首页 | 本学科首页   官方微博 | 高级检索  
相似文献
 共查询到20条相似文献,搜索用时 62 毫秒
1.

Background

Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR).

Methods

This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10–13).

Results

A total of 765 patients were randomly allocated to receive bilastine, fexofenadine, or placebo (256, 254, and 255 patients, respectively). The mean change in TNSS from baseline at Week 2 was significantly decreased by bilastine (?0.98) compared to placebo (?0.63, P = 0.023). Bilastine and fexofenadine showed no significant difference in the primary endpoint. However, the mean change in TNSS from baseline on Day 1 was more significantly decreased by bilastine (?0.99) than by placebo (?0.28, P < 0.001) or fexofenadine (?0.62, P = 0.032). The active drugs also improved instantaneous TNSS 1 h after the first and before the second drug administration on Day 1 (P < 0.05). The study drugs were well tolerated.

Conclusions

After 2-week treatment period, bilastine 20 mg once daily was effective and tolerable in Japanese patients with PAR, and exhibited a rapid onset of action.  相似文献   

2.

Background

The efficacy of epinastine 0.05% ophthalmic solution for pollen allergic conjunctivitis has already been shown in a conjunctival allergen challenge (CAC) test using cedar pollen as a challenge. The present study investigated the efficacy of this solution against birch pollen conjunctivitis in a CAC test.

Methods

Ten adult subjects (eight males and two females) with asymptomatic birch pollen conjunctivitis were enrolled in this study. The average age of the subjects was 41.1 years. This study was conducted during a period without birch pollen dispersion. In each subject, the epinastine 0.05% ophthalmic solution was instilled in one eye, and an artificial tear fluid was instilled in the fellow eye in a double-blind manner. Five minutes or 4 h after the drug instillation, both eyes were challenged with an optimal concentration of birch pollen, and ocular itching and conjunctival hyperemia were then graded. Tears were collected before the drug instillation and 20 min after the pollen challenge, and the histamine level was measured.

Results

The ocular itching scores and palpebral conjunctival hyperemia scores of the epinastine-treated eyes were significantly lower than those of the contralateral control eyes when the eyes were pretreated with the drug 4 h before the CAC. There was a significant correlation between the tear histamine level and mean ocular itching score of three time points (3, 5 and 10 min) following the CAC in the control eyes but not the epinastine-treated eyes.

Conclusions

Epinastine is effective in suppressing ocular itching and conjunctival hyperemia in birch pollen conjunctivitis.  相似文献   

3.

Background

Bilastine, a novel non-sedating second-generation H1-antihistamine, has been widely used in the treatment of allergic rhinoconjunctivitis and urticaria with a recommended dose of 20 mg once daily in most European countries since 2010. We evaluated its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU).

Methods

We conducted a multicenter, randomized, double-blind, placebo-controlled phase II/III study (trial registration No. JapicCTI-142574). Patients (age, 18–74 years) were randomly assigned to receive bilastine 20 mg, 10 mg or placebo once daily for 2 weeks. The primary efficacy endpoint was the change from baseline (Day ?3 to 0) in total symptom score (TSS) at 2 weeks (Day 8–14), consisting of the itch and rash scores.

Results

A total of 304 patients were randomly allocated to bilastine 20 mg (101 patients), bilastine 10 mg (100 patients), and placebo (103 patients). The changes in TSS at 2 weeks were significantly decreased by bilastine 20 mg than did placebo (p < 0.001), demonstrating the superiority of bilastine 20 mg. Bilastine 10 mg also showed a significant difference from placebo (p < 0.001). The TSS changes for the bilastine showed significant improvement from Day 1, and were maintained during the treatment period. The Dermatology Life Quality Index scores were also improved in bilastine than in placebo. The bilastine treatments were safe and well tolerated.

Conclusions

Two-week treatment with bilastine (20 or 10 mg) once daily was effective and tolerable in Japanese patients with CSU, demonstrating an early onset of action.  相似文献   

4.

