Abstract

Objective: This study aims to explore the effectiveness and safety of tranexamic acid (TXA) in reducing the bleeding amount of surgical patients with degenerative spinal disease in the perioperative period. Methods: A total of 80 cases of patients, who underwent elective posterior lumbar interbody fusion surgeries under general anesthesia, were enrolled in this study. The age of these patients ranged within 41-69 years old, and the surgical vertebral body segments were ≥2. The ASA classification was Level I or Level II. These patients were divided into two groups using the random number table (n = 40): TXA group and control group (S group). In the TXA group, the skin was incised after the anesthesia induction, and 20 mg/kg of TXA was immediately injected into the vein. The injection continued at a rate of 10 mg·kg(-1)·h(-1) during the surgery, until the surgery was finished. In the S group, IV and pump injection with an equal amount of normal saline (NS) were performed. Then, the RBC, Hb, HCT, AST, ALT, BUN, Cr, PT, TT, APTT, FIB, and D-dimer were measured before the surgery and at 1 day after the surgery, and the SSFQ, intraoperative bleeding amount, homologous transfusion volume, urine volume, infusion quantity, surgical duration, drainage volume at 24 h after the surgery, total bleeding amount and adverse event occurrence at 1 week after the surgery were recorded. Results: The RBC, Hb and HCT at 1 day after the surgery were higher in TXA group than in the S group (average P < 0.05). Intraoperative bleeding, drainage volume at 24 h after surgery, and total blood loss were lower in the TXA group than in the S group (average P < 0.05). The SSFQ score and length of stay were lesser in the TXA group than in the S group (average P < 0.05). The differences in AST, ALT, BUN, Cr, PT, TT, APTT, FIB, and D-dimer at 1 day after the surgery for these two groups of patients had no statistical significance (average P > 0.05). Conclusion: TXA can reduce the bleeding amount of surgical patients with degenerative spinal disease in the perioperative period and decrease the length of stay, but does not increase the occurrence rate of adverse events, thereby promoting postoperative rehabilitation. Clinical Trial Registration: www.chictr.org.cn/index.aspx, identifier: ChiCTR2000033597.

Abstract

BACKGROUND Gastrointestinal bleeding is the most common clinical manifestation of gastrointestinal stromal tumor. It is of great significance to the prognosis of patients. But the results are controversial. The purpose of this study was to evaluate the relationship between gastrointestinal bleeding and clinical prognosis in patients with GIST. METHODS A systematic literature search was performed in Pumbed, Cochrane Library, EMBASE, ClinicalTrials.gov, CNKI, VIP and wanfang databases with the pattern of unlimited languages. 12 studies with 2781 individuals were included in the final analysis. The overall survival (OS), recurrence-free survival/disease-free survival (RFS/DFS) and related factors affecting bleeding in patients with gastrointestinal stromal tumor (GIST) were extracted. Hazard ratio (HR) and 95% confidence interval (CI) were used for in the meta-analysis. RESULTS A total of 12 articles were included in the study, including 2781 patients with GIST, including 845 patients with gastrointestinal bleeding. The OS of GIST patients with gastrointestinal bleeding was significantly worse (HR = 2.54, 95% CI = 1.13-5.73, P = 0.025). But there was no significant difference in RFS between gastrointestinal bleeding patients and non-bleeding patients (HR = 1.35, 95% CI = 0.70-2.61, P = 0.371). Further analysis of the related factors of GI bleeding in GIST patients was observed, besides the aging factor (HR = 1.02, 95% CI = 0.69-1.50, P = 0.929), Small intestinal stromal tumor (HR = 0.56, 95% CI = 0.41-0.76, P < 0.001), tumor diameter ≥ 5 cm (HR = 2.09, 95% CI = 1.20-3.63, P = 0.009), Mitotic index ≥ 5/50 HPF (HR = 1.66, 95% CI = 1.11-2.49, P = 0.014) and tumor rupture (HR = 2.04, 95% CI = 1.0-3.82, P = 0.026) all increased the risk of GI bleeding in patients with GIST. CONCLUSIONS The OS of GIST patients with GI bleeding was worse than non-GI bleeding, but had no significant effect on RFS. Nevertheless the aging factor, the location of GIST in the small intestine, tumor diameter ≥ 5 cm, Mitotic index ≥ 5/50 HPF and tumor rupture all increased the risk of GI bleeding in patients with GIST.

