中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

胎龄<28周早产儿动脉导管未闭的治疗进展

动脉导管未闭(PDA)是早产儿常见疾病,目前早产儿PDA的自然发展过程仍未完全明确,PDA发生的有些高危因素仍存在争议,对PDA是否进行药物、手术干预,以及何时进行药物、手术干预仍存在争议。尽管已经有相当多的证据证实动脉导管持续开放可能有害,但目前尚缺乏关闭导管治疗方案的远期益处或害处的相关证据。大多数临床试验旨在评估短期导管开放对患儿的影响。目前尚无评估动脉导管持续开放对早产儿死亡率及并发症影响的临床试验。近年来PDA治疗上最大的变化是减少对PDA的治疗。该文重点总结胎龄28周早产儿PDA的治疗策略。     

In Vivo Kinematics of Functional Ankle Instability Patients and Lateral Ankle Sprain Copers During Stair Descent

Patients with mechanic ankle instability experience increased tibiotalar and subtalar joint laxity. However, in vivo joint kinematics in functional ankle instability (FAI) patients and lateral ankle sprain (LAS) copers, especially during dynamic activities, are poorly understood. Ten FAI patients, 10 LAS copers, and 10 healthy controls were included in this study. A dual fluoroscopic imaging system was used to analyze the tibiotalar and subtalar joint kinematics during stair descent. Five key poses of stair descent were analyzed. Kinematic data from six degrees of freedom were calculated utilizing a solid modeling software. The range of motion and joint positions in each degree of freedom were compared among the three groups. The tibiotalar joints of FAI patients and LAS copers were significantly more inverted than those of healthy controls during the foot strike (p = 0.016, = 0.264). The subtalar joints of FAI patients were significantly more anteriorly translated (pose 2, p = 0.003, = 0.352; pose 3, p < 0.001, = 0.454; pose 4, p = 0.004, = 0.334), inverted (pose 4, p = 0.027, = 0.234; pose 5,p = 0.034, = 0.221), and externally rotated (pose 4, p = 0.037, = 0.217; pose 5; p = 0.004, = 0.331) than those of healthy controls during the mid‐stance and the heel off. The FAI patients showed excessive tibiotalar inversion and subtalar joint hypermobility during stair descent. Meanwhile, the LAS copers maintained subtalar joint stability, and only showed excessive tibiotalar inversion in foot strike. These data provide insight into the mechanisms behind the development of FAI after initial LAS. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1860–1867, 2019     

负压进针在心血管内科病人中的应用

[目的]探讨负压进针在心血管内科病人的静脉输注中是否优于常规进针法.[方法]将2004年1月-2005年6月我科收治且静脉穿刺难度大的病人随机分为实验组和对照组,实验组150例应用负压进针法,对照组150例应用常规进针法,比较两组的穿刺成功率和回血率.[结果]负压进针法比常规进针法的穿刺成功率提高了12%,回血率提高了13%,两组间穿刺成功率和回血率的差异有统计学意义(P＜0.01).[结论]负压进针大大提高了穿刺成功率和回血率,减少了病人的痛苦,提高护理人员的工作效率和住院病人满意度.     

上海市闵行区性病门诊本地和外来病人的比较研究

目的分析和比较上海市闵行区性病门诊本地与外来病人的流行病学特征。方法对2001~2004年上海市闵行区3家设有标准化性病门诊的公立医院进行门诊病历的回顾性分析。结果外来人口约占全部性病门诊病人的50%,其中女性病例占18.2%,未婚者占23.8%,均高于本地同类人员的比例;外来病人年龄偏低,多重感染者比例较高;男女外来病人与本地病人的首诊原因和症状排位相同,均以淋病感染为主;外来病人随访率(81.2%)较本地病人低(86.0%)。结论性病门诊本地和外来病人在人口学特征、诊疗行为上存在差异,防制措施应有所不同和侧重。     

硬膜外麻醉用于老年病人经尿道前列腺汽化术的麻醉

目的　探讨老年病人经尿道前列腺汽化术 (TUVP)的麻醉方法。方法　 1 0 2例老年病人在连续硬膜外麻醉下行尿道前列腺汽化术 ,观察了麻醉手术效果、生命体征的变化、手术操作条件及术中术后的麻醉手术并发症的发生情况。结果　 1 0 2例病人均痊愈出院。麻醉效果优良率 94%。Bromage <2的例数占 84%。术中出现血压下降等麻醉手术并发症较少且都得到及时纠正。结论　低浓度局麻药硬膜外麻醉用于老年病人TUVP手术对病人干扰少、经济、安全实用 ,可以作为首选的麻醉方法     

