ABSTRACT
Abstract Objective: To describe the behavior of total alkaline phosphatase (tALP) in patients with metastatic castration-resistant prostate cancer receiving radium-223 therapy, in a real-world scenario, and to describe overall survival (OS) among such patients. Materials and Methods: This was a retrospective study involving 97 patients treated between February 2017 and September 2020. Patients were stratified by the baseline tALP (normal/elevated). A tALP response was defined as a ≥ 30% reduction from baseline at week 12. For patients with elevated baseline tALP, we also evaluated treatment response as a ≥ 10% reduction in tALP after the first cycle of treatment. We defined OS as the time from the first treatment cycle to the date of death. Results: There was a significant reduction in the median tALP after each cycle of treatment (p < 0.05 for all). Data for tALP at week 12 were available for 71 of the 97 patients. Of those 71 patients, 26 (36.6%) responded. Elevated baseline tALP was observed in 47 patients, of whom 19 (40.4%) showed a response. Longer OS was observed in the patients with normal baseline tALP, in those with elevated baseline tALP that showed a response to treatment (≥ 10% reduction), and in those who received 5-6 cycles of therapy. Conclusion: The tALP may be used to predict which patients will benefit from treatment with a greater number of cycles of radium-223 therapy and will have longer OS.
Resumo Objetivo: Descrever o comportamento da fosfatase alcalina total (tALP) em pacientes com carcinoma de próstata metastático resistente a castração, submetidos a terapia com rádio-223 em um cenário do mundo real, e a sobrevida global (SG) desses pacientes. Materiais e Métodos: Estudo retrospectivo envolvento 97 pacientes, no período de fevereiro/2017 a setembro/2020. Os pacientes foram estratificados de acordo com a tALP basal (normal/elevada). A resposta à tALP foi definida como uma redução em relação à linha de base de ≥ 30% na semana-12. Para pacientes com tALP basal elevada, também foi avaliada a resposta ao tratamento como uma redução de ≥ 10% de tALP após o primeiro ciclo. A SG foi definida como o tempo entre o primeiro ciclo e a data do óbito. Resultados: A redução da tALP média após cada ciclo foi significativa (p < 0,05). A tALP na semana 12 estava disponível para 71 dos 97 pacientes. Desses 71 pacientes, 26 (36,6%) responderam. Dezenove (40,4%) dos 47 pacientes com tALP elevada apresentaram resposta. Foi observada uma SG mais longa nos pacientes com tALP basal normal, nos pacientes com tALP basal elevada que apresentaram resposta ao tratamento (redução de ≥ 10%) e nos pacientes que receberam 5-6 ciclos. Conclusão: A tALP pode ser usada para prever parte dos pacientes que se beneficiarão do tratamento com um maior número de ciclos e uma SG mais longa.
ABSTRACT
Chronic low-back pain (CLBP) is one of the most common pain conditions. Current clinical guidelines for low-back pain recommend acupuncture for CLBP. However, there are very few high-quality acupuncture studies on CLBP in older adults. Clinical acupuncture experts in the American Traditional Chinese Medicine Association (ATCMA) were interested in the recent grant on CLBP research announced by the National Center for Complementary and Integrative Health. The ATCMA experts held an online discussion on the subject of real-world acupuncture treatments for CLBP in older adults. Seven participants, each with more than 20 years of acupuncture practice, discussed their own unique clinical experience while another participant talked about the potential mechanism of acupuncture in pain management. As a result of the discussion, a picture of a similar treatment strategy emerged across the participants for CLBP in older adults. This discussion shows that acupuncture may have complicated mechanisms in pain management, yet it is effective for the treatment of chronic pain involving maladaptive neuroplasticity; therefore, it should be effective for CLBP in older adults.
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Background: Vildagliptin is a dipeptidyl peptidase IV inhibitor (DPP4i). Its efficacy and safety of DPP4i in Chilean real life type 2 diabetic (T2D) patients is not well known. Aim: To assess the safety profile and effectiveness of 12 weeks of treatment with Vildagliptin for glycemic control in T2D Chilean patients with a poor glycemic control. Patients and Methods: Retrospective assessment of the effects of Vildagliptin treatment during 12 weeks in 103 T2D patients aged 29 to 92 years (47% males). The main outcomes were changes in glycosylated hemoglobin and the occurrence of adverse effects. Results: After 12 weeks of Vildagliptin use, glycosylated hemoglobin decreased from 8.3 ± 1.4 to 7.2 ± 1.1% (p < 0.01). Fasting plasma glucose and the number of hypoglycemic events also decreased significantly. No significant weight change was observed. The treatment had good compliance, tolerance and patient satisfaction. Conclusions: Vildagliptin treatment reduced glycosylated hemoglobin by 1.1% and was well tolerated in this group of diabetic patients.
