强化他汀治疗对急性冠状动脉综合征患者的疗效及安全性观察

目的观察强化他汀治疗对急性冠状动脉综合征(ACS)患者的疗效及安全性。方法纳入2013年1月至12月行介入治疗的ACS患者112例,入院采血后立即予阿托伐他汀80 mg口服,此后每日予阿托伐他汀40 mg口服维持治疗。观察治疗前和治疗后1个月血脂变化,随访药物安全性及主要心血管不良事件的发生率。结果治疗后总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)均较治疗前显著下降(P<0.01);丙氨酸转氨酶(ALT)、肌酐(Cr)无改变(P>0.05)。治疗后1个月内的不良反应发生率如下(肌痛3.6%、无力10.7%、腹泻0.9%),主要心血管不良事件(MACE)总发生率31.3%(心肌梗死后心绞痛24.1%、心力衰竭6.3%、心源性死亡0.9%)。结论 ACS患者介入治疗术后早期服用大剂量的阿托伐他汀可显著降低血脂水平,且不影响肝肾功能,除无力外其他不良反应发生率较低。     

Myopathy in older people receiving statin therapy: a systematic review and meta-analysis

Objective

The aim of the present study was to determine the risk of myopathy in older people receiving statin therapy.

Methods

Eligible studies were identified searching Ovid Medline, EMBASE, Scopus, CINAHL, Cochrane and PSYCHINFO databases (1987 to July 2014). The selection criteria comprised randomized controlled studies that compared the effects of statin monotherapy and placebo on muscle adverse events in the older adult (65+ years). Data were extracted and assessed for validity by the authors. Odds ratios and 95% confidence intervals (CIs) were used to calculate binary outcomes. Evidence from included studies were pooled in a meta-analysis using Revman 5.3.

Results

The trials assessed in the systematic review showed little or no evidence of a difference in risks between treatment and placebo groups, with myalgia [odds ratio (OR) 1.03, 95% CI 0.90, 1.17; I² = 0%; P = 0.66] and combined muscle adverse events (OR 1.03, 95% CI 0.91, 1.18; I² = 0%; P = 0.61) (myopathy). No evidence was found for an increased risk of rhabdomyolysis (OR 2.93, 95% CI 0.30, 28.18; I² = 0%; P = 0.35) in the seven trials that reported this. No trials reported mortality due to a muscle-related event. Discontinuations due to an adverse effect were reduced in the treatment group compared with placebo (OR 0.74, 95% CI 0.50, 1.09; I² = 0%; P = 0.13).

Conclusion

The results obtained from the present review suggest that statins are relatively safe, even in older people. There was no evidence to suggest an increased risk of myopathy in older adults receiving statin therapy. There is slightly increased seen with rhabdomyolysis when compared with the general population, although the event is relatively rare. Statins should be prescribed to elderly people who need it, and not withheld, as its myopathy safety profile is tolerable.     

柴胡加龙骨牡蛎汤治疗冠心病合并焦虑抑郁状态疗效和安全性的系统评价与Meta分析

目的：系统评价柴胡加龙骨牡蛎汤对冠心病合并焦虑抑郁状态患者的疗效。方法：计算机检索中国知网、万方、维普、CBM、PubMed、Web of Science、The Cochrane Library、EMbase数据库,纳入应用柴胡加龙骨牡蛎汤治疗冠心病合并焦虑抑郁状态的随机对照试验,采用Cochrane Risk of Bias对纳入文献进行质量评价,运用RevMan 5.3软件进行Meta分析。结果：共纳入符合标准的文献12篇,包含800例患者,Meta分析结果显示,与安慰剂或空白对照相比,加用柴胡加龙骨牡蛎汤可以降低冠心病合并焦虑抑郁状态患者HAMA评分[MD=-5.57,95%CI（-7.10,-4.03）,P<0.000 01]、提高心绞痛症状改善率[RR=1.25,95%CI（1.13,1.39）,P<0.000 1]。与单用精神类药物相比,加用柴胡加龙骨牡蛎汤可以进一步降低HAMA评分[MD=-4.12,95%CI（-5.25,-3.00）,P<0.000 01]、降低HAMD评分[MD=-3.92,95%CI（-5.13,-2.70）,P<0.000 01]、提高心绞痛症状改善率[RR=1.36,95%CI（1.17,1.58）,P<0.000 1]、提高中医证候改善率[RR=1.27,95%CI（1.04,1.55）,P=0.02]。结论：无论单用或在精神类药物基础上加用柴胡加龙骨牡蛎汤,均可以进一步改善冠心病合并焦虑抑郁状态患者的临床疗效,且安全性良好,但仍需更多高质量的临床研究加以验证。     

