Impact of chronic liver disease in intensive care unit acquired pneumonia: a prospective study

Purpose

To assess the impact of chronic liver disease (CLD) on ICU-acquired pneumonia.

Methods

This was a prospective, observational study of the characteristics, microbiology, and outcomes of 343 consecutive patients with ICU-acquired pneumonia clustered according to the presence of CLD.

Results

Sixty-seven (20 %) patients had CLD (67 % had liver cirrhosis, LC), MELD score 26 ± 9, 20 % Child–Pugh class C). They presented higher severity scores than patients without CLD both on admission to the ICU (APACHE II, LC 19 ± 6 vs. other CLD 18 ± 6 vs. no CLD 16 ± 6; p < 0.001; SOFA, 10 ± 3 vs. 8 ± 4 vs. 7 ± 3; p < 0.001) and at onset of pneumonia (APACHE II, 19 ± 6 vs. 17 ± 6 vs. 16 ± 5; p = 0.001; SOFA, 11 ± 4 vs. 9 ± 4 vs. 7 ± 3; p < 0.001). Levels of CRP were lower in patients with LC than in the other two groups (day 1, 6.5 [2.5–11.5] vs. 13 [6–23] vs. 15.5 [8–24], p < 0.001, day 3, 6 [3–12] vs. 16 [9–21] vs. 11 [5–20], p = 0.001); all the other biomarkers were higher in LC and other CLD patients. LC patients had higher 28- and 90-day mortality (63 vs. 28 %, p < 0.001; 72 vs. 38 %, p < 0.001, respectively) than non-CLD patients. Presence of LC was independently associated with decreased 28- and 90-day survival (95 % confidence interval [CI], 1.982–17.250; p = 0.001; 95 % confidence interval [CI], 2.915–20.699, p = 0.001, respectively).

Conclusions

In critically ill patients with ICU-acquired pneumonia, CLD is associated with a more severe clinical presentation and poor clinical outcomes. Moreover, LC is independently associated with 28- and 90-day mortality. The results of this study are important for future trials focused on mortality.     

Sumatriptan in Acute Migraine Using a Novel Cartridge System Self-Injector

SYNOPSIS
This double-blind. randomized, placebo-controlled, parallel-group, multicenter study assessed the efficacy, acceptability, safety, and tolerability of subcutaneous sumatriptan 6 mg administered using a novel cartridge system self-injector for the acute treatment of migraine.
Eighty-six patients treated one migraine attack at home with sumatriptan or placebo. A second identical injection was available after 1 hour for inadequate relief or if the headache recurred. Rescue medication was available I hour later. The primary end point was headache relief (improvement in headache from moderate or severe to mild or no pain) within 60 minutes of the first injection. Secondary end points included the acceptability of the self-injector, requirement for and efficacy of a second dose, relief of nonheadache symptoms, use of rescue medication, and adverse events.
Significantly more patients taking sumatriptan than placebo reported headache relief I hour after the first injection (88% vs 11%, P <0.001). The device was well accepted by patients; about 90% found it easy to use and wanted to take further medication using it. Significantly fewer patients taking sumatriptan than placebo required a second injection (33% vs 92%, P <0.001) or rescue medication after the second injection (35% vs 67% P <0.05). Significantly more patients taking sumatriptan than placebo reported headache relief after the second injection (83% vs 32%, P <0.01), and resolution of non-headache migraine symptoms (54% vs 23%, P <0.01). Sumatriptan was generally well tolerated.
Subcutaneous sumatriptan 6 mg self-administered using the novel self-injector is an effective, well accepted, and well tolerated acute treatment of migraine.     

The nature and impact of urinary incontinence experienced by patients receiving community nursing services: a cross-sectional cohort study

BACKGROUND: Nurses have played a pivotal role in the delivery of continence services yet little is known about the nature or impact of urinary symptoms experienced by patients in receipt of such care. AIM: To define the nature and impact of urinary symptoms experienced by patients in receipt of community nursing services. METHOD: The Leicestershire Urinary Symptoms Questionnaire was administered to 1078 patients with incontinence identified from 176 community nurses' caseloads in 157 general practices in England. Information included type and severity of urinary symptoms, impact on quality of life, help with coping, use of continence products and health service resources. RESULTS: Nine hundred and ninety nine (92.7%) patients (median age 79.0 years) returned completed questionnaires. Most patients had incontinence between 1 and 5 years duration, women were more likely than men to have had long standing ( > 5 years) symptoms and more than half the sample reported severe leakage. Women were more likely than men to report symptoms of stress incontinence (71.7% and 46.8%, respectively, p < 0.001) and urge incontinence UI (86.3% vs. 74.8%, respectively, p < 0.01). Half of the men and most women also experienced leakage as a result of difficulty getting to, on or off, a toilet/commode. Men were more likely than women to report getting up three or more times a night to pass urine (53.6% vs. 37.0%, respectively, p < 0.05). Most patients reported that their symptoms had a significant impact on many aspects of quality of life, and 45.7% would be very dissatisfied to continue "the way they are now". Professional help appeared principally one of containment. CONCLUSION: Many people with incontinence receiving community nursing services experience two or more urinary symptoms which, in the majority, have a significant impact on quality of life. Many older patients were not satisfied to "put up" with their urinary symptoms. Current service provision appears to be failing those who are most in need of such care.     

