scholarly journals The observation on curative effect of Shouhuitongbian capsule in the treatment of functional constipation: A real world study

2020 ◽  
Author(s):  
Hongxi Zhang ◽  
Bao Han ◽  
Zhiyun Zhang ◽  
Yongduo Yu ◽  
Zhenguo Tian
Keyword(s):  
Quality Of Life ◽  
Functional Constipation ◽  
Convincing Evidence ◽  
Common Disease ◽  
Efficacy And Safety ◽  
Wexner Score ◽  
Improvement Effect ◽  
Duration Of Disease

Abstract Background: Chronic constipation is a common disease caused by a variety of reasons. This study was to observe the improvements on symptoms, quality of life and satisfaction of patients with functional constipation by Shouhuitongbian capsule, and evaluate its safety.Methods: The study was divided into four groups according to the duration of disease. The primary observational indicators were efficacy and safety of Shouhuitongbian capsule after 14 days of treatment, and changes of Wexner score of intestinal function. Effect of Shouhuitongbian capsule on quality of life of patients, and the long-term efficacy and safety of taking capsule after 1 month, 2 months and 3 months were used as secondary observational indicators .Results: The results showed that the improvement effect of capsules on 14th day was better that on the 7th day (P＜0.001). Besides, compared with patients with longer duration of disease, the improvement effect of patients with shorter duration of disease was better (P＜0.001). The long-term improvement effect of patients taking capsules was greater than the short-term improvement effect (P＜0.001). The long-term improvement of patients with shorter duration of disease after taking capsules was more effective than that of patients with longer duration of disease (P＜0.001).Conclusion: The experimental results provide a strong/powerful/ convincing evidence for the re-evaluation of efficacy and safety of Shouhuitongbian capsule after its marketing.

scholarly journals Efficacy of the trans‑obturator and retropubic mid‑urethral slings for stress urinary incontinence

2019 ◽  
Vol 88 (3-4) ◽  
pp. 115-124
Author(s):  
Matej Keršič ◽  
Maruša Keršič ◽  
Tina Kunič ◽  
Matija Barbič ◽  
Ivan Verdenik ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Incontinence ◽  
Surgical Treatment ◽  
Short Form ◽  
Long Term Results ◽  
Efficacy And Safety ◽  
Severity Scale ◽  
Exclusion Criteria

Background: The aim of our study was to report the extended long-term results of the use of tension-free vaginal tape (TVT) and trans-obturator tape (TOT) for the treatment of female urinary stress incontinence (SUI) at the Division of Gynaecology and Obstetrics / UMC Ljubljana. There are few data on this topic in the literature. Our aim was to find out whether and how the procedure improved the patients’ quality of life and for how long, whether the patients had complications after the procedure, and how this type of procedure affected the long-term results.Methods: A retrospective clinical trial comparing the use of TVT and TOT was carried out from January to August 2017 and included all the patients operated on at the Division of Gynaecology and Obstetrics / UMC Ljubljana with TVT or TOT procedure for stress or mixed urinary incontinence (UI) associated with urethral hyper mobility (the stress component was clinically predominant). The exclusion criteria were more than 10 years from procedure, age more than 80 years in 2016, previous anti-incontinence surgery and/or pelvic organ prolapse more than stage I on POP–q in any vaginal compartment. After inclusion and exclusion criteria, 1104 patients were sent quality-of-life questionnaires (PGI-S, PGI-I, SANDVIK SEVERITY SCALE, UDI-6, IIQ-7, ICIQ-UI Short Form (Slovenian)) with questions about the diagnosis, procedures, complications, reoperations, post-operative results, and satisfaction with the procedure. Till August 2017 (6 months after sending) we received 466 questionnaires (42.2 % response rate). After 225 questionnaires were excluded due to incomplete data, 241 questionnaires were analysed.Results: In the analysed group of patients (N = 241), 189 (78 %) had TOT and 52 (22 %) had TVT. Our retrospective study has confirmed that the efficacy and safety of TOT and TVT in the surgical treatment of SUI are comparable. The TOT and TVT groups did not differ significantly from each other in PGI-S, PGI-I, SANDVIK SEVERITY SCALE, UDI-6, IIQ-7, and ICIQ-UI Short Form or in postoperative complication rate. Repeat surgery was needed in 25/189 (13.2 %) TOT patients and 12/52 (23.1 %) TVT patients; p = 0.082. Urinary retention appeared in 18/189 (9.5 %) TOT patients and 7/52 (13.5 %) TVT patients; p = 0.411. Mesh erosion/inflammation appeared in 12/189 (6.3 %) TOT patients and 2/52 (38 %) TVT patients; p = 0495.Conclusion: We can conclude that the efficacy and safety of TOT and TVT in the surgical treatment of SUI are comparable. The choice of the technique should be based on the relative pros and cons of techniques and the surgeon’s experience.

