中医药随机对照试验中安慰剂应用科学性与伦理性评价

目的探讨中医药随机对照试验安慰剂的科学性和伦理性。方法计算机检索1979年1月至2008年4月中国期刊全文数据库、中文科技期刊全文数据库、万方数字化期刊全文数据库和中国生物医学文献数据库中医药安慰剂对照试验，并手工检索中医药专业期刊的相关文献，对文献的安慰剂中医药特点、科学性和伦理性进行评价。结果共检索到中医药安慰剂随机对照研究231个，占随机对照试验（RCT）的2．09％；其中79个研究（34．20％）有明确的随机序列产生方法，10个研究（4．33％）有分配隐藏，129个研究（55．84％）采用盲法；70篇（30．30％）记录中医证型，48篇（20．78％）应用中医证候疗效指标及判断标准；106篇文献（45．89％）设计了基础干预，13篇文献（5．63％）制定了干预措施的质控标准，139篇文献（60．17％）说明了安慰剂的制作，10个研究（10．33％）制定了急救预案；纳入文献中有48个RCT（20．78％）安慰剂应用缺乏科学性；221个RCT（95．67％）未通过伦理委员会审批；187个RCT（80．95％）无受试者知情同意。结论中医药安慰剂对照试验的应用并不广泛，且部分研究缺乏科学性，绝大部分研究不符合伦理学要求。     

军队部分离退休干部高血压患病情况分析

目的分析2002-2007年军队60～81岁部分离退休老年干部高血压患病率及有关特点。方法以800例60～81岁心血管病危险因素调查结果为研究样本，对老年人高血压的患病率、高血压的类型、高血压患者合并其他心血管危险因素等情况进行分析。结果（1）该人群60～81岁高血压的患病率、治疗率、控制率分别为61．4％，62．8％，23．1％；（2）随着年龄增长，男女高血压患病率呈持续增加趋势P〈0．05；（3）老年人单纯收缩期高血压患病率为27．9％，占老年高血压的45．5％；（4）老年高血压合并至少一种其他心血管危险因素的比例为86．7％。结论高血压是军队老年离退休干部的常见心血管疾病，单纯收缩期高血压是老年高血压的常见类型，老年高血压患者绝大多数合并有其他心血管危险因素。     

维持性血液透析合并高血压治疗状况的多中心调查

目的 调查分析维持性血液透析（MHD）患者高血压治疗现状及相关危险因素。方法 对南京市5所三级甲等医院电97例MHD合并高血压患者的有关临床资料进行调查，用多因素Logistic回归分析该组人群人口学资料、透析时间、透析剂量、降压药物应用情况以及各种实验室参数与透析前、透析后高血压的关系。结果 ①297例MHD患者中，221例（74．4％）血压控制不理想[透析前和（或）透析后血压≥140／90mmHg（1mmHg=0．133kpa）]，242例患者服用降压药物，其中91例（37．6％）用单药降压，151例（62．4％）患者联合降压；所有降压药物中CCBs应用最为广泛（85．1％），其次为β-受体阻滞剂、ACEIS、ARBs（分别为44．6％、20．7％、16．5％），所有患者平均用药数量为1．54种；②MHD患者主要以单纯收缩压（收缩压≥140mmHg，舒张压〈90mmHg）升高为主，透析前、透析后所占比例分别为63．9％、72．0％。单纯舒张压升高（收缩压〈140mmHg，舒张压≥90mmHg）的患者较少（透析前、透析后仅为2．1％、6．9％）；③应用降压药物数量与血红蛋白浓度（r=-0．250，P=0．001）存在负相关关系。④多因素Logistic回归分析表明透析不充分（Kt/v〈1．4）（OR=5．308，95％CI1．60817．560）、血红蛋白浓度（OR=O．956，95％C10．914～0．999）是透析前血压未得到控制的主要危险因素；中重度贫血（OR=2．493，95％CI 1．085～5．728）是透析后血压未得到控制的主要危险因素。结论 MHD患者高血压控制不达标仍较突出，以收缩压升高为主，提高透析充分性、纠正贫血可能有助于透析患者血压控制。     

