AIM: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS). METHODS: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources. RESULTS: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses. CONCLUSIONS: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.
- MeSH
- analýza nákladové efektivity MeSH
- analýza nákladů a výnosů MeSH
- fingolimod hydrochlorid terapeutické užití MeSH
- imunosupresiva terapeutické užití MeSH
- lidé MeSH
- natalizumab terapeutické užití MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- roztroušená skleróza * farmakoterapie MeSH
- státní lékařství MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Spojené království MeSH
AIM: Foreshortened mesentery or thick abdominal wall constitutes a rationale for laparoscopic intracorporeal ileocolic anastomoses (ICA). The aim of this study was to compare intracorporeal to extracorporeal ICA in terms of surgical site infections in patients with Crohn's ileitis and overweight patients with right colon tumors. METHOD: This was a prospective propensity score-matched cohort study enrolling consecutive patients with Crohn's terminal ileitis and overweight patients with right colon tumors undergoing elective laparoscopic right colon resection with intracorporeal or extracorporeal ICA. Propensity score matching with a 1:1 ratio was employed to compare diagnosis-matched patients for age, BMI, ASA, and previous abdominal surgery. RESULTS: Overall, 453 patients were enrolled: 233 intracorporeal vs. 220 extracorporeal. Propensity score matching left 195 intracorporeal and 195 extracorporeal patients comparable for age (p = 0.294), gender (p = 0.683), ASA (p = 0.545), BMI (p = 0.079), previous abdominal surgery (p = 0.348), and diagnosis (p = 0.301). Conversion rates (5.1 vs. 3.6%; p = 0.457) and intraoperative complications (1 vs. 2.1%; p = 0.45) were similar. Overall morbidity (5.1 vs. 12.8%; p = 0.008) and re-intervention rates (3.1 vs. 8.7%; p = 0.029) were significantly higher in extracorporeal patients. Anastomotic leak rates (0.5 vs. 1.5%; p = 0.623) did not differ. Incisional SSI rate was significantly higher in extracorporeal patients (p = 0.01). CONCLUSION: Laparoscopic intracorporeal ICA reduced incisional SSI rates as compared to its extracorporeal counterpart.
- MeSH
- anastomóza chirurgická škodlivé účinky MeSH
- ileum chirurgie MeSH
- infekce chirurgické rány epidemiologie prevence a kontrola MeSH
- kohortové studie MeSH
- kolon chirurgie MeSH
- laparoskopie * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- perioperační péče MeSH
- pooperační komplikace etiologie MeSH
- tendenční skóre * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
Časné pooperační komplikace hojení anastomózy představují pro pacienta významné riziko zvýšení morbidity, mortality i zhoršení dlouhodobých výsledků. Existuje řada opatření redukujících rizika vzniku těchto komplikací včetně peroperačního hodnocení kvality kolorektální anastomózy. Postupy hodnocení spolehlivosti anastomózy se vyvíjely od mechanického testování přes endoskopickou vizualizaci střevního lumen až po moderní techniky hodnotící mikroperfuzi perianastomotických tkání. Mechanické testování kolorektální anastomózy a částečně i endoskopické techniky prokazatelně do jisté míry redukují riziko pooperačních komplikací hojení kolorektální anastomózy. Moderní postupy hodnotící mikrocirkulaci, založené na fluorescenční angiografii pomocí indocyaninové zeleně, mají potenciál zásadně zlepšit posouzení bezpečnosti kolorektální anastomózy a významně přispět k rozhodnutí o dalším postupu včetně vynechání protektivní ileostomie.
Early postoperative anastomotic complications have serious clinical implications for the patient's morbidity, mortality as well as long-term results. A number of measures can be undertaken to reduce the risk of anastomotic complications, including intraoperative colorectal anastomotic integrity assessment. Methods used to assess anastomotic reliability have gradually developed from basic mechanical techniques, direct visual endoluminal inspection, to microperfusion assessment of perianastomotic tissue. Moderate benefit in terms of reduced postoperative anastomotic complications has been shown with mechanical patency testing and partly with intraoperative endoscopic visualization of colorectal anastomoses. More recently, indocyanine green (ICG) fluorescence imaging methods have emerged as major contributions to anastomotic patency assessment and intraoperative decision making during surgical colorectal procedures including decreased numbers of ileostomies.
- MeSH
- anastomóza chirurgická * metody využití MeSH
- blízká infračervená spektroskopie metody využití MeSH
- fluoresceinová angiografie * metody využití MeSH
- hojení ran MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- peroperační péče * metody využití MeSH
- pooperační komplikace prevence a kontrola MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
BACKGROUND AND OBJECTIVE: We explored which clinical and biochemical variables predict conversion from clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (CDMS) in a large international cohort. METHODS: Thirty-three centres provided serum samples from 1047 CIS cases with at least two years' follow-up. Age, sex, clinical presentation, T2-hyperintense lesions, cerebrospinal fluid (CSF) oligoclonal bands (OCBs), CSF IgG index, CSF cell count, serum 25-hydroxyvitamin D3 (25-OH-D), cotinine and IgG titres against Epstein-Barr nuclear antigen 1 (EBNA-1) and cytomegalovirus were tested for association with risk of CDMS. RESULTS: At median follow-up of 4.31 years, 623 CIS cases converted to CDMS. Predictors of conversion in multivariable analyses were OCB (HR = 2.18, 95% CI = 1.71-2.77, p < 0.001), number of T2 lesions (two to nine lesions vs 0/1 lesions: HR = 1.97, 95% CI = 1.52-2.55, p < 0.001; >9 lesions vs 0/1 lesions: HR = 2.74, 95% CI = 2.04-3.68, p < 0.001) and age at CIS (HR per year inversely increase = 0.98, 95% CI = 0.98-0.99, p < 0.001). Lower 25-OH-D levels were associated with CDMS in univariable analysis, but this was attenuated in the multivariable model. OCB positivity was associated with higher EBNA-1 IgG titres. CONCLUSIONS: We validated MRI lesion load, OCB and age at CIS as the strongest independent predictors of conversion to CDMS in this multicentre setting. A role for vitamin D is suggested but requires further investigation.
- MeSH
- analýza přežití MeSH
- dospělí MeSH
- hodnocení rizik MeSH
- imunoglobulin G analýza MeSH
- jaderné proteiny analýza MeSH
- kohortové studie MeSH
- lidé MeSH
- magnetická rezonanční tomografie MeSH
- následné studie MeSH
- oligoklonální proužky genetika MeSH
- prediktivní hodnota testů MeSH
- prognóza MeSH
- progrese nemoci MeSH
- roztroušená skleróza patologie MeSH
- vitamin D krev MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH