Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

BackgroundThe efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness.ObjectiveTo compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC.MethodBetween May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn’s and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1–3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years.ResultsThe 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) –0.0088 to 0.0682;p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI –0.032 to 0.096;p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI –0.0250 to 0.0353;p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188;p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493;p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546;p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917;p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114;p = 0.998); deaths (all three who died received infliximab;p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference –£5632, 95% CI –£8305 to –£2773;p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin.ConclusionsTotal cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1–3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin.Trial registrationCurrent Controlled Trials ISRCTN22663589.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.

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Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT

Health Technology Assessment ◽

10.3310/hta23530 ◽

2019 ◽

Vol 23 (53) ◽

pp. 1-108

Author(s):

Kevin Cooper ◽

Suzanne Breeman ◽

Neil W Scott ◽

Graham Scotland ◽

Rodolfo Hernández ◽

...

Keyword(s):

Cost Effectiveness ◽

Second Generation ◽

Clinical Effectiveness ◽

Health Technology ◽

Endometrial Ablation ◽

Total Hysterectomy ◽

Significant Difference ◽

Post Randomisation

Background Heavy menstrual bleeding (HMB) is a common problem that affects many British women. When initial medical treatment is unsuccessful, the National Institute for Health and Care Excellence recommends surgical options such as endometrial ablation (EA) or hysterectomy. Although clinically and economically more effective than EA, total hysterectomy necessitates a longer hospital stay and is associated with slower recovery and a higher risk of complications. Improvements in endoscopic equipment and training have made laparoscopic supracervical hysterectomy (LASH) accessible to most gynaecologists. This operation could preserve the advantages of total hysterectomy and reduce the risk of complications. Objectives To compare the clinical effectiveness and cost-effectiveness of LASH with second-generation EA in women with HMB. Design A parallel-group, multicentre, randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). Surgeons and participants were not blinded to the allocated procedure. Setting Thirty-one UK secondary and tertiary hospitals. Participants Women aged < 50 years with HMB. Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size > 11 cm; any fibroids > 3 cm; contraindications to laparoscopic surgery; previous EA; and inability to give informed consent or complete trial paperwork. Interventions LASH compared with second-generation EA. Main outcome measures Co-primary clinical outcome measures were (1) patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score at 15 months post randomisation. The primary economic outcome was incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained. Results A total of 330 participants were randomised to each group (total n = 660). Women randomised to LASH were more likely to be satisfied with their treatment than those randomised to EA (97.1% vs. 87.1%) [adjusted difference in proportions 0.10, 95% confidence interval (CI) 0.05 to 0.15; adjusted odds ratio (OR) from ordinal logistic regression (OLR) 2.53, 95% CI 1.83 to 3.48; p < 0.001]. Women randomised to LASH were also more likely to have the best possible MMAS score of 100 (68.7% vs. 54.5%) (adjusted difference in proportions 0.13, 95% CI 0.04 to 0.23; adjusted OR from OLR 1.87, 95% CI 1.31 to 2.67; p = 0.001). Serious adverse event rates were low and similar in both groups (4.5% vs. 3.6%). There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs. Based on an extrapolation of expected differences in cost and QALYs out to 10 years, LASH cost an additional £1362 for an average QALY gain of 0.11, equating to an incremental cost-effectiveness ratio of £12,314 per QALY. Probabilities of cost-effectiveness were 53%, 71% and 80% at cost-effectiveness thresholds of £13,000, £20,000 and £30,000 per QALY gained, respectively. Limitations Follow-up data beyond 15 months post randomisation are not available to inform cost-effectiveness. Conclusion LASH is superior to EA in terms of clinical effectiveness. EA is less costly in the short term, but expected higher retreatment rates mean that LASH could be considered cost-effective by 10 years post procedure. Future work Retreatment rates, satisfaction and quality-of-life scores at 10-year follow-up will help to inform long-term cost-effectiveness. TriaI registration Current Controlled Trials ISRCTN49013893. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 53. See the NIHR Journals Library website for further project information.