强化他汀治疗对合并睡眠呼吸暂停综合征的冠心病患者PCI术后的影响

目的研究不同剂量阿托伐他汀对合并睡眠呼吸暂停综合征的冠心病患者PCI术后的影响。方法将PCI术后的冠心病患者依据多导睡眠呼吸监测结果随机分为不合并睡眠呼吸暂停综合征组(对照组,90例)及合并睡眠呼吸暂停综合征组(SAS组,90例),之后再依据阿托伐他汀应用剂量,分别随机分为10 mg、20 mg、40 mg剂量组各30例;分别检测两组患者C反应蛋白(CRP)及白细胞介素-6(IL-6)水平;随访6个月内各剂量组心血管事件发生例数;PCI术后6个月复查冠脉造影,利用Gensini评分系统,分别对各剂量组患者进行冠状动脉病变程度评分。结果入院时,SAS组患者的CRP及IL-6水平高于对照组;PCI术后6个月,SAS 10 mg、20 mg剂量组CRP、IL-6水平高于对照组(P<0.05)。随访6个月后,SAS 10 mg、20 mg剂量组心绞痛、心力衰竭、心律失常发生例数多于对照组(P<0.05),但40 mg剂量组间比较差异无统计学意义(P>0.05);此外,SAS组患者的心血管事件发生率随着阿托伐他汀剂量的增大逐渐降低,且不同剂量组间差异有统计学意义(P<0.05);PCI术后6个月时,SAS组10 mg、20 mg组患者的Gensini积分较对照组明显偏高(P<0.05),但40 mg剂量组间比较差异无统计学意义(P>0.05)。结论强化他汀治疗可以降低合并睡眠呼吸暂停综合征冠心病患者PCI术后的炎症因子水平及心血管事件发生率,同时可以有效降低冠状动脉的病变程度。     

Efficacy and safety of telavancin: a systematic review and meta-analysis

The emergence and rapid spread of multidrug-resistant gram-positive bacteria has become a vital and serious medical problem. A literature search was conducted in PubMed, EMBASE, and Elsevier databases to identify relevant publications. To calculate the risk ratios (RRs) with 95% confidential intervals (CIs), a fixed- or random-effects model was applied based on the heterogeneity across studies. Five studies containing seven RCTs were included in this meta-analysis. Regarding cSSTIs, HAP, SAB, there was no statistically significant difference in the rate of clinical cure between telavancin and vancomycin or standard therapy in intention-to-treat population (ITT) (RR 1.01, 95% CI 0.97–1.05, P = 0.72; FEM) and clinically evaluable population (CE) (RR 1.01, 95% CI 0.98–1.04, P = 0.41; FEM). However, telavancin was more effective than vancomycin or standard therapy in MRSA eradication rate (RR 1.08, 95% CI 1.02–1.14, P = 0.009; FEM). Regarding the safety profile, no statistically significant differences were found in all-cause mortality (9.0% vs. 8.4%; RR 1.07, 95% CI 0.88–1.31, P = 0.49; FEM) and overall adverse events (77.0% vs. 72.3%; RR 1.08, 95% CI 0.98–1.20, P = 0.12; FEM) between telavancin and vancomycin or standard therapy. Pooled data from cSSTIs, HAP and SAB studies on telavancin indicated higher rates of adverse-event related withdrawals (7.7% vs. 5.4%; RR 1.43, 95% CI 1.12–1.83, P = 0.05; FEM) and creatinine elevation (10.0% vs. 5.1%; RR 1.95, 95% CI 1.53–2.48, P<0.00001; FEM)than vancomycin or standard therapy.Telavancin and vancomycin or standard therapy are equally effective for the treatment of cSSTIs, HAP and SAB, and telavancin might be an option for the treatment of difficult-to-treat serious infections caused by MRSA. However, telavancin is associated a higher incidence of creatinine elevation and adverse-event related withdrawals.     

