Abstract

PURPOSE To compare the long-term clinical efficacy provided by intra-articular injections of either Pure Platelet-rich Plasma (P-PRP) or sham saline to treat knee osteoarthritis (KOA). METHODS This prospective, parallel-group, double-blind, multi-center, sham-controlled randomized clinical trial recruited participants with KOA from orthopedic departments at nine public hospitals (five tertiary medical centers, four secondary medical units) starting January 1, 2014, with follow-up completed on February 28, 2021. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 1, 2021, to July 15, 2021. Three sessions (1 every week) of P-PRP or sham saline injected by physicians. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 6, 12, 24, 60 months of follow-up. Secondary outcomes included the International Knee Documentation Committee (IKDC) subjective score, visual analogue scale (VAS) score, intra-articular biochemical marker concentrations, cartilage volume, and adverse events. Laboratory of each hospital analyzed the content and quality of P-PRP. RESULTS 610 participants (59% women) with KOA who received three sessions of P-PRP (n = 308, mean age 53.91 years) or sham saline (n = 302, mean age 54.51 years) injections completed the trial. The mean platelet concentration in PRP is 4.3-fold (95% confidence interval 3.6-4.5) greater than that of whole blood. Both groups showed significant improvements in IKDC, WOMAC, and VAS scores at 1 month of follow-up. However, only the P-PRP group showed a sustained improvement in clinical outcome measurements at month 24 (P < 0.001). There were statistically significant differences between the P-PRP and sham saline groups in all clinical outcome measurements at each follow-up time point (P < 0.001). The benefit of P-PRP was clinically better in terms of WOMAC-pain, WOMAC-physical function and WOMAC-total at 6, 12, 24, and 60 months of follow-up. No clinically significant differences between treatments were documented in terms of WOMAC-stiffness at any follow-up. A clinically significant difference favoring P-PRP group against saline in terms of IKDC and VAS scores was documented at 6, 12, 24 and 60 months of follow-up. At 6 months after injection, TNF-α and IL-1β levels in synovial fluid were lower in the P-PRP group (P < 0.001). Tibiofemoral cartilage volume decreased by a mean value of 1171 mm(3) in the P-PRP group and 2311 mm(3) in the saline group over 60 months and the difference between the group was statistically significant (intergroup difference, 1140 mm(3), 95% CI - 79 to 1320 mm(3); P < 0.001). CONCLUSIONS In this randomized clinical trial of patients with KOA, P-PRP was superior to sham saline in treating KOA. P-PRP was effective for achieving at least 24 months of symptom relief and slowing the progress of KOA, with both P-PRP and saline being comparable in safety profiles.

Abstract

OBJECTIVE To explore the 3D-slicer software-assisted endoscopic treatment for patients with hypertensive cerebral hemorrhage. METHODS A total of 120 patients with hypertensive cerebral hemorrhage were selected and randomly divided into control group and 3D-slicer group with 60 cases each. Patients in the control group underwent traditional imaging positioning craniotomy, and patients in the 3D-slicer group underwent 3D-slicer followed by precision puncture treatment. In this paper, we evaluate the hematoma clearance rate, nerve function, ability of daily living, complication rate, and prognosis. RESULTS The 3D-slicer group is better than the control group in various indicators. Compared with the control group, the 3D-slicer group has lower complications, slightly higher hematoma clearance rate, and better recovery of nerve function and daily living ability before and after surgery. The incidence of poor prognosis is low. CONCLUSION The 3D-slicer software-assisted endoscopic treatment for patients with hypertensive intracerebral hemorrhage has a better hematoma clearance effect, which is beneficial to the patient's early recovery and reduces the damage to the brain nerve of the patient.

