Assessment of systemic inflammatory response markers in workers exposed to Pb from Pb battery plant

Abstract

The aim of present study was to assess the systemic inflammatory response markers (SIR) in male lead-exposed workers with the contemplation of lifestyle factors. The SIR markers and blood lead levels (BLLs) were assessed in two groups of Pb-exposed workers. The first group consists of 250 workers with their BLLs is ≤32 µg/dl and consider them as low-exposure. The second group consists of 229 workers with their BLL is >32 µg/dl and consider them as high exposure. White blood cell count (p?=?.05), neutrophils (p?=?.03) and systemic immune-inflammatory index (SII) (p?=?.03) parameters were significantly increased in high-exposure group. A significant correlation was noted between BLLs and C-reactive protein (CRP) and CRP/albumin ratio in the high-exposure group. The results of linear regression analysis presented that the CRP, CRP/albumin ratio, white blood cell count, neutrophils, lymphocyte, prognostic index and Glasgow prognostic score were positively associated with body mass index (BMI). The extent of alcohol consumption presented the negative association with lymphocyte and positive association with the platelet-lymphocyte ratio (PLR). The experience presented a negative association with prognostic nutritional index. The smoking habit was presented the positive association with lymphocyte and negative association with the platelet-lymphocyte ratio. The results of the study indicated that the Pb-exposure and lifestyle factors significantly influenced the systemic inflammatory response markers.     

Titanium cages versus autogenous iliac crest bone grafts in anterior cervical discectomy and fusion treatment of patients with cervical degenerative diseases: a systematic review and meta-analysis

Objective: A systematic review and partial meta-analysis is conducted to compare the efficacy and safety of anterior cervical decompression and fusion procedures employing either rectangular titanium cages or iliac crest autografts in patients suffering from cervical degenerative disc diseases.

Methods: Medline, PubMed, CENTRAL, and Google Scholar databases were searched up to June 2015, using the key words cervical discectomy; bone transplantation; titanium cages; and iliac crest autografts. Outcomes of interbody fusion rates were compared using odds ratios (ORs) with 95% confidence intervals (CIs). Values of the Japanese Orthopaedic Association score, and visual analog scale before and after operation were also compared.

Results: The rate of interbody fusion was similar between patients in the iliac crest autograft and titanium cage groups (pooled OR?=?0.33, 95% CI?=?0.07 to 1.66, P?=?.178). The overall analysis showed that patients in the two groups did not have significantly different post-surgery Japanese Orthopaedic Association score (pooled difference in means?=??0.05, 95% CI?=?0.73 to 0.63, P?=?.876). Improvement in arm and neck pain scores were assessed with a visual analog scale and differed significantly between patients in the iliac crest autograft and titanium cage groups (pooled difference in means?=?0.16, 95% CI?=??0.44 to 0.76, P?=?.610; and pooled difference in means?=??0.44, 95% CI?=??2.23 to 1.36, P?=?.634, respectively).

Conclusions: Our results suggest that the use of titanium cages constitutes a safe and efficient alternative to iliac crest bone autografts for anterior cervical discectomy with fusion.     

Severe acute respiratory infection surveillance in Montenegro, 2014−2017

Aim: The study aim was to analyze the epidemiology and clinical characteristics of severe acute respiratory infection (SARI) cases and to compare demographic and clinical characteristics as well as outcomes of influenza-positive SARI cases to those of influenza-negative SARI cases in Montenegro.

Methods: SARI surveillance was established in 2014 in nine healthcare institutions. Retrospective analysis of case-based surveillance data pertaining to all reported SARI cases during three seasons was conducted.

Results: Among the 90 identified SARI cases, 64 (71%) were influenza positive. Death outcome was reported in 25 (28%) of all registered SARI cases. Cardiovascular disease was more prevalent among the patients in the influenza-positive SARI group (36% vs. 12%, p?=?.021), as was concurrence of two or more chronic medical conditions (57% vs. 30%, p?=?.042). These patients were also more likely to be immunocompromised (16% vs. 0%, p?=?.057) and have viral pneumonia (14.4% vs. 20.3%, p?=?.017), compared to those in the influenza-negative SARI group. Younger age, presence of cardiovascular disease and being immunocompromised were patient characteristics independently associated with SARI related to influenza.

