires evidence of clinical benefit and financial impa ct. The Pediatric Asthma Care Patient Outcomes Research Team II trial evaluated 2 asthma care strategies: a peer leader-based physician behavior change interve ntion (PLE) and a practice-based redesign called the planned asthma care interv ention (PACI). Objective: To estimate the cost-effectiveness of the interventio ns. Methods: This was a 3-arm, cluster randomized trial conducted in 42 primary care practices. A total of 638 children (age range, 3-17 years) with mild to m oderate persistent asthma were followed up for 2 years. Practices were randomize d to PLE (n = 226), PACI (n = 213), or usual care (n = 199). The primary outcome was symptom-free days (SFDs). Costs included asthma-related health care utili zation and intervention costs. Results: Annual costs per patient were as follows : PACI, ＄1292; PLE, ＄504; and usual care, ＄385. The difference in annual SFDs was 6.5 days (95%confidence interval [CI], -3.6 to 16.9 days) for PLE vs usual care and 13.3 days (95%CI, 2.1-24.7 days) for PACI vs usual care. Comp ared with usual care, the incremental costeffectiveness ratio was ＄18 per SFD g ained for PLE (95%CI, ＄5.21-dominated) and ＄68 per SFD gained for PACI (95% CI, ＄37.36-＄361.16). Conclusions: Results of this study show that it is possi ble to increase SFDs in children and move organizations toward guideline recomme ndations on asthma control in settings where most children are receiving control ler medications at baseline. However, the improvements were realized with an inc rease in the costs associated with asthma care.

关键词：慢性哮喘 II 患者转归成本效益分析组织变革持续性哮喘随机试验多址控制指南临床受益

胰岛素泵与每日多次胰岛素注射治疗妊娠合并1型糖尿病:CONCEPTT随机试验的预设分析

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中华围产医学杂志 2020年第4期23卷 231-231页

作者：杨馨蕊杨慧霞北京大学第一医院妇产科

2018年12月,Diabetes Care杂志发表了一篇对“1型糖尿病女性孕期连续血糖监测的研究”(Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial,CONCEPTT)的预设性二级分析,探讨胰岛素泵治疗妊娠合并1型糖尿病的疗效[1].CONCEPTT是一项多中心、非盲、随机试验,用于评估实时连续血糖监测(real-time continuous glucose monitoring,CGM)联合自我血糖监测(self-monitoring of blood glucose,SMBG)与单独进行SMBG的临床有效性差异,结果显示CGM对采用腺岛素泵和每日多次胰岛素注射(multiple daily injections,MDI)孕妇的血糖控制及减少新生儿并发症都有积极作用。

关键词：连续血糖监测 1型糖尿病自我血糖监测新生儿并发症随机试验妊娠合并胰岛素泵

报告随机对照试验的CONSORT声明修订版:说明与详述(三)

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中国实用内科杂志 2006年第8期26卷 635-637页

作者： Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gtzsch Thomas Lang 英国健康科学研究所医学统计学中心ICRF医学统计学组美国北卡罗莱纳州研究三角园国际家庭健康定量研究组加拿大东安大略湖所儿童医院ThomasC.ChalmersCente系统评价中心英国布里斯托尔大学MRC健康服务研究协作网美国内科医师协会《内科学年鉴》英国热带医学伦敦公共卫生学院北欧Cochrane中心 13849 Edgewater Drive for the CONSORT Group (牛津OX37LF) (POBox139503) (渥太华K1H8L1) (布里斯托尔B582PR) (费城PA19106) 医学统计学单元 (伦敦WC1E7HT) (哥本哈根DK-2100C) Lakewood OH44107

第7a条:如何确定样本量举例我们认为……有症状的深静脉血栓、肺栓塞或死亡的发生率在安慰剂组为4%,在阿地肝素钠组为1.5%.据0.9的检验效能(P=0.05,双侧),每组须纳入976例病人,我们计划每组纳入1 000例病人以补充一些结果不能评估的病人... 详细信息

