奥达卡替治疗绝经后妇女骨质疏松症的疗效及安全性的Meta分析

目的系统评价奥达卡替治疗绝经后妇女骨质疏松症的疗效及安全性。方法检索Cochrane临床对照实验中心数据库、Pub MED、Embase、中国生物医学文献数据库、中国知网全文数据库和维普数据库中奥达卡替治疗绝经后妇女骨质疏松症的临床研究,按照纳入及排除标准筛选出随机对照试验,采用"Cochrane协作网的偏倚评价标准"来对纳入文献进行质量评价。提取有效数据,采用Rev Man 5.3软件进行Meta分析。结果共纳入双盲、随机对照试验4项,结果显示奥达卡替治疗12个月后,腰椎及股骨颈骨密度升高幅度比安慰剂对照组分别高3.3%(95%CI:1.6%~4.99%,P=0.0001)、2.03%(95%CI:1.09%~2.96%,P<0.0001),血清中1型胶原C端肽及尿N-端肽降低幅度比安慰剂对照组分别高48.24%(95%CI:-65.56%~-30.92%,P<0.0001)、52.26%(95%CI:-61.28%~-43.24%,P<0.00001)。对随访期间发生的严重不良事件及皮肤不良反应事件,采用固定效应模型进行Meta分析,两组间并无显著差异(P>0.05)。结论奥达卡替组相对安慰剂对照组可显著提高腰椎及股骨颈骨密度,降低血清中1型胶原C端肽及尿N-端肽浓度,两者的安全性近似。     

雷奈酸锶对绝经后妇女骨质疏松症性骨痛及骨密度和骨代谢的影响

目的:研究雷奈酸锶在绝经后妇女骨质疏松症治疗中对骨痛、骨密度、骨代谢及骨质疏松性骨折风险的作用,评价其疗效和安全性。方法:40例老年绝经后骨质疏松症妇女被随机分为雷奈酸锶组(20例)和对照组(20例),进行开放、对比研究。雷奈酸锶组:雷奈酸锶2 g.d-1,口服,同时口服钙剂600 mg.d-1;对照组:钙剂600 mg.d-1,口服。治疗前后分别测定2组患者腰背痛的VAS评分、L1-L4椎体、股骨颈、全髋的骨密度值及T值、骨代谢指标,并观察2组骨质疏松性骨折的发生率及服药后的不良反应。结果:治疗后雷奈酸锶组VAS评分明显改善,低于对照组,但骨痛缓解过程较为缓慢;雷奈酸锶组L1-L4椎体、股骨颈、全髋的骨密度值及T值在治疗6月后较治疗前上升显著,明显优于对照组(P<0.01);骨代谢指标在治疗6月后骨钙素(N-MID)明显上升,β-CTX明显下降,与对照组有显著性差异(P<0.01);骨质疏松脆性骨折的发生率对照组明显高于雷奈酸锶组;雷奈酸锶的主要不良反应为恶心、腹泻及皮疹,对照组主要为便秘。结论:雷奈酸锶能有效缓解骨质疏松症骨痛,但作用较为缓慢。它能有效提高骨质量,改善骨代谢标志物,降低骨质疏松脆性骨折的发生率,不良反应少。     

狄诺塞麦和双膦酸盐治疗绝经后妇女骨质疏松症效果及安全性的Meta分析

目的系统评价狄诺塞麦与双膦酸盐治疗绝经后妇女骨质疏松症(osteoporosis,OP)的疗效及安全性的差异。方法在以下几个数据库进行检索:中国生物医学文献数据库CBM、Embase、PubMED、CNKI、维普数据库以及Cochrane临床对照实验中心数据库,获得狄诺塞麦与双膦酸盐对妇女绝经后OP治疗的临床研究,依据纳入与排除标准获得随机对照试验文献,使用"Cochrane协作网的偏倚评价标准"评估纳入文献质量。获得所需数据,应用RevMan 5.3软件进行Meta分析。结果共获得符合条件的文献9篇,结果显示患有骨质疏松症的绝经后妇女治疗1年后,狄诺塞麦组腰椎、髋部及股骨颈骨密度升高幅度比双膦酸盐组分别高1.42%(95%CI:0.93%~1.90%,P<0.00001)、1.11%(95%CI:0.97%~1.25%,P<0.00001)及1.01%(95%CI:0.81%~1.22%,P<0.00001)。狄诺塞麦组不良反应事件、严重不良反应事件、骨折及死亡的发生率和双膦酸盐组相似,差异无统计学意义;狄诺塞麦组因不良反应导致的患者退出率低于双膦酸盐组,差异具有显著的统计学意义。结论相比双膦酸盐,狄诺塞麦可明显提升绝经后OP妇女的髋部、腰椎、股骨颈等处的骨密度,而安全性,两者相似。     