Conclusion: Continued and extended monitoring of SARI is necessary in order to fully assess the burden of flu disease, define risk groups and establish better control measures.     

Occurrence of composite cardiac endpoints with change in resting heart rate among Chinese patients with coronary artery disease: Chinese cohort from the real-world BISO-CAD study

Objective: We evaluated change in resting heart rate (RHR) and its impact on prognosis in Chinese coronary artery disease (CAD) patients treated with bisoprolol, and also assessed drug safety and tolerability.

Methods: This phase IV, single arm observational study was a sub-study of the BISO-CAD study conducted across 20 hospitals in China between October 2011 and July 2015 with follow-up at 6, 12 and 18 months after baseline. The primary endpoint was occurrence of composite cardiac events.

Results: A total of 663 CAD patients (baseline RHR 75.47?±?6.62 bpm) were enrolled in the intent-to-treat (ITT) set, and 513 patients were included in the efficacy analysis (EA) set. In the ITT set, the risk and the number of composite cardiac events in patients with mean RHR 69–74 bpm were significantly higher than in the <65 bpm group (ITT: estimate 1.03?±?0.47, p?=?.029). The incidence of the composite cardiac endpoint was not affected by continuous mean RHR (p?=?.5070). RHR significantly decreased from baseline to 18 months, most obviously in the first 6 months (p?<?.0001). Ejection fraction and fractional shortening significantly improved in both the ITT and EA sets. An average RHR of 69–74 bpm had a significant effect on admission to hospital for acute coronary syndrome in the ITT (estimate 1.10, HR 3.004, p?=?.0196) and EA (estimate 1.26, HR 3.526, p?=?.0132) groups. Seven (1.1%) patients reported drug related adverse events.

Conclusion: Reduction in RHR with bisoprolol lowered the incidence of composite cardiac events along with an acceptable safety and tolerability profile.     

Erlotinib-based targeted dual agent versus erlotinib alone in previously treated advanced non-small-cell lung cancer: a meta-analysis of 13 randomized controlled trials

Objectives: To compare the effects of an erlotinib-based targeted dual agent with erlotinib alone in previously treated patients with advanced non-small lung cancer (NSCLC).

Patients and methods: The PubMed and Embase databases and the Cochrane Central Register of Controlled Trials were searched for publications between January 2005 and March 2016. Hazard ratios (HRs) with their 95% confidence intervals (CIs), or data for calculating HRs with 95% CIs were derived. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and toxicity were assessed.

Results: Thirteen trials with a total of 4509 patients were included in this meta-analysis. Compared with erlotinib alone, combination therapy showed no improvement in OS (HR?=?0.95; 95% CI, 0.89–1.02; P?=?.132) though significantly prolonged PFS (HR?=?0.82; 95% CI, 0.75–0.90; P?<?.001). Combination therapy significantly increased ORR (RR?=?1.32; 95% CI, 1.09–1.60; P?=?.005) and DCR (RR?=?1.26; 95% CI, 1.17–1.36, P?<?.001). Sub-analysis assessment failed to identify any sub-groups which could benefit from combination therapy in terms of OS. Combination therapy was associated with more grade 3 or higher toxic effects (RR?=?1.54; 95% CI, 1.22–1.95; P?<?.001). Patients treated with combination therapy had more grade 3 or greater fatigue (RR?=?1.49; 95% CI, 1.16–1.91; P?=?.002), but did not develop more diarrhea (RR?=?2.02; 95% CI, 0.86–4.77; P?=?.107) or rash (RR?=?1.29, 95% CI, 0.90–1.85; P?=?.172). This study had limitations about heterogeneities among the included trials, and the analysis was not based on individual patient data.

Conclusions: Compared with erlotinib alone, the erlotinib-based targeted dual agent showed a minimal magnitude of improvement in PFS but did not improve OS. The role of erlotinib-based combinations in previously treated patients with NSCLC seemed insignificant.     

Drug-delivering endovascular treatment versus angioplasty in artery occlusion diseases: a systematic review and meta-analysis

Objective: The best management of patients with femoropopliteal and infrapopliteal artery occlusion disease is not clear. This study aimed to compare the efficacy of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal or infrapopliteal arterial occlusive disease.

Methods: Medline, Cochrane, Embase, and Google Scholar databases were searched for randomized controlled trials from 1 January 2000 until 30 June 2016.

