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Fontolizumab,人源化抗干扰素γ抗体治疗中重度克罗恩病的临床研究:一项关于剂量升级、安慰剂对照、双盲、药物单剂量应用和多剂量应用的安全性与耐受性的研究

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世界核心医学期刊文摘（胃肠病学分册） 2006年第12期2卷 42-43页

作者： Reinisch W. Hommes D.W. Van Assche G. 王铮 Universitaetsklinik Innere Medizin IV Abteilung Gastroenterologie and HepatologieWaehringer Guertel 18-20A-1090 ViennaAustria Prof.

Introduction:This study was designed to evaluate the safety of fontolizumab,a humanised anti-interferon γ antibody,in patients with moderate to severe Crohn’s disease(CD) .Patients and methods:Forty five patients with a CD activity index(CDAI) of 250-450 were randomised in a double blind,placebo controlled,dose escalating fashion to receive single doses of fontolizumab(0.1,1.0,and 4.0 mg/kg) or *** day 29,patients with clinical response were re-randomised to receive three additional doses of one half their initial fontolizumab dose or placebo at four weekly *** objectives were safety and *** outcomes included assessments of immunogenicity,clinical activity,and potential pharmacodynamic ***:Treatment was generally well *** were slightly more reports of chills,flu-like syndrome,asthenia,nausea,and vomiting in the 1.0 mg and 4.0 mg/kg fontolizumab *** serious adverse events rated as worsening of CD occurred under *** to fontolizumab were confirmed in one *** differences in clinical activity parameters were noted between any of the active treatment groups and placebo,with the placebo group having a particularly favourable outcome(60% response and 40% remission) .By day 29,a more enhanced decrease in median Crohn’s disease endoscopic index of severity(p = 0.02) and serum C reactive protein(p< 0.001) was observed in the 4.0 mg/kg(n = 14) fontolizumab cohort compared with placebo(n = 10) .Pharmacodynamic effects were observed by ***:Fontolizumab was well tolerated with minimal immunogenicity at doses of up to 4.0 mg/kg in patients with CD.A biological activity of fontolizumab is suggested.

关键词：克罗恩病 Fontolizumab 剂量应用干扰素γ 人源化安慰剂对照药效动力学免疫源性免

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麻醉与镇痛 2008年第6期4卷 60-63页

作者： Anil Agarwal, MD Sanjay Dhiraaj, MD Sandeep Pawar, MD Rakesh Kapoor,McH Devendra Gupta, MD Prabhat K. Singh, MD 周全红(译) 江伟(校) Departments of Anesthesia and Surgical Urology Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow India 不详

背景导尿管引起的尿管相关性膀胱不适（CRBD）令人痛苦。本研究评估了加巴喷丁用于预防CRBD的有效性。方法108例行择期经皮肾切开取石术的成年患者，ASAI～Ⅱ级，男女不限，随机分为2组，每组54例患者。对照组用安慰剂，G组用加巴喷丁60... 详细信息

背景导尿管引起的尿管相关性膀胱不适（CRBD）令人痛苦。本研究评估了加巴喷丁用于预防CRBD的有效性。方法108例行择期经皮肾切开取石术的成年患者，ASAI～Ⅱ级，男女不限，随机分为2组，每组54例患者。对照组用安慰剂，G组用加巴喷丁600mg。2组患者均在手术前1小时口服药物。患者在麻醉诱导后将16F的Foley导尿管插入膀胱，气囊注入生理盐水10ml。手术后患者进入麻醉恢复室，分别在到达恢复室（0小时）、1、2和6小时的时间点评估CRBD的发生率与严重程度（轻、中、重度）。结果对照组CRBD的发生率达80％（43／54），而加巴喷丁组CRBD的发生率降低到50％（27／54）（P〈0．05）。加巴喷丁还可减轻CRBD的严重程度和手术后疼痛程度，该组手术后需要芬太尼镇痛的人数和芬太尼使用的总量都减少（P〈0．05）。结论手术前1小时口服加巴喷丁（600mg）可以减少CRBD的发生率和严重程度，减少手术后疼痛，使手术后需要芬太尼镇痛的患者例数和芬太尼需求量明显减少。

关键词： Foley导尿管加巴喷丁安慰剂对照插入膀胱有效性评估双盲研究不适

氨茶碱在缓慢收缩心率性心脏停搏中的运用:随机安慰剂对照试验

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世界核心医学期刊文摘（心脏病学分册） 2006年第7期2卷 4-5页

作者： Abu-Laban R.B. McIntyre C.M. Christenson J.M. 罗亮 University of British Columbia Vancouver BC Canada Dr.

