背景与目的 对卫生保健干预措施进行决策权衡需要有不良和有益的可靠证据,然而绝大多数系统评价针对的是研究方法非常成熟的随机对照试验及其有效性评价,系统地评价不良反应的方法尚未完善,对研究者而言,能作为相关指南的资源很少.为此,作者在文中报告了对不良反应进行系统评价的新近体会,同时提出进一步实践和研究的建议.方法 描述并比较3个包含不良反应评价的药物干预的系统评价的方法学,重点评价其研究问题、研究设计和质量评价.结果 1个研究关注于如何根据提供的特殊不良反应数据建立卫生经济学模式,而其它两个研究涉及更广泛的问题.尽管每个评价对纳入标准的定义不同,但它们均纳入了随机和观察性数据.对研究质量的评价采用了标准方法.由于研究设计不良、报告不充分和现有研究工具有限,在运用纳入标准和评估研究质量时,研究者遇到了各种问题.最终发现,3个评价都做了大量的工作,但对卫生保健决策者有用的资料不多.研究者确认,改善的关键在于如何提出系统评价的问题和发展不良反应研究的质量评价方法学.结论 若不良反应的系统评价只专注于一个中心问题,那么它会提供与临床决策更相关的资料,也有利于明确纳入系统评价研究的类型.系统评价中不良反应的质量评估的方法学需要进一步完善.
ObjectiveTo systematically review the efficacy and safety of laparoscopic versus open nephrectomy in the treatment of autosomal dominant polycystic kidney disease (ADPKD). MethodsWe searched databases including MEDLINE, EMbase, The Cochrane Library (Issue 1, 2015), Web of Science, CBM and WanFang Data to collect relevant clinical studies comparing the efficacy and safety of laparoscopic versus open nephrectomy for ADPKD from inception to Jan, 2015. Two reviewers independently screened literature, extracted data and assessed the risk bias of included studies. Then, RevMan 5.4 software was used for meta-analysis. ResultsA total of six retrospective cohort studies involving 182 patients were included. The results of the meta-analysis showed that:compared with the open nephrectomy group, the average hospitalization time was shorter (MD=-4.38 days, 95%CI -5.93 to -2.83, P=0.000 01) and the blood transfusion risk was lower (OR=0.25, 95%CI 0.10 to 0.62, P=0.003) in the laparoscopic nephrectomy group. However, there was no significant difference between two groups in the incidence of overall complications (OR=0.51, 95%CI 0.24 to 1.06, P=0.07). ConclusionThe application of laparoscopic nephrectomy for ADPKD can reduce the hospitalization time and blood transfusion risk when compared with the open nephrectomy, but the two operations have similar overall complication rate. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
Testing Treatments is a book to help the public understand how to validate the efficacy of testing treatments and the possible bias and error in clinical trial, as well as to call for help to promote good study thus to improve the quality of health care. No matter for the first or the second edition, this book is very popular around the world, and its second edition has been translated into more than ten languages. To help the readers understand the content of the book, we established a website (www.testingtreatments.org) and other sibling sites in different languages. The website not only provided the full-texts to download, but also collected various popular science resources (videos, audios and cartoons) to help the readers assimilate more knowledge. The editors of all the different language websites have established an TTi Editorial Alliance to share experience and provide each other with mutual support, thus to promote health professionals, patients and public around the world to use reliable research to inform their health decisions.
