Continuous infusion of low-dose doxorubicin, epirubicin and mitoxantrone in cancer chemotherapy: A review

With the recent development of reliable portable pumps and safe venous access systems, continuous infusion of chemotherapeutic agents on an out-patient basis has become feasible. Advantages of continuous infusion are the long-term exposure of tumour cells to the drug and the fact that most toxic effects are reduced for doxorubicin, epirubicin and mitoxantrone due to elimination of the high peak plasma levels. Preliminary data for doxorubicin suggest that its antitumour activity is maintained. Pharmacokinetic studies with epirubicin and mitoxantrone showed a linear relationship between drug dose infused and the steady-state plasma level for these drugs. The area under the curve for leukocytes drug level was higher during continuous infusion than after an equitoxic bolus injection of epirubicin and mitoxantrone. Well-randomized clinical trials will be necessary to investigate the role of continuous infusion of antracyclines and mitoxantrone in cancer chemotherapy in the future.     

Clinical trials in children

Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children.     

The impact of alfentanil supplementation on the sedation of bronchoscopy: A meta-analysis of randomized controlled trials

Background:The efficacy of alfentanil supplementation for the sedation of bronchoscopy remains controversial. We conduct a systematic review and meta-analysis to explore the influence of alfentanil supplementation on the sedation during bronchoscopy.Methods:We search PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through December 2019 for randomized controlled trials (RCTs) assessing the effect of alfentanil supplementation versus placebo for the sedation during bronchoscopy. This meta-analysis is performed using the random-effect model.Results:Five RCTs are included in the meta-analysis. Overall, compared with control group for bronchoscopy, alfentanyl supplementation is associated with significantly reduced coughing scores (Std. MD = –0.55; 95% CI = –0.96 to –0.14; P = 0.009) and dose of propofol (Std. MD = –0.34; 95% CI = –0.64 to –0.04; P = 0.03), but reveals the increase in hypoxemia (RR = 1.56; 95% CI = 1.17 to 2.08; P = 0.002).Conclusions:Alfentanyl supplementation benefits to reduce coughing scores and dose of propofol for bronchoscopy, but increases the incidence of hypoxemia. The use of alfentanyl supplementation for bronchoscopy should be with caution.     

Core muscle functional strength training for reducing the risk of low back pain in military recruits: An open-label randomized controlled trial

Background: Core muscle functional strength training(CMFST) has been reported to reduce injuries to the lower extremity. However, no study has confirmed whether CMFST can reduce the risk of low back pain(LBP).Objective: This study identified the effects of CMFST on the incidence of LBP in military recruits.Design, setting, participants and intervention: We performed a prospective, open-label, randomized, controlled study in a population of young healthy male naval recruits from a Chinese basic c...     

六味地黄汤治疗Ⅲa型前列腺炎随机平行对照研究

[目的]观察六味地黄汤治疗Ⅲa型前列腺炎疗效。[方法]使用随机平行对照方法,将60例门诊患者按随机数字表法为两组。对照组30例龙金通淋胶囊2~3粒/次,3次/d。治疗组30例六味地黄汤(熟地15g,山药、山茱萸各12g,茯苓、泽泻、牡丹皮、车前子、牛膝、黄柏各10g,萆薢15g),1剂/d,水煎200mL,早晚温服。连续治疗30d为1疗程。观测临床症状、NIH-CPSI总体评分、前列腺液、IL-8水平、不良反应。治疗1疗程,判定疗效。[结果]治疗组痊愈9例,显效10例,有效9例,无效2例,总有效率93.33%。对照组痊愈7例,显效6例,有效8例,无效9例,总有效率70.00%。治疗组疗效优于对照组(P0.05)。NIH-CPSI总体评分、IL-8水平均有改善(P0.05,P0.01),治疗组优于对照组(P0.01)。[结论]六味地黄汤治疗Ⅲa型前列腺炎疗效显著,值得推广。     

Aligned acupuncture at muscle regions plus cutaneous needle for upper limb spasticity after stroke: A multicenter randomized controlled trial

Objective： To evaluate the clinical efficacy of aligned acupuncture at the muscle regions plus cutaneous needle for post-stroke upper limb spasticity. Methods： By adopting a design of multicenter randomized controlled clinical trial, 488 patients with post-stroke upper limb spasticity were randomized into a treatment group and a control group, 244 in each group. In addition to rehabilitation training, the treatment group received aligned acupuncture at the muscle regions plus cutaneous needle therapy and the control group received conventional Western medicine. After successive 3-week treatments, the clinical efficacy, spasticity degree of the upper limb, joint function, and neurological defect degree were evaluated in the two groups. Results： The total effective rate was 93.4% in the treatment group versus 61.5% in the control group, and the difference was statistically significant （P 〈 0.05）. The upper-limb spasticity degree, joint function, and neurological defect degree were improved significantly in both groups after intervention （P〈0.05）, and the improvements in the treatment group were more significant than those in the control group （P〈0.05 or P〈0.01）. Conclusion： Aligned acupuncture at the muscle regions plus cutaneous needle therapy is effective in treating post-stroke upper limb spasticity.     

Metformin Decreases Circulating Androgen and Estrogen Levels in Nondiabetic Women With Breast Cancer

IntroductionDiabetic patients treated with metformin have a lower risk of developing BC or a better BC prognosis. Metformin might reduce cancer growth through direct antiproliferative effects or through indirect mechanisms, particularly the reduction of insulin. In a randomized study on nondiabetic BC patients in natural menopause with high testosterone levels, we observed a significant decrease in insulin and in testosterone levels with metformin 1500 mg/d compared with 1000 mg/d. We present the results of a new analysis of our study on the effect of metformin on the bioavailability of sex hormones.Patients and MethodsOne hundred twenty-four eligible women were initially invited to take metformin 500 mg/d for 3 months. The 108 women who completed the first 3 months continued the study using 1000 mg/d for 1 month. The women were then randomized into 2 groups, and, for the subsequent 5 months, 1 group increased the dose to 1500 mg/d, and the other group continued with 1000 mg/d.ResultsNinety-six women completed the study, 43 receiving metformin 1500 mg/day, and 53 receiving 1000 mg/day. The women receiving 1500 mg/d showed a greater and significant reduction of free testosterone (?29%) and estradiol (?38%), a borderline significant reduction of estrone and insulin-like growth factor-1, and a nonsignificant reduction of androstenedione. They also showed a nonsignificant increase of dehydroepiandrosterone sulfate.ConclusionMetformin does not interfere with the production of dehydroepiandrosterone sulfate. Besides, it decreases estradiol levels, basically through the reduction of testosterone. These hormonal changes might have clinical relevance.     

Focus group interviews: how aromatherapists feel about changing their practice through undertaking a randomised controlled trial?

In 2003/2007 a randomised controlled trial (RCT) was undertaken into the efficacy of aromatherapy in reducing levels of anxiety amongst palliative care patients. In the study patients were randomised into one of three treatment groups. The participating aromatherapists treated patients according to a strict research protocol. As the trial commenced, the therapists indicated a concern about a potential loss of their holistic principles while undertaking the trial. These genuine concerns formed the impetus to undertake a qualitative study to illuminate the aromatherapists' experience of changing their practice. Findings and discussions are through the themes that emerged. It appears that participating in a RCT does impact on aromatherapists' holistic practice but equally important is their commitment to undertake the research.