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1.
J Cardiothorac Vasc Anesth ; 37(8): 1424-1432, 2023 08.
Article in English | MEDLINE | ID: mdl-37179127

ABSTRACT

OBJECTIVE: The effect of dexmedetomidine on postoperative renal function was investigated in patients undergoing cardiac valve surgery under cardiopulmonary bypass (CPB). DESIGN: A randomized controlled trial. SETTING: University teaching, grade A tertiary hospital. PARTICIPANTS: A total of 70 patients scheduled to undergo cardiac valve replacement or valvuloplasty under CPB were eligible and randomly divided into groups D (n = 35) and C (n = 35) between January 2020 and March 2021. INTERVENTIONS: Patients in group D were administered 0.6 µg/kg/h of dexmedetomidine intravenously from 10 minutes before anesthesia induction to 6 hours after surgery; normal saline was used instead of dexmedetomidine in group C. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of acute kidney injury (AKI). Acute kidney injury was defined according to the Kidney Disease Improving Global Outcomes (2012). It was 22.86% and 48.57% in groups D and C, respectively (p = 0.025). The secondary outcomes were intraoperative hemodynamics and various indices in serum. Ten minutes before CPB (T1), 10 minutes after CPB (T2), and 30 minutes after CPB (T3), mean arterial pressure in group D was lower than that in group C, with statistical significance (74.94 ± 8.52 v 81.89 ± 13.66 mmHg, p=0.013; 62.83 ± 11.27 v 71.86 ± 7.89 mmHg, p < 0.001; 72.26 ± 8.75 v 78.57 ± 8.83 mmHg, p = 0.004). At T1, the heart rate in group D was significantly lower than in group C (80.89 ± 14.04 v 95.54 ± 12.53 bpm, p=0.022). The tumor necrosis factor α, interleukin-6, C-reactive protein, and cystatin C levels in group D were lower than those in group C after the surgery (T4) and 24 hours after surgery (T5), with statistical significance. The duration of mechanical ventilation, intensive-care-unit stay time, and hospital stay time in group D were significantly shorter than in group C. The incidences of tachycardia, hypertension, nausea, and vomiting in group D were similar to those in group C. CONCLUSIONS: Dexmedetomidine may be considered as a way to reduce the incidence and severity of postoperative AKI in patients undergoing cardiac valve surgery under cardiopulmonary bypass.


Subject(s)
Acute Kidney Injury , Dexmedetomidine , Humans , Cardiopulmonary Bypass/adverse effects , Heart Valves/surgery , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Kidney/physiology
2.
Aging (Albany NY) ; 14(21): 8839-8855, 2022 11 14.
Article in English | MEDLINE | ID: mdl-36375472

ABSTRACT

BACKGROUND: lncRNA, a type of non-coding RNA, plays an important role in the osteogenic differentiation of bone marrow-derived mesenchymal stem cells (BM-MSCs). In this study, lncRNA and mRNA microarrays were performed to study the change of gene expression during osteogenic differentiation of BM-MSCs. We focused on Hedgehog interacting protein (HHIP), because HHIP mRNA and lncRNA HHIP-AS1 were gradually down-regulated on days 0, 7, and 14 during osteogenic differentiation. In addition, the gene coding lncRNA HHIP-AS1 is located on the anti-sense of Hhip gene, implying the potential interaction between lncRNA HHIP-AS1 and HHIP mRNA. METHODS: BM-MSCs with over-expressed or silenced lncRNA HHIP-AS1 were constructed to explore the biological role of HHIP-AS1 in osteogenic differentiation. BM-MSCs were lysed to determine the alkaline phosphatase activity. Fluorescence in situ hybridization and immunofluorescence were performed to analyze HHIP-AS1, HHIP, RUNX2 and osteocalcin. RESULTS: Overexpression of lncRNA HHIP-AS1 increased HHIP expression, which suppressed Hedgehog signaling pathway, as indicated by the reduction of SMO, Gli1 and Gli2. The suppression of Hedgehog signal was associated with the inhibited osteogenesis. HHIP knockdown abolished the suppression of osteogenesis induced by lncRNA HHIP-AS1 overexpression. Through binding to HHIP mRNA, lncRNA HHIP-AS1 recruited ELAVL1 to HHIP mRNA, whereby increasing the mRNA stability and the protein level. CONCLUSIONS: This study revealed that down-regulation of HHIP due to lncRNA HHIP-AS1 reduction promoted the osteogenic differentiation of BM-MSCs though removing the suppression of Hedgehog signal.