第7a条:如何确定样本量举例我们认为……有症状的深静脉血栓、肺栓塞或死亡的发生率在安慰剂组为4%,在阿地肝素钠组为1.5%.据0.9的检验效能(P=0.05,双侧),每组须纳入976例病人,我们计划每组纳入1 000例病人以补充一些结果不能评估的病人.……

关键词：样本量差异分配隐藏研究者随机分配 CONSORT 随机试验概率试验不均衡性最小化声明

不典型鳞状细胞病例不同处理方案的随机试验结果

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实用妇产科杂志 2004年第1期 77-77页

作者：汪清 The ASCUS-LSIL Triage Study(ALTS) Group

药剂师处方改善社区居民血压的随机试验:Alberta改善高血压临床试验

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中华高血压杂志 2015年第7期23卷 643-643页

作者：刘莉叶鹏 Tsuyuki RT Houle SK Charrois TL Kolber MR Rosenthal MM Lewanczuk R Campbell NR Cooney D McAlister FA

高血压控制率高居不下。执业药师的临床作用不断扩大,其在改善社区高血压治疗方面可能有较大帮助。该研究旨在确定药剂师处方对社区居住患者血压控制的影响。方法：研究人员进行随机对照试验,通过Alberta省23个社区药店、医院或基层医... 详细信息

高血压控制率高居不下。执业药师的临床作用不断扩大,其在改善社区高血压治疗方面可能有较大帮助。该研究旨在确定药剂师处方对社区居住患者血压控制的影响。方法：研究人员进行随机对照试验,通过Alberta省23个社区药店、医院或基层医疗小组,纳入血压高于目标血压的成年患者。

关键词：高血压控制率社区居民药剂师临床试验随机试验处方随机对照试验成年患者

使用手动负压吸引处理不全流产时的宫颈旁阻滞治疗:一项临床随机试验

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世界核心医学期刊文摘（妇产科学分册） 2005年第8期1卷 33-34页

作者： Gómez P.I. Gaitán H. Nova C. Paradas A. 成健 Dr.Clinical Research Institute Universidad Nacional de Colombia Institute Materno Infantil Carrera 10#1-66 sur Bogotá Colombia

OBJECTIVE: To estimate the effectiveness of paracervical block in controlling pain among women treated with manual vacuum aspiration for an incomplete abortion METHODS: A randomized clinical trial was conducted at Nuestra Senora de Altagracia, a maternal and perinatal referral hospital in the Dominican Republic The sample size was based on a clinical difference of 1.5 points in the level of pain measured with the visual analog scale using 90%power and a sampling error of 0.04. Women who were at 12 weeks of gestation or less with an incomplete abortion were eligible to participate. They were randomly assigned to receive either the standard treatment of care (manual vacuum aspiration for uterine evacuation with psychological support but no paracervical block) or manual vacuum aspiration treatment with psychological support and paracervical block using 1.0%lidocaine. Patients with active infections, severe illnesses, psychiatric disorders, or allergies to lidocaine were excluded. Intraoperative pain as reported by the women and as documented by an external observer was measured. RESULTS: Although Ae paracervical block technique used showed a slight reduction in severe pain, there were no clinically or statistically significant differences in intraoperative pain between the 2 groups (relative risk 0.73; 95%confidence interval 0.43, 1.23) with 50%of all patients registering 7 or higher score on a visual analog pain scale of 0-10. However, statistically significant differences were found in each group when comparing the level of preoperative and intraoperative pain described by the patient (P < .001). The manual vacuum aspiration technique and the paracervical Hock were not accompanied by complications. CONCLUSION: The paracervical block technique used in this study along with psychological support was comparable with pain control using psychological support alone; neither pain management regimen provided sufficient pain control. It is recommended that randomized comparative studies be designed to determine the effecti

关键词：阻滞治疗不全流产负压吸引随机试验多卡因清宫术利多卡因过敏止痛疗效视觉类统计学显著性

采用依那西普治疗获得改善的银屑病患者的临床结局自述——一项Ⅲ期随机试验结果

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世界核心医学期刊文摘（皮肤病学分册） 2006年第3期2卷 43-44页

