Efficacy of Bovine Hydroxyapatite and Collagen Along With Platelet-Rich Fibrin as a Scaffold and Human Chorion as a Membrane for Ridge Preservation: A Case-Control Study
AIM: The present study aims to determine the efficacy of bovine hydroxyapatite and collagen (G-graft) mixed with platelet-rich fibrin (PRF) used as a scaffold and chorion membrane as a barrier in post-extraction sockets with extraction sites alone. METHODS AND MATERIAL Thirty individuals were randomly assigned into two groups. In the control group, after debridement of the extracted tooth socket, no additional treatment was done. In the test group, after debridement of the extracted tooth socket, the sockets were filled with bovine hydroxyapatite and collagen (G-graft) mixed with PRF. They were covered by a chorion membrane, and a non-absorbable suture material was used to secure the membrane in place. Clinical parameters assessed were plaque index, gingival index, buccolingual width, buccal bone plate height, and lingual bone plate height at baseline and at six months. RESULTS Clinically, there was a more significant reduction in the buccolingual width of the control group than the test group after six months. A statistically significant difference between the two groups for vertical ridge height at the mesial and distal socket sites was observed. No statistically significant difference in buccal and lingual bone plate height was observed between the two groups (p>0.05). CONCLUSIONS Both groups showed a significant reduction in the Buccolingual width, but it was less in the ridge preservation group. Thus, the use of G-graft with PRF and chorion membrane was highly effective in ridge preservation. Key messages: Natural bovine bone mineral, along with PRF and chorion as a membrane, can be utilized effectively for ridge preservation in extracted tooth sockets due to periodontal disease.
Clinical effect of minimally invasive aspiration and drainage of intracranial hematoma in the treatment of cerebral hemorrhage
Pakistan journal of medical sciences. 2022;38(1):95-99
OBJECTIVES To explore the clinical value of minimally invasive aspiration and drainage of intracranial hematoma in the treatment of cerebral hemorrhage. METHODS Seventy-eight patients with cerebral hemorrhage who were treated in the Taian City Central Hospital and the Second Affiliated Hospital of Shandong First Medical University between June 2018 and December 2019 were selected. The patients were randomly numbered and divided into two groups by drawing lots, 39 in each group. The control group was treated with the traditional internal medicine conservative therapy, and the observation group was treated with minimally invasive intracranial hematoma aspiration and drainage. The indexes of the two groups were compared. RESULTS The efficacy rate of the observation group was significantly higher than that of the control group, and the difference was statistically significant (P<0.05). The National Institutes of Health Stroke Scale (NIHSS) score of the observation group was lower than that of the control group after treatment, and the difference was statistically significant (P<0.05). After treatment, the good recovery rate of the observation group was higher compared to the control group, and the difference had statistical significance (P<0.05). The incidence of complications in the observation group was lower than that of the control group, with a statistically significant difference (P<0.05). CONCLUSION In the treatment of cerebral hemorrhage, minimally invasive intracranial hematoma aspiration and drainage facilitates the recovery of patients, promotes the improvement of neurological function, and has a high safety profile and an ideal prognostic quality.
Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery
Revista espanola de cirugia ortopedica y traumatologia. 2022
OBJECTIVE Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3 gr of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in two parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS Total blood loss (TBL) for the placebo group was 831.5 ml and 662.3 ml for the TXA group. The difference between the two groups was 169.2 ml; which means a save of 20.4 per cent; this difference being statistically significant (p<0.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.
Assessing deterioration using impairment and functional outcome measures in chronic inflammatory demyelinating polyneuropathy: a post-hoc analysis of the IOC trial
Journal of the peripheral nervous system : JPNS. 2022
BACKGROUND AND AIMS It is unclear whether frequently used cut-off values for outcome measures defining minimal clinically important differences (MCIDs) can accurately identify meaningful deterioration in chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS We used data from the IOC trial, in which sixty clinically stable CIDP patients were randomized to IVIg withdrawal or continuation. We calculated change scores of the Inflammatory Rasch-Built Overall Disability Scale (I-RODS), grip strength, and MRC sum score (MRC-SS) and classified visits based on a treatment anchor (i.e. decision to restart/increase treatment after reaching a predefined early endpoint of deterioration). The variability of scores in patients without deterioration was calculated using the limits of agreement. We defined optimized MCIDs for deterioration and specific combinations of MCIDs from different outcome measures, and subsequently calculated the accuracies of the (combined) MCIDs. RESULTS Substantial variability was found in scores of the I-RODS, grip strength and MRC-SS in patients without deterioration over time, and most MCIDs were within the limits of the variability observed in patients without deterioration. Some MCID cut-offs were insensitive but highly specific for detecting deterioration, e.g. the MCID-SE of -1.96 of the I-RODS and -2 point on the MRC-SS. Others were sensitive, but less specific, e.g. -4 centiles of the I-RODS. Some combined MCIDs resulted in high specificities and moderate sensitivities. INTERPRETATION Our results suggest that clinically important deterioration cannot be distinguished from variability over time with currently used MCIDs on the individual level. Combinations of MCIDs might improve the accuracy of determining deterioration, but this needs validation.
