Background: Linaclotide is approved for treating irritable bowel syndrome with constipation (IBS-C; 290 µg QD) and chronic idiopathic constipation (CIC; 145 µg or 72 µg QD). These analyses aimed to assess linaclotide safety in a large, pooled Phase 3 population.
Methods: In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12–26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks. Laboratory values, vital signs, and treatment-emergent adverse events (TEAEs) were assessed.
Results: Overall, 3853 patients received ≥1 dose of linaclotide. The most common TEAE was diarrhea (majority [90.5% in RCTs] mild/moderate). Linaclotide patients experienced 1.1 diarrhea TEAE per patient-year in the RCTs (0.2 in placebo), and 0.3 in the LTS studies. In RCTs, 6.9% linaclotide and 3.0% placebo patients discontinued due to any adverse event (AE); 4.0% linaclotide and 0.3% placebo patients discontinued due to diarrhea. In LTS studies, 9.4% patients discontinued due to any AE, and 3.8% due to diarrhea. Serious AEs (SAEs) were rare and similar across treatment groups; there were no SAEs of diarrhea.
Conclusion: These pooled analyses of patients treated for ≤104 weeks confirm linaclotide’s overall safety. 相似文献
Polyethylene glycol (PEG) is often considered as the first-line treatment for functional constipation in children. Descurainia sophia (L.) Webb et Berth (D. sophia) is a safe recommended medicine in Iranian folk and Traditional Persian Medicine for the treatment of constipation.
Objectives:
To clinically compare D. sophia with PEG 4000 (without electrolyte) in pediatric constipation and to assess its efficacy and side effects.
Patients and Methods:
120 patients aged 2 - 12 years with constipation for at least 3 months were included in an 8 weeks lasting randomized controlled trial within two parallel-groups. Children received either PEG, 0.4 g/kg/day, or D. sophia seeds, 2 grams (for children aged 2 - 4 years) and 3 grams (for those aged > 4 years) per day.
Results:
A total of 109 patients completed the study (56 in D. sophia and 53 in PEG group). At the end of the study, 36 (64.3%) patients in D. sophia group and 29 (54.7%) in PEG group were out of Rome III criteria (P = 0.205). Median weekly stool frequency in 0, 1, 2, 3 weeks of the treatment was found to be 2, 5, 5, 5 in D. sophia and 3, 4, 4, 5 in PEG group (P = 0.139, 0.076, 0.844, 0.294), respectively. The number of patients who suffered flatulence was less (5, 8.9%) in D. sophia group as compared to PEG group (6, 11.3%) at the end of the trial (P = 0.461). D. sophia taste was less tolerated.
Conclusions:
D. sophia is introduced as a cheap and available medication which can be applied as a safe alternative to conventional PEG in the management of pediatric chronic functional constipation. 相似文献
PURPOSE One finding in patients with constipation is the paradoxical puborectalis contraction, i.e. , activation of the sphincter muscles during straining instead of relaxation. The aims of this study were to evaluate the
importance of needle placement in sphincter-electromyography and to evaluate a strain/squeeze index in constipated patients
and control subjects.
METHODS We investigated consecutively 194 constipated patients and 16 control subjects with integrated electromyography during straining
and squeezing and calculated a strain/squeeze index. The examination was performed in the puborectalis and in the external
anal sphincter muscle through hook-electrodes.
RESULTS There was a strong correlation between indices in the puborectalis muscle and in the external anal sphincter muscle (r = 0.70–0.80, P < 0.001). Forty-seven patients (24 percent) had a mean index of greater than 50 compared with none in the control group (P = 0.01). Mean overall index in patients was 24 (range, 0–306) vs. 18 (range, 0–45) in controls (P = 0.12). Patients with an index greater than 50 had impaired rectal evacuation (P < 0.001), increased threshold for urge (P < 0.05), and tended to have fewer stools (P = 0.06).
CONCLUSION Quantification of paradoxical contraction in the puborectalis and external anal sphincter with a strain/squeeze index differentiates
patients in whom paradoxical activity may be a cause of constipation. An index above 50 may be of pathologic significance.
Correlations between activity in the puborectalis and external anal sphincter muscle were strong which suggests that investigation
in one of them is sufficient.
