作为"临床试验中对受试者疼痛管理的伦理考虑"系列标准之一,主要论述《儿科人群临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围,以及儿科人群临床试验中受试者疼痛等负担的来源和识别、在儿科人群临床试验方案设计和临床试验执行过程时使受试者疼痛最小化的措施,以期从伦理角度对儿科人群临床试验中受试者疼痛管理提出指导意见.其适用于伦理审查中对于儿科人群临床试验中受试者疼痛管理的伦理考虑,以及研究者制定临床试验方案和试验流程对儿科人群疼痛管理的关注.对临床试验中儿科人群疼痛予以更多关注,是保护儿科受试者权益的措施之一,有助于保障儿科临床试验顺利开展.

论述《临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围,以及临床试验中疼痛的主要来源,临床试验中对受试者疼痛管理的伦理一般考虑和临床试验中试验操作程序引起的受试者疼痛等负担的伦理考虑等,以期从伦理角度对临床试验中受试者疼痛管理提出指导意见.适用于伦理审查中对于受试者疼痛管理的伦理考虑,以及研究者制定临床试验方案和试验流程对受试者疼痛管理的关注.对临床试验中受试者疼痛予以更多关注,是保护受试者权益的措施之一,有助于保障临床试验顺利开展.

Background. Clinical practice guidelines or recommendations often require timely and regular updating as new evidence emerges, because this can alter the risk-benefit trade-off. The scientific process of developing and updating guidelines accompanied by adequate implementation can improve outcomes. To promote better management of patients receiving vancomycin therapy, we updated the guideline for the therapeutic drug monitoring (TDM) of vancomycin published in 2015. Methods. Our updated recommendations complied with standards for developing trustworthy guidelines, including timeliness and rigor of the updating process, as well as the use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. We also followed the methodology handbook published by the National Institute for Health and Clinical Excellence and the Spanish National Health System. Results. We partially updated the 2015 guideline. Apart from adults, the updated guideline also focuses on pediatric patients and neonates requiring intravenous vancomycin therapy. The guideline recommendations involve a broadened range of patients requiring TDM, modified index of TDM (both 24-hour area under the curve and trough concentration), addition regarding the necessity and timing of repeated TDM, and initial dose for specific subpopulations. Overall, 1 recommendation was deleted and 3 recommendations were modified. Eleven new recommendations were added, and no recommendation was made for 2 clinical questions. Conclusions. We updated an evidence-based guideline regarding the TDM of vancomycin using a rigorous and multidisciplinary approach. The updated guideline provides more comprehensive recommendations to inform rational and optimized vancomycin use and is thus of greater applicability.

目的 通过与护士静脉采血对比,验证自动静脉采血机器人的安全性和有效性.方法 将180例受试者按区组随机化方法分为对照组90例和试验组90例.对照组由护士采血;试验组由自动静脉采血机器人采血.比较2组的采血成功率、穿刺疼痛感和不良事件发生率.结果 试验组和对照组的采血成功率分别为94.44％(85例/90例)和82.22％(74例/90例),穿刺疼痛感分别为0.20±0.39和1.40±0.54,差异均有统计学意义(P<0.05,P<0.01).试验组和对照组分别有6例(6.67％)和8例(8.89％)受试者发生了不良事件.结论 自动静脉采血机器人可提高采血成功率,减少患者痛苦,降低不良事件的发生率.

