Efficacy of platelet poor plasma gel in combination with fractional CO(2) laser in striae distensae: a clinical, histological and immunohistochemical study
Journal of cosmetic dermatology. 2021
BACKGROUND Platelet-poor plasma gel is a semi-solid plasma formulation that recently recommended as autologous bio-filler for treatment of atrophic dermal scars. OBJECTIVE To compare the therapeutic efficacy and safety of intradermal injection of plasma gel in combination with fractional CO(2) laser versus fractional CO(2) laser alone in striae distensae (SD). PATIENTS AND METHODS This study included 36 SD patients treated by 3 sessions (one session/1.5 months) of fractional CO(2) laser on all SD lesions following intradermal injection of plasma gel on one side, and saline (as placebo) on the other side. RESULTS Significant clinical improvements associated with remarkable narrowing of SD lesions and prominent enhancement of skin texture were observed on both treatment sides. Obviously, higher degrees of clinical improvements of SD lesions were reported following combined therapy with fractional CO(2) laser and plasma gel rather than fractional CO(2) laser monotherapy. However, post-inflammatory hyperpigmentation (PIH) was reported more frequently with fractional CO(2) laser monotherapy. Histopathological and immunohistochemical examinations revealed significant epidermal improvement, and homogenization, and orientation of dermal collagen bundles as a result of both therapeutic procedures. CONCLUSION Plasma gel in combination with fractional CO(2) laser could be considered a promising novel treatment modality for SD. Plasma gel not only improves the efficacy of fractional CO(2) laser, but also decreases the frequency of PIH.
A randomized trial of albumin infusion to prevent intradialytic hypotension in hospitalized hypoalbuminemic patients
Critical care (London, England). 2021;25(1):18
BACKGROUND Intradialytic hypotension (IDH) is a frequent complication of intermittent hemodialysis (IHD), occurring from 15 to 50% of ambulatory sessions, and is more frequent among hospitalized patients with hypoalbuminemia. IDH limits adequate fluid removal and increases the risk for vascular access thrombosis, early hemodialysis (HD) termination, and mortality. Albumin infusion before and during therapy has been used for treating IDH with the varying results. We evaluated the efficacy of albumin infusion in preventing IDH during IHD in hypoalbuminemic inpatients. METHODS A randomized, crossover trial was performed in 65 AKI or ESKD patients with hypoalbuminemia (albumin < 3 g/dl) who required HD during hospitalization. Patients were randomized to receive 100 ml of either 0.9%sodium chloride or 25% albumin intravenously at the initiation of each dialysis. These two solutions were alternated for up to six sessions. Patients' vital signs and ultrafiltration removal rate were recorded every 15 to 30 min during dialysis. IDH was assessed by different definitions reported in the literature. All symptoms associated with a noted hypotensive event as well as interventions during the dialysis were recorded. RESULTS Sixty-five patients were submitted to 249 sessions; the mean age was 58 ([Formula: see text] 12), and 46 (70%) were male with a mean weight of 76 ([Formula: see text] 18) kg. The presence of IDH was lower during albumin sessions based on all definitions. The hypotension risk was significantly decreased based on the Kidney Disease Outcomes Quality Initiative definition; (15% with NS vs. 7% with albumin, p = 0.002). The lowest intradialytic SBP was significantly worse in patients who received 0.9% sodium chloride than albumin (NS 83 vs. albumin 90 mmHg, p = 0.035). Overall ultrafiltration rate was significantly higher in the albumin therapies [NS - 8.25 ml/kg/h (- 11.18 5.80) vs. 8.27 ml/kg/h (- 12.22 to 5.53) with albumin, p = 0.011]. CONCLUSION In hypoalbuminemic patients who need HD, albumin administration before the dialysis results in fewer episodes of hypotension and improves fluid removal. Albumin infusion may be of benefit to improve the safety of HD and achievement of fluid balance in these high-risk patients. ClinicalTrials.gov Identifier: NCT04522635.
Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
The journal of sexual medicine. 2021
BACKGROUND Animal studies postulate that platelet-rich plasma (PRP) injections improve key elements of the pathophysiologic mechanisms leading to erectile dysfunction (ED). AIM: To conduct the first double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of PRP injections in patients with mild and moderate ED. METHODS Sixty sexually active patients with mild and moderate ED were randomly assigned to two sessions, with a one-month difference, of 10 mL PRP (n = 30) or placebo (n = 30) intracavernosal injections. An FDA-approved separation system was used. Patients were evaluated at 1, 3 and 6 months after completion of the treatment protocol. A per-protocol analysis was applied. All participants withheld any ED treatment during the trial. OUTCOMES The achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function - Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment. Erectile function at all time points, as well as safety of PRP injections, were also evaluated. RESULTS At 6 months, a MCID was achieved by 20/29 (69%) patients in the PRP group compared to 7/26 (27%) in the placebo group. The risk difference between the two groups was 42% (95%CI: 18-66), P < 0.001 and the baseline-adjusted mean between-group-difference in the IIEF-EF score was 3.9 points (95%CI: 1.8-5.9). Similarly, a statistically significant difference of both the number of participants attaining a MCID and the IIEF-EF score was also observed at the 1- and 3-month evaluation between the two groups. Accordingly, patients receiving PRP were more satisfied with the treatment. No adverse events were observed during the study period. CLINICAL IMPLICATIONS Intracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to moderate ED. STRENGTHS & LIMITATIONS We conducted the first clinical trial exploring the role of PRP in the management of ED. Conversely, our findings lack external validity due to single-center design. Furthermore, our results cannot be extrapolated to other PRP separation systems. CONCLUSIONS PRP intracavernosal injections may be a promising addition to the urologist's armamentarium for the management of ED. Still, further high-quality studies are warranted to corroborate our findings. Evangelos P, Mykoniatis I, Pyrgidis N, et al. Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Sex Med 2021;XX:XXX-XXX.
Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy
JACC. Heart failure. 2021
OBJECTIVES The study sought to examine the effect of intravenous iron on heart failure events in hemodialysis patients. BACKGROUND Heart failure is a common and deadly complication in patients receiving hemodialysis and is difficult to diagnose and treat. METHODS The study analyzed heart failure events in the PIVOTAL (Proactive IV Iron Therapy in Hemodialysis Patients) trial, which compared intravenous iron administered proactively in a high-dose regimen with a low-dose regimen administered reactively. Heart failure hospitalization was an adjudicated outcome, a component of the primary composite outcome, and a prespecified secondary endpoint in the trial. RESULTS Overall, 2,141 participants were followed for a median of 2.1 years. A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group (HR: 0.66; 95% CI: 0.46-0.94; P = 0.023). There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group, giving a rate ratio of 0.59 (95% CI: 0.40-0.87; P = 0.0084). Most patients presented with pulmonary edema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event. CONCLUSION Compared with a lower-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in patients undergoing hemodialysis, with large relative and absolute risk reductions. (UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients; 2013-002267-25).
Haemodialysis patients enrolled in the PIVOTAL trial (n= 2,141).
Intravenous iron administered proactively in a high-dose regimen (n= 1,093).
Low-dose regimen administered reactively (n= 1,048).
A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group. There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group. Most patients presented with pulmonary oedema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event.
Application of hepatitis B immunoglobulin in prevention of mother-to-child transmission of chronic hepatitis B in HBsAg- and HBeAg-positive mother
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2021;:1-6
The aim of our study was to compare the efficacy of two dosages of hepatitis B immunoglobulin (HBIG) combined with HBV vaccine (HBVac) to prevent mother-to-child transmission (MTCT) of hepatitis B in HBsAg- and HBeAg-positive mother. We enrolled 331 mother-infant pairs with HBsAg- and HBeAg-positive maternal state from the Women's Hospital School of Medicine of Zhejiang University. Newborns were randomly distributed into two groups according to the dosages of HBIG injection: 100 IU and 200 IU. Newborns from both groups were injected with HBVac in the same doses. We compared the immune outcomes between the two groups and explore the influencing factors of immune outcomes through regression analysis. There was no statistically significant relationship between HBsAg serological transmission of newborns and dosages of HBIG in HBsAg- and HBeAg-positive mother (p > .05). The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive. In conclusion, combined application of HBVac and a single dose of 100 IU HBIG can achieve the ideal MTCT interruption results for HBsAg- and HBeAg-positive pregnant women.IMPACT STATEMENTWhat is already known on this subject? Passive-active immunoprophylaxis is proved to be effective in preventing mother-to-child transmission of hepatitis B. Hepatitis B vaccine combined with 100 IU or 200 IU immunoglobulin is mostly recommended in China.What do the results of this study add? At present, there is still a lack scientific basis for improving existing strategies and measures to prevent mother-to-child transmission of hepatitis B in China.What are the implications of these findings for clinical practice and/or further research? 100 IU and 200 IU immunoglobulin show equivalent blocking effect, and combined use of hepatitis B vaccine and 100 IU immunoglobulin is more cost-effective.