Reprints are not available. 相似文献
PURPOSE: The aim of this study was to assess the clinical and functional outcome of surgery for recurrent rectal prolapse and compare it with the outcome of patients who underwent primary operation for rectal prolapse. METHODS: All patients who underwent surgery for rectal prolapse were evaluated for age, gender, procedure, anorectal manometry and electromyography findings, and morbidity. The results for patients who underwent surgery for recurrent rectal prolapse were compared with a group of patients matched for age, gender, surgeon, and procedure who underwent primary operations for rectal prolapse. RESULTS: A total of 115 patients underwent surgery for rectal prolapse. Twenty-seven patients, 10 initially operated on at this institution and 17 operated on elsewhere, underwent surgery for recurrent rectal prolapse. These 27 patients were compared with 27 patients with primary rectal prolapse operated on in our department. In the recurrent rectal prolapse group, prior surgery included rectopexy in 7 patients, Delorme's procedure in 7 patients, perineal rectosigmoidectomy in 7 patients, anal encirclement procedure in 4 patients, and resection rectopexy in 2 patients. Operations performed for recurrence were perineal rectosigmoidectomy in 14 patients, resection rectopexy in 8 patients, rectopexy in 2 patients, pelvic floor repair in 2 patients, and Delorme's procedure in 1 patient. There were no statistically significant differences between the groups in preoperative incontinence score (recurrent rectal prolapse, 13.6±7.8vs. rectal prolapse, 12.7±7.2; range, 0–20) or manometric or electromyography findings, and there were no significant differences in mortality (0vs. 3.7 percent), mean hospital stay (5.4±2.5vs. 6.9±2.8 days), anastomotic complications (anastomotic stricture (0vs. 7.4 percent), anastomotic leak (3.7vs. 3.7 percent) and wound infection (3.7vs. 0 percent)), postoperative incontinence score (2.8±4.8vs. 1.5±2.7), or recurrence rate (14.8vs. 11.1 percent) between the two groups at a mean follow-up of 23.9 (range, 6–68) and 22 (range, 5–55) months, respectively. The overall success rate for recurrent rectal prolapse was 85.2 percent. CONCLUSION: The outcome of surgery for rectal prolapse is similar in cases of primary or recurrent prolapse. The same surgical options are valid in both scenarios.Funded in part by a generous grant from the Eleanor Naylor Dana Charitable Trust Fund and the Caporella Family.Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Philadelphia, Pennsylvania, June 22 to 26, 1997. 相似文献
Constipation is a common community health problem. There are many factors that are widely thought to be associated with constipation but real-world evidence of these associations is difficult to locate. These potential risk factors may be categorised as demographic, lifestyle and health-related factors. This review presents the available evidence for each factor by an assessment of quantitative data from cross-sectional studies of community-dwelling adults published over the last 30 years. It appears that there is evidence of an association between constipation and female gender, residential location, physical activity and some health-related factors such as self-rated health, some surgery, certain medical conditions and certain medications. The available evidence for most other factors is either conflicting or insufficient. Therefore, further research is necessary to determine if each factor is truly associated with constipation and whether it can be regarded as a potential risk factor. It is recommended that studies investigating a broad range of factors are conducted in populations in community settings. Multivariate analyses should be performed to account for all possible confounding factors. In this way, valuable evidence can be accumulated for a better understanding of potential risk factors for constipation in the community. 相似文献
BACKGROUND: By using a technique designated sham fecaloma, we were able to identify two types of segmentary motor phenomenon: displacement motor phenomena and nondisplacement motor phenomena. The aim of the study contained herein was to evaluate for identification of patients with different types of slow-transit constipation. METHODS: Studies were performed in healthy subjects (n=5; colonic transit time <30 hours) and in constipated patients (n=6; colonic transit time >125 hours; normal rectoanal manometry). A Foley®-type recording probe with two perfused catheters (proximal and distal) was used. A rigid sigmoidoscope was used to place the probe at the sigmoid colon. Values recorded by the distal catheter were subtracted (point by point) from the values recorded by the proximal catheter. Subtraction curves were analyzed to quantify characteristics of displacement motor phenomena (an anally directed pressure gradient) and nondisplacement motor phenomena (an orally directed pressure gradient). RESULTS: All healthy subjects had contractions during the recording session. Displacement motor phenomena were predominant (displacement motor phenomena/30 minutes = 21.2±13.2; range, 3–39). Constipated patients yielded two different patterns: three patients had a very small number of contractions, and three patients had a prevalence of nondisplacement motor phenomena, with numbers similar to numbers of displacement motor phenomena in healthy subjects. A comparison of the patterns of constipated patients revealed a statistically significant difference (P=0.039). CONCLUSION: Sham fecaloma is a simple and safe test. Constipated patients in this study had two different patterns of colonic motility scarce activity without haustration and normal activity without displacement motor phenomena. This method might be useful as a diagnostic tool for clarification of the pathophysiology of severe colonic motor disorders.Supported in part by a grant from Fondo de Investigaciones Sanitarias (FIS) (Spain) and by a grant from Junta de Comunidades de Castilla-La Mancha (Spain).Software and analytic systems used during the course of this study were developed by Prof. P. Carrion, Prof. F. Garcia-Sevilla, and Prof. M. Martinez-Iniesta, all of Castilla-La Mancha University (Department of Electronics) Albacete, Spain. 相似文献
IntroductionConstipation and sleep disturbances commonly affect elderly population results in compromised physical and mental health. Mind-body interventions like yoga not only address the mental and physical health but also promote healthy ageing. This study evaluates the effect of 3 months yoga intervention on the sleep and constipation related quality of life (QoL) among the elderly.Materials and methodsNinety six participants aged between 60 and 75 who did not had any history of yoga practice for past 1 year and having a zubrod score of 0–2 were randomized in to yoga (n = 48) or waitlisted control (n = 48). The yoga group received yoga interventions at a frequency of 3 sessions per week for 3 months. Pittsburg Sleep Quality Index (PSQI) and Patient Assessment of Constipation QoL (PAC-QOL) were used to assess the improvement. Intention to treat analysis method was used to include the drop-out participants.ResultsEighty one participants (Yoga = 48, waitlisted control = 33) completed the study. Wilcoxon's sign rank test has shown that the yoga group had statistically significant changes in most of the parameters in PSQI and PAC-QOL (P ≤ 0.05). Mann Whitney test revealed that yoga group has better improvement in the sleep quality and constipation related QOL (P ≤ 0.05) compared to the controls.DiscussionThe results signify yoga can ease old age related issues like constipation and insomnia. This is encouraging for inclusion of yoga as a daily practice regimen to improve the constipation and sleep related quality of life in elderly population. 相似文献