A prospective cohort study to investigate cost-minimisation,of Traditional open,open fAst track recovery and laParoscopic fASt track multimodal management,for surgical patients with colon carcinomas (TAPAS study)

Background

The present developments in colon surgery are characterized by two innovations: the introduction of the laparoscopic operation technique and fast recovery programs such as the Enhanced Recovery After Surgery (ERAS) recovery program. The Tapas-study was conceived to determine which of the three treatment programs: open conventional surgery, open 'ERAS' surgery or laparoscopic 'ERAS' surgery for patients with colon carcinomas is most cost minimizing?

Method/design

The Tapas-study is a three-arm multicenter prospective cohort study.All patients with colon carcinoma, eligible for surgical treatment within the study period in four general teaching hospitals and one university hospital will be included. This design produces three cohorts: Conventional open surgery is the control exposure (cohort 1). Open surgery with ERAS recovery (cohort 2) and laparoscopic surgery with ERAS recovery (cohort 3) are the alternative exposures. Three separate time periods are used in order to prevent attrition bias.Primary outcome parameters are the two main cost factors: direct medical costs (real cost price calculation) and the indirect non medical costs (friction method). Secondary outcome parameters are mortality, complications, surgical-oncological resection margins, hospital stay, readmission rates, time back to work/recovery, health status and quality of life.Based on an estimated difference in direct medical costs (highest cost factor) of 38% between open and laparoscopic surgery (alfa = 0.01, beta = 0.05), a group size of 3×40 = 120 patients is calculated.

Discussion

The Tapas-study is three-arm multicenter cohort study that will provide a cost evaluation of three treatment programs for patients with colon carcinoma, which may serve as a guideline for choice of treatment and investment strategies in hospitals.

Trial registration

ISRCTN44649165.

     

麝香保心丸对内皮素-1诱导原代培养的人脐动脉血管平滑肌细胞增殖的影响

目的:观察麝香保心丸(SXBXW)对内皮素-1(ET-1)诱导原代培养的人脐动脉血管平滑肌细胞(VSMCs)增殖作用的影响。方法:建立ET-1刺激原代培养人脐动脉VSMCs增殖的细胞模型,设对照组、ET-1组、ET-1+SXBXW0.25g/L组、ET-1+SXBXW0.5g/L组、ET-1+SXBXW1.0g/L组和ET-1+SXBXW2.0g/L组,采用MTT法测定ET-1和SXBXW对细胞增殖的影响;用台盼蓝拒染和乳酸脱氢酶检测方法观察不同浓度的SXBXW对VSMCs的毒性作用;用流式细胞术观察ET-1和SXBXW对VSMCs增殖周期的影响。结果:与对照组相比,ET-1可显著促进VSMCs的增殖,一定剂量的SXBXW能够有效地抑制ET-1诱导的VSMCs细胞增殖,呈剂量依赖性;SXBXW抑制细胞增殖,但对活细胞数目和乳酸脱氢酶释放量均没有影响,提示对VSMCs无毒性作用。ET-1能够刺激VSMCs从G1期进入S期,从而促进细胞增殖,而SXBXW能抑制这一作用。结论:SXBXW能够有效抑制ET-1诱导的VSMCs增殖作用,其作用机制可能与其抑制细胞周期从G1期进入S期有关。     

Prevention and management of hepatitis B virus reactivation in patients with hematological malignancies treated with anticancer therapy

Hepatitis due to hepatitis B virus(HBV) reactivation can be severe and potentially fatal, but is preventable. HBV reactivation is most commonly reported in patients receiving cancer chemotherapy, especially rituximabcontaining therapy for hematological malignancies and those receiving stem cell transplantation. All patients with hematological malignancies receiving anticancer therapy should be screened for active or resolved HBV infection by blood tests for hepatitis B surface antigen(HBs Ag) and antibody to hepatitis B core antigen(antiHBc). Patients found to be positive for HBs Ag should be given prophylactic antiviral therapy to prevent HBV reactivation. For patients with resolved HBV infection, no standard strategy has yet been established to prevent HBV reactivation. There are usually two options. One is pre-emptive therapy guided by serial HBV DNA monitoring, whereby antiviral therapy is given as soon as HBV DNA becomes detectable. However, there is little evidence regarding the optimal interval and period of monitoring. An alternative approach is prophylactic antiviral therapy, especially for patients receiving highrisk therapy such as rituximab, newer generation of anti-CD20 monoclonal antibody, obinutuzumab or hematopoietic stem cell transplantation. This strategy may effectively prevent HBV reactivation and avoid the inconvenience of repeated HBV DNA monitoring. Entecavir or tenofovir are preferred over lamivudine as prophylactic therapy. Although there is no well-defined guideline on the optimal duration of prophylactic therapy, there is growing evidence to recommend continuing prophylactic antiviral therapy for at least 12 mo after cessation of chemotherapy, and even longer for those who receive rituximab or who had high serum HBV DNA levels before the start of immunosuppressive therapy. Many novel agents have recently become available for the treatment of hematological malignancies, and these agents may be associated with HBV reactivation. Although there is currently limited evidence to guide the optimal preventive measures, we recommend antiviral prophylaxis in HBs Ag-positive patients receiving novel treatments, especially the Bruton tyrosine kinase inhibitors and the phosphatidylinositol 3-kinase inhibitors, which are B-cell receptor signaling modulators and reduce proliferation of malignant B-cells. Further studies are needed to clarify the risk of HBV reactivation with these agents and the best prophylactic strategy in the era of targeted therapy for hematological malignancies.     