长托宁用于全身麻醉前用药的有效性评价

目的系统评价长托宁作为全身麻醉前用药是否能减少呼吸道粘液分泌和维持心率稳定。方法计算机检索Cochrane图书馆（2007年第3期）、MEDLINE（1966—2007．4）、EMbase（1988～2007．4）、CBMweb（1978～2007．4）、VIP（1989～2007．4）和CNKI（1994～2007．4），收集所有长托宁用于全身麻醉前用药的随机对照试验（RCT），使用Cochrane系统评价方法，评价纳入研究的方法学质量并提取有效数据进行分析。结果共纳入23个RCT，共2790例患者。各纳入研究的方法学质量均为B级，仅1篇文献正确描述了随机分配方法。其中11个RCT比较了长托宁与阿托品作为全身麻醉前用药的疗效，但仅2个RCT比较了术毕气道分泌物量的差异，结果显示差异有统计学意义[WMD=-8．00，95％CI（-8．16，-7．85），P〈0．00001]，长托宁作为术前用药可以有效减少呼吸道粘液分泌。12个RCT比较了长托宁与东莨菪碱的疗效，但仅2个RCT比较了术毕气道分泌物量的差异，结果显示差异无统计学意义[WMD=-17．07，95％CI（-45．49，11．35），P=0．24]。3个RCT比较了长托宁和安慰剂的疗效，结果显示差异有统计学意义[WMD=-10．60，95％CI（-13．64，-7．56），P〈0．00001]。尚未检索出比较长托宁不同剂量用于全身麻醉前用药的文献。7个RCT报告了用药后的不良反应，未发现严重不良反应。结论与阿托品比较，长托宁能有效减少呼吸道粘液分泌且副作用发生率明显较低；与东莨菪碱比较，长托宁疗效与东莨菪碱相似；与不用药比较，长托宁效果明显。但因证据强度较低，本系统评价结论尚需更多高质量RCT进一步论证。     

ICU导管相关性血流感染危险因素分析及预防措施

目的探讨医院ICU导管相关性血流感染的风险因素及防护措施，为进一步降低血流感染发生率提供依据。方法对283例符合导管相关性血流感染诊断标准的病例进行回顾性分析。结果3年中ICU导管相关性血流感染发生率约6．29％；发生感染的283例患者中原发感染占86．4％，继发感染占13．6％；年龄〉62岁占患者50．5％；抗菌药物使用率80．6％，70．9％患者使用时间≥7d，经验性用药占60．1％；置管时间≥7d占80．1％；G‘球菌：凝固酶阴性葡萄球菌、金黄色葡萄球菌，肠球菌，G^-杆菌：鲍曼不动杆菌、铜绿假单胞菌、肺炎克雷伯菌，真菌：念珠菌为分离出最常见菌种。结论年龄、住院时间、长期使用抗菌药物史、侵入性操作和长时间置管史均是引发导管相关性血流感染易感因素。医院应制定导管相关性血流感染的预防措施和规范的操作流程，加强医护人员的教育培训，加强控制医院感染技术的研究，以降低感染率的发生。     

