Short-term results of incremental penile girth enhancement using liquid injectable silicone： words of praise for a change

Aim： To report our experience with penile girth augmentation using liquid injectable silicone. Methods： Between August 2003 and July 2006, 324 men （mean age 35 years, range 19-65 years） received a series of liquid silicone subcutaneous injections between the penile skin and the corpora cavernosa on the dorsal and lateral aspects of the penile shaft, under local anesthesia. Digital photographs taken pre- and post-procedure （n = 324）, and penile contour measurements （n = 30） yielded objective results. Subjective results were derived from patient and partner testimony of satisfaction. Follow-up averaged 20 months （range 1-36 months）. Results： Three hundred and twenty-four procedures were primary augmentations. Most men （61%） were married, 7% were accompanied by their partners, and 93% were circumcised. The mean measured penile circumference was 9.5 cm （7.5-11.5 cm） pretreatment and 12.1 cm （10.3-15.3 cm） post-treatment （mean increase of 27% in circumference and 0.84 cm in diameter）. Patient and partner satisfaction was already expressed after the first two treatments. Sexual activity could be resumed after 8 h. Complications （mild bruising） were easily resolved. Conclusion： Penile girth augmentation using liquid injectable silicone yields very satisfactory short-term results with no immediate or short-term complications.     

Chitosan microparticles as injectable scaffolds for tissue engineering

The use of chitosan microparticles as injectable carriers for cell transplantation represents a promising alternative to avoid the drawbacks of the implantation of other forms of three-dimensional (3D) scaffolds seeded with cells. In this study, a 3D construct is obtained in vitro by combining chitosan microparticles crosslinked with genipin and goat bone marrow stromal cells (GBMCs). Cell viability and the morphology of GBMCs were evaluated after culture for 7 and 14 days. Our results show the feasibility of chitosan microparticles as potential injectable scaffolds for tissue engineering and regenerative medicine.     

国产八氟丙烷人血白蛋白微球注射液的安全耐受性

目的观察八氟丙烷人血白蛋白微球注射液在中国健康受试者中的安全性及耐受程度,为Ⅱ期临床试验给药剂量的确定提供依据。方法本研究采用开放、随机的试验设计,将符合入选标准的30名健康中国男性受试者随机分为5组,每组6名,分别注射八氟丙烷人血白蛋白微球注射液0．005、0．01、0．02、0．03、0．04mL·kg-1,观察临床体征及实验室检查指标的变化。结果八氟丙烷人血白蛋白微球注射液在剂量0．005～0．04n1L·k-1内无任何不良反应发生,生命体征和实验室检查均未出现有临床意义的变化。结论在剂量0．005—0．04mL·kg-1内的八氟丙烷人血白蛋白微球注射液对健康受试者是安全和耐受良好的,临床推荐其剂量以不超过0．04mL·kg-1为宜。     

注射用与药用聚氧乙烯脱水山梨醇单油酸酯(吐温-80)类过敏反应比较研究

目的:比较注射用与药用聚氧乙烯脱水山梨醇单油酸酯(吐温-80)的类过敏反应特点,以探讨不同级别吐温-80的安全性。方法:小鼠耳廓血管通透性分析:将ICR小鼠随机分组,包括生理盐水组、阳性药Compound 48/80 25 mg.kg-1组、0.2%,1%,5%的药用吐温-80和相同浓度的注射用吐温-80组,分别一次性尾静脉注射含0.4%伊文思蓝的各种受试物(20mL.kg-1),观察给药后30 min后动物的行为学变化及耳廓蓝染情况。记录给药后各组动物耳廓血管通透性增高反应的阳性率,按照耳廓蓝染程度评分,并定量测定耳廓伊文思蓝渗出量。大鼠皮肤血管渗透性试验:将6只Wistar大鼠分别一次性尾静脉注射0.6%伊文思蓝0.4 mL,10 min后沿脊柱两侧皮内注射50μL 5%葡萄糖,Compound 48/80 10 g.L-1,0.2%,0.4%,1%,5%的药用吐温-80和注射用吐温-80,20 min后记录注射点的皮内蓝染面积,测定注射点的伊文思蓝渗出量。结果:5%的药用吐温-80和注射用吐温-80可造成ICR小鼠耳廓血管通透性明显增高,而且药用吐温-80血管通透性增高程度明显强于注射用吐温-80;其他浓度吐温-80未造成明显小鼠耳廓蓝染。不同浓度的吐温-80溶液在注射部位造成一定程度的蓝斑,而且相同浓度的注射用吐温-80蓝斑直径较药用吐温-80的蓝斑直径小,除阳性药外,各组伊文思蓝渗出量无明显差距。结论:吐温-80有明显的增强血管通透性的作用,提示其有致类过敏作用,并且其致类过敏作用有一定的剂量效应关系,另外注射用吐温-80比药用吐温-80安全性高,但应严格控制用量以降低类过敏反应的发生。     

