氨氯地平治疗轻、中度高血压有效性与安全性的Meta分析

目的 :了解氨氯地平治疗轻、中度高血压有效性及不良反应 (安全性 )的差异。方法 :应用Meta分析对 2 6篇文献 2 8项研究氨氯地平与其他抗高血压药物治疗轻、中度高血压的有效性、安全性进行同质性检验及合并效应量的估计。结果 :(1)同质性检验 :有效性 ,χ2 =2 9.13,自由度为 2 7;安全性 ,χ2 =2 7.95 ,自由度为 2 4 ,两者P均大于 0 .0 5。 (2 )合并效应量的估计 :有效性 ,OR合并 =1.2 6 1,OR合并95 %可信区间为 1.0 18～ 1.5 6 2。OR合并 的检验 :χ2 =4 .5 1,P <0 .0 5 ;安全性 :OR合并 =1.0 13,OR合并95 %可信区间为 0 .80 1～ 1.2 82。OR合并 的检验 :χ2 =0 .0 13,P >0 .0 5。结论 :氨氯地平治疗轻、中度高血压的疗效总体上优于目前常用药物 ,且其安全性较高。     

厄贝沙坦治疗轻、中度高血压的疗效和安全性Meta分析

目的:采用Meta分析系统评价厄贝沙坦与其它降压药物治疗轻、中度高血压的临床疗效和安全性差异。方法:计算机检索中国学术期刊全文数据库、中文科技期刊数据库、万方数据资源系统和中国生物医学文献数据库(CBMdisc),在严格的文献质量评价基础上,应用Meta分析对纳入文献研究厄贝沙坦与其它降压药物治疗轻、中度高血压的有效率、安全性进行同质性检验及合并效应量的估计。结果:共纳入15篇文献,1528例患者。厄贝沙坦治疗轻、中度高血压的总有效率略优于其它降压药物,差异无统计学意义[合并OR=1.22,95%可信区间(0.95,1.58),Z=1.56,P=0.12];厄贝沙坦安全性优于其它降压药物,差异有统计学意义[合并OR=0.61,95%可信区间(0.44,0.85),χ2=2.89,P=0.004]。结论:厄贝沙坦治疗轻、中度高血压在疗效上与其它降压药物比较无显著性差异,但在安全性方面优于其它降压药物。     

厄贝沙坦与依那普利治疗轻中度原发性高血压疗效与安全性比较的Meta分析

目的:比较厄贝沙坦与依那普利治疗轻、中度原发性高血压的疗效及安全性。方法:应用Meta分析对有关厄贝沙坦与依那普利治疗轻、中度原发性高血压的有效性、安全性进行定量综合分析,共入选21项研究可进行同质性检验及合并效应量的估计。结果:(1)同质性检验:有效性,χ2=26.00,自由度(df)=20;安全性,χ2=17.02,df=19,二者P值均>0.05。(2)合并效应量估计:有效性的OR合并=1.94(95%可信区间为1.53～2.44)。合并效应量的检验Z=5.58,P<0.00001;安全性的OR合并=0.32(95%可信区间为0.24～0.43)。合并效应量的检验Z=7.62,P<0.00001。结论:厄贝沙坦治疗轻、中度原发性高血压的总体疗效明显优于依那普利,而不良反应的发生总体上低于依那普利。     

缬沙坦治疗轻、中度原发性高血压有效性与安全性的Meta分析

目的:了解缬沙坦治疗轻、中度原发性高血压有效性及安全性的差异。方法:应用Meta分析对16篇文献研究中缬沙坦与其它常用抗高血压药治疗轻、中度原发性高血压的有效性、安全性进行同质性检验及合并效应量的估计。结果:同质性检验的有效性:χ2=9.6268,df=15;安全性:χ2=11.8158,df=15,二者P>0.05。合并效应量的估计,有效性:OR合并=0.9897,OR合并95%可信区间为0.7836～1.2484,OR合并的检验:χ2=0.0854,P>0.05;安全性:OR合并=0.5657,OR合并95%可信区间为0.4188～0.7641,OR合并的检验:χ2=13.7909,P<0.01。结论:缬沙坦治疗轻、中度原发性高血压有效率总体上与对照组比较无显著性降低,安全性比较亦无显著性差异。     