Background

T-cell response outcome is determined by co-stimulatory/inhibitory signals. Programmed cell death-1 ligand-1 (PD-L1) is a member of these co-signaling molecules with known soluble form in human serum. Soluble PD-L1 (sPD-L1) is also recognized in patients with some types of malignancy or autoimmune disorders, though there are few studies on sPD-L1 roles in allergic diseases. The purpose of this survey was to evaluate the association between sPD-L1 levels with eosinophil count as well as disease severity in allergic rhinitis (AR) patients.

Methods

90 patients with AR were selected. Disease severity was determined by a modified Allergic Rhinitis and its Impact on Asthma (ARIA) classification as mild, moderate and severe. Whole blood samples were collected. Then eosinophil count and serum sPD-L1 were detected by a hematologic analyzer and a commercial ELISA kit.

Results

13 (14.44%), 31 (34.44%), and 46 (51.12%) of patients had mild, moderate and severe disease, respectively. The mean levels of sPD-L1 and eosinophil count were ascertained 18.38 ± 14.42 ng/ml and 422.43 ± 262.26 cell/μl. A significant inverse correlation was determined between sPD-L1 levels and eosinophil count (r = ?0.364, P < 0.001). Moreover, we detected a significant negative association between sPD-L1 levels and disease severity (r = ?0.384, P < 0.001).

Conclusions

It is deduced that sPD-L1 can be used as a helpful marker to determine the severity of AR. Furthermore, this study indicated that sPD-L1 may have an inhibitory role in AR development, and its modulation may be considered as a useful accessory therapeutic approach for reduction of AR progression.  相似文献   

5.

Background

Expanding patient selection beyond the Milan criteria in living donor liver transplantation (LDLT) for hepatocellular carcinoma (HCC) has long been a matter for debate. We have used the Kyushu University Criteria – maximum tumor diameter <5 cm or des-γ-carboxy prothrombin <300 mAU/ml – in LDLT for HCC since June 2007. The aim of the present study was to present the results of our prospective patient selection by Kyushu University Criteria and to confirm whether or not our criteria were justified.

Methods

The entire study period was divided into the pre-Kyushu era (July 1999–May 2007) and the Kyushu era (June 2007–November 2014). Eighty-nine and 90 patients underwent LDLT for HCC in the pre-Kyushu era and the Kyushu era, respectively.

Results

In the pre-Kyushu era, there were significant differences in recurrence-free and disease-specific survival between the beyond-Milan and the within-Milan patients. In the Kyushu era, however, the differences in recurrence-free and disease-specific survival between the beyond-Milan and the within-Milan patients disappeared. The 5-year overall patient survival in the Kyushu era was 89.4%.

Conclusion

Our selection criteria enabled a considerable number of beyond-Milan patients to undergo LDLT without jeopardizing the recurrence-free, and disease-specific, and overall patient survival.  相似文献   

6.

Background

Prophylactic drainage after liver resection remains a common practice amongst hepatic surgeons. However, there is little information about the optimal timing of drain removal.

Methods

From April 2008 to December 2012 (conventional group), the drains were removed based on the treating surgeon's view. From January 2013 to April 2016 (ERP group), the drains were removed on POD 3 if the bile concentration of the drain discharge was less than three times the serum bilirubin on POD 3, and the amount of drain discharge was <500 ml on POD 3. The postoperative outcomes of the two groups were compared using one-to-one propensity score-matching analysis.

Results

One hundred nine patients were extracted from ERP group (n = 226) and conventional group (n = 246). The time to drain removal was significantly shorter in the ERP group than in the conventional group (3 days vs. 5 days, P < 0.001). The frequency of delayed bile leakage or the appearance of symptomatic abdominal fluid collection after drain removal did not differ between the two groups (3% vs. 4%, P = 0.791).

Conclusion

Drain removal on POD 3 based on the volume and bile concentration is safe.  相似文献   

7.

Background

Margin status is the main surgical determinant of long-term outcome in pancreatic cancer. Intraoperative frozen section (IOFS) detects microscopic positive margins at a stage when margin revision is possible. The aim of this study was to determine if IOFS driven-revision of pancreatic resection margin(s) improves overall survival (OS) in pancreatic cancer.