Physician-prompting statin therapy intervention improves outcomes in patients with coronary heart disease.

STUDY OBJECTIVE: To evaluate the effectiveness of a posthospital discharge intervention that prompted physicians to increase the use and effectiveness of statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) in patients with coronary heart disease (CHD). METHODS: Participants were 612 patients with CHD who were admitted to a coronary care unit. The control group (303 patients admitted from October 1-December 31, 1998) received no follow-up intervention. The intervention group (309 patients admitted fromJanuary 1-March 31, 1999) had follow-up letters sent or phone calls made to their primary care physicians with patient-specific recommendations concerning assessment of lipid profiles and statin therapy. Over a 2-year follow-up period, assessment of lipid profiles, use of therapy, and adverse clinical outcomes were compared between the control and intervention groups. RESULTS: At hospital discharge, there was no significant difference in the use of statins between the groups. At each reported follow-up interval, the percentages of patients having lipid profiles measured, being treated with a statin, receiving titrated dosages of a statin, and achieving low-density lipid (LDL) cholesterol goals set by the National Cholesterol Education Program (NCEP) were significantly greater in the intervention group compared with the control group (all p<0.05). At the end of the 2-year follow-up period, nearly three-fourths (72%) of the intervention group were receiving a statin, compared with 43% of the control group. In addition, 55% of the intervention group achieved their NCEP LDL goal, compared with only 10% of the control group. Recurrent myocardial infarction, hospitalization for myocardial ischemia, coronary revascularization, and cardiovascular mortality were significantly reduced in the intervention group compared with the control group (all p<0.05). CONCLUSION: A relatively simple physician-prompting intervention significantly increased assessment of lipid status, frequency of statin use, achievement of LDL treatment goals, and titration of lipid drug dosages. In addition, the improved use of statins significantly reduced adverse cardiovascular outcomes. This intervention tool should be more broadly applied in patient populations eligible to receive these agents.     

糖尿病合并冠心病患者经皮冠状动脉介入术后三联抗血小板治疗的效果及安全性研究

目的观察糖尿病合并冠心病患者经皮冠状动脉介入（PCI）术后三联抗血小板治疗的临床效果及安全性。方法将166例糖尿病合并冠心病患者按随机数字表分为对照组（80例）和观察组（86例）,对照组给予阿司匹林100mg／d、氯吡格雷75mg／d;观察组在双联基础上加西洛他唑100mg／d。记录分析2组基线资料、冠状动脉造影和PCI的结果差异,随访观察2组主要终点和次要终点事件发生率的差异。,结果术后随访观察组最小管腔直径明显高于对照组[（2．76±0．53）mm比（1．35±0．32）ml／1,P〈0．05];观察组管腔晚期丢失和再狭窄率均明显低于对照组[（1．28±0．33）mm比（0．71±0．23）mm,2．3％（2／86）比11．2％（9／80）,均P〈0．05]。随访1个月及1年,观察组主要终点事件发生率明显低于对照组,差异有统计学意义[1个月：2．3％（2／86）比8．8％（7／80）,P〈0．05;1年：5．8％（5／86）比11．2％（1／80）,P〈0．05];次要终点发生率比较差异无统计学意义[1个月：1．16％（2／86）比1．25％（1／80）;1年：2．3％（2／86）比2．5％（2／80）,P〉0．05]。结论PCI术后预防支架内再狭窄患者氯吡格雷、阿司匹林和两洛他唑三联抗血小板治疗,疗效确切,可进一步降低主要不良心脑血管事件的发生率,同时并不增加出血风险。     