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A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial

Health Technology Assessment ◽

10.3310/hta19880 ◽

2015 ◽

Vol 19 (88) ◽

pp. 1-118 ◽

Cited By ~ 129

Author(s):

Janesh K Gupta ◽

Jane P Daniels ◽

Lee J Middleton ◽

Helen M Pattison ◽

Gail Prileszky ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Medical Treatment ◽

Standard Treatment ◽

Surgical Intervention ◽

Randomised Trial ◽

Clinical Effectiveness ◽

Health Technology ◽

Medical Treatments

BackgroundHeavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®, Bayer) compared with usual medical treatment, with exploration of women’s perspectives on treatment.DesignA pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study.SettingWomen who presented in primary care.ParticipantsA total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment.InterventionsLNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment.Outcome measuresThe primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost–utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses.ResultsThe MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points;p < 0.001]. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI –0.6 to 8.3 points;p = 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women’s experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments.ConclusionsThe LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women’s assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause.Trial registrationCurrent Controlled Trials ISRCTN86566246.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information

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Tiotropium (SPIRIVA®) in mild COPD: Is it worth it?

Dalhousie Medical Journal ◽

10.15273/dmj.vol46no1.9827 ◽

2019 ◽

Vol 46 (1) ◽

Author(s):

Lina Mahmoud ◽

Hannah Ng ◽

Jade Roberts

Keyword(s):

Quality Of Life ◽

Exercise Duration ◽

Cochrane Library ◽

Chronic Obstructive ◽

Serious Adverse Events ◽

Main Trial ◽

Copd Exacerbations ◽

Increased Risk ◽

Significant Difference

Purpose:Tiotropium (SPIRIVA®) is used in the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in patients with persistent dyspnea despite using a short acting bronchodilator (SABD).This paper explores the role of tiotropium in the treatment of mild COPD. Methods:The Cochrane Library, EMBASE, Pubmed, and Clinicaltrials.gov were searched on February 2018.We included randomized controlled trials (RCTs) that evaluated tiotropium in patients with mild COPD.Three authors assessed studies for eligibility. Outcomes included symptoms, quality of life, exercise duration, lung function, COPD exacerbations and hospitalizations, and serious adverse events. Results: Three RCTs were selected as the best available evidence. Based on the results of the main trial, quality of life and symptoms were improved with tiotropium as compared to placebo with a difference between groups at 24 months to be 1.2 (95% CI: 0.5 to 1.9; p=0.0011) using the COPD Assessment test (CAT) score. Frequency of acute exacerbations of COPD (AECOPD) requiring hospitalization was reduced by 10.3% (28.9% with tiotropium vs 39.2% with placebo) in patients receiving tiotropium. One RCT reported no statistically significant difference in exercise duration (27 ± 27 secs) in the tiotropium group vs 50 ± 21 secs in the placebo group; (p=0.4153). Oropharyngeal discomfort was more common with tiotropium (number needed to harm of 12) compared to placebo. Conclusions: Evidence suggests that tiotropium may reduce COPD exacerbations and hospitalizations and improve quality of life in patients with mild COPD.There is an increased risk of oropharyngeal discomfort with tiotropium.

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DOP24 Patient-reported health-related quality-of-life outcomes with vedolizumab vs. adalimumab treatment of ulcerative colitis: Results of the VARSITY trial

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.063 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S063-S063

Author(s):

E V Loftus ◽

S W Schreiber ◽

S Danese ◽

L Peyrin-Biroulet ◽

J F Colombel ◽

...

Keyword(s):