目的 评价经椎间孔椎体间融合术(TLIF)治疗腰椎退行性疾病的有效性及安全性.方法 本研究为回顾性多中心研究,采用"评价脊柱融合系统用于椎体间融合术中效果的开放、随机、对照、多中心临床验证[强生(苏州)医疗器材有限公司,项目注册号为NCT02252185,方案版本号(日期)为V1.2(2015-04-01)]"数据,依据病例纳入与排除标准选取2014年8月至2015年3月8所医疗机构因腰椎退行性疾病接受TLIF手术的患者,提取其一般临床资料、手术资料、临床疗效评价指标[术前与术后末次随访的腰疼痛视觉模拟评分(VAS)、下肢VAS评分、腰椎日本骨科协会评分(JOA)和腰椎JOA评分改善率]以及术后严重不良事件和并发症等数据信息,采用SPSS 20.0软件对数据进行统计学分析.结果 本研究纳入97例患者,男32例,女65例,年龄为(54.04±10.13)岁.术后随访时间为(5.68±1.13)个月.手术时间为(173.28±92.98)min,估计失血量为(438.14±226.39)ml.术前与末次随访的平均腰VAS评分(4.97 vs.0.98)、平均下肢VAS评分(5.38 vs.0.65)和平均腰椎JOA评分(12.54 vs.25.77)差异均有统计学意义(P均<0.001).腰椎JOA评分改善率为(77.75±25.01)％.未见手术相关严重并发症.结论 采用椎间孔椎体间融合术治疗退行性腰椎疾病安全有效.

目的 观察人工虎骨粉胶囊治疗骨量低下与原发性骨质疏松症的临床疗效及安全性.方法 人选120例受试者,并予以人工虎骨粉胶囊每次1.2g,tid,口服,连续52周.用双能X线吸收仪(DXA)法测定骨密度(BMD),统计其临床疗效和药物不良反应的发生情况.结果 与基线比较,治疗52周后腰椎(L2-I4)BMD提高1.15％,符合方案数据集(PPS)的总有效率为81.73％ (85例/104例).研究期间未出现明显与药物有关的药物不良反应.结论 人工虎骨粉胶囊用于骨量低下与原发性骨质疏松症的治疗,可抑制BMD下降,但未能显著提高腰椎和和股骨颈的BMD,可有效缓解骨质疏松症的主要临床症状,从而改善患者生活质量,且安全性较高.

目的 通过Meta分析和综述比较的方法探讨颈前板限制性和非限制性2种固定方式对术后早期融合效果的影响.方法 应用循证医学的方法在中英文数据库中系统检索颈前板限制性固定与非限制性固定早期融合率的相关文献,文献发表时间为2000年1月至2017年7月.英文数据库包括Embase数据库、Clinical Trial数据库、PubMed数据库、Cochrane Library数据库以及Springer Link数据库等,检索词包括"anterior cervical plate"、"fusion"、"static"、"dynamic"、"lock"、"non-lock"、"fixed"、"vari-able"、"constraint"、"unconstraint"、"restriction"和"non-restriction".中文数据库包括CHKD期刊全文数据库(CNKI)、万方医学期刊数据库(万方)、中国生物医学文献数据库(CBM)等,检索词包括"颈"、"颈椎"、"前路"、"固定"、"动态"、"活动"、"静力"、"动力"、"限制""非限制"、"板"和"融合"等.采用STATA 14.2统计学软件对文献中报道的术后早期(4～9个月)融合率进行Meta分析.结果 共纳入文献8篇,包括5篇英文文献和3篇中文文献.8篇文献报道的病例中,限制性固定组230例,非限制性固定组253例.Meta分析结果显示,术后平均6.8个月限制性和非限制性固定早期融合率的区间分别为95％CI:64.27％～100％和95％CI:69.48％～97.32％,2种固定方式的融合率差异无统计学意义(P>0.05).对纳入的文献进行异质性检验,发现OR=1.35>1,无异质性,且无发表偏倚,敏感性分析结果可靠.结论 颈前板限制性和非限制性固定在促进植骨融合和提高术后早期融合率方面差异不显著.

目的:分析含苯酚医院制剂的风险因素,探索有效的预防措施进行风险控制.方法:统计《医疗单位制剂规程》、《中国医院制剂规范》中含苯酚医院制剂的所有品种,检索和查阅相关文献、法律法规、标签和说明书,分析存在的问题,探讨可能造成此类制剂风险的原因.结果:含苯酚医院制剂风险环节主要为处方合理性有待商榷、原辅料管理欠规范、职业暴露、质量标准和检验手段落后及疗效和安全性评价不足.结论:采取有效的风险管理措施,严格实施GPP建设,加强原辅料的质量控制、完善质量标准和检验手段、监测不良反应和用药错误,最大程度降低风险危害.