Background: Endogenous adenosine might cause or perpetuate bradyasystole. Our aim was to determine whether aminophylline, an adenosine antagonist, increases the rate of return of spontaneous circulation(ROSC) after out-of-hospital cardiac arrest. Methods: In a double-blind trial, we randomly assigned 971 patients older than 16 years with asystole or pulseless electrical activity at fewer than 60 beats per minute, and who were unresponsive to initial treatment with epinephrine and atropine, to receive intravenous aminophylline(250 mg, and an additional 250 mg if necessary)(n=486) or placebo(n=485). The patients were enrolled between January, 2001 and September, 2003, from 1886 people who had had cardiac arrests. Standard resuscitation measures were used for at least 10 mins after the study drug was administered. Analysis was by intention-to-treat. This trial is registered with the *** registry with the number NCT00312273. Findings: Baseline characteristics and survival predictors were similar in both groups. The median time rom the arrival of the advanced life-support paramedic team to study drug administration was 13 min. The proportion of patients who had an ROSC was 24.5%in the aminophylline group and 23.7%in the placebo group(difference 0.8%; 95%CI-4.6%to 6.2%; p=0.778). The proportion of patients with non-sinus tachyarrhythmias after study drug administration was 34.6%in the aminophylline group and 26.2%in the placebo group(p=0.004). Survival to hospital admission and survival to hospital discharge were not significantly different between the groups. A multivariate logistic regression analysis showed no evidence of a significant subgroup or interactive effect from aminophylline. Interpretation: Although aminophylline increases non-sinus tachyarrhythmias, we noted no evidence that it significantly increases the proportion of patients who achieve ROSC after bradyasystolic cardiac arrest.

关键词：心脏停搏安慰剂对照快速性心律失常心律失常者双盲试验初始治疗拮抗剂自主循环无收缩亚组

左旋咪唑治疗局限性和缓慢扩散性白癜风的随机双盲安慰剂对照研究

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世界核心医学期刊文摘（皮肤病学分册） 2005年第10期1卷 33-34页

作者： Agarwal S Ramam M Sharma V.K 罗素菊 Department of Dermatology and Venereology All India Institute of Medical Sciences New Delhi 110 029 India

Background:A previous uncontrolled, open trial of levamisole in patients with limited and slowly spreading vitiligo had shown that new lesions did not develop in 94%of patients after 2-4 months of treatment with the drug. Objectives:To assess the efficacy of levamisole in the treatment of slowly spreading, limited vitiligo. Methods:In a randomized double-blind trial at the Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India, 60 patients with vitiligo involving < 2%of the body surface area and with slowly spreading disease (defined as one to five new lesions in the previous month or six to 15 new lesions in the previous 3 months) were randomly allocated to receive oral levamisole 150 mg or placebo on two consecutive days in a week. Children received oral levamisole 100 mg. All patients applied mometasone furoate 0.1%cream on the depigmented macules once daily. Patients were evaluated monthly for 6 months. The main outcome measure was the occurrence of new lesions, counted at each monthly visit. The secondary outcome measures comprised:(i) a dermatology-specific instrument, the Dermatology Life Quality Index or Childrens Dermatology Life Quality Index questionnaires, which were completed by the patients at baseline and at every visit, and (ii) a general health questionnaire, the World Health Organization Quality of Life Brief Questionnaire, which was completed at baseline and at the end of the study. Results Forty-three patients completed 6 months of follow-up. The mean±SD number of new lesions that developed during the study period of 6 months was 1.9±2.0 (range 0-8) in the levamisole group and 1.8±2.0 (range 0-7) in the placebo group (P=0.92). The proportion of patients who did not develop any further new lesions for the remainder of the study period was higher in the levamisole group at all the monthly evaluation points, although it was statistically significant (P=0.05) only at the fourth month. Improvement in quali

关键词：左旋咪唑随机双盲安慰剂对照扩散性皮肤病与性病脱色素医学科学研究体表面积生活质量糠酸莫米松

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

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世界核心医学期刊文摘（神经病学分册） 2006年第9期2卷 4-5页

作者： Winblad B. Kilander L. Eriksson S. 周永(译) Karolinska Institutet Alzheimer's Disease Research Center Department of Neurotec Huddinge 14186 Stockholm Sweden 不详

