Subject‐driven titration of biphasic insulin aspart 30 twice daily is non‐inferior to investigator‐driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized,open‐label,parallel‐group,multicenter trial

Aims/Introduction

The present study was to compare the efficacy and safety of subject‐driven and investigator‐driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID).

Materials and Methods

In this 20‐week, randomized, open‐label, two‐group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self‐mixed human insulin were randomized 1:1 to subject‐driven or investigator‐driven titration of BIAsp 30 BID, in combination with metformin and/or α‐glucosidase inhibitors. Dose adjustment was decided by patients in the subject‐driven group after training, and by investigators in the investigator‐driven group.

Results

Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA_1c) reduction was 14.5 mmol/mol (1.33%) in the subject‐driven group and 14.3 mmol/mol (1.31%) in the investigator‐driven group. Non‐inferiority of subject‐titration vs investigator‐titration in reducing HbA_1c was confirmed, with estimated treatment difference −0.26 mmol/mol (95% confidence interval −2.05, 1.53) (–0.02%, 95% confidence interval –0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self‐measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient‐year) was reported in the subject‐driven (1.10) and investigator‐driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA_1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA_1c target without confirmed hypoglycemia throughout the trial in the subject‐driven and investigator‐driven groups, respectively.

Conclusions

Subject‐titration of BIAsp 30 BID was as efficacious and well‐tolerated as investigator‐titration. The present study supported patients to self‐titrate BIAsp 30 BID under physicians’ supervision.     

Titration morphinique intraveineuse en salle de surveillance post-interventionnelle (SSPI) après chirurgie bariatrique sous cœlioscopie

Objective

There is limited information available regarding intravenous (IV) morphine admistration in obese patients in PACU. The aim of this study was to compare two IV morphine titration (IMT) regimen in two surgical centers.

Study design

Observational study.

Patients

Laparoscopic bariatric surgery in one private (Saint-Grégoire Clinic) and one public (University Hospital of Amiens) surgical center.

Methods

A strict and common protocol of IMT was implemented if PACU of both centers according to the recommendations of the French Society of Anaesthesia and Intensive Care. When pain score increased to > 30, IMT was titrated every 5 min in 3 mg increments until pain relief (VAS ≤30 mm). Pain level, dose of morphine (per total and ideal body weight), effectiveness, and side events were recorded.

Results

Data were recorded for 159 adult patients (129 women). Mean age and BMI were 42 ± 12 yrs and 43.8 ± 6.9 kg/m². Ninety-eight patients were eligible for IMT regimen but only 76 patients received IV morphine (47.8 %). Mean dose was 7.3 mg ± 3.5 mg [1–19 mg], (60.4 μg/kg and 115.8 μg/kg). IMT was less frequent, mean dose was greater (8.6 ± 4.2 vs 6.2 ± 2.9 mg) and number of patients with pain relief was higher (73.7 vs 35.6 %) in the public hospital. No severe adverse events have been recorded and there was no difference in both centers regarding these events.

Conclusion

Implementation of a IMT regimen in PACU was not associated with effective pain relief after laparoscopic surgery in obese patients.     

背景滴定用于阿片类药物耐受癌痛患者的可行性分析

目的：探讨背景滴定用于阿片类药物耐受癌痛患者镇痛治疗的可行性。方法38例阿片类药物耐受的癌痛控制不稳定患者,分为背景滴定组和短效吗啡滴定组分别进行滴定,比较两组患者滴定周期、最高疼痛评分、滴定达稳态时间、滴定达稳态阿片类药物剂量及不良反应。结果背景滴定组与短效吗啡滴定组的滴定周期分别为（1.4±0.5）、（2.1±0.8）次,滴定达稳态时间分别为（19.9±10.2）、（24.5±8.4）h,滴定过程中最高疼痛评分分别为（5.4±0.8）、（6.3±0.9）分,两组间比较均有统计学差异（均P＜0.05）;两组不良反应发生率则无统计学差异（P＞0.05）。结论背景滴定用于阿片类药物耐受癌痛患者的镇痛治疗,疼痛控制迅速平稳,不良反应可耐受,是一种安全有效的镇痛治疗方案。     

水质分析中CODCr测定方法的优化

针对COD快速测定法对于中小规模实验室批量测试成本高的问题，我们研究了一种使标准法与分光光度法相结合的CODcr新测定方法。新的COD测定方法比传统的测定法可减少重铬酸钾、硫酸汞用量50％，硫酸用量减少51％，不仅节省费用，还可以减轻实验室对环境的污染。     