瑞舒伐他汀治疗老年冠心病患者高胆固醇血症的疗效及安全性研究

目的 评价瑞舒伐他汀治疗老年冠心病患者高胆固醇血症的疗效及按入院次序安全性,并与辛伐他汀作对比.方法 采用单盲随机对照的研究方法将87例年龄大于60岁的冠心病高胆固醇血症患者按入院次序随机分为瑞舒伐他汀组(44例)和辛伐他汀组(43例).瑞舒伐他汀组给予瑞舒伐他汀10 mg,1次/d;辛伐他汀组给予辛伐他汀20 mg,1次/d,疗程8周,观察两药的疗效及安全性.结果 瑞舒伐他汀组经8周治疗,血浆LDL-C下降幅度(43.2%)明显大于辛伐他汀组(35.3%),差异有统计学意义(P<0.05),瑞舒伐他汀组LDL-C达标率(85.1%)明显高于辛伐他汀组(59.8%),差异有统计学意义(P<0.05);瑞舒伐他汀组HDL-C升高幅度(6.5%)也明显大于辛伐他汀组(1.6%),2组比较差异具有统计学意义(P<0.05);瑞舒伐他汀组TC、TG降低幅度(分别为32.2%,17.O%)略优于辛伐他汀组(30.8%,15.2%),2组比较差异无统计学意义(P>0.05).患者用药过程中无严重不良事件发生,主要不良反应为轻度腹胀、乏力,2组间不良反应发生率比较差异无统计学意义.结论 对老年冠心病高胆固醇血症人群,瑞舒伐他汀具有更强的降脂效果和良好的安全性.

Abstract：

Objective To evaluate the efficacy and safety of rosuvastatin in aged patients with coronary heart disease and hypercholesterolemia.Methods The selected patients were randomly divided into the rosuvastatin group(n=44,rosuvastatin 10 mg,qn)and simvastatin group(n=43,simvastatin 20 mg,qn)for 8 weeks.Results After treatment of 8 weeks,the decrease of plasma low-density lipoprotein cholesterol(LDL-C)in rosuvastatin group (43.2%) was significantly greater than that of simvastatin group(35.3%)(P<0.05).Compliance rate of LDL-C in rosuvastatin group(85.1% was higher than that in the simvastatin group (59.8%).The rate of HDL-C increase in rosuvastatin group(6.5%) was significantly greater than that in simvastatin group (1.6%)(P<0.05).he rate of TC,TG decreasing in msuvastatin group (respectively 32.2%,17.0%) was slishfly better than that in the simvastatin group (30.8%VS 15.2%),there was no significant difference between two groups(P>0.05).In this study the main adverse reactions were mild abdominal distension,fatigue.Conclusion For elderly people with coronary heart disease with hypercholestemlemia,rosuvastatin has a high lipid-lowering effect and good safety.     

小剂量硝酸甘油联合氯吡格雷治疗冠心病心绞痛患者的疗效及安全性评价

目的研究小剂量硝酸甘油联合氯吡格雷治疗冠心病心绞痛患者的疗效及安全性。方法选取2019年4月至2021年11月山丹县人民医院收治的96例冠心病心绞痛患者为研究对象, 采用随机数字表法将患者分为常规组和试验组, 每组各48例。常规组中男30例、女18例, 年龄47～76(61.55±7.31)岁, 采用氯吡格雷治疗;试验组中男29例、女19例, 年龄46～77(62.35±6.89)岁, 采用小剂量硝酸甘油(0.2 mg/次)联合氯吡格雷治疗。比较两组临床疗效、治疗前、治疗3个月后心绞痛发作情况、心功能指标[舒张早期二尖瓣血流速度与舒张晚期二尖瓣血流速度比值(E/A)、射血分数(EF)、心排出量(CO)、心脏指数(CI)]、血小板颗粒膜蛋白(GMP140)、高迁移率族蛋白B1(HMGB1)、白细胞介素-18(IL-18)、C反应蛋白(CRP)水平及不良反应。统计学方法采用t检验、χ2检验。结果试验组总有效率为95.83%(46/48), 高于常规组[81.25%(39/48)], 差异有统计学意义(χ2=5.031, P=0.025);治疗3个月后试验组心绞痛发作次数、发作持续时间低于常...     