Abstract

BACKGROUND Early lactate-guided resuscitation was endorsed in the guidelines of the Surviving Sepsis Campaign as a key strategy to decrease the mortality of patients admitted to the ICU department with septic shock. However, its effectiveness in elderly Asian patients is uncertain. METHOD We conducted a single-center trial to test the effectiveness of the early lactate-guided resuscitation of older Asian patients at the Second Hospital of Hebei Medical University. Eligible septic shock patients who consented to participation in the study were randomly assigned to receive early lactate-guided treatment or regular treatment as controls. RESULT A total of 82 patients met the hyperlactatemia criteria and participated in the trial. Forty-two patients received early lactate-guided treatment (lactate group) and 40 received regular treatment (control group). The lactate group received more fluids at initial 6 hours (3.3 ± 1.4 vs 2.4 ± 1.7 L, P = 0.01), but similar proportions of patients in both groups required the use of vasopressors and vasodilators. Patients in the lactate group showed significantly reduced ICU needs compared to the control group, which were weaned from mechanical ventilation more quickly (median 7, IQR 4 to 14 vs median 9, IQR 4.3 to 17.8, P = 0.02) and transferred out of the ICU earlier (median 4.5, IQR 2.8 to 7.3 vs median 6, IQR 3.2 to 8, P = 0.01). However, the hospital mortality (35.7% vs 42.5%, P = 0.35) and ICU mortality (31.0% vs 37.5%, P = 0.38) for both groups were not reduced. CONCLUSION For critically ill patients (elderly Asian patients) admitted to the ICU department with hyperlactatemia, early lactate-guided treatment reduced ICU needs but did not reduce mortality.

Abstract

BACKGROUND Elbow joint open arthrolysis is an effective method to release contracted tissue and débride heterotopic ossification in cases of post-traumatic elbow stiffness. Recurrence remains one of the most common concerns for surgeons. Soft tissue contracture may result from intra- and/or extra-articular bleeding, edema, effusion, and granulation. The increasing incidence of intraoperative and postoperative bleeding has caused uncertainty about surgical outcomes. Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty. PURPOSE To investigate whether topical TXA can decrease blood loss and effusions in patients treated with elbow joint open arthrolysis and whether it affects final function. PATIENTS AND METHOD A prospective comparative study was conducted. Sixty-one patients with joint stiffness were enrolled and randomly divided into 2 groups: one consisting of 31 patients treated with topical TXA intraoperatively after open arthrolysis (experimental group) and the other consisting of 30 patients who received saline administration (control group). The operation time, tourniquet time, and intraoperative blood loss were recorded. Drainage volume, elbow rotation, elbow motion arc, Mayo Elbow Performance Score, and operation-related complications were followed up and recorded, whereas hematoma volume remaining in the joint space after drainage tube removal was assessed on ultrasonography. RESULTS Tourniquet time, intraoperative blood loss, and postoperative drainage were significantly lower in the TXA group than in the control group. However, no significant intergroup differences were found in the incidence of related complications and final function evaluated at the final follow-up. CONCLUSION Topical TXA improves surgical quality by controlling intraoperative bleeding, decreases the amount of blood loss soon after surgery, and could become a routine procedure in elbow joint open arthrolysis.

Abstract

BACKGROUND Patients with septic shock in whom Norepinephrine (NE) infusion alone is insufficient to raise blood pressure require the concomitant administration of Vasopressin (VP). However, current guidelines do not advise clinicians as to which vasoactive agent to discontinue first once the patient's septic shock begins to resolve. Moreover, there is controversial data guiding clinicians on how to discontinue vasopressors for septic shock patients who are receiving a combination therapy of NE and VP. METHODS The PubMed, Embase and Cochrane Central Register databases were searched from the database inception until October 18, 2018. Studies were limited to adult patients with septic shock who received concomitant NE and VP treatment, that included different orders of vasopressor discontinuation. The primary outcome was the incidence of hypotension. Overall mortality, ICU mortality and length of stay in the ICU (LOS) were secondary outcomes. Sensitivity and subgroup analyses, as well as trial sequential analysis (TSA), were performed. RESULTS One prospective randomized controlled trial and seven retrospective cohort studies were included in present meta-analysis. Compared with discontinuing VP first, the incidence of hypotension was significantly lower when NE was discontinued first (OR 0.3, 95% CI 0.10 to 0.86, P = 0.02; I = 91%). No significant difference was detected in either overall mortality (OR 1.28, 95% CI 0.77 to 2.10, P = 0.34) or ICU mortality (OR 0.99, 95% CI 0.74 to 1.34, P = 0.96) between these two groups. Furthermore, ICU length of stay (LOS) was also evaluated in five studies, and no statistical significance was observed between the two groups with different orders in weaning vasopressors (mean difference, 1.35, 95% CI -2.05 to 4.74, P = 0.44). The subgroup analyses suggested a significant association between hypotension and the practice of discontinuing VP first specifically in patients with a low usage rate of corticosteroids (OR 0.18, 95% CI 0.04 to 0.78, P = 0.02). The TSA indicated a lack of sufficient evidence to draw conclusions from the current results (RIS = 11,821). CONCLUSIONS In adults with septic shock treated with concomitant VP and NE therapy, discontinuing VP first may lead to a higher incidence of hypotension but is not associated with mortality or ICU LOS. Further prospective studies with larger sample sizes are warranted.