广州市白云街11个社区老年高血压患者就医状况调查

目的：调查社区老年高血压患者就医状况，并分析其发病途径及就诊医院与病情控制的关系。方法：调查于2001—04／11在广州市东山区中医针灸门诊部完成。11个社区共筛查4015人，资料完整者3755人，符合纳入高血压标准676例。高血压患者的一般情况：①男326例（48．2％），女350例（51．8％），年龄60～95岁，平均（70．2&;#177;6．2）岁。②文化程度：文盲73例（10．8％），小学211例（31.2％），初中164例（24.3％），高中90例（13.3％），中专29例（4.3％）。大专以上109例（16．1％）。③婚姻状况：未婚12例（1．8％），已婚517例（76．5％），离婚12例（1．8％），丧偶135例（20．0％）。④职业状况：工人47例（7．0％），干部111例（16．4％），经商9例（1．3％），离退休464例（68．6％），其他45例（6．7％）。在统一指导用语下采用人户访谈逐一登记方式，进行问卷调查。调查内容包括个人资料、医疗费用负担方式、疾病的初次发现方式及就医情况、病情控制情况。结果：纳入老年高血压患者676例，均进入结果分析。①疾病的发现途径：34．8％为体检时发现高血压，29．7％是治疗其他疾病时发现，35．5％为高血压引起不适而发现。②就诊医院分布情况：14．5％患者常于社区卫生站治疗，22．3％于区街医院治疗，53．3％于省市医院治疗，其它占9．9％。③检查治疗情况：有86．7％患者接受长期治疗，82．1％患者会定期检查，病情控制率为98．0％。④医疗费用负担方式：公费医疗42．2％，劳保41．7％，统筹医疗12．1％，医疗保险0．6％，自费12．9％，其他0．6％。⑤治疗不同地点与目前病情状况：在省市医院求治好转率39．4％，稳定率58．6％，恶化率1．9％；在社区卫生站求治好转率80．6％，稳定率18．4％，恶化率1．0％。结论：本次调查中社区老年人高血压发现率约1／3在体检时发现，说明老年人有了疾病预防的观念。并且近90％的患者可定期检查和坚持长期治疗，使病情控制率达98％。数据中显示在区级以下医院患者病情好转率相对较高，分析原因可能与去治疗者的病情较轻有关。但同时提示坚持在社区基层医疗机构求治，可以对老年高血压的预防、发现、治疗起到很好的控制作用。     

独一味胶囊疗效和安全性的循证评价

目的系统评价藏药独一味胶囊止血、镇痛和抗炎的疗效与安全性。方法计算机检索CBM光盘版（1978～2008．6）、CNKI（1980～2008．6）、MEDLINE（1966～2008．6）以及Cochrane Central Register of Controlled Trial（Cochrane图书馆2008年第2期）数据库发表的独一味胶囊文献，结合厂家提供的独一味胶囊临床研究，筛选合格随机对照试验（RCT）。根据Cochrane评价员手册5．0评估纳入研究偏倚风险，采用RevMan5．0软件进行统计分析。结果共纳入70个RCT，其中止血20篇，止血及镇痛10篇，镇痛29篇，抗炎11篇。纳入研究存在发生偏倚的高度风险，Meta分析结果显示：①止血：纳入30个RCT，独一味胶囊止血总有效率优于有效药物[OR=3．86，95％CI（2．56，5．82）]和空白对照[OR=14．85，95％CI（7．16，30．80）]，对出血量的影响优于有效药物和空白对照，对出血时间的影响优于空白对照，但与有效药物比较差异无统计学意义。②镇痛：纳入37个RCT，独一味胶囊镇痛总显效率优于有效药物[OR=3．01，95％CI（2．23，4．06）]、空白对照[OR=6．06，95％CI（3．14，11．70）]和安慰剂[OR=2．91，95％CI（1．48，5．73）]。与空白对照比较可以降低疼痛患者的疼痛积分[MD=-0．84，95％CI（-0．97，-0．72）]。③抗炎：独一味胶囊抗炎总有效率优于有效药物[OR=3．36，95％CI（1．90，5．96）]，单个RCT显示独一味胶囊降低关节肿胀度优于有效药物，但关节肿胀数两组比较差异无统计学意义。④安全性：共有12个研究报告了轻微不良反应，如轻微恶心、轻度腹泻、胃部不适，未见严重不良反应事件。结论现有研究显示独一味胶囊治疗不同原因引起的出血、疼痛和炎症有一定疗效，且安全性好。但纳入研究间存在异质性和发生偏倚的高度风险，影响结果的真实性和可靠性，故应谨慎看待结果。仍需高质量、多中     