抗骨质疏松药物治疗原发性骨质疏松症有效性的网状Meta分析

目的：采用网状Meta分析方法系统评价不同抗骨质疏松药物治疗原发性骨质疏松症的临床疗效,为临床用药提供循证依据。方法：计算机检索PubMed、Embase、Cochrane Library、中国知网和万方数据库,搜集关于不同抗骨质疏松药物治疗原发性骨质疏松症患者的随机对照试验（randomized controlled trials, RCTs）,检索时限均为建库至2023年2月。由2名研究者对文献进行筛选、提取数据和质量评价,采用Stata16.0软件进行网状Meta分析。结果：该研究共纳入62篇RCTs,涉及10种干预措施,包括50 704名患者。网状Meta分析结果显示,在增加腰椎骨密度（bone mineral density, BMD）方面,SUCRA概率排序依次是罗莫单抗>阿巴洛肽>特立帕肽>雷奈酸锶>地舒单抗>唑来膦酸>阿仑膦酸>伊班膦酸>利塞磷酸>雷洛昔芬>安慰剂;在增加髋骨骨密度方面,SUCRA概率排序依次是罗莫单抗>地舒单抗>雷奈酸锶>阿巴洛肽>唑来膦酸>阿仑膦酸>伊班膦...     

钙联合维生素D3预防老年人骨质疏松性骨折有效性和安全性的Meta分析

目的:对钙联合维生素D3预防老年人骨质疏松性骨折的随机对照试验(RCTs)进行Meta分析,旨在评估其有效性及安全性。方法:系统检索Pub Med、Embase、Cochrane Library、Clinical Trials. gov、CBM、CNKI、万方、维普数据库,收集相关RCTs研究。筛选文献并提取数据。使用Cochrane偏倚风险评估工具对纳入研究的质量进行评定,利用Rev Man 5.3软件进行Meta分析。结果:纳入23项研究,共计78 966例患者。Meta分析结果显示,在骨折预防方面,钙联合维生素D3相比于安慰剂或未治疗组显著降低总体骨折、髋部骨折的发生。在影响骨密度方面,钙联合维生素D3相比于安慰剂或未治疗组显著增加全身骨密度、股骨颈骨密度、腰椎L2-4骨密度,并增加血清25(OH) D浓度。在安全性方面,钙联合维生素D3不良反应发生高于安慰剂或未治疗组。结论:钙联合维生素D3能够有效预防老年人骨质疏松骨折,并提高老年人群骨密度水平和血清25(OH) D浓度,但相较于安慰剂或未治疗增加了不良反应的发生。     

唑来膦酸注射液治疗老年骨质疏松症的临床研究

目的 探讨唑来膦酸注射液、注射用骨肽和维D₂磷葡钙片联用治疗老年骨质疏松症的临床效果和安全性。方法 选取2017年7月至2019年6月高州市人民医院收治的44例老年骨质疏松症患者作为研究对象,采用随机数字表法将其分为对照组(22例)和治疗组(22例)。对照组患者进行常规治疗(维D₂磷葡钙片+注射用骨肽);治疗组患者进行联合治疗(维D₂磷葡钙片+注射用骨肽+唑来膦酸注射液)。两组患者均治疗6个月。比较两组患者的总有效率、治疗前后腰椎及股骨颈骨密度、不良反应总发生率。结果 治疗后,治疗组患者的治疗总有效率(95.45%)高于对照组(59.09%),差异有统计学意义(P<0.05);两组患者治疗后腰椎L_1～4及股骨颈的骨密度高于本组治疗前,且治疗组患者治疗后腰椎L_1～4及股骨颈的骨密度高于对照组,差异有统计学意义(P<0.05);治疗期间,治疗组患者的不良反应总发生率(13.64%)低于对照组(100.00%),差异有统计学意义(P<0.05)。结论 唑来膦酸注射液...     