丹红注射液治疗糖尿病周围神经病变疗效的Meta分析

［摘要］目的利用Meta分析方法对丹红注射液治疗糖尿病周围神经病变的临床试验进行分析,评价其治疗效果。方法检索1994～2008年国内发表的丹红注射液治疗糖尿病周围神经病变临床试验的相关文献,应用Meta分析对10项研究进行同质性检验和合并效应量的估计。结果①同质性检验：χ2＝2.810 0,自由度df＝9,P＞0.05。②合并效应量的估计：OR合并95%可信区间为3.015 3～6.029 1。OR合并的检 验：χ2＝67.320 0,P＞0.05。结论丹红注射液治疗糖尿病周围神经病变安全有效。     

氨氯地平联合复方阿米洛利与联合替米沙坦治疗轻、中度高血压的疗效与安全性Meta分析

目的:采用Meta分析系统评价氨氯地平联合复方阿米洛利与氨氯地平联合替米沙坦治疗轻、中度高血压的临床疗效及安全性的差异。方法:以氨氯地平、复方阿米洛利、替米沙坦、高血压为主题词,检索Pubmed、Web of Science、中国知网(CNKI)和万方数据库,收集氨氯地平联合复方阿米洛利或替米沙坦治疗高血压的相关文献,在严格的文献质量评价基础上,应用Meta分析对纳入的文献:研究氨氯地平分别联合复方阿米洛利、替米沙坦治疗轻、中度高血压的有效性与安全性,进行同质性检验及合并效应量的估计。结果:共纳入13篇文献,16 192例研究对象,其中复方阿米洛利组8 098例,替米沙坦组8 094例。有效性的同质检验:χ2=14.50,df=12,P=0.27;安全性的同质性检验:χ2=5.86,df=7,P=0.56。两者合并效应量的估计,有效性:OR合并=0.93,95%可信区间为0.81~1.06。安全性OR合并=1.23,95%可信区间为1.04~1.45。结论:氨氯地平联合复方阿米洛利治疗轻、中度高血压有效性与氨氯地平联合替米沙坦无统计学差异,但安全性方面氨氯地平联合替米沙坦优于氨氯地平联合复方阿米洛利。     

天麻素注射液治疗眩晕Meta分析

目的:利用Meta分析方法对天麻素注射液治疗眩晕的临床研究进行合并分析,评价其治疗眩晕的临床效果.方法:按照循证医学的要求全面检索中国期刊全文数据库、PubMed数据库等,把符合纳入标准的16篇文献作为Meta分析的对象.采用Cochrane协作网免费提供的RevMan5.0专用软件进行统计分析.结果:16项研究经Meta分析合并,结果显示,16项研究同质性检验结果,X2=17.59,自由度为15,P=0.29(P＞0.01),表明16项研究具有同质性,故选择固定效应模型的Peto法进行分析计算、汇总统计量.合并效应量的估计:16篇研究的合并比值比OR台并=3.30,95%CI为[2.53,4.31],OR合并的95%CI上下限均大于1,表明11项研究的合并效应有统计学意义.OR合并检验:Z=8.77(P＜0.01)表明天麻素注射液与对照组相比,临床疗效的差异有统计学意义.结论:现有的临床证据表明,天麻素注射液治疗眩晕的疗效优于目前常用药物,不良反应差异无明显统计学意义.     

中、西药治疗婴幼儿湿疹的Meta分析

目的:通过文献分析,系统评价中、西药治疗对婴幼儿湿疹的临床疗效和安全性,从而客观地、科学地指导临床用药。方法:检索中国期刊网数据库(1979~2012)和万方数据库(1998~2012),收集与中、西药治疗婴幼儿湿疹相关的研究报道文献,评价其研究质量,采用Jadad量表对文献记分,通过RevMan 5.0软件进行Meta分析。结果:共纳入27个符合要求的随机对照研究。Meta分析示:①异质性检验:固定效应模型分析发现Q=28.54,P=0.280.05,表明研究间的效应量是同质的。②合并效应量OR合并=0.24,95%可信区间CI[0.18,0.32]。③χ2=9.71(P0.00001),总体OR合并有统计学意义,说明中药临床有效率明显高于西药对照组。结论:经Meta分析中药治疗婴幼儿湿疹较西药临床疗效和安全性更好,如果有更多更优质的中、西医治疗婴幼儿湿疹的随机对照研究文章,则会对本研究的结果提供更充分的支持,从而为临床治疗提出更完备的方案。     