A Double-blind, Randomized Trial to Evaluate Miltefosine and Topical Granulocyte Macrophage Colony-stimulating Factor in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis in Brazil
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2021;73(7):e2465-e2469
BACKGROUND The treatment of cutaneous leishmaniasis (CL) in Brazil using pentavalent antimony (Sbv) is associated with a high rate of failure. Miltefosine has proven efficacy for CL caused by L. braziliensis, with a cure rate (CR) of 75%. A combined treatment with granulocyte macrophage colony-stimulating factor (GM-CSF) and miltefosine could increase CR and decrease healing time. METHODS A randomized, double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M + GM) vs miltefosine and placebo (M + P) vs Sbv in 133 patients with CL caused by L. braziliensis in Bahia, Brazil. RESULTS The final CR at 180 days after the initiation of treatment was 44.4% in the Sbv group, 76.6% in the M + P group (P = .003 vs Sbv), and 75.6% in the M + GM group (P = .004 vs Sbv). The median healing time for cure was 102 days for the Sbv group and 60 days for both miltefosine groups (P = .0009). During the 6-month follow-up period, 4 relapses were documented: 1 in the Sbv group, 1 in the M + P group, and 2 in the M + GM group. Mild adverse events occurred in 65% of patients from the Sbv group, 76% and 79% from the M + P and M + GM groups respectively. CONCLUSIONS Miltefosine is more effective than Sbv for the treatment of CL caused by L. braziliensis in Brazil and accelerates the healing time. Association with GM-CSF does not improve therapeutic outcome. CLINICAL TRIALS REGISTRATION NCT03023111.
Efficacy of autologous platelet-rich plasma gel in the treatment of refractory pressure injuries and its effect on wound healing time and patient quality of life
Clinics (Sao Paulo, Brazil). 2021;76:e2355
OBJECTIVES To evaluate the efficacy of autologous platelet-rich plasma (PRP) gel in the treatment of refractory pressure injuries and its effect on wound healing time and quality of life of patients. METHODS A random number table method was used to group 102 patients with refractory pressure injuries into either a control group (CG) (51 cases) receiving negative pressure wound therapy (NPWT) or a study group (SG) (51 cases) receiving NPWT+PRP gel. RESULTS The total efficacy rate in the SG (92.16%) was higher than that in the CG (76.47%) (p<0.05). The SG exhibited lower visual analog scale (VAS) scores and pressure ulcer scale for healing (PUSH) scores, smaller wound sizes and depths, and shorter wound healing times than the CG after 21 days of treatment (p<0.05). After 6 months of treatment, the SG scored higher than the CG on the psychological, physiological, social functions, and daily activity domains on the World Health Organization Quality of Life (WHOQOL-BREF) scale (p<0.05). The incidence of postoperative complications in the SG (13.73%) was not significantly different from that of the CG (7.84%) (p>0.05). CONCLUSION In the treatment of refractory pressure injuries, PRP gel can accelerate wound healing, reduce wound pain, shorten the treatment cycle, regulate tissue inhibitor matrix metalloproteinase-1 (TIMP-1) and matrix metalloproteinase-9 (MMP-9) levels and the expression of specific proteins in granulation tissue, reduce the levels of the inflammatory factors interleukin-1β (IL-1β), IL-8, and tumor necrosis factor-α (TNF-α), and improve the quality of life of patients without increasing complications.
The Effects of Lower Versus Higher Cell Number of Platelet-Rich Plasma (PRP) in Hair Density and Diameter in Androgenetic Alopecia (AGA): A Randomized, Double-Blinded, Placebo, Paralleled Group Half-Scalp IRB Study
Aesthetic surgery journal. 2021
BACKGROUND Androgenetic alopecia (AGA) is a common disorder in male and female patients that may benefit from the use of platelet-rich plasma. OBJECTIVES To compare the safety, efficacy, and satisfaction of a lower or higher number of platelets over 6 months. METHODS A prospective randomized, double-blinded, placebo, paralleled group, half-scalp IRB study among eight subjects with moderate AGA. Participants received intradermal PRP injections (baseline and month 3), according to two treatment protocols (high vs low platelet numbers) to the frontal and crown portions of the hemi-scalp and normal saline to control sites. Phototrichoscans were measured at baseline and six months, while global photography and subject and investigator satisfaction questionnaires were obtained at baseline, 3, and 6 months. RESULTS At the end of 6-month evaluation period, both groups demonstrated numerical increases in total hair densities, follicle diameters and terminal hair densities, as well as absolute and percent changes at the frontal and crown targeted sites compared to baseline. These improvements tended to occur more often in areas treated with higher platelet numbers than with lower numbers. Vellus hair densities did not exhibit any significant changes to either PRP dosages. Treatments were assessed by investigator and subjects as "satisfied" at month-3 and were associated with no adverse reactions. CONCLUSIONS Intradermal injections with two therapeutic quantities of platelets were equally safe and efficacious among men and women with androgenetic alopecia. Findings suggest that higher numbers of platelets may have a greater effect than lower number of platelets in regard to hair densities, follicle diameters and terminal hair densities but exhibited minimal effects on vellus hair densities at the month-6 evaluation period. Further studies are required to determine whether any significant advantages occur when delivering either lower or higher numbers of platelets in AGA treatments as long as therapeutic levels are administered.
