Comparative study between oxytocin and combination of tranexamic acid and ethamsylate in reducing intra-operative bleeding during emergency and elective cesarean section after 38 weeks of normal pregnancy.

OBJECTIVE: Cesarean Section (CS) is associated with an increased risk of hemorrhage. Many drugs are used to decrease this risk. We aim to compare the combination of ethamsylate and tranexamic acid, oxytocin, and placebo in women undergoing CS. METHODS: We conducted a double-blinded, randomized, placebo-controlled trial between October and December 2020 in four university hospitals in Egypt. The study included all pregnant women in labor without any complications who accepted to participate in the study between October and December 2020. The participants were divided into three groups. The subjects were randomly allocated to receive either oxytocin (30 IU in 500 ml normal saline during cesarean section), combined one gram of tranexamic acid with 250 mg of ethamsylate once before skin incision, or distilled water. Our main outcome was the amount of blood loss during the operation. The secondary outcomes were the need for blood transfusion, hemoglobin and hematocrit changes, hospital stay, operative complications, and the need for a hysterectomy. The one-way ANCOVA test was used to compare the quantitative variables between the three groups while the Chi-square test was used to compare the qualitative variables. Post hoc analysis then was performed to compare the difference between every two groups regarding the quantitative variables. RESULTS: Our study included 300 patients who were divided equally into three groups. Tranexamic acid with ethamsylate showed the least intra-operative blood loss (605.34 ± 158.8 ml) compared to oxytocin (625.26 ± 144.06) and placebo (669.73 ± 170.69), P = 0.015. In post hoc analysis, only tranexamic acid with ethamsylate was effective in decreasing the blood loss compared to placebo (P = 0.013); however, oxytocin did not reduce blood loss compared to saline (P = 0.211) nor to tranexamic acid with ethamsylate (P = 1). Other outcomes and CS complications showed no significant difference between the three groups except for post-operative thrombosis which was significantly higher in the tranexamic and ethamsylate group, P < 0.00001 and the need for a hysterectomy which was significantly increased in the placebo group, P = 0.017. CONCLUSION: The combination of tranexamic acid and ethamsylate was significantly associated with the least amount of blood loss. However, in pairwise comparisons, only tranexamic acid with ethamsylate was significantly better than saline but not with oxytocin. Both oxytocin and tranexamic acid with ethamsylate were equally effective in reducing intra-operative blood loss and the risk of hysterectomy; however, tranexamic acid with ethamsylate increased the risk of thrombotic events. Further research with a larger number of participants is needed. TRIAL REGISTRATION: The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202009736186159 and was approved on 04/09/2020.

Pre-operative tranexemic acid vs. etamsylate in reducing blood loss during elective cesarean section: randomized controlled trial.

OBJECTIVES: To investigate whether etamsylate may be an alternative to tranexamic acid in reduction of blood loss during elective cesarean section. METHODS: Prospective double-blinded multi-center randomized controlled trial involving 180 qualified women equally divided into three groups each containing 60 women received either tranexamic acid, etamsylate or placebo 20 min before elective cesarean section and blood loss was estimated. RESULTS: Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo. CONCLUSIONS: Etamsylate is an effective second-line therapy (after tranexamic acid) in reducing blood loss during elective cesarean section with low risk of side effects, therefore, it can be an effective alternative to tranexamic acid in cases with contraindications or anticipated to be at high-risk of developing side effects from tranexamic acid.

Eviprostat has an identical effect compared to pollen extract (Cernilton) in patients with chronic prostatitis/chronic pelvic pain syndrome: a randomized, prospective study.

BACKGROUND: Previously reported results of a prospective, randomized placebo-controlled study showed that the pollen extract (Cernilton) significantly improved total symptoms, pain, and quality of life in patients with inflammatory prostatitis/chronic pelvic pain syndrome (CP/CPPS) without severe side effects. A phytotherapeutic agent, Eviprostat, is reportedly effective in a rat model of nonbacterial prostatitis. The aim of the present study was to compare the efficacy and safety of Eviprostat to that of the pollen extract in the management of CP/CPPS. METHODS: The patients with category III CP/CPPS were randomized to receive either oral capsules of Eviprostat (two capsules, q 8 h) or the pollen extract (two capsules, q 8 h) for 8 weeks. The primary endpoint of the study was symptomatic improvement in the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks. RESULTS: In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat (n = 50) or the pollen extract (n = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There was no significant difference in the total, pain, urinary, and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8 weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study. CONCLUSION: Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat may have an identical effect on category III CP/CPPS compared the pollen extract. TRIAL REGISTRATION: The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618); registration date: 3 November 2015.