作者： trial Krueger G.G. Langley R.G. Finlay A.Y. 焦婷 Department of Dermatology University of Utah Health Sciences Center Building 4B454 30 N 1900 E Salt Lake City UT 84132-0001United States

Background: Etanercept, a soluble tumour necrosis factor receptor, lessens the severity of psoriasis as measured by physician-reported clinical outcomes. Equally important is the patient perspective on the effect of etanercept therapy on daily life. Objectives: To assess patient-reported outcomes (PROs) in patients with psoriasis receiving etanercept therapy. Methods: In this multinational, randomized, phase III trial, patients with psoriasis received placebo (n = 193), etanercept 50 mg per week (n = 196) or etanercept 50 mg twice weekly (n = 194) during the initial 12-week, double-blind period. Thereafter, all patients received open-label etanercept (50 mg per week). The following PROs were assessed: Dermatology Life Quality Index (DLQI), Short Form- 36 Health Survey (SF- 36) , patient rating of pruritus, and patient global assessment of psoriasis. Results: At week 12, DLQI total score improved by 65- 70% in patients receiving etanercept compared with 6% in patients receiving placebo (P 5-point improvement or 0 score) for 72- 77% of patients receiving etanercept therapy. All DLQI and SF- 36 subscales and the SF- 36 physical and mental component summary scores demonstrated significantly greater improvement with etanercept therapy than with placebo, illustrating that etanercept benefits patients with psoriasis across multiple domains that contribute to health-related quality of life. With etanercept therapy, distributions of patient ratings of pruritus and global assessment of disease shifted from moderate to severe (baseline) to minimal to good (week 12). Etanercept-induced benefits of PROs were maintained for patients who reduced their dose after 12 weeks. Conclusions: Etanercept therapy improves PROs in patients with psoriasis and makes a meaningful difference to their lives. These results support the efficacy profile of physician reported clinical measures while providing a more complete understanding of the benefits experienced by patients with ps

关键词：银屑病患者依那西普临床结局随机试验 Ⅲ期试验可溶性肿瘤坏死因子受体治疗严重程度服药期间 12周

全子宫切除与次全子宫切除的医疗资源消耗:一项随机试验结果

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世界核心医学期刊文摘（妇产科学分册） 2005年第8期1卷 35-36页

作者：成健 Dr.Institute for Health Policy Studies Univ. of California San Francisco 3333 California Street San Francisco CA 94118-1944 United States

OBJECTIVE: Hysterectomy is the most common major surgical procedure performed in the United States for nonobstetric reasons. Although most hysterectomies include removal of the cervix, the rate of supracervical procedures has increased in recent years. To provide evidence about the outcomes of both types of hysterectomy, we conducted a randomized clinical trial of total (TAH) or supracervical (SCH) hysterectomy (the “TOSH”trial). We report here an analysis of 24-month resource use by patients in this trial. METHODS: A randomized controlled trial was performed at 3 clinical centers to compare resources used by 120 patients who received a total or supracervical abdominal hysterectomy. Service use during a 24-month follow-up period was identified from medical and billing records and patient reports. Each service used was assigned a relative value, which was then converted into 2002 U.S. dollars. RESULTS: Overall resource use was similar in the 2 study groups in the first 12 months after randomization (TAH ＄5,870; SCH ＄6,018; 95%confidence interval for difference -＄960, ＄1,255; P <.79) and for the full 24 months (TAH ＄6,448; SCH ＄7,479; 95%confidence interval for difference -＄533, ＄2,616; P <.20). In exploratory multivariable analyses, resource use was significantly associated with baseline body mass index greater than or equal to 35 kg/m2 (＄8,440 versus ＄6,398, P = .02) and heavy bleeding (＄7,550 versus ＄5,368, P = .02). CONCLUSION: We conclude that the use of medical care resources over a 24-month period is comparable for total and supracervical hysterectomy. The association of a womans weight and bleeding pattern with subsequent resource use requires further investigation.

关键词：次全子宫切除部分子宫切除术随机试验医疗记录临床对照试验产科原因随机对照试验临床中心服务情况多元分析