唑来膦酸对高龄女性骨质疏松症患者骨密度和血清骨转换标志物的影响

目的了解唑来膦酸对高龄女性骨质疏松症患者骨密度(BMD)和血清骨转换标志物(BTMs)的影响。方法纳入年龄≥80岁的女性骨质疏松症患者30例,予碳酸钙D3咀嚼片1片,嚼服,bid;骨化三醇胶丸0.25μg,po,bid。12个月后予唑来膦酸5 mg静脉滴注1次,并维持原补钙和活性维生素D方案。检测入组时、唑来膦酸治疗前、治疗后12个月患者血清Ⅰ型胶原交联C-末端肽(CTX)、Ⅰ型前胶原N-端前肽(PINP)和骨钙素(OC)的水平,同时测量股骨颈、总髋部和腰椎1-4处的BMD。观察应用唑来膦酸72 h内不良反应发生情况。结果与入组时比较,唑来膦酸治疗前患者血清CTX、PINP和OC水平有所升高,股骨颈、总髋部和腰椎1-4处的BMD有所降低,但大部分指标差异无显著意义(P>0.05)。唑来膦酸治疗后12个月,患者血清CTX、PINP和OC水平均明显低于入组时和唑来膦酸治疗前(P<0.05或P<0.01),而股骨颈、总髋部和腰椎1-4处的BMD则显著高于入组时和唑来膦酸治疗前(P<0.05或P<0.01)。未见严重不良反应发生。结论唑来膦酸能降低高龄女性骨质疏松症患者的血清BTMs水平,并提高BMD。     

唑来膦酸联合特立帕肽治疗绝经后骨质疏松症对骨密度影响的临床观察

目的 观察唑来膦酸联合特立帕肽治疗绝经后骨质疏松症对骨密度(BMD)的影响.方法 60例绝经后骨质疏松症患者随机分成唑来膦酸组、特立帕肽组和特立帕肽+唑来膦酸组,观察各组用药后13、26和52周时腰椎、髋部和股骨颈BMD相对于基线的变化.结果 特立帕肽+唑来膦酸组用药后13和26周的腰椎BMD增长百分比与唑来膦酸组、特立帕肽组相比存在显著差异(P＜0.01).用药后52周,特立帕肽+唑来膦酸组与特立帕肽组腰椎BMD无统计学差异,但显著高于唑来膦酸组(P＜0.01).唑来膦酸组、特立帕肽+唑来膦酸组用药后13、26和52周的髋部和股骨颈BMD增长百分比与特立帕肽组相比,差异有统计学意义(P＜0.05),特立帕肽+唑来膦酸组用药后13周的髋部BMD增长百分比与唑来膦酸组相比,差异有统计学意义(P＜0.05).结论 唑来膦酸和特立帕肽联合治疗对提高绝经后骨质疏松症患者的BMD有益.     

阿法骨化醇联合唑来膦酸对骨质疏松症患者骨密度和血清骨代谢指标的影响

目的:探究阿法骨化醇联合唑来膦酸对骨质疏松症患者骨密度和血清骨代谢指标的影响。方法:选取2017年5月~2018年6月我院收治的骨质疏松症患者80例,根据随机数表法分为对照组和联合组,各40例。对照组采用阿法骨化醇进行治疗,联合组采用阿法骨化醇联合唑来膦酸进行治疗。观察两组治疗前后骨密度和骨代谢指标,比较两组的治疗效果以及不良反应发生情况。结果:治疗后,联合组总有效率95.00%显著高于对照组的67.50%,差异有统计学意义(P<0.05)。联合组腰椎L2-L4和单侧髋部股骨颈骨密度明显高于对照组和治疗前(P<0.05)。两组治疗后骨特异性碱性磷酸酶(BALP)、β-胶原片段(β-CTX)、尿脱氧吡啶啉/肌酐(DPD/Cr)、抗酒石酸酸性磷酸酶(TRACP-5b)水平明显低于治疗前,降钙素(hCT)明显高于治疗前(P<0.05),且联合组BALP、β-CTX、DPD/Cr、TRACP-5b水平明显低于对照组,hCT水平明显高于对照组,差异均有统计学意义(P<0.05)。两组不良反应发生率比较差异无统计学意义(P>0.05)。结论:阿法骨化醇联合唑来膦酸治疗骨质疏松症疗效显著,可改善骨密度和骨代谢指标,且具有一定的安全性。     

