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Purpose We studied the effect of a platelet-rich fibrin matrix (PRFM) combined with prostaglandin E-1 (PGE-1) injection on erectile function in patients refractory to response for phosphodiesterase type 5 inhibitors (PDE5-Is). Methods This randomized, double-blind, placebo-controlled study included 80 patients. The patients were randomly assigned to four groups and blinded together with the administrating physicians to the nature of the intracorporeal injection (ICI) therapies. Group (1) received saline, group (2) received platelet-rich fibrin matrix (PRFM), group (3) received prostaglandin E-1 (PGE-1), and group (4) received a combination of PRFM + PGE-1. The patients received ICI therapy weekly for 8 consecutive weeks. Clinical information and follow-up data were obtained at 1, 2, 3, and 6 months. Results A significant increase occurred in the validated Arabic version of the International Index of Erectile Function (ArIIEF-5) score in group (4) compared to the other three groups ( p value = 0.037). There was a significant difference in erection hardness scale (EHS) scores among all groups after receiving the different treatments ( p  = 0.004). A significant increase was seen in the ArIIEF-5 score in groups 4 and 3 compared to that in groups 1 and 2 ( p  < 0.001). There was also a significant increase in the arterial dilatation % in groups 4 and 3 compared to that in groups 1 and 2 ( p  = 0.019). Conclusion The combination of PRFM plus PGE-1 had shown significant improvement in the ArIIEF-5 score, yet the patients still had mild to moderate ED.

Background One-lung ventilation (OLV) requires a high inspired oxygen concentration (FiO 2 ) to promote oxygenation improvement, yet it increases the risk of postoperative pulmonary complications. Therefore, this study aimed to investigate the effects of prostaglandin E 1 (PGE 1 ) in reducing FiO 2 during general anesthesia and mechanical ventilation on oxygenation and postoperative complications in patients undergoing OLV. Method A total of 120 patients scheduled for elective left thoracotomy esophageal cancer surgery were randomly divided into four groups ( n  = 30): Group L (FiO 2  = 0.4, PGE 1  = 0.1 µg /kg), Group M (FiO 2  = 0.5, PGE 1  = 0.1 µg /kg), Group H (FiO 2  = 0.6, PGE 1  = 0.1 µg /kg), and Group C (FiO 2  = 0.4, normal saline solution). The primary outcome was oxygenation during OLV. Secondary outcomes included intrapulmonary shunt (Qs/Qt), incidence of postoperative pulmonary complications, and changes in inflammatory cytokines. Results Group H exhibited higher PaO 2 values than Groups L, M, and C at all time points T1-T6. Group M also showed higher PaO 2 values than Groups L and C at all time points T1-T6. In contrast, Group L demonstrated significantly higher PaO 2 values than Group C at time points T2-T4. The nebulization groups (L, M, H) had significantly higher PaO 2 /FiO 2 than Group C at time points T2-T4. Group H had higher Qs/Qt values than Groups L, M, and C at all time points T1-T6. At time points T2-T4, Group L had significantly lower Qs/Qt values compared to both Group C and Group M, which in turn had significantly lower values than Group C. Regarding interleukin-6 (IL-6) levels, Group C was significantly higher than the nebulization groups at time points T5-T8, while Group L was significantly lower than Groups M and H at T8. In terms of tumor necrosis factor-α(TNF-α) levels, Group C was significantly higher than the nebulization groups at time points T7-T8. With respect to clinical pulmonary infection score (CPIS), Group L was significantly lower than Groups M, H, and C. There was no statistically significant difference in the overall incidence of postoperative complications probability (PPCs) among the four groups, nor were there statistically significant differences in pneumothorax, pulmonary infection, anastomotic leakage, ICU stay duration, or total hospital stay duration among the groups. Conclusion PGE 1 demonstrates a significant advantage in reducing the incidence of hypoxemia, effectively improving oxygenation status in patients undergoing OLV with lower FiO 2 . Given the effects of PGE 1 on oxygenation and inflammatory factors, as well as the CPIS, the results of this study suggest that a clinical regimen of 0.4 FiO 2  + 0.1 µg /kg PGE 1 is appropriate. Trial registration Chictr.org.cn identifier: Retrospectively registered, ChiCTR1800018288(09/09/2018).

