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find Keyword "临床研究" 117 results
  • Influence of prior percutaneous coronary intervention on outcome of coronary artery bypass grafting: A multi-center clinical study

    Objective To investigate the influence of prior percutaneous coronary intervention (PCI) on the outcome of coronary artery bypass grafting (CABG). Methods Clinical data of 5 216 patients from Jiangsu Province CABG registry who underwent primary isolated CABG from 2016 to 2019 were retrospectively analyzed. Patients were divided into a PCI group (n=673) and a non-PCI group (n=4 543) according to whether they had received PCI treatment. The PCI group included 491 males and 182 females, aged 62.6±8.2 years, and the non-PCI group included 3 335 males and 1 208 females, aged 63.7±8.7 years. Multivariable logistic regression and propensity score matching (PSM) were used to compare 30-day mortality, incidence of major complications and 1-year follow-up outcomes between the two groups. Results Both in original cohort and matched cohort, there was no statistical difference in the 30-day mortality [14 (2.1%) vs. 77 (1.7%), P=0.579; 14 (2.1%) vs. 11 (1.6%), P=0.686], or the incidence of major complications (myocardial infarction, stroke, mechanical ventilation≥24 h, dialysis for new-onset renal failure, deep sternal wound infection and atrial fibrillation) (all P>0.05). The rate of reoperation for bleeding in the PCI group was higher than that in the non-PCI group [19 (2.8%) vs. 67 (1.5%), P=0.016; 19 (2.8%) vs. 7 (1.0%), P=0.029]. Both in original cohort and matched cohort, there was no statistical difference in 1-year survival rate between the two groups [613 (93.1%) vs. 4225 (94.6%), P=0.119; 613 (93.1%) vs. 630 (95.2%), P=0.124], while the re-admission rate in the PCI group was significantly higher than that in the non-PCI group [32 (4.9%) vs. 113 (2.5%), P=0.001; 32 (4.9%) vs. 17 (2.6%), P=0.040]. Conclusion This study shows that a history of PCI treatment does not significantly increase the perioperative mortality and major complications of CABG, but increases the rate of cardiogenic re-admission 1 year postoperatively.

    Release date:2022-11-22 02:01 Export PDF Favorites Scan
  • A Randomized, Doubleblind Controlled Clinical Study on Tiopronin Sodium in the Treatment of Acute and Chronic Hepatitis

    目的:评价硫普罗宁钠治疗急慢性肝炎的有效性与安全性。方法:采用随机、双盲模拟、阳性药平行对照试验方法。硫普罗宁钠200mg静滴Qd,对照组用凯西莱(硫普罗宁)200mg静滴Qd。疗程均为4周,停药后随访4周。结果:共治疗急性肝炎患者7例,慢性肝炎患者18例。急性肝炎组:试验组与对照组4周末ALT下降率分别为69.14±39.23%及68.23±45.12%,试验组显效率33.33%,总有效率100%,对照组显效率25%,总有效率100%,两组疗效比较无显著性差异(Pgt;0.05)。慢性肝炎组:试验组与对照组4周末ALT下降率分别为44.34±53.1%及35.01±74.67%,试验组显效率22.2%,总有效率77.8%,对照组显效率11.11%,总有效率66.67%,两组疗效比较无显著性差异(Pgt;0.05)。急性肝炎组未见不良反应,慢性肝炎组中试验组及对照组不良反应发生率均为5.00%。结论: 硫普罗宁钠具有保肝降酶作用,临床上用于治疗急慢性肝炎患者安全有效。

    Release date:2016-09-08 10:04 Export PDF Favorites Scan
  • A multicentre randomized controlled clinical trial on amoxicillin/sulbactam in the treatment of acute bacterial infections

    Objective To evaluate the efficacy and safety of amoxicillin/sulbactam (AMX/SBT) in the treatment of acute bacterial infections. Method A multicentre randomized controlled clinical trial was conducted. Ampicillin/sulbactam (AMP/SBT) was chosen as the control drug. 113 patients were enrolled in the study (58 cases in test group and 55 cases in control group). AMX/SUL and AMP/SUL were administered 4.5-6.0 g and 4.5-12.0 g every day respectively. Both drugs were given intravenously for 7-14 days. Results The cure rates and the efficacy rates of the two groups were 75.86%, 80.0% and 94.83%, 98.18% respectively. The β-lactamase producing rates were 67.35% , 69.57% and the bacterial clearance rates were 93.88%, 95.65%.There were no significant differences of the above results between the two groups (Pgt;0.05). There was no serious adverse drug reaction in AMX/SBT groups. Conclusion This study suggests that AMX/SBT is an effective and safe drug for treating acute bacterial infections.

