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- Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice. [JOURNAL ARTICLE]
- BMC Cancer 2014 Oct 24; 14(1):779.
Patients with transitional cell carcinoma of the urothelial tract (TCCU) who fail initial platinum-based chemotherapy for advanced disease represent a challenge in daily clinical practice. Vinflunine is approved by the European Medicine Agency (EMA) but, up to now, limited experience has been reported outside clinical trials.We assessed the efficacy and safety of vinflunine in an unselected group of 102 consecutive patients with metastatic TCCU.The median age was 67 years (range 45-83). Among the most common comorbidities that patients presented at baseline were hypertension (50.5%) and diabetes (20.7%).Distant metastases were present in retroperitoneal nodes (58%), lung (29.3%), and bone (20.2%). The ECOG 0, 1 and 2 performance status at the start of vinflunine were 31.3%, 60.6% and 8.1%, respectively. The most commonly reported adverse events of any grade were constipation 70.6% (5.9% grade 3-4), vomiting 49.1% (2% grade 3-4), neutropenia 48.1% (12.8% grade 3-4) and abdominal pain 34.3% (4.9% grade 3-4). A median of 4 cycles of vinflunine was administered per patient (range 1-18). Median progression free and overall survival for all patients (N = 102) were 3.9 months (2.3-5.5) and 10 months (7.3-12.8), respectively. Time to tumor progression was 4.3 months (2.6-5.9). Two patients (2%) achieved CR, 23 (22.5%) patients had PR, and 42 (41.2%) presented SD as best response. The clinical benefit rate with vinflunine was 65.7%.Our results show that the behavior of vinflunine in routine clinical practice resembles that of the pivotal phase III randomized study.
- [Nutrition support treatment for refractory constipation patients complicated with superior mesenteric artery syndrome.] [JOURNAL ARTICLE]
- Zhonghua Wei Chang Wai Ke Za Zhi 2014 Oct 25; 17(10):972-976.
To determine the incidence and risk factors associated to with refractory constipation patients complicated with superior mesenteric artery syndrome (SMAS), and to observe the role of nutritional support in its treatment.A prospective nested case-control study was conducted from a constipation cohort(n=973) to assess the incidence and risk factors of SMAS. Pitents with SMAS were matched to controls with a ratio of 1:4 by age and gender. Cases developed SMAS in long-term follow-up(n=26) and controls did not(n=104). Nutritional support was used in 26 patients with SMAS. The efficacy of nutritional support was evaluated by retrospective analysis.The incidence of SMAS in this cohort of patients was 2.7%. Multivariate logistic analysis revealed BMI≤18 kg/m(2) (OR=2.89, 95%CI:1.14-7.31) and prolonged colon transit time(OR=3.57, 95%CI:1.36-9.35) were independent risk factors of SMAS in patients with refractory constipation. A total of 22 patients recovered after treatment of nutritional support. The successful rate of conservative treatment was 84.6%. The clinical symptoms, gastrointestinal quality of life index, Wexner constipation score and nutritional status were all significantly improved after treatment.A BMI of less than 18 kg/m(2) and prolonged colon transit time are independent risk factors in refractory constipation patients complicated with SMAS. Nutrition support should be carried out according to illness condition and nutritional status, and combined with theatment of constipation simultaneously.
- Bloating and functional gastro-intestinal disorders: Where are we and where are we going? [REVIEW]
- World J Gastroenterol 2014 Oct 21; 20(39):14407-14419.
