The extensive research and application of human gene editing technology have raised many ethical issues,sparking heated debates among scholars.These debates mainly manifest in three aspects,including the limitation of human autonomy in the future,the ambiguity of self-identity,and the intensification of life hierarchy.The root causes of these debates mainly lie in the complexity of the subject's ethical sense of responsibility in the subjective aspect,the negative effects of technology in the objective aspect,and the insufficient external regulations in the social aspect.These issues require the following measures to be taken to resolve,such as enhancing the sense of ethical responsibility of subject,strengthening the internal ethical supervision of human gene editing technology,and establishing an ethical supervision committee and a unified ethical governance framework.

Objective::To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation.Methods::In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure.Results::Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III-IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up.Conclusion::This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

Objective::To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation.Methods::In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure.Results::Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III-IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up.Conclusion::This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

Humans ; Mitral Valve/surgery* ; Heart Valve Prosthesis ; Cardiac Surgical Procedures

Humans ; Mitral Valve/surgery* ; Heart Valve Prosthesis ; Cardiac Surgical Procedures

AIM:To analyze curative effect of phacoemulsification through clear corneal tunnel incision on cataract and the influences on subjective sylptols of dry eye questionnaire scores(SDES)and break-up time(BUT).

METHODS: During the period from June 2015 to January 2019, 117 cataract patients(139 eyes)who underwent cataract surgery in the hospital were divided into group A(n=65, 72 eyes)and group B(n=52, 67 eyes)by random number table method. Groups A and B underwent phacoemulsification through 2.2mm and 3.0mm micro-incision, respectively. The general surgical status, SDES, BUT and curative effect indexes \〖best corrected visual acuity(BCVA), spherical equivalent(SE), endothelial cell density(ECD)\〗 were compared between the two groups.

RESULTS: There was no significant difference in ultrasound time, cumulative released energy, operation time or postoperative complications between two groups(P>0.05). After surgery, SDES scores in both groups were significantly increased, BUT was decreased compared with that at 1d before surgery. At 3mo after surgery, SDES and BUT recovered to preoperative levels. At 1d and 1wk after surgery, SDES score in group A was significantly lower than that in group B, while BUT was significantly higher than that in group B(P<0.05). After surgery, BCVA LogMAR and ECD in both groups were significantly decreased, while SE and corneal diopter were significantly increased, without significant difference between the two groups(P>0.05).

CONCLUSION:The curative effect of phacoemulsification through clear corneal tunnel incision is reliable on cataract. The tear film function is better through 2.2mm micro-incision.

The human health is seriously affected by central nervous system(CNS) diseases, but the pathogenesis of CNS diseases is still not completely clear. Currently, the drugs used to treat CNS diseases are mainly receptor modulators and neurotransmitter inhibitors, which have serious side effects; and there are short of drugs for treating CNS diseases clinically. Studies suggest that animal medicines mainly include protein, polypeptide and small-molecule compounds, and have such pharmacological effects in calming, resisting convulsions and improving brain tissues. Plenty of studies suggest that animal medicines usually have a strong activity and good curative effect on these diseases, with a promising prospect in research and development of drugs treating CNS diseases. Based on systematic reviews of literatures, this paper summarizes active ingredients and main pharmacological effects of animal medicines in "extinguishing wind to arrest convulsions" for the CNS diseases, epilepsy and cerebral ischemia, and discusses their study value and application prospects. The results showed that the studies of protein and peptides were relatively simple, and some animal medicines were still blank. The authors believed that amino acids and small molecular compounds should be transferred to oligopeptide, advanced protein extraction and separation techniques shall be adopted for identifying the protein polypeptide composition structure and studying the efficacy, and the methods of biological technology were used to develop peptide biological products for the treatment of CNS diseases. This paper could provide ideas and reference for developing animal medicine products for the treatment of CNS diseases.