Use of complementary and alternative medicine therapies to control symptoms in women living with lung cancer

Complementary and alternative medicine (CAM) use by cancer patients, especially women, is increasing. However, CAM use among patients with lung cancer, who have been reported to have the highest symptom burden, is poorly documented. This study describes types and frequencies of specific CAM therapies used by women with lung cancer to manage symptoms, and examines differences in demographic and clinical characteristics between CAM users and non-CAM users. Participants included 189 women with non-small cell lung cancer and > or =1 of 8 symptoms. Six CAM therapies, used to control symptoms, were assessed, including herbs, tea, acupuncture, massage, meditation, and prayer. Forty-four percent (84 women) used CAM therapies, including prayer (34.9%), meditation (11.6%), tea (11.6%), herbs (9.0%), massage (6.9%), and acupuncture (2.6%). Complementary and alternative medicine use was greatest for difficulty breathing and pain (54.8% each), with prayer the most commonly used CAM for all symptoms. Significant differences (P < .05) were found for age (t = 2.24), symptom frequency (t = -3.02), and geographic location (chi = 7.51). Women who were younger, experienced more symptoms, and lived on the West Coast or South (vs Northeast) were more likely to use CAM. We found that CAM use is variable by symptom and may be an indicator of symptom burden. Our results provide important initial data regarding CAM use for managing symptoms by women with lung cancer.     

How well are we caring for caregivers? Prevalence of grief-related symptoms and need for bereavement support among long-term care staff

To define the prevalence and correlates of grief-related symptoms among long-term care staff who care for patients near the end of life, a cross-sectional survey was conducted at six Program of All-inclusive Care for the Elderly (PACE) organizations that provide long-term care in the home and in institutions. All clinical and non-clinical program staff were surveyed to examine the prevalence of 20 grief-related symptoms and assess current sources of bereavement support, as well as willingness to use additional sources of support. Surveys were completed by 203/236 staff (86%), who described a wide variety of symptoms they attributed to the death of one of their patients in the past month. Most staff (147/203; 72%) reported at least one symptom. Staff with more symptoms had experienced more patient deaths in the past month (Spearman rho = 0.20, P = 0.007), had worked for a longer time at a PACE organization (Spearman rho = 0.16, P = 0.031), and reported a closer and longer relationship with the last patient who died (Spearman rho = 0.32, P < 0.001; rho = 0.24, P = 0.001). Although staff identified several informal sources of bereavement support (mean 2.3 sources, range 0-6), almost all (n = 194; 96%) said they would use additional support services if they were offered. These community-based long-term care staff experience a variety of symptoms attributable to the deaths of their patients, and would welcome additional sources of bereavement support.     

Efficacy of sumatriptan tablets in migraineurs self-described or physician-diagnosed as having sinus headache: a randomized, double-blind, placebo-controlled study

BACKGROUND: Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as "sinus' headache, while ignoring the possible diagnosis of migraine. OBJECTIVE: The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients with migraine presenting with "sinus" headache. METHODS: A randomized, double-blind, placebo-controlled, multicenter study was conducted in adult (aged 18-65 years) migraine patients presenting with self-described or physician-diagnosed "sinus" headache. From November 2001 to March 2002, patients meeting International Headache Society criteria for migraine (with > or =2 of the following: unilateral location, pulsating quality, moderate or severe intensity, aggravation by moderate physical activity; and > or =1 of: phonophobia and phonophobia, nausea and/or vomiting) and with no evidence of bacterial rhinosinusitis were enrolled and randomized in a 1:1 ratio via computer-generated randomization schedule to receive either 1 sumatriptan 50-mg tablet or matching placebo tablet. The primary efficacy end point was headache response (moderate or severe headache pain reduced to mild or no headache pain) at 2 hours after administration. The presence or absence of migraine-associated symptoms and sinus and nasal symptoms was also measured. Tolerability was assessed through patient-reported adverse events (AEs). RESULTS: Two hundred sixteen patients with self-described or physician-diagnosed "sinus" headache received a migraine diagnosis and treated 1 migraine attack with sumatriptan 50 mg. The efficacy (intent-to-treat) analysis included 215 patients treated with sumatriptan 50 mg (n = 108; mean [SD] age, 39.6 [12.3] years; mean [SD] weight, 77.7 [17.7] kg; sex, 71% female; race, 69% white) or placebo (n = 107; mean [SD] age, 41.0 [11.3] years; mean [SD] weight 80.7 [20.9] kg; sex, 69% female; race, 64% white). Significantly more patients treated with sumatriptan 50 mg achieved a positive headache response at 2 and 4 hours after administration compared with those treated with placebo (69% vs 43% at 2 hours and 76% vs 49% at 4 hours, respectively; both, P < 0.001). Significantly more sumatriptan-treated patients were free from sinus pain compared with placebo recipients at 2 hours (63% vs 49% placebo, P = 0.049) and 4 hours (77% vs 55%, P = 0.001). All treatments were generally well tolerated. The most common drug-related AEs reported in the sumatriptan and placebo groups, respectively, were dizziness (5% vs < 1%), nausea (3% vs 2%), other pressure/tightness (defined as sense of heaviness; heaviness of upper body, upper extremities; jaw tension; neck tension) (4% vs 0%), and temperature sensations (defined as warm feeling of back of neck, or flushing) (2% vs 0%). No patients experienced any serious AEs. CONCLUSIONS: Sumatriptan 50-mg tablets were effective and generally well tolerated in the treatment of these patients presenting with migraine headaches that were self-described or physician-diagnosed as sinus headaches.     

合并不同糖尿病病程的胰腺癌患者临床特征及相关危险因素对胰腺癌发病年龄的影响

  目的  分析胰腺癌(pancreatic cancer, PC)合并糖尿病(diabetes mellitus, DM)患者的临床特征及不同因素对PC发病年龄的影响。  方法  1985年1月至2014年10月北京协和医院收治的PC合并DM且符合一定纳入标准的患者, 先分析总体人群基本特征, 再根据不同DM病程, 将总体人群分为新发DM组(病程≤ 2年)和长病程DM组(病程>2年), 分析不同亚组的临床特征、肿瘤特征、既往疾病史及用药情况, 并分析不同因素包括性别、生活方式、家族史、既往史、用药情况对PC发病年龄的影响。  结果  共327例PC合并DM患者纳入本研究。总体人群及按病程分组人群中男性比例均较高, 且发病年龄较女性更低[(60.2±9.5)岁比(65.7±8.5)岁, P < 0.001]。新发DM组较长病程DM组PC发病年龄更低[(60.6±9.5)岁比(64.4±9.0)岁, P < 0.001], 有DM家族史者比例更低(13.8%比24.3%, P=0.016), 平均体重下降程度更明显(9.0 kg比5.0 kg, P=0.003), 空腹血糖水平更低(8.2 mmol/L比9.1 mmol/L, P=0.003), 肿瘤平均直径更大(4.0 cm比3.5 cm, P=0.007), 胰岛素和降压药的使用比例均较低(41.9%比71.3%, P < 0.001;32.9%比49.6%, P=0.004)。男性(P < 0.001)、吸烟(P < 0.001)、饮酒(P < 0.001)、有DM家族史(P=0.048)、使用二甲双胍(P=0.046)的患者PC发病年龄更低, 而服用阿卡波糖者PC发病年龄更高(P=0.042)。  结论  无DM家族史、伴体重明显下降、有吸烟、饮酒史的新发DM患者, 可能是患PC的高危人群, 需格外警惕, 注意早期筛查。     

A randomized, double-blind, parallel-group comparison of controlled- and immediate-release oxybutynin chloride in urge urinary incontinence

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of a new PO controlled-release (CR) QD oxybutynin tablet relative to PO immediate-release (IR) TID oxybutynin in patients with urge urinary incontinence (UI). METHODS: In this multicenter, double-blind trial, patients with UI (> or = 7 episode/wk) and frequency (> or = 8 micturitions/d) were randomized to CR or IR oxybutynin for 6 weeks. Patients initiated treatment at 15 mg/d and the dose was adjusted (in 5-mg/d increments) over 2 weeks according to tolerability. Efficacy (UI episodes, voids, absorbent pads used, urgency, and volume voided per micturition) was assessed during the final 2 weeks of treatment. Tolerability was assessed by evaluating adverse events and treatment withdrawals. RESULTS: Of the 125 patients randomized, 94 (75%) were evaluable for efficacy; tolerability was assessed in all patients. In the CR group, 48 patients (91%) were women and 5 (9%) were men; the mean (SD) age was 58.0 (12.4) years (range, 26-78 years). In the IR group, 37 patients (90%) were women and 4 (10%) were men; the mean (SD) age was 60.6 (14.8) years (range, 26-83 years). Both CR and IR oxybutynin significantly reduced the mean number of total UI episodes per week (both P < 0.001 vs baseline). Both treatments produced equivalent reductions in mean voiding frequency and urinary urgency (all P < 0.001 vs. baseline). Significantly more patients rated CR oxybutynin tolerable on the initial dose of 15 mg/d (P = 0.020) and completed the study at a dose of > or = 15 mg/d (P = 0.018). Dry mouth was the most common adverse event, reported by 68% and 72% of patients in the CR and IR oxybutynin groups, respectively. CONCLUSIONS: Among the patients with urge UI included in this study, CR oxybutynin was as effective as IR oxybutynin for improving primary symptoms, with the additional benefit of QD administration.     

Use of changes in symptoms to predict changes in lung function in assessing the response to asthma therapy

BACKGROUND: The majority of adult patients with asthma are managed by primary care providers. Although there is no generally accepted gold standard for the assessment of asthma severity in general practice, treatment decisions and modifications to therapy are strongly influenced by patients' symptoms and history of asthma medication use. OBJECTIVES: The primary goal of this study was to determine whether there is a correlation between changes in asthma symptoms during treatment and changes in lung function, as measured by peak expiratory flow (PEF). A secondary goal was to compare the relative efficacy (in terms of improvement in asthma symptoms and lung function) of 3 commonly used asthma treatments: inhaled fluticasone propionate, inhaled salmeterol xinafoate, and oral zafirlukast. METHODS: This was a retrospective comparison employing regression analyses of asthma symptom and lung function data from 2890 male and female adolescent and adult patients with persistent asthma who were enrolled in 8 randomized, double-blind, double-dummy, parallel-group studies. Data on patients' self-rated symptoms, PEF, supplemental albuterol use, nighttime awakenings, and frequency of asthma exacerbations were used to ascertain whether there was a correlation between changes in asthma symptoms and changes in pulmonary function, and to compare treatment effects. RESULTS: Changes in patients' ratings of asthma symptoms after treatment with study medications showed a strong correlation with changes in lung function. Similarly, changes in lung function were strongly correlated with changes in supplemental beta-agonist use and quality of life. In addition, fluticasone or salmeterol treatment resulted in significantly greater increases in mean morning PEF (P < 0.001), significantly greater decreases in symptom scores (P < or = 0.004), significantly fewer nights with awakenings due to symptoms (P < or = 0.017), and significantly greater reductions in supplemental beta-agonist use (P < 0.001) compared with zafirlukast treatment or placebo. Patients treated with fluticasone or salmeterol also experienced significantly lower rates of asthma exacerbation (3%) during treatment than did those receiving zafirlukast (7%) or placebo (12%) (P < 0.001 and P = 0.015, fluticasone and salmeterol, respectively). CONCLUSION: These findings support the validity of primary care practitioners' basing asthma-management decisions on patients' symptoms.     

Effect of zanamivir on duration and resolution of influenza symptoms

BACKGROUND: Zanamivir is a neuraminidase inhibitor, the first of a new class of drugs with potent, specific antiviral activity against influenza A and B. Administration by inhalation results in direct delivery to the respiratory tract, the principal site of viral replication. OBJECTIVE: This study was undertaken to determine the effectiveness of zanamivir on duration and resolution of influenza symptoms. METHODS: Using a method similar to that employed in amantadine treatment studies to obtain supporting evidence of efficacy for US Food and Drug Administration consideration, pooled data from 6 zanamivir phase II and III clinical trials involving primarily previously healthy adults were analyzed to categorize patients as accelerated resolvers (temperature <37.8 degrees C < or = 24 hours after dosing, plus a > or = 50% reduction in symptom score by 36 hours), early resolvers (temperature <37.8 degrees C < or = 36 hours after dosing), and nonaccelerated resolvers (febrile >36 hours after dosing). Patients in the accelerated and early categories were termed rapid resolvers; the others were slow resolvers. Patients recorded their symptom severity, temperature, ability to perform normal daily activities, and use of relief medication on a diary card. The primary end point of median time to alleviation of symptoms was also reexamined, with the additional requirement that patients were not taking relief medication when their symptoms were alleviated. This analysis was intended to control for the possible effect of relief medication on the primary end point. RESULTS: In the influenza-positive population (n = 1572), significantly more zanamivir-treated patients were rapid resolvers compared with those receiving placebo (807 [72%] vs 765 [64%], P < 0.001). Significant benefits of zanamivir treatment were observed in patients with a baseline temperature of > or = 37.8 degrees C (630 [68%] vs 595 [57%], P < 0.001) or > or = 38.3 degrees C (382 [67%] vs 365 [52%], P < 0.001) and in patients considered by their physi- cian to have severe symptoms at the start of therapy (252 [70%] vs 222 [63%], P = 0.02). Differences were even more apparent in patients with high-risk conditions (74% vs 53%, P = 0.014) and in those aged > or = 50 years (70% vs 54%, P = 0.005). Zanamivir treatment was also associated with a significant reduction in time to alleviation of symptoms with no use of relief medication. This was particularly noticeable in those aged > or = 50 years; time to alleviation was 13 days in patients receiving placebo and 6 days in patients receiving zanamivir (P < 0.001). In these trials, adverse events were reported at a similar frequency in patients receiving zanamivir and those receiving placebo. CONCLUSIONS: Zanamivir is more effective than placebo in patients with influenza at providing early symptom relief and a reduced duration of illness at a time when use of relief medication has ended. These benefits are seen across different patient groups but appear to be particularly marked in patients who are aged > or = 50 years, who have underlying illnesses, who are considered high risk, or who are more severely ill at the beginning of therapy.     

