| Objective:Platelet-rich plasma (PRP) is a fraction of plasma that can be produced by centrifugal separation of whole blood having a platelet concentration above baseline. PRP works via the degranulation of alpha-granule in platelets, which contain the synthesized and prepackaged GFs, such as PDGF, TGF-β, IGF, VEGF, and EGF. Studies suggest that PRP can promote repair of skin, ligaments, tendons and other tissue injury. PRP also contains a high concentration of white blood cells, in theory, having some kind of antibacterial effects. The study is designed to calculate the recovery rate and enrichment factor and to analyse the correlation by measuring the concentrations of platelets, leukocyte, and growth factors in PRP so as to evaluate the feasibility and stability of a set of PRP preparation.The degeneration of articular cartilage as part of the clinical syndrome of osteoarthritis (OA) is one of the most common causes of pain and disability in middle-aged and older people. Owing to a limited capacity of self-healing of articular cartilage, the end result of articular degenerative lesions is often the development of OA. The treatment includes a wide spectrum of approaches but at present, these approaches are merely palliative. So damaged cartilage repair still remains a challenging problem for orthopedic surgeon. PRP technology as we treat osteoarthritis provides a new treatment ideas and methods. This study was designed to determine the safety and efficacy of intra-articular injection of PRP in Chinese patients with articular cartilage degeneration. We evaluated the safety by collecting and assessing the number of adverse events, time of occurrence, severity, duration and treatment results. Moreover, the short-term results were analysized to determine feasibility and application modalities for further wider studies.Chronic wound treatment has been the focus of medical research. Traditional wound dressing, debridement, vacuum suction and topical application of various drugs and other treatments are able to remove the local focus of infection or necrotic tissue, reduce ulcer secretions, but there are still many difficulties to heal wounds. The primary objective of the 3-month study was to determine the safety and effectiveness of treating chronic refractory wounds with PRP. Secondary objective was to evaluate its antibacterial effect in vitro.Methods:The peripheral blood(40 mL) was collected from 30 volunteers accorded with the inclusion criteria, and then 4 mL PRP was prepared using the package produced by Shandong Weigao Group Medical Polymer Company Limited. Automatic hematology analyzer was used to count the concentrations of platelets and leukocyte in whole blood and PRP. The enrichment factor and recovery rate of platelets or leukocyte were calculated; the platelet and leukocyte concentrations of male and female volunteers were measured, respectively. The concentrations of platelet-derived growth factor (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF) were assayed by ELISA.Patients with history of chronic (at least 4 months) pain or swelling of the knee and imaging findings (radiograph or MRI) of degenerative changes in the joint were included in this study. Exclusion criteria included pregnant and lactating women, diabetes, rheumatoid arthritis, gout, blood diseases, severe cardiovascular diseases, infections, immunosuppressive agents, taking anticoagulant agent, patients with Hb values of<11g/L, platelets values of<1.5 X 109/L. Patients in PRP group (experimental group) and SH group (control group) were matched by age, gender and Body-Mass-Index (BMI) and grade of OA (Kellgren & Lawrence grade). Thirty consecutive patients, affected by chronic degenerative condition of the knee, were treated with PRP (15 knees treated)intra-articular injections, Sodium hyaluronate (SH) as a control (15 knees treated). PRP of 3.5ml or SH of 2ml each was used for the injections.Injections were administered every 3 weeks for 3 times continuously. The adverse events, time of occurrence,severity,duration and treatment results were recorded to evaluate the safety of this treatment. Patients were clinically prospectively evaluated before and at 3,4 and 6-month follow-up. International Knee Documentation Committee (IKDC) subjective knee evaluation form, Western Ontario and McMaster Universities (WOMAC) evaluation form and Lequesne index assessment form were used for evaluation of treatment results.From September 2010 to December 2014, twenty-one patients, affected by chronic refractory wounds were treated with 2-7 mL PRP. There were 8 males and 13 females, aged from 48 to 78 years (54.8 years