Objectives To systematically review the economic burden of surgical treatment for ankle fracture in China. Methods PubMed, EMbase, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on economic burden of surgical treatment for ankle fracture in China from inception to December 1st, 2017. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Description analysis were then performed by Excel software. Results A total of 67 studies were included. The analysis showed that: the average cost of hospitalization generally tend to rise during 2004 to 2013. The highest was 17 700 yuan in 2013. After 2013, the expense gradually stabilized. The average annual growth rate of hospitalization costs was 12.3% during 2004 to 2016. The percentage of hospitalization costs accounted for the per capita disposable income of households in region was stable during 2004 to 2016 (around 60%). Conclusions Although the average hospitalization costs in China generally show an upward trend, the percentage of hospitalization costs accounted for the per capita disposable income of household is relatively stable. The study on the indirect economic burden is required to be further carried out. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To systematically review the abroad studies on patients for patient safety, and compare them with the current status of domestic studies, so as to provide suggestions for evidence-based strategic decision about how to conduct the education of patients for patient safety and improve the medical quality. Methods The databases of MEDLINE, EMbase and Chinese Biomedical Literature Database (CBM) were searched to identify the relevant studies and their references. Literatures were screened with data extraction in accordance with the predefined inclusive and exclusive criteria. The quality of literatures was assessed with the standard of Cochrane Handbook 5.0 and Critical Appraisal Skills Programme, and the data were comprehensively analyzed with qualitative research methods.Results Among 28 included studies, 5 were Chinese literatures, 1 was RCT, and the others were cross-sectional studies. The results showed that: a) Generally, the patients at home and abroad were poor in the awareness of patient safety, but they were eager to participate in the patient safety; b) Factors affecting patients’ participation were their characteristics, disease-related, and emotional feelings; c) Three studies reported the methods of involving patients in patient safety from the aspects of infection, malpractice, and medication; d) Some studies showed that patients’ participation could effectively promote the standardized operation of medical staffs, prevent unsafe events, and reduce damages; and e) The research contents of the included Chinese literatures were just related to the patients’ awareness of patient safety, attitude to participation, and influencing factors. Conclusion The limited studies relevant to patients for patient safety are short of high-quality RCTs for proving the effectiveness of patient participation methods, so it indicates that the stress should be laid on evaluating the effectiveness of patients for patient safety in future research.
ObjectiveTo systematically review the efficacy and safety of crizotinib in the treatment of non-small cell lung cancer (NSCLC).MethodWe electronically searched databases including the Cochrane Library (Issue 5, 2017), PubMed, Embase, China Biology Medicine Database, China National Knowledge Internet Database, VIP Database and Wangfang Data from the establishment to May 2017. The randomized controlled trials (RCTs), non-RCTs, case series and case reports on crizotinib for NSCLC were included. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, assessed the methodological quality of included studies, then make Meta-analysis and descriptive analysis.ResultA total of 15 studies were included, including 4 RCTs, 1 non-RCT, 4 case series and 6 case reports. The results indicated that the progression-free survival time of crizotinib group was 8 months, which was better than chemotherapy group (4.6 months). The results of Meta-analysis showed that the response rate in the crizotinib group was higher than that in the chemotherapy group [RR=2.35, 95%CI (1.59, 3.46), P<0.000 1]. The one year survival rate in the crizotinib group was 74.5%-78.6%. The incidences of adverse reactions including dysopsia, dysgeusia, diarrhea, vomiting, constipation, transaminase lifts, upper respiratory tract infection, edema and dizziness in the crizotinib group were higher than those in the chemotherapy group (P<0.05), while the incidences of adverse reactions including leukopenia, thrombocytopenia, alopecia and fatigue in crizotinib group were lower than those in the chemotherapy group (P<0.05). Subgroup analysis under precision treatment showed the progression-free survival time of anaplastic lymphoma kinase (ALK)-positive group was 8 months, and it was longer than ALK-negative group of 4 months.ConclusionsBased on current evidence, crizotinib is better than chemotherapy for NSCLC. Due to limited quality of the included studies, the above conclusion needs to be verifed by more high quality studies.
Objective To assess the analgesic effect of caudal bupivacaine with neostigmine for hypospadias surgery in children. Methods We searched The Cochrane Library (Issue 2, 2008), MEDLINE (1966-2008), EMbase (1980-2008), CBMdisc (1978-2008), CNKI (1989-2008) and Wanfang Database using the keywords “bupivacaine”, “neostigmine” and “hypospadias” to identify randomized control trials (RCTs) of caudal bupivacaine with neostigmine versus bupivacaine alone for hypospadias surgery in children. The methodological quality of included RCTs was evaluated by two reviewers independently, and Meta-analysis was conducted using RevMan 5.0.13 software. Results We identified 3 RCTs including 160 patients which had an uncertain risk of bias. The results of meta-analysis showed no significant difference found between bupivacine alone and bupivacine plus 1 µg/kg neostigmine (WMD= 0.05, 95%CI – 6.76 to 6.86, P= 0.99), but a difference was found between bupivacine alone and bupivacine plus 1 µg/ kg, 2 µg/kg, or 3 µg/ kg neostigmine (WMD= 12.79, 95%CI 10.96 to 14.62, Plt; 0.000 01; WMD= 12.10, 95%CI – 6.76 to 6.86, Plt; 0.000 01; WMD= 11.90, 95%CI 9.17 to 14.63, Plt;0.000 01). The duration of postoperative analgesia of the bupivacaine with neostigmine group was longer than that of bupivacine alone. Conclusions Because of the small sample size and the unclear risk of bias in the included RCTs, the effectiveness of caudal bupivacaine with neostigmine for postoperative pain management after hypospadias surgery in children is not completely confirmed. So more large sample size, double-blind RCTs are needed.