Ferric carboxymaltose for the treatment of iron deficiency in heart failure: a multinational cost-effectiveness analysis utilising AFFIRM-AHF
European journal of heart failure. 2021
AIMS: Iron deficiency is common in patients with heart failure (HF). In AFFIRM-AHF, ferric carboxymaltose (FCM) reduced the risk of hospitalisations for HF (HHF) and improved quality of life vs. placebo in iron-deficient patients with a recent episode of acute HF. The objective of this study was to estimate the cost-effectiveness of FCM compared with placebo in iron-deficient patients with left ventricular ejection fraction <50%, stabilised after an episode of acute HF, using data from the AFFIRM-AHF trial from Italian, UK, US and Swiss payer perspectives. METHODS AND RESULTS A lifetime Markov model was built to characterise outcomes in patients according to the AFFIRM-AHF trial. Health states were defined using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Subsequent HHF were incorporated using a negative binomial regression model with cardiovascular and all-cause mortality incorporated via parametric survival analysis. Direct healthcare costs (2020 GBP/USD/EUR/CHF) and utility values were sourced from published literature and AFFIRM-AHF. Modelled outcomes indicated that treatment with FCM was dominant (cost saving with additional health gains) in the UK, USA and Switzerland, and highly cost-effective in Italy [incremental cost-effectiveness ratio (ICER) EUR 1269 per quality-adjusted life-year (QALY)]. Results were driven by reduced costs for HHF events combined with QALY gains of 0.43-0.44, attributable to increased time in higher KCCQ states (representing better functional outcomes). Sensitivity and subgroup analyses demonstrated data robustness, with the ICER remaining dominant or highly cost-effective under a wide range of scenarios, including increasing treatment costs and various patient subgroups, despite a moderate increase in costs for de novo HF and smaller QALY gains for ischaemic aetiology. CONCLUSION Ferric carboxymaltose is estimated to be a highly cost-effective treatment across countries (Italy, UK, USA and Switzerland) representing different healthcare systems.
Comparing novel versus conventional technique of platelet rich plasma therapy in periorbital hyperpigmentation: A randomized prospective split face study
Journal of cosmetic dermatology. 2021
BACKGROUND Platelet rich plasma (PRP) has been found to be effective in treating periorbital hyperpigmentation (POH). PRP prepared by double spin (DS) method and activated by calcium has been used conventionally. PRP can be prepared by single spin (SS) and activated at low temperature (novel method), but the evidence is limited. OBJECTIVE To compare the novel and conventional PRP in the treatment of periorbital hyperpigmentation. METHODS We selected 21 patients of POH and randomly divided the face in two halves. One half of the face (group A) was treated with novel PRP (SS and low temperature activation). The other half (group B) was treated with conventional PRP (DS and calcium activation). Total of 3 PRP injections were given at 4 weekly interval. Patients were observed and assessed on 12(th) week by photography, dermoscopy, visual analogue scale (VAS) score, Dermatology life quality index (DLQI). Platelets counts and growth factors were assessed in PRP. RESULTS Mean platelet count in novel and conventional PRP was 7.41± 1.76 lacs and 8.17±2.23 lacs (p= 0.348). Mean photographic and dermoscopic assessment at the end of study in group A and group B was 52.33 ± 6.468 and 53.14 ± 6.99 (p= 0.151). Change in VAS in groups A and B was 3.85 ± 1.27 and 3.90 ± 1.04 (p 0.895). Levels of various growth factors assessed by ELISA did not differ significantly. There was significant decline in DLQI. CONCLUSION The novel method is not inferior to conventional method of PRP in the treatment of periorbital hyperpigmentation.