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.
Objective To evaluate the efficacy and safety of the midvastus approach in total knee arthroplasty. Methods We searched The Cochrane Library, EMBASE, PubMed, and CBM to identify clinical controlled trials comparing the midvastus approach with the medial parapatellar approach in total knee arthroplasty. The quality of the included studies was critically assessed and the data analyses were performed by the Cochrane Collaboration’s RevMan 5.0. Results Eight studies were included, involving 4 randomized controlled trials (RCTs), 2 quasi-RCTs and 2 non-RCTs. Meta-analyses showed that rate of lateral retinacular release (RR=0.75, 95%CI 0.52 to 1.08, P=0.12), range of motion at 6 week postoperation (MD=2.65, 95%CI –1.20 to 6.50, P=0.18), operation time (MD=1.04, 95%CI –3.50 to 5.58), and adverse events postoperation (OR=1.04, 95%CI 0.43 to 2.52, P=0.94) were similar between the midvastus approach and the medial parapatellar approach in total knee arthroplasty. One study showed that there was no significant difference in blood loss interoperation between the two approaches, and two showed that the midvastus approach had less blood loss interoperation than the medial parapatellar approach. There was no statistical analysis about the blood loss interoperation in one study. For the time of straight leg raise, there was no significant difference in two studies. But in one study, it showed that patients needed longer time for straight leg raise. Conclusion Based on the current evidence, the midvastus approach for total knee arthroplasty is as safe and effective as the medial parapatellar approach, but blood loss interoperation and time of straight leg raise are not decided. Due to the poor quality of the included trials, more high-quality RCTs are needed.
目的:探讨大鼠外耳道腺的正常组织结构及年龄组间,雌雄动物间有无差异,以期为药物评价过程中药物对耳腺影响的评价提供客观的依据。方法:将20只同龄SD大鼠随即分为A和B两组,每组均雌雄各半,分别与12周和17周龄处死,取外耳道腺进行病理学分析。观察外耳道腺在不同年龄组间、雌雄组间有无区别。结果:A组动物雌雄组间外耳道腺的组织结构无明显差异。B组动物雌雄动物间外耳道腺的组织结构无明显差异。A组雌性动物与B组雌性动物间外耳道腺的组织结构无明显差异。A组雄性动物与B组雄性动物间外耳道腺的组织结构无明显差异。结论:SD大鼠外耳道腺的组织结构在雌雄动物间及年龄在12周及17周间无明显差异,因此在进行药物对耳腺的影响的评价过程中12周龄和17周龄的受试大鼠所得到的结果应具备可比性。
ObjectiveTo evaluate the effectiveness of Cross-Union surgery for the treatment of pseudarthrosis of the tibia (PT) with neurofibromatosis type 1 (NF1). MethodsThe clinical data of 8 children of PT with NF1 who met the selection criteria between January 2018 and December 2023 was retrospectively analyzed. There were 5 boys and 3 girls, and the operative age ranged from 1.8 to 13.3 years with a median age of 3.5 years. According to Paley classification, there were 2 cases of type 2a, 2 cases of type 3, 2 cases of type 4a, and 2 cases of type 4c. There were 5 cases of first operation and 3 cases of re-fracture after previous operation. Six cases had leg length discrepancy before operation, and 2 of them had shortening over 2.0 cm. Except for 1 case of ankle fusion, the other 7 cases had ankle valgus. Preoperative coronal/sagittal angulation was recorded. Postoperative pseudarthrosis healing and refracture were observed. Leg length discrepancy and tibiotalar angle were measured and recorded before operation and at last follow-up. Inan imaging evaluation criteria was used to evaluate the imaging effect. ResultsAll patients were followed up 12-37 months (mean, 23.5 months). One pseudarthrosis failed to heal at 12 months after operation and healed at 3 months after reoperation, while the other pseudarthrosis healed with a healing rate of 87.5% and a healing time of 4-8 months (mean, 5.3 months). No refracture occurred during the follow-up. At last follow-up, there were 2 new cases with leg length discrepancy, which were 0.7 cm and 1.3 cm, respectively. In 2 cases with the leg length discrepancy more than 2.0 cm before operation, the improvement was from 4.1 cm and 12.6 cm to 2.1 cm and 9.0 cm, respectively. There was no significant difference in leg length discrepancy between pre- and post-operation in 8 cases (P>0.05). At last follow-up, 6 patients still had ankle valgus, and there was no significant difference in the tibiotalar angle between pre- and post-operation (P>0.05); the tibial coronal/sagittal angulation significantly improved when compared with that before operation (P<0.05). According to Inan imaging evaluation criteria, 1 case was good, 6 cases were fair, and 1 case was poor. Conclusion Cross-Union surgery is an effective method for the treatment of PT with NF1 in children, can achieve good bone healing results with a low risk of re-fracture. The surgery may not have significant effects on leg length discrepancy and ankle valgus, and further treatment may be required.
