Safety,tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial

BackgroundJapan licensed the conjugate Haemophilus influenzae type b vaccine, Vaxem™ Hib, based on clinical studies using subcutaneous injection. The present study was performed to ensure this vaccine is suitable for intramuscular injection in Japanese children.MethodsThirty-one healthy 2–6-month-old infants received three doses of Vaxem™ Hib by intramuscular injection at 4-week intervals and a booster dose 1 year later, concomitant with routine infant (DTaP-IPV and pneumococcal) and toddler (measles–rubella) vaccines. Immunogenicity was assessed before and after the primary series and booster dose by enzyme-linked immunosorbent assay for anti-polyribosyl-ribitol-phosphate (PRP) antibodies. Safety was assessed by medical examination and diary cards completed by the subjects’ parents/legal guardians.ResultsThere were no vaccine-related serious adverse events or withdrawals; all children completed the study. Four weeks after the primary series, the geometric mean anti-PRP titer (GMT) was 19.68 μg/mL, and all children had seroprotective titers (≥0.15 μg/mL) that persisted until the booster dose. Proportions of titers indicative of long-term protection (≥1.0 μg/mL) were 100% after the primary series and 77.4% before the booster. Anamnestic responses to the booster had a GMT of 51.33 μg/mL, and 100% had titers ≥1.0 μg/mL. All but one subject reported injection site reactions as resolved within 3 days of vaccination; systemic reactions due to Hib and routine vaccines were also resolved within this period.ConclusionsVaxem™ Hib was generally well tolerated and immunogenic in Japanese children when administered by intramuscular injection in a three-dose primary series and as a booster with concomitant routine vaccines.Clinical trial registry: Registered on Clinical Trials.gov: NCT02074345.     

Comparison of Postinjection Protocols After Intratendinous Achilles Platelet-Rich Plasma Injections: A Cadaveric Study

The purpose of the present investigation was to evaluate the distribution of intratendinous injected platelet-rich plasma (PRP) after 15 minutes of prone resting versus immediate manipulation simulating weightbearing. Ten cadaveric lower limbs were injected under ultrasound guidance with PRP dyed with India blue ink. The dyed PRP was injected into the mid-portion of the Achilles tendon, after which 5 specimens were placed in the prone position for 15 minutes (simulating rest) and the remaining 5 specimens were manipulated through 100 cycles of ankle dorsiflexion and plantarflexion (simulating walking). Thereafter, the specimens were dissected, and the distribution of the India blue dye was ascertained. In the simulated rest group, every specimen showed dyed PRP in the Achilles tendon and in the space between the paratenon and tendon. The median craniocaudal spread of the PRP was 140 (range 125 to 190) mm. In 4 of the simulated rest tendons (80%), the distribution of PRP extended across the entire transverse plane width of the tendon. In the simulated motion group, every specimen showed dyed PRP extending across the entire transverse plane width of the tendon and in the space between the paratenon and tendon. The median craniocaudal spread was 135 (range 115 to 117) mm. No statistically significant difference was found in the amount of craniocaudal spread between the simulated motion and rest groups. In conclusion, it does not appear to matter whether the ankle has been moved through its range of motion or maintained stationary during the first 15 minutes after PRP injection into the mid-portion of the Achilles tendon. The precise meaning of this information in the clinical realm remains to be discerned.     

关节镜清理联合富血小板血浆治疗冈上肌钙化性肌腱炎的疗效观察

目的 探讨关节镜清理联合富血小板血浆（PRP）治疗冈上肌钙化性肌腱炎的临床效果。方法选取该院采用关节镜清理与PRP治疗冈上肌钙化性肌腱炎的患者46例,分为实验组和对照组,各23例。实验组行肩关节镜下钙化灶清理+PRP注射,对照组行单纯关节镜清理,比较两组的治疗效果。结果 所有患者均得到有效随访。实验组中,5例行肩袖修补术（3例为术前确诊肩袖撕裂,2例为钙化灶较大,清理后行肩袖修补）,对照组中,3例行肩袖修补术（2例为术前确诊肩袖撕裂,1例为钙化灶较大,清理后行肩袖修补）。两组患者术后1个月视觉模拟评分法（VAS）明显低于术前,美国肩肘外科协会（ASES）评分明显高于术前,差异均有统计学意义（P <0.05）。实验组术后1个月VAS明显低于对照组,术后1个月ASES评分明显高于对照组,差异均有统计学意义（t=-5.52,t=8.73,P=0.001）。结论 关节镜清理联合PRP治疗冈上肌钙化性肌腱炎,是一种有效、微创的方法。关节镜可以尽量清除钙盐,能对肩袖损伤范围精确评估,并对明确的、损伤较大的肩袖损伤,行带线锚钉肩袖修补。同时,结合PRP注射,可加快损伤肩袖的修复,减轻疼痛,加速...     