地舒单抗注射液对比唑来膦酸注射液治疗绝经后骨质疏松症的系统评价及成本-效果分析

目的：系统评价地舒单抗注射液对比唑来膦酸注射液治疗绝经后骨质疏松症的有效性及安全性,并基于成本-效果分析探讨两者的经济性。方法：检索中国知网、中国生物医学文献数据库、万方数据库和维普数据库等中文数据库,以及PubMed、Embase和the Cochrane Library等英文数据库,搜索地舒单抗注射液对比唑来膦酸注射液治疗绝经后骨质疏松症的随机对照试验(研究组患者使用地舒单抗注射液;对照组患者使用唑来膦酸注射液),检索时间为各数据库创建至2022年5月。经过文献筛选与资料,对两种方案的疗效进行Meta分析。并从医疗保健系统的角度,采用成本-效果分析法比较两者的经济性。结果：经过筛选最终纳入3项研究,共1 163例患者。Meta分析结果显示,与唑来膦酸注射液比较,地舒单抗注射液能显著提高绝经后骨质疏松症患者腰椎、髋骨的骨密度变化百分比(腰椎：MD=1.07,95%CI=0.23～1.91,P=0.01;髋骨：MD=0.89,95%CI=0.13～1.65,P=0.02),差异均有统计学意义;但并未显著降低骨折风险(OR=0.52,95%CI=0.23～1.17,P=0.11),差异无...     

头孢哌酮/舒巴坦治疗临床感染的有效性和安全性：系统综述和荟萃分析

目的 系统评价注射用头孢哌酮钠/舒巴坦钠(商品名：舒普深)在中国治疗临床感染的有效性和安全性。方法 系统检索万方、中国知网、维普、SinoMed、PubMed和Cochrane Library数据库,收集1978年至2019年7月4日公开发表的关于头孢哌酮/舒巴坦在中国治疗临床感染方面的文献,按照纳入排除标准进行筛选,使用Stata 15.0和SAS 9.4软件进行荟萃(Meta)分析。主要结局指标包括临床有效率与痊愈率,次要结局指标包括细菌清除率(株)与不良事件发生率。结果 最终纳入110篇文献,其中有82篇、87篇分别纳入有效率和痊愈率的Meta分析。结果显示,头孢哌酮/舒巴坦治疗临床感染的总有效率为80.3%[95%置信区间(CI):77.4%～83.0%],痊愈率为50.1%(95%CI:45.1%～55.1%)。共38项研究报告了细菌清除率,结果显示细菌清除率为81.1%(95%CI:76.9%～84.9%)。62篇文献报告治疗中发生的不良事件例数,合计不良事件的发生率为7.4%(95%CI:6.1%～8.9%),包括血液系统不良事件、胃肠道不良事件、肝肾功能损害及皮肤不良事...     

利噻膦酸钠治疗绝经期妇女骨质疏松症疗效的Meta分析

目的:系统评价利噻膦酸钠治疗绝经期妇女骨质疏松症的临床疗效,以为临床提供循证参考。方法:计算机检索The Cochrane Library、PubMed、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库、万方数据库,收集利噻膦酸钠治疗绝经期妇女骨质疏松症的随机对照试验(RCT),提取资料后采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入14项RCT,合计1 372名患者。Meta分析结果显示,试验组患者有效率[RR=1.77,95%CI(1.57,2.00),P<0.000]、腰椎骨密度[MD=4.51,95%CI(3.62,5.41),P<0.000]、髋骨骨密度[MD=1.84,95%CI(1.24,2.44),P<0.000]显著高于对照组,血清骨钙素水平[MD=-1.89,95%CI(-2.07,-1.72),P<0.01]、血钙水平[MD=-0.04,95%CI(-0.08,-0.01),P<0.01]、碱性磷酸酶水平[MD=-11.08,95%CI(-15.24,-6.91),P<0.01]、尿I型胶原交联氨基末端肽与肌酐比值[MD=-27.97,95%CI(-44.50,-11.44),P<0.01]显著低于对照组,两组比较差异均有统计学意义。结论:利噻膦酸钠治疗绝经期妇女骨质疏松症疗效较好,可以防止绝经后妇女的骨丢失,降低骨转换,改善骨密度。由于文献存在漏检可能,研究方法报道不详尽,期待今后国内研究更加注重对研究方法学的报道,以提高研究报道质量。     