Methods

A systematic review of major reference databases was undertaken. Patients were divided into 3 groups based on initial FS (FSR0 for negative margin and FSR1 for positive microscopic margin) and final Permanent Section report (PSR0 for negative margin and PSR1 for positive microscopic margin): Group 1 (FSR0 → PSR0), Group 2 (FSR1 → PSR0), and Group 3 (FSR1 → PSR1). Patients in Groups 2 and 3 had surgical revision of the FSR1 margin. Data was meta-analysed.

Results

4 studies included in the final analysis. No difference in OS and incidence of lymph node metastases between Groups 2 and 3 (P = 0.590 and P = 0.410).

Conclusions

IOFS-based revision of R1 pancreatic resection margin does not improve OS, even when it results in an R0 margin. This suggests that any benefit of margin revision based on FS is over-ridden by markers of more advanced or aggressive disease.  相似文献   

8.

Introduction

Resection of perihilar cholangiocarcinoma (PHC) entails high-risk surgery with postoperative mortality reported up to 18%, even in specialized centers. The aim of this study was to compare outcomes of PHC patients who underwent associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) to patients who underwent resection without ALPPS.

Methods

All patients who underwent ALPPS for PHC were identified from the international ALPPS registry and matched controls were selected from a standard resection cohort from two centers based on future remnant liver size. Outcomes included morbidity, mortality, and overall survival.

Results

ALPPS for PHC was associated with 48% (14/29) 90-day mortality. 90-day mortality was 13% in 257 patients who underwent major liver resection for PHC without ALPPS. The 29 ALPPS patients were matched to 29 patients resected without ALPPS, with similar future liver remnant volume (P = 0.480). Mortality in the matched control group was 24% (P = 0.100) and median OS was 27 months, comparted to 6 months after ALPPS (P = 0.064).

Discussion

Outcomes of ALPPS for PHC appear inferior compared to standard extended resections in high-risk patients. Therefore, portal vein embolization should remain the preferred method to increase future remnant liver volume in patients with PHC. ALPPS is not recommended for PHC.  相似文献   

9.

Background

Limited data are currently available to address the safety and efficacy of combined resection of the liver and inferior vena cava (IVC) for hepatic malignancies.

Methods

A systematic review was performed to identify relevant studies. Pooled individual data were examined for the clinical outcome of combined resection of the liver and IVC for hepatic malignancies.

Results

A total of 258 patients were described in 38 articles eligible for inclusion. Resections were performed for colorectal liver metastasis (CLM) [n = 128 (50%)], intrahepatic cholangiocarcinoma (ICC) [n = 51 (20%)], hepatocellular carcinoma (HCC) [n = 48 (19%)], and other pathologies [n = 31 (11%)]. There were 14 (5%) perioperative deaths. The median survival duration was 34 months, and the 1-, 3- and 5-year overall survival (OS) rate was 79%, 46% and 33%, respectively. The 5-year OS rate was 26% for CLM, 37% for ICC, and 30% for HCC.

Conclusion

Combined resection of the liver and IVC for hepatic malignancies is safe and applicable, and offers acceptable survival outcomes.  相似文献   

10.
11.

Background

The clinical relevance of fibrosis with regard to tumor progression is supported by the correlation between fibrosis and poor outcomes. Fecal elastase-1 (FE-1) level has been used to assess exocrine dysfunction of the pancreas and to predict pancreas fibrosis. The aim of this study was to assess the impact of FE-1 on the survival of pancreatic cancer patients.

Methods

Between January 2006 and December 2014, 136 patients with pancreatic adenocarcinoma underwent R0 resection at Gangnam Severance Hospital, Korea. Preoperative FE-1 levels were available in 94 patients who were enrolled in the study. Patients were classified into two groups according to preoperative FE-1: “normal” (≥200 μg/g) or “reduced” (<200 μg/g).