复方当归粉针剂对垂体后叶素诱导大鼠心肌缺血的保护作用

摘要目的：观察复方当归粉针剂对垂体后叶素诱导的大鼠缺血心肌的保护作用。方法：将60只大鼠分为空白对照组、模型对照组、复方当归粉针剂低、中、高剂量组,阳性对照组,大鼠腹腔注射垂体后叶素建立急性心肌缺血模型,观察复方当归粉针剂对各组大鼠血清中超氧化物歧化酶（SOD）、丙二醛（MDA）以及心肌梗死面积的影响。结果：复方当归粉针剂可对抗垂体后叶素所致的大鼠急性心肌缺血,增加血清中SOD活力,减少MDA生成,缩小心梗面积。结论：复方当归粉针剂对大鼠心肌缺血有保护作用,其机制可能与抗脂质过氧化有关。     

Paste-like inorganic bone matrix: preclinical testing of a prototype preparation in the porcine calvaria

Objective: To evaluate the osteoconductive properties and the volume stability of an injectable paste‐like inorganic bone matrix (PBM) in porcine calvaria defects. Material and methods: We created six circumferential defects in the calvaria of 12 adult iberico pigs. The defects were filled with either PBM, Bio‐Oss® of different particle size, carrier alone, or left empty. PBM was composed of Bio‐Oss® with a particle size ranging from 250 to 500 μm and a hydrogel‐carrier of carboxymethylcellulose and collagen. After 6 and 12 weeks of healing, the animals were sacrificed and undecalcified ground sections were prepared and subjected to histologic and histomorphometric analysis. To quantify the osteoconductive properties of PBM, bone volume per tissue volume (BV/TV) in the defect area was determined. To determine the volume stability, bone substitute volume per tissue volume (BSV/TV) was measured. Results: After 6 weeks, PBM particles in the center of the defect were surrounded by fibrous connective tissue, which was later replaced by bone. BV/TV in the PBM group increased from 29.7±12.7% (minimum 12.2%, maximum 43.7%) after 6 weeks to 43.9±14.9% (minimum 27.8%, maximum 63.9%) after 12 weeks (Mann–Whitney test; P=0.6). According to the Friedman test, BV/TV in groups containing Bio‐Oss® of different particle sizes, the carrier and the empty defects was similar to the results obtained with PBM (6 weeks P=0.8; 12 weeks P=0.22). BSV/TV in the PBM group was stable over time, with 10.1±9% (minimum 3.3%, maximum 27.6%) and 16.5±12.9% (minimum 1%, maximum 32.7%), after 6 and 12 weeks, respectively (P=0.72). BSV/TV in the PBM group was comparable to the results obtained with the Bio‐Oss® particles of different sizes (Friedman test; 6 weeks P=0.0503; 12 weeks P=0.56). Conclusions: The results of this preclinical study showed that the PBM is osteoconductive and maintains the augmented volume, similar to commercial Bio‐Oss®. These data suggest that the osteoconductive properties of Bio‐Oss® are maintained at the smaller particle size and in the presence of the carrier.     

高强度可注射型硫酸钙植骨材料治疗胫骨平台骨折21例

解放军第二军医大学附属长海医院2005-10/2007-10治疗21例胫骨平台骨折患者，其中SchatzkerⅡ型12例，SchatzkerⅢ型5例，SchatzkerⅣ型2例，SchatzkerⅤ型1例，SchatzkerⅥ型1例。17例使用MIIG™X3型高强度可注射硫酸钙，4例使用MIIG™X3HiVisc型高强度可注射硫酸钙。20例患者获得随访，平均22.1个月。所有患者均获得骨性愈合，无骨不连发生；无感染情况发生；2例患者切口有渗出，渗出液细菌培养为阴性。术后4周高强度可注射硫酸钙开始明显吸收，术后12周基本吸收，术后6个月高强度可注射硫酸钙植入区域与正常松质骨一致。20例术后半年Rasmussen膝关节功能平均25.8分，12例术后1年Rasmussen膝关节功能平均26.9分。术后1年1例发生胫骨平台高度丢失约 2 mm，但无关节功能障碍。结果提示应用MIIG™X3或MIIG™X3HiVisc可注射式人工植骨材料治疗胫骨平台骨折，能有效避免骨折再移位和关节面高度的丢失，与宿主无生物相容性不良反应，并具有提高关节早期功能锻炼安全性的特点。     