ObjectiveTo systematically review the pharmacoeconomics of high-dose intravenous iron ferric carboxymaltose in the treatment of patients with iron deficiency anemia. MethodsPharmacoeconomic studies of ferric carboxymaltose in the treatment of patients with iron deficiency anemia were searched in PubMed, The Cochrane Library, York University CRD, Web of Science, EBSCO, CNKI, WanFang Data and VIP databases, and relevant health technology assessment websites from inception to September 30th, 2021. A descriptive analysis was performed after two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. ResultsA total of 11 studies were included, most of them compared the health economics of ferric carboxymaltose with other therapies from a hospital perspective. The main costs included in these studies were costs for iron, infusion, blood transfusion, EPO, hospitalization, and transportation, as well as productivity cost. The ferric carboxymaltose was presumed to be more economical than other intravenous irons. ConclusionIt is suggested that the ferric carboxymaltose be considered in more clinical settings to improve the ischemic condition of patients with iron deficiency anemia, so as to promote the rational utilization of medical resources.
Objective To systematically evaluate the effects of magnesium sulfate on postoperative pain and complications after general anesthesia. Methods A literature search was conducted in following databases as The Cochrane Library, EMbase, PubMed, EBSCO, Springer, Ovid, CNKI and CBM from the date of establishment to September 2011 to identify randomized controlled trials (RCTs) about intravenous infusion of magnesium sulfate during general anesthesia. All included RCTs were assessed and the data were extracted according to the standard of Cochrane systematic review. The homogenous studies were pooled using RevMan 5.1 software. Results A total of 11 RCTs involving 905 patients were included. The results of meta-analyses showed that compared with the control group, intravenous infusion of magnesium sulfate during general anesthesia significantly reduced the visual analog scale (VAS) scores at the time-points of 2, 4, 6, 8, 16, and 24 hours, respectively, after surgery, the postoperative 24 hours morphine requirements, and the incidents of postoperative nausea and vomiting (RR=0.61, 95%CI 0.40 to 0.91, P=0.02) and chilling (RR=0.29, 95%CI 0.14 to 0.59, P=0.000 7). Although the incidents of bradycardia (RR=1.93, 95%CI 1.05 to 3.53, P=0.03) increased, there were no adverse events or significant differences in the incidents of hypotension and serum concentration changes of magnesium. Conclusion Intravenous infusion of magnesium sulfate during general anesthesia may obviously decrease the pain intensity, and the incidents of nausea and vomiting and chilling after surgery, without increasing cardiovascular adverse events and risk of hypermagnesemia. The results still need to be confirmed by more high-quality and large-sample RCTs.
Objective To systematically evaluate the impact of pulmonary hypertension (PH) on the prognosis of patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). Methods A computerized search was conducted in CNKI, Wanfang Data, VIP, CBM, PubMed, The Cochrane Library, EMbase, and Web of Science databases from inception to June 2023 for cohort studies on the prognostic impact of PH in severe AS patients undergoing TAVR. Two researchers independently screened the literature, extracted data, and assessed the quality of included studies. Stata 17.0 software was used for meta-analysis. Results A total of 16 cohort studies were included, all with Newcastle-Ottawa Scale scores≥7. Meta-analysis results showed that, compared with AS patients without PH, those with PH had significantly higher 1-year all-cause mortality after TAVR [OR=2.10, 95%CI (1.60, 2.75), P<0.01], 30-day all-cause mortality [OR=2.09, 95%CI (1.54, 2.83), P<0.01], and cardiovascular mortality [OR=1.49, 95%CI (1.18, 1.90), P<0.01]. The differences between the two groups in major bleeding events, stroke, myocardial infarction, pacemaker implantation, and postoperative renal failure were not statistically significant. For outcome indicators with significant heterogeneity, subgroup analyses were performed based on PH measurement methods, diagnostic criteria, and different types of PH. The results showed that most subgroup combined results were consistent with the overall findings and that heterogeneity was significantly reduced. Conclusion PH significantly increases the 30-day all-cause mortality, 1-year all-cause mortality, and cardiovascular mortality in patients with severe AS undergoing TAVR.