Results

Median preoperative FE-1 level was 130.1 μg/g (IQR 32.0; 238.3). 62 patients (66.0%) had reduced pancreatic function and 32 patients (34.0%) had normal pancreatic function. The two groups had significantly different disease-free survival (P < 0.001). On multivariate analysis, normal FE-1, no lymph node metastasis and completion of adjuvant chemotherapy were found to be independent prognostic factors for better DFS (P = 0.001, P = 0.017, P = 0.038, respectively).

Conclusion

FE-1 is a simple and non-invasive predictive clinical marker for prognosis of pancreatic cancer after attempted curative resection.  相似文献   

12.

Background

Although acute cholecystitis (AC) is a surgical disease, patients with the condition may be admitted to medical-related services (MS). This may lead to delayed cholecystectomy thereby affecting outcomes and quality of care.

Methods

Between July 2010 and March 2013, 329 patients under 70 years old presented to a community-based tertiary care hospital with AC and underwent same admission cholecystectomy. Outcomes were compared between patients admitted to MS and surgical services (SS).

Results

Two hundred fifteen patients (65.3%) were admitted to a MS. Patients under the MS had longer LOS (3.0 days vs. 2.0 days, p < 0.001), waiting time to surgical consultation (7.3 h vs. 5.0 h, p < 0.001) and to cholecystectomy (1.0, 0–2 days vs. 1.0, 0–1 day, p < 0.001), and increased hospital costs ($3685 vs. $4,688, p < 0.001) compared to the SS. Readmission and mortality rates were not significantly different between groups.

Conclusion

Patients under 70 years old with AC undergoing cholecystectomy admitted to MS had increased LOS, delay to the operation, and hospital costs compared to those admitted to a SS. Admission of patients with AC to a SS needs to be emphasized to reduce costs and improve quality of care.  相似文献   

13.

Background

Procedural conversion rates represent an important aspect of the feasibility of minimally invasive surgical (MIS) approaches. This study aimed to outline the rates and predictors of procedural completion/conversion for MIS hepatectomy and pancreatectomy.

Methods

All 2014 ACS-NSQIP laparoscopic and robotic hepatectomy and pancreatectomy procedures were identified and grouped into pure, open assist, or unplanned conversion to open. Risk adjusted multinomial logistic regression models were generated with completion (Pure) set as the primary outcome.

Results

1667 (laparoscopic = 1360, robotic = 307) resections were captured. After risk adjustment, robotic DP was associated with similar open assist (relative risk ratio ?1.9%, P = 0.602), but lower unplanned conversion (?8.2%, P = 0.004) and open assist + unplanned conversion (?10.1%, P = 0.015) compared to laparoscopic DP; while robotic PD was associated with lower open assist (?22.2%, P < 0.001), unplanned conversions (?15%, P = 0.006) and open assist + unplanned conversions (?37.2, P < 0.001) compared to laparoscopic PD. The robotic and laparoscopic approaches to hepatectomy were not associated with differences in pure MIS completion rates (P = NS) after risk adjustment.

Conclusions

The robotic approach to pancreatectomy was associated with higher rates of pure MIS completion compared to laparoscopy, whereas no difference in MIS completion rates was noted for robotic versus laparoscopic hepatectomy.  相似文献   

14.

Background

Transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT) remains controversial. This systematic review sought to examine the role of TACE in the treatment of HCC with PVT in either the main portal vein (MPV) or portal vein branches (PVB).

Methods

PubMed was searched for “hepatocellular carcinoma” and “transarterial chemoembolization” from January 1, 2006 to August 31, 2016. Cohorts treated with TACE for HCC with PVT were included. Meta-analysis of overall survival (OS), mRECIST response, and complication incidence was performed. MPV and PVB subgroups were compared.

Results

Of 136 search results, 13 studies with 1933 TACE patients were included. Median OS (95% CI) was eight (5–15) months. Survival rates after one, three, and five years were 29% (20%–40%), 4% (1%–11%), and 1% (0%–5%), respectively. Only 1% experienced liver failure and 18% had post-treatment complications. Patients with MPV thrombosis had worse survival than PVB patients (p < 0.001), but similar mRECIST response rates (14% vs. 16%, p = 0.238).