虚拟现实技术在枢椎椎弓根螺钉精确植入中的应用研究

目的探索以虚拟现实技术为基础的枢椎椎弓根螺钉置人方法。方法选取8具成人颅一颈椎标本，采用改良四柱式定位框架固定于枕颈，使颅-颈-肩形成统一刚体，保持空间位置恒定，CT薄层扫描获取枢椎三维定位信息，采用Aero—Tech立体定向手术规划系统三维建模，设计安全、可视化、个体化的虚拟置钉路径，反复虚拟演示验证钉道安全后，导向弓把持下置人导向钢针，复查CT评价置钉的准确性。结果16个枢椎椎弓根置钉过程中，方向出现偏差（横突孔突破）1个，失败率为6．25％。结论目标椎弓根的容积三维重建、置钉路径可视化设计和虚拟演示，使操作过程简单、直观而精确，不需要线形和角性参数的测量；加上导向抓持装置提供的稳定性，使该技术具有很好的临床应用前景。     

神经外科麻醉对体感诱发电位的影响

目的探讨神经外科手术麻醉对体感诱发电位（SEP）的影响,以期为麻醉和手术处理提供依据。方法随机抽取我科17例全麻手术病人,分成颅内疾病手术组（A组）与脊柱、脊髓疾病手术组（B组）,于术前、麻醉（诱导完成）、术始、术中、术毕和术后6个时程连续监测SEP的潜伏期、波幅及波形并记录。结果麻醉后SEP潜伏期延长5.96%,波幅下降24.00%,未出现波形消失的情况。结论麻醉抑制SEP,表现为潜伏期延长和波幅下降,但未出现波形消失的情况。     

Laparoscopic Local Resection Based on Sentinel Node Evaluation for Early Gastric Cancer: A Preliminary Report

We previously reported that lymphatic mapping using isosulfan blue can be used to identify sentinel nodes (SNs). This study was undertaken to evaluate the feasibility of using the SN technique in treating early gastric cancer and to explore its usefulness for minimal invasive surgery. Twenty-three patients with early gastric cancer who underwent SN biopsy were retrospectively evaluated. Based on SN evaluation, individualized surgery was performed in five patients with T1N0M0 gastric cancer. When pathological examination of frozen sections revealed metastasis in SNs, we performed a standard D2 gastrectomy. Laparoscopic local resection was applied when the SN biopsy was negative. Our results showed that the success rate with SN biopsy in early gastric cancer was 100%, as were the accuracy, sensitivity, and specificity. All five patients with early gastric cancer had SNs negative for metastases both by frozen section and by postoperative pathology. Thus, all these patients underwent laparoscopic local resection without extended lymphadenectomy. We conclude that SN biopsy is a useful tool to individualize the operative procedure, and laparoscopic local resection can be safely performed using SN guidance in selected patients with early gastric cancer.     

使用便携式微量输液泵持续输注氟尿嘧啶的临床观察及护理

目的：探讨使用便携式微量输液泵在肿瘤化疗中持续输注氟尿嘧啶的应用效果。方法：选取我科2006年3月-2008年7月96例癌症化疗病人按入院先后顺序分为对照组和实验组,每组48例。对照组采用传统的化疗方式,采用浅静脉留置针直接从外周静脉输注氟尿嘧啶（5-Fu）连续5天,每天维持6-8小时。实验组采用浅静脉留置针连接便携式微量输液泵持续泵入氟尿嘧啶（5-Fu）120h～135h,两组均以21天为1个周期,观察两组病人化疗毒副反应发生情况。结果：实验组化疗毒副反应发生率明显低于对照组,平均住院时间明显缩短,两组比较差异有统计学意义（P〈0.01）。结论：使用便携式微量输液泵持续泵入氟尿嘧啶能减轻病人的毒副反应,缩短住院时间,提高肿瘤病人生活质量,有效减轻护士的工作负担。