To investigate the efficacy, tolerability, and patient’s preference of alprostadil cream for topical use administered within the urethral meatus versus the standard administration route, in erectile dysfunction (ED) treatment. Seventy-one patients (mean age 59.7 ± 9.0 years) affected by ED were analyzed in this multicenter, randomized, two-administration routes, cross-over trial. All patients received a single dose of alprostadil cream applying the dispenser to the tip of the penis (without contacting the urethral meatus) (Standard administration route or ST.AR) alternating with a single dose of alprostadil cream applying the dispenser within the urethral meatus (New administration route or NEW.AR) separated by a one-week washout period, according to randomization. The primary objective of the study was to evaluate the change in International Index of Erectile Function (IIEF-5) total score from baseline to the control visit by comparing the ST.AR and NEW.AR. Secondary objectives of the study were to compare the different methods of administration by evaluating the change in the Sexual Encounter Profile (SEP-2 and SEP-3) questionnaire score and the Patient Reported Outcomes (PROs) by scoring the Patient Self-Assessment of Erection (PSAE) questionnaire. The treatment safety profile was assessed by analysis of adverse events (AEs). Based on the study findings it is evident that the NEW.AR is more efficacious than the ST.AR in improving IIEF-5 and SEP scores from baseline to control visit (IIEF-5: +3.8 vs +6.3; p < 0.001; positive response to SEP-2: 10 vs 27; p = 0.002) and in terms of PSAE (a significant improvement from the baseline in 31% of patients; p < 0.001). As regards the safety profile, no difference in terms of local and systemic side effects was found.

Erectile dysfunction (ED) is a highly prevalent condition with a variety of possible risk factors and/or etiologies. Despite significant advances regarding ED pharmacological management, there are still insufficient responders to existing pharmacological treatments e.g., approximately 30% of patients are insufficient responders to phosphodiesterase type 5 inhibitors (PDE5-Is). It has been recently proposed that botulinum toxin A intracavernosally (IC) delivered could be effective in these patients. Data from a retrospective uncontrolled single center study of 47 ED patients, consecutively recruited, insufficient responders to existing pharmacological treatments e.g., PDE5-Is or IC PGE1 injections treated with IC abobotulinumtoxinA 250 or 500 U as free combination with their existing treatment have been analyzed. Response rate, according to the International Index of Erectile Function-Erectile Function domain score, 6 weeks following IC abobotulinumtoxinA in combination with prior pharmacological treatment, was 54%. Two patients have reported mild penile pain on injection or during the 3 days following injection. Therapeutic efficacy did not seem to be influenced by the etiologies and/or risk factors for ED. Conversely, the less severe ED, the higher the response rate. Preliminary evidence for the therapeutical potential with acceptable safety of IC abobotulinumtoxinA as add-on therapy for ED not sufficiently responsive to standard therapy should be confirmed in randomized clinical trials.

Purpose Limaprost, a prostaglandin E 1 analog, has vasodilatory properties and increases blood flow of the nerve root. However, it has not been clarified whether limaprost affects pain sensation associated with radiculopathy due to lumbar spinal stenosis (LSS). The aim of this study was to compare the efficacy of oral limaprost with nonsteroidal anti-inflammatory drugs (NSAIDs) for radiculopathy. Methods We performed a multicenter prospective randomized trial. Patients with LSS who had radicular-type neurologic intermittent claudication assessed based on a self-reported diagnostic support tool were randomized into three treatment groups. Limaprost, NSAIDs, or limaprost plus NSAIDs were administered orally for 6 weeks. Leg pain, low back pain (LBP) and the associated symptoms were assessed by a numerical rating scale (NRS) both at rest and on movement as well as the Roland–Morris Disability Questionnaire (RDQ) and Short Form (SF)-36. Results Sixty-one patients were enrolled in the study. Each treatment finally reduced radicular pain, and the improvement was prominent in a combination treatment. There were no significant differences in radicular pain among three groups at final follow-up. LBP was not influenced by limaprost, and a significant reduction of LBP and RDQ was confirmed in a combination treatment compared with limaprost. Physical function of the SF-36 subscales after a combination treatment showed a marked alleviation compared with NSAIDs. Conclusions These obtained findings suggest that the effects of limaprost seem to be limited to radicular pain, not for LBP. Overall, a combination treatment might be more effective in the management of radiculopathy induced by LSS than monotherapy with either agent.