Short-term efficacy of intravitreal dobesilate in central serous chorioretinopathy.

PURPOSE: To report the anatomic and functional outcome of intravitreal dobesilate to treat recurrent central serous chorioretinopathy (CSC). METHODS: This is an interventional case report in which dobesilate was intravitreally injected in a case of recurrent CSC. Main measures included fundoscopy, Snellen visual acuity (VA) testing, fluorescein angiography and optical coherence tomography (OCT). RESULTS: We present anatomical and functional evidences, obtained as early as eleven days after the treatment, of the efficacy of intravitreal dobesilate, in the treatment of chronic CSC condition. The effect after intravitreal dobesilate injection for CSC might be related to the normalization of retinal architecture. CONCLUSIONS: Intravitreal dobesilate may be an effective treatment option for recurrent CSC.

[One-week effects of Tamsulosin on benign prostatic hyperplasia assessed with a daily symptom score].

The early effects of Tamsulosin within one week of administration on lower urinary tract symptoms in patients with benign prostatic hyperplasia (BPH) were investigated. Patients with newly diagnosed BPH were randomized into a Tamsulosin group and a Eviprostat group. Changes in subjective symptoms daily for 7 days after the start of administration and in the 4th week (8 times in total) were evaluated using seven symptoms in the International Prostate Symptom Score (IPSS) and the quality of life (QOL) index entered in a self-scoring diary kept by the patients daily. In the Tamsulosin group, the IPSS total score showed significant improvements. Significant improvements were observed in the incomplete emptying and frequency scores from the day after the start of administration, in the intermittence and straining scores from day 2, in the urgency and weak stream scores from day 3 and in the nocturia score from day 5. The QOL index significantly improved on day 7. In comparison with Eviprostat, Tamsulosin showed a stronger improvement tendency in the total IPSS, voiding symptoms score and incomplete emptying score and the difference was significant. The difference between the two groups was especially marked for the intermittence and weak stream scores and Tamsulosin showed significantly better early effects. Tamsulosin also showed significantly better early effects than Eviprostat in the QOL index. In conclusion, it was clear that Tamsulosin caused significant improvement in lower urinary tract symptoms associated with BPH as a whole from a very early stage within one week after administration.

[Assessment of clinical usefulness of Eviprostat for benign prostatic hyperplasia--comparison of Eviprostat tablet with a formulation containing two-times more active ingredients].

We compared the usefulness of Eviprostat tablet, a therapeutic agent for benign prostatic hyperplasia (BPH), and EVI-F tablet, a new formulation of Eviprostat containing two times more active ingredients (Chimaphila umbellata extract, Populus tremula extract, Pulsatilla pratensis extract, Equisetum arvense extract and purified wheat germ oil) and consequently designed to reduce the number of tablets per dose by half. In this study, patients with BPH were randomly assigned to either Eviprostat group (6 tabs/day) or EVI-F group (3 tabs/day) using the envelope method. The clinical efficacy of these two drugs were evaluated by the International Prostate Symptom Score (IPSS) and QOL score at the end of the treatment period, and their safety was evaluated by the incidence of side effects. Based on the clinical study guidelines for dysuria, the change in the IPSS total score and QOL score were comparable to the previously reported data for other treatment agents for BPH, and these indices showed gradual improvement with the treatment period. Both treatments were well tolerated. The clinical usefulness of the monotherapy with EVI-F tablet or Eviprostat tablet was reasonably demonstrated in this study. Furthermore, both treatments reduced nocturia, which has an impact on the QOL of patients with BPH.

[Evaluation of supplemental administration of Eviprostat in patients with benign prostatic hyperplasia with persistent symptoms following treatment with alpha1-adrenoceptor blocker].

