BACKGROUND: Gentamicin bead chain is an effective drug delivery system for treatment of osteomyelitis, but it cannot be degraded, need to be removed by second operation, and can breed pathogens. As a result, biodegradable drug delivery systems become a hotspot. Nano-hydroxyapatite/poly(β-hydroxybutyrate-co-β-hydroxyvalerate)-polyethylene glycol-gentamicin (nano-HA/PHBV-PEG-GM-DDS) is considered to be a good choice for the current predicament. OBJECTIVE: To evaluate the acute or chronic toxic reactions of the whole body and local tissues, intracutaneous stimulation, cytotoxicity and hemolytic reactions after bone remodeling and implantation of nano-HA/PHBV-PEG-GM-DDS, thus providing a new kind of material for treating osteomyelitis. METHODS: Plastic nano-HA/PHBV-PEG-GM-DDS was prepared using plastic fibrin glue as microsphere scaffold and nano-HA as the core carrier of GM that was coated with PHBV and PEG. The acute, subacute/chronic toxicity, implantation, hemolysis, cytotoxicity and intracutaneous stimulation tests were performed according to the evaluated criteria of medical implanted materials as wel as biological and animal trials recommended in GB/T16886.1-1997. RESULTS AND CONCLUSION: The plastic nano-HA/PHBV-PEG-GM-DDS was nontoxic and caused no apparent changes in liver and kidney function and serum biochemical indexes. Pathological examination showed that the implanted material was covered with tissues, and inflammation changes accorded with the general regularity of inflammatory outcomes. After implantation, the nano-HA/PHBV-PEG-GM-DDS was biodegraded and replaced by osseous tissues. The hemolytic rate of the material extract to the composite diffusion solution was 1.2%, which was below the standard criteria (5%). Human bone marrow cells cultured in vitro with the plastic nano-HA/PHBV-PEG-GM-DDS grew normally with good morphology. There was no stimulation reaction according to the criteria after the diffusion solution was subcutaneously injected into the back of the animal. These findings indicate that the plastic nano-HA/PHBV-PEG-GM-DDS for treating osteomyelitis possesses excel ent biocompatibility and security.

Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.

Abstract: There are two stages for selecting the clinical intervention outcome variables. One is crude collection and the other is precise collection. The selection methods include brainstorming method, Delphi method, Gordon method, systematic review, systematic analysis method, mathematic model method and so on. Each method has some advantages or disadvantages. When selecting the clinical intervention outcome variables, researchers should make sure the research aim, the representative and the sensitivity of the variables, and select all kinds of recommended methods comprehensively, then decide which method should be used.

Soladulcidine is a steroidal alkaloid abundant in Solanum dulcamara L. with antitumor and other biological activities. In this study, ten soladulcidine derivatives were synthesized through esterification at C-3-hydroxy group, modification at NH group of F ring of esterification of E ring-opening products. The in vitro antiproliferative activity of these synthesized derivatives against prostate cancer (PC-3) cell line was assessed. Within this series of compounds, compound 19 exhibited the most potent inhibitory effect against the proliferation of PC-3 cell line (IC50=4.80±.9μmol/L).

Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.

Chronic wounds are characterized by complex pathogenesis, long course of disease, and occur mostly in middle-aged and elderly people. As the population ages, chronic wounds have gradually become significant burden on the affected patients and the healthcare system. In the past decade, cold atmosphere plasma (CAP) was found to have the effects of resisting infection and promoting wound healing. By reviewing recent researches on the treatment of chronic wounds and biological effects of CAP at home and abroad, this article summarizes the research progress of CAP in the treatment of chronic wounds, aiming at providing a reference for the treatment of chronic wounds.

The relationship between pulmonary arteriovenous malformations (PAVMs) and stroke remains unclear. With the development of imaging technology, studies shows that PAVMs are an important cause of cryptogenic stroke (CS). Most PAVMs are not diagnosed until the onset of stroke. The main pathogenesis of PAVMs-related CS is paradoxical embolism and increased blood viscosity caused by iron deficiency anemia. Antiplatelet therapy and interventional therapy may have a preventive effect on recurrent stroke in such patients. This article summarizes the pathophysiological mechanism, diagnosis and treatment of PAVMs-related CS, hoping to provide new ideas for the diagnosis and treatment of CS.