Quality Of Life ◽

Ulcerative Colitis ◽

Randomised Trial ◽

Double Blind ◽

Specific Domain ◽

Faecal Calprotectin ◽

Meaningful Improvement ◽

Treatment Difference ◽

Patient Reported

Abstract Background Patients with ulcerative colitis (UC) experience substantial impairment in quality of life (QOL). Patient QOL endpoints are important measures of treatment outcome. We evaluated the effects of intravenous vedolizumab vs. adalimumab on QOL in VARSITY, the first head-to-head trial comparing the efficacy and safety of biologics in patients with moderately to severely active UC. Methods VARSITY was a phase 3b, double-blind, double-dummy, randomised trial (NCT02497469; EudraCT 2015-000939-33). QOL was assessed using the inflammatory bowel disease questionnaire (IBDQ) at baseline, Week (Week) 30, and Week 52. Endpoints included clinically meaningful IBDQ improvement (defined as an increase in total score of ≥16 points from baseline to Week 52), IBDQ remission (defined as a total score of >170 points at Week 52) and change from baseline in IBDQ-specific domain scores (bowel symptoms, systemic symptoms, emotional function, and social function) at Week 30 and Week 52. Serum C-reactive protein (CRP) and faecal calprotectin (FCP) were also assessed as indicators of disease activity. Results Among randomised patients, 383 (vedolizumab) and 386 (adalimumab) patients received ≥1 dose of study drug (N=769). At Week 52, clinically meaningful IBDQ improvement was observed in 52.0% (vedolizumab) vs. 42.2% (adalimumab) of patients (treatment difference 9.7%; 95% confidence interval [CI], 2.7% to 16.7%), while IBDQ remission was achieved by 50.1% (vedolizumab) vs. 40.4% (adalimumab) of patients (treatment difference 9.6%; 95% CI, 2.8% to 16.5%). Mean (standard deviation [SD]) changes in IBDQ total score from baseline for observed cases favoured vedolizumab over adalimumab (Week 30: 61.3 [39.8] vs. 52.6 [42.8]; Week 52: 66.1 [41.8] vs. 60.4 [42.2]; Figure 1). IBDQ subscores showed similar favourable trends for vedolizumab (Figure 2). At Week 52, mean (SD) changes from baseline in CRP for patients treated with vedolizumab vs. adalimumab were –50.9 (174.8) nmol/l vs. –37.2 (169.2) nmol/l and for FCP were –2187.3 (7440.4) µg/g vs. –1846.6 (4560.6) µg/g (Figure 3). Among patients with FCP >250 µg/g at baseline, the proportion of patients achieving FCP ≤250 µg/g was 33.9% vs. 24.5% at Week 30 and 35.2% vs. 28.9% at Week 52 for patients treated with vedolizumab vs. adalimumab, respectively. Conclusion Based on IBDQ total score and subscores, more patients with UC treated with vedolizumab than with adalimumab achieved clinically meaningful improvement and clinical remission. Reduced inflammation, as indicated by improvements in CRP and FCP, was consistent with improvements in QOL.

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Patient views about the impact of ulcerative colitis and its management with drug treatment and surgery: a nested qualitative study within the CONSTRUCT trial

BMC Gastroenterology ◽

10.1186/s12876-019-1085-y ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Frances Rapport ◽

Clare Clement ◽

Anne C. Seagrove ◽

Laith Alrubaiy ◽

Hayley A. Hutchings ◽

...

Keyword(s):

Ulcerative Colitis ◽

Disease Duration ◽

Qualitative Interview ◽

Steroid Resistant ◽

Appropriate Treatment ◽

Qualitative Interview Study ◽

The Impact ◽

Trial Participants ◽

Prompt Diagnosis

Abstract Background A nested qualitative interview study within the CONSTRUCT trial was conducted to explore experiences and perceptions of patients with acute severe ulcerative colitis following treatment with infliximab or ciclosporin, surgery, or other medication. Methods Two hundred seventy patients with steroid-resistant ulcerative colitis were randomised to either infliximab or ciclosporin. Interviews were conducted with 20 trial participants. Thirty-five data capture events took place in total, 20 interviews conducted 3 months after treatment and a further 15 interviews with the same cohort as second interviews at 12 months. Results Disease duration varied but similar stories emerged about how people adjusted to living with ulcerative colitis. Issues raised by patients included; the debilitating effect of the disease on quality of life, living with the unpredictability of symptoms and treatment, dealing with embarrassment and stigma and the desire to share knowledge of the disease with others to combat the private nature of this debilitating illness and bring greater visibility to patient experience of symptoms and outcomes. Conclusion Patients were more positive about treatment with infliximab than ciclosporin, mainly due to the cumbersome intravenous regimen required for ciclosporin. Prompt diagnosis is required and early reporting of changes in symptoms is encouraged to ensure appropriate treatment. Trial registration This trial is registered with the ISRCTN registry; number ISRCTN22663589. The date of registration was 16/05/2008.

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Work Productivity Loss in Inflammatory Bowel Disease Patients in Turkey

Gastroenterology Research and Practice ◽

10.1155/2020/6979720 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Firdevs Topal ◽