Bloating is one of the most common and bothersome symptoms complained by a large proportion of patients. This symptom has been described with various definitions, such as sensation of a distended abdomen or an abdominal tension or even excessive gas in the abdomen, although bloating should probably be defined as the feeling (e.g. a subjective sensation) of increased pressure within the abdomen. It is usually associated with functional gastrointestinal disorders, like irritable bowel syndrome, but when bloating is not part of another functional bowel or gastrointestinal disorder it is included as an independent entity in Rome III criteria named functional bloating. In terms of diagnosis, major difficulties are due to the lack of measurable parameters to assess and grade this symptom. In addition, it is still unclear to what extent the individual patient complaint of subjective bloating correlates with the objective evidence of abdominal distension. In fact, despite its clinical, social and economic relevance, bloating lacks a clear pathophysiology explanation, and an effective management endorsement, turning this common symptom into a true challenge for both patients and clinicians. Different theories on bloating etiology call into questions an increased luminal contents (gas, stools, liquid or fat) and/or an impaired abdominal empting and/or an altered intra-abdominal volume displacement (abdomino-phrenic theory) and/or an increased perception of intestinal stimuli with a subsequent use of empirical treatments (diet modifications, antibiotics and/or probiotics, prokinetic drugs, antispasmodics, gas reducing agents and tricyclic antidepressants). In this review, our aim was to review the latest knowledge on bloating physiopathology and therapeutic options trying to shed lights on those processes where a clinician could intervene to modify disease course.
- Effects of dietary fiber with Bacillus coagulans lilac-01 on bowel movement and fecal properties of healthy volunteers with a tendency for constipation. [JOURNAL ARTICLE]
- Biosci Biotechnol Biochem 2014 Oct 23.:1-7.
To elucidate the effects of Lilac LAB (Bacillus coagulans lilac-01 and okara [soy pulp] powder) on bowel movements/fecal properties, we conducted a double-blind placebo-controlled randomized trial with healthy Japanese volunteers with a tendency for constipation (n = 297). The subjects ingested 2 g/d placebo (okara powder) or test food (Lilac LAB, 1 × 10(8) CFU) once a day for 2 weeks. In the test group of functionally constipated subjects, the changes in the average scores of self-reported fecal size, sensation of incomplete evacuation, and defecation frequency were significantly improved compared to the placebo group (p < 0.05), and fecal color and odor tended to improve (p = 0.07). In the test food group of all subjects and among the non-functionally constipated subjects, the fecal size tended to improve compared to the placebo group (p = 0.06, p = 0.07, respectively). Lilac LAB was effective in improving bowel movements and fecal properties in functionally constipated persons.
- Unilateral labial mass in a neonate: a rare clinical presentation of focal dermal hypoplasia. [Journal Article]
- J Clin Neonatol 2014 Jul; 3(3):167-9.
A full-term female baby presented at birth with a swollen left labia and atrophic lesions affecting the sacrum and left buttocks. A diagnosis of focal dermal hypoplasia was made from the histopathology of the labial lesion. Patient presented at the age of 2 years with urinary incontinence and constipation and imaging of the neuro-spinal axis showed lipomyelomeningocele with tethered cord.
- A case of parasitic myoma 4 years after laparoscopic myomectomy. [Journal Article]
- J Minim Access Surg 2014 Oct; 10(4):202-3.
We present a case of parasitic myoma complaining of abdominal pain, constipation, dyspareunia and dysmenorrhea 4 years after laparoscopic myomectomy. We performed laparoscopic myomectomy for multiple parasitic myomas. Three myomas were very firmly attached to bowel and mesentery. Parasitic myoma after laparoscopic surgery is very rare condition there are almost 35 cases in the literature. It is related with variable symptoms or can be asymptomatic. Laparoscopic surgeons should be aware of this situation, and further investigation should be made in case of suspicion. Surgery for parasitic myomas can be difficult in case of bowel and mesentery involvement and patient should be informed about the extensive surgery.
- [Randomized controlled trials of acupuncture and moxibustion for post-stroke constipation: a meta analysis]. [English Abstract, Journal Article]
- Zhongguo Zhen Jiu 2014 Aug; 34(8):833-6.
The clinical efficacy of acupuncture and moxibustion for post-stroke constipation was systematically reviewed. By computerized and manual retrieval of clinical research literature regarding acupuncture and moxibustion for post-stroke constipation, the randomized control trials (RCTs) that met the inclusive criteria were collected. Cochrane systematic review method was used and Revmen 5.2 software was adopted to perform this Meta analysis. Totally 8 articles were included, involving 610 cases of post-stroke constipation. As a result, the total effective rate and cured rate of acupuncture and moxibustion for post-stroke constipation were significantly superior to those of the control group [total effective rate: OR = 2.10, 95% CI (1.25, 3.54), Z = 2.78, P = 0.005; cured rate: OR = 2.37, 95% CI (1.57, 3.58), Z = 4.10, P < 0.0001]. This result indicated that acupuncture was effective for post-stroke constipation and had some advantages compared with other therapies. But the quality of included RCTs was low, and high-quality, large-sample and multi-center RCTs were needed to perform further verification.