颈椎病患者动态血压特点

目的：定量分析高血压、颈椎病、颈椎病合并高血压患者及正常人的24h动态血压监测数据，观察颈椎病对动态血压的影响。 方法：选择2004／2005在山东省通信公司门诊部进行普通健康查体的136例受试者，根据有无高血压和颈椎病分为颈椎病合并高血压组（37例）、原发性高血压组（39例）、颈椎病组（33例）、对照组（27饥）。各组之间年龄具可比性，原发性高血压组和颈椎病合并高血压组的体质量指数明显高于颈椎病组和对照组。所有受试者完成常规体检项目后用TM-2421型动态血压监测仪记录24h血压，观察血压均值（包括24h的、白天、夜间的收缩压、舒张压）和血压昼夜节律（夜间血压下降率≥20％为深勺型；≥10％，但〈20％为勺型；≥0％，但〈10％为非勺型；〈0为反勺型，勺型为正常。 结果：136例全部进入结果分析。①动态血压均值：颈椎病合并高血压组高于其他3组（P〈0．01或0．05）；原发性高血压组明显高于对照组和颈椎病组（P〈0．01或0．05）；颈椎病组的收缩压均值也明显高于对照组（P〈0．01）。②昼夜变化模式：反勺型仅出现于原发性高血压组及颈椎病合并高血压组；各组均可见勺型、深勺型及非勺型模式。对照组、颈椎病组、原发性高血压组和颈椎病合并高血压组收缩压勺型模式发生率分别为63．0％，66．7％，38．5％和40．5％，各组比较差异不显著（P〉0．05）：舒张压勺型模式发生率分别为55．6％，72．7％，43．6％和29．7％，各组比较差异显著（P〈0．05），与颈椎病组比，原发性高血压组和颈椎病合并高血压组夜间舒张压下降显著减少（P〈0．01或0．05）。 结论：颈椎病对动态血压昼夜节律有一定的影响作用。动态血压昼夜勺型变化模式的比例也反映出了高血压的损害性作用及颈椎病可能加重这种损害性的作用。     

广州地区肺功能检查专用呼吸过滤器应用现状的调查和分析

目的：对广州地区肺功能专用呼吸过滤器的应用现状进行调查。方法：通过走访或电话问访．对广州地区74家医院进行问卷调查。结果：41．9％（31／74）的医院已开展肺功能检查，其中三级医院有23家，占74．2％（23／31），二级医院有8家，占25．8％（8／31）。在已开展肺功能检查的医院中，41．9％（13／31）的医院目前有使用呼吸过滤器，主要为三级医院，占84．6％（11／13）。在目前有使用呼吸过滤器的医院中，15．4％（2／13）的医院用于所有受试者，30．8％（4／13）的医院仅用于经济条件较好的受试者，53．8％（7／13）的医院用于有明显病情需要的受试者。对已开展肺功能检查的医院但未使用呼吸过滤器的原因进行进一步调查，其中27．8％（5／18）的医院表示“使用呼吸过滤器成本较高”；22．2％（4／18）的医院认为“呼吸过滤器与仪器接口不配套”。目前常用的肺功能检查专用呼吸过滤器主要为一次性抛弃型产品，在使用一次性呼吸过滤器的医院中，53．8％（7／13）的医院将使用后的过滤器消毒后循环使用．7．7％（1／13）的医院将一次性过滤器给同一个患者多次使用，30．8％（4／13）的医院将其作为一次性医疗垃圾进行处理后丢弃.结论：目前广州地区医院肺功能检查中呼吸过滤器的使用率较低且大多数医院使用不规范，应引起重视。[著者文摘]     