Efficacy and tolerability of paracetamol/tramadol (325 mg/37.5 mg) combination treatment compared with tramadol (50 mg) monotherapy in patients with subacute low back pain: a multicenter, randomized, double-blind, parallel-group, 10-day treatment study

BACKGROUND: In various pain studies, the single-dose combination of paracetamol/tramadol (PIT) was found to be more effective than either agent alone. PIT could provide benefit in patients with subacute low back pain (LBP). OBJECTIVE: This study compared the efficacy and tolerability of PIT with tramadol alone (T) in patients with subacute LBP and assessed whether, under comparable analgesic conditions, PIT would be better tolerated. METHODS: This was a multicenter, randomized, double-blind, parallel-group study. Patients were enrolled if they suffered from nonspecific LBP lasting 10 to 42 days and experienced at least moderate pain (> or =40 mm on a 100-mm visual analog scale). Patients were randomized and treated for 10 days with PIT (325 mg/37.5 mg) or T (50 mg). The study outcomes were treatment efficacy (pain intensity, pain relief, patient satisfaction, physicians' assessment of pain control) and tolerability (adverse events [AEs], patients' tolerability judgment). RESULTS: A total of 119 patients were enrolled (PIT, n = 59; T, n = 60). Demographic characteristics of patients were comparable between the PIT and T groups in regard to age (mean, 56.5 vs 54.1 years, respectively), sex (women/men, 38121 vs 31129), race (white, 96.1% vs 94.2%), and body mass index (24.9 vs 26.1 kg/m2). Pain intensity (mean [SD] percentage of worst imaginable pain) improved from nearly identical levels at baseline (P/T, 67.5 [13.0] vs T, 65.3 [14.6]; P = NS) to similarly low levels at the final visit (P/T, 27.9 [22.7] vs T, 24.8 [21.6]; P = NS). The reduction in pain intensity was significant in both treatment groups (P < 0.001). Adequate pain relief (ie, "moderate," "important," or "complete") was observed in 81.6% (40149) of PIT patients versus 82.9% (39147) of T patients (P = NS). Comparably high rates of overall patient satisfaction (72.5% [37151] vs 72.9% [35148], respectively; P = NS) were achieved. Both treatment groups took a comparable number of daily units of study medication, which resulted in significantly (P < 0.001) lower daily doses of tramadol in the P/T group (mean [SD], 172.5 [46.6] mg) than in the T group (227.3 [59.7] mg). More P/T patients (84.3%) than T patients (68.8%) judged treatment tolerability as good or very good (P = NS). Significantly fewer AEs (P < 0.001) were observed in PIT patients, and the overall incidence of AEs (mostly opioid-typical AEs [eg, nausea, dizziness/vertigo, sleepiness/drowsiness, constipation, vomiting]) was much lower after P/T compared with T (P = 0.019). The most common AEs in the P/T and T groups were nausea (8159 vs 21160 patients, respectively; P = 0.012) and dizziness (3/59 vs 15/60 patients; P= 0.006). CONCLUSIONS: Tramadol, alone and in combination with paracetamol, provided highly effective analgesia for these patients with subacute LSP However, the combination of PIT, which resulted in 25% less tramadol than equianalgesic daily doses of T alone, considerably reduced the incidence of AEs and improved tolerability.     