替米沙坦治疗高血压的Meta分析

目的 探讨替米沙坦治疗高血压的有效性及安全性的差异.方法 应用Meta分析12篇关于替米沙坦与其他常用抗高血压药治疗高血压病的研究文献,对其有效性及安全性进行同质性检验及合并效应量的估计.结果 有效性的同质性检验:X2＝5.74,df=12,P=0.929;安全性的同质性检验:X2＝5.97,df=8, P=0.651.二者合并效应量的估计,有效性:OR合并=1.07,OR合并95%可信区间为1.00 ～ 1.14.安全性OR合并=0.8,OR合并95%可信区间为0.6-1.06.结论 替米沙坦治疗高血压有效性总体上与对照组比较无显著性差异,安全性比较亦无显著性差异.     

中西药联合治疗慢性尿酸性肾病疗效的Meta分析

目的 系统评价中西药结合治疗慢性尿酸性肾病的疗效及安全性. 方法 检索2000～2011年国内发表的中西药结合治疗慢性尿酸性肾病临床试验的相关文献,采用RevMan5.0对符合纳入标准的文献进行Meta分析. 结果共有14篇文献,1 050例患者满足纳入标准. Meta分析显示,中西药结合治疗慢性尿酸性肾病的有效率的合并检验分析结果为：Z＝9.85,P<0.000 01,合并后的OR值为5.32,95%的可信区间为 3.82～7.42;药物不良反应发生率的合并检验分析结果为：Z＝5.46,P<0.000 01,合并后的OR值为0.14,95%的可信区间为 0.07～0.28. 结论 中西药结合治疗慢性尿酸性肾病是一种有效的方法.     

Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials.

BACKGROUND: Memantine, a moderate-affinity, uncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors, is the first non-cholinergic agent approved for the treatment of Alzheimer's disease (AD), and the first medication approved in the US and Europe for the treatment of moderate to severe stages of the disease. The objective of this study was to analyse safety and tolerability data from phase III memantine trials and from the open-label extensions of those trials. METHOD: We conducted an analysis of the pooled data for tolerability and safety from six double-blind, placebo-controlled, memantine trials with a minimum duration of 24 weeks (three trials in mild to moderate AD and three in moderate to severe AD; 20 mg/day; 2311 patients) and four open-label extensions of those trials (two in mild to moderate AD and two in moderate to severe AD; 20 mg/day, 1405 patients), for a total treatment period of up to 2 years. RESULTS: The analysis revealed that adverse events occurring during both short- and long-term memantine treatment were minimal, and similar in type and frequency to those reported for placebo-treated patients. The most frequently reported adverse events in placebo-controlled trials included agitation (7.5% memantine vs 12.0% placebo), falls (6.8% vs 7.1%), dizziness (6.3% vs 5.7%), accidental injury (6.0% vs 7.2%), influenza-like symptoms (6.0% vs 5.8%), headache (5.2% vs 3.7%) and diarrhoea (5.0% vs 5.6%). Discontinuations due to adverse events were similar in memantine- and placebo-treated groups (8.9% vs 9.8%, respectively). CONCLUSION: Consistent with the favourable tolerability profile of memantine observed in clinical use, this analysis of pooled safety data indicates that both short- and long-term memantine treatment of patients with AD is safe and well tolerated, with an adverse event profile similar to that of placebo.     

爱维治片剂治疗阿耳茨海默病的多中心双盲研究

目的：评估爱维治片剂治疗轻至中度阿耳茨海默病（ＡＤ）的疗效。方法：轻至中度ＡＤ病人６８例入组，其中３４例（男性１７例，女性１７例，年龄６９±ｓ９ａ）用爱维治４００ｍｇ，ｐｏ，ｔｉｄ。另３４例（男性２４例，女性１０例，年龄７０±１０ａ）用安慰剂（淀粉）４００ｍｇ，ｐｏ，ｔｉｄ。疗程均为１２ｗｋ。结果：爱维治组在认知功能、临床总体疗效方面改善率均显著高于安慰剂组（Ｐ＜０．０１），爱维治组日常生活功能也较治疗前有明显提高（Ｐ＜０．０１）。该药不良反应轻微。结论：爱维治片剂治疗轻至中度ＡＤ有效且安全性好。     