We examined the effectiveness of supplemental administration of Eviprostat in patients with benign prostatic hyperplasia (BPH) whose lower urinary tract symptoms (LUTS) caused by BPH were not adequately relieved by an alpha1-adrenoceptor blocker. Twenty-nine patients with insufficient improvement in the International Prostate Symptom Score (IPSS) and quality of life (QOL) score after administration of 50 mg naftopidil for 4 weeks or more received 6 tablets of Eviprostat in addition to naftopidil for another 2 weeks or more. With supplemental administration of Eviprostat, significant improvement was observed in the symptoms of incomplete emptying, daytime frequency, intermittency, weak stream, total IPSS, sum of the IPSS subscores for voiding symptoms (intermittency, weak stream and straining), sum of the IPSS subscores for storage symptoms (daytime frequency, urgency and nocturia), and QOL score. Supplemental administration of Eviprostat is therefore effective for the improvement of LUTS and QOL in BPH patients resistant to an alpha1-adrenoceptor blocker.

[Hemostatic therapy for hemorrhages during first and second trimesters].

Hemorrhages during pregnancy are the conditions requiring emergency therapy. The aim of the investigation was to study the efficiency of tranexamic acid (the drug Tranexam) in arresting bleeding and prolonging pregnancies in women with a history of threatened abortion and miscarriage. In the group of women taking tranexamic acid as part of pathogenetic treatment, hemostasis occurred more rapidly than in the control group and hence uterine hematomas resolved on shorter notice. Inclusion of tranexamic acid into the treatment regimen for patients with threatened and incipient abortion is effective in rapidly arresting hemorrhage and prolonging pregnancy.

[The enzyme therapy within a complex treatment of hemophthalmos in patients with diabetes mellitus]. / Fermentoterapiia v kompleksnom lechenii gemoftal'ma u bol'nykh sakharnym diabetom.

The efficiency of the enzyme therapy was studied in patients with hemophthalmos concurrent with diabetes mellitus of different types. Sixty-eight patients received parabulbar injections of the hemase and collelizin enzymes and another 25 patients underwent the routine therapy comprising injections of dicynone, emoxipin and heparinum. The method of ultrasound B-scanning was used to determine the area of hemorrhage spread into the vitreous body. A high efficiency of the enzyme therapy, as used within the complex treatment of hemophthalmos in patients with diabetes mellitus, was demonstrated. Ultrasound B-scanning is a highly informative technique in evaluating the enzyme-therapy efficiency. The enzyme therapy can be recommended as the most effective method for the treatment of hemophthalmos in patients with diabetes mellitus.

Bleeding from endometrial and vaginal malignant tumors treated with activated recombinant factor VII.

The authors report two cases of successful employment of human recombinant activated factor VII in gynecological oncological patients (endometrial cancer and vaginal sarcoma) without pre-existing coagulopathy. They conclude that recombinant factor VIIa may be an important and effective drug in severe bleeding in gynecological oncology.

Orally administered proteases in aesthetic surgery.

Increasing demand for shortening the sequel period after aesthetic surgery has led to comparative testing of optional approaches. Systemic enzyme therapy with its pharmacological effects represents a preventive and curative option for inflammatory process including healing. Excellent results were presented, namely, in the treatment of secondary lymphoedema. The incidence of hematoma, edema, and pain was followed, and the results were compared in a randomized group of 20 patients with upper eyelid blepharoplasty treated with proteases (Wobenzym drg) and in a similar group treated with systemic antiedema and hemostyptic therapy (Dicynone drg and Reparil drg). No undesirable side effects were observed. In addition, proteases apparently have no limitation for patients with the risk of concurrent cardiovascular, hepatic, or renal diseases.

[Negative interference with peroxidase-coupled enzymatic serum creatinine assay by a hemostatic drug containing a hydroquinone structure].

We report a discrepancy between serum creatinine levels obtained by the method based on alkaline picric acid (Jaffé reaction) and that by automated analyzer employing enzymatic assay based on peroxidase-coupled reaction in a patient with renal dysfunction taking Ethamsylate, a capillary vessel stabilizer. Serum creatinine level obtained by the Jaffé reaction was 83 mg/l, and that by the enzymatic method was 22 mg/l. Recovery test of creatinine using the patient's serum showed 101 to 102% recovery by the Jaffé reaction and 77 to 89% by the enzymatic method. The same results were observed both in an in vitro test and in serum obtained from a healthy volunteer who had been given Ethamsylate previously. As the chemical structure of Ethamsylate includes a hydroquinone unit, it was thought that the compound may consume hydrogen peroxide produced by the reaction of peroxidase as the hydrogen donor and compete with the substrate used as the hydrogen donor for the color development. Thus evaluation of test results obtained by peroxidase coupled methods should be carefully interpreted in a patient who is consuming drugs which hydrogen peroxide such as hydroquinone.