    Release date:2016-08-25 03:16 Export PDF Favorites Scan
  • Clinical studies on treatment of AIDS by traditional Chinese medicine compound preparations: an evidence map analysis

    ObjectiveTo systematically search and sort out the clinical research literature on the treatment of AIDS by traditional Chinese medicine compound preparations by using the evidence map method, and to understand the distribution of evidence in this field. MethodsThe CNKI, WanFang Data, VIP, CBM, PubMed and Cochrane Library databases were electronically searched to collect studies on the treatment of AIDS with traditional Chinese medicine compound preparations from inception to August 2022. The distribution characteristics of evidence were analyzed and presented in the form of charts and words. ResultsA total of 337 articles were included, involving 268 intervention studies, 66 observational studies and 4 systematic reviews/meta-analysis. A total of 92 kinds of traditional Chinese medicine compound preparations were obtained, and the literature quantity of different preparations was obviously stratified, with Kangaibaosheng preparation being the most frequently reported. In recent years, the number of published literature has been declining, the quality of literature is generally low, and the level of evidence is not high. As for the intervention duration, this field tends to have a longer intervention observation period. As for the outcome indicators, the evaluation criteria of some indicators are not uniform, and the characteristics of TCM advantages are not reflected. The quantity and quality of systematic reviews/meta-analyses were insufficient. No normative consensus or guidelines for the treatment of AIDS with traditional Chinese medicine compound preparations had been formed. Conclusionstudies on the effectiveness and safety of traditional Chinese medicine compound preparations in treating AIDS has initially formed a certain scale of evidence group. In the future, it is necessary to further improve the quality of studies, explore outcome indicators that can reflect the advantages of TCM efficacy, and formulate relevant guidelines in a standardized manner.

    Release date:2023-05-19 10:43 Export PDF Favorites Scan
  • Current status and progress of clinical research on distal femoral fractures

    Objective To investigate current status and latest progress of clinical research on distal femoral fractures. Methods The related literature was extensively reviewed to summarize the trend of the researches and their clinical application in the treatment of distal femoral fractures. Results Distal femoral fractures are likely to occur in young people who suffer from high-energy damage and the elderly with osteoporosis, which is always comminuted and unstable fractures, and often involved in the articular surface and combined with serious soft tissue injury. Therefore, the treatment faces many challenges. External fixation is now used as a temporary means of controlling injury. The vast majority of patients are feasible to internal fixation, including plates system and intramedullary nail system. Different internal fixator also has its own characteristics, such as double plates can strengthen the medial support of the femur, less invasive stabilization system protects the blood supply of fractures, distal cortial locking plate is theoretically more fit for the requirements of bone healing, retrograde intramedullary nail can resist varus and valgus. Conclusion The treatment of distal femoral fractures should be based on the type of fracture and the characteristics of internal fixators.

    Release date:2018-02-07 03:21 Export PDF Favorites Scan
  • Principles of latent variable mixture modeling and its value in clinical research applications

    In medical research, latent subgroups often emerge with characteristics or trends distinct from the general population, yet identifying them directly remain challenging. The latent variable mixture modeling, grounded in the idea that a population consists of a limited mixture of subgroups, assigns latent categories to individuals based on posterior probabilities. This model is suitable for both cross-sectional and longitudinal datasets. Approaching from a statistical perspective, this paper thoroughly explicates the foundational principles of four prevalent methods within the latent variable mixture modeling realm, outlining the essential modeling workflow. By integrating insights from previous cases and real-world data, we review the rational applications of these methods. The latent variable mixture modeling stands as a flexible classification tool for identifying and analyzing latent categories within research populations, further facilitating the in-depth exploration of predictors influencing these latent categories and their consequent effects on outcome variables.

