当前国际形势的变化及中国经济社会的发展为生物医药产业提供了难得的历史机遇，抓住这个历史机遇，实现国内与国际、产业与市场的两个有效对接，是推动我国生物医药产业发展的关键和有效手段。为了探索国内与国际对接的有效方式，我们发起“王朝计划”，并于今年6月17日在深圳第五届中国生物产业大会上，由卫生部医药卫生科技发展研究中心与英国MRCT、武汉光谷生物产业基地及上海新生源集团公司分别签订了共同推进“王朝计划”和共建“卫生部科技中心国际临床医学基地”的战略合作协议。 “王朝计划”的核心思想是将英国领先的医药研发能力与中国巨大的市场需求相对接，实现技术和项目的双向转移。“王朝计划”有3个重要特点：① 民间发起的国际合作计划，而非政府间合作计划；② 商业合作计划，而非单纯的科技合作计划；③ 开放的合作计划，是集成技术、成果、人才、资本各种资源的计划。 为了探索产业与市场对接的有效方式，我们启动了“卫生部科技中心国际临床医学基地”的建设工作。其宗旨是利用科技手段，努力解决长期存在的产业与临床应用两张皮的问题；加快和规范生物医药技术和产品的市场推广；实现医疗技术水平和生物医药产业相互促进，共同发展。其建设思路紧紧围绕1个重点，针对2个需求，开展3项业务，实现4个目标。围绕1个重点：重点开展上市后医药技术和产品的临床研究，而不是主要承担以上市申报为目的的临床试验。与通常的CRO不同，我们的主要产出是临床研究的科研成果，而不是临床试验的申报资料。针对2个需求：① 已上市的产品或技术对开拓市场的需求；② 广大医务工作者开展科学研究，提高医疗水平的需求。开展3项业务：① 吸纳多方投入，建立临床科研基金，组织开展临床科研项目，探索既实现科研投入多元化，又确保具体的科研活动不受商业利益牵制的有效机制；② 建立针对不同疾病或症候群的临床研究数据库，实现医学知识的系统积累，产出更多的高水平科研成果，推动流行病学、循证医学和转化医学的发展；③ 将卫生技术评估体系与产业对接，完善我国医药技术和成果的评价体系，提高医药企业的技术决策能力。实现4个目标：① 做强优势技术、成果和企业；② 推动临床科技进步和技术水平提升；③ 催生新的服务产业模式；④ 是完善园区的技术孵化和产业促进体系，增强园区的招商引资能力。 “国际临床医学基地”将由卫生部科技发展中心与武汉光谷生物基地共建，在湖北省卫生厅等有关方面的支持下，实行理事会领导下的主任负责制，依托由园区直属国有企业与其他企业合资设立的专门公司进行具体运作。卫生部科技中心主要负责整体设计、宏观决策、政策支持和监督把关，不参与实体公司的股份和单纯市场运作。“王朝计划”和“国际临床医学基地”既密切相关，相互促进，又各有独立的业务发展方向。这两项事业都是全新的探索，要走的路还很长，还有许多困惑和挑战，都需要政府、企业、临床医疗机构和投资机构等多方面的大力支持。为了生物技术能向信息技术那样，真正实现全方位、大规模的产业化，真正全面改变我们的世界和生活，让我们共同努力！ 收稿日期：2011–12–06 本文编辑：杜亮
目的 总结反复黏膜感染的IgA肾病的临床病理特点。 方法 采用单中心流行病学调查及回顾性研究，收集2006年1月－2009年12月253例经肾活检确诊为IgA肾病的住院患者的临床病理资料，对114例反复黏膜感染的IgA肾病患者（A组）及139例偶发或从未发生黏膜感染的IgA肾病患者（B组）的临床病理指标进行比较。 结果 A组患者年龄较B组小（t=2.913，P=0.004），临床表现无明显症状者比例较B组多，临床分型以反复发作肉眼血尿型为多，病理分级较B组轻（Z=?2.042，P=0.041），IgA+IgM+C3沉积率高（P＜0.001）；B组IgA+IgG+C3沉积率高（P＜0.001），纤维连接蛋白沉积率高（P＜0.001）。 结论 反复黏膜感染的IgA肾病组患者年龄小，反复发作肉眼血尿型多，临床表现及病理分级较轻；两组FN沉积及免疫球蛋白沉积的主要类型不同，提示两组发病机制可能有所不同。
ObjectiveTo review the current progresses in purification strategies, biological characters, and functions of endothelial progenitor cells (EPCs) derived extracellular vesicles (EVs) (EPC-EVs). MethodsRecent relevant publications on the EPC-EVs were extensively reviewed, analyzed, and summarized. ResultsEPC-EVs are usually isolated by differential centrifugation and exhibit a homogenous pattern of spheroid particles with a diameter ranging from 60 to 160 nm under transmission electron microscopy. EPC-EVs are positive for cell-surface markers of EPCs (CD31, CD34, and CD133), and negative for markers of platelets (P-selectin and CD42b) and monocytes (CD14). Recent studies have shown the effectiveness of EPC-EVs in ischemic injuries, anti-Thy1 glomerulonephritis, and cardiomyocyte hypertrophy, and also shown their predictive role in cardio-cerebral-vascular diseases. ConclusionAn alluring prospect exists on the EPC-EVs-related research. Further studies are required to decipher the composition of EPC-EVs and their precise role in pathophysiological processes, and to investigate the molecular mechanisms for their targeting and function.