OBJECTIVE: To investigate the effect of tirofiban on the plasma soluble OX40L (sOX40L) in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI) treatment. METHODS: 66 cases of ACS were included in ACS group and divided into stent group and tirofiban group according to different treatment. Stent group was given the PCI treatment, and the tirofiban group was given the PCI combined with tirofiban treatment. 30 patients suspected to coronary disease and digonsed as no coronary artery stenosis by contrast examination were included in control group. The plasma sOX40L and hs-CRP levels were measured 1 d before surgery, immediately after operation, 24 h, 48 h and 10 d after operation. RESULTS: The preoperative plasma sOX40L and hs-CRP levels of ACS group were significantly higher than control group (P0.05). In different clinical types of ACS, the sOX40L and hs-CRP levels of MI group were significantly higher than the UA group (P0.05). In different count of coronary artery disease, the order of sOX40L and hs-CRP levels was as follows: three artery lesion groupdouble artery lesion groupsingle artery lesion group, there was significant difference among three groups (P0.05). Immediately after operation,24 h,48 h and 10 d after operation, the sOX40L level of tirofiban group was significantly lower than that of stent group (P0.05). There was no serious complications in the tirofiban group. CONCLUSIONS: The plasma sOX40L level of ACS patients increases significantly, and it is closely related to the severity of coronary atherosclerosis. Tirofiban can reduce the level of plasma sOX40L in ACS patients after PCI treatment.

OBJECTIVE:To investigate the application of anti-osteoporosis(OP) agents in our hospital.METHODS:Pharmacoeconomic parameters such as DDDs and DDC were employed to statistically analyze anti-osteoporosis prescriptions in our hospital during 2009-2010.RESULTS:The use of anti-osteoporosis agent was based on calcium supplements and vitamine D in our hospital.Calcitonin accounted for the biggest proportion of consumption sum.Bisphosphonates and selective estrogen receptor modulator(SERM) were the conventional therapeutic medicine;single drug treatment took up about 76% of the total prescriptions.CONCLUSION:The drug use structure of anti-osteoporosis prescription is basically stable in accordance with the clinical therapy guideline,but the patients compliance research should be further strengthened.

OBJECTIVE To establish a method for the determination of vitamin E in vitamin E cream.METHODS An ODS-C18 column(4.6 mm×250 mm,5 μm) was used,the mobile phase was methanol and the detection wavelength was 285 nm.RESULTS The linear correlation was good in the range of 0.100 4-1.004 mg·mL-1.The average recovery was 99.09% with RSD=0.66%.CONCLUSION The method is simple,rapid and accurate.

目的:阐述药患投诉的概念、分类,提出处理药患投诉的方法和管理策略。方法:借鉴"ACTION"投诉处理方法,结合心理学、社会学知识探讨处理投诉的原则和技巧。结果:灵活运用"ACTION"方法,可以有效处理药患投诉并且促进医院药学发展。结论:投诉管理是全面质量管理的重要组成部分,药剂科可从流程再造来实施投诉管理。

OBJECTIVE:To discuss the development prospect of the hospital pharmacists in clinical trials and to accumulate experience for the development of hospital pharmacy. METHODS: The current strengths,weakness,opportunities and threats of the hospital pharmacists were systematically analyzed and evaluated with the Porter's five strengths and PSET models;the development strategies were formulated by SWOT matrix. RESULTS: There were not only the apparent strengths and weakness but also the opportunities and threats for hospital pharmacists in clinical trials. CONCLUSION: At present,hospital pharmacists should take advantage of the opportunities of clinical trials market,stick to the aim of the professional development,spare no effort in discipline construction and training of professional talents and establish the space for their development and their indispensable position by giving priority to scientific research with service as target.