Prospective observational study of patient-reported outcomes for azithromycin versus usual care in the treatment of bacterial acute exacerbation of chronic bronchitis

BACKGROUND: The 3-day course of azithromycin (AZM) 500 mg/d was introduced to the US market in June 2002. OBJECTIVE: The objective of this study was to evaluate changes in health-related quality of life (HRQOL) as measured by the St. George's Respiratory Questionnaire (SGRQ) over a 1-month period in patients receiving a 3-day course of AZM for bacterial acute exacerbation of chronic bronchitis (AECB). METHODS: This was a prospective, multicenter, observational study evaluating outpatient adults with AECB who received either 3 days of AZM 500 mg/d or 5- to 14-day courses of other antibiotics (usual care [UC]) as directed by the clinician. Patients completed 2 HRQOL instruments-the SGRQ and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)-at baseline, day 14, and end of study (EOS) at days 24 to 28. In addition, patients kept a diary for the first 14 days after initiating antibiotic therapy. RESULTS: One hundred twenty-eight patients (57 AZM, 71 UC) were clinically evaluable. There were no significant differences between treatment groups in clinical presentation or baseline demographics, with the exception of a higher percentage of patients with diabetes mellitus in the UC group compared with the AZM group (16.9% vs 3.5%; P = 0.02). Both groups reported similar improvements in signs and symptoms, absenteeism, concomitant respiratory medication use, resource utilization, compliance, and treatment satisfaction as reported in the patient diary. The AZM group reported statistically significant improvement (simple contrasts for end of study vs baseline) in SGRQ measures (total score, P < 0.001; symptoms, P = 0.031; activity, P < 0.001; impacts, P < 0.001) and the SF-36 mental and physical summary components, compared with baseline (both, P < 0.001). Similarly, the UC group reported significant improvement in all SGRQ measures and in the SF-36 physical component score (P < 0.01), but not in the SF-36 mental component score, compared with baseline. At EOS, 80.0% of AZM patients and 59.0% of UC patients had a > or =4-point improvement on the SGRQ total score; however, this difference was not statistically significant in the multivariate analysis. In addition, 89.5% of AZM patients and 89.9% of UC patients were satisfied or very satisfied with their treatment (P = NS). Resource utilization was similar between the groups. CONCLUSIONS: In this observational study, patients with AECB treated with a 3-day course of AZM experienced significant improvements in HRQOL as measured by a change of > or =4 points on the SGRQ and SF-36 physical and mental component scores versus baseline.     

Effectiveness of sumatriptan in reducing productivity loss due to migraine: results of a randomized, double-blind, placebo-controlled clinical trial

OBJECTIVE: To determine the effect of sumatriptan on migraine-related workplace productivity loss. PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, parallel-group trial, adult migraineurs self-injected 6 mg of sumatriptan or matching placebo to treat a moderate or severe migraine within the first 4 hours of a minimum of an 8-hour work shift. Outcome measures included productivity loss and number of patients returning to normal work performance 2 hours after injection and across the work shift, time to return to normal work performance, and time to headache relief. RESULTS: A total of 206 patients underwent screening, 140 (safety population) of whom returned for clinic treatment. Of these 140 patients, 119 received migraine treatment in the workplace (intent-to-treat population), 116 of whom comprised the study population. Of these 116 patients, 76 self-administered sumatriptan, and 40 self-administered placebo. Sumatriptan treatment tended to reduce median productivity loss 2 hours after injection compared with placebo (25.2 vs 29.9 minutes, respectively; P = .14). Significant reductions in productivity loss were obtained across the work shift after sumatriptan treatment compared with placebo (36.8 vs 72.6 minutes, respectively; P = .001). Significantly more sumatriptan-treated patients vs placebo-treated patients experienced shorter return to normal work performance at 2 hours (53/76 [70%] vs 12/40 [30%], respectively) and across the work shift (64/76 [84%] vs 23/40 [58%], respectively; P < .001). Significantly more sumatriptan-treated patients experienced headache relief 1 hour after injection compared with placebo-treated patients (48/76 [63%] vs 13/40 [33%], respectively; P = .004). CONCLUSION: Across an 8-hour work shift, sumatriptan was superior to placebo in reducing productivity loss due to migraine.     