Abstract

OBJECTIVES To evaluate the efficacy of double-filtration plasmapheresis (DFPP) treatment of myasthenia gravis (MG) through a systematic review and meta-analysis. METHODS PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang databases were searched for randomized controlled trials (RCTs) and clinical controlled trials (CCTs) on DFPP for MG from database establishment to June 2019. Two researchers independently screened the articles, extracted the data, and cross checked the results. RevMan 5.3 was used for statistical analyses. RESULTS Seven RCTs and 2 CCTs were found comprising 329 patients. The results showed that clinical MG remission rate after DFPP treatment was significantly higher (OR = 4.33; 95% confidence interval [CI], 1.97-9.53; P < .001) and the serum levels of antititin antibody was significantly decreased (standardized mean difference [SMD] = 9.30; 95% CI, 7.51-11.08; P < .001). In addition, the quantitative MG (QMG) score, hospital stay and time to remission of MG symptoms, and acetylcholine receptor antibody (AchRAb) decreased in the DFPP treatment group; however, these outcomes had high heterogeneity among the studies. Only one study has reported on the adverse effects, including hypotension and hematoma. CONCLUSION This meta-analysis suggests that DFPP can be recommended for the short-term mitigation of MG. Because our review was limited by the quantity and quality of the included studies, the above conclusions should be verified by additional high-quality studies.

Abstract

PURPOSE The purpose of this study was to compare the clinical efficacy of the patients with medial compartment knee osteoarthritis who underwent either opening-wedge high tibial osteotomy alone (HTO) or simultaneous HTO and pure platelet rich plasma therapy (HTO-P-PRP). METHODS Eighty patients were divided into two groups randomly, the HTO alone group (n=41) and the HTO combined with intra-articular P-PRP group (n=39). Patients were matched for preoperative age, sex and body mass index (BMI). The outcomes studies included Visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lysholm score. The minimum width of medial knee joint (MJSW), medial proximal tibial angle (MPTA), femoral tibial angle (FTA) and weight bearing line (WBL) were measured preoperatively, immediately postoperatively and 1, 6, 12 and 24 months postoperatively. Paired T-test and chi-square test were used for statistical analysis. RESULTS All patients were followed up at 1, 6, 12 and 24 months postoperatively. At 1, 6 and 12 months, pain and function scores in the HTO-P-PRP group were better than those in the HTO alone groups, especially at 6 months in Lysholm score (HTO alone, 72.5 ±10.6, HTO-P-PRP, 83.1 ±14.7; P =.003, 95%CI=-14.13 to -10.42) and WOMAC score (HTO alone, 90.3 ±11.9, HTO-P-PRP, 75.6 ±15.4; P ＜.001, 95%CI=13.36 to 20.11). For both groups, no difference was found between preoperatively (HTO alone, varus 3.5 ± 3.9, HTO-P-PRP, varus 4.1 ± 4.0; P= 0.898) and postoperatively (HTO alone, valgus 6.7 ± 4.5; HTO-P-PRP, valgus 7.7 ± 2.3; P= 0.768) in FTA and WBL. The increase of the MJSW in the HTO-P-PRP group was significantly greater than which in the HTO alone group during the first year, especially at 6 months (HTO alone, 3.8 ±1.2mm, HTO-P-PRP, 4.6 ±1.1mm; P=0.001, 95%CI=-1.27 to -0.35). CONCLUSIONS Compared with HTO alone, HTO combined with intra-articular P-PRP improved the minimum medial knee joint space width during the first year postoperatively. Clinically, higher proportions of patients in HTO-P-PRP group exceeded minimal clinically important differences (MCID) in the first year, especially at 6 months in Lysholm score (HTO alone, 65.9%; HTO-P-PRP, 97.4%) and WOMAC score (HTO alone, 82.9%; HTO-P-PRP, 100.0%).

Abstract

BACKGROUND The efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with intravenous TXA in patients undergoing total hip arthroplasty and total knee arthroplasty in a systematic review and meta-analysis. METHODS We conducted a meta-analysis to identify randomized controlled trials (RCTs) involving oral and intravenous TXA in total hip arthroplasty and total knee arthroplasty up to December 2019 by searching databases including PubMed, Web of Science, Embase, the Cochrane Controlled Trials Register, the Cochrane Library China Biology Medicine, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang. The mean difference or standard mean difference was used to assess continuous outcomes such as hemoglobin (Hb) drop, total blood loss, drain blood loss, and length of hospital stay, with a 95% confidence interval. Relative risks with a 95% confidence interval were used to assess dichotomous outcomes such as transfusion rate and the incidence of deep venous thrombosis and calf muscular vein thrombosis. Review Manager was used for the meta-analysis. RESULTS Ten RCTs containing 1080 participants met the inclusion criteria. We found no significant differences in terms of the average Hb drop (P = .60), total blood loss (P = .60), transfusion rate (P = .99), drain blood loss (P = .91), length of hospital stay (P = .95), and the incidence of deep venous thrombosis (P = .55) and calf muscular vein thrombosis (P = .19) between oral and IV TXA. CONCLUSIONS Compared with the IV TXA, oral TXA has similar effects on reducing the Hb drop, total blood loss, transfusion rate, drain blood loss, and length of hospital stay without increasing the risk of calf muscular vein thrombosis and deep venous thrombosis. Furthermore, oral TXA is easy to access and administer, which decreases the workload of nurses and even delivers cost-saving benefits to the health care system. We thus conclude that oral TXA may be an optimal approach in total joint arthroplasty. However, more high-quality and multicenter RCTs are still needed to confirm our conclusions. REGISTRATION The current meta-analysis was registered on PROSPERO (International Prospective Register of Systematic Reviews), and the registration number was CRD42018111291.

