微创穿刺术治疗基底节区脑出血临床随机对照研究

目的评价比较微创穿刺血肿粉碎清除术与内科保守治疗两种方法治疗基底节区脑出血(25～40m l)的疗效异同。方法采用多中心、随机对照试验的方法,42个参研医院共随机入选465例基底节区脑出血患者,根据纳入与排除标准共排除88例,其中资料不全者16例;不符合入选标准者72例,分别为Glasgow评分≤8分(64例)、术前出血量>40m l(7例)、从发病到达急诊室时间>72h(1例)。评价治疗14d时两组患者神经功能缺损程度和日常生活活动能力、治疗3个月时的日常生活活动能力以及3个月和住院期间病死率。结果最终符合入组标准的病例数为377例,其中微创治疗组195例,对照组182例。微创治疗组患者于治疗14d时,神经功能改善明显优于对照组(χ2=7.931,P=0.02);治疗3个月时达良好功能状态的患者比例明显多于对照组(35.91%vs21.82%;χ2=8.294P=0.004)。微创治疗组病,残率明显低于对照组(40.88%vs63.03%,χ2=16.948,P<0.01);两组病死率间差异无显著性意义(6.67%vs8.79%)。结论与单纯内科保守治疗相比,应用微创穿刺血肿粉碎清除术治疗基底节区小血肿不增加病死率,并可明显提高脑出血患者的日常生活活动能力,降低病残率。     

Supporting insensitive mothers: the Vilnius randomized control trial of video-feedback intervention to promote maternal sensitivity and infant attachment security

Objective   This randomized control trial examined the effects of a short-term, interaction-focused and attachment-based video-feedback intervention (VIPP: video-feedback intervention to promote positive parenting).
Design   VIPP effect on mothers' sensitive responsiveness and infant–mother attachment security was evaluated in a sample ( n  = 54) of low sensitive, non-clinical, middle class Lithuanian mothers.
Methods   Maternal sensitivity was assessed in a free play session with the Ainsworth's sensitivity scale, and attachment security was observed using the Attachment Q sort for home observations.
Results   We found that the intervention mothers indeed significantly improved their sensitive responsiveness through participation in our VIPP. The effect size was large according to Cohen's criteria, d  = 0.78. VIPP enhanced maternal sensitive responsiveness even when maternal age, educational level, depression, daily hassles, efficacy, infant gender, and infant negative and positive affect were controlled for. However, attachment security in the VIPP infants was not enhanced after the intervention, compared with the control infants, and the infants did not seem to be differentially susceptible to the increase in maternal sensitivity dependent on their temperamental reactivity.
Conclusion   We suggest that a relatively brief and low-cost programme can provide effective support for mothers who lack sensitivity in the interactions with their infants.     

A study comparing biopharmaceutic characteristics of four once daily controlled release diltiazem preparations

Summary— In the present study we have compared the steady state biopharmaceutic characteristics of four diltiazem once daily controlled release capsules: Mono-Tildiem LP 300® (300 mg), Adizem® XL (300 mg)¹, Cardizem® (300 mg) and Dilacor® (240 mg). Sixteen healthy male volunteers (aged 22.9 ± 3.3 years, range 19–31 years) completed an open label, multiple oral dose, randomized, four-period crossover study without a washout period in between. The volunteers received each diltiazem formulation once daily for four days. Trough diltiazem and metabolites plasma concentrations were determined on days 3 and 4. The 24-h plasma concentration-time profiles were assessed after the dose on day 4 of each period. The following steady state pharmacokinetic parameters for diltiazem were calculated: the minimum plasma concentration (c_min), the maximum plasma concentration (c_max), the time to reach that concentration (t_max), the time interval during which the plasma concentration exceeds 50% of c_max (t₅₀), the area under the plasma concentration-time curve (AUC_72–96) and the peak-to-trough fluctuation (PTF). For the metabolites of diltiazem, N-mono-desmethyl-diltiazem (NDM) and desacetyldiltiazem (DAD), AUC_72–96 (AUC_NDM and AUC_DAD) and the ratio metabolite/parent compound were calculated. Steady state was achieved on day 3. Except one, all controlled release formulations have satisfactory controlled release properties allowing once daily administration. However, significant (P < 0.05) differences were found between the pharmacokinetic characteristics which do not allow exchange of the various formulations. Concentrations well below 50 ng·mL^-1 in the morning hours were observed for Dilacor® (240 mg) and Adizem® XL (300 mg), which could be a disadvantage of these formulations as it is well-known that ischaemic events occur at a higher rate during that part of the day. The plasma concentration profiles of NDM and DAD, the major circulating metabolites, parallel the plasma concentration profiles for the parent compound. From a clinical point of view, all treatments were well tolerated.     

The effectiveness of 'nursing beds': a review of the literature

A literature search was conducted to identify 'nursing led in-patient units' where the nurse is the designated leader of the clinical team. The review concentrates on studies which have attempted to measure the impact of nursing-led in-patient units and reviews both the methodology and outcomes. Three major bodies of work were identified. Lydia Hall's evaluation of the Loeb Center for Nursing and Rehabilitation (USA) is reviewed in some detail. This work was the model for 'nursing beds' at the two Oxfordshire Nursing Development Units (UK) in the 1980s. Studies evaluating these centres are reviewed and reports of similar UK units discussed. A third body of work evaluates a nurse-managed critical care environment. Common features include a case mix based on nursing need with nurses having authority to admit and discharge patients. While results are generally favourable, with improved patient independence, fewer readmissions, lower mortality and cost savings reported in some or all of the studies, all studies reviewed demonstrate the difficulties of applying an experimental model to real life clinical services. Methodological limitations render firm conclusions difficult. Techniques adopted from studies in field settings, the so-called 'quasi-experiment', are advocated as a remedy, as is further study of the process of care in investigating this model of care delivery.     