scholarly journals A pilot study of topiramate in children with Lennox-Gastaut syndrome

1999 ◽  
Vol 57 (2A) ◽  
pp. 167-175 ◽  
Author(s):  
MARILISA M. GUERREIRO ◽  
MARIA LUIZA G. MANREZA ◽  
ANNA ELISA SCOTONI ◽  
E.A. SILVA ◽  
CARLOS A. M. GUERREIRO ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Adjunctive Therapy ◽  
Term Treatment ◽  
Daily Activities ◽  
Efficacy And Safety ◽  
Long Term Treatment ◽  
Chronic Use

We conducted an open, add-on study with topiramate (TPM) as adjunctive therapy in Lennox-Gastaut syndrome (LGS), to assess the long-term efficacy and safety and to evaluate quality of life (QL) measurements in the chronic use of TPM. We studied 19 patients (11 male; age ranging from 4 to 14 years) with uncontrolled seizures receiving 2-3 anti-epileptic drugs. Patients were followed up to 36 months of treatment. A questionnaire was used to query parents about QL. Seven patients completed the study at 36 months and seizure frequency was reduced > 75% in 4, and < 50% in 3 patients. Two children became seizure free for more than 24 months. Most side effects were CNS related, with the most frequent being somnolence and anorexia. These were generally transient. One patient dropped-out due to powder in the urine. None of the patients required hospitalization. At 36 months, patients' alertness (2/7), interaction with environment (5/7), ability to perform daily activities (5/7), and verbal performance (6/7) improved on TPM. We conclude that TPM may be useful as adjunctive therapy in the treatment of LGS. The efficacy of TPM was maintained in long-term treatment in more than 40% of patients, long term safety was confirmed and QL improved on TPM.

scholarly journals One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study

2021 ◽  
pp. bmjspcare-2020-002816
Author(s):  
Manuel Cobo Dols ◽  
Carmen Beato Zambrano ◽  
Luis Cabezón-Gutiérrez ◽  
Rodolfo Chicas-Sett ◽  
María Isabel Blancas López-Barajas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real World ◽  
Adverse Reactions ◽  
Response To Treatment ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Patients With Cancer ◽  
One Year

ObjectivesNaloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.MethodsThis one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L).ResultsA total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment.ConclusionThe results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.

Chronic non-cancer pain and the long-term efficacy and safety of opioids: Some blind men and an elephant?

2012 ◽  
Vol 3 (1) ◽  
pp. 5-13 ◽  
Author(s):  
C. Peter ◽  
N. Watson
Keyword(s):  
Quality Of Life ◽  
Adverse Effects ◽  
Cancer Pain ◽  
Functional Status ◽  
Efficacy And Safety ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

AbstractBackgroundThe use of opioids for chronic non-cancer pain (CNCP) remains very controversial. There are a number of randomized controlled trials (RCTs) showing efficacy and safety in the short-term, but long-term data are limited.MethodsThis article contains 10 case reports (followed to 2011) that were selected from a survey of 84 patients with intractable CNCP treated with opioids and followed every 3 months now for a median of 10 years. The previous published survey of this group reported outcomes of pain severity, adverse effects, pain relief, satisfaction, mood, problematic opioid use, tolerance, physical dependency, functional status, health-related quality of life (HRQL), immune status and sexual function. The outcome measures for that study included a numerical rating scale (NRS) for pain, Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory Interference Scale (BPI-I), the Pain Disability Index (PDI), and for Health Related Quality of Life (HRQL) the Short Form Health Survey 12 version 2 (SF12v2). These selected patient reports were chosen to illustrate some important aspects of the diagnostic categories of CNCP, the opioids and doses used, particular issues (concurrent addiction history, bipolar disorder, and combination therapy), disease-specific and other outcomes (pain severity and relief, adverse effects, mood, function) and duration of follow-up with complex pain problems.ResultsOpioids were found to be safe and effective in the long-term for these particular patients, as well as in the larger group from which they originate. Most patients in the total sample reported 50% or greater relief and a moderate improvement in disability. Scores for functional status and HRQL were not severely affected (PDI and BPI-I ratings moderate or less and SF12v2 slightly below normative values for age). Problematic use, tolerance, and serious adverse effects including constipation were not major issues.ConclusionThese 10 reports of patients with intractable CNCP treated with opioids with some success over many years put a face on some of the participants in the larger survey of 84 suggesting that this approach is effective and safe for some patients over many years.ImplicationsThese data may not be generalizable to a larger population of patients with CNCP because of the probable selection of patients who benefit and who do not have intolerable adverse effects.