Conclusion

TACE is a safe treatment for a highly selected population of HCC patients with PVT. Despite worse survival rates compared to PVB thrombosis, PVT in the MPV should not be considered an absolute contraindication to TACE.  相似文献   

15.

Background

Conditional survival is the life expectancy from a point in time for a patient who has survived a specific period after presentation.The aim of the study was to estimate conditional survival for patients with unresectable perihilar cholangiocarcinoma.

Methods

Patients with unresectable perihilar cholangiocarcinoma from two academic hospitals in the Netherlands between 2002 and 2012 were assessed. A multivariable Cox proportional hazards analysis was performed to identify risk factors associated with overall survival. Survival was estimated using the Kaplan–Meier method to evaluate factors associated with overall survival.

Results

In total, 572 patients were included. Overall survival was 42% at one year and 6% at three years. The conditional chance of surviving three years was 15% at 1 year and increased to 38% at 2 years. Independent poor prognostic factors for overall survival were age ≥65 years, tumor size >3 cm on imaging, bilirubin levels (>250 μmol/L), CA19-9 level at presentation (>1000 U/ml), and suspected distant metastases on imaging. The conditional survival of patients with and without these prognostic factors was comparable after patients survived the first two or more years.

Conclusion

The conditional chance of surviving for patients with unresectable perihilar cholangiocarcinoma increases with time. Poor prognostic factors become less relevant once patients have survived two years.  相似文献   

16.

Background

Recurrence of colorectal liver metastases after a first hepatectomy is common (4–48% of patients). This review investigates the utility of repeated hepatic resection of colorectal liver metastases.

Methods

A systematic search of the literature was performed in the Cochrane Library, MEDLINE, EMBASE, and trial registers. All studies comparing repeated hepatic resection for colorectal liver metastases with patients who underwent only one hepatectomy were eligible. Outcome criteria were safety parameters and survival rates. Data were analyzed using the random-effects model.

Results

In eight observational clinical studies, 450 patients with repeated hepatic resection were compared with 2669 single hepatic resections. Morbidity such as hepatic insufficiency (OR [95% CI] 1.46 [0.69; 3.08], p = 0.32) and biliary leakage and fistula (OR [95% CI] 1.22 [0.80; 1.85], p = 0.35) was comparable between the two groups. Mortality (OR [95% CI] 1.13 [0.46; 2.74], p = 0.79) and overall survival (HR [95% CI] 1.00 [0.63; 1.60], p = 0.99) were not significantly different between the two groups.

Discussion

Repeated hepatic resection for colorectal liver metastases is safe in selected patients. A prospective, multicenter high-quality trial or register study of repeated hepatic resection will be required to clarify patient-oriented outcomes such as overall survival and quality of life.  相似文献   

17.

Background

Both fistula risk score (FRS) and drain amylase in postoperative day 1 (POD1DA) have been promoted as tools to guide placement and removal of surgical drains following pancreaticoduodenectomy (PD). However, their individual utility has not been compared.

Methods

A consecutive cohort of PD patients from 2013 to 2015 were identified from a prospectively collected institutional database. Pearson correlation coefficients and receiver operating characteristic (ROC) curves were calculated for FRS (negligible/low vs. moderate/high) and POD1DA of 600 U/L and 5000 U/L as predictors of clinically relevant postoperative pancreatic fistula (CR-POPF).

Results

The incidence of CR-POPF was 27% in 216 patients. Sensitivity and specificity of FRS, POD1DA >600 U/L, and POD1DA >5000 U/L for predicting CR-POPF were 83% and 55%, 94% and 60%, 33% and 90%. The ROC area under the curve (AUC) for POD1DA >600 U/L (0.764) and FRS (0.749) were not significantly different (p = 0.713). However, POD1DA >5000 U/L (0.615) was significantly worse at predicting CR-POPF (p = 0.015). When FRS and POD1DA >600 U/L were combined; there was no improvement (p = 0.624).

Discussion

FRS and POD1DA are equally accurate in predicting CR-POPF. Patients with negligible/low FRS or POD1DA <600 U/L should be considered for drain removal.  相似文献   

18.