Subject(s)
Mesenchymal Stem Cells , RNA, Long Noncoding , Hedgehog Proteins/genetics , Osteogenesis/genetics , RNA, Long Noncoding/genetics , In Situ Hybridization, Fluorescence , Cell Differentiation/genetics , RNA, Messenger , Signal Transduction/genetics , Cells, Cultured
3.
Am J Cancer Res ; 12(3): 1264-1281, 2022.
Article in English | MEDLINE | ID: mdl-35411246

ABSTRACT

Chordoma is a rare bone tumor, and the recurrence rate of chordoma is high, the treatment is difficult, and the prognosis is poor. Therefore, it is of great significance to find key target genes for the treatment of chordoma. Microarray was used to analyze the significant gene associated with chordoma. Western blot and RT-PCR were used to detect protein and mRNA expression levels of RP11-867G2.8 and FUT4. Fluorescence in situ hybridization (FISH) assay was used to locate the position of RP11-867G2.8 in chordoma cells. MTT assay, colony formation assay, transwell assay and Xenograft Mouse Model were used to clarify the function of RP11-867G2.8 and FUT4. RNA pull-down, RNA immunoprecipitation, RNA stability assay and polysome profiling analysis were used to clarify the relationship between RP11-867G2.8 and FUT4. We found that RP11-867G2.8 is highly expressed in chordoma tissues and cells, and RP11-867G2.8 overexpression promotes the malignant biological behavior of chordoma cells. RP11-867G2.8 overexpression alters the expression pattern of genes modulating signaling pathway. FUT4 is accumulated in chordoma tissues, and RP11-867G2.8 is antisense RNA of FUT4. RP11-867G2.8 can bind to FUT4 mRNA, increasing FUT4 mRNA stability and facilitating translation of FUT4. RP11-867G2.8 binds to EIF4B and PABPC1, which increases the translation of FUT4. Further studies found that FUT4 silence counteracts the effect of RP11-867G2.8 in vivo and in vitro. Our results suggest that RP11-867G2.8 promotes the development and progression of chordoma by up-regulating the expression of FUT4.

6.
Medicine (Baltimore) ; 97(51): e13822, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30572546

ABSTRACT

To investigate the clinical efficacy of surgical treatment for thoracic spinal tuberculosis with kyphosis deformity via posterolateral debridement, fusion, posterior instrumentation and local continuous chemotherapy. A total of 25 patients with thoracic tuberculosis received surgery by posterolateral decompression, fusion, posterior instrumentation, and postural drainage with local continuous chemotherapy between June 2009 and October 2011. The clinical outcomes was evaluated using statistical analysis about deformity correction, bone fusion, neurologic status, and the visual analog score (VAS) and erythrocyte sedimentation rate (ESR). All of 25 patients were followed up for 39.0 ±â€Š10.7 months (range, 24-60 months) postoperatively. There was no recurrence of tuberculosis, breakage and looseness of internal fixation. Bony fusion was achieved in all cases with 6.7 ±â€Š1.9 months. The values of ESR recovered to normal within 6 months postoperatively. All patients with neurological deficit had significant improvement at the final follow-up. The average preoperative Cobb angles were significantly decreased to 12.2 ±â€Š2.9° (range, 8-17°) postoperatively, and at final follow-up were 12.9 ±â€Š2.7°. Our results showed that single-stage posterolateral debridement fusion, posterior instrumentation and local continuous chemotherapy can be expected to yield satisfactory clinical and radiographic outcomes in patients with thoracic spinal tuberculosis.