Results: Compared with PTA, significant benefits in favor of DCB and DES were found for target lesion revascularization (TLR) (OR?=?0.38, 95% CI?=?0.22 to 0.66, p?=?.001 for DCB; OR?=?0.51, 95% CI?=?0.32 to 0.81, p?p?=?.001) and DES (p?p?=?.039) but not in the DES group. Subgroup analysis found a lower rate of TLR and a higher rate of primary patency in the active group (DCB and DES) compared with the control group (PTA) in patients with femoropopliteal arterial occlusion (p?≤?.016) but not in patients with infrapopliteal arterial occlusion (p?≥?.063). Mortality was similar between active replacement and control groups both in the femoropopliteal arterial occlusion and the infrapopliteal arterial occlusion subgroups (all p?>?.05).

Conclusions: Significantly better TLR and primary patency rate were found in the drug-delivering endovascular treatments compared with the PTA group for patients with femoropopliteal arterial occlusion but not for patients with infrapopliteal arterial occlusion.     

Sex differences in the relationships between childhood adversity,attachment anxiety and current smoking

Background: Smoking behavior and smoking cessation are complex. Interpersonal factors such as childhood adversity are associated with smoking, especially in women. Identifying how and in whom these individual factors contribute to smoking behavior may support individualized smoking cessation strategies. Attachment insecurity (attachment avoidance and attachment anxiety) involves biological and psychological processes in close relationships and is associated with both childhood adversity, and in select populations, smoking. This study aims to identify an association between attachment insecurity and smoking in adults and to determine if attachment insecurity is a plausible mediator between childhood adversity and smoking.

Methods: In a cross-sectional survey, 348 primary care patients reported childhood adversity, attachment insecurity and smoking status. Statistical analyses were performed using regression and PRODCLIN.

Results: Sixty-one percent of participants had experienced childhood adversity and 20% were current smokers. In women, attachment anxiety was associated with both childhood adversity (p?=?.002) and current smoking (p?=?.04). The PRODCLIN test indicated that attachment anxiety may be a mediator between childhood adversity and current smoking in women (95%CI 0.003, 0.236). In men, current smoking was not associated with childhood adversity (p?=?.673) or attachment anxiety (p?=?.29). Attachment avoidance was not related to current smoking in men (p?=?.31) or in women (p?=?.16).

Conclusions: In women but not in men, attachment anxiety is associated with current smoking and may mediate the relationship between childhood adversity and current smoking. Childhood adversity and attachment anxiety may be factors to consider in the design of cessation strategies for women.     

ROI-C置入术和椎间融合器联合前路钛板术治疗多节段脊髓型颈椎病的疗效对比

目的 对比新型前路颈椎桥型锁定融合器（ROI-C）置入术和椎间融合器联合前路钛板术治疗多节段脊髓型颈椎病（MCSM）的临床疗效。方法 回顾性分析2014年7月至2019年1月河南大学第一附属医院骨科住院治疗的76例MCSM患者的临床资料,均行颈椎前路椎间盘切除减压、植骨融合内固定手术治疗,根据术中固定方式不同分为ROI-C组（35例,ROI-C置入固定）和对照组（41例,椎间融合器联合前路钛板固定）。记录两组患者手术时间、术中透视次数、失血量、术后并发症发生率等手术指标,术后1周、3个月、6个月以日本整形外科及骨科学会（JOA）评分、视觉模拟疼痛（VAS）评分评估手术效果。结果 与对照组相比,ROI-C组手术时间较短,术中透视次数和失血量较少,差异有统计学意义（P<0.05）;两组患者术后住院时间及感染、血肿、神经损伤、食管损伤发生率比较,差异均无统计学意义（P>0.05）,ROI-C组吞咽不适发生率2.86%低于对照组的19.51%,差异有统计学意义（P<0.05）。两组患者术后1周、3个月、6个月JOA评分随着时间改变依次升高,VAS评分依次降低,差异均有统计学意义（P<0.05）;术后3个月、6个月颈椎生理曲度、椎间隙高度均较术前升高,差异有统计学意义（P>0.05）;但两组患者术前、术后不同时间点JOA评分、VAS评分及颈椎生理曲度、椎间隙高度比较,差异均无统计学意义（P>0.05）。结论 ROI-C置入术、椎间融合器联合前路钛板术治疗MCSM均可取得满意疗效,有助于恢复颈椎生理弧度与椎间隙高度,但前者具有操作简便、手术时间短、术中透视次数和出血量少、术后吞咽不适发生率低等优点,可优先选择。     

Local infiltration for postsurgical analgesia following total hip arthroplasty: a comparison of liposomal bupivacaine to traditional bupivacaine

Objective: To assess postsurgical clinical and economic outcomes of patients who received local infiltration containing liposomal bupivacaine versus traditional bupivacaine for pain management following total hip arthroplasty (THA).