代谢综合征高血压的用药对策

代谢综和征（MS）的患病率日趋增高，我国20岁以上成人中，MS的患病率为14％～16％，50岁以上人群中，70％以上至少有一种代谢综和征的表现。MS是心血管疾病多重危险因素的集合，主要是指糖耐量下降、糖尿病、肥胖、脂代谢紊乱、高血压等其中两项或两项以上的组合。中华医学会糖尿病分会根据我国国情，建议诊断代谢综和征应具备以下4项中的3项或全部；（1）超重和（或）肥胖体指数[BMI≥25千克体重／身高]。（2）高血糖空腹血糖（FBG）≥6．1mmol／L及（或）餐后2小时血糖（2hpG）≥7．8mmol／L及（或）已确认为糖尿病并治疗者。（3）高血压血压≥140／90，及（或）已确认为高血压并治疗者。（4）血脂紊乱空腹甘油三酯（TG≥1．7mmol／L及（或）空腹血高密度脂蛋白胆固醇（HLD—C）≤0．9mmoL／L（男），或〈1．0mmol／L（女）。高血糖、高血压、血脂紊乱都是引起动脉硬化、冠心病及中风的主要危险因素。因此MS患者选择抗高血压药物时，除了关注药物的降压效果外应顾及药物是否对心、脑、肾有保护作用，以及药物对血糖、血脂的影响等诸多因索。在此就MS高血压的用药谈几点看法，以便共同提高临床用药水平。     

Randomized controlled trials in pediatric critical care: a scoping review

Introduction

Evidence from randomized controlled trials (RCTs) is required to guide treatment of critically ill children, but the number of RCTs available is limited and the publications are often difficult to find. The objectives of this review were to systematically identify RCTs in pediatric critical care and describe their methods and reporting.

Methods

We searched MEDLINE, EMBASE, LILACS and CENTRAL (from inception to April 16, 2013) and reference lists of included RCTs and relevant systematic reviews. We included published RCTs administering any intervention to children in a pediatric ICU. We excluded trials conducted in neonatal ICUs, those enrolling exclusively preterm infants, and individual patient crossover trials. Pairs of reviewers independently screened studies for eligibility, assessed risk of bias, and abstracted data. Discrepancies were resolved by consensus.

Results

We included 248 RCTs: 45 (18%) were multicentered and 14 (6%) were multinational. Trials most frequently enrolled both medical and surgical patients (43%) but postoperative cardiac surgery was the single largest population studied (19%). The most frequently evaluated types of intervention were medications (63%), devices (11%) and nutrition (8%). Laboratory or physiological measurements were the most frequent type of primary outcomes (18%). Half of these trials (50%) reported blinding. Of the 107 (43%) trials that reported an a priori sample size, 34 (32%) were stopped early. The median number of children randomized per trial was 49 and ranged from 6 to 4,947. The frequency of RCT publications increased at a mean rate of 0.7 RCTs per year (P<0.001) from 1 to 20 trials per year.

Conclusions

This scoping review identified the available RCTs in pediatric critical care and made them accessible to clinicians and researchers (http://epicc.mcmaster.ca). Most focused on medications and intermediate or surrogate outcomes, were single-centered and were conducted in North America and Western Europe. The results of this review underscore the need for trials with rigorous methodology, appropriate outcome measures, and improved quality of reporting to ensure that high quality evidence exists to support clinical decision-making in this vulnerable population.     