Subject(s)
Antitubercular Agents/administration & dosage , Bone Transplantation/methods , Decompression, Surgical/methods , Isoniazid/administration & dosage , Spinal Fusion/methods , Thoracic Vertebrae , Tuberculosis, Spinal/therapy , Adult , Blood Loss, Surgical/statistics & numerical data , Female , Humans , Kyphosis/diagnostic imaging , Kyphosis/etiology , Kyphosis/surgery , Magnetic Resonance Imaging , Male , Middle Aged , Operative Time , Thoracic Vertebrae/surgery , Tomography, X-Ray Computed , Tuberculosis, Spinal/complications , Tuberculosis, Spinal/diagnostic imaging , Tuberculosis, Spinal/pathology , Young Adult
7.
Medicine (Baltimore) ; 97(39): e12471, 2018 Sep.
Article in English | MEDLINE | ID: mdl-30278531

ABSTRACT

Literature about postoperative relapse of Pott's disease is rare. Accordingly, the risk factors and clinical treatments for postoperative relapse of Pott's disease remain controversial. In order to evaluate the clinical outcomes of surgical treatment of postoperative Pott's disease relapse, and to investigate its optimal therapeutic procedures with respect to focal characteristics, we performed a retrospective review of clinical and radiographic data that were prospectively collected between July 2008 and May 2014 from 753 consecutive spinal tubercular patients including 67 patients who were diagnosed and treated as postoperative relapse of Pott's disease in our hospital. Apart from 9 patients being treated conservatively, the remaining 58 cases received surgery in our series. Specifically, 12 cases underwent anterior debridement, interbody fusion with instrumentation; 15 cases received posterior instrumentation anterior debridement, and bone grafting; 10 cases underwent posterior decompression, bone grafting, and instrumentation; 7 cases with debridement, 5 with debridement and sinus resection. Nine cases received percutaneous drainage and low-dose local continuous chemotherapy. Clinical outcomes before and after treatment were evaluated with statistical analysis based on hematologic and radiographic examinations, bone fusion, and neurologic status. Patients were followed-up for a mean of 39.2 ±â€Š8.2 months (range, 24-60 months). Postoperatively, the erythrocyte sedimentation rate (ESR) became normal within 4-6 months in all patients, and solid bone fusion was achieved within 8 months. Patients exhibited significant improvements in neurological deficits postoperatively, while the visual analog scale for pain showed significant improvements in all patients at final follow-up. The outcomes of follow-up showed that the reasons for postoperative relapse of Pott's disease were multiple. Individualized therapeutic methods should be chosen in accordance with the patient's general condition, recurrence focal characteristic, surgeon's experience, but above all is administration of appropriate chemotherapy.


Subject(s)
Decompression, Surgical/instrumentation , Postoperative Complications/epidemiology , Spinal Fusion/instrumentation , Tuberculosis, Spinal/diagnostic imaging , Tuberculosis, Spinal/surgery , Adult , Antitubercular Agents/administration & dosage , Antitubercular Agents/therapeutic use , Blood Sedimentation/drug effects , Bone Transplantation/methods , Debridement/methods , Decompression, Surgical/methods , Drainage/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pain Measurement/drug effects , Perioperative Period/standards , Postoperative Complications/etiology , Recurrence , Retrospective Studies , Risk Factors , Spinal Fusion/methods , Treatment Outcome , Tuberculosis, Spinal/drug therapy
8.
Medicine (Baltimore) ; 97(34): e11925, 2018 Aug.
Article in English | MEDLINE | ID: mdl-30142806

ABSTRACT

This retrospective cohort study aimed to evaluate the clinical outcomes of posterior surgical treatment of ankylosing spondylitis (AS) with spinal tuberculosis (STB). This was a retrospective study including 12 patients treated between January 2004 and April 2014 for AS with STB at our department. All patients underwent 1-stage posterior internal fixation, debridement, and bone fusion. The patients were evaluated based on the American Spinal Injury Association (ASIA), kyphotic Cobb angle, and the visual analog score (VAS). All patients were followed up for an average of 42.7 ±â€Š13.2 months after surgery and bone fusion was achieved 6.8 ±â€Š1.3 months. According to ASIA, 2 cases were rated as Grade D, 10 cases were Grade E at last follow-up. The average preoperative Cobb angle was 26.7 ±â€Š7.6° (range 15-36) and the average postoperative Cobb angle was 7.8 ±â€Š1.2° (range 6-9). The mean latest follow-up Cobb angle was 9.1 ±â€Š1.0° (range 6-10). Compared with the average preoperative Cobb angle, there were significant differences regarding the kyphotic Cobb angle measured postoperatively and at final follow-up (P < .05). The VAS significantly was considerably improved between the preoperative and the last clinical visits. These positive results demonstrate that 1-stage surgical treatment for AS with STB by posterior debridement, fusion, and instrumentation can be an effective and feasible treatment method for this specific condition. It should be noted that it is necessary to carry out antiosteoporosis treatment and perform long-segmental instrumentation in order to obtain spinal stabilization.