Methods: This retrospective study included two groups of consecutive patients undergoing THA. The experimental group received local infiltration with a combination of liposomal bupivacaine, bupivacaine HCl 0.25% with epinephrine 1:200,000, and ketorolac for postsurgical analgesia. The historical control group received the previous standard of care: local infiltration with a combination of bupivacaine HCl 0.25% with epinephrine 1:200,000 and ketorolac. Key outcomes included distance walked, length of stay (LOS), opioid medication use, numeric pain scores, hospital charges, hospital costs, all-cause 30?day readmission rate, and adverse events (AEs). Both unadjusted and adjusted (i.e. age, sex, insurance type, living situation, body mass index, procedure side, and comorbidity) outcomes were compared between the two groups.

Results: The experimental group (n?=?64) demonstrated statistically significant improvement versus the historical control group (n?=?66) in mean distance walked on discharge day (249.2 vs. 180.0 feet; unadjusted p?=?.025, adjusted p?=?.070), mean LOS (2.0 vs. 2.7 days; p?p?=?.002), proportion of patients who used opioid rescue medication on postoperative day (POD) 1 (29.7% vs. 56.1%; p?=?.002, p?=?.003) and POD 2 (7.8% vs. 30.3%; p?=?.001, p?=?.003), mean cumulative area under the curve for pain score on POD 0 (127.6 vs. 292.5; p?p?p?=?.006, both). Among a subgroup of patients with available financial information, mean hospital charges were lower in the experimental group ($43,794 [n?=?24] vs. $48,010 [n?=?66]; p?Conclusions: Infiltration at the surgical site with liposomal bupivacaine was associated with improved postsurgical outcomes when compared with traditional bupivacaine in patients undergoing THA.     

右美托咪定对快速心房起搏后兔心房电生理学特性及Cx43 Cx40表达的影响

目的 探讨右美托咪定对快速心房起搏后兔心房电生理学特性及Cx43、Cx40表达的影响。方法 选择成年雄兔24只,随机分为对照组（C组）、快速心房起搏组（RAP组）与快速心房起搏+右美托咪定灌流组（RAP+DEX组）,每组8只。制备Langendorff离体心脏灌注模型,通过快速心房起搏构建房颤模型。分别检测3组心房90%单相动作电位复极时程（MAPD₉₀）、心房有效不应期（ERP）、ERP与MAPD₉₀比值（ERP/MAPD₉₀）、房颤诱发率及持续时间,取心房组织,采用Western-bolt法和免疫荧光法检测Cx43、Cx40的蛋白含量和分布。结果 T₁~T₃时,3组MAPD₉₀比较,差异有统计学意义（P<0.05）。RAP组MAPD₉₀随时间的推移有逐渐下降趋势（P<0.05）,不同的处理方式和时间对MAPD₉₀有交互作用（P<0.05）。T₃时,RAP组ERP、ERP/MAPD₉₀、Cx43和Cx40蛋白含量均低于C组和RAP+DEX组,房颤诱发率高于C组和RAP+DEX组,差异有统计学意义（P<0.05）。3组房颤持续时间比较,差异无统计学意义（P>0.05）。电镜下,RAP组Cx43和Cx40分布不规律且侧面分布增多,而C组和RAP+DEX组Cx43和Cx40分布较规律且主要集中在两端。结论 右美托咪定可抑制房颤时的心房电重构,降低房颤的易感性,其机制可能与其抑制Cx43、Cx40的表达下调和再分布有关。     

Cyclosporine-based immunosuppressive therapy for patients with steroid-resistant focal segmental glomerulosclerosis: a meta-analysis

Objective: Focal segmental glomerulosclerosis (FSGS) is a leading cause of end-stage kidney disease that requires immunosuppressive treatment as therapy. Few studies have been specifically designed to assess the efficacy of cyclosporine (CSA) in patients with steroid-resistant FSGS. This study investigated the efficacy of CSA-based therapy in steroid-resistant FSGS.

Methods: Medline, Cochrane, EMBASE, and Google Scholar databases were searched through April 30, 2014 using the keywords “cyclosporine”, “steroid-resistant”, “focal segmental glomerulosclerosis”, and “FSGS”. Studies with an adult and children with steroid-resistant primary FSGS treated with CSA-based therapy with or without steroid use were included. Complete, partial, and overall remission were the primary outcomes. Change in proteinuria, serum creatinine, and estimated glomerular filtration rate (eGFR) following treatment were secondary outcomes.

Results: Seven randomized controlled trials with a total of 373 patients were included. Five studies were included in the meta-analysis to assess complete, partial, and overall remission of FSGS. Compared with other treatments, CSA-based therapy resulted in a significantly greater partial remission rate (p?=?.018), but complete (p?=?.226) or overall remission rate (p?=?.050). CSA-based therapy also resulted in similar change in proteinuria (p?=?.084), serum creatinine (p?=?.772), and eGFR (p?=?.155) compared with other therapy. Study limitations included small sample size and heterogeneity in age and comparative treatments across the studies.

Conclusions: Cyclosporin-based treatments provided a significantly better partial remission rate as compared with other therapies.     

Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis

Objective: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS).

Methods: This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n?=?81) or AS (n?=?70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations. Effectiveness was assessed using the 4-item Disease Activity Score 28 with C-reactive protein (DAS28-CRP) for RA patients, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. Safety was assessed by withdrawals and adverse events (AEs).

Results: A total of 129 patients (RA: 67; AS: 62) were included in the effectiveness analysis. CT-P13 treatment significantly improved DAS28-CRP scores at 12 and 24 weeks (p?=?.0001 vs baseline for both timepoints) in patients with RA and BASDAI scores at 12 and 24 weeks (p?=?.0001 vs baseline for both timepoints) in patients with AS. CRP levels were significantly reduced at 12 and 24 weeks (p?=?.0001 vs baseline for both timepoints). Among 713 infusions, 34 AEs were reported (4.8% of infusions), of which 11 were considered related to CT-P13 treatment. Two of seven serious AEs were considered possibly (hepatocellular injury) or definitely (dyspnoea due to allergic infusion reaction) treatment-related. Eight patients discontinued CT-P13 due to AEs and four patients were withdrawn due to therapeutic failure.

Conclusions: CT-P13 was effective and safe in a real-life setting in patients with active RA or AS.     

Restrictive versus liberal blood transfusion in patients with coronary artery disease: a meta-analysis

Objectives: To compare clinical outcomes between restrictive versus liberal blood transfusion strategies in patients with coronary artery disease (CAD).

Research design and methods: A literature search from January 1966 to May 2016 was performed in PubMed, EMBASE and Cochrane Library to find trials evaluating a restrictive hemoglobin transfusion trigger of ≤8?g/dL, compared with a more liberal trigger. Two study authors independently extracted data from the trials. The primary outcome was mortality and the secondary outcome was subsequent myocardial infarction. Relative risks (RRs) with their 95% confidence intervals (CIs) were assessed.

Results: Six trials involving 133,058 participants were included in this study. Pooled results revealed no difference in mortality between the liberal transfusion and restrictive transfusions (RR?=?1.17, 95% CI?=?0.91–1.52, P?=?.22). Subgroup analysis revealed that a restrictive transfusion strategy was associated with a higher risk of in-hospital mortality (RR?=?1.38, 95% CI?=?1.15–1.67, P?P?=?.03), compared with the liberal strategy. No significant difference was found between the liberal transfusion strategy and restrictive transfusion strategy in risk for subsequent myocardial infarction (RR?=?1.09, 95% CI?=?0.57–2.06, P?=?.80).

Limitations: Limitations include (1) limited number of trials, especially those evaluating myocardial infarction, (2) observed heterogeneity, (3) confounding by indication and other inherent bias may exist.

Conclusion: The findings suggest that restrictive blood transfusion was associated with higher in-hospital and 30?day mortality than liberal blood transfusion in CAD patients. The conclusions are mainly based on retrospective studies and should not be considered as recommendation before they are supported by randomized controlled trials.     