Objective To assess the effectiveness and safety of irbesartan for hypertensive patients with hyperuricaemia. Methods The databases such as The Cochrane Library (Issue 2, 2010), MEDLINE (by the end of April 2010), SCI (by the end of April 2010), CBM (by the end of April 2010) and CNKI (by the end of April 2010) were searched to collected randomized controlled trails (RCTs) on irbesartan for hypertensive combined with hyperuricaemia. Studies were screened according to the inclusion and exclusion criteria; data were extracted; the methodological quality was evaluated; and meta-analyses were conducted by using RevMan 5.0.0 software. Results Nine studies involving 977 patients were included. The results of meta-analyses showed that compared with the control group, irbesartan was superior in decreasing serum uric acid (SUA) (MD=57.12, 95%CI 16.08 to 98.15, P=0.006); it was similar in controlling blood pressure (Systolic pressure: MD= –0.24, 95%CI –2.19 to 1.71, P=0.81; Diastolic pressure: MD=0.46, 95%CI –1.58 to 2.50, P=0.66), and lower in the incidence rate of adverse reaction (RR=0.07, 95%CI 0.02 to 0.24, P=0.000 1). Conclusion The study suggests that irbesartan is effective and safe to control blood pressure and decrease serum uric acid for hypertensive patients with hyperuricaemia. But because all nine included studies are graded C in quality, the conclusion still needs to be further verified by long-term, large scale and high quality studies.
Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.
Objective To assess the effectiveness and safety of mycophenolate mofetil (MMF) in the treatment of proliferative lupus nephritis. Methods We searched CBM (November 1979 to February 2006), Chinese Cochrane Centre Database (2005), The Cochrane Library (Issue 4, 2005), MEDLINE (November 1966 to February 2006) and EMBASE (1975 to February 2006) for randomize controlled trials. Data were extracted and analyzed using The Cochrane Collaboration’s RevMan 4.2.7. Results Nine randomize controlled trials involving 512 patients met the inclusion criteria. The meta-analysis showed that the total clinical effective rate and complete remission rate were not significantly higher for MMF than for cyclophosphamide, azathioprine, or both. Renal survival rate and relapse rate of MMF were not significantly different from those for cyclophosphamide, azathioprine, or both. Patient survival rate and safety of MMF were significantly improved compared with cyclophosphamide, azathioprine, or both. Conclusion More large-scale multi-center randomized trials are needed to investigate the role of MMF in the treatment of proliferative lupus nephritis.
Objective To evaluate the safety of mycophenolate mofetil (MMF) versus azathioprine (AZA) for rejection after renal transplantation. Methods We searched MEDLINE (1966 to Jun. 2004), EMBASE (1984 to Jun. 2004), The Cochrane Library (Issue 2, 2004) and Chinese Biomedical Database (CBM, 1979 to Jun. 2004). Randomized controlled trials (RCTs) comparing MMF with AZA for rejection after renal transplantation were included. The quality of included studies such as randomization, blinding, allocation concealment was evaluated and meta-analysis was performed using RevMan 4.1.1 software. Results Twenty-Four RCTs comparing MMF (2 g/day or 3 g/day) with AZA for rejection after renal transplantation were identified. The digest system morbidity of MMF group was higher than that of AZA group. The incidence of vomiting, bellyache and diarrhea of MMF 3 g/day group was statistical by higher than that of AZA group (P＜0.05). The cytom egalovirus (CMV) infection morbidity of MMF 3 g/day group during 6 months, 1 year and 2 years follow-up was higher than AZA group with statistical difference, but for MMF 2 g/day group, this difference was only seen during 1 year follow-up. Leukopenia incidence of MMF 3g/day group was higher than AZA group with statistical difference, but this difference was not seen in MMF 2 g/day group. Thrombocytopenia incidence of MMF 3 g/day group was lower than AZA group with statistical difference. For skin carcinoma morbidity, no statistical difference was found among MMF 3 g/day, MMF 2 g/day and AZA groups. Conclusions Compared with AZA, MMF represents higher digest system side-effects incidence, higher morbidity of leucopenia and CMV infection and lower incidence of thrombocytopenia. The dose-response relationship of adverse drug reaction is found.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
The most important difference between systematic review and traditional narrative review lies in their respective quality, namely the degree of bias control. Generally speaking, the sources of bias include the process of literature searching, study selection, data extraction and original studies. A systematic review may greatly reduce bias, as it takes effective steps such as developing search strategies, undertaking funnel plot analysis, using established criteria for study selection, and assessment of the methodology quality of studies. All these help to control, identify and, describe the possible bias.