Evaluation of the safety and efficacy of platelet-rich plasma in the treatment of female patients with chronic telogen effluvium: A randomised, controlled, double-blind, pilot clinical trial
Indian journal of dermatology, venereology and leprology. 2022;:1-9
BACKGROUND Chronic telogen effluvium is characterised by diffuse loss of hair of the scalp. One of the emerging lines of treatment is platelet-rich plasma. However, not much of published data exist. AIMS A pilot study was conducted on chronic telogen effluvium patients to evaluate the efficacy and safety of platelet-rich plasma, and to compare two different methods of platelet-rich plasma preparation. METHODS The study included 30 female patients with chronic telogen effluvium. Patients were randomised into three groups: Group (1): Special platelet-rich plasma tubes centrifuged at 3500 rpm; Group (2): Ordinary laboratory tubes centrifuged at 1000 rpm; Group (3): Normal saline as a placebo. Patients' evaluation was done with visual analog scale, hair pull test, trichoscopy, photos, satisfaction questionnaire, and safety. All patients received four monthly sessions. Patients were evaluated one month and three months after the last session. RESULTS The hair pull test,visual analogue scale, and patient satisfaction results showed a statistically significant difference between group 1 vs. group 3 and group 2 vs.group 3 at one and three months after the sessions, while there was no difference between group1 vs. group 2. Trichoscopy results (baseline, one and three months after treatment) showed a significant increase in hair density and thickness in the frontal area, temporal area, and the vertex in groups 1 and 2 only. There was no statistically significant difference between the three groups with regards to side effects. LIMITATIONS The sample size was small with ten patients in each group. Furthermore, the follow-up of patients was for only three months. CONCLUSIONS Platelet-rich plasma could be considered as a promising therapy for patients with chronic telogen effluvium with an excellent safety profile. The ordinary laboratory low-cost tubes might be a reliable alternative to the expensive special platelet-rich plasma kits tubes. The trial registry number is PACTR202006539654415.
Safety and efficacy of Ninjin'yoeito along with iron supplementation therapy for preoperative anemia, fatigue, and anxiety in patients with gynecological disease: an open-label, single-center, randomized phase-II trial
BMC women's health. 2022;22(1):229
BACKGROUND Preoperative anemia affects perioperative outcomes and often causes fatigue and psychological disorders. Therefore, anemia should be treated before a patient undergoes surgery. Ninjin'yoeito (NYT), a Japanese Kampo medicine composed of ginseng and Japanese angelica root with the other 10 herbs, is administered for anemia, fatigue and anxiety; however, there are a few reports that have prospectively examined the effects of NYT before surgery for gynecological diseases. Hence, we tended to investigate its efficacy and safety. METHODS In this open-label randomized trial, women with gynecological diseases accompanied by preoperative anemia (defined as < 11.0 g/dL Hemoglobin [Hb]) were randomly assigned (1:1) into the iron supplementation and NYT groups. Patients of the iron supplementation group and the NYT group received 100 mg/day iron supplementation with and without NYT (7.5 g/day) for at least 10 days before surgery. The primary endpoint was improvement in Hb levels before and after treatment, and Cancer Fatigue Scale (CFS) and Visual Analogue Scale for Anxiety (VAS-A) scores between groups. Statistical analyses were performed with Wilcoxon signed rank test, Wilcoxon rank sum test, and Fisher's exact test as appropriate. RESULTS Forty patients were enrolled of whom 30 patients were finally analyzed after allocating 15 to each group. There was no difference in the characteristics between both groups. Hb significantly increased in both groups (iron supplementation group, 9.9 ± 0.8 g/dL vs. 11.9 ± 1.6 g/dL; NYT group, 9.8 ± 1.0 g/dL vs. 12.0 ± 1.0 g/dL); the difference in the elevations in Hb between both groups was statistically insignificant (P = 0.72). Contrarily, CFS (17.9 ± 10.2 vs. 8.1 ± 5.2) and VAS-A (56 mm (50-70) vs. 23 mm (6-48)) scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014). Liver dysfunction occurred in one patient of the NYT group. CONCLUSIONS For treating preoperative anemia in women with gynecological conditions, NYT administration along with iron supplementation safely and efficiently improved the preoperative fatigue and anxiety in addition to the recovery from anemia. TRIAL REGISTRATION jRCT1051190012 (28/April/2019, retrospectively registered).
