Efficacy and safety of multiple-dose intravenous tranexamic acid for reducing blood loss in complex tibial plateau fractures: A prospective randomized controlled trial / 中国修复重建外科杂志

OBJECTIVE@#To investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial.@*METHODS@#A study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference ( P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion.@*RESULTS@#① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups ( P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant ( P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant ( P>0.05). There was no significant difference in the operation time between groups ( P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups ( P<0.05); there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant ( P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups ( P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups ( P>0.05), while there was a significant difference in IL-6 between groups ( P<0.05).@*CONCLUSION@#Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.

<b>Effectiveness of Acupuncture Therapy on </b><i><b>Hiesho </b></i><b>(Cold Disorder) in Maturate Stage Females : A Multicenter, Randomized, Prospective, Controlled T</b><b>rial</b> / 日本東洋医学雑誌

<p><b>Objective </b>: To determine the effectiveness of acupuncture therapy on <i>hiesho </i>in maturate stage females.<br> <b>Design </b>: Multicenter, randomized, prospective, open blind, waiting list-controlled trial.<br><b>Setting </b>: A clinical center attached to three universities and one vocational school.<br><b>Participants </b>: Twenty two females between 18-39 years of age and with a level of more than four points on the “<i>hiesho </i>sensation scale” proposed by Kusumi et al for <i>hiesho</i>. <b>Interventions </b>: Participants were randomly assigned to receive therapies of either acupuncture or no therapy (waiting list controls). Acupuncture therapy was provided by needle retention to SP 6 and electro-acupuncture therapy to BL 32 at a frequency of 1 Hz for 20 minutes. One session per week of this therapy was provided for a total of four sessions. <b>Method of Measurement </b>: The primary outcome of change in <i>hiesho </i>intensity was measured using the visual analogue scale (VAS). Secondary changes were measured by an eight heading score and three component summaries of the standard edition SF-36 v 2.<br><b>Results </b>: The statistical analyses used an intent-to-treat analysis that included two participants who dropped out, and the mixture of one participant targeted for exclusion who was censored from the analyses. As a result, 21 participants were classified as either in the acupuncture group (n = 12) or the control group (n = 9). Efficacy with acupuncture therapy was not found for effect size (Cohen <i>d</i>, point-biserial correlation <i>r</i>) for VAS and the scores of SF-36 between the two groups.<br><b>Conclusions </b>: Effectiveness of the acupuncture therapy was not found, which suggests that it may be due to the smaller sample size, frequency of intervention, and symptoms associated with autonomic dysfunction.</p>