Abstract

Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are a new class of oral medicines being developed for the treatment of anemia in chronic kidney disease (CKD) patients. This study aimed to compare the efficacy and safety of HIF-PHI vs epoetin and darbepoetin in CKD patients with anemia not undergoing dialysis. The PubMed, Embase, Cochrane Library, Web of Science, and http://clinicaltrials.gov/ clinicaltrials.gov databases were searched from inception to October 2019 for randomized controlled trials investigating different agents (six HIF-PHIs, epoetin, darbepoetin, and placebo) for treating CKD patients with anemia that did not undergo dialysis. The outcomes included a change in hemoglobin (Hb) levels and all-cause mortality. A total of 19 studies were included. Compared with the placebo, except for vadadustat (mean differences: 1.12, 95% confidence interval [CI]: 0.11-2.35), the other drugs significantly increased Hb levels, with mean differences of 2.46 (95% CI: 0.933.99) for desidustat, 1.81 (0.872.75) for enarodustat, 1.68 (0.642.72) for molidustat, 1.66 (0.892.44) for epoetin, 1.63 (0.692.56) for darbepoetin, 1.61 (0.992.22) for roxadustat, and 1.55 (0.742.36) for daprodustat. No differences were found in the Hb level elevations among these eight drugs. Compared with the placebo, there also was no significant association between the drugs and all-cause mortality (molidustat of RR, 0.39 [95% CI, 0.062.59]; roxadustat, 0.40 (0.062.84); enarodustat, 0.33 (0.0116.25); desidustat, 0.34 (0.0117.00); epoetin, 0.50 (0.181.42); daprodustat, 0.54 (0.093.31); darbepoetin, 1.03 (0.651.65); and vadadustat, 1.43 (0.1513.27)). No differences were observed in the all-cause mortality among the drugs. In conclusion, these HIF-PHIs are effective and relatively tolerant for treating anemia patients with CKD not undergoing dialysis. Further research should consider the limitations of our study to evaluate the value of these HIF-PHIs in clinical settings.

Abstract

Objective: Daprodustat is a novel oral agent in treating anemia of chronic kidney disease (CKD), and several clinical trials have been conducted to compare daprodustat with recombinant human erythropoietin (rhEPO) or placebo. Our systematic review aimed to investigate the efficacy and safety of daprodustat for anemia treatment in both dialysis-dependent (DD) and non-dialysis-dependent (NDD) patients. Methods: Six databases were searched for randomized controlled trials (RCTs) reporting daprodustat vs. rhEPO or placebo for anemia patients in CKD. The outcome indicators were focused on hemoglobin (Hb), ferritin, transferrin saturation (TSAT), total iron-binding capacity (TIBC), vascular endothelial growth factor (VEGF), and serious adverse events (SAEs). Results: Eight eligible studies with 1,516 participants were included. For both NDD and DD patients, changes in Hb levels from baseline were significantly higher in daprodustat group than that in the placebo (mean difference (MD) = 1.73, [95% confidence interval (CI), 0.34 to 3.12], p = 0.01; MD = 1.88, [95% CI, 0.68 to 3.09], p = 0.002; respectively), and there was no significant difference between daprodustat and rhEPO group (MD = 0.05, [95% CI, -0.49 to 0.59], p = 0.86; MD = 0.12, [95% CI, -0.28 to 0.52], p = 0.55; respectively). The indexes of iron metabolism were improved significantly in the daprodustat group compared to placebo- or rhEPO-treated patients, while there was no similar change in terms of TSAT for DD patients. Furthermore, no trend of increasing plasma VEGF was observed in daprodustat-treated subjects. As for safety, there was no significant difference in the incidence of SAEs between daprodustat and placebo treatment, while the incidence of SAEs in the daprodustat group was significantly lower than that in the rhEPO group. Conclusion: Daprodustat was efficacious and well tolerated for anemia in both NDD and DD patients in the short term based on current RCTs. And daprodustat may become an effective alternative for treatment of anemia with CKD. Since the application of daprodustat is still under exploration, future researches should consider the limitations of our study to evaluate the value of daprodustat.