Pharmacologic Prophylaxis of Stress Ulcer in Non-ICU Patients: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials

PurposeAcid-suppressive medications are widely used in non–intensive care unit (non-ICU) patients for stress ulcer (SU) prophylaxis. However, SU prophylaxis in this population is still controversial. The purpose of this study was to systematically evaluate the efficacy and tolerability of these agents for SU prophylaxis in non-ICU patients.MethodsElectronic databases including Cochrane, ClinicalTrials.gov, Ovid-Medline, Embase, Chinese CNKI, and Wanfang Data were systematically searched on July 10, 2019, for randomized controlled trials (RCTs) that evaluated acid-suppressive medications in non-ICU patients. Network meta-analysis and pairwise meta-analysis were performed to calculate odds ratios (ORs) and 95% CIs. A random-effects model was used for generating pooled estimates. The primary outcome was occurrence of SU bleeding, and the adverse drug events (ADEs) were described as the secondary outcome.FindingsA total of 17 RCTs involving 1985 patients were eligible. Meta-analysis results indicated that the occurrence of SU bleeding was significantly decreased with all acid-suppressive medications compared with placebos (gastric mucosa protectants, OR = 0.29 [95% CI, 0.14–0.61]; H2-receptor antagonists, OR = 0.3 [95% CI, 0.18–0.50]; proton pump inhibitors [PPIs]: OR = 0.08 [95% CI, 0.04–0.16]). The occurrence of SU bleeding was significantly decreased with PPIs compared with gastric mucosa protectants (OR = 0.29; 95% CI, 0.12–0.72) and H2-receptor antagonists (OR = 0.28; 95% CI, 0.16–0.48). There was no significant difference between any 2 classes of PPIs on SU bleeding or any 2 acid-suppressive medications on ADEs.ImplicationsPPIs could significantly decrease SU bleeding risk without increasing ADEs than other acid-suppressive medications for SU prophylaxis in non-ICU patients. However, RCTs of high quality were required to confirm the findings of this investigation.     

Use of α2-Adrenergic Agonists to Improve Surgical Field Visibility in Endoscopy Sinus Surgery: A Systematic Review of Randomised Controlled Trials

Purpose

We assessed the evidence for the use of α₂-adrenergic agonists (A2AAs) in bleeding control and field quality in endoscopic sinus surgery.

Manual therapies for migraine: a systematic review

Migraine occurs in about 15% of the general population. Migraine is usually managed by medication, but some patients do not tolerate migraine medication due to side effects or prefer to avoid medication for other reasons. Non-pharmacological management is an alternative treatment option. We systematically reviewed randomized clinical trials (RCTs) on manual therapies for migraine. The RCTs suggest that massage therapy, physiotherapy, relaxation and chiropractic spinal manipulative therapy might be equally effective as propranolol and topiramate in the prophylactic management of migraine. However, the evaluated RCTs had many methodological shortcomings. Therefore, any firm conclusion will require future, well-conducted RCTs on manual therapies for migraine.     

Fish oils in the care of coronary heart disease patients: a meta-analysis of randomized controlled trials

What is the place of fish oils in the care of coronary heart disease (CHD) patients? As several clinical trials have already addressed this question without giving definitive answers, we did a meta‐analysis of trials regarding the efficacy of omega‐3 fatty acids in preventing cardiovascular mortality and morbidity. We searched the MEDLINE (1966–2003), EMBASE databases, proceedings abstracts and references of reviewed articles. Randomized controlled trials (RCTs) of the efficacy of omega‐3 fatty acids among adults with recent or acute myocardial infarction (MI), or angina were selected. Two reviewers abstracted data independently. Five relevant outcomes, mortality from all causes, fatal and non‐fatal MI, non‐fatal stroke and angina, were measured. Data were synthesized using a fixed effect model. Ten RCTs with 14 727 patients were included. No significant heterogeneity was detected. Daily intake of omega‐3 fatty acids for a mean duration of 37 months decreased all causes of mortality by 16% (relative risk 0.84, 95% confidence interval [0.76; 0.94]) and the incidence of death due to MI by 24% (0.76, [0.66; 0.88]). No significant effect was found for the other outcomes. Because of the suboptimal quality of the studies included into the meta‐analysis and the absence of data in patients receiving statins, these results do not justify adding fish oils systematically to the heavy pharmaceutical assortment already recommended in CHD patients.     