scholarly journals Hand Eczema: Quality of Life and Disease Severity in an Outpatient Portuguese Population

2018 ◽  
Vol 76 (2) ◽  
pp. 137-142
Author(s):  
Rui Pedro Santos ◽  
Laura Igreja ◽  
Cristina Resende ◽  
Teresa Pereira ◽  
Celeste Brito
Keyword(s):  
Quality Of Life ◽  
Disease Severity ◽  
Life Quality ◽  
Severity Index ◽  
Hand Eczema ◽  
Common Disease ◽  
Female Predominance ◽  
Duration Of Disease ◽  
A Prospective Study

Introduction: Hand eczema is a very common disease with a significant social and occupational impact.Objectives: To characterize a Portuguese outpatient population with hand eczema; to evaluate the impairment of the disease in quality of life (QoL); to relate the disease severity with QoL.Methods: The authors designed a prospective study. Information about atopy, psoriasis, occupational exposure and duration of disease, was recorded. The QoL was assessed by the DLQI questionnaire (Dermatology Life Quality Index) and the severity was assessed using the hand eczema severity index (HECSI). All participants were patch tested.Results: Eighty-five patients were included with a female predominance (78.8%). The median DLQI was 9.0. We found statistically significant differences in the variable HECSI between genders with greater impact in males. A significant positive correlation was found between HECSI and DLQI. DLQI and HECSI were independent of atopy, psoriasis or etiology. Increasing age significantly affects DLQI but not HECSI.Conclusions: Hand eczema has a significant impact in QoL. Although the disease is more prevalent among women it was found to be of greater severity among men. The QoL seems to be influenced by disease severity and increasing age but it was independent of the other studied variables.

Quality of life measurements in major depression

1996 ◽  
Vol 11 (3) ◽  
pp. 123-126 ◽  
Author(s):  
P Bech
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Major Depression ◽  
External Validity ◽  
Randomized Clinical Trials ◽  
Internal Validity ◽  
Efficacy And Safety ◽  
Quality Of Life Measurements

SummaryIn randomized clinical trials in patients with major depression quality of life is considered as an important dimension of treatment outcome in relation to clinical efficacy and safety. The internal validity, reliability, as well as external validity of quality of life scales have been analysed. It is concluded that such scales have their most appropriate applicability in medicine and long-term trials with antidepressants.

scholarly journals Long-Term Functional Outcome and Quality of Life After Restorative Proctocolectomy With Mucosectomy and Hand Suture IPAA: 20 Years' Experience in 326 Patients

2016 ◽  
Vol 101 (5-6) ◽  
pp. 202-211
Author(s):  
Christos Christou ◽  
Theofilos Rosenberg ◽  
Aristotelis Chatziioannou ◽  
Theodoros Emmanouil ◽  
Efthymios Ladoukakis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Outcome ◽  
Restorative Proctocolectomy ◽  
Anastomotic Stricture ◽  
Safe Procedure ◽  
Wexner Score ◽  
Anastomotic Strictures ◽  
Sf 36