Hakan Camyar ◽

Elif Saritas Yuksel ◽

Suleyman Gunay ◽

Fatih Topal ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Online Survey ◽

Productivity Loss ◽

Young Patients ◽

Significant Difference ◽

Inflammatory Bowel ◽

The Impact

Background. Beyond the medical treatment in inflammatory bowel disease (IBD), there are other issues which influence the quality of life adversely. The aim of this study was to determine the impact of the IBD patients’ illness on working and education life. Method. The participants were invited to participate in the online survey from the Turkish Crohn’s and Ulcerative Colitis Patient Association network. The data was analysed and then discussed to improve the health-related quality of working and education life. Results. One hundred and fifteen patients had ulcerative colitis (UC) (57.2%), and 86 had Crohn’s disease (CD) (42.8%). There was a statistically significant difference in UC between retirement age group 1 (<40 age) and groups 2 (40-49 ages) and 4 (60-65 ages) (p<0.05). There was the same significant difference in CD. Even though the data did not have significant statistical difference, there was clustering around negative perceptions the patients have about their working and education lives. Conclusion. Our survey revealed a very strong causative relationship between work and IBD involving problems before, during, and at the end of employment. Young patients lower their career expectations, and that announces a clear need to support them and improve career guidance.

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Efficacy of Oral Ginger (Zingiber officinale) for Dysmenorrhea: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2016/6295737 ◽

2016 ◽

Vol 2016 ◽

pp. 1-10 ◽

Cited By ~ 6

Author(s):

Chen X. Chen ◽

Bruce Barrett ◽

Kristine L. Kwekkeboom

Keyword(s):

Systematic Review ◽

Methodological Quality ◽

Weighted Mean Difference ◽

Meta Analysis ◽

Grey Literature ◽

Zingiber Officinale ◽

Mean Difference ◽

Significant Difference ◽

Meta Analyses

This systematic review examines the efficacy of oral ginger for dysmenorrhea. Key biomedical databases and grey literature were searched. We included randomized controlled trials comparing oral ginger against placebo or active treatment in women with dysmenorrhea. Six trials were identified. Two authors independently reviewed the articles, extracted data, and assessed risk of bias. Discrepancies were resolved by consensus with a third reviewer. We completed a narrative synthesis of all six studies and exploratory meta-analyses of three studies comparing ginger with placebo and two studies comparing ginger with a nonsteroidal anti-inflammatory drug (NSAID). Ginger appeared more effective for reducing pain severity than placebo. The weighted mean difference on a 10 cm visual analogue scale was 1.55 cm (favoring ginger) (95% CI 0.68 to 2.43). No significant difference was found between ginger and mefenamic acid (an NSAID). The standardized mean difference was 0 (95% CI −0.40 to 0.41). Available data suggest that oral ginger could be an effective treatment for menstrual pain in dysmenorrhea. Findings, however, need to be interpreted with caution because of the small number of studies, poor methodological quality of the studies, and high heterogeneity across trials. The review highlights the need for future trials with high methodological quality.

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Docetaxel HIPEC Combined with Endostar versus Docetaxel HIPEC Alone in Treatment of Malignant Ascites：A Retrospective Study

10.21203/rs.3.rs-306501/v1 ◽

2021 ◽

Author(s):

Jing Wu ◽

Hao Jiang ◽

Liting Chen ◽

Bingqi Yu ◽

Zhibing Wu

Keyword(s):

Qualitative Data ◽

Adverse Reactions ◽

Clinical Effect ◽

Objective Response ◽

Malignant Ascites ◽

Control Group ◽

Observation Group ◽

Improvement Rate ◽

Significant Difference

Abstract Objective：The purpose of this study is to retrospectively observe the clinical efficacy and adverse reactions of docetaxel hyperthermic intraperitoneal chemotherapy (HIPEC) combined with endostar in treatment of malignant ascites. Methods：56 cases of malignant ascites admitted to Zhejiang Hospital from July 2019 and October 2020 had received no less than second-line chemotherapy. The observation group (n = 29) was treated with endostar 60mg d1,4,7 Q3W intraperitoneal injection combined with docetaxel 60mg/m2 d4 HIPEC Q3W for 2 cycles. The control group (n = 27) was just treated with docetaxel 60mg/m2 d1 HIPEC Q3W for 2 cycles. The general clinical data and qualitative data of the treatment results were processed by SPSS26.0 using χ2 test, and quantitative data were processed by t test. When P < 0.05, statistical data can be considered statistically significant.Results：There were significant differences between the observation group and the control group in objective response rate (ORR) (65.5% vs 37.0%，P=0.033)，in the improvement rate of KPS (48.3% vs 22.2%, P=0.042)，also in the median control time (57dvs 45d，P=0.027). The incidence of III to IV adverse reactions was low, and no treatment-related death was observed. There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion：Endostar combined with docetaxel HIPEC has good clinical effect on malignant ascites and can improve patients’ quality of life, and the adverse reactions can be tolerated.