达比加群酯预防房颤患者卒中的临床研究

目的 观察达比加群酯预防房颤患者卒中的疗效及安全性。方法 纳入房颤患者80例均符合抗凝治疗指征。按照奇偶数法随机分为观察组（n=40）和对照组（n=40）。观察组给予达比加群酯110 mg,2次/d;对照组给予华法林2.5 mg/d,并定期测定国际标准化比值（INR）,根据INR调整剂量。两组疗程均为6个月。记录两组患者卒中、全身性栓塞和大出血发生情况。两组患者出院时检查凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FIB）和D-二聚体等凝血指标。结果 观察组患者卒中/全身性栓塞的发生率为17.5%,对照组为37.5%,两组患者卒中/全身性栓塞发生率有统计学差异（P<0.05）;观察组患者大出血发生率显著低于对照组,差异有统计学意义（P<0.05）。两组患者凝血功能指标差异均无统计学意义。治疗后,两组血脂水平均较治疗前显著改善,同组治疗前后比较差异有统计学意义（P<0.05）;且观察组血脂水平改善更为明显,组间差异有统计学意义（P<0.05）。结论 与华法林比较,对有房颤患者行抗凝治疗达比加群酯具备同等疗效,且安全性更高。     

Comparison of clinicopathological and prognostic characteristics in patients with mucinous carcinoma and signet ring cell carcinoma of the stomach

Aim: To determine whether there are any clinicopathological or prognostic differences between mucinous gastric carcinoma (MGC) and signet ring cell carcinoma (SRCC).

Methods: Pathological parameters, clinical parameters, and treatment efficacy were compared in patients with MGC and SRCC.

Results: In total, 193 patients (51 with MGC and 142 with SRCC) were included in this study. Patients with SRCC in particular had notably higher lymphovascular invasion, perineural invasion, rate of Borrmann types III and IV, and stage III–IV cancer (according to its TNM stage) compared with patients with MGC. However, tumor size was larger in patients with MGC (tumor size ≥5?cm). Median overall survival (OS) was 29.8 months in the MGC group and 16.6 months in the SRCC group (p?=?.04). The median OS in stage I–III patients was 59.9 and 42.5 months in the MGC and SRCC groups, respectively (p?=?.35). Comparing OS between MGC and SRCC stage IV patients revealed that the median OS was 10.1 and 8.8 months, respectively (p?=?.96). Multivariate analysis of the entire patient group revealed that the presence of weight loss at diagnosis, distant metastasis, and lymph node involvement were significantly related to OS. Multivariate analysis also revealed that weight loss at the diagnosis and T3–4 tumors were significant factors influencing OS in the stage I–III group.

Conclusions: Patients with SRCC had generally poorer prognosis and lower survival rates compared with patients with MGC. Further studies on the prognosis and treatment plan based on the pathological subtypes of SRCC and MGC are still needed.     

Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process

Abstract

The objective of this study was to improve the disintegration and dissolution characteristics of a highly water-soluble tablet matrix by altering the manufacturing process. A high disintegration time along with high dependence of the disintegration time on tablet hardness was observed for a high drug loading (70% w/w) API when formulated using a high-shear wet granulation (HSWG) process. Keeping the formulation composition mostly constant, a fluid-bed granulation (FBG) process was explored as an alternate granulation method using a 2^(4?1) fractional factorial design with two center points. FBG batches (10 batches) were manufactured using varying disingtegrant amount, spray rate, inlet temperature (T) and atomization air pressure. The resultant final blend particle size was affected significantly by spray rate (p?=?.0009), inlet T (p?=?.0062), atomization air pressure (p?=?.0134) and the interaction effect between inlet T*spray rate (p?=?.0241). The compactibility of the final blend was affected significantly by disintegrant amount (p?<?.0001), atomization air pressure (p?=?.0013) and spray rate (p?=?.05). It was observed that the fluid-bed batches gave significantly lower disintegration times than the HSWG batches, and mercury intrusion porosimetry data revealed that this was caused by the higher internal pore structure of tablets manufactured using the FBG batches.     