The use of the rat facial nerve model to assess the effect of differing nerve anastomotic agents on the facial nerve

There are relatively few papers which prove that one nerve anastomotic agent for the facial nerve is superior to any other. Previous experiments on the division and anastomosis of the facial nerve have failed to consider the indeterminate variables involved, i.e. operator variability, controls and the reaction of the materials on normal nerve tissue. In this experiment, a variety of anastomotic agents were tested to see if the anastomotic agents themselves affected the extra-temporal facial nerve function. The absorbable suture, non-absorbable suture, glue and tube wrap used had no effect on normal nerve tissue or on the anastomosis of the sectioned facial nerve of the rat compared with simple laying together of the divided ends of the divided nerve.     

ROMEO: rethink organization to improve education and outcomes.

AIMS: Scarcity of resources, expertise and evidence-based models have so far limited delivery of patient-centred diabetes education. We have developed and validated a group care approach that is applicable to everyday clinical practice and cost-effective in improving metabolic control, knowledge of diabetes, health behaviours, and quality of life in Type 2 diabetes. A clinical trial (ROMEO) was planned to evaluate applicability and reproducibility of group care in other outpatients facilities and assess its impact on a larger patient population. METHODS: Multicentre, randomized, controlled clinical trial of group vs. individual care in the routine management of Type 2 diabetes. Nine hundred patient aged < 80, with diabetes of > or =1 year known duration, treated by either diet alone or diet and oral agents, will be recruited in 15 centres and followed for 4 years. Training of physicians, nurses and dietitians included preparation of operating manual and videos, interactive sessions, and evaluation of local facilities and resources. RESULTS: Primary measurements: 3-monthly HbA1c, fasting blood glucose, body weight, waist-hip ratio, yearly blood lipids, and bi-yearly assessment of knowledge of diabetes, health behaviours and quality of life. Secondary outcomes: systolic and diastolic blood pressure, evaluation of ECG for ischaemia and QT interval, hypoglycaemic and anti-hypertensive medication and cardiovascular events. Analysis will be by intention-to-treat. DISCUSSION: If ROMEO confirms that group care can be successfully implemented in different clinics, a novel clinico-pedagogic tool will have been acquired to support patient-centred education, improve lifestyle and outcomes, support team work, enhance providers' attitudes and competencies and ameliorate diabetes care organization.     

The current status of thrombolytic therapy

Fibrinolytic therapy substantially reduces mortality from acute myocardial infarction. Patient selection is, however, important. The patient must present within 12 hours of the onset ofischaemic symptoms, have definite ECG changes of ST elevation or left bundle branch block and no contraindications. The major contraindications are those for risk of an intracerebral bleed, recent stroke, intracranial tumour or risk of a major systemic bleed. Age and hypertension are not contraindications but may modify the regimen used.
Heparin is required with recombinant tissue plasminogen activator but is optional with streptokinase.
The recent COBALT trial suggests that the accelerated weight related t-PA regimen given over 90 minutes is more satisfactory than double bolus t-PA. However, inpatients under 75 years of age, the two regimens were equivalent.
For patients suffering acute myocardial infarction, practitioners should now individualise choice of therapy, rather than give the same cocktail to all patients. The choice of regimen will depend on the cardiac risk, the stroke risk, the bleeding risk and the cost.     

Fusion and failure following anterior cervical plating with dynamic or rigid plates: 6-months results of a multi-centric, prospective, randomized, controlled study

Anterior cervical plate fixation is an approved surgical technique for cervical spine stabilization in the presence of anterior cervical instability. Rigid plate design with screws rigidly locked to the plate is widely used and is thought to provide a better fixation for the treated spinal segment than a dynamic design in which the screws may slide when the graft is settling. Recent biomechanical studies showed that dynamic anterior plates provide a better graft loading possibly leading to accelerated spinal fusion with a lower incidence of implant complications. This, however, was investigated in vitro and does not necessarily mean to be the case in vivo, as well. Thus, the two major aspects of this study were to compare the speed of bone fusion and the rate of implant complications using either rigid- or dynamic plates. The study design is prospective, randomized, controlled, and multi-centric, having been approved by respective ethic committees of all participating sites. One hundred and thirty-two patients were included in this study and randomly assigned to one of the two groups, both undergoing routine level-1- or level-2 anterior cervical discectomy with autograft fusion receiving either a dynamic plate with screws being locked in ap - position (ABC, Aesculap, Germany), or a rigid plate (CSLP, Synthes, Switzerland). Segmental mobility and implant complications were compared after 3- and 6 months, respectively. All measurements were performed by an independent radiologist. Mobility results after 6 months were available for 77 patients (43 ABC/34 CSLP). Mean segmental mobility for the ABC group was 1.7 mm at the time of discharge, 1.4 mm after 3 months, and 0.8 mm after 6 months. For the CSLP- group the measurements were 1.0, 1.8, and 1.7 mm, respectively. The differences of mean segmental mobility were statistically significant between both groups after 6 months (P = 0.02). Four patients of the CSLP-group demonstrated surgical hardware complications, whereas no implant complications were observed within the ABC-group (P = 0.0375). Dynamic plate designs provided a faster fusion of the cervical spine compared with rigid plate designs after prior spinal surgery. Moreover, the rate of implant complications was lower within the group of patients receiving a dynamic plate. These interim results refer to a follow-up period of 6 months after prior spinal surgery. Further investigations will be performed 2 years postoperatively.