Subject(s)
Debridement/methods , Fracture Fixation, Internal/methods , Spondylitis, Ankylosing/surgery , Tuberculosis, Spinal/surgery , Adult , Drug Therapy , Female , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome , Tuberculosis, Spinal/drug therapy
9.
Medicine (Baltimore) ; 97(27): e11401, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29979434

ABSTRACT

Literature on the treatment of cervical spinal tuberculosis (CSTB) is uncommon, the surgical approaches to cervical spinal tuberculosis were controversial. The aim of the study was to evaluate the clinical outcomes of 3 surgical techniques in CSTB patients, and to determine the most appropriate approach for CSTB patients. Between April 2006 and June 2012, we performed a retrospective review of clinical and radiographic data that were collected from 850 consecutive spinal tubercular patients, including 87 patients who were diagnosed and treated for CSTB in our hospital. Apart from 9 patients being treated conservatively, the remainder (78 cases) underwent surgery by anterior debridement, interbody fusion and instrumentation (A group), posterior instrumentation and anterior debridement, fusion and instrumentation in a single or two-stage operation (AP group), or posterior debridement, fusion and posterior instrumentation (P group). The patients were evaluated preoperatively and postoperatively on the basis of hematologic, radiographic examinations, and neurologic function. The 78 patients were followed up for a mean duration of 41.2 ±â€Š7.2 months (range, 24-65 months). Postoperatively, the preoperative erythrocyte sedimentation rate (ESR) value returned to normal within 3 to 6 months in all patients, and solid bone fusion was achieved in 3 to 8 months. The patients exhibited significant improvement in deformity and neurological deficit postoperatively, while the visual analog scale for pain showed significant improvement in all patients at the last follow up visit. The follow-up outcomes demonstrated that all 3 surgical methods were viable management options for CSTB. Individualized therapeutic strategies should be selected according to the patient's general condition, focal characteristics, and the surgeon's experience.


Subject(s)
Debridement/methods , Decompression, Surgical/methods , Spinal Fusion/methods , Tuberculosis, Spinal/surgery , Adult , Aged , Antitubercular Agents/therapeutic use , Blood Sedimentation , Cervical Vertebrae/pathology , Cervical Vertebrae/surgery , Debridement/adverse effects , Decompression, Surgical/adverse effects , Female , Humans , Male , Middle Aged , Pain Measurement , Postoperative Complications/epidemiology , Retrospective Studies , Spinal Fusion/adverse effects , Treatment Outcome , Young Adult
10.
Medicine (Baltimore) ; 97(30): e11704, 2018 Jul.
Article in English | MEDLINE | ID: mdl-30045331

ABSTRACT

Literature reporting on lumber brucella spondylitis (LBS) is rare, therefore, the purpose of this study was to evaluate the outcomes of one-stage surgical management for lumber brucella spondylitis by anterior debridement, autogenous grafts, and instrumentation. This was a retrospective cohort study including 16 patients with lumber brucella spondylitis by treated from January 2009 to October 2011 in our department. All cases underwent one-stage anterior internal fixation, debridement, and bone fusion; clinical and radiographic results were analyzed and compared. All patients were followed up for an average of 35.3 ±â€Š8.1 months (range, 24-48 months). Brucella spondylitis was completely cured in all patients with bone fusion achieved in 4.8 ±â€Š1.3 months. Visual analog scale (VAS) scores were significantly improved between the preoperative and last follow-up visit and neurological function classification showed significant improvement after surgical intervention. Preoperatively, the Cobb angle was 20.7 ±â€Š9.8°, and measured 8.1 ±â€Š1.3° at the last follow-up visit. The outcomes of follow-up demonstrated that one-stage surgical treatment with anterior debridement, fusion, and instrumentation can be an effective and feasible treatment method for lumber brucella spondylitis.