他克林治疗阿尔采末病:在中国的多中心双盲研究

目的：验证他克林治疗轻至中度阿尔采末病（ＡＤ）的疗效。方法：轻至中度ＡＤ病人６８例完成验证,其中３４例（男性１８例,女性１６例,年龄６７ａ±７ ａ）用他克林自 １０ ｍｇ,ｐｏ, ｑｉｄ起,另外 ３４例（男性 １８例,女性 １６例,年龄 ６７ ａ±９ ａ）用安慰剂（淀粉）自 １０ ｍｇ,ｐｏ, ｑｉｄ起。 ２组每 ６ Ｗｋ日量各增加 ４０ｍｇ,最高日量 ４０ ｍｇ,ｐｏ, ｑｉｄ。总疗程均为２４ ｗｋ。结果：他克林组在认知功能、日常生活及总体疗效方面改善率均显著高于安慰剂组（ Ｐ＜ ０． ０５或０．０１）,他克林副作用主要为胃肠道反应,包括ＡＬＴ升高（１４％）。结论：他克林治疗轻至中度ＡＤ病人有效。     

A 28-week, double-blind, placebo-controlled study with Cerebrolysin in patients with mild to moderate Alzheimer's disease

Cerebrolysin (Cere) is a compound with neurotrophic activity which has been shown to be effective in the treatment of Alzheimer's disease (AD) in earlier trials. The efficacy and safety of repeated treatments with Cere were investigated in this randomized, double-blind, placebo-controlled, parallel-group study. One hundred and forty-nine patients were enrolled (76 Cere; 73 placebo). Patients received i.v. infusions of 30 ml Cere or placebo 5 days per week for 4 weeks. This treatment was repeated after a 2-month therapy-free interval. Effects on cognition and clinical global impressions were evaluated 4, 12, 16, and 28 weeks after the beginning of the infusions using the Clinical Global Impression (CGI) and the Alzheimer's Disease Assessment Scale-cognitive subpart (ADAS-cog). All assessments, including the 28-week follow-up visit were performed under double-blind conditions. At week 16, the responder rate of the Cere group was 63.5% on the CGI, compared to 41.4% in the placebo group (P < 0.004). In the ADAS-cog, an efficacy difference of 3.2 points in favour of Cere was observed (P < 0.0001). Notably, improvements were largely maintained in the Cere group until week 28, 3 months after the end of treatment. Adverse events were recorded in 43% of Cere and 38% of placebo patients. Cere treatment was well tolerated and led to significant improvement in cognition and global clinical impression. A sustained benefit was still evident 3 months after drug withdrawal.     

Cerebrolysin in Alzheimer's disease

Cerebrolysin is a neuropeptide preparation mimicking the action of endogenous neurotrophic factors. Positive effects of Cerebrolysin on β-amyloid- and tau-related pathologies, neuroinflammation, neurotrophic factors, oxidative stress, excitotoxicity, neurotransmission, brain metabolism, neuroplasticity, neuronal apoptosis and degeneration, neurogenesis and cognition were demonstrated in experimental conditions. These pleiotropic effects of Cerebrolysin on Alzheimer's disease-related pathogenic events are consistent with a neurotrophic-like mode of action, and seems to involve the activation of the phosphatidylinositol 3-kinase/Akt/glycogen synthase kinase-3 β intracellular signaling pathway. The clinical efficacy of Cerebrolysin in Alzheimer's disease was evaluated in several randomized, double-blind, clinical trials, showing consistent benefits on global clinical function and cognition, improvements in behavior at high doses, and minor effects on daily living activities in patients with mild to moderate Alzheimer's disease, as well as in subgroups of moderate to moderately severe patients. In addition, the clinical benefits of Cerebrolysin were largely maintained for several months after ending treatment, a finding that supports its discontinuous administration. Cerebrolysin was generally well tolerated and did not induce significant adverse events in Alzheimer's patients. Although long-term studies are needed, the data available suggest that Cerebrolysin is effective as monotherapy and constitutes a promising option for combined therapy in Alzheimer's disease.     