- Constipation: An Unusual Presentation of Ulcerative Pancolitis in an Elderly Adult. [LETTER]
- J Am Geriatr Soc 2014 Oct; 62(10):2013-2014.
- Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States. [JOURNAL ARTICLE]
- J Med Econ 2014 Oct 21.:1-31.
Abstract Objectives: To use techniques of decision-analytic modeling to evaluate the effectiveness and costs of linaclotide versus lubiprostone in the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). Methods: Using model inputs derived from published literature, linaclotide Phase III trial data and a physician survey, a decision-tree model was constructed. Response to therapy was defined as (1) a ≥ 14-point increase from baseline in IBS-Quality of Life (IBS-QOL) Questionnaire overall score at Week 12 or (2) one of the top two responses (moderately/significantly relieved) on a seven-point IBS symptom relief question in ≥ 2 of 3 months. Patients who do not respond to therapy are assumed to fail therapy and accrue costs associated with a treatment failure. Model time horizon is aligned with clinical trial duration of 12 weeks. Model outputs include number of responders, quality-adjusted life-years (QALYs), and total costs (including direct and indirect). Both one-way and probabilistic sensitivity analyses were conducted. Results: Treatment for IBS-C with linaclotide produced more responders than lubiprostone for both response definitions (19.3% vs. 13.0% and 61.8% vs. 57.2% for IBS-QOL and symptom relief, respectively), lower per-patient costs ($803 vs. $911 and $977 vs. $1,056), and higher QALYs (0.1921 vs. 0.1917 and 0.1909 vs. 0.1894) over the 12-week time horizon.. Results were similar for most one-way sensitivity analyses. In probabilistic sensitivity analyses, the majority of simulations resulted in linaclotide having higher treatment response rates and lower per-patient costs. Limitations: There are no available head-to-head trials that compare linaclotide with lubiprostone; therefore, placebo-adjusted estimates of relative efficacy were derived for model inputs. The time horizon for this model is relatively short, as it was limited to the duration of available clinical trial data. Conclusions: Linaclotide was found to be a less costly option versus lubiprostone for the treatment of adult patients with IBS-C.
- Potential effect of Sildenafil beyond pulmonary hypertension in a patient with diffuse systemic sclerosis and cryoglobulinemic vasculitis. [Journal Article]
- Springerplus 2014.:559.
Pulmonary arterial hypertension (PAH) is a serious complication of systemic sclerosis (SSc), has a dramatic impact on prognosis and survival and is a leading cause of death.A 40 years old female patient with difuse cutaneous SSc (dcSSc) presented with progressive dyspnea, choking sensation, cough, abdominal distension, constipation and dysphagia to solids. The muscle power was mildly reduced and multiple purpuric eruptions were present on the legs of variable sizes. The patient was ANCA negative and had positive cryoglobulinemia. The hepatitis C virus test was positive and the skin biopsy histopathology proved small vessel (leucocytoclastic) vasculitis. The modified Rodnan total skin score (MRSS) was 37. There was deterioration of the pulmonary function tests and transesophageal echocardiography revealed PAH (RVSP 60 mmHg). Sildenafil 50 mg/day resulted in a remarkable improvement of the dyspnea and Raynauds' with a significant improvement of the skin tightness as the MRSS became 22. The small vessel vasculitic rash remarkably improved and the RVSP became 34 mmHg with a dramatic improvement of the PAH.Sildenafil enhances vasodilatation, has antiproliferative effects and is effective in the treatment of PAH. The remarkable improvement in the vasculitic skin lesions in this case after sildenafil is the second report after the described dramatic improvement of small vessel vasculitis in a case with Takayasu arteritis. The emerging trends make it necessary to exploit the full therapeutic potential of Sildenafil in scleroderma and PAH with other extrapulmonary manifestations.We report a very rare association of dcSSc with small vessel cryoglobulinemic vasculitis with a remarkable improvement after sildenafil.