[Effect of etamsylate on hemorrhagic diathesis of children with oncologic diseases. Retrospective matched-pair analysis of 64 patients in a study of 100 patients of the Münster University Pediatric Clinic]. / Einfluss von Etamsylat auf die Blutungsneigung von Kindern mit onkologischen Erkrankungen. Retrospektive Matched-pair-Analyse von 64 Patienten bei Untersuchung von 100 Patienten der Universitätskinderklinik Münster.

The hemostatic efficacy of ethamsylate studied by a matched-pair analysis was not proved to be statistically significant. The appearance of bleeding signs as well as the frequency of platelet transfusions have been examined. An important side-effect was found in patients receiving ethamsylate: severe leucocytopenia (less than 1000 leucocytes/microliters) was noticed more frequently followed by an enhanced susceptibility to infections. The incidence of septic infections was proved to be significantly increased in an extended sample of 100 patients.

[Intra-partum ethamsylate (dicynone) administration in the prevention of cerebral hemorrhage in premature infants]. / Intrapartum elkezdett ethamsylate (dicynone) kezelés a koraszülöttek agyvérzésének megelözésére.

Dicynone has been in use in all premature births prophylactically since 1987 by the authors. The administration of the drug begins before or during delivery. The diagnoses of cerebral haemorrhage was established on autopsy and the cases were compared with the previous years when Dicynone was not administered. During prophylactic use of Dicynone the cerebral haemorrhages significantly reduced among premature babies. It is well known, that the etiology of the cerebral haemorrhages are multifactorial. Their favourable experiences confirm the literary communications, whereas use of Dicynone can be one of the efficacious preventive drug against palsy of the premature babies.

Intraventricular hemorrhage in the premature infant--current concepts. Part II.

Diagnosis of periventricular-intraventricular hemorrhage (IVH) and its neuropathological consequences and accompaniments in the living infant has been facilitated greatly by the introduction of real-time cranial ultrasonography. The major advantages of the technique include high-resolution capability, portable instrumentation, lack of ionizing radiation, and relative affordability. Prognosis in infants with IVH relates to the mechanisms of brain injury, the most important of which are prior hypoxic-ischemic insults, posthemorrhagic hydrocephalus, and periventricular hemorrhagic infarction. The last of these is most critical and it is now clear that careful quantitative assessment of the ultrasonographic appearance of the periventricular parenchyma in the infant with IVH during the acute period of illness is of major value in estimating outcome. Prevention of IVH remains the most important goal. Prenatal interventions include prevention of premature birth (currently a very elusive goal in the United States), transportation of the premature infant to a tertiary facility in utero rather than after birth (an approach of proven value), prenatal administration of phenobarbital or vitamin K (initially promising data that require confirmation and amplification), and optimal management of labor and delivery. Postnatal interventions include careful resuscitation of newborns, correction of fluctuating cerebral blood flow velocity, correction or prevention of other major hemodynamic disturbances, and correction of abnormalities of coagulation. Of these interventions the use of muscle paralysis to correct fluctuating cerebral blood flow velocity has shown the most striking benefit vis-à-vis prevention of IVH. Postnatal pharmacological interventions that have been studied in detail include the use of phenobarbital, indomethacin, ethamsylate, and vitamin E. No single agent among this group has been shown consistently to lead to a decrease in incidence and severity of IVH.(ABSTRACT TRUNCATED AT 250 WORDS)

A new approach to the problems encountered with Opsite as a donor site dressing: systemic ethamsylate.

A prospective clinical trial has shown that systemic ethamsylate reduces the problems with exudation sometimes seen when Opsite is used as a dressing for split skin graft donor sites.

[Conservative treatment of benign prostatic hypertrophy: reevaluation of the effect of eviprostat by subjective symptoms and uroflowmetry].

The clinical effect of Eviprostat was evaluated in 53 patients with benign prostatic hypertrophy. Subjective symptoms were improved in 86.2% of the patients who were treated with Eviprostat. Nomogram unit of uroflowmetry also improved in 51.4% of the patients. The overall clinical efficacy estimated by the combination of subjective symptoms and uroflowmetry was observed in 90.9% of the patients. In conclusion, Eviprostat was considered to be useful in patients with discomfort symptoms who had no immediate indication for prostatectomy.