Subject(s)
Brucellosis/surgery , Debridement/methods , Decompression, Surgical/methods , Lumbar Vertebrae/surgery , Ribs/transplantation , Spinal Fusion/methods , Spondylitis/surgery , Adult , Aged , Autografts , Back Pain/prevention & control , Blood Loss, Surgical , Debridement/adverse effects , Decompression, Surgical/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Operative Time , Retrospective Studies , Spinal Fusion/adverse effects , Treatment Outcome
11.
Neurochem Int ; 108: 372-380, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28532680

ABSTRACT

Diabetic neuropathic pain (DNP) plays a major role in decreased life quality of diabetes patients, however, the neural mechanisms underlying DNP remain unclear. Endomorphins are the endogenous ligands for mu-opioid receptor. There is increasing evidence implicating the involvement of spinal endomorphin-2 (EM2) in neuropathic pain. In this study, using a streptozotocin induced diabetic rat model that displayed obvious mechanical allodynia, it was found that the expression of spinal EM2 was significantly decreased in DNP rats. While intrathecal administration of exogenous EM2 attenuated mechanical allodynia in DNP rats, the mu-opioid receptor antagonist ß-funaltrexamine facilitated these events. It was found that the reduction in spinal EM2 was mediated by increased activity of dipeptidylpeptidase IV, possibly as a consequence of diabetes-induced oxidative stress. Taken together, our results provide the first evidence that the reduction in the level of an endogenous opioid in primary afferents was significantly associated with DNP. This indicates that the chronic pain associated with DNP might be due to the loss of an inhibitory effect on pain signal transmission.


Subject(s)
Diabetes Mellitus, Experimental/metabolism , Diabetic Neuropathies/metabolism , Hyperalgesia/metabolism , Oligopeptides/metabolism , Receptors, Opioid, mu/metabolism , Spinal Cord/metabolism , Animals , Diabetes Mellitus, Experimental/pathology , Diabetic Neuropathies/pathology , Hyperalgesia/pathology , Male , Pain Measurement/methods , Rats , Rats, Sprague-Dawley , Spinal Cord/pathology , Streptozocin
12.
J Zhejiang Univ Sci B ; 17(7): 568, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27381734

ABSTRACT

The original version of this article unfortunately contained a mistake. In "Abstract" and the 1st para-graph of Section 2.1, the full name of the abbreviation "ASA" was incorrect in "American Standards Association (ASA)". The correct version should be "American Society of Anesthesiologists (ASA)".

13.
Eur Spine J ; 25(2): 557-68, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26071944

ABSTRACT

AIM: To investigate the efficacy and safety of temporary internal distraction corrective surgery for extremely severe scoliosis. METHODS: Eleven scoliosis patients (3 males and 8 females) with curves ≥130° (mean 148.8°; range 130°-157°) who underwent a two-stage surgery, including a posterior temporary internal distraction correction and definitive posterior spinal correction with posterior pedicle screw instrumentation from 2008 to 2011 were retrospectively reviewed. Minimum follow-up was 2-years (mean 41.8 months; range 27.0-63.0 months). The analysis focused on the impact of temporary internal distraction on curve correction, pulmonary function tests (PFTs), complications and surgical outcomes. Neurosurveillance of sensory (somatosensory-evoked potentials) and motor (motor-evoked potentials) potential was performed in all cases. Posterior instrumentation was used in all patients. RESULTS: After the use of internal distraction, the preoperative major curve (mean 148.8°; range 130°-157°) was corrected to a mean of 79° (range 63°-87°), the T5-T12 kyphosis Cobb angle (mean 79°; range 30°-97°) was corrected to a mean of 59° (range 20°-75°), the coronal imbalance (mean 0.8 cm; range -3.6 to 2.8 cm) was improved to a mean of 0.6 cm (range -1.5 to 2.0 cm), the forced vital capacity percentage (FVC%) was improved from 59.3 ± 11.6 to 68.7 ± 13.7, and the forced expiratory volume in 1 s (FEV1%) was improved from 61.4 ± 13.6 to 71.3 ± 9.3. The average increase in body height was 6.7 cm, and the dorsum razor was corrected to 3-5 cm. During definitive surgery, the final major curves were corrected to a mean of 55° (range 32°-72°), the T5-T12 kyphosis Cobb was corrected to 35° (range 15°-68°), the coronal imbalance was improved to 0.5 cm (range -1.2 to 1.8 cm), the FVC% was improved to 71.2 ± 8.3, the FEV1% was improved to 76.3 ± 16.7, the increase in body height was 3.1 cm, and the dorsum razor was corrected to 1-3 cm. The mean interval time between the two surgeries was 3.5 months. None of the patients exhibited postoperative neurologic deficits or infections. No instrument complications were found during the final follow-up. CONCLUSIONS: Temporary internal distraction in a two-stage corrective surgery provided patients who had extremely severe and rigid scoliosis, an effective and safe solution for scoliosis without significant complications.