肌骨超声引导下PRP技术应用于半月板损伤术后康复效果评价

目的探讨应用肌骨超声引导下富血小板血浆(PRP)技术联合康复训练对半月板损伤关节镜术后的临床疗效评价。方法选取2018年1月至10月在某院行半月板损伤关节镜手术的患者38例进行研究,按照随机数表法分成两组,两组患者均接受入院后术前床边健康与康复宣教,对照组予以关节镜手术前后的常规护理,早期常规康复锻炼,观察组在常规护理与康复的基础上术后予以在肌骨超声引导下的PRP注射并早期进入康复科训练,PRP注射于术后2周开始,1次/周,连续4次。比较两组患者在治疗前、术后6周、术后12周的Lysholm评分、视觉模拟评分法(VAS)评分及两组患者膝功能恢复评分。结果两组患者治疗前、术后6周、术后12周的Lysholm评分分别为观察组(55.7±16.2)分、(95.7±3.6)分、(96.4±3.3)分;对照组(52.3±14.1)分、(72.3±4.1)分、(74.5±6.8)分。VAS评分分别为观察组(5.4±1.7)分、(2.4±1.9)分、(1.6±0.5)分;对照组(5.6±2.8)分、(3.6±2.8)分、(3.2±1.6)分,均较术前改善(P<0.05)。两组患者膝关节功能恢复观察组评分明显高于对照组(P<0.05)。结论膝关节半月板损伤术后在肌骨超声引导下注射PRP定位更加准确,对半月板病变的愈合效果更加明显,且结合早期的正规康复训练,更能有效促进膝关节功能恢复,其操作安全,无并发症,可改善患者的生活质量。     

Platelet-rich plasma with keratinocytes and fibroblasts enhance healing of full-thickness wounds

Advances in tissue engineering led to the development of various tissue-engineered skin substitutes (TESS) for the treatment of skin injuries. The majority of the autologous TESS required lengthy and costly cell expansion process to fabricate. In this study, we determine the possibility of using a low density of human skin cells suspended in platelet-rich plasma (PRP)-enriched medium to promote the healing of full-thickness skin wounds. To achieve this, full-thickness wounds of size 1.767 cm² were created at the dorsum part of nude mice and treated with keratinocytes (2 × 10⁴ cells/cm²) and fibroblasts (3 × 10⁴ cells/cm²) suspended in 10% PRP-enriched medium. Wound examination was conducted weekly and the animals were euthanized after 2 weeks. Gross examination showed that re-epithelialization was fastest in the PRP+cells group at both day 7 and 14, followed by the PRP group and NT group receiving no treatment. Only the PRP+cells group achieved complete wound closure by 2 weeks. Epidermal layer was presence in the central region of the wound of the PRP+cells and PRP groups but absence in the NT group. Comparison between the PRP+cells and PRP groups showed that the PRP+cells-treated wound was more mature as indicated by the presence of thinner epidermis with single cell layer thick basal keratinocytes and less cellular dermis. In summary, the combination of low cell density and diluted PRP creates a synergistic effect which expedites the healing of full-thickness wounds. This combination has the potential to be developed as a rapid wound therapy via the direct application of freshly harvested skin cells in diluted PRP.     

富血小板血浆促进软组织损伤修复的实验研究

目的观察富血小板血浆（platelet-rich plasma,PRP）对犬软组织损伤的修复作用,探讨其促进软组织修复的机制。方法杂种犬4只,体重：18kg～24kg,雌雄不限。随机选择每只犬的一侧后腿的大腿内侧分别制作两个直径为4cm×3cm椭圆形创面和长度为3cm的直线伤口,深及皮下筋膜层,再随机选择一个椭圆形创面和直线伤口为实验创面,用PRP凝胶覆盖创面,对照组创面任其渗血在创面凝固,两组都用3M愈肤膜覆盖损伤处。分别于术后7天、14天、21天、28天通过大体观察和组织学观察对比两侧创伤愈合情况。结果术后7天,对照组创面少许肉芽组织生长,伤口周围有炎症反应;实验组创面清洁,有较多肉芽组织生长,伤口周围无明显炎症反应。术后7～28天,两组的椭圆形创面逐渐缩小,但实验组创面缩小明显并无明显瘢痕;实验直线伤口于术后14～21天完全愈合,无明显瘢痕,对照组可见到明显瘢痕。组织学观察：实验组创面愈合较快,至术后28天,形成比较成熟的皮肤组织,而对照组创面可见到较多瘢痕组织;实验组直线伤口术后14～21天即形成较成熟的皮肤组织,对照组直线形伤口于21～28天形成较成熟的皮肤组织,但瘢痕组织较多。结论 PRP能加快犬软组织损伤的愈合,并能减少瘢痕。