Abstract

BACKGROUND Intravenous crystalloid solutions are administered commonly for critically ill patients. We performed this meta-analysis of randomized trials with trial sequential analysis (TSA) to evaluate effects of chloride content of intravenous crystalloid solutions on clinical outcomes among critically ill adult patients. METHODS Electronic databases were searched up to June 1, 2018, for randomized trials of use of balanced crystalloids versus 0.9% saline solutions in critically ill adult patients. The outcome variables included mortality, renal outcomes, serum content alterations and organ function. Subgroup analysis was conducted according to patient settings, types or volume of crystalloid fluid, or among sepsis versus non-sepsis, TBI versus non-TBI or subpopulations by the categories of baseline kidney function. Random errors were evaluated by trial sequential analysis. RESULTS Eight studies with 19,301 patients were analyzed. A trend of in-hospital survival benefit with no statistical difference could be observed with balanced crystalloids compared with 0.9% saline (RR 0.92, 95% CI 0.85-1.0, p = 0.06). The use of balanced crystalloid solutions was associated with longer RRT-free days (SMD 0.09, 95% CI 0.06-0.12, p < 0.001), less risk of increase in serum concentrations of chloride (SMD - 1.23, 95% CI - 1.59 to - 0.87, p < 0.001) and sodium (SMD - 1.28, 95% CI - 1.65 to - 0.92, p < 0.001), less risk of decline in serum base deficit (SMD - 0.58, 95% CI - 0.98 to - 0.18, p = 0.004), longer ventilator-free days (SMD 0.08, 95% CI 0.05-0.11, p < 0.001) and vasopressor-free days (SMD 0.04, 95% CI 0.00-0.07, p = 0.02). Subgroup analysis showed that balanced crystalloid solutions were associated with a reduced in-hospital mortality rate among septic patients (RR 0.86, 95% CI 0.75-0.98; p = 0.02) and non-traumatic brain injury patients (RR 0.90, 95% CI 0.82-0.99, p = 0.02), while the TSA results indicated a larger sample size is still in need. CONCLUSIONS Limited evidence supported statistical survival benefit with balanced crystalloid solutions, while it benefited in reducing organ support duration and fluctuations in serum electrolyte and base excess and was associated with decreased in-hospital mortality in subpopulation with sepsis and non-TBI. Large-scale rigorous randomized trials with better designs are needed to provide robust evidence for clinical management. Trial registration The protocol for this meta-analysis was registered on PROSPERO International prospective register of systematic reviews (CRD42018102661), https://www.crd.york.ac.uk/prospero/#recordDetails.

Abstract

The main aim of this study was to investigate the effects of human gamma globulin (HGG) on inflammation targets in children. A total of 80 children were randomly divided into observation and control group with 40 cases in each group. The control group was given comprehensive treatment while the observation group was treated with HGG. The time of disappearance of clinical signs and symptoms, time of improvement of pulmonary iconography, inflammatory indices, time and degree of improvement of lung function and adverse reactions were observed. The total effective rate in the observation group was 97.5% and significantly higher than control group (77.5%). The time of fever clearance, imaging improvement as well as cough and pulmonary rales disappearance in the observation group was shorter than control group. After treatment, the levels of inflammatory indicators such as erythrocyte sedimentation rate (ESR) and C-reaction protein (CRP) in the observation group were lower than control group. No obvious abnormalities of urea nitrogen, creatinine, serum alanine amino transferase (ALT) and aspartate amino transferase (AST) were found in the two groups. Overall, HGG effectively shortened the course of RMPP, improved the cure rate, reduced the inflammatory reaction and promoted the recovery of lung function without obvious adverse reaction.