Abstract

The study aimed to investigate the effects of postoperative position of knee on blood loss and functional recovery after total knee arthroplasty (TKA). We enrolled patients who underwent TKA from 2017 to 2019 in our department with osteoarthritis of the knee in this prospective and randomized study. The patients were randomly allocated to flexion or extension group. In the flexion group, the affected leg was elevated by 30 degrees at the hip and the knee was flexed by 30-degree, postoperatively, while in the extension group, the affected knee was fully extended postoperatively. Patients' data related to postoperative blood loss, Hospital for Special Surgery scores, pain intensity, usage of analgesic drugs, circumference of knee, and range of motion (ROM) of knee were recorded to assess the influence of postoperative leg position on clinical outcomes. Although the transfusion rate was similar between the two groups (p > 0.05), other parameters related to blood loss (including total blood loss, hidden blood loss, usage of analgesic drugs, and postoperative circumference of knee) were significantly lower in the flexion group than those in the extension group (p < 0.05). After 6 weeks and 6 months of rehabilitation, patients gained a similar ROM in the affected knee in both groups (p > 0.05). The length of hospital stay and medical expenses were similar in both groups. Incidence of wound infection and other complications was also similar in both groups (p > 0.05). Elevation of the hip by knee flexion of 30 degrees is an effective and simple method to reduce blood loss after TKA, and contributes to reduction of the dosage of analgesic drugs in the early postoperative period. The routine application of the present protocol also did not increase medical costs and length of hospital stay after TKA.

Abstract

BACKGROUND This meta-analysis was performed to determine the additive effectiveness of autologous platelet-rich fibrin in the treatment of intrabony defects in chronic periodontitis patients. METHODS Pertinent studies were identified by a search in Medline, EMBASE, the Web of Science, and the Cochrane Library. The trials searched were evaluated for eligibility. Cochrane Collaboration's Review Manager software was used to perform the meta-analyses. RESULTS Twelve eligible clinical trials were included. Pooled data found that adjunctive platelet-rich fibrin exactly yielded a significantly superior probing depth reduction compared with open flap debridement alone (weighted mean difference, 1.01; 95% confidence interval 0.95-1.08; P < .00001). The clinical attachment level (CAL) gain after treatment for 9 months was higher in patients treated with platelet-rich fibrin plus open flap debridement group than in open flap debridement-treated patients (weighted mean difference, 1.29; 95% confidence interval 0.96- 1.61; P < .00001). Similarly, the meta-analysis demonstrated that platelet-rich fibrin was superior to single open flap debridement with respect to gingival marginal level change (weighted mean difference, 0.45; 95% confidence interval 0.31-0.58; P < .00001). Regarding the hard tissue radiographic parameters, including defect depth reduction and percentage of fill defects in bone, adjunctive platelet-rich fibrin yielded significantly superior results compared with open flap debridement alone. CONCLUSION Adjunctive use of platelet-rich fibrin with open flap debridement significantly improves fill defects when compared to open flap debridement alone. However, additional powered studies with much larger sample sizes are needed to obtain a more concrete conclusion.

Abstract

OBJECTIVE To investigate the influence of TXA on blood loss and blood transfusion in multiple-level spine surgery and evaluate whether hemoglobin and platelet levels are altered as a result. METHOD This meta-analysis conducted an exhaustive search of literature from Pubmed, Embase, Cochrane Library, Web of Science, and CNKI databases. Stata 11.0 was used to analyze the pooled data. Mean differences (MD) of blood loss, transfusion volume, hemoglobin and platelet levels, as well as odds ratio (OR) of proportion of transfusion were extracted and compared between the TXA group and controls. Publication bias and sensitive analysis were also performed in this study. RESULT A total of 11 studies (6 RCTs and 5 retrospective studies) were enrolled in this meta-analysis according to the inclusion criteria. The data showed that administration of TXA can decrease intraoperative blood loss and perioperative blood transfusion compared to controls (SMD = -0.50; 95 % CI: -0.84, -0.16; I(2) = 52.9 %; p = 0.004) (OR = 0.48; 95 % CI: 0.29, 0.78; I(2) = 0 %; p = 0.003). Moreover, TXA can maintain a superior hemoglobin level after surgery than control group (SMD = -0.27; 95 % CI: 0.07, 0.47; I(2) = 0 %; p = 0.009). The above results were also observed and verified after accounting for publication bias and sensitive analysis. CONCLUSION The application of TXA can effectively reduce intraoperative blood loss and perioperative blood transfusion in patients undergoing multiple-level spine surgery, as well as restore hemoglobin levels after surgery.