Reflection on the Relationship between the Ethical Principles and Rules of Biomedical Science and Technology / 中国医学伦理学

Clarifying the relationship between ethical principles and rules is the key to promote the legitimate governance of scientific and technological ethics. Ethical principles and rules, as the two basic elements of science and technology ethics, are both different and related. The ethical principles are the basis and direction of the formulation of the ethical rules which are the most direct expression of following the ethical principles and an effective means to improve the effect of ethical governance. Among them, ethical standards are the general standard rules with strong universality. Based on the analysis of the relationship between the ethical principles and the ethical guidelines, this paper put forward the expression mode and reasonable application of science and technology ethical principles in the ethical rules, so as to promote the improvement of the national ethics governance system of biomedical science and technology.

The Current Status and Future Prospects of Oncolytic Viruses in Clinical Trials against Melanoma, Glioma, Pancreatic, and Breast Cancers.

Oncolytic viral therapy has been accepted as a standard immunotherapy since talimogene laherparepvec (T-VEC, Imlygic®) was approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for melanoma treatment in 2015. Various oncolytic viruses (OVs), such as HF10 (Canerpaturev-C-REV) and CVA21 (CAVATAK), are now actively being developed in phase II as monotherapies, or in combination with immune checkpoint inhibitors against melanoma. Moreover, in glioma, several OVs have clearly demonstrated both safety and a promising efficacy in the phase I clinical trials. Additionally, the safety of several OVs, such as pelareorep (Reolysin®), proved their safety and efficacy in combination with paclitaxel in breast cancer patients, but the outcomes of OVs as monotherapy against breast cancer have not provided a clear therapeutic strategy for OVs. The clinical trials of OVs against pancreatic cancer have not yet demonstrated efficacy as either monotherapy or as part of combination therapy. However, there are several oncolytic viruses that have successfully proved their efficacy in different preclinical models. In this review, we mainly focused on the oncolytic viruses that transitioned into clinical trials against melanoma, glioma, pancreatic, and breast cancers. Hence, we described the current status and future prospects of OVs clinical trials against melanoma, glioma, pancreatic, and breast cancers.

Application and research progress of 3D printing technology in biomedicine / 国际生物医学工程杂志

3D printing technology has unique advantages and broad application prospect in biomedicine field. In recent years, cell printing, tissue printing, and organ printing technologies h have appeared successively, and drug printing and medical device printing have been realized. For complex surgical cases, surgeons and researchers have explored a surgical program that involves 3D printing technology, and completed many clinical applications including case discussions, surgical simulations and implantation surgeries. These efforts promoted the application and development of 3D printing technology in medical field. The purpose of this paper is to describe the application and research status of 3D printing technology in medical field from the aspects of medical teaching, orthopedic surgery, stomatology, bioprinting, drug printing, medical device manufacturing, etc., and put forward the prospects for future development.

Algorithm for generating personalized external fixation model based on STL file / 国际生物医学工程杂志

Objective To study the generating algorithm of personalized external fixation model based on STL file, so as to realize the fabrication of personalized external fixation through 3D scanning, model generation and 3D printing. Compared with the traditional plaster fixation, the external fixation obtained by the proposed method has the advantages of good adhesion to the external surface of the limb, good gas permeability and light weight. Methods In order to generate a personalized external fixation model, the key generating algorithms of the model were studied. The point cloud file of the residual limb was obtained by a 3D scanner, and then was converted into an STL format file. The triangular patches were processed by cutting, offsetting, triangulating and hollowing to create an external fixation model with good gas permeability and conformable surface that is fully fitted with the body surface. Finally, the external fixation was fabricated by 3D printing. Results Using the improved point offset algorithm, the problem of severe distortion of the point offset at the plane and sharp corners was solved. Using the tangent sort method, the points on the contour ring were sorted clockwise to obtain a triangular profile. The hollowing of the model was achieved by using the typical three-dimensional "cutting tool" mathematical model and the STL file space intersection method. Conclusions The improved model generating algorithm was validated based on a wrist case, and the personalized external fixed fixation model with conformable surface was obtained. It is proved that the proposed model generating algorithm is effective and practical.

Genomic Signature of the Natural Oncolytic Herpes Simplex Virus HF10 and Its Therapeutic Role in Preclinical and Clinical Trials.