Background: The cholinesterase inhibitor donepezil is used to treat mild-to-moderate Alzheimer’s disease. Its efficacy in severe dementia has not been assessed and is controversial. Our aim was to ascertain the effectiveness of donepezil in patients with severe Alzheimer’s disease, by focusing primarily on cognition and activities of daily living. Methods: We did a 6-month, double-blind, parallel-group, placebo-controlled study in 248 patients with severe Alzheimer‘s disease (mini mental state examination score 1-10) who were living in assisted care nursing homes ran by trained staff in Sweden. We assigned patients oral donepezil (5 mg per day for 30 days then up to 10 mg per day thereafter, n=128) or matched placebo (n=120). Our primary endpoints were change from baseline to month 6 in the severe impairment battery (SIB) and modified Alzheimer’s Disease Cooperative Study activities of daily living inventory for severe Alzheimer’s disease (ADCS-ADL-severe). We analysed outcomes for patients with data at baseline and at one or more other timepoints (modified intent-to-treat population) with last observation carried forward used to replace missing data. Findings: 95 patients assigned donepezil and 99 patients assigned placebo completed the study. Patients treated with donepezil improved more in SIB scores and declined less in ADCS-ADL-severe scores at 6 months after initiation of treatment compared with baseline than did controls (least squares [LS] mean difference, 5.7, 95%CI 1.5-9.8; p=0.008, and 1.7, 0.2-3.2; p=0.03, respectively). The incidence of adverse events was comparable between groups (donepezil 82%[n=105] vs placebo 76%[n=91]), with most being transient and mild or moderate in severity. More patients discontinued treatment because of adverse events in the donepezil group (n=20) than in the placebo group (n=8). Interpretation: Donepezil improves cognition and preserves function in individuals with severe Alzheimer’s disease who live in nursing homes.

关键词：阿尔茨海默病患者意向性治疗安慰剂对照多奈哌齐重度对照研究双盲平行

非甾体抗炎药(包括环氧化酶-2抑制剂)在治疗膝关节骨关节炎所致疼痛中的作用:随机安慰剂对照临床试验的汇总分析

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英国医学杂志中文版 2005年第3期8卷 154-158页

作者： Jan Magnus Bjordal Anne Elisabeth Ljunggren Atle Klovning Lars SlΦdal 张卓莉 Department of Public Health and Primary Health Care University of Bergen 5018 Bergen Norway Department of Laboratory Medicine，Children's and Women's Health，Norwegian University of Science and Technology 7489 Trondheim Norway

目的评价包括选择性环氧化酶2抑制剂(昔布类)在内的非甾体抗炎药(NSAIDs)在膝关节骨关节炎患者中的镇痛作用。试验设计对随机安慰剂对照的临床试验进行系统回顾和汇总分析。文献回顾本项研究共对23项研究中的10845例患者进行了回顾性分... 详细信息

目的评价包括选择性环氧化酶2抑制剂(昔布类)在内的非甾体抗炎药(NSAIDs)在膝关节骨关节炎患者中的镇痛作用。试验设计对随机安慰剂对照的临床试验进行系统回顾和汇总分析。文献回顾本项研究共对23项研究中的10845例患者进行了回顾性分析,患者的平均年龄为62.5岁,其中7807例患者接受了适当剂量的NSAIDs治疗,3038例患者接受了安慰剂治疗。患者入选时,经100mm视觉模拟尺(VAS)测定的权重疼痛分数基线的平均值为64.2mm,症状存在的平均时间为8.2年。主要观察指标总体疼痛程度的变化。结果各项临床试验的方法学质量可以接受,但是其中13项试验在随机化之前排除了对NSAIDs治疗没有反应的患者。一项试验报告了长期疗效的数据,结果提示治疗1～4年期间,NSAIDs的疗效与安慰剂相当。汇总所有入选试验的数据显示,在治疗2～13周后疼痛程度的差值为VAS10.1mm(95%可信区间为7.4～12.8),优于安慰剂15.6%。来自不同试验所得到的结果之间差异很大,随机效应模型显示,疼痛改善的效应量为0.32(0.24～0.39)。10项没有排除对NSAIDs治疗没有反应患者的试验中,结果比较一致,疼痛改善的效应量为0.23(0.15～0.31)。结论NSAIDs能够在短期内减轻骨关节炎患者的膝关节疼痛,其疗效略优于安慰剂,但是现在的分析不支持对这种疾病长期应用NSAIDs。由于口服NSAIDs可以导致严重的不良反应,因此只推荐有限制的使用。

