Current Issue : April - June Volume : 2021 Issue Number : 2 Articles : 6 Articles
Tranexamic acid (TXA) is increasingly used in orthopedic surgery to reduce blood loss; however, there are concerns about the risk of venous thromboembolic (VTE) complications. The aim of this study was to evaluate TXA safety in patients undergoing lower limb orthopedic surgical procedures. Design. A meta-analysis was performed on the PubMed, Web of Science, and Cochrane Library databases in January 2020 using the following string (Tranexamic acid) AND ((knee) OR (hip) OR (ankle) OR (lower limb)) to identify RCTs about TXA use in patients undergoing every kind of lower limb surgical orthopedic procedures, with IV, IA, or oral administration, and compared with a control arm to quantify the VTE complication rates. Results. A total of 140 articles documenting 9,067 patients receiving TXA were identified. Specifically, 82 studies focused on TKA, 41 on THA, and 17 on other surgeries, including anterior cruciate ligament reconstruction, intertrochanteric fractures, and meniscectomies. The intravenous TXA administration protocol was studied in 111 articles, the intra-articular in 45, and the oral one in 7 articles. No differences in terms of thromboembolic complications were detected between the TXA and control groups neither in the overall population (2.4% and 2.8%, respectively) nor in any subgroup based on the surgical procedure and TXA administration route. Conclusions. There is an increasing interest in TXA use, which has been recently broadened from the most common joint replacement procedures to the other types of surgeries. Overall, TXA did not increase the risk of VTE complications, regardless of the administration route, thus supporting the safety of using TXA for lower limb orthopedic surgical procedures....
There is no treatment for septic acute kidney injury (sAKI). The anti-inflammatory activity of prolonged-release pirfenidone (PR-PFD) could be beneficial in this clinical setting. Methods. This study was a double-blind randomized clinical trial in sAKI patients with nephrology consultation at the Civil Hospital of Guadalajara, in addition to the usual treatment of AKI associated with sepsis; patients were randomized to receive either PR-PFD at 1,200 mg/day (group A) or 600 mg/day (group B) or a matched placebo for 7 consecutive days.Theprimary objective was the decrease in serum creatinine (sCr) and increase in urinary volume (UV); the secondary objectives were changes in serum electrolytes, acid-base status, and mortality. Results. Between August 2016 and August 2017, 88 patients were randomized. The mean age was 54 (17 ± SD) years, and 47% were male. The main site of infection was the lung (39.8%), septic shock was present in 39.1% of the cases, and the mean SOFA score was 8.8 points. 28 patients received PFD 1,200 mg, 30 patients received PFD 600 mg, and 30 patients received placebo. During the study, sCr did not differ among the groups. The reversion rate of sCr, UV, and mortality was not different among the groups (p= 0.70, p = 0.47, and p = 0.38, respectively). Mild adverse events were not different among the groups. Conclusion. PR-PFD did not improve the clinical course of sAKI and seemed to be safe in terms of adverse events. This trial is registered with NCT02530359....
Sahastara (SHT) remedy is a Thai traditional medicine described in the Thai National List of Essential Medicine (NLEM) for the relief of muscle pain. The purpose of this study was to investigate the efficacy and safety of SHTremedy extract capsule for treating primary OA. A phase 2, double-blind, randomized, and controlled trial study was used to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee OA. The outcome of reduce pain was measured from VAS, 100 meter time walk, and theWOMAC score of day 14 and day 28 which should reduce significantly when compared with day 0 and should be equal with or better than diclofenac. Blood pressure and blood chemistry values at day 14 and day 28 did not change when compared with day 0. The results found that SHTremedy ethanolic extract capsule can reduce allOAknee scores at day 14 and day 28 significantly when compared with day 0 and also no significant difference with diclofenac (P > 0.05). The SHTalso showed safety values on blood pressure and blood chemistry.The SHTwas observed that it had no serious side effect.The results of this study are the first report of using the SHTethanolic extract capsule in the treatment of primary osteoarthritis of the knee. It can be recommended as an anti-inflammatory herbal drug for reducing pain in knee osteoarthritis patients....