Comparative efficacy of the addition of ezetimibe to statin vs statin titration in patients with hypercholesterolaemia: systematic review and meta-analysis

Abstract

Objective:

To systematically review and analyse evidence for cholesterol-lowering efficacy of at least 4 weeks of add-on ezetimibe vs doubling statin dose, in adults with primary hypercholesterolaemia.     

Efficacy and safety of canagliflozin in subjects with type 2 diabetes: systematic review and meta-analysis

Purpose

To assess the efficacy and safety of the novel sodium glucose co-transporter 2 (SGLT2) inhibitor—canagliflozin for type 2 diabetes (T2DM).

Methods

A search of Medline (1946–January 2014), Embase (1950–January 2014), and The Cochrane Library for randomized controlled trials of canagliflozin compared to placebo or active comparator in T2DM was performed. Clinical Trials website and unpublished U.S. Food and Drug Administration data were also searched.

Results

Ten trials including 6,701 patients were analyzed. Compared with placebo, canagliflozin produced absolute reductions in glycated hemoglobin A_1c levels when used as monotherapy (weighted mean difference (WMD) ?1.08 %, 95 % confidence interval (CI) [?1.25 to ?0.90], p?p?HbA1c by ?0.21 % (WMD, 95 %CI [?0.33 to ?0.08], p?=?0.001). Canagliflozin led to greater body weight loss (vs. placebo, WMD ?2.81 kg, 95 %CI [?3.26 to ?2.37]; vs. active comparators, WMD ?3.49 kg, 95 %CI [?4.86 to ?2.12]). Hypoglycemia with canagliflozin was similar to placebo or sitagliptin, and was lower than glimepiride (risk ratio (RR) 0.15, 95 %CI [0.10 to 0.22]). Genital tract infections were more common with canagliflozin (vs. placebo, RR 3.76, 95 %CI [2.23 to 6.35]; vs. active comparators, RR 4.95, 95 %CI [3.25 to 7.52]). Similar incidences of urinary tract infections were noted with canagliflozin compared with control groups.

Conclusion

Canagliflozin led to improvements in reducing glycated hemoglobin A_1c levels and body weight with low risk of hypoglycemia in patients with T2DM. Common adverse effects including genital tract infections and osmotic diuresis-related AEs were identified and reviewed. Risks of cardiovascular events are even less certain, and more data on long-term effects are needed.     

The effect of ivabradine therapy on heart failure patients with reduced ejection fraction: a systematic review and meta-analysis

Background Ivabradine is currently indicated to lower heart rate in Heart Failure with Reduced Ejection Fraction (HFrEF) patients. However its effect apart from beta-blockers is not clear. Aim of the review To study the additional effect of ivabradine, apart from the effect of beta-blockers, on cardiovascular death, all-cause mortality, hospitalization due to HF and heart rate in HFrEF population. Method Electronic searches were conducted up to June 2016 to include randomized controlled trials where ivabradine was compared to a control group. Relative risks RRs and their 95% confidence intervals (CI 95%) were pooled and the random and fixed effect were used to summarize the results according to heterogeneity levels. Heterogeneity among studies was measured by the I-squared statistic Results Of 1790 studies, seven met the inclusion criteria for the systematic review and meta-analysis. The population consisted of 17,747 patients. Risk of bias was generally high for beta-blocker doses lower than recommended. Interventions lasted 1.5–22.9 months and pooled relative risks RR (95%) for all-cause mortality, cardiovascular death and hospitalization for HF were 0.98 (0.90–1.06); 0.99 (0.91–1.08); and 0.87 (0.68–1.12) respectively. Heart rate (CI 95%) decreased by 8.7 (6.37–11.03) beats per minute with ivabradine compared to the control group. Subgroup analysis by beta-blocker dose showed that for patients on recommended treatment (at least 50% of the beta-blocker target dose), heart rate (CI 95%) decreased by 4.70 (3.67–5.73), whereas for patients not on recommended treatment or with unreported dose, heart rate decreased by 8.60 (8.13–9.08). Conclusion Ivabradine significantly reduced heart rate and its additional effect on heart rate appears to be inversely correlated with the dose of beta-blocker. It showed no significant effect for all-cause mortality, cardiovascular death and hospitalization due to HF. Unreported beta-blocker doses and beta-blocker doses lower than recommended limited the conclusions.     