This paper was designed to evaluate the functional outcome and assess the long-term quality of life (QoL) of patients who underwent restorative proctocolectomy with mucosectomy and hand suture ileal pouch-anal anastomosis (IPAA) over 20 years. Restorative proctocolectomy with IPAA is the surgical treatment of choice to all familial adenomatous polyposis (FAP) patients and those with ulcerative colitis (UC) not responding to conservative management. The procedure has been modified from a transanal hand-suture IPAA after mucosectomy to a stapled IPAA without mucosectomy, but the benefits are still debatable. We studied retrospectively all UC and FAP patients subjected to the procedure between 1987 and 2006, using the SF-36 Health Survey, the Wexner score for incontinence, and an additional questionnaire evaluating various aspects of functional outcome and late complications. A total of 326 patients (53% male) were included in the study. Pouchitis was recorded in 31% of UC and 5% of FAP patients. Anastomotic stricture was observed in 24% of UC and 8% of FAP patients. IPAA-related pouch failures occurred in 9% of UC and 3% of FAP. The median number of bowel movements per 24 hours was 6 (range: 2–20) with 1 (range: 0–8) bowel motion occurring at night. Wexner score was 3.27 (±0.32) for UC and 1.22 (±0.36) for FAP. The overall norm-based SF-36 score for physical/mental health status was 52.85/50.31 and 57.29/50.05 respectively. Restorative proctocolectomy with mucosectomy and hand suture IPAA is a safe procedure with good functional results and quality of life in well-satisfied patients. Pouchitis, anastomotic strictures, and pouch failures were mainly observed in the UC group.

scholarly journals Global open-label extension: 24-month data of patisiran in patients with hattr amyloidosis

2021 ◽  
Author(s):  
Wilson Marques Jr ◽  
David Adams ◽  
Alejandra González- Duarte ◽  
Elizabeth Mauricio ◽  
Thomas Brannagan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Progression ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Extension ◽  
Life Threatening

Introduction: Hereditary transthyretin-mediated (hATTR) amyloidosis is a progressive, life- threatening disease. The efficacy and safety of patisiran has been demonstrated in Phase 3 (APOLLO) and Phase 2 Open-Label Extension (OLE) studies in patients with hATTR amyloidosis with polyneuropathy. Objective: To describe interim 24-month efficacy and safety analyses of the ongoing Global OLE study. Methods: International OLE study (NCT02510261) in eligible patients who completed parent studies, including APOLLO patients randomized to placebo (APOLLO/placebo, n=49) or patisiran (APOLLO/patisiran, n=137) and Phase 2 OLE patients (n=25). Results: As of 10/07/2019, 178/211 patients had 24-month assessments. Safety profile remained consistent with previous studies. After 24 months of additional patisiran treatment in the OLE, durable improvement was seen for mNIS+7 (mean change [SEM]) in APOLLO/patisiran (-4.9 [2.1]) and Phase 2 OLE (-5.9 [2.1]) groups vs. parent study baselines. Norfolk QOL-DN continued to show durable improvement in APOLLO/patisiran patients (-2.4 [2.4]) following additional 24- months treatment. In the Global OLE, APOLLO/placebo patients experienced halting of disease progression and quality of life (QOL) improvement compared to Global OLE baseline after 24 months of patisiran (mNIS+7: +0.1 [3.3], Norfolk QOL-DN: -4.1 [3.3]), although they had progressed relative to APOLLO baseline (mNIS+7: +26.3 [5.0], Norfolk QOL-DN: +15.8 [4.5]) given progression while on placebo in APOLLO. Conclusion: Patients with long-term exposure to patisiran continue to demonstrate durability of efficacy. Despite marked progression on placebo during APOLLO, previously untreated patients continue to exhibit halting of disease progression and QOL improvement following 24 months of patisiran. Patisiran continues to demonstrate a positive benefit:risk profile.

Thinking Beyond Language: Intervention for Severe Aphasia

2009 ◽  
Vol 19 (1) ◽  
pp. 15-22 ◽  
Author(s):  
Nina Simmons-Mackie
Keyword(s):  
Quality Of Life ◽  
Communication Training ◽  
Language Intervention ◽  
Specific Training ◽  
Environmental Support ◽  
Total Communication ◽  
Communication Partners

Abstract Purpose: This article addresses several intervention approaches that aim to improve life for individuals with severe aphasia. Because severe aphasia significantly compromises language, often for the long term, recommended approaches focus on additional domains that affect quality of life. Treatments are discussed that involve increasing participation in personally relevant life situations, enhancing environmental support for communication and participation, and improving communicative confidence. Methods: Interventions that have been suggested in the aphasia literature as particularly appropriate for people with severe aphasia include training in total communication, training of communication partners, and activity specific training. Conclusion: Several intervention approaches can be implemented to enhance life with severe aphasia.

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