Objective:To investigate the mid-term clinical efficacy and imaging changes of Waveflex semi-rigid internal fixation system combined with posterior lumbar interbody fusion (PLIF) in the treatment of double segmental lumbar degenerative diseases.Methods:The data of 51 patients with lumbar degenerative diseases who underwent surgery from September 2014 to September 2015 were retrospectively analyzed, including 29 males and 22 females, aged 65.5±5.6 years (range 58-73 years). Preoperative intervertebral space degeneration grade by University of California at Los Angeles (UCLA) and Pfirrmann intervertebral disc degeneration grade were recorded. 23 cases of primary responsible segments were treated with decompression, fixation and fusion, and adjacent secondary responsible or degenerative segments were treated with Waveflex semi-rigid internal fixation (combined group); 28 cases of double segments were treated with decompression, fixation and fusion (fusion group). Disc height index (DHI) and intervertebral foramina height (IFH) of the semi-rigid fixation segments, DHI and IFH of the upper adjacent intervertebral space, and horizontal displacement of the upper adjacent vertebral body (HD) were measured on lateral X-ray films of lumbar spine; In the fusion group, DHI and IFH adjacent to the upper vertebral space and HD adjacent to the upper vertebral body were measured. The efficacy was evaluated by short-form McGill Pain Questionnaire (SF-MPQ) and Oswestry disability index (ODI).Results:51 cases were followed up for 5.4±0.3 years (range 5.2-6.3 years). The low back and leg pain and function in the combined group and fusion group were significantly improved compared with those before operation. SF-MPQ and ODI at 3 months, 1 year, 5 years after operation were significantly different from those before operation ( P<0.05). In the combined group, the DHI of semi-rigid internal fixation segments before operation and 3 months, 1 year, 5 years after operation were 37.8%±7.6%, 37.9%±7.4%, 36.5%±6.9% and 36.0%±7.1% respectively ( P>0.05); The IFH of semi-rigid internal fixation segments before operation and 3 months, 1 year, 5 years after operation were 21.5±2.8, 21.4±2.8, 20.4±2.7, 19.4±2.4 mm respectively ( P<0.05); The DHI of the upper segment adjacent to semi-rigid internal fixation before operation and 3 months, 1 year, 5 years after operation were 37.1%±9.3%, 36.8%±9.1%, 35.2%±9.1%, 33.9%±8.8% respectively ( P>0.05); The IFH of the upper segment adjacent to semi-rigid internal fixation before operation and 3 months, 1 year, 5 years after operation were 21.9±3.0, 21.4±3.0, 20.4±2.9, 19.5±2.7 mm, respectively ( P<0.05). The HD of upper vertebral body adjacent to semi-rigid internal fixation before operation and 3 months, 1 year, 5 years after operation were 2.2±0.7, 2.3±0.5, 2.5±0.5, 2.8±0.5 mm respectively ( P<0.05). At the last follow-up, one case of semi-rigid titanium rod fracture, one case of screw loosening at semi-rigid internal fixation segment, three cases with unsatisfied numbness relief, and 2 cases of facet joint spontaneous fusion at semi-rigid fixation segment occurred in the combined group. Conclusion:Waveflex semi-rigid internal fixation can protect the degenerative lumbar intervertebral disc, and delay the degeneration of semi-rigid internal fixation segment and adjacent upper segment after interbody fusion, but long-term follow-up and study are needed.

Objective: To investigate the relationship between the erythrocyte membrane protein gene mutations and the clinical severity of hereditary spherocytosis (HS). Methods: Targeted sequencings were performed on 25 HS patients, correlation between HS mutations and patients’ clinical characteristics were evaluated. Results: A total of 25 HS patients were enrolled, including 13 males and 12 females with median age of 20 (4-55) years, including 9 compensatory hemolysis patients, 9 patients with mild anemia, 3 patients with moderate anemia and 4 patients with severe anemia. Of them, 18 patients (72%) harbored HS-related mutations, including ANK1 mutation in 6 cases, SLC4A1 mutation in 6 cases, SPTB mutation in 5 cases and 1 case with EPB41 mutation. Seven patients (28%) didn’t carry common HS mutations. SPTB and SLC4A1 mutations mainly affected male patients. There was no significant difference between the age of diagnosis (P=0.130) and HGB level (P=0.585) in patients with HS mutation and those without mutation, however, the EMA binding fluorescence intensity (P=0.015), AGLT50 (P=0.032) and EOF minimal hemolytic concentration (P=0.027) were significantly different in these two groups of HS patients. Conclusion To screen erythrocyte membrane protein coding gene mutations could favor the diagnosis of HS, and patients without mutations have mild clinical phenotype.

Objective:To discuss the quantitative evaluation of left ventricular systolic function in patients with light-chain amyloidosis (AL) by pressure-strain loop (PSL).Methods:Forty-six patients with clinically diagnosed as AL in the Affiliated Tumor Hospital of Zhengzhou University from January 2018 to December 2020 were selected as case group, and they were divided into 2 groups according to whether the thickness of interventricular septum and posterior wall at end-diastole was >12 mm; ①cardiac amyloidosis (CA) group (21 cases, the thickness>12mm); ②non cardiac amyloidosis (NCA) group (25 cases, the thickness≤12 mm). Twenty five healthy volunteers were selected as control group at the same time. Routine echocardiography was performed in all subjects.Two-dimensional dynamic images of the left ventricular apical two-chamber, three-chamber, and four-chamber views were collected for three consecutive cardiac cycles using two-dimensional speckle-tracking. A tracing analysis was conducted and blood pressure was entered on the off-line Echo PAC 203 software, and the left ventricular global longitudinal strain (GLS), peak strain time dispersion(PSD), global myocardial work index (GWI), global constructive work (GCW), global wasted work (GWW) and global work efficiency (GWE) were obtained. The differences of GLS, PSD and myocardial work (GWI, GCW, GWW, GWE) parameters were compared between groups, and Pearson correlation was used to analyze the correlations.Results:①Routine echocardiography: Compared with the control group and NCA group, inter-ventricular septum thickness (IVST), left ventricle posterior wall thickness (LVPWT), left ventricular mass index (LVMI), left atrial diameter (LAD), and E/e′ in CA group were increased, while left ventricular ejection fraction (LVEF) was decreased; ②Compared with the control group, GLS, GWI, and GCW in NCA group were decreased, while there were no statistically differences in GWE, PSD, and GWW between the two groups (all P>0.05); Compared with the control group and NCA group, GLS, GWI, GCW, and GWE were obviously decreased, while PSD and GWW were obviously increased in CA group.③ Correlation analysis showed that: the absolute value of GLS was positively correlated with GWI, GCW and GWE ( r=0.654, 0.695, 0.788; all P<0.001), and negatively correlated with GWW, and PSD ( r=-0.710, -0.625; all P<0.001). Besides, PSD had negative correlation with GWI, GCW and GWE ( r=-0.754, -0.653, -0.702; all P<0.001), and positive correlation with GWW ( r=0.676, P<0.001). Conclusions:PSL can quantitatively evaluate the left ventricular systolic function of AL patients, while the myocardial work parameters are conducive to evaluate the degree of cardiac involvement in the course of AL patients.