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首页> 外文期刊>Thyroid: official journal of the American Thyroid Association >Efficacy of the Natural Clay, Calcium Aluminosilicate Anti-Diarrheal, in Reducing Medullary Thyroid Cancer-Related Diarrhea and Its Effects on Quality of Life: A Pilot Study
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Efficacy of the Natural Clay, Calcium Aluminosilicate Anti-Diarrheal, in Reducing Medullary Thyroid Cancer-Related Diarrhea and Its Effects on Quality of Life: A Pilot Study

机译:天然粘土,铝硅酸钙止泻药在减少与甲状腺髓样癌相关的腹泻及其对生活质量的影响中的功效:一项初步研究

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Introduction: Medullary thyroid cancer (MTC)-related diarrhea can be debilitating, reduces quality of life (QOL), and may be the only indication for initiating systemic therapy. Conventional antidiarrheal drugs are not always helpful and may have side effects. Calcium aluminosilicate antidiarrheal (CASAD), a natural calcium montmorrilonite clay, safely adsorbs toxins and inflammatory proteins associated with diarrhea. It was hypothesized that CASAD would reduce the severity of diarrhea and improve QOL in MTC patients. Methods: This was a prospective pilot trial (NCT01739634) of MTC patients not on systemic therapy with self-reported diarrhea of three or more bowel movements (BMs) per day for a week or more. The study design included a one-week run-in period followed by one week of CASADa two-week optional continuation period. The primary endpoint was efficacy of one week of CASAD treatment in decreasing the number of BMs per day by 20% when compared with the baseline run-in period. Secondary objectives included tolerability and safety and the impact on QOL using the MD Anderson Symptom Inventory-Thyroid questionnaire (MDASI-THY). Results: Ten MTC patients (median age=52 years, 70% female, 80% white) were enrolled. All had distant metastases, and median calcitonin was 5088ng/mL (range 1817-42,007ng/mL). Ninety percent had received prior antidiarrheals, and 40% of these had used two or more drugs, including tincture of opium (30%), loperamide (50%), diphenoxylate/atropine (20%), colestipol (10%), or cholestyramine (10%). Of seven evaluable patients, four (56%) had 20% reduction in BMs per day. Six out of seven patients discontinued their prior antidiarrheals. Best response ranged from 7% to 99% reduction in mean BMs/day from baseline. Five out of seven patients considered CASAD a success, and they opted for the two-week continuation period. Improvements in diarrhea and all six interference items assessed by MDASI-THY were noted at weeks 1 and 3. Total interference score was significantly improved at three weeks compared with baseline (p=0.05). An oral levothyroxine absorption test was performed in one patient; malabsorption of levothyroxine was not observed. Adverse events included flatulence (40%), bloating (10%), heartburn (10%), and constipation (10%). Conclusions: CASAD is a promising strategy for treatment of MTC-related diarrhea. In this small pilot study, improvements in frequency and quality of diarrhea as well as QOL were noted. Further studies in this population are warranted.
机译:简介:与甲状腺髓样癌(MTC)相关的腹泻可能使人衰弱,降低生活质量(QOL),并且可能是开始全身治疗的唯一指征。传统的止泻药并非总是有用,并且可能有副作用。铝硅酸钙止泻药(CASAD)是一种天然钙蒙脱土,可安全地吸收与腹泻有关的毒素和炎性蛋白质。假设CASAD可以减轻MTC患者的腹泻严重程度并改善QOL。方法:这是一项前瞻性先导试验(NCT01739634),该试验针对未接受全身治疗且每天自我报告的腹泻次数为三个或三个以上排便(BMs)且持续一周或更长时间的MTC患者。研究设计包括一个为期一周的磨合期,随后为一个星期的CASADa,为期两周的可选延续期。主要终点是与基线磨合期相比,CASAD治疗一周能有效降低每天BM的数量20%。次要目标包括耐受性和安全性以及使用MD Anderson症状量表-甲状腺问卷(MDASI-THY)对QOL的影响。结果:招募了10名MTC患者(中位年龄= 52岁,女性70%,白人80%)。所有患者均具有远处转移,降钙素中位数为5088ng / mL(范围1817-42,007ng / mL)。 90%的人以前曾接受过止泻药,其中40%曾使用两种或多种药物,包括鸦片30(30%),洛哌丁胺(50%),苯甲酚酯/阿托品(20%),考来替泊(10%)或胆甾胺(10%)。在7名可评估的患者中,有4名(56%)每天的BMs降低了20%。七分之六的患者停止了先前的止泻药。最佳响应范围是每天平均BMs从基线降低7%至99%。 7名患者中有5名认为CASAD成功,他们选择了两周的延续期。在第1周和第3周记录了腹泻的改善和MDASI-THY评估的所有6个干扰项目。与基线相比,在3周时总干扰评分显着提高(p = 0.05)。一名患者进行了口服左甲状腺素吸收试验。没有观察到左甲状腺素吸收不良。不良事件包括肠胃气胀(40%),腹胀(10%),胃灼热(10%)和便秘(10%)。结论:CASAD是治疗MTC相关性腹泻的一种有前途的策略。在这项小型的先导研究中,注意到腹泻频率和质量以及生活质量的改善。有必要对该人群进行进一步研究。

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