Oncolytic viruses (OVs) are opening new possibilities in cancer therapy with their unique mechanism of selective replication within tumor cells and triggering of antitumor immune responses. HF10 is an oncolytic herpes simplex virus-1 with a unique genomic structure that has non-engineered deletions and insertions accompanied by frame-shift mutations, in contrast to the majority of engineered OVs. At the genetic level, HF10 naturally lacks the expression of UL43, UL49.5, UL55, UL56, and latency-associated transcripts, and overexpresses UL53 and UL54. In preclinical studies, HF10 replicated efficiently within tumor cells with extensive cytolytic effects and induced increased numbers of activated CD4+ and CD8+ T cells and natural killer cells within the tumor, leading to a significant reduction in tumor growth and prolonged survival rates. Investigator-initiated clinical studies of HF10 have been completed in recurrent breast carcinoma, head and neck cancer, and unresectable pancreatic cancer in Japan. Phase I trials were subsequently completed in refractory superficial cancers and melanoma in the United States. HF10 has been demonstrated to have a high safety margin with low frequency of adverse effects in all treated patients. Interestingly, HF10 antigens were detected in pancreatic carcinoma over 300 days after treatment with infiltration of CD4+ and CD8+ T cells, which enhanced the immune response. To date, preliminary results from a Phase II trial have indicated that HF10 in combination with ipilimumab (anti-CTLA-4) is safe and well tolerated, with high antitumor efficacy. Improvement of the effect of ipilimumab was observed in patients with stage IIIb, IIIc, or IV unresectable or metastatic melanoma. This review provides a concise description of the genomic functional organization of HF10 compared with talimogene laherparepvec. Furthermore, this review focuses on HF10 in cancer treatment as monotherapy as well as in combination therapy through a concise description of all preclinical and clinical data. In addition, we will address approaches for future directions in HF10 studies as cancer therapy.

Phase I Dose-escalation Clinical Trial of HF10 Oncolytic Herpes Virus in 17 Japanese Patients with Advanced Cancer.

Oncolytic virus therapy is a promising new therapeutic method, one of an eagerly anticipated class of biological therapies against cancer. There are many different classes of oncolytic virus. One of these, herpes oncolytic virus, is strongly oncolytic and has a large DNA genome as 150k bp. HF10 is a spontaneous mutant of herpes simplex virus -1 (HSV-1) that replicates within tumors and destroys cancers without damaging normal tissue and organs. Clinical trials of HF10 are underway in Japan and the United States. The first pilot study of HF10 was initiated in Japan in 2003. This study examined the safety and efficacy of HF10 in the treatment of breast cancer and head and neck cancers; the trial also included careful dose escalation studies. In 2005, a clinical trial using HF10 to treat pancreatic cancer was initiated. screened In this Japanese study, 17 patients received HF10 in their tumor sites. A clinical trial in the United States is also ongoing to evaluate safety, tolerability and evidence of antitumor activity in patients with refractory superficial solid tumors. Here, we report the evaluation of the 17 patients treated in Japan. Among the patients, 6 had recurrent breast cancer, 3 had recurrent head and neck cancer, and 8 had non-resectable pancreatic cancer. No severe adverse side effects have been observed, and some therapeutic potential has been reported based on pathological findings, tumor markers, and diagnostic radiography. Those results should encourage further clinical trials of HF10 around the world.

Clean intermittent catheterization of spinal cord injured patients / 中国康复理论与实践

@#ObjectiveTo investigate the nursing management of clean intermittent catheterization (CIC) of spinal cord injured (SCI) patients.Methods72 SCI patients were randomly divided into two groups: CIC group (37 cases) and sterile intermittent catheterization (SIC) group (35cases); urine cultures were performed before and after catheterization in each group, hand cultures were also performed before catheterization only in CIC group. Results10 cases of CIC group and 11 cases of SIC group had different results of urine culture before and after intermittent catheterization, but there was no statistical difference between two groups (P>0.05). 5 cases had positive results of hand culture, but the colony counting was in the normal range. Follow up was made six months after intermittent catheterization. There were 35 cases (94.59%) in CIC group and 33 cases (94.29%) in SIC group who could urinate regularly with post void residual less than 50 ml. One case in each group had symptomatic urinary tract infection respectively. ConclusionsCIC is a simple, safe and effective method to resolve the bladder dysfunction of SCI patients.

对后期脊髓损伤患者康复教育需求的调查及分析 / 中国康复理论与实践

@#目的探讨对后期脊髓损伤患者实行康复教育的内容及方式。方法采取自行设计问卷 ,对在我院康复病房住院的72例脊髓损伤患者进行问卷调查。结果后期脊髓损伤患者需求的康复知识主要为康复训练指导、泌尿系统感染的预防、膀胱训练、安全护理、肠道护理(或上呼吸道感染的预防),对康复教育方式主要选择交谈、病友交流和实际操作。结论对后期脊髓损伤患者进行康复教育,应考虑患者的损伤部位、心理状态、教育方式等,要因人而异,内容具体,使康复教育达到最佳效果。