Tranexamic versus aminocaproic acids in patients with total hip arthroplasty: a retrospective study.

BACKGROUND: Recently, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been applied in total hip arthroplasty (THA). However, doubts in clinicians' minds about which medicine is more efficient and economical in THA need to be clarified. Therefore, this study compared the efficacy and cost of the intraoperative administration of TXA and EACA per surgery in decreasing perioperative blood transfusion rates in THA. METHODS:  This study enrolled patients who underwent THA between January 2019 to December 2020. A total of 295 patients were retrospectively divided to receive topical combined with intravenous TXA (n = 94), EACA (n = 97) or control (n = 104). The primary endpoints included transfusions, estimated perioperative blood loss, cost per patient and the drop in the haemoglobin and haematocrit levels. RESULTS: Patients who received EACA had greater total blood loss, blood transfusion rates, changes in HGB levels and mean cost of blood transfusion per patient (P < 0.05) compared with patients who received TXA. In addition, both TXA and EACA groups had significantly fewer perioperative blood loss, blood transfusion, operation time and changes in haemoglobin and haematocrit levels than the control group (P < 0.05). Cost savings in the TXA and EACA groups were 736.00 RMB and 408.00 RMB per patient, respectively. CONCLUSIONS: The application of perioperative antifibrinolytics notably reduces the need for perioperative blood transfusions. What's more, this study demonstrated that TXA is superior to EACA for decreasing blood loss and transfusion rates while at a lower cost per surgery. These results indicate that TXA may be the optimum antifibrinolytics for THA in Chinese area rather than EACA.

In vivo biocompatibility evaluation of Zn-0.05Mg-(0, 0.5, 1wt%)Ag implants in New Zealand rabbits.

Bio-absorbable Zn alloys have been attractive replacements for the traditionally permanent implants due to their reasonable mechanical strength and elongation, degradation rate, and biocompatibility. The hybridization addition of Mg and Ag elements could greatly improve the mechanical properties and antibacterial ability of Zn, respectively. In the present paper, in vivo biocompatibility for the Zn-0.05Mg-(0, 0.5, 1 wt%) Ag implants in New Zealand rabbit was qualitatively evaluated during the implantation periods of 4, 12, and 24 weeks. The blood serum biochemical parameters and in vivo integrity of the implants in the live rabbits were monitored by using clinical chemistry analyzing and X-ray radiographic imaging techniques during the implantation process, respectively. There is no great difference in the serum biochemical indicator between the implanted rabbits and the control group. Especially the levels of serum Zn and serum Mg normalize after implantation of 24 weeks. The interfacial adherence between the implants and newly formed bones, and the histopathological morphology of heart, liver, and kidney were observed morphologically under the microscope. The new bones formed and grew surrounding the implants after 12 weeks' post-operation, which were well joined with the original cortical bones after post-implantation of 24 weeks. The heart, liver and kidney were not negatively influenced as evidenced from the serum biochemical indicators and morphologies of the tissues. Zn-0.05Mg-(0, 0.5, 1 wt%) Ag alloys are proved to be in vivo biocompatible and potential candidates for the biodegradable medical implants.

Laplace approximation, penalized quasi-likelihood, and adaptive Gauss-Hermite quadrature for generalized linear mixed models: towards meta-analysis of binary outcome with sparse data.

BACKGROUND: In meta-analyses of a binary outcome, double zero events in some studies cause a critical methodology problem. The generalized linear mixed model (GLMM) has been proposed as a valid statistical tool for pooling such data. Three parameter estimation methods, including the Laplace approximation (LA), penalized quasi-likelihood (PQL) and adaptive Gauss-Hermite quadrature (AGHQ) were frequently used in the GLMM. However, the performance of GLMM via these estimation methods is unclear in meta-analysis with zero events. METHODS: A simulation study was conducted to compare the performance. We fitted five random-effects GLMMs and estimated the results through the LA, PQL and AGHQ methods, respectively. Each scenario conducted 20,000 simulation iterations. The data from Cochrane Database of Systematic Reviews were collected to form the simulation settings. The estimation methods were compared in terms of the convergence rate, bias, mean square error, and coverage probability. RESULTS: Our results suggested that when the total events were insufficient in either of the arms, the GLMMs did not show good point estimation to pool studies of rare events. The AGHQ method did not show better properties than the LA estimation in terms of convergence rate, bias, coverage, and possibility to produce very large odds ratios. In addition, although the PQL had some advantages, it was not the preferred option due to its low convergence rate in some situations, and the suboptimal point and variance estimation compared to the LA. CONCLUSION: The GLMM is an alternative for meta-analysis of rare events and is especially useful in the presence of zero-events studies, while at least 10 total events in both arms is recommended when employing GLMM for meta-analysis. The penalized quasi-likelihood and adaptive Gauss-Hermite quadrature are not superior to the Laplace approximation for rare events and thus they are not recommended.