Management of cognition and function: new results from the clinical trials programme of Aricept(R) (donepezil HCl)

Ideally, treatment for Alzheimer's disease (AD) should prevent or cure the disease. Unfortunately, these goals appear unobtainable in the foreseeable future. Nevertheless, symptomatic relief is a feasible treatment option for AD patients and is available currently in the form of cholinesterase inhibitors such as tacrine, donepezil, metrifonate and rivastigmine. Donepezil is a second-generation, piperidine-class, selective and reversible acetylcholinesterase inhibitor. Four double-blind, placebo-controlled clinical trials of donepezil, involving over 1900 individuals with mild to moderate AD, have been published recently. In all trials, significant improvements in cognition were observed consistently for both therapeutic doses of donepezil (5 and 10 mg/d), relative to placebo. Similar donepezil-associated benefits were reported for global functioning. In addition, in one 24-wk, multinational clinical trial, patients receiving donepezil (10 mg/d) performed better than placebo-treated patients in their ability to perform complex daily functioning tasks. Donepezil was well tolerated in all trials, with approx. 79% of all donepezil-treated patients completing the studies compared with approx. 84% of placebo-treated patients. The most common adverse events associated with donepezil were generally cholinergic-induced and gastrointestinal in nature (e.g. nausea, diarrhoea, and vomiting) which were generally mild, transient and tended to occur after the dose was increased to 10 mg/d from 5 mg/d after 1 wk only. Sleep disturbances also occurred as the clinical trials utilized a bedtime dosing regimen. There was no evidence of organ toxicity or clinically significant treatment-emergent laboratory test abnormalities. Thus, donepezil appears to be a beneficial symptomatic treatment for patients with mild to moderate AD.     

Galantamine: a review of its use in Alzheimer's disease

Currently, acetylcholinesterase (AChE) inhibitors are the most promising class of drugs for the treatment of Alzheimer's disease (AD). Galantamine is a reversible, competitive, tertiary alkaloid AChE inhibitor. The drug is selective for AChE rather than butyrylcholinesterase. In addition to inhibition of AChE galantamine interacts allosterically with nicotinic acetylcholine receptors to potentiate the action of agonists at these receptors. Recipients of galantamine 16 or 24 mg/day achieved significant improvements in cognitive and global symptoms relative to placebo recipients in large (n = 285 to 978 patients with mild to moderate AD) well-designed trials of 3 to 6 months' duration. Galantamine also improved activities of daily living in these patients and significantly reduced the requirement for caregiver assistance with activities of daily living. Moreover, galantamine recipients achieved significantly better outcomes on behavioural symptoms than placebo recipients. In a long term study (12 months), galantamine 24 mg/day slowed the progression of symptoms of the disease and maintained cognitive function and activities of daily living in patients with mild to moderate AD. Galantamine was generally well tolerated with the majority of adverse events being mild to moderate in intensity and transient. Predictably, adverse events were cholinergic in nature and generally related to the gastrointestinal system. These effects were reduced in patients receiving the recommended dose escalation regimen. Galantamine had no clinically relevant effects on vital signs, haematological or biochemical laboratory parameters and, importantly, there were no reports of hepatotoxicity. The incidence of serious adverse events was similar between galantamine (8 to 32 mg/day) and placebo groups (6 to 16% of patients across all treatment groups). CONCLUSIONS: Galantamine is an effective well tolerated symptomatic treatment for AD which improves cognition, function and activities of daily living in the short term (up to 6 months) in patients with mild to moderate AD. In addition, it delays the development of behavioural disturbances and psychiatric symptoms, and reduces caregiver burden (as measured by caregiver time). In the long term (up to 1 year), galantamine maintains cognition and activities of daily living. Adverse events associated with galantamine are mainly cholinergic, usually mild to moderate in intensity and transient. Galantamine has been evaluated in several large well-designed studies and, given the relative lack of established treatment options, it may be considered as one of the first-line pharmacological treatments in patients with mild to moderate AD.     