伊布利特联合阿托伐他汀对冠状动脉搭桥围术期房颤的预防效果

目的 探讨伊布利特联合阿托伐他汀对冠状动脉搭桥围术期房颤的预防作用。方法 回顾性分析2020年1月—2020年12月在安徽省立医院接受治疗的148例施行冠状动脉搭桥术的冠心病患者,根据不同治疗方式分为对照组（n＝73）和试验组（n＝75）。两组患者施行冠状动脉搭桥术后均常规给予阿司匹林、酒石酸美托洛尔等常规药物治疗。对照组术前7 d及术后第2天给予阿托伐他汀钙片口服,每次20 mg,每晚1次。试验组在对照组的基础上于术后第2天加用富马酸伊布利特注射液,1 mg加0.9%氯化钠注射液20 mL,10 min内静脉推注给药。静推过程中若患者转为窦性心律,则停止推注。静推后10 min若患者仍未转复为窦性心律,则间隔30 min再次给予富马酸伊布利特注射液1 mg,若仍房颤,则镇静后,给予200 J同步直流电复律。两组术后均常规抗凝,疗程7 d。术后7 d比较两组患者的临床疗效、术后房颤发生情况,分别于给药前、第1次给药后30 min及第1次给药后24 h测定患者左心房内径、血清肌钙蛋白I（CTnI）、P波离散度,观察治疗期间两组患者不良反应发生情况。结果 治疗后,试验组总有效率为93.33%,显著高于对照组的73.97%,两组比较差异有统计学意义（P<0.05）。两组术后房颤起始时间比较差异无统计学意义（P>0.05）;试验组最大心室率、单次房颤持续时间均显著低于对照组,差异有统计学意义（P<0.05）。治疗前,两组左心房内径、CTnI水平比较差异无统计学意义（P>0.05）;第1次给药后30 min,两组左心房内径、CTnI水平均显著升高（P<0.05）,但两组左心房内径、CTnI水平比较差异无统计学意义（P>0.05）;第1次给药后24 h,两组左心房内径、CTnI水平均低于治疗前（P<0.05）,试验组恢复程度优于对照组,差异有统计学意义（P<0.05）。治疗前,两组P波最大值、P波宽度水平比较差异无统计学意义（P>0.05）;第1次给药后30 min,两组P波最大值、P波宽度水平均显著升高（P<0.05）,但两组P波最大值、P波宽度水平比较差异无统计学意义（P>0.05）;第1次给药后24 h,两组P波最大值、P波宽度水平均低于治疗前（P<0.05）,试验组恢复效果优于对照组,差异有统计学意义（P<0.05）。两组用药期间不良反应发生情况差异无统计学意义（P>0.05）。结论 伊布利特联合阿托伐他汀可有效预防冠脉搭桥术后房颤的发生,可有效控制心房内径增大,延缓心肌重构。     

稳心颗粒联合决奈达隆治疗老年阵发性房颤的疗效观察

目的 探讨稳心颗粒联合盐酸决奈达隆片治疗老年阵发性房颤的临床疗效。方法 选取2018年11月-2020年1月在开封市人民医院治疗的108例老年阵发性房颤患者为研究对象,按照随机数字表法将所有患者分为对照组和治疗组,每组各54例。对照组口服盐酸决奈达隆片,1片/次,2次/d。治疗组在对照组治疗基础上口服稳心颗粒,1袋/次,3次/d。两组患者均连续治疗6个月。观察两组的临床疗效,比较两组的房颤发作、心率情况、心功能指标和不良反应情况。结果 治疗后,对照组总有效率为74.07%,治疗组总有效率为90.74%,差异有统计学意义（P<0.05）。治疗后,两组房颤发作次数、静息心率显著降低,房颤持续时间显著缩短（P<0.05）;但治疗组改善的更多,差异有统计学意义（P<0.05）。治疗后,两组患者左室射血分数（LVEF）显著升高,左心室舒张末期内径（LVEDD）、左心室收缩末期内径（LVESD）、P波离散度（Pd）均显著下降（P<0.05）;但治疗组心功能指标改善更多,差异有统计学意义（P<0.05）。治疗后,对照组不良反应发生率为27.78%,治疗组不良反应发生率为5.56%,差异有统计学意义（P<0.05）。结论 稳心颗粒联合盐酸决奈达隆片治疗老年阵发性房颤具有较好的临床疗效,能够降低房颤发作和心率,显著改善患者心功能,安全性好。