Background

Laparoscopic common bile duct exploration (LCBDE) during laparoscopic cholecystectomy (LC) is as effective as two-stage endo-laparoscopic treatment, but with shorter hospital stay, lower cost and recurrent stone rate. Aim of this paper was to report the authors’ experience with LCBDE during LC.

Methods

A retrospective analysis of patients who underwent LCBDE for ductal stones was performed. Recurrent stones were defined as CBD stones detected beyond 6 months from the procedure. Postoperative biliary stricture was defined as a symptomatic reduction of CBD diameter.

Results

Out of 3444 patients who underwent LC, 384 (11%) had CBD stones treated by trans-cystic duct exploration [214 (6%) patients, TCD-CBDE] or choledochotomy [170 (5%) patients, C-CBDE]. For TCD-CBDE and C-CBDE, mean operative time was 127 ± 69 and 191 ± 74 min, respectively. Major morbidity rate was 3% (n = 6) in TCD-CBDE and 6% (n = 11) in C-CBDE. The incidence of residual stones was 5% (n = 20) and complete ductal clearance rate was 95% (n = 364). After long-term follow-up (mean 189 ± 105 months) the recurrent stone rate was 2%.

Discussion

In expert centers, LCBDE during LC is safe and effective with low short and long term morbidity rates.  相似文献   

19.

Background

Outcomes following the inability to control the cystic duct due to a hostile triangle of Calot during cholecystectomy remain unknown. The purpose of this study was to analyze the safety and efficacy of subtotal cholecystectomy, with attention to the necessity for secondary interventions.

Methods

Sixteen thousand five hundred ninety six cholecystectomies from January 2002 to August 2014 were reviewed, identifying patients managed with subtotal cholecystectomy, defined as the inability to isolate/transect the cystic duct. After propensity matching, we investigated surgical indications, perioperative outcomes, and the necessity for secondary ERCP, percutaneous drainage, and completion cholecystectomy.

Results

65 (0.39%) patients underwent subtotal cholecystectomy; 54 (83.1%) began laparoscopically, of which 30 (55.6%) required conversion to laparotomy. Subtotal cholecystectomy, performed more frequently for acute cholecystitis (70.8% vs 34.6%), was associated with extended hospitalizations (4 d vs 2 d) and frequent surgical site infections (20% vs 4.6%). 25 (38.5%) subtotal cholecystectomy patients required ≥1 secondary intervention, and compared to standard cholecystectomy, underwent higher rates postoperative ERCP (30.8% vs 5.4%), percutaneous drainage (9.2% vs 1.5%), and completion cholecystectomy (6.2% vs 0%) [all P < 0.05].

Discussion

Subtotal cholecystectomy fails to control the cystic duct, resulting in significant morbidity. Most do not require completion cholecystectomy; however, patients demand close observation and, frequently, secondary interventions.  相似文献   

20.

Background

Fistula Risk Score (FRS) is a previously developed tool to assess the risk of clinically relevant postoperative pancreatic fistula (CR-POPF) following pancreatoduodenectomy (PD).

Methods

Prospectively collected databases from 4 university affiliated and non-affiliated HPB centers in United States and Canada were used. The influence of individual baseline characteristics, FRS and FRS group on CR-POPF was assessed in univariate and multivariate analyses. FRS calculator performance was assessed using a C-statistic.

Results

444 patients were identified. Pathology, soft pancreas texture and pancreatic duct size were associated with CR-POPF rates (p < 0.001 for each); EBL was not (p = 0.067). The negligible risk group consisted of 50 (11.3%) patients, low risk of 118 (26.6%), moderate 234 (52.7%) and high risk group of 42 (9.5%) patients. The overall rate of CR-POPF was 20%. Of the patients in the negligible risk group, 2% developed CR-POPF, 13.6% of the low risk, 23.1% moderate and 42.9% in the high risk group (p < 0.001). Overall C-statistic was 0.719.

Conclusion

FRS is robust and able to stratify the risk of developing CR-POPF following PD in diverse North American academic and non-academic institutions. The FRS should be used in research and to guide clinical management of patients post PD in these institutions.  相似文献   

设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号