不同工艺六味地黄丸制剂对小鼠溶血素含量的影响

目的观察六味地黄丸四种不同工艺对小鼠溶血素抗体生成的影响,比较各种工艺的药效差异,以此考察工艺.方法以绵羊红细胞(SRBC)为免疫原,分别用地塞米松和环磷酰胺建立免疫低下模型,给小鼠灌服六味地黄丸各工艺制备的溶液后,测定小鼠的溶血素含量,比较各工艺制剂疗效的差异性.结果环磷酰胺模型组与各给药组对SRBC致敏小鼠的溶血素生成反应低下,半数溶血值(HC50)整体偏低,工艺Ⅱ、Ⅲ、Ⅳ组其均值低下,与模型组比较有显著性差异.地塞米松模型组与工艺Ⅰ各剂量组、浓缩六味地黄丸组比较差异不显著,且工艺Ⅰ高中低剂量组间差异无统计学意义.结论六味地黄丸服用量存在减小可能,但仍需改进制剂工艺并进一步验证;本方主治肾阴虚证,在选择免疫低下造模药时,建议选地塞米松为宜;实验时需增加其他观察指标以全面反映其疗效,反映剂型改革的合理性.     

Increased importance of the documented development stage in process validation

Current trends in pharmaceutical quality assurance moved when the Federal Drug Administration (FDA) of the USA published its new guideline on process validation in 2011. This guidance introduced the lifecycle approach of process validation. In this short communication some typical changes from the point of view of practice of API production are addressed in the light of inspection experiences. Some details are compared with the European regulations.     

颅脑损伤在手术室中的护理救治流程

创伤已成为青壮年人群的“第一杀手”［1］，是社会劳动力丧失的主要原因。而在创伤人群中，颅脑损伤居全身各部位损伤中的第二位，仅次于四肢损伤，但其病死率和致残率均居首位，平均为30％～40％［2］，其主要死亡原因为急性顽固性高颅压、大面积脑缺血、脑水肿，目前最有效的治疗方法为手术。近年来，本院全军战创伤中心建立和完善严重创伤救治绿色通道，提高了创伤急救人员的素质和相关科室的急诊意识，使严重创伤患者的救治成功率大为提高。我科护理组人员根据该项工作的经验，结合本科室工作特色，进一步梳理和规范了有关工作流程，使其操作性更强，更易于本专科人员学习和掌握。手术室救治流程再造后，患者到达医院至手术开始的时间，从2008年的82．6min缩短到现在的48．6min，手术室护理救治流程再造促进了“绿色通道”的建设，并取得了显著成效。现将我科手术室护理救治流程再造汇报如下。     

PRACTICE GUIDELINES IN PEDIATRIC HEMATOONCOLOGY: Implementation and Survey. A Possible Way for Medical Quality Assurance

The Hungarian Pediatric Oncology Working Group intended to change the practice of prescribing diagnostic tests as well as to examine the possibility of introducing indicators about the time factors of medical care. A nationwide accepted protocol was established for these tests. The examined time factors were the length of elapsed time from admittance to treatment and the length of hospital stay for different reasons (diagnosis, treatment, complications). Included in to this study are the new cases of 5 common groups of malignancies (acute lymphoblastic leukemia and non-Hodgkin lymphoma, osteosarcoma, soft tissue sarcoma, Wilms tumor, neuroblastoma) for a study period of 1 year. The follow-up data of 152 patients were examined; the length of survey was 1-12 months, depending on when the patients entered the study. As a continuous clinical audit, a system of survey was set up for each follow-up test, using a questionnaire about the conformity of physicians to the protocol, evaluating the principal reasons of deviation from the protocol. Using the data provided by this questionnaire, a renewal of the protocols for each disease was made three times during the whole study period. The principal reasons of nonconformity to the protocol were (1) complications, (2) the nonuse of the protocol, (3) nonacceptance of the protocol, and (4) technical problems. The authors intended to use their time indicators for benchmarking, to make a comparison possible between centers concerning the length of treatment, occurrence of complications, and delays in chemotherapy. However, the examination of the time indicators in the most frequent disease (acute lymphoblastic leukemia, n = 73) showed inverse correlation between the numberof admissions per year per center and the length of time elapsed up to the beginning of treatment. This points to a need for better cooperation in small centers at the initial phase of the diagnosis. The main result of this study is the successful elaboration and implementation of practice guidelines by information linked to performance (the feedback) in daily practice: Compliance during the first 3 months of the study was 28%, and compliance during the last 3 months was 61%.     