To observe the clinical efficacy of different doses of alprostadil (lipo-prostaglandin E1, lipo-PGE1) in the treatment of painful diabetic peripheral neuropathy (DPN). Sixty patients with painful DPN were equally and randomly assigned into three groups. Two groups received different doses of lipo-PGE1 by intravenous drip injection (A group: low-dose lipo-PGE1; B group: high-dose lipo-PGE1) following intravenous bolus injection of mecobalamin (MeCbl, 0.5mg once daily (QD)); the third group received MeCbl alone (C group). All patients received optimized treatment to lower blood glucose, blood pressure, and blood lipids to target levels. The efficacy of lipo-PGE1 in the three groups of patients was observed after 3weeks of treatment. The overall response rate was 90% in the B group, significantly higher than that in the A and C groups (80% and 55%, respectively; P<0.05). During the observation period, there was no incidence of serious adverse reactions (e.g., acute heart failure, sudden drop in blood pressure, or malignant arrhythmias) in any of the three groups. High-dose lipo-PGE1 has better efficacy than low-dose lipo-PGE1 or MeCbl alone in the treatment of painful DPN.

Background：Several studies have demonstrated that primary percutaneous coronary intervention （PCI） can result in reperfusion injury.This study aims to investigate the effectiveness of liposomal prostaglandin E l （Lipo-PGE1,Alprostadil,Beijing Tide Pharmaceutical Co.,Ltd.） for enhancing microcirculation in reperfusion injury.In addition,this study determined the optimal administration method for acute ST elevation myocardial infarction （STEMI） patients undergoing primary PCI.Methods：Totally,68 patients with STEMI were randomly assigned to two groups：intravenous administration ofLipo-PGE 1 （Group A）,and no Lipo-PGE1 administration （Group B）.The corrected thrombolysis in myocardial infarction （TIMI） frame count （cTFC） and myocardial blush grade （MBG） were calculated.Patients were followed up for 6 months.Major adverse cardiac events （MACE） were also measured.Results：There was no significant difference in the baseline characteristics between the two groups.The cTFC parameter in Group A was significantly lower than Group B （18.06 ± 2.06 vs.25.31 ± 2.59,P ＜ 0.01）.The ratio of final MBG grade-3 was significantly higher （P ＜ 0.05） in Group A （87.9％） relative to Group B （65.7％）.There was no significant difference between the two groups in final TIMI-3 flow and no-reflow.Patients were followed up for 6 months,and the occurrence of MACE in Group A was significantly lower than that in Group B （6.1％ vs.25.9％ respectively,P ＜ 0.05）.Conclusions：Myocardial microcirculation of reperfusion injury in patients with STEMI,after primary PCI,can be improved by administering Lipo-PGE1.

▲ Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation. ▲ Oral lubiprostone was effective in the treatment of patients with constipation-predominant irritable bowel syndrome (IBS-C) in large (n= 193−583) phase II (dose-finding) and phase III randomized, double-blind, placebo-controlled, multicentre trials. ▲ The number of patients with IBS-C demonstrating an overall response to treatment (primary endpoint) in the two phase III trials was significantly greater in patients receiving lubiprostone 8 μg twice daily for 3 months than in those receiving placebo. In addition, a randomized, 4-week withdrawal period at the end of one of the phase III trials demonstrated that discontinuation of lubiprostone was not associated with rebound of IBS symptoms. ▲ Lubiprostone was generally well tolerated in clinical trials, with the majority of adverse events being of mild to moderate severity. In patients with IBS-C who received lubiprostone 8 μg twice daily, nausea was the most frequently occurring adverse event that was considered possibly or probably treatment related. No serious treatment-related adverse events were reported in a 36-week open-label extension to the phase III trials.

Proper colonic cleansing prior to colonoscopy is paramount to ensuring complete mucosal visualization and polyp identification. In a double-blind fashion, we compared single-dose lubiprostone (24 microg) versus placebo pretreatment prior to a split-dose polyethylene glycol electrolyte (PEG-E) bowel preparation without dietary restriction to determine the efficacy, safety, and patient tolerability. Two hundred patients referred for outpatient colorectal cancer screening were randomized to receive a single-dose of unlabeled lubiprostone (24 microg) or placebo prior to a split-dose PEG-E bowel preparation without dietary restriction. The patients were surveyed prior to the colonoscopy on the tolerability of the bowel preparation, and any adverse events were recorded. The cleanliness of the colon was graded by the endoscopist during the procedure utilizing the Ottawa bowel preparation scale. One hundred ninety-one patients completed the study (95%). Split-dose PEG-E with lubiprostone pretreatment was found to be more effective at bowel cleansing in each segment of the colon when compared with split-dose PEG-E with placebo (P < 0.001). Patients enrolled in the lubiprostone treatment arm rated the overall experience as more tolerable (P 0.003) and complained of less abdominal bloating (P 0.049). No differences were observed between the groups for treatment-emergent side effects or adverse events (P > 0.05). Single-dose lubiprostone prior to split-dose PEG-E without dietary restriction significantly improves colonic mucosa visualization during colonoscopy and is well tolerated by patients.