Efficacy and safety of different proprotein convertase subtilisin/kexin type 9 inhibitors in patients with hypercholesterolemia at high cardiovascular risk: a systematic review and meta-analysis

OBJECTIVE To evaluate the efficacy and safety of different PCSK9 inhibitor therapy in hypercholesterolemia patients at high cardiovascular risk.METHODS Pubmed, Embase, Cochrane Library and Clinical Trials.gov were searched from their inception up to January 2019. Inclusion criteria were randomized clinical trials, hypercholesterolemia patients at high cardiovascular risk and received PCSK9 inhibitor. Study-arm-level weighted mean differences(WMDs) and 95% CIs were pooled for continuous data, meanwhile relative risks(RRs) and 95%CIs were pooled for discontinuous data, both using random-effects model. Subgroup analysis based on drug types, doses, race and control types were conducted.The primary outcomes were mean or percent change in low density lipoprotein cholesterol(LDL-C) and percentages of participants who have experienced treatmentemergent adverse events(TEAEs). The secondary outcomes were percent change in other lipid profiles, incidence of major cardiovascular events and incidence of adverse events of interest. RESULTS 27 trials recruiting37,630 individuals were included in the meta-analysis. Of these, 27 062(71.9%) were men and the mean age was61.6; 4 trials included only Asians and the population of the remaining trials were mainly Caucasian(>75%).Alirocumab and evolocumab presented significant reduction of LDL-C(alirocumab: WMD: 1.48; 95% CI:-1.74～1.22; P<0.01; evolocumab: WMD:-2.14; 95%CI:-2.43～-1.85; P<0.01) and no racial difference was found. Results of indirect comparison with placebo as reference control showed that evolocumab was superior to alirocumab for the levels of absolute change of LDL-C(WMD: 0.60; 95%CI: 0.24～0.97; P=0.01) and percent change of several other lipid profiles(P<0.05). Evolocumab was also associated with lower risk of major cardiovascular events(RR: 0.86; 95% CI: 0.80 to 0.92; P<0.01). PCSK9 inhibitor presented overall good safety except the significantly increased risk of injection site reactions(RR: 1.82; 95%CI: 1.28～2.60; P=0.01). Bococizumab presented a notable increase of TEAEs(RR: 1.15; 95%CI:1.08-1.23; P<0.01)and higher risk of injection site reactions(RR: 6.57, 95%CI: 4.28-10.08; P<0.01). CONCLUSION Both alirocumab and evolocumab were effective and safe for hypercholesterolemia patients at high cardiovascular risk of all races.Evolocumab performed relatively better for the lipid-management improvement.     