Subject(s)
Saccharomyces cerevisiae Proteins/metabolism , Saccharomyces cerevisiae/metabolism , Telomerase/metabolism , Mutation , Protein Binding , Protein Structure, Tertiary , Recombinant Proteins/genetics , Recombinant Proteins/metabolism , Saccharomyces cerevisiae Proteins/genetics , Saccharomyces cerevisiae/genetics , Telomerase/geneticsABSTRACT
BACKGROUND: The Modality of Insulin Treatment Evaluation (MOTIV) study was performed to provide real-world data concerning insulin initiation in Korean type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control with oral hypoglycemic agents (OHAs). METHODS: This multicenter, non-interventional, prospective, observational study enrolled T2DM patients with inadequate glycemic control (glycosylated hemoglobin [HbA1c] > or =7.0%) who had been on OHAs for > or =3 months and were already decided to introduce basal insulin by their physician prior to the start of the study. All treatment decisions were at the physician's discretion to reflect real-world practice. RESULTS: A total of 9,196 patients were enrolled, and 8,636 patients were included in the analysis (mean duration of diabetes, 8.9 years; mean HbA1c, 9.2%). Basal insulin plus one OHA was the most frequently (51.0%) used regimen. After 6 months of basal insulin treatment, HbA1c decreased to 7.4% and 44.5% of patients reached HbA1c <7%. Body weight increased from 65.2 kg to 65.5 kg, which was not significant. Meanwhile, there was significant increase in the mean daily insulin dose from 16.9 IU at baseline to 24.5 IU at month 6 (P<0.001). Overall, 17.6% of patients experienced at least one hypoglycemic event. CONCLUSION: In a real-world setting, the initiation of basal insulin is an effective and well-tolerated treatment option in Korean patients with T2DM who are failing to meet targets with OHA therapy.
Subject(s)
Humans , Body Weight , Diabetes Mellitus, Type 2 , Hypoglycemic Agents , Insulin , Korea , Observational Study , Pragmatic Clinical Trials as Topic , Prospective StudiesABSTRACT
The purpose of this workshop was to discuss on various issues for the development of a protocol for the Ja pan-Korea research collaboration. An important issue is to select/develop the experimental design of the clinical trial for individualized therapy done in Japan and Korea. Randomizedn-of-1 trial and randomization test were proposed as an possible candidate. A pilot study using randomized n-of-1 trial was done using intradermal acupuncture on pollinosis, and the methodological issues on the generalizability of randomized n-of-1 trial and the need of the selection of target disease were discussed. Onthe other hand, the literature survey has shown that the individualized acupuncture therapy is more effective than those of the standardized' fixed acupuncture therapy in usual RCTs. The diagnosis and selection of acupuncture point and method of manipulation were also shown to be an important factor. Further discussions will be required for the development of the adequate protocol for the individualized therapy.
ABSTRACT
[Background] Over the last thirty years, majority of researches on clinical effectiveness of acupuncture have been explanatory (or experimental) randomized controlled trial. The benefits of acupuncture in clinical trials are stillcontroversial and most studies concluded that further control studies were required. Standardized combinations of acupuncture points for all the experimental subjects in various past studies have been criticized because such treatments do not reflect current routine clinical treatment.<BR>[Objective] This paper aims to review pragmatic clinical trials on the effect of acupuncture treatment and to develop the ideal clinical research methodology of acupuncture study.<BR>[Method] Clinical studies of acupuncture relevant with pragmatic or individualized trials were searched mainly in Pubmed and Science direct databases. All articles were fully reviewed by researchers, and data were evaluated by usage of a standardized form.<BR>[Results & Suggestion] Pragmatic acupuncture researches were tried for various symptoms (eg. low back pain, hypertension, depression during pregnancy, sleep quality in HIV disease, chronic poststroke leg spasticity, headache, etc). Individualized acupuncture treatments based on oriental disease pattern diagnosis reflexes practical treatments which is more effective than unified and fixed acupuncture treatments without any theoretical basis of oriental medical philosophy.<BR>[Conclusion] To overcome the controversies and limitations of past explanatory acupuncture trials, more individualized and tailored acupuncture trials with the theoretical basis of oriental medical diagnosis is highly recommended. Also clear definition and categorization of pattern identification should be established for further active clinical researches and applications of acupuncture.