The impact of supraventricular tachycardias on driving ability in patients referred for radiofrequency catheter ablation

AIM: The aim of the present study was to evaluate the occurrence of arrhythmia-related symptoms in patients with supraventricular tachycardia (SVT) referred for radiofrequency catheter ablation (RF ablation) with special focus on driving ability. METHODS AND RESULTS: Of the 301 patients referred for RF ablation between November 1998 and December 2000 due to SVT 226 were active drivers. The present study is an interview study with structured questions. Hemodynamic symptoms were frequently encountered during tachycardia. The symptoms occurred irrespective of driving. In the 226 active drivers, fatigue was reported in 77%, dizziness in 47%, breaking into a cold sweat in 52%, near-syncope in 50%, and syncope in 14%. Women experienced all symptoms more frequently than men: fatigue (P < 0.05), dizziness (P < 0.01), cold sweat (P < 0.05), near-syncope (P < 0.001), and syncope (P < 0.01). Fifty-seven percent of the patients had experienced tachycardia while driving, and 42% of those patients had to stop because of it. Twenty-four of all patients considered their tachycardia as an obstacle to driving. There was a significant correlation (P < 0.001) between having experienced near-syncope and considering the risk for tachycardia as an obstacle. CONCLUSIONS: SVT frequently occurs during driving and is often associated with hemodynamic symptoms including near-syncope and syncope. Women reported tachycardia-related hemodynamic symptoms more often than men. There is a correlation between having experienced near-syncope and considering tachycardia as an obstacle to driving. The risk for serious tachycardia-related symptoms should be considered, especially in occupational drivers.     

肺癌患者放射治疗前后癌因性疲乏的调查与护理

目的探讨肺癌患者在放疗前后的疲乏等不适症状的变化，为有效对疲乏进行护理干预提供指导，减轻患者痛苦，提高生存质量。方法采用问卷调查法调查142例肺癌患者放疗前后不适症状及疲乏程度的变化。结果肺癌患者在放疗前后生理不适症状变化有统计学意义（Z=-2、10，P=0．036），其中食欲减退，疲劳，背痛，吞咽痛，口干，放射性皮肤反应的不适症状较放疗前明显加重；疲乏程度变化有差异有统计学意义（t=-3、24，P=0．001）。结论肿瘤专科护士必须帮助患者正确认识癌因性疲乏，制定出有效护理措施，缓解肿瘤治疗所带来的不适症状，减轻疲乏，提高生存质量。     

Outpatient opiate therapy in cancer patients during their last days of life

BACKGROUND: Pain is one of the symptoms that many tumor patients are especially afraid of in the final phase of their illness. Symptoms can change rapidly, making quick adaptation of the therapy necessary. This poses particular challenges to organizational structures in outpatient treatment if the patients' desire to spend their last days of life in their accustomed surroundings is to be realized. METHODS: Pain intensity and the associated symptoms in a WHO step III opiate therapy during the last 3 days of life were investigated retrospectively among 601 tumor patients who had received medical care from Home Care Berlin. Differences in gender, age, living conditions/care situation and place of death were evaluated with due consideration for the different pain medications administered and for the different forms and routes of administration. RESULTS: More than 80% of the patients reported freedom from pain or only moderate pain during the opiate therapy. Care provided by the hospice-at-home medical service Home Care Berlin allowed excellent control of tumor patients' symptoms with only moderate side-effects in their final days of life. Among patients receiving opioids by the transdermal route there were significantly more frequent complaints of pain (p=0.004) and nausea (p=0.001). During the last days of life continuous subcutaneous infusions containing opiates facilitated good analgesia within an acceptable spectrum of side-effects. Most problems with controlling symptoms in outpatients were encountered in younger patients. CONCLUSION: Morphine emerged as the drug of first choice in this investigation, because it can be given parenterally and also because of its price. The use of subcutaneous and intravenous administration systems such as PCA pumps requires trained nursing services and regular house visits by physicians experienced in palliative medicine.     

腹腔镜胆囊切除术与根治性胆囊切除术治疗早期胆囊癌的疗效比较

目的 通过对比研究,评价腹腔镜胆囊切除术(LC)与根治性胆囊切除术(RC)两种方法治疗早期胆囊癌的临床疗效.方法 采用回顾性研究,选择2001年1月至2008年12月在我院确诊并行手术治疗的63例早期胆囊癌患者,按其所接受的治疗方法分为LC组(28例)与RC组(35例).对2组患者术后的并发症发生率、生存率及复发率等方面进行比较.结果 LC组患者术后并发症发生率为7.1%(2/28),与RC组的48.6%(17/35)发生率相比,差异有统计学意义(χ2=12.675,P＜0.01).RC组中Ⅰ期患者的术后第1、3、5年累积生存率均为100%,Ⅱ期为76.2%、42.9%和23.8%;LC组Ⅰ期为81. 8%、54.5%和27.3%,Ⅱ期为17.6%、5.9%、0.0%.两组同期生存曲线经log-rank检验,差异均有统计学意义(Ⅰ期:χ2=20.74,P＜0.01;Ⅱ期:χ2=11.35,P＜0.01),RC组的生存率优于LC组.RC组术后1、3、5年肿瘤累积复发率分别为20.0%、48.6%、68.6%,LC组为60.7%、85.7%、92.9%,两组比较,差异有统计学意义(χ2=10.30,P=0.0013),RC组术后的复发率显著低于LC组.结论 对于早期胆囊癌患者,首选的外科治疗方法是根治性胆囊切除术,这对降低术后肿瘤复发率,提高远期生存质量有重要作用.     