OBJECTIVE To establish an HPLC method to measure free hydroxyproline(HYP) in serum.METHODS Both o-phthalaldehyde(OPA) and 9-fluorenylmethylchloroformate(FMOC) were used in pre-injection reaction.HYP was assayed by HPLC with the following conditions:ODS C18 column,UV detective wavelength 265 nm,flow rate 1.0 mL·min-1,and gradient elution of sodium acetate buffer and acetonitrile.RESULTS The analytical time was only 27 min.RSD within a day and between days were 1.95 % and 2.02%.Recovery rate was(100.5±4.0) %.Linear range was 0.26 ~64 mg·L-1.The method was applied in healthy blood donors.The average values of serum free hydroxyproline of male and female were(1.4±0.5) mg·L-1 and(1.10±0.32) mg·L-1,respectively.CONCLUSION This method can directly detect free hydroxyproline in serum without dealing with derivative product is suitable for using in clinic.

OBJECTIVE: To apply the chromatic aberration method in the determination of the color of Breviscapine injection. METHODS: The color of 14 batches of sample solutions was determined by chromatic aberration method, which was then compared with that by visualization. RESULTS: The determination result by chromatic aberration method was more objective and more accurate than that by visualization method. CONCLUSION: The chromatic aberration method can be applied to determine the color of Brevoscapine injection.

灯盏花素注射液为灯盏花全草中提取的黄酮类活性成分的制剂,其主要成分为灯盏花乙素(scutellarin),即野黄芩苷,主要用于治疗脑动脉硬化、脑血管栓塞、脑血管病后瘫痪、失语等症及心血管疾病等.

目的:介绍我院药品质量监控体系的工作模式和成效,探讨医院药学质量体系的构建思路。方法:引入QA(质量保证)、QC(质量控制)概念,采用质量巡视和QA会议的工作方法,构建药品质量监控体系。结果:一年来数据显示:QA-QC工作模式取得了良好的业绩,较充分地体现了药师在质量管理方面的价值。结论:QA-QC工作模式在医院药学领域有较好的前景。

OBJECTIVE To investigate the particulate producer matters in different transfusions from different producer, quanti the deviation between the count of particulate matters of the intravenous admixtures prepared in Pharmacy Intravenous Admixture (PIVA) preparing room and the count of unsoluable prepared in common wards and observe the interception of apparatus infusionis for those unsoluable particu-lates.METHODS The light blockage method was used to record the count of particulate matters of the transfusions reconstituted in different environments. RESULTS The significant difference of transfusions from different producer was observed. The particulate matter count of the intravenous admixture prepared in PIVA was distinctly less than the count of those prepared in wards. The transfusions and those reconstituted via the apparatus infusionis all meet the limitation (for those volume ≥ 100 mL) of the standards of China Pharmacopeia.CONCLUSION The quality of the injections and high volume transfusions, the reconstituting environments are key factors for the count of particulate matter in the intravenous admixture. Furthermore the apparatus infusionis takes a significant role to prevent the particulate matter in transfusion from getting into human bodies.

玻璃安瓿是小容量水针剂的主要包装形式,临床使用量大,护士在掰开抽取药液的过程中可能会引入不溶性微粒,微粒的多少取决于安瓿的质量和操作者的动作.因此,选择适宜的安瓿材质和开启安瓿的方法,对于减少引入的不溶性微粒和保护操作人员都是有意义的.我国现行药典尚未限制小容量注射剂中不溶性微粒的数量,而<美国药典>(第24版)规定小体积注射液每个容器≥10μm微粒不得超过3000个,≥25μm的微粒不得超过300个.

Objective:To make a Meta-analysis for the efficacy and safety of levetiracetam as an adjunctive therapy in adult patients with partial epilepsy. Methods: Using Medline, EmBase and the Cochrane Library database, the efficacy and safety information of 1023 patients who presented 50% less episode of their seizures post add-on treatments with levetiracetam were extracted from four randomized, double blind, placebo-controlled trials. Results: The analyses demonstrated that the relative risk and the risk difference in a 50% response to the treatment were 2.94 [2.18,3.961 and 0.24 [0.19,0.29] (95% CI), respectively, in the absence of dosing consideration. The risks in the incidence of mild to moderate adverse reactions in the add-on treatment group signified more than the placebo group with respect to somnolence, asthenia and dizziness. Conclusion: Levetiracetam offers an add-on alternative in the treatment of refractory partial seizures.