Subject(s)
Kyphosis/surgery , Pedicle Screws , Scoliosis/surgery , Spinal Fusion/methods , Adolescent , Body Height , Evoked Potentials, Motor , Evoked Potentials, Somatosensory , Female , Humans , Kyphosis/physiopathology , Male , Postoperative Complications , Postoperative Period , Respiratory Function Tests , Retrospective Studies , Scoliosis/physiopathology , Severity of Illness Index , Treatment Outcome , Vital Capacity , Young Adult
14.
J Zhejiang Univ Sci B ; 16(12): 1042-8, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26642187

ABSTRACT

OBJECTIVE: To explore the relationship of postoperative cognitive dysfunction (POCD) in one-lung ventilation (OLV) patients and regional cerebral oxygen saturation (rSO2). METHODS: Twenty-nine male and twenty-one female cases of OLV received thoracic surgery, with American Standards Association (ASA) physical status being at Grades I-III. Neuropsychological tests were performed on the day before operation and 7 d after operation, and there was an intraoperative continuous monitoring of rSO2. The values of rSO2 before anesthesia induction (t1), at the beginning of OLV (t2), and at the time of OLV 30 min (t3), OLV 60 min (t4), the end of OLV (t5), and the end of surgery (t6) were recorded. The intraoperative average of rSO2 , the intraoperative minimum value of rSO2 (rSO(2, min)), and the reduced maximum percentage of rSO2 (rSO(2, %max)) when compared with the baseline value were calculated. The volume of blood loss, urine output, and the amount of fluid infusion was recorded. RESULTS: A total of 14 patients (28%) in the 50 cases suffered from POCD. The values of mini-mental state examination (MMSE), the digit span and the digit symbol on the 7th day after the operation for POCD in OLV patients were found to be significantly lower than those before the operation (P<0.05). The values of MMSE and vocabulary fluency scores were significantly lower than those in the non-POCD group (P<0.05). The values of rSO2 in the POCD group of OLV patients at t2 and t3 and the values of rSO2 in the non-POCD group at t2 were found to be significantly higher than those at t1 (P<0.05). The values of rSO(2, %max) in the POCD group were significantly higher than those in the non-POCD group (P<0.05). When the value of rSO(2, %max) is more than 10.1%, it may act as an early warning index for cognitive function changes. CONCLUSIONS: POCD after OLV may be associated with a decline in rSO2.


Subject(s)
Brain/metabolism , Cognition Disorders/etiology , One-Lung Ventilation/adverse effects , Oxygen/blood , Postoperative Complications/etiology , Adult , Aged , Brain/blood supply , Case-Control Studies , Cognition , Cognition Disorders/blood , Cognition Disorders/diagnosis , Female , Humans , Male , Middle Aged , Neuropsychological Tests , Postoperative Complications/blood , Postoperative Complications/diagnosis , Predictive Value of Tests , Risk Factors , Time Factors
15.
Arch Orthop Trauma Surg ; 135(4): 491-7, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25720848

ABSTRACT

OBJECTIVE: Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. METHODS: After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann-Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05. RESULTS: 88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients' request. The total perioperative blood loss was approximately 31% lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study. CONCLUSIONS: In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss.


Subject(s)
Batroxobin/administration & dosage , Blood Loss, Surgical/prevention & control , Spinal Fusion , Adolescent , Adult , Aged , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Hemostatics/administration & dosage , Humans , Injections, Intravenous , Male , Middle Aged , Postoperative Period , Prospective Studies , Young Adult
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