Symptom prevalence, characteristics, and distress in AIDS outpatients.

Symptom distress is an important but poorly characterized aspect of quality of life in AIDS patients. To assess and characterize the symptoms and symptom distress associated with AIDS, 504 ambulatory patients with AIDS were evaluated between December, 1992 and December, 1995. The assessment included measures of symptom distress, physical and psychosocial functioning, and demographic and disease-related factors. Patients described symptoms during the previous week using the Memorial Symptom Assessment Scale Short Form (MSAS-SF), a validated measure of physical and psychological symptom distress. The mean age was 38.6 years (range 18-69); 56% were male. African-Americans comprised 40% of the sample, Caucasians 35%, and Hispanics 23%. Ninety-three percent had CD4+ T-cell counts below 500, and 66% had counts below 200; 69% were classified in CDC category C (history of AIDS-defining conditions). Fifty-two percent reported intravenous drug use. Karnofsky performance status was > or = 70 in 80% of the patients. No patients were taking protease inhibitors. The mean (+/- SD) number of symptoms was 16.7 +/- 7.3. The most prevalent symptoms were worrying (86%), fatigue (85%), sadness (82%), and pain (76%). Patients with Karnofsky performance scores < 70 had more symptoms and higher symptom distress scores than patients with scores > or = 70 (21.2 +/- 6.5 vs. 15.6 +/- 7.1 symptoms/patient; 2.3 +/- 0.8 vs. 1.6 +/- 0.8 on the Global Distress Index [GDI] of the MSAS-SF; P < 0.0001 for both). Patients who reported intravenous drug use as an HIV transmission factor reported more symptoms and higher overall and physical symptom distress than those who reported homosexual or heterosexual contact as their transmission factor (17.8 +/- 7.5 vs. 15.4 +/- 6.9 symptoms/patient, P = 0.0002; 1.9 +/- 0.9 vs. 1.6 +/- 0.8 on the MSAS-GDI, P = 0.002). Both the number of symptoms and symptom distress were highly associated with psychological distress and poorer quality of life; for example, r = -0.69 (P < 0.0001) between GDI scores and scores on a validated measure of quality of life. Neither gender nor CD4+ T-cell count was associated with symptom number or distress. Responses from this self-referred sample of AIDS outpatients indicate that AIDS patients experience many distressing physical and psychological symptoms and a high level of distress. Both the number of symptoms and the distress associated with them are associated with a variety of disease-related factors and disturbances in other aspects of quality of life. Symptom assessment provides information that may be valuable in evaluating AIDS treatment regimens and defining strategies to improve quality of life.     

Prevalence of diabetes and incidence of angiopathy in patients with chronic viral liver disease

Patients with chronic liver disease (CLD) often develops glucose intolerance. We explored the prevalence of diabetes mellitus in viral CLD, and analyzed factors profoundly affecting the diabetic angiopathies. 229 CLD patients (124 chronic hepatitis and 105 liver cirrhosis) entered the study. The diagnosis of diabetes was made with the criteria by World Health Organization. Laboratory investigation included serum asparate aminotransferase, alanine aminotransferase, albumin, fasting blood sugar, hemoglobin A1c (HbA1c), fasting immunoreactive insulin, and HOMA-R (FBS*IRI/405). The incidence of macro- and microangiopathy were also examined. Forty (17.5%) CLD patients were diagnosed diabetes, giving a significantly higher incidence than that of general cohort (5.3%) (p<0.001). Among them, 12 (30%) had the triopathy, significantly lower than that in a matched group of diabetic patients without CLD (65%) (p<0.001). Significantly increased levels of HbA1c and HOMA-R were observed in diabetic CLD with angiopathy compared with diabetic CLD without. Incidence of diabetes was increased in viral CLD patients. The rate of diabetic angiopathies in CLD, however, was relatively low, this could be explained by low coagulability in these patients. Poor control of hyperglycemia, partly due to insulin resistance, might explain the onset of angiopathy in diabetic CLD.     

End-of-Life Health Care Utilization Between Chronic Obstructive Pulmonary Disease and Lung Cancer Patients

Context

At the end of life, chronic obstructive pulmonary disease (COPD) and lung cancer (LC) patients exhibit similar symptoms; however, a large-scale study comparing end-of-life health care utilization between these two groups has not been conducted in East Asia.