甲磺酸加替沙星片剂与环丙沙星片剂治疗皮肤软组织感染随机对照临床研究

目的：评价甲磺酸加替沙星片治疗皮肤软组织细菌性感染的有效性和安全性。方法：采用区组分层均衡随机单盲试验设计．甲磺酸加替沙星片治疗19例及环丙沙星片治疗21例共40例感染患者的临床试验。结果：试验组与对照组病例的一般项目基本相似，甲磺酸加替沙星片与环丙沙星片的临床有效率分别为94．7％和90．5％．细菌学有效率分别为92．9％和100％，细菌清除率为92．9％和100％，不良反应发生率分别为0、14．3％。结论：甲磺酸加替沙星片是一种安全有效的广谱抗菌药物．抗菌活性强，可用于治疗多种细菌引起的皮肤软组织感染。     

左氧氟沙星与头孢曲松联合阿奇霉素治疗社区获得性下呼吸道感染的对照研究

目的比较左氧氟沙星注射液与头孢曲松注射液＋口服阿奇霉素在治疗社区获得性下呼吸道感染中的疗效和安全性。方法采用随机、开放、对照研究，共入选88例患者，其中试验组43例，接受左氧氟沙星治疗，500mg每日1次静脉滴注；对照组45例，接受头孢曲松＋阿奇霉素治疗，头孢曲松2g每日1次静脉滴注，阿奇霉素口服，每日0．25g（首次0．5g）。治疗7～10d后评价临床和细菌学疗效。结果左氧氟沙星组的总有效率为86．0%，头孢曲松＋口服阿奇霉素组为84．4％；试验组细菌清除率为93．3％，对照组为92．9％，差异均无显著性（P〉0．05）。两组患者中发现非典型病原体感染共12例，其中5例为肺炎支原体，4例为肺炎衣原体，3例为嗜肺军团菌。所有12例非典型病原体感染患者均痊愈。患者对左氧氟沙星和头孢曲松＋口服阿奇霉素均有良好的耐受性。结论左氧氟沙星和头孢曲松＋口服阿奇霉素都可以作为治疗社区获得性下呼吸道感染的有效、安全的药物。     

Prospective randomized controlled study of ciprofloxacin versus imipenem-cilastatin in severe clinical infections.

In a randomized prospective study, 66 patients with serious bacterial infections--mainly lower respiratory tract infections--were treated with either imipenem plus cilastatin (32 patients) or ciprofloxacin (34 patients); 30 patients in each group were evaluable for efficacy. Substantial underlying disease was present in most of the patients; pathogens isolated prior to treatment (77 isolates) consisted mainly of members of the family Enterobacteriaceae, Pseudomonas aeruginosa, Staphylococcus aureus, Haemophilus influenzae, and streptococci. Of the etiologic bacteria, 67% were eradicated by ciprofloxacin treatment and 79% by imipenem therapy; however, two patients (6.7%) failed in the ciprofloxacin group, and six patients (20%) did not respond to imipenem treatment (P = 0.25). All patients with therapeutic failures suffered from severe fatal underlying diseases, which had substantial impact on the outcome of treatment. Therapeutic drug monitoring in the ciprofloxacin patients revealed higher concentrations in serum at days 4 and 8 in comparison with day 1 of treatment, indicating that steady-state conditions were reached between days 1 and 4. The total number of side effects was relatively high--eight imipenem patients (25%) and six ciprofloxacin patients (18%) had reactions. Treatment had to be discontinued due to adverse reactions for three ciprofloxacin patients and two imipenem patients. Major side effects in both groups were gastrointestinal and central nervous system-related symptoms. In terms of clinical and bacteriological efficacy and safety, there was no statistical difference between the two groups, and both groups gave good to excellent results for bacterial infections that were difficult to treat.     

A randomized controlled trial of aromatherapy massage in a hospice setting

Research suggests that patients with cancer, particularly in the palliative care setting, are increasingly using aromatherapy and massage. There is good evidence that these therapies may be helpful for anxiety reduction for short periods, but few studies have looked at the longer term effects. This study was designed to compare the effects of four-week courses of aromatherapy massage and massage alone on physical and psychological symptoms in patients with advanced cancer. Forty