To compare the efficiency of transcutaneous electrical acupoint stimulation (TEAS) with those of conventional and TCM herb on bone marrow suppression in small cell lung cancer (SCLC) patients after initial chemotherapy. Methods. We recruited 139 participants with pathologically confirmed SCLC who had not received chemotherapy. The conventional group (n 37) received gemcitabine and cisplatin chemotherapy and routine care. The TCM herb group (n 35) received 3 Diyushengbai tablets thrice a day for one day prior to chemotherapy and maintained during the trial. The TEAS group (n 42) received TEAS at a frequency of 65–100 Hz with a pulse width of 100–200 μsec. Acupoints were selected from Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4) and were treated on days 1, 2, 3, 5, 8, 14, 21, and 28 of chemotherapy for 30 min each day. All three groups underwent a 28-day treatment for a total of one treatment course. Changes in the white blood cell, neutrophil, platelet, and hemoglobin indices on day 1 before chemotherapy and days 5, 8, 11, 14, 21, and 28 days after chemotherapy were compared among the groups. Comfort levels of patients on day 1 before chemotherapy and days 5, 11, and 21 after chemotherapy were observed. Results. Compared with the conventional group, the white blood cell counts in the TEAS group on days 8 (7.07 ± 2.11 vs. 5.97 ± 2.10 ×109/L) and 14 (6.14 ± 1.51 vs. 5.07 ± 2.41 × 109/L) of chemotherapy and that in the TCM herb group on day 14 (6.63 ± 3.44 vs. 5.07 ± 2.41 × 109/L) of chemotherapy were increased (P < 0.05). Compared with the conventional group, the neutrophil count in the TEAS group on days 5 (4.28 ± 1.54 vs. 3.01 ± 1.41 × 109/L), 8 (3.75 ± 1.21 vs. 2.77 ± 1.17 ×109/L), 11 (3.46 ± 1.31 vs. 2.31 ± 1.24 ×109/L), 14 (3.18 ± 1.29 vs. 2.07 ± 1.14 ×109/L), and 21 (4.67 ± 1.31 vs. 3.58 ± 1.23 ×109/L) of chemotherapy and that in the TCM herb group on day 5 (3.88 ± 1.05 vs. 3.01 ± 1.41 × 109/L) of chemotherapy were increased (P < 0.05). Compared with the conventional group, the platelet count of patients in the TEAS group increased on days 5 (264.7 ± 64.1 vs. 201.0 ± 55.7 ×109/L), 8 (251.3 ± 74.9 vs. 188.2 ± 65.8 ×109/L), 11 (236.7 ± 74.9 vs. 181.3 ± 84.3 ×109/L), and 14 (238.3 ± 75.9 vs. 192.8 ± 95.8 ×109/L) of chemotherapy (P < 0.05). Compared with the TCM herb group, the platelet count in the TEAS group increased on days 5 (264.7 ± 64.1 vs. 216.3 ± 57.9 ×109/L), 8 (251.3 ± 74.9 vs. 213.7 ± 70.3 ×109/L), 11 (236.7 ± 74.9 vs. 181.3 ± 84.3 ×109/L), and 21 (254.8 ± 81.8 vs. 213.9 ± 82.6 ×109/L) of chemotherapy (P < 0.05). Compared with the conventional group, the hemoglobin level in the TCM herb group increased on day 14 (135.03 ± 28.06 vs. 122.09 ± 12.63 g/L) of chemotherapy (P < 0.05). Compared with the conventional group, the comfort score of the TEAS group increased on days 5 (78.31 ± 10.21 vs. 70.18 ± 9.34 score) and 11 (80.07 ± 10.44 vs. 72.11 ± 9.47 score) of chemotherapy (P < 0.05). Conclusion. TEAS is an effective and safe treatment modality for improving bone marrow suppression in SCLC patients after initial chemotherapy. TEAS improved comfort levels more effectively than did conventional and TCM herb....
The probable impact of growth hormone (GH) as a heart failure (HF) treatment strategy is still less investigated. Therefore, we aimed to evaluate the relation of 3-month GH prescription on left ventricular ejection fraction (LVEF), interventricular septum (IVS), posterior left ventricle (LV) thickness, end systolic and end diastolic diameters (ESD and EDD), and pulmonary arterial pressure (PAP) among Iranian individuals suffering from HF due to MI attack. Methods. A total of 16 clinically stable participants with HF diagnosis and LVEF < 40% were selected for enrollment in this pilot randomized doubleblinded study. They were randomly assigned equally to groups received 5 IU subcutaneous GH or placebo. Injections were done every other day for a total of 3-month duration. After termination of intervention and nine months afterwards, cardiac outcomes were assessed. Results. Baseline and 12-month posttrial participants’ characteristics were similar. LVEF was increased significantly by three months started from baseline in individuals receiving GH (32 ± 3:80% to 43:80 ± 4:60%, P = 0:002). During the next 9 months of follow-up concurrent with cessation of injections, LVEF was declined (43:80 ± 4:60% to 32:20 ± 6:97%, P = 0:008). LVEF and ESD were remarkably higher and lower in GH group compared with controls by the end date of injections (43:80 ± 4:60% vs. 33:14 ± 4:84%, P = 0:02 and 39:43 ± 3:45mm vs. 33 ± 3:16 mm, P = 0:03, respectively). No other considerable association was found in terms of other predefined variables in neither GH nor placebo groups. Conclusions. GH administration in HF patients was associated with increased LVEF function. Several randomized clinical trials are necessary proving this relation. This trial is registered with IRCT201704083035N1....
Considering the favorable overall safety profile of trastuzumab emtansine (T-DM1), the low expected rate of cardiotoxicity, and the synergistic effect of anthracyclines with Human Epidermal Growth Factor Receptor 2 (HER2)-targeting agents, it is hypothesized that T-DM1 may be safely combined with non-pegylated liposomal doxorubicin (NPLD). In the THELMA trial, the effect of adding NPLD to T-DM1 was evaluated with the aim of enhancing T-DM1 efficacy using an extensive cardiological assessment in trastuzumab- and taxane-pretreated patients with HER2-positive metastatic breast cancer. Despite an unlikely drug synergism, this combination was generally well tolerated without clinically relevant worsening of cardiac function. No relationship was identified between early predictors of heart failure and left ventricular ejection fraction changes. Thus, the combination of T-DM1 plus NPLD is safe, but this regimen does not seem to improve T-DM1 antitumor activity in this setting....
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