Implementation of Guideline-Based Care for Depression in Primary Care

Evidence-based clinical practice guidelines for treating depression in primary care settings were developed, in part, to ensure that health services are provided in a consistent, high-quality, and cost-effective manner. Yet for a variety of reasons, guideline-based primary care for depression remains the exception rather than the rule. This work provides a brief review of effective strategies used to customize and then deliver evidence-based treatment for depression in primary care settings; describes two representative case studies that illustrate locally customized collaborative care strategies for treatment delivery; and concludes with principles and implications for policy and practice based on our practical experiences.     

甲状腺术中喉返神经监测技术的标准化

目的在甲状腺手术中缺少术中神经监测(intra operative neuromonitoring,IONM)的标准化操作可导致结果变异性强,这些结果可产生错误信息并增加喉返神经损伤的危险性。因此有必要进行IONM操作的标准化。方法本研究共招募了289例进行过甲状腺切除术的患者(435根神经有危险),均由一位外科医师实施手术。每例患者均由同一位麻醉师使用EMG气管导管进行插管。每例患者均进行标准化IONM操作。该操作包括术前和术后对声带运动进行录像监测、保证电极在正确位置、喉返神经剥离前后刺激迷走神经并记录EMG信号,并摄像记录暴露的喉返神经。结果5例患者出现IONM波形异常,是由于电极错位所致,这一问题被立刻监测到。监测到1例患者在手术较早阶段出现非喉返神经损伤。甲状腺剥离时18例患者的神经失去了EMG信号,使用我们的标准化IONM操作后神经损伤的原因得以清楚阐明。结论标准化IONM操作不仅在消除错误的IONM结果方面有用且有帮助,而且有助于阐明喉返神经损伤的机制。在确定外科手术的缺陷并提高外科手术技巧后,本研究显著降低了神经麻痹的发生率。     

Current topical and systemic approaches to treatment of rosacea

Rosacea is a common, often overlooked, chronic facial dermatosis characterized by intermittent periods of exacerbation and remission. Clinical subtypes and grading of the disease have been defined in the literature. On the basis of a genetic predisposition, there are several intrinsic and extrinsic factors possibly correlating with the phenotypic expression of the disease. Although rosacea cannot be cured, there are several recommended treatment strategies appropriate to control the corresponding symptoms/signs. In addition to adequate skin care, these include topical and systemic medications particularly suitable for the papulopustular subtype of rosacea with moderate to severe intensity. The most commonly used and most established therapeutic regimens are topical metronidazole and topical azelaic acid as well as oral doxycycline. Conventionally, 100–200 mg per day have been used. Today also a controlled release formulation is available, delivering 40 mg per day using non-antibiotic, anti-inflammatory activities of the drug. Anti-inflammatory dose doxycycline in particular allows for a safe and effective short- and long-term therapy of rosacea. Topical metronidazole and topical azelaic acid also appear to be safe and effective for short-term use. There are indications that a combined therapy of anti-inflammatory dose doxycycline and topical metronidazole could possibly have synergy effects. Further interesting therapy options for the short- and long-term therapy of rosacea could be low-dose minocycline and isotretinoin; however, too little data are available with regard to the effectiveness, safety, optimal dosage and appropriate length of treatment for these medications to draw final conclusions.

Conflicts of interest

None declared.     

Major depression in primary medical care practice: Research trends and future priorities

This paper reviews recent developments in assessing and treating major depression in primary care practice and proposes needed research directions for the coming years. Topics warranting attention include the predictive validity of psychiatric nomenclatures specific to general medical settings; the impact of patient, clinician, and system factors on the physician's assessment of major depression; the relationship between diagnostic and treatment decisions; and the course of this disorder when treated in primary care facilities by generalists or specialists.     

醋氨酚缓释包衣颗粒研究

包衣颗粒体外溶出试验证明在释放量达66%以前为零级恒速释放,此后释放速率降低为非零级释放。颗粒在室温下密闭贮存21个月后,释放速率增快,但仍为零级释放,也是在释放量达66%以后转变为非零级释放。用尿药排泄速率法研究了包衣颗粒的体内动力学并与常规片剂作比较,并测出两者的消除速率常数。常规片剂所得药物t 1/2=3.21h,而包衣颗粒剂所得半衰期约延长2.5倍。通过吸收百分率与体外溶出百分率在不同时间下数值的比较得到线性关系,相关系数r=0.9886。说明体外溶出数据可以作为控制吸收率的依据。按一级吸收一室模型公式计算了一定剂量下的血药浓度,在13h以内血药浓度都在治疗浓度范围(5～20μg/ml)以内。最高浓度为10.5μg/ml,达峰时间为3.27h。本品一次服1.1g可延效12h。