ObjectiveTo investigate the negative emotions of patients before cardiac surgery in West China Hospital in order to analyze the related factors.MethodsThe Huaxi emotional-distress index (HEI), a screening tool for mood disorders developed by the Mental Health Center of West China Hospital, was used for preoperative psychological evaluation of 1 968 adult patients hospitalized in cardiac surgery from March 2016 to July 2014. There were 835 males and 1 133 females at age of 49±13 years.Results Fifty-one patients (2.6%) had negative emotions, among whom 6 patients were screened for suicide risk. After intervention, none of them had serious consequences caused by adverse emotions, such as automatic discharge from hospital, avoidance of surgery and suicide.ConclusionThis study found that most of the cardiac surgery patients in West China Hospital have good psychological status before surgery, and a few suffered from negative emotions. “Huaxi emotional-distress index” is simple, effective and worth promoting.
ObjectiveTo observe the prevalence of ocular ischemic appearance (OIA) associated with carotid artery stenosis, and to explore the correlation between the ocular ischemic appearance and the carotid stenosis degree and location. MethodsA total of 132 patients with carotid artery stenosis diagnosed by color Doppler ultrasound and CT angiography were enrolled in this prospective study. The carotid stenosis degree and location were identified. The ophthalmic symptoms was inquired. The corrected vision, diopter, intraocular pressure, slit lamp microscope and fundus examination were used to determine if OIA exists. The correlation between the OIA and the carotid stenosis degree and location were analyzed. The carotid stenosis degree was divided into 4 types: mild (≤50%), moderate (<50% but ≤75%), severe (<75% but ≤99%) and occlusion (100%). ResultsThe distribution of carotid stenosis degree as follow: mild in 16 patients (12.1%), moderate in 46 patients (34.8%), severe in 50 patients (37.9%) and occlusion in 20 patients (15.2%). The stenosis located in the external carotid artery in 21 patients (15.9%), in internal carotid artery in 46 patients (34.8%), in crotch of extracranial internal carotid artery in 55 patients (41.7%), and in common carotid artery in 10 patients (7.6%). There were 54 patients (40.9%) with ocular ischemic diseases, which including retinal arterial obstruction (5 patients, 9.2%), retina change of venous stasis (13 patients, 24.1%), neovascular glaucoma (7 patients, 13.0%), ischemic optic neuropathy (19 patients, 35.2%), ocular ischemia syndrome (10 patients, 18.5%). The ophthalmic symptoms included transient amaurosis, decreased visual acuity, eye and periorbital pain, retinal hemorrhage and exudation, diplopia, rubeosis iridis and increased intraocular pressure. There was highly positive correlation between the carotid stenosis degree and OIA (r=0.287, P=0.018). There was no correlation between the carotid stenosis location and OIA (P>0.05). Conclusion40.9% carotid stenosis patients has OIA. There is relationship between the carotid stenosis degree and OIA, but carotid stenosis location showed no correlation with OIA.
Objective To investigate the effects of ovarian tissue cryopreservation by needle immersed vitrification (NIV) method and subsequently orthotopic transplantation on ovarian function reconstruction in chemotherapy-induced ovary damage rat model. Methods A total of 52 matured virginal female Wistar rats at age of 8-9 weeks housed in specific-pathogen-free facilities, weighing 250-300 g. Vaginal smears were obtained daily, 50 rats having at least 2 consecutive normal estrous cycles were included in the experiment. Ten rats were selected as donors randomly, and NIV method was used for cryopreserving ovarian tissues. The remaining 40 rats were divided into 3 groups according to different treatments: cyclophosphamide group (C group, n=14), cyclophosphamide/transplantation group (C/T group, n=12), and control group (NS group, n=14). In C group and C/T group, the rats received peritoneal injection of cyclophosphamide every day for 21 days to establish the chemotherapy-induced ovary damage models; and then the frozen-thawed ovarian tissues orthotopically transplanted into the left ovarian bursae in C/ T group. The rats received peritoneal injections of 0.9% saline solution every day for 21 days in NS group. Estrous cycle recovery time, ovary weight, morphology change of ovarian tissues, and follicle count were compared among 3 groups. Results One rat died at 2 days after transplantation in C/T group; the other rats survived to the completion of the experiment. At 4 weeks after the end of injection, no significant difference in body weight was found among 3 groups (P gt; 0.05). The rats of NS group had regular estrous cycle, but cyclic changes in vaginal smears were observed in C group and C/T group during cyclophosphamide treatment. The median estrous cycle recovery was 9 days (95%CI: 7.9-10.1 days) in C group, and was 6 days (95%CI: 4.9-7.1 days) in C/ T group, showing significant difference (χ2=6.571, P=0.010). The ovarian weight showed an obvious downtrend in C group at 4 weeks after cyclophosphamide treatment, and an upward trend was observed in C/T group. The ovarian grafts survived and grew well in C/T group. Primordium follicles and primary follicles in C/T group and NS group were significantly more than those in C group (P lt; 0.05), but no significant difference was found between NS group and C/T group (P gt; 0.05). There was no significant difference in secondary follicles and antral follicles among the 3 groups (P gt; 0.05). Conclusion The method of ovarian tissue cryopreservation by NIV and subsequently orthotopic transplantation can significantly shorten the estrous cycle recovery time in chemotherapy-induced ovary damage rat model. Ovarian grafts grow well, follicle count is similar to normal level. So it has the potential ability of ovarian endocrine and fertility reconstruction after chemotherapy.