Safety of botulinum toxin type A: a systematic review and meta-analysis

OBJECTIVE: To define quantitatively the safety and tolerability profile of botulinum toxin type A (BTX-A) across all common therapeutic indications. The review was limited to the evaluation of the safety profile of one preparation of BTX-A (BOTOX) because distinct formulations of BTX-A are associated with different clinical profiles, requiring separate consideration for an analysis of safety. RESEARCH DESIGN AND METHODS: We identified randomized controlled trials of BTX-A through searches of the MEDLINE, EMBASE, and Cochrane Controlled Trial databases for the years 1966-2003. Studies were double-blind, randomized, crossover, or of parallel group design. The search strategy included the terms 'botulinum toxin', 'therapeutic use', 'randomized controlled trial', 'controlled clinical trial', 'randomized clinical trial', and 'placebo controlled trial'. Only randomized controlled trials of at least 7 days duration that reported adverse events were included in the analysis. MAIN OUTCOME MEASURE: Safety was assessed by means of a meta-analysis of the number and frequency of adverse events. RESULTS: Thirty-six studies involving 2309 subjects met the inclusion criteria. These reported on 1425 subjects receiving BTX-A treatment. No study reported any severe adverse events. The meta-analysis of any mild to moderate adverse events showed a rate of roughly 25% in the BTX-A-treated group (353/1425 patients) compared with 15% in the control group (133/884 patients, p < 0.001). Focal weakness was the only adverse event that occurred significantly more often with BTX-A treatment than control. CONCLUSION: The results of this meta-analysis and experience from long-term, open-label investigations demonstrate that the formulation of BTX-A evaluated here has a favorable safety and tolerability profile across a broad spectrum of therapeutic uses.     

加兰他敏片治疗阿尔采末病的多中心、随机双盲评价

目的 :验证加兰他敏治疗轻、中度阿尔采末病 (AD)的疗效和不良反应。方法 :轻中度AD病人97例 ,其中 4 7例 [男性 2 1例 ,女性 2 6例 ,年龄 (72±s 6 )a],用加兰他敏 1片 ,po ,tid。另外 5 0例 [男性 2 7例 ,女性 2 3例 ,年龄 (71± 6 )a],用安慰剂 ,开始 1片 ,po ,tid。 2组治疗 1wk后 ,分别加至 2片 ,po ,tid。疗程为 8wk。以精神状态判断量表作疗效判断。结果 :加兰他敏组总有效率 5 3% ,安慰剂组为 18% ,加兰他敏组不良反应主要为胃肠道反应 ,多为恶心 ,呕吐等。结论 :加兰他敏组在认知功能、总体疗效等方面改善率均显著高于安慰剂组 ,对轻、中度AD病人治疗有效     

Safety of botulinum toxin type A: a systematic review and meta-analysis

SUMMARY

Objective: To define quantitatively the safety and tolerability profile of botulinum toxin type A (BTX-A) across all common therapeutic indications. The review was limited to the evaluation of the safety profile of one preparation of BTX-A (Botox*) because distinct formulations of BTX-A are associated with different clinical profiles, requiring separate consideration for an analysis of safety.

Research design and methods: We identified randomized controlled trials of BTX-A through searches of the MEDLINE, EMBASE, and Cochrane Controlled Trial databases for the years 1966–2003. Studies were double-blind, randomized, crossover, or of parallel group design. The search strategy included the terms ‘botulinum toxin’, ‘therapeutic use’, ‘randomized controlled trial’, ‘controlled clinical trial’, ‘randomized clinical trial’, and ‘placebo controlled trial’. Only randomized controlled trials of at least 7?days duration that reported adverse events were included in the analysis.

Main outcome measure: Safety was assessed by means of a meta-analysis of the number and frequency of adverse events.

Results: Thirty-six studies involving 2309 subjects met the inclusion criteria. These reported on 1425 subjects receiving BTX-A treatment. No study reported any severe adverse events. The meta-analysis of any mild to moderate adverse events showed a rate of roughly 25% in the BTX-A-treated group (353/1425 patients) compared with 15% in the control group (133/884 patients, p < 0.001). Focal weakness was the only adverse event that occurred significantly more often with BTX-A treatment than control.

Conclusion: The results of this meta-analysis and experience from long-term, open-label investigations demonstrate that the formulation of BTX-A evaluated here has a favorable safety and tolerability profile across a broad spectrum of therapeutic uses.