Effects of Autologous Platelet-Rich Plasma on Healing of Peptic Ulcers: A Randomized Controlled Trial
Gastroenterology research and practice. 2022;2022:7944849
PURPOSE Peptic ulcer is a multifactorial and complex disease and affects a wide range of people worldwide. We provided a novel therapeutic approach for peptic ulcer and observed its effect. METHODS Peptic ulcer patients were enrolled from 2016 to 2017 in Chongqing and randomly assigned to two groups: a control group that used only rabeprazole and a platelet-rich plasma (PRP) group that received a combination therapy of autologous PRP (aPRP) and rabeprazole. The therapeutic effect was assessed via the ulcer size and symptom score. RESULTS A total of 27 patients were included (12 patients in the control group and 15 patients in the PRP group) in this study. Our results showed that all participants have healed in 30 days, and there was no significant difference in healing time between the PRP group and the control group in different independent variables. However, regression analysis revealed that the healing time was 6.99 days shorter in the PRP group than that in the control group, and patients with higher symptom scores in the initial examination need more time to heal during treatment. Endoscopic results showed that the repaired ulcer in the PRP group was more similar to the normal gastric mucosa tissue than that the control group. CONCLUSION This study showed an encouraging preliminary result that aPRP has a positive result in patients with peptic ulcer and seems to be a better choice for refractory peptic ulcer treatment. Although further follow-up studies are needed to determine the duration of efficacy of aPRP, the approach will be helpful in improving the clinical treatment of peptic ulcer.
Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial
Lancet (London, England). 2022;399(10324):530-40
BACKGROUND Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited. METHODS In this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581. FINDINGS From Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66-1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14-4·29); for patients who were antibody negative, the OR was 0·51 (0·29-0·90; p(interaction)=0·001). INTERPRETATION When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry. FUNDING US National Institutes of Health.
Hospitalised patients with COVID-19 enrolled in the ITAC trial in 11 countries (n= 593).
Hyperimmune intravenous immunoglobulin (hIVIG), (n= 301).
Placebo (n= 292).
The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extra-pulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7. Infusion reactions were more common in the hIVIG group (18.6%) than placebo (9.5%). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%).
The Effect of Sex-Mismatched Red Blood Cell Transfusion on Endothelial Cell Activation in Critically Ill Patients
Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie. 2022;49(2):98-105
BACKGROUND Observational studies suggest that sex-mismatched transfusion is associated with increased mortality. Mechanisms driving mortality are not known but may include endothelial activation. The aim of this study is to investigate the effects of sex-mismatched red blood cell (RBC) transfusions on endothelial cell activation markers in critically ill patients. STUDY DESIGN AND METHODS In patients admitted to the intensive care unit who received a single RBC unit, blood samples were drawn before (T(0)), 1 h after (T(1)), and 24 h after transfusion (T(24)) for analysis of soluble syndecan-1, soluble intercellular adhesion molecule-1, soluble thrombomodulin (sTM), von Willebrand factor antigen, interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNFα). Changes in the levels of these factors were compared between sex-matched and sex-mismatched groups. RESULTS Of 69 included patients, 32 patients were in the sex-matched and 37 patients were in the sex-mismatched group. Compared to baseline, sex-matched transfusion was associated with significant reduction in sTM level (p value = 0.03). Between-group comparison showed that levels of syndecan-1 and sTM were significantly higher in the sex-mismatched group compared to the sex-matched group at T(24) (p value = 0.04 and 0.01, respectively). Also, TNFα and IL-6 levels showed a statistically marginal significant increase compared to baseline in the sex-mismatched group at T(24) (p value = 0.06 and 0.05, respectively), but not in the sex-matched group. DISCUSSION Transfusion of a single sex-mismatched RBC unit was associated with higher syndecan-1 and sTM levels compared to transfusion of sex-matched RBC unit. These findings may suggest that sex-mismatched RBC transfusion is associated with endothelial activation.
Application of Different Doses of Tranexamic Acid Plus Traditional Chinese Medicine in Hip Arthroplasty in Patients with Diabetes and Its Influence on Intraoperative Blood Loss and Postoperative Drainage
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:1197495
OBJECTIVE To evaluate the efficacy of different doses of tranexamic acid plus traditional Chinese medicine (TCM) in hip arthroplasty in diabetic patients and the effect on intraoperative hemorrhage and postoperative drainage. METHODS One hundred patients admitted to our hospital from January 2019 to September 2021 were randomly divided into group B (n = 50) and group A (n = 50), and tranexamic acid was injected intravenously at a dose of 10 mg/kg and 20 mg/kg 30 min before skin incision, and then tranexamic acid 1.0 g was injected into the joint cavity through the drainage after incision closure, followed by 3 h of drainage clamping. The amount of blood loss, coagulation index, postoperative drainage, and incidence of venous thromboembolism (VTE) were compared between the groups. RESULTS Group A had significantly less total blood loss, dominant blood loss, and hidden blood loss than group B (P < 0.05). No significant difference in postoperative coagulation indexes and postoperative drainage flow was found between the two groups (P > 0.05). Serological examination results demonstrated no statistical difference in D-dimer (D-D) levels between the two groups. The absence of VTE in both groups was determined by imaging. CONCLUSION Tranexamic acid is effective in reducing intraoperative hemorrhage in diabetic patients undergoing hip arthroplasty. The dose of 20 mg/kg outperforms 10 mg/kg in terms of clinical efficacy with a favorable safety profile, which can be applied according to the patient's actual condition.