Protocol registration or development may benefit the design, conduct and reporting of dose-response meta-analysis: empirical evidence from a literature survey.

BACKGROUND: To investigate the prevalence of protocol registration (or development) among published dose-response meta-analyses (DRMAs), and whether DRMAs with a protocol are better than those not. METHODS: Three databases were searched for eligible DRMAs. The modified AMSTAR (14 items) and PRISMA checklists (26 items) were used to assess the methodological and reporting quality, with each item assigned 1 point if it met the requirement or 0 if not. We matched (1,2) DRMAs with registered or published protocol to those not, by region and publication years. The summarized quality score and compliance rate of each item were compared between the two groups. Multivariable regression was employed to see if protocol registration or development was associated with total quality score. RESULTS: We included 529 DRMAs, with 45 (8.51%) completed protocol registration or development. We observed a higher methodological score for DRMAs with protocol than the matched controls (9.47 versus 8.58, P <  0.01); this embodied in 4 out of 14 items of AMSTAR [e.g., Duplicate data extraction (rate difference, RD = 0.17, 95% CI: 0.04, 0.30; P = 0.01). A higher reporting score (cubic transformed) for DRMAs with protocol than the matched controls was also observed (11,875.00 versus 10,229.53, P <  0.01); which embodied in 6 out of 26 items of PRISMA [e.g. Describe methods for publication bias (RD = 0.08, 95% CI: 0.01, 0.14; P = 0.02)]. Regression analysis suggested positive association between protocol registration or development and total reporting score (P = 0.012) while not for methodological score (P = 0.87). CONCLUSIONS: Only a small proportion of DRMAs completed protocol registration or development, and those with protocol were better reported than those not. Protocol registration or development is highly desirable.

The use of one-stage meta-analytic method based on individual participant data for binary adverse events under the rule of three: a simulation study.

OBJECTIVE: In evidence synthesis practice, dealing with binary rare adverse events (AEs) is a challenging problem. The pooled estimates for rare AEs through traditional inverse variance (IV), Mantel-Haenszel (MH), and Yusuf-Peto (Peto) methods are suboptimal, as the biases tend to be large. We proposed the "one-stage" approach based on multilevel variance component logistic regression (MVCL) to handle this problem. METHODS: We used simulations to generate trials of individual participant data (IPD) with a series of predefined parameters. We compared the performance of the MVCL "one-stage" approach and the five classical methods (fixed/random effect IV, fixed/random effect MH, and Peto) for rare binary AEs under different scenarios, which included different sample size setting rules, effect sizes, between-study heterogeneity, and numbers of studies in each meta-analysis. The percentage bias, mean square error (MSE), coverage probability, and average width of the 95% confidence intervals were used as performance indicators. RESULTS: We set 52 scenarios and each scenario was simulated 1,000 times. Under the rule of three (a sample size setting rule to ensure a 95% chance of detecting at least one AE case), the MVCL "one-stage" IPD method had the lowest percentage bias in most of the situations and the bias remained at a very low level (<10%), when compared to IV, MH, and Peto methods. In addition, the MVCL "one-stage" IPD method generally had the lowest MSE and the narrowest average width of 95% confidence intervals. However, it did not show better coverage probability over the other five methods. CONCLUSIONS: The MVCL "one-stage" IPD meta-analysis is a useful method to handle binary rare events and superior compared to traditional methods under the rule of three. Further meta-analyses may take account of the "one-stage" IPD method for pooling rare event data.

The methodological quality of dose-response meta-analyses needed substantial improvement: a cross-sectional survey and proposed recommendations.

OBJECTIVES: To investigate methodological quality of published dose-response meta-analysis (DRMA) and explore study characteristics associated with the quality. STUDY DESIGN AND SETTING: We searched three databases for published DRMAs and used a modified AMSTAR (15 items) checklist to assess the methodological quality. We summarized the compliance of those DRMAs to the AMSTAR items and used multivariable regression analysis to explore the association between prespecified study characteristics with the overall methodological quality. RESULTS: We identified 529 DRMAs. Of the methodological quality items, six were well complied (80% or more) and six poorly complied (30% or fewer) by these DRMAs. The median score was nine points [first and third quartile: 7, 10] and only 64/529 had score over 10 points. Regression analysis suggested that studies with more authors (ß = 0.19; 95% confidence interval [CI]: 0.05, 0.33), published more recently (ß = 0.29; 95% CI: 0.21, 0.36), with financial support (ß = 0.41; 95% CI: 0.13, 0.70), conducted by authors from European (other regions vs. European, ß = -0.68; 95% CI: -1.05, -0.31) were associated with better methodological quality. CONCLUSION: The methodological quality of published DRMAs was suboptimal. Substantial efforts are warranted to improve the quality, including developing methodology guideline, involving more methodological trained authors, and so forth.