精益六西格玛管理法在提高24 h尿液标本留取合格率中的应用

目的　提高患者24 h尿液标本留取合格率，明确诊断，及时治疗，提高患者满意度。方法　本研究采用前瞻性研究，于2021年1月至12月，在广州中医药大学第二临床医学院芳村医院内分泌科选取需要留取24 h尿液标本检验的患者。对照组为2021年1—5月50例住院患者，观察组为2021年6—12月53例住院患者。对照组男30例，女20例，年龄（57.30±12.88）岁，病程（5.78±4.82）年；观察组男30例，女23例，年龄（58.00±12.19）岁，病程（6.83±5.76）年。对照组采用常规方法，观察组采用精益六西格玛管理体系，使用DMAIC（define， measure， analyze， improve， control）循环，即界定、测量、分析、改进、控制5个阶段构成的过程，改进方法进行项目推进，同时利用鱼骨图工艺改进工具，优化24 h尿液标本的留取流程，并对全过程进行有效监控。比较两组患者留尿时间正确率、标本污染率、标本量不足率、记录尿量正确率、护士规范宣教率、满意度。采用χ²检验、Fisher确切概率法、独立样本t检验。结果　对照组留尿时间正确率为90.00%（45/50），观察组留尿时间正确率为100.00%（53/53），差异有统计学意义（P=0.024）；对照组记录尿量正确率为90.00%（45/50），观察组记录尿量正确率为100.00%（53/53），差异有统计学意义（P=0.024）。调查患者的满意度，实施前后均调查50人，患者总体满意度评分由实施前的（3.86±0.57）分提升为实施后的（4.20±0.45）分，实施前后结果比较，差异有统计学意义（t=3.310，P=0.001）。结论　基于精益六西格玛管理，24 h尿液标本留取流程取得了较好的改进效果，能提升护理服务质量和患者满意度，得出一套适用于医院推广和借鉴的留取24 h尿液标本的优化流程。     

Economic evaluation comparing From Home To Operation same day admission and preoperative admission one day prior to the surgery process : a randomized,controlled trial of laparoscopic cholecystectomy

ABSTRACT

Objective: A novel preoperative procedure From Home To Operation (FHTO) seeks to combat increasing operation and infection rates. This is the first prospective randomized controlled trial (RCT) comparing the cost-effectiveness and cost-utility of FHTO and conventional ward procedures for standardized Laparoscopic Cholecystectomy (LC).

Research design and methods: During 12/2004–7/2005, 47 patients with symptomatic gallstones were randomized to receive LC in the FHTO (28 patients) or in a conventional manner (19 patients) in a Finnish hospital setting. The 15D quality of life tool was administered at the baseline and 1 month after.

Main outcome measures: A stochastic approach over a month interval for hospital costs, length of postoperative stay, infection rate and Quality-Adjusted Life Years (QALY) was employed.

Results: Baseline group characteristics were similar. The mean health care costs with FHTO (1695 EUR) were significantly lower (?p < 0.001) than in the conventional arm (2234 EUR). The number of patients discharged on the first postoperative day was 27 (96.4%) and 15 (78.9%) with two (7.1%) infections in the FHTO and four (21.1%) in the conventional arm. A difference in QALYs gained (0.0174; p = 0.030) favouring FHTO was observed. According to a cost-effectiveness acceptability curve, the probability of FHTO being cost-effective was 99%. The results were robust to probabilistic sensitivity analyses.

Conclusions: FHTO can introduce substantial cost savings and have a positive impact on both clinical measures and quality of life. Studies with larger numbers of patients are needed to assess whether conventional ward procedure can be a source of infections, which can be avoided with FHTO.

Clinical Trial Registry: ICJME-qualified registry of the Hospital District of Helsinki and Uusimaa (number 217849).     

Implementation of Robert's Coping with Labor Algorithm© in a large tertiary care facility

Objectiveto implement use of Roberts’ Coping with Labor Algorithm^© (CWLA) with laboring women in a large tertiary care facility.Designthis was a quality improvement project to implement an alternate approach to pain assessment during labor. It included system assessment for change readiness, implementation of the algorithm across a 6-week period, evaluation of usefulness by nursing staff, and determination of sustained change at one month. Stakeholder Theory (Friedman and Miles, 2002) and Deming's (1982) Plan-Do-Check-Act Cycle, as adapted by Roberts et al (2010), provided the framework for project implementation.Settingthe project was undertaken on a labor and delivery (L&D) unit of a large tertiary care facility in a southwestern state in the USA. The unit had 19 suites with close to 6000 laboring patients each year.Participantsfull, part-time, and per diem Registered Nurse (RN) staff (N=80), including a subset (n=18) who served as the pilot group and champions for implementing the change.Findingsa majority of RNs held a positive attitude toward use of the CWLA to assess laboring women's coping with the pain of labor as compared to a Numeric Rating Scale (NRS). RNs reported usefulness in using the CWLA with patients from a wide variety of ethnicities. A pre-existing well-developed team which advocated for evidence-based practice on the unit proved to be a significant strength which promoted rapid change in practice.Implications for practicethis work provides important knowledge supporting use of the CWLA in a large tertiary care facility and an approach for effectively implementing that change. Strengths identified in this project contributed to rapid implementation and could be emulated in other facilities. Participant reports support usefulness of the CWLA with patients of varied ethnicity. Assessment of change sustainability at 1 and 6 months demonstrated widespread use of the algorithm though long-term determination is yet needed.     

业务流程再造在门诊拥挤期病人护理中的应用

目的探讨业务流程再造在门诊拥挤期病人护理中的应用效果。方法将100例门诊拥挤期病人,随机分为对照组和观察组,各50例。对照组采用常规护理。观察组采用业务流程再造护理。比较两组患者满意度和健康知识掌握程度。结果观察组满意度,健康知识掌握程度明显优于对照组,两组比较有显著性差异(P0.01)。结论再造后的业务流程规避了护理纠纷,提高医疗质量和患者满意度。