司美格鲁肽周制剂治疗成人超重和肥胖有效性与安全性的系统评价和Meta分析

目的：系统评价司美格鲁肽周制剂治疗成人超重和肥胖的有效性与安全性。方法：计算机检索PubMed、Embase、Cochrane Library、The ClinicalTrials.gov、中国知网、万方数据库、维普数据库,查找关于司美格鲁肽周制剂治疗成人超重和肥胖的随机对照试验（randomised controlled trials,RCTs）。由2名研究员独立筛选文献、提取资料,并进行方法学质量评价,应用RevMan 5.3软件进行Meta分析。结果：最终纳入7项RCTs,共计4 711例患者。Meta分析结果显示,与安慰剂组相比,司美格鲁肽可有效降低受试者体质量[MD=-10.75,95% CI （-13.22,-8.28）,P<0.001];提高减重>5%、10%和15%的患者分别占总体的比例[RR=2.29,95% CI （1.73,3.04）,P<0.001]、[RR=4.54,95% CI （2.94,7.02）,P<0.001]、[RR=6.91,95% CI （4.32,11.05）,P<0.001];降低身体质量指数[MD=-3.85,95% CI （-5.51,-2.19）,P<0.001];减小腰围[MD=-8.01,95% CI （-10.05,-5.97）,P<0.001];降低收缩压[MD=-3.88,95% CI （-4.93,-2.82）,P<0.001]和舒张压[MD=-1.79,95% CI （-2.95,-0.62）,P=0.003],差异均有统计学意义。司美格鲁肽总不良反应发生率与安慰剂组接近[RR=1.05,95% CI （1.00,1.10）,P=0.040];严重不良反应发生率高于安慰剂组,但差异无统计学意义[RR=1.49,95% CI （0.87,2.56）,P=0.150];胃肠道不良反应发生率显著高于安慰剂组,差异有统计学意义[RR=1.58,95% CI （1.41,1.78）,P<0.001]。结论：司美格鲁肽周制剂在成人超重和肥胖患者中的减重效果较好,但应警惕其胃肠道不良反应。     

Strontium ranelate in osteoporosis

Strontium ranelate is composed of an organic moiety (ranelic acid) and of two atoms of stable non-radioactive strontium. In vitro, strontium ranelate increases collagen and non-collagenic proteins synthesis by mature osteoblast enriched cells. The effects of strontium ranelate on bone formation were confirmed as strontium ranelate enhanced pre-osteoblastic cells replication. The stimulation by strontium ranelate of the replication of osteoprogenitor cells and collagen as well as non-collagenic protein synthesis in osteoblasts provides substantial evidence to categorise SR ranelate as a bone forming agent. In the mouse calvaria culture system, SR ranelate induces a dose-dependent inhibition of labelled calcium release. The inhibitory effects of SR ranelate on bone resorption were close to those of salmon calcitonin. In the isolated rat osteoclast assay, a pre-incubation of bone slices with SR ranelate induced a dose-dependent inhibition of the bone resorbing activity of a treated rat osteoclast. SR ranelate also dose-dependently inhibited, in a chicken bone marrow culture, the expression of both CA II and the alpha-subunit of the vitronectin receptor. These effects showing that SR ranelate significantly affects bone resorption due to direct and/or matrix-mediated inhibition of osteoclast activity and also inhibits osteoclasts differentiation are compatible with the profile of an anti-resorptive drug. In normal rats, administration of SR ranelate induces an improvement in the mechanical properties of the humerus and/or the lumbar vertebra associated with a commensurate increase in bone dimension, shaft and volume. This was not related to any change in the stiffness, suggesting the absence of a mineralisation defect. After oral administration of SR ranelate in humans, the absolute bio-availability of SR ranelate is 27 % after a dose of 2g is given as sachets. The simultaneous intake of SR ranelate and calcium remarkably reduces the bio-availability of SR. SR ranelate was administered in 160 early postmenopausal women, in a 24-month, double-blind, placebo-controlled, prospective randomized study. Daily oral dose of 125 mg, 500 mg, 1 g of SR ranelate were compared to a placebo. At the conclusion of the study, the percent variation of lumbar adjusted BMD from baseline was significantly different in the group receiving 1 g/day of SR as compared to placebo (+ 1.41 % versus 0.98 % respectively). Increase in total hip and neck BMD averages respectively 3.2 % and 2.5 %. SR ranelate does not induce any significant adverse reaction compared to those observed in women receiving a placebo for the same duration. In a phase II study, the effect of SR ranelate in postmenopausal women with vertebral osteoporotic fractures were assessed during a double-blind, placebo-controlled trial. SR ranelate (500 mg, 1 g, 2 g per day) or placebo were given to 353 Caucasian women with prevalent osteoporosis. At the conclusion of this two-year study, the annual increase in lumbar adjusted BMD of the group receiving 2 g of SR ranelate was + 2.97 %. This result was significantly different as compared to placebo. A significant decrease in pyridinium crosslinks (NTX) and an increase in bone specific alkaline phosphatase were evident after 3 and 6 months of treatment. During the second year of treatment, the dose of 2 g was associated with a 4 % reduction in the number of patient experiencing a new vertebral deformity. Bone histomorphometry showed no mineralisation defects. The same percentage of withdrawal following an adverse effect was observed for patients receiving placebo and for those receiving 2 g of strontium ranelate. Currently, strontium ranelate is further investigated in a large Phase III program that includes two extensive trials for the treatment of severe osteoporosis, one assessing SR ranelate effects on the risk of vertebral fractures (SOTI) and one evaluating the effects of SR ranelate on peripheral (non spinal) fractures (TROPOS). The primary analysis of the SOTI study, evaluating the effect of 2 g of strontium ranelate on vertebral fracture rates are expected to be released during the summer 2002.     

