N Engl J Med：利那洛肽治慢性便秘完成Ⅲ期临床实验
2012-01-11 MedSci原创 MedSci原创
2011年5月召开的美国消化疾病周（DDW）上，美国波士顿贝斯以色列妇女医院的学者报告了利那洛肽（Linaclotide）治疗慢性便秘的两项Ⅲ期临床实验结果，无论在自主肠蠕动的次数和质量上，服用该药物的患者均可获得显著改善。研究结果8月发表于N Engl J Med杂志上。 利那洛肽是一种微量吸收的鸟苷酸环化酶C 受体肽激动剂。两项研究均纳入超过600例（共1276例）患者，分别予安慰剂或利
2011年5月召开的美国消化疾病周（DDW）上，美国波士顿贝斯以色列妇女医院的学者报告了利那洛肽（Linaclotide）治疗慢性便秘的两项Ⅲ期临床实验结果，无论在自主肠蠕动的次数和质量上，服用该药物的患者均可获得显著改善。研究结果8月发表于N Engl J Med杂志上。
利那洛肽是一种微量吸收的鸟苷酸环化酶C 受体肽激动剂。两项研究均纳入超过600例（共1276例）患者，分别予安慰剂或利那洛肽（145μg 或290μg，qd）治疗。以每周有≥ 3次完全自发排便（CSBM）及在12周中的至少9周、CSBM较基线增加≥1次为主要疗效终点。
结果显示，与安慰剂组相比，无论高剂量还是低剂量利那洛肽组达到主要疗效终点的比率均显著增高（P均＜0.01）。两个利那洛肽组所有次要终点的改善亦显著优于安慰剂组。除腹泻[使2例利那洛肽组患者（4.2%）停止治疗]外，不良事件的发生率在各研究组中相似。
两项研究的主要研究者兰博（Lembo）指出，两项试验均达到了主要研究终点，且在次要终点方面，也较基线时及安慰剂组有显著的改善。此外，该药物仅造成15%的患者出现腹泻症状，4%因之终止治疗。(生物谷 Bioon.com)
拓展阅读:
Two Randomized Trials of Linaclotide for Chronic Constipation
Anthony J. Lembo, M.D., Harvey A. Schneier, M.D., Steven J. Shiff, M.D., Caroline B. Kurtz, Ph.D., James E. MacDougall, Ph.D., Xinwei D. Jia, Ph.D., James Z. Shao, M.S., et al.
Background
Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase C receptor. In two trials, we aimed to determine the efficacy and safety of linaclotide in patients with chronic constipation.
Methods
We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation. Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks. The primary efficacy end point was three or more complete spontaneous bowel movements (CSBMs) per week and an increase of one or more CSBMs from baseline during at least 9 of the 12 weeks. Adverse events were also monitored.
Results
For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all comparisons of linaclotide with placebo). Improvements in all secondary end points were significantly greater in both linaclotide groups than in the placebo groups. The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups.
Conclusions
In these two 12-week trials, linaclotide significantly reduced bowel and abdominal symptoms in patients with chronic constipation. Additional studies are needed to evaluate the potential long-term risks and benefits of linaclotide in chronic constipation. (Funded by Ironwood Pharmaceuticals and Forest Research Institute; ClinicalTrials.gov numbers, NCT00765882 and NCT00730015.)
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#临床实验#
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#Eng#
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#Engl#
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#利那洛肽#
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#Ⅲ期临床#
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#Med#
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