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The Effect of Combination Use of Hemodialysis and Hemoperfusion on Microinflammation in Elderly Patients with Maintenance Hemodialysis

Blood Purification ◽

10.1159/000518857 ◽

2022 ◽

pp. 1-8

Author(s):

Jun Li ◽

Hui Li ◽

Wenjiao Deng ◽

Lixin Meng ◽

Wenya Gong ◽

...

Keyword(s):

Quality Of Life ◽

Elderly Patients ◽

Adverse Reactions ◽

Statistical Significance ◽

Continuous Treatment ◽

Maintenance Hemodialysis ◽

Control Group ◽

Observation Group ◽

Significant Difference

Background: Patients with maintenance hemodialysis (MHD) generally have a microinflammatory state. The aim of this study was to investigate the effects of hemodialysis (HD) combined with hemoperfusion (HP) on microinflammatory state in elderly patients with MHD. Methods: One hundred and fifty elderly patients with MHD were randomly divided into the control group and the observation group. The control group received simple HD treatment, and the observation group received combined HD + HP treatment on the basis of the control group. After 6 months of continuous treatment, the patients were evaluated to compare the quality of life, inflammation, adverse reactions, and nutritional indicators in the 2 groups before and after treatment. Results: There was no significant difference in the quality of life between the 2 groups before treatment. After treatment, the scores of psychological aspects, physiological aspects, social aspects, environmental aspects, and independent ability in the observation group were higher than those in the control group, with statistical significance (p < 0.05). There was no statistical significance in the level of inflammation between 2 groups before treatment. After treatment, the levels of hs-CRP, Hcy, IL-6, and TNF-α in the observation group were significantly lower than those in the control group, with statistical significance (p < 0.05). The incidence of dry mouth, skin reaction, neuritis, and subcutaneous tissue fibrosis in the observation group was lower than that in the control group, with statistical significance (p < 0.05). There was no statistical significance in nutritional level indexes between 2 groups before treatment (p1 > 0.05). After treatment, the levels of hemoglobin, total protein, albumin, and transferrin in the observation group were significantly higher than those in the control group, with statistical significance (p < 0.05). Conclusion: The clinical effect of HD combined with HP in elderly MHD patients is significant, which can effectively reduce the incidence of adverse reactions and inflammation in the patients and improve the quality of life and nutritional indicators of the patients.

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RAPID ASSESSMENT OF BILATERAL COCHLEAR IMPLANTATION FOR CHILDREN IN KAZAKHSTAN

International Journal of Technology Assessment in Health Care ◽

10.1017/s026646231400049x ◽

2014 ◽

Vol 30 (4) ◽

pp. 361-365 ◽

Cited By ~ 2

Author(s):

Lyazzat Kosherbayeva ◽

David Hailey ◽

Laura Kozhageldiyeva

Keyword(s):

Cochlear Implantation ◽

English Language ◽

Rapid Assessment ◽

Clinical Effectiveness ◽

Health Technology ◽

Deaf Children ◽

Rehabilitation Period ◽

The Republic ◽

Impaired Children

Objectives:The aim of this study was to evaluate the effectiveness of bilateral cochlear implantation (CI) compared with unilateral CI for deaf children in the context of the Republic of Kazakhstan health system.Methods.A literature search was conducted, using the PubMed, Cochrane, and Embase data bases for studies that compared the effectiveness of bilateral and unilateral CI in children. The search included English language, publications from 2002–2012. Two reviewers independently evaluated all relevant studies. Administrative data relevant to CI in Kazakhstan were obtained from the Ministry of Health.Results: Three relevant systematic reviews and an health technology assessment report were found. There was evidence of incremental benefits from bilateral CI but the quality of the available studies was poor and there was little information on longer term outcomes. No conclusions could be drawn regarding later incremental improvements to speech perception, learning, and quality of life. To date, in the Republic of Kazakhstan there is not full coverage of audiological screening due to the lack of medical equipment. This leads to late detection of hearing-impaired children and a long rehabilitation period, requiring more resources. Age of implantation in children is late and only a small minority attend general schools.Conclusions:The clinical effectiveness of bilateral CI, an expensive health technology, requires further study. Given the current situation in Kazakhstan with audiological screening and access to unilateral CI, there appeared to be other priorities for improving services for children with profound hearing impairment.

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