关键词：非甾体抗炎药汇总分析膝关节骨关节炎对照临床试验随机安慰剂选择性环氧化酶-2抑制剂 NSAIDs 关节炎患者随机效应模型疼痛程度安慰剂对照回顾性分析安慰剂治疗方法学质量膝关节疼痛镇痛作用系统回顾试验设计

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

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世界急危重病医学杂志 2007年第4期4卷 1969-1972页

作者：陈力（编译）解放军总医院急诊科北京100853

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。

关键词：重症急性坏死性胰腺炎抗生素治疗安慰剂对照随机早期双盲周围组织感染美罗培南

金黄膏外敷治疗膝骨关节炎的随机、双盲、安慰剂对照临床观察

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上海中医药杂志 2015年第12期49卷 31-34页

作者：刘锦涛姜宏江苏省苏州市中医医院骨伤科江苏苏州215009

目的观察金黄膏外敷治疗膝骨关节炎的临床疗效。方法将80例膝骨关节炎患者随机分为治疗组与对照组,每组40例。治疗组予金黄膏外敷,对照组予安慰剂膏外敷。两组疗程均为21天,观察膝部疼痛VAS评分、改良JOA评分及中医证候积分的变化情况... 详细信息

目的观察金黄膏外敷治疗膝骨关节炎的临床疗效。方法将80例膝骨关节炎患者随机分为治疗组与对照组,每组40例。治疗组予金黄膏外敷,对照组予安慰剂膏外敷。两组疗程均为21天,观察膝部疼痛VAS评分、改良JOA评分及中医证候积分的变化情况。结果 1试验期间,治疗组脱落2例,对照组无脱落,最终完成试验者78例。2治疗前后组内比较,两组膝部疼痛VAS评分、改良JOA评分及中医证候积分的差异均有统计学意义(P<0.05)。组间治疗前后膝部疼痛VAS评分、改良JOA评分及中医证候积分的差值比较,差异均有统计学意义(P<0.05)。结论金黄膏外敷治疗膝骨关节炎,可显著减轻膝部疼痛,改善患者关节活动能力及生活质量。

关键词：膝骨关节炎金黄膏安慰剂对照非手术治疗

功能性电刺激促进首次急性卒中患者下肢运动康复和行走能力:一项随机安慰剂对照试验

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世界核心医学期刊文摘（神经病学分册） 2005年第6期1卷 55-56页

作者： Hui- Chan C.W.Y. Li L.S.W. 沈才飞 Dept. of Rehabilitation Sciences Hong Kong Polytechnic University Hung Hum Kowloon Hong Kong Dr.

Background and Purpose - The effectiveness of functional electrical stimulation (FES) has been investigated in chronic hemiplegia. The present study examines whether FES, given during acute stroke, was more effective in promoting motor recovery of the lower extremity and walking ability than standard rehabilitation alone. Methods - Forty- six subjects, 70.9± 8.0 years old and 9.2± 4.1 days after stroke, were assigned randomly to 1 of 3 groups receiving standard rehabilitation with FES or placebo stimulation or alone (control). FES was applied 30 minutes and placebo stimulation 60 minutes, 5 days per week for 3 weeks. Outcome measurements included composite spasticity score, maximum isometric voluntary contraction of ankle dorsi- flexors and planter- flexors, and walking ability. They were recorded before treatment, weekly during the 3- week treatment, and at week 8 after stroke. Results - No significant differences were found in the baseline measurements. After 3 weeks of treatment, there was a significant reduction in the percentage of composite spasticity score, and a significant improvement in the ankle dorsiflexion torque, accompanied by an increase in agonist electromyogram and a reduction in electromyogram cocontraction ratio in the FES group, when compared with the other 2 groups (P < 0.05). All subjects in the FES group were able to walk after treatment, and 84.6% of them returned home, in comparison with the placebo (53.3% ) and control (46.2% , P < 0.05) groups. Conclusions - Fifteen sessions of FES, applied to subjects with acute stroke plus standard rehabilitation, improved their motor and walking ability to the degree that more subjects were able to return to home.

关键词：功能性电刺激急性卒中下肢运动行走能力安慰剂对照康复治疗证实有效屈肌背侧收缩情况