Abstract

BACKGROUND Understanding the latest human immunodeficiency virus (HIV) epidemic in voluntary blood donors could be of great value to further increase blood safety in China, as transfusion-transmitted infection places a heavy burden on both infected individuals and the whole society. Therefore, we evaluated the national HIV prevalence of voluntary blood donors in China and characteristics of HIV-infected blood donors. STUDY DESIGN AND METHODS We searched literature in Chinese and English concerning the prevalence of HIV infections in Chinese voluntary blood donors from 2010 to 2017, yielding 97 eligible papers. We performed a meta-analysis to calculate pooled HIV prevalence, and characteristics of HIV-infected blood donors were also extracted. RESULTS The pooled sample consisted of 21,100,755 voluntary blood donors and 4,755 HIV-infected blood donors. Pooled HIV prevalence of China voluntary blood donors during 2010 to 2017 was 21.02 in 100,000. Pooled HIV prevalence varied in different provinces, showing greater severity in Southwest, Northwest, and South China. Subgroup analysis also showed a significantly increasing trend from 2010 to 2017. The majority of HIV-infected blood donors in China were male, young, unmarried, nonlocal residents, receiving 12 years or less of schooling, and first-time donors. Nearly 90% of HIV-infected blood donors acquired their infections through sexual contact. CONCLUSION The prevalence of HIV increased in China among voluntary blood donors during 2010 to 2017, highlighting the risk of HIV transmission by transfusion. Blood centers and public health services should improve screening and intervention programs targeting voluntary blood donors and expand education on blood safety in areas experiencing severe epidemics and among high-risk populations.

Abstract

BACKGROUND This project involved the development and evaluation of a new visual bleeding feedback (VBF) system for tourniquet training. We hypothesized that dynamic VBF during junctional tourniquet training would be helpful and well received by trainees. MATERIALS AND METHODS We designed the VBF to simulate femoral bleeding. Medical students (n = 15) and emergency medical service (EMS) members (n = 4) were randomized in a single-blind, crossover study to the VBF or without feedback groups. Poststudy surveys assessing VBF usefulness and recommendations were conducted along with participants' reported confidence using a 7-point Likert scale. Data from the different groups were compared using Wilcoxon signed-rank and rank-sum tests. RESULTS Participants rated the helpfulness of the VBF highly (6.53/7.00) and indicated they were very likely to recommend the VBF simulator to others (6.80/7.00). Pre- and post-VBF confidence were not statistically different (P = 0.59). Likewise, tourniquet application times for VBF and without feedback before crossover were not statistically different (P = 0.63). Although participant confidence did not change significantly from beginning to end of the study (P = 0.46), application time was significantly reduced (P = 0.001). CONCLUSIONS New tourniquet learners liked our VBF prototype and found it useful. Although confidence did not change over the course of the study for any group, application times improved. Future studies using outcomes of this study will allow us to continue VBF development as well as incorporate other quantitative measures of task performance to elucidate VBF's true benefit and help trainees achieve mastery in junctional tourniquet skills.

Abstract

We perform a meta-analysis from published randomized controlled trials to assess the efficacy and safety of aprotinin in total hip arthroplasty (THA). The following electronic databases were searched: PubMed (1966 to December 2018), EMBASE (1974 to December 2018), the Cochrane Library (1974 to December 2018), and Web of Science (1990 to December 2018). We also used Google Search to search for more potentially eligible studies up to December 2018. The methodological quality of the included studies was assessed independently by the two reviewers described by the Cochrane Collaboration for Systematic Reviews. Data analysis was performed with STATA13.0. Four randomized controlled trials were included in the meta-analysis. Our study indicated that intravenous aprotinin was associated with improved outcomes in terms of total blood loss, hemoglobin decline, and transfusion rates. There was no significant difference regarding the length of stay and the risk of deep venous thrombosis and pulmonary embolism. Intravenous aprotinin was effective and safe to use in reducing total blood loss after total hip arthroplasty. Further high-quality studies are required to confirm the conclusion.