Systematic evaluation of the quality of randomized controlled trials in diabetes

OBJECTIVE: We sought to systematically ascertain the quality of randomized controlled trials (RCTs) in diabetes. RESEARCH DESIGN AND METHODS: We identified the 10 most recently published trials as of 31 October 2003 in each of six general medical, five diabetes, and five metabolism and nutrition journals and further enriched our sample with 10 additional RCTs from each of five journals that published the most eligible RCTs in a year. We explored the association between trial characteristics and reporting quality using univariate analyses and a preplanned multivariate regression model. RESULTS: After excluding redundant reports of included trials and one trial that measured outcomes on the health system and not on patients, we included 199 RCTs: 119 assessed physiological and other laboratory outcomes, 42 assessed patient-important outcomes (e.g., morbidity and mortality, quality of life), and 38 assessed surrogate outcomes (e.g., disease progression or regression, HbA(1c), cholesterol). Fifty-three percent were of low methodological quality, as were one-third (36-40%) of trials reporting patient-important or surrogate outcomes and two-thirds (64%) of laboratory investigations. Independent predictors of low quality were nonprofit funding source (odds ratio 3.1 [95% CI 1.5-6.2]), measure of physiological and laboratory outcomes (2.3 [1.2-4.4]), and cross-over design (2.3 [1.1-4.8]), all characteristics of laboratory clinical investigations. CONCLUSIONS: There is ample room for improving the quality of diabetes trials. To enhance the practice of evidence-based diabetes care, trialists need to pay closer attention to the rigorous implementation and reporting of important methodological safeguards against bias in randomized trials.     

中医药随机对照试验与我国疾病负担的关系

目的评估中医药临床研究是否与我国主要疾病负担相关。方法首先从1999年-2004年出版的13种中医、中西医结合杂志中手工检索出随机对照试验(RCT),并提取出杂志名称、出版年限、治疗的疾病类别及样本含量等数据。然后采用死亡率和伤残调整寿命年(DALY)作为衡量标准,统计2002年我国疾病负担前30位病因的RCT数量,采用秩相关分析这些疾病负担与发表的中医药RCT及其受试者数量的关系。结果最终确认7 422个RCT,约38%的RCT来自于3种国家级杂志。这些RCT覆盖了我国疾病负担中的主要病种,其中4 280个RCT(57.7%)研究前30位病因合并产生的42个病种,只有3个病种(7%)没有任何RCT研究。采用DALY得到的相关系数分别是0.108(P=0.569)、0.092(P=0.628),通过死亡率产生的相关系数分别是0.453(P=0.012)、0.536(P=0.002)。结论中医药RCT与采用死亡率衡量的疾病负担明显相关,但采用DALY分析却未发现二者存在相关性。中医药临床研究可能更注重死亡率高的病种,一定程度上忽略了DALY衡量的疾病负担。     

Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials

Purpose

Palonosetron, a 5-hydroxytryptamine 3 receptor antagonist (5-HT₃RA) with a strong binding affinity and long half-life, has been used in numerous trials for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). We systematically reviewed the efficacy and safety of palonosetron compared to other 5-HT₃RAs in CINV prophylaxis.

Methods

A literature search of Ovid MEDLINE, EMBASE, and CENTRAL was conducted to identify randomized controlled trials (RCTs) comparing palonosetron to other 5-HT₃RAs in CINV prophylaxis. Primary endpoints were the percentage of patients achieving a complete response (CR), complete control (CC), no emesis, no nausea, or taking no rescue medications. Secondary endpoints were the percentage of patients suffering from 5-HT₃RA-related adverse events.