缩泉胶囊治疗儿童遗尿症的系统评价

目的:系统评价缩泉胶囊治疗小儿遗尿症的有效性和安全性.方法:计算机检索Pubmed、The Cochrane Library、EMbase以及中国期刊全文数据库,收集使用缩泉胶囊治疗小儿遗尿症的随机对照试验,检索时限均从各数据库建库至2021年4月1日.评价纳入研究文献的质量,合并结果进行Meta分析.结果:共纳入11篇试验文献,合计患儿1163例.采用缩泉胶囊治疗的试验组的临床总有效率[RR=1.16,95％CI(1.09,1.23),P<0.001]、遗尿症复发情况[RR=0.41,95％CI(0.26,0.66),P=0.0002]得到提高和显著改善,并且不良反应的发生情况也显著低于对照组[RR=0.38,95％CI(0.18,0.80),P=0.01].比较两组的膀胱容量[SMD=0.80,95％CI(-0.39,1.98),P=0.19]和OABSS评分[SMD=-7.86,95％CI(-20.33,4.61),P=0.22]没有显著差异.结论:缩泉胶囊能有效治疗小儿遗尿症,并且安全性较高.     

Guanfacine for attention deficit and hyperactivity disorder in pediatrics: A systematic review and meta-analysis

To review the evidence from randomized controlled trials (RCTs) on the safety and efficacy of guanfacine in pediatric attention deficit hyperactivity disorder (ADHD), a bibliographic search up to May 2014 was performed using the Cochrane Library׳s Central Register of Controlled Trials, the Embase, PsycINFO, and Medline databases, and clinical trials registers. The search terms used were: [“guanfacine”] and [“child” or “adolescent” or “pediatrics”] and [“randomized controlled trial”] and [“Attention Deficit Disorder with Hyperactivity” or “Attention Deficit Disorder” or “Attention Hyperactivity Disorder” or “Hyperactivity” or “ADHD”]. A meta-analysis was performed using response, defined as a score≤2 on the Clinical Global Impression Improvement score, as the outcome measure. In all, 7 out of 48 studies were included, for a total of 1752 participants. All studies compared guanfacine versus placebo, with a duration ranging from 6 to 16 weeks. In all, the Clinical Global Impression Improvement score was reported as a secondary measure. Overall, 694/1177 (59.0%) participants in the guanfacine group benefited from the treatment compared to 192/575 (33.3%) in the placebo group (pooled OR 3.2; 95%CI 2.4–4.1). The participants with at least one adverse event were 948 (82.4%) in the guanfacine and 376 (67.9%) in the placebo group (OR 2.6; 95%CI 1.6–4.4). Somnolence (OR 4.9), sedation (OR 2.8), and fatigue (OR 2.2), were the adverse events with the greatest risk of occurrence in the guanfacine versus the placebo group. On the basis of seven randomized, placebo controlled trials guanfacine resulted safe and effective in treating children and adolescents with ADHD     