Dual microband electrodes: current distributions and diffusion layer ‘titrations’. Implications for electroanalytical measurements

The simulation of transport to double microband electrodes in generator–collector mode is reported focusing especially on the ‘titration curve’ approach to electroanalysis in which a titrant is electrogenerated from a redox active precursor on the generator electrode and reacts homogeneously with the target analyte. The current on the detector electrode reflects the amount of titrant ‘surviving’ passage between the two electrodes. The form of the titration curve – plots of detector current as a function of generator current – is shown to be highly sensitive to the electrode kinetics of the redox couple driven at the generator electrode. Accordingly the na??ve use of such methodology for analysis without accompanying simulation and kinetic analysis is fraught with danger. Use of the conformal mapping approach in combination with the ADI method for investigation of the ‘titration’ current distributions at the double band system gives fast and precise simulation of this and similar problems. Convergence analysis is described which allows for the automatic selection of the simulation grid size so as to obtain a chosen accuracy (for example 1%) of the current for all experimentally meaningful values of the geometrical and physico-chemical parameters of the system to be investigated.     

格列美脲含量测定方法的改进

目的改进格列美脲原料含量测定的方法。方法采用高效液相色谱法,Agilent Zorbax SB-C18色谱柱(4.6 mm×250 mm,5μm),以磷酸二氢钠溶液(取0.5 g磷酸二氢钠,加水500 mL溶解,用磷酸调pH至2.5)-乙腈(500∶500)为流动相,流速1.0 mL·min-1,检测波长为228 nm。结果系统适用性符合要求,格列美脲的定量限为0.1 ng,在87.92¹ 318.80 ng范围内线性关系良好(r=1.000 0)。平均回收率为100.3%,RSD为0.8%(n=9)。结论建立的方法准确、灵敏,可代替滴定法用于格列美脲的含量测定。     

The use of RT-PCR for determination of separate end-points for the strains IB H120 and IB D274 in titration of the combination vaccine Poulvac IB primer

Poulvac IB^® Primer is a lyophilized vaccine containing two attenuated infectious bronchitis strains in one vial, IB H120 and IB D274. For quantification of the viral content of the vaccine, dilution series of the final product are inoculated in embryonated chicken eggs. After the incubation period of seven days standard practice is for the embryos to be taken from each egg and examined visually for IB specific lesions; these readings are used to determine an end-point in viral titrations. The result is a titre value to which both strains contribute. However, it is not clear what the live virus titre is for strain IB H120 and for strain IB D274. In order to determine end-points in the titration for each of the two strains, we collected the allantoic fluids from each egg after the incubation period and tested these for the presence of IB H120 and IB D274 by a strain specific reverse phase PCR. Based on the data obtained by PCR we were able to determine an end-point for each of the two strains. For a given commercial batch of Poulvac IB primer we determined titres of 10^6.31 EID₅₀ per vial for IB H120 and 10^6.59 EID₅₀ for IB D274 using PCR for end-point determination. These end-points matched well with the end-point determined for both strains cumulatively after visual examination, i.e. 10^6.67 EID₅₀ per vial. It is concluded that PCR is a suitable means to determine end-points in titrations of live viruses.     

Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in insulin-naïve type 2 diabetes: Design and population

Background and aims

Fostering patient's self-managing of basal insulin therapy could improve glucose control, by removing patient's and physician's barriers to basal insulin initiation, titration and glucose monitoring. The Italian Titration Approaches Study (ITAS) aims at demonstrating non-inferiority (<0.3% margin) in efficacy of glucose control (change in glycated hemoglobin [HbA1c] after 24 weeks) by the same titration algorithm of insulin glargine 300 U/mL (Gla-300), managed by the (nurse assisted) patient versus the physician, in insulin naïve patients with Type 2 Diabetes Mellitus (T2DM), uncontrolled with previous treatments.

络合滴定法测定葡萄糖酸钙含量的不确定度评定

目的建立葡萄糖酸钙含量测定的不确定度评定方法。方法以评价络合滴定法测定葡萄糖酸钙含量的不确定度为例,分析滴定过程中不确定度分量的来源并进行评估〔2〕。结果扩展不确定度为0.25%,取κ=2（置信概率95）。结论通过分析不确定度的分量大小指导实验优化,使测定结果更加可靠。