Results

Sixteen RCTs were identified with 2,896 patients randomized to palonosetron and 3,187 patients randomized to other 5-HT₃RAs. Palonosetron was consistently statistically superior in CR, CC, no emesis, or no nausea and was sometimes superior in no rescue medication. Subgroup analyses demonstrated similarity in efficacy between highly and moderately emetogenic chemotherapy cohorts. In the acute phase, statistical superiority of palonosetron was found for trials that did not allow dexamethasone; conversely, RCTs that administered dexamethasone to all patients were nonsignificant. Palonosetron was statistically significantly safer in dizziness and mean QTc interval change and similar in constipation, headache, and diarrhea. Clinical superiority of palonosetron was reached in 3 of 19 analyzed efficacy and safety endpoints.

Conclusions

Palonosetron is safer and more efficacious than other 5-HT₃RAs. Future antiemetic guidelines should discuss the merits of including palonosetron as a first-line treatment.     

《中国中西医结合杂志》发表随机对照试验报告的质量评价

目的调查《中国中西医结合杂志》发表的随机对照试验(RCT)报告的方法学质量。方法手工检索《中国中西医结合杂志》1999～2004年刊载的RCT,采用CONSORT标准修订版和自拟其它评价指标对所有RCT进行质量评价。结果共检索了6卷72期2765篇已发表的文献,其中RCT1288篇,占临床试验类文献(1874篇)的68.73%。该1288篇RCTs中,描述了随机方法的有630篇(48.92%),与1999年以前相比,其差异有统计学意义(P<0.001),但采用安慰剂对照仅有21篇(1.63%),描述了终点指标者有114篇(8.85%),进行了样本量估算者有7篇(0.55%),无一篇描述随机分配,采用盲法的有54篇(4.20%)、对具体P值进行了描述的有9篇(0.70%)、无一篇报道随机试验流程图,描述了依从性的有2篇(0.16%),报告阴性结果的有1篇(0.08%),进行了辅助分析的有33篇(2.57%),采用多中心试验的有10篇(0.78%),进行了伦理学审批者为零,报道了患者知情同意者有3篇(0.24%),进行了致谢的有3篇(0.24%),描述了中医证型的有163篇(12.66%),采用了干预措施质量控制标准的有2篇(0.15%),采用模拟方法的有8篇(0.63%),描述了中医证候疗效指标的有258篇(20.04%),以上调查项目的质量评分均偏低。结论随着循证医学理念的深入和中国生物医学杂志编辑的重视,中医药临床试验报告质量已有提高,但与目前国际公认的CONSORT标准比较尚有差距。     

肺动脉高压联合治疗的荟萃分析

目的 对现已完成的肺动脉高压联合治疗的随机对照试验进行荟萃分析,评价肺动脉高压联合治疗的有效性和安全性.方法 检索Cochrane图书馆、MEDLINE、EMBASE、PubMed、Elsevier数据库、中国生物医学文献数据库和ClinicalTrials.gov等中2001～2012年已完成的有关肺动脉高压联合治疗的随机对照试验,按纳入排除标准收集相关资料.按Cochrane系统评价方法,由2名评价者独立评价所纳入研究的文献质量,提取有效数据后,采用RevMan 5.1软件进行荟萃分析.结果 纳入9个随机对照研究,包括979例肺动脉高压患者.荟萃分析结果显示:与单药治疗组相比,联合用药组能改善患者6分钟步行距离,加权标准差(WMD)=24.37 m,95％CI=11.24～37.50(P＜0.01)、降低临床恶化率(RR =0.50,95％ CI =0.31～0.83,P＜0.01),但不能降低患者病死率(RR=0.55,95％CI=0.21～1.44,P＞0.05).联合用药组与单药治疗组间药物相关的严重不良事件率和研究中断率(RR=0.86,95％ CI =0.52～1.44,P＞0.05)差异无统计学意义.结论 与单药治疗相比,联合用药可提高肺动脉高压患者运动耐量,减少临床恶化,而且联合用药是安全的、易耐受的;但对患者病死率无影响.尚需更多大型的随机对照试验来进一步评价联合治疗的有效性和安全性.