阿托伐他汀强化治疗冠心病患者血脂异常的临床疗效

目的比较阿托伐他汀每日服20与10mg治疗冠心病伴高胆固醇血症患者的疗效和安全性。方法入选病例60例随机分为2组,A组30例,每晚口服阿托伐他汀20mg;B组30例,每晚口服10mg。治疗8wk。治疗前后分别测定血清总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C),并观察患者的不良反应。结果60例均完成试验。2组治疗前各项血脂基线值差异无统计学意义,而治疗前后TC、TG、LDL-C下降值比较差异有统计学意义(P<0.05)。治疗过程中无严重不良事件。结论阿托伐他汀20mg治疗冠心病伴高胆固醇血症安全且更加有效。     

Efficacy and safety of lorcaserin in obesity: a systematic review and meta-analysis of randomized controlled trials

ABSTRACT

Background: Lorcaserin is a novel, selective 5-hydroxytryptamine 2C serotonin receptor agonist, approved for the treatment of obesity. Several phase 3 randomized controlled trials (RCTs) trials have shown a significant reduction in body weight with lorcaserin.

Research design and methods: We systematically searched the database of PubMed, Embase, The Cochrane Library and ClinicalTrials.gov up to 31 July 2019 and retrieved all the studies conducted with lorcaserin for ≥1 year that have explicitly reported the efficacy and safety outcomes versus placebo. Subsequently, we studied the effect of lorcaserin on weight reduction, FDA-defined valvulopathy, depression and suicidal risks in RCTs.

Results: The meta-analysis of four RCTs (N = 16,856) demonstrated a significant decrease in body weight (mean ? ?3.076 Kg; 95% CI, ?3.49 to ?2.66; P < 0.00001), compared to placebo. No significant difference in FDA-defined valvulopathy (RR 1.20; 95% CI, 0.89 to 1.63; P = 0.24), depression (RR 1.07; 95% CI, 0.80 to 1.43; P = 0.67) or suicidal risk (RR 1.43; 95% CI, 0.96 to 2.15; P = 0.08) has been observed with lorcaserin compared to placebo.

Conclusions: Lorcaserin reduces body weight modestly, with no obvious serious adverse side effects. The common adverse events noted with lorcaserin include nausea, dizziness, and transient headache.     

Efficacy and safety of outpatient parenteral antibiotic therapy in patients with infective endocarditis: a meta-analysis

BackgroundTo investigate the clinical outcome of patients with infective endocarditis (IE) during and after outpatient parenteral antimicrobial treatment (OPAT), and to further clarify the safety and efficacy of OPAT for IE patients.MethodsThrough December 20, 2021, a total of 331 articles were preliminarily searched in Pubmed, Web of Science, Cochrane Library and Embase, and 9 articles were eventually included in this study.ResultsA total of 9 articles comprising 1,116 patients were included in this study. The overall mortality rate of patients treated with OPAT was 0.04 (95% CI, 0.02-0.07), that means 4 deaths per 100 patients treated with OPAT. Separately, mortality was low during the follow-up period after OPAT treatment, with an effect size (ES) of 0.03 (95%CI, 0.02-0.07) and the mortality of patients during OPAT treatment was 0.04 (95% CI, 0.01-0.12). In addition, the readmission rate was found to be 0.14 (95% CI, 0.09-0.22) during the follow-up and 0.18 (95% CI, 0.08-0.39) during treatment, and 0.16 (95% CI, 0.10-0.24) for patients treated with OPAT in general. Regarding the relapse of IE in patients, our results showed a low overall relapse rate, with an ES of 0.03 (95% CI, 0.01-0.05). In addition, we found that the incidence of adverse events was low, with an ES of 0.26 (95% CI, 0.19-0.33).ConclusionIn general, the incidence of adverse events and mortality, readmission, and relapse rates in IE patients treated with OPAT are low both during treatment and follow-up period after discharge, indicating that OPAT is safe and effective for IE patients. However, our study did not compare routine hospitalization as a control group, so conclusions should be drawn with caution. In order to obtain more scientific and rigorous conclusions and reduce clinical risks, it is still necessary to conduct more research in this field and improve the patient selection criteria for OPAT treatment, especially for IE patients. Finally, clinical monitoring and follow-up of OPAT-treated patients should be strengthened.     