    Release date:2024-11-12 03:38 Export PDF Favorites Scan
  • Randomized Controlled Trial of Severe Acute Pancreatitis Treated by Chaiqin Chengqi Decoction and Alanylglutamine Dipeptide in Early Stage

    摘要:目的: 探讨益活清下法早期联用用丙氨酰谷氨酰胺二肽治疗重症急性胰腺炎(severe acute pancreatitis, SAP)的疗效。 方法 :依据纳入和排除标准,选取我院中西医结合科收治的SAP80例,按1︰1随机分成早期组(40例)和晚期组(40例),早期组入院时便应用丙氨酰谷氨酰胺二肽治疗;晚期组入院5 d后加用丙氨酰谷氨酰胺二肽治疗。 结果 :两组入院时Ranson评分、CT评分、APACHEⅡ评分无统计学差异(P >005),治疗15 d后早期组APACHEⅡ评分(497±239分)明显低于晚期组(863±357分)(P <001);两组并发ARDS、肾功能衰竭、休克、肝功能不全、心功能衰竭、脑病及肠麻痹的发生率无统计学差异(P >005);早期组ARDS、肾功能衰竭、休克、肝功能不全、脑病及肠麻痹持续时间及住院病程短于晚期组(P<005 );早期组感染率、手术中转率及病死率低于晚期组(P<005 )。 结论 :益活清下法早期应用丙氨酰谷氨酰胺二肽治疗SAP,可缩短并发症的持续时间及病程,降低病死率和手术中转率。Abstract: Objective: To compare the effects of integrated basal treatment of Chaiqin Chengqi Decoction with alanylglutamine Dipeptide giving in different times for sever acute pancreatitis. Methods : The randomized parallel control was adopted. 80 patients of SAP were randomized to earlytreated group (40 cases were treated by AlaGln as soon as who entered hospital) and latetreated group (40 cases were treated by AlaGln after 5 days from who had entered hospital). The mortality, incidences of complication, operation and mortality,the duration of complication and the course of diseases, hospitalization were compared. Results : The mortality shown that in earlytreated group was lower than the latertreated group, there was statistically significantly difference. Ranson score, CT score, Acute Physiology and Chronic Heath EvaluationⅡscore (APACHEⅡ score) and the incidences of complications were no statistical differencein the two groups(P >005)in the early stage of hospitalization. But the APACHEⅡ score (497±239)in earlytreated group was lower than those in latetreated group(863±357)after 15 days(P <001 The duration of acute respiratory distress syndrome(ARDS ),renal failure, shock, hepatic failure, encephalopathy and enteroplegia were shorter in earlytreated group than those in latetreated group(P<005 . The incidence of infection, operation and mortality were lower in earlytreated group than those in latetreated group(P<005 . The course of diseases of earlytreated group was shorter than that of latetreated group (P<005 . Conclusion : SAP treated by (CQCQD) and AlaGln in early stage can shorten the duration of complications and the hospitalization period, and reduce the incidences of infection, operation rates and mortality rate.

    Release date:2016-09-08 10:12 Export PDF Favorites Scan
  • Interpretation of the COMET handbook (version 1.0) and its insight for developing core outcome sets in clinical trials of traditional Chinese medicine

    A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.

    Release date:2018-01-20 10:08 Export PDF Favorites Scan
  • Clinical Study of Elastic Fixation for Lumbar Intervertebral Fusion

    ObjectiveTo assess the feasibility and clinical value of lumbar elastic fixation through the clinical research of elastic fixation for lumbar intervertebral fusion. MethodsAccording to the criteria, we selected 12 patients with lumbar degenerative disease diagnosed between September 2011 and March 2013 as our study subjects. Among them, 8 were females, and 4 were males, aged between 40 and 62 years old, averaging 52.9 years. Elastic fixation was adopted in the lumbar fusion. Evaluation indicators included visual analogue scale (VAS) scores, Oswestry disability index (ODI) score and its rate of improvement, intervertebral height changes, the rate of intervertebral fusion, intervertebral bone callus formation, patient satisfaction and clinical success rate. ResultsAll patients were followed up. During various postoperative follow-up points, VAS score and ODI score improved significantly (P<0.05). A large amount of callus formation was shown in lumbar CT. No fracture, loosened or shifted internal fixation occurred. ConclusionElastic fixation for lumbar intervertebral fusion provides another choice for the treatment of lumbar degenerative disease.

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  • The methodological framework of surgical innovation: the introduction of IDEAL framework and recommendation

    Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.

    Release date:2021-03-05 06:30 Export PDF Favorites Scan
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