Tunable Collagen Hydrogels are Modified by the Therapeutic Agents They are Designed to Deliver

Abstract

Injectable hydrogels are increasingly being developed for biomedical applications due to their ability to be delivered in a minimally invasive manner. One potential use for such materials is in cell delivery for cardiac regeneration. While the materials’ properties are often characterized, how these properties (and in particular gelation) are affected by the addition of the therapeutic agent(s) they are designed to deliver is often overlooked. The aim of this study was to examine the interactive effects between collagen-based hydrogels and different additives (cells and microspheres). The results demonstrated that the incorporation of either cells or microspheres to a collagen hydrogel decreased its gelation time and increased its viscosity. Increased concentrations of the EDC/NHS cross-linker resulted in greater loss of cell viability. However, it was found that this cell loss could be minimized by delivering cells with the cross-linker scavenger glycine. A better understanding of how materials and cells (and other additives) respond to each other will help towards the goal of improving scaffolds being developed for regenerative therapy.     

Switching long acting antipsychotic medications to aripiprazole long acting once-a-month: expert consensus by a panel of Italian and Spanish psychiatrists

ABSTRACT

Introduction: Aripiprazole long acting once-monthly (AOM) is a long acting atypical antipsychotic with proven efficacy in schizophrenia and with a pharmacological and a side effect profile that is different from other antipsychotics. These and other characteristics make AOM a possible alternative in patients requiring a change in long acting antipsychotic treatment due to issues such as lack of efficacy or persistent side effects. Both clinical and pharmacological factors should be considered when switching antipsychotics, and specific guidelines for long acting antipsychotic switching that address all these factors are needed.

Areas covered: A panel of Italian and Spanish experts in psychiatry met to discuss the strategies for the switch to AOM in patients with schizophrenia. Real life clinical experiences were shared and the clinical strategies to improve the likelihood of success were discussed.

Expert Opinion: Due to its specific pharmacological and tolerability profile, AOM represents a suitable alternative for patients with schizophrenia requiring a switch to a new LAI treatment because of lack of efficacy or persistent side effects from another LAI. Possible strategies for the switch to AOM are presented in this expert consensus paper in an attempt to provide guidance throughout the entire switching process     

Relapse Prevention in Schizophrenia and Schizoaffective Disorder with Risperidone Long-Acting Injectable vs Quetiapine: Results of a Long-Term, Open-Label, Randomized Clinical Trial

Chronic management of schizophrenia and schizoaffective disorders is frequently complicated by symptomatic relapse. An open-label, randomized, active-controlled, 2-year trial evaluated 710 patients with schizophrenia or related disorders who were switched from stable treatment with oral risperidone, olanzapine, or conventional neuroleptics to risperidone long-acting injectable (RLAI) or oral quetiapine. Primary effectiveness evaluation was time-to-relapse. Safety evaluations included adverse events (AEs) reported for the duration of the study, Extrapyramidal Symptom Rating Scale (ESRS), clinical laboratory tests, and vital signs. A total of 666 patients (n=329 RLAI, n=337 quetiapine) were evaluable for effectiveness measures. Baseline demographics were similar between treatment groups. Kaplan–Meier estimate of time-to-relapse was significantly longer with RLAI (p<0.0001). Relapse occurred in 16.5% of patients with RLAI and 31.3% with quetiapine. RLAI and quetiapine were both safe and well tolerated. Weight gain affected 7% of patients with RLAI and 6% with quetiapine, with mean end point increases of 1.25±6.61 and 0±6.55 kg, respectively. There were no significant between-group differences in weight gain. ESRS total scores decreased similarly after randomization to either RLAI or quetiapine. Extrapyramidal AEs occurred in 10% of patients with RLAI and 6% with quetiapine. Treatment-emergent potentially prolactin-related AEs were reported in 15 (5%) patients with RLAI and 5 (2%) patients with quetiapine; hyperprolactinemia was reported in 43 (13.1%) patients with RLAI and 5 (1.5%) patients with quetiapine. Somnolence occurred in 2% of patients with RLAI and 11% with quetiapine. To our knowledge, this is the first report of a randomized clinical trial directly comparing relapse prevention with a second-generation long-acting injectable antipsychotic and oral therapy. Time-to-relapse in stable patients with schizophrenia or schizoaffective disorder was significantly longer in patients randomized to RLAI compared with those randomized to oral quetiapine. Both antipsychotics were generally well tolerated.