Efficacy and safety of innovator versus generic drugs in patients with epilepsy: a systematic review

Generic antiepileptic drugs achieve blood concentrations similar to those of innovator drugs in healthy volunteers, but their comparative effectiveness has not been well evaluated. Thus, we assessed the efficacy, tolerability, and safety of innovator versus generic antiepileptic drugs. We searched the MEDLINE database, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science for studies that evaluated innovator and generic antiepileptic drugs in patients with epilepsy and reported data on prespecified outcomes. We extracted data on study design, interventions, quality criteria, study population, baseline characteristics, and outcomes. Compared with initiation of innovator antiepileptic drugs, initiation of generic antiepileptic drugs did not significantly alter seizure occurrence (relative risk [RR] 0.87, 95% confidence interval [CI] 0.64-1.18; strength of evidence: low) or frequency (standardized mean difference 0.03, 95% CI -0.08-0.14; strength of evidence: low), withdrawals due to lack of efficacy (RR 1.02, 95% CI 0.41-2.54; strength of evidence: low) or adverse events (RR 0.79, 95% CI 0.28-2.20; strength of evidence: low), pharmacokinetic concentrations (maximum, minimum, or area under the curve [strength of evidence: low]), or a myriad of adverse events (strength of evidence: low or insufficient) in clinical trials. In qualitatively evaluated observational studies, switching between forms of antiepileptic drug (innovator to generic, generic to generic) may increase the risk of hospitalization (strength of evidence: low), hospital stay duration (strength of evidence: low), and a composite end point of medical service utilization (strength of evidence: insufficient) but may not increase outpatient service utilization (strength of evidence: low). Data are limited predominantly to carbamazepine, phenytoin, and valproic acid. Clinical trials are limited by small sample size, short-term nature, and lack of specification of A-rated generic products (generics that the United States Food and Drug Administration has deemed bioequivalent to the innovator drug). Observational trials lack full accounting for confounders and have inherent limitations. With a low strength of evidence, it appears that initiating an innovator or generic antiepileptic drug will provide similar efficacy, tolerability, and safety but that switching from one form to the other may be associated with more hospitalizations and longer hospital stays.     

心房颤动合并冠心病冠状动脉介入治疗术后达比加群酯 抗凝治疗的有效性及安全性研究

目的 研究达比加群酯(dabigatran etexilate)在心房颤动(房颤)合并冠心病冠状动脉介入治疗(PCI)术后抗凝治疗中的有效性及安全性。方法 选取2015年3月至2016年3月安徽医科大学第二附属医院收治的房颤合并冠心病冠状动脉介入治疗病人90例,采用随机数字表法分为观察组和对照组,每组45例。观察组每天两次口服达比加群酯110 mg;对照组予以华法林治疗,调节国际标准化比值(INR)至2.0~3.0之间;同时两组均予以阿司匹林100 mg/d。观察随访12个月,比较两组病人实验室指标变化、新发急性心肌梗死、急性脑梗死、非中枢神经系统栓塞、出血事件及不良反应的发生率。结果 观察组中栓塞事件发生率(8.9%)与对照组(17.8%)相比差异无统计学意义(χ²=1.538,P=0.215);达比加群酯在降低与血栓形成有关的实验室指标上较华法林更优,同时观察组出血事件发生率低于对照组(χ²=4.406,P=0.036);两组在不良反应事件发生率上均差异无统计学意义(P>0.05)。结论 达比加群酯在房颤合并冠心病PCI术后病人抗凝治疗中与华法林的疗效相似,且达比加群酯的安全性更高,是此类病人抗凝治疗的理想选择。