on average). The bacterial culture results, wound healing size and rate were used for evaluation of treatment efficacy. The wound deterioration,aggravated infection, bacteremia, wound recurrence and other adverse reactions were recorded to evaluate the safety of this treatment. Patients were clinically prospectively evaluated before and at 1,2,4 and 12-week follow-up. As the most common seen strains, staphylococcus aureus was selected to be incubated in PRP and PRP gel. Staphylococcus aureus were sampled and compared at multiple time points.Results:The platelet concentrations of whole blood and PRP were (131.40±29.44)×109/L and (819.47±136.32)×109/L, respectively, showing significant difference (t=-27.020, P=0.000). The recovery rate of platelets was 60.85%±8.97%, and the enrichment factor was 6.40±1.06. The leukocyte concentrations of whole blood and PRP were (5.57±1.91)×1012/L and (32.20±10.42)×1012/L, respectively, showing significant difference (t=-13.780, P=0.000). The recovery rate of leukocyte was 58.30%±19.24%, and the enrichment factor was 6.10±1.93. The concentrations of platelets and leukocyte in PRP were positively correlated with the platelet concentration (r=0.652, P=0.000) and leukocyte concentration (r=0.460, P=0.011) in whole blood. The concentrations of platelet and leukocyte in PRP between male and female were not significantly different (P>0.05). The concentrations of PDGF, TGF-β, and VEGF in PRP were (698.15±64.48), (681.36±65.90), and (1071.55±106.04) ng/mL, which were (5.67±1.18), (6.99±0.61), and (5.74±0.83) times higher than those in the whole blood, respectively. PDGF concentration (r=0.832, P=0.020), TGF-P concentration (r=0.835, P=0.019), and VEGF concentration (r=0.824, P=0.023) in PRP were positively correlated with platelet concentration of PRP. No complications such as infection, marked muscle atrophy, deep vein thrombosis, fever, hematoma, or other major adverse events occurred among study subjects. No statistically significant longer duration of adverse reactions was obtained between experimental group and control group (P=0.862). Most patients suffered from pain reaction, which occurred in not more than four days. The results indicated that the symptoms and function of patients from PRP group kept stable within 6 months, while the same results of SH group was obtained only within the first 4 months, six months follow-up showed significant reduction (PIKDC=0.003, PWOMAC=0.048, PLequesne=0.002). Within the first 4 months, improvement of the status of the PRP group was not superior to the SH group (P>0.05), but the improvement of IKDC score and Lequesne index showed significant difference (PIKDC=0.000, PLequesne=0.013). The preliminary results indicated that the treatment with PRP injections was safe and there was no significant difference between SH and PRP injections within 4 months, but the effect of PRP injections was better than SH injections at 6-month follow-up. No complications such as wound deterioration, aggravated infection, bacteremia, wound recurrence, or other major adverse events occurred among study subjects. Only two weeks after PRP injection, chronic wounds contracted significantly in 21 patients with purulence and necrosis tissue cleaned up, circulation of soft tissue improved and exposed bone or muscle tissue covered by neogenetic granulation. Wound sizes after 1,2 and 4 weeks of follow-up, were (5.5±3.9) mL, (3.5±2.9) mL and (2.0±2.1) mL, respectively. The chronic wounds decreased by (55.1±22.6)%, (72.0±16.2)%, (84.3±14.0)%after PRP therapy when compared with preoperation, showing significant difference (P<0.05). Three months after PRP injection, the average coverage rate was (85.6±12.5)%, when compared with (84.3±14.0)%of 4-week after therapy, showing no significant difference (P=0.7). The average cure rate and subjective satisfaction rate were 57.1% and 95.23%, respectively. In vitro experiment showed PRP gel the strongest antibacterial effect, the number of bacteria decreased to a minimum after 4 hours incubation.Conclusions:PRP with high concentrations of platelets,white blood cells and growth factors can be prepared stably by this package. Although short-term results of this study showed positive role in intra-articular injection of PRP to treat articular cartilage degeneration, it still needs high-level studies to further evaluate the safety and efficacy of this new approach. The results of this study show that PRP is safe and effective for use in the treatment of chronic non-healing wounds. Its potential anti-bacterial effect need better designed studies to illustrate. |
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