Improving the quality of reporting of systematic reviews of dose-response meta-analyses: a cross-sectional survey.

BACKGROUND: Dose-response meta-analysis (DRMA) is a useful tool to investigate potential dose-response relationship between certain exposure or intervention and the outcome of interest. A large number of DRMAs have been published in the past several years. However, the standard of reporting for such studies is not known. METHODS: Medline, Embase, and Wiley Library were searched for systematic reviews with DRMAs (SR-DRMAs) published from January 2011 to July 2017. We used the combination of PRISMA and MOOSE statements, containing 33 items, to assess the reporting of included SR-DRMAs. The adherence of reporting was defined as the proportion of SR-DRMAs meeting the reporting requirement of an item. We explored the association between five pre-specified variables with the total score of reporting on both fully as well as each domain of the checklist. RESULTS: In total, 529 SR-DRMAs were eligible. Ten out of 33 items were under reported, and this mainly refers to the methods domain: only a small proportion of SR-DRMAs stated whether a review protocol existed (45, 8.5%); clarified the qualifications of searchers (1.7%); presented full electronic search strategy (25.9%); described any effort to include all available studies (22.9%), described methods for languages other than English (27.4%), and stated the process for selecting studies (20.2%). Multiple regression analysis suggested that studies with more authors (regression coefficient = 0.78; 95% CI: 0.35, 1.20; P <  0.001), published more recently (regression coefficient = 0.38; 95% CI: 0.28 to 0.47; trend P <  0.001), used reporting guideline (regression coefficient = 0.98; 95% CI: 0.68 to 1.32; P <  0.001), and involvement of methodologist (regression coefficient = 0.86; 95% CI: 0.42 to 1.32; P <  0.001) were associated with higher score of reporting. Further regression suggested that the improvement on the quality mainly concentrated on the methods and results domains. CONCLUSIONS: The reporting of SR-DRMAs needs to be further improved, particularly in the issues refer to the methods. The quality of reporting may improve when involving more authors and methodologists and employing any reporting guidelines.

Micro Perfusion and Quantitative Analysis of the Femoral Head Intraosseous Artery.

The present study investigates the feasibility of micro perfusion of femoral head specimens from femoral neck fracture patients by the inferior retinacular arteries and performing intraosseous artery quantitative analysis of the femoral head. Twelve femoral neck fracture patients who had undergone conventional hip replacement surgery were included in this study. Femoral head specimen arteries were first dissected and exposed and then perfused by the inferior retinacular arteries and all the femoral heads underwent micro-CT scanning. After micro-CT scanning, a digital 3-D model was reconstructed to quantify the femoral head intraosseous arteries for comparison with a normal femoral head. The artery length density, artery volume density, and artery length/volume ratio were calculated separately and compared with normal femoral head parameters. Micro-CT scanning displayed the epiphyseal arterial network structure and their fine vascular branches in all 12 femoral neck fractures. Blood was supplied from the inferior retinacular artery to the epiphyseal arterial network then to all the fine blood vessels within the femoral head. No statistical differences were observed in femoral heads' intraosseous artery length densities or volume densities between the normal and femoral neck fracture specimens, while the artery length/volume ratio showed a statistical difference, and the ratio increased from 19 to 46. Micro perfusion of the femoral head by the inferior retinacular arteries is possible and can present the epiphyseal network and their fine arterial branches in pathologic conditions to provide a morphological basis for the study of femoral head disease.

[Effect of Bushen Antai Recipe on prostaglandin I2 expression and its nuclear receptor at implantation site in mice with blastocyst implantation dysfunction].

OBJECTIVE: To observe the effect of Bushen Antai Recipe (BAR) on expression of prostaglandin I2 (PGI2) and its nuclear receptor peroxisome proliferators-activated receptor delta (PPARdelta) at implantation site in mice with blastocyst implantation dysfunction. METHODS: Pregnant mice were divided into three groups randomly, the normal group, the model group and the BAR group. The pregnant uterus of all mice was cut off on the 4th (D4), 5th (D5), 6th (D6) and 8th (D8) day of pregnancy for determining the PGI2 expression with radio immunoassay; and the mRNA and protein expression of PPARdelta with RT-PCR and immunohistochemistry at implantation site. RESULTS: PGI2 expression in the model group was obviously lower than that in the normal group (P < 0.01), and also lower than that in the BAR group (P < 0.01), while the index was insignificantly different between the normal and the BAR group. Compared with the normal group, the expression of PPARdelta in the model group was delayed temporally and spatially (P < 0.05), while that in the BAR group was not significantly different. CONCLUSION: BAR can improve the implantation in mice with blastocyst implantation dysfunction through promoting the PGI2 expression and its nuclear receptor PPARdelta at implantation site.