普瑞巴林治疗广泛性焦虑障碍的疗效与安全性的系统评价

目的系统评价普瑞巴林治疗广泛性焦虑障碍(GAD)的临床疗效和安全性。方法电子检索CENTRAL、Pubmed、EMbase和中国生物文献数据库文献(CBM),全面收集普瑞巴林治疗GAD的随机对照试验(RCTs),采用Cochrane系统评价方法评价纳入RCTs的方法学质量后,采用RevMan 5.1.4软件对提取的数据进行分析。结果纳入7个RCTs,共2 410例患者。与安慰剂相比,普瑞巴林150 mg·d~(-1)治疗GAD有效率无统计学差异[RR=1.32,95%CI(0.98,1.79),P=0.07],普瑞巴林固定剂量200～450 mg·d~(-1)[RR=1.60,95%CI(1.34,1.93),P<0.01]、600 mg·d~(-1)[RR=1.42,95%CI(1.18,1.70),P=0.000 2]以及可变剂量组[RR=1.25,95%CI(1.06,1.49),P=0.01]有效率差异均有统计学意义。与安慰剂组相比,普瑞巴林固定剂量组150～450 mg·d~(-1)以及可变剂量组因不良反应退出试验人数差异无统计学意义(分别为P=0.26,P=0.12);而普瑞巴林600 mg·d~(-1)组因不良反应退出试验人数差异有统计学意义[RR=1.76,95%CI(1.16,2.68),P=0.008]。结论普瑞巴林200～450 mg·d~(-1)治疗GAD有效且安全性好。     

帕博利珠单抗治疗早期三阴性乳腺癌患者的安全性系统评价

目的 通过Meta分析评估帕博利珠单抗（pembrolizumab）治疗早期三阴性乳腺癌（ETNBC）的安全性。方法 计算机检索PubMed、Web of science、Cochrane数据库、Embase、clinicaltrials.gov、中国知网、万方和CBM,收集传统化疗联合帕博利珠单抗（试验组）对比传统化疗联合安慰剂（对照组）或紫杉醇联合帕博利珠单抗（试验组）对比紫杉醇联合安慰剂（对照组）的临床试验,检索时间为从建库至2023年4月1日。筛选文献、提取数据和评价质量后,采用RevMan 5.3软件进行统计分析、敏感性分析。结果 共纳入3篇文献,合计1 509例患者,试验中结局指标（即3～5级不良事件）主要为腹泻、中性粒细胞减少、贫血、疲乏和皮肤反应。Meta分析结果显示,试验组患者3～5级腹泻（RR=1.83, 95%CI:0.81～4.12, P=0.15）、中性粒细胞减少症（RR=1.03, 95%CI:0.88～1.20, P=0.73）、贫血（RR=1.20, 95%CI:0.92～1.55, P=0.18）、皮肤反应（RR=3.14, 95%CI:0.28～35...     

双膦酸盐预防中国妇女绝经后骨质疏松骨折的系统评价及药物经济学分析

目的：评估3种双膦酸盐预防中国妇女绝经后骨质疏松骨折的有效性、安全性和经济性。方法：计算机检索国内外常用文献数据库中使用阿仑膦酸、利塞膦酸、唑来膦酸预防中国妇女绝经后骨质疏松骨折的随机对照试验（RCT）,提取资料后进行Meta分析,并建立决策树模型进行成本-效果分析。结果：Meta分析结果显示,与单用钙剂/维生素D₃方案相比,联用双膦酸盐能显著减少中国妇女绝经后骨质疏松的椎体骨折[RR 0.50,95%CI（0.33,0.74）]和非椎体骨折[RR 0.36,95%CI（0.20,0.65）]的风险,差异有统计学意义（P<0.01）。亚组分析显示,唑来膦酸能显著减少中国妇女绝经后骨质疏松椎体骨折[RR 0.44,95% CI（0.25,0.77）]风险,阿仑膦酸和利塞膦酸亦表现出减少绝经后骨质疏松非椎体骨折的风险的优势[RR 0.16,95% CI（0.04,0.72）和RR 0.28,95% CI（0.10,0.80）]。安全性方面,加用双膦酸盐期间不良事件的发生率与对照组比较差异无统计学意义。成本-效果分析显示,联用双膦酸盐较单用钙剂和维生素D₃方案经济性更优,阿仑膦酸联合钙剂/维生素D₃方案为经济性最优方案。结论：联用双膦酸盐（尤其是阿仑膦酸）较单用钙剂/维生素D₃方案能显著地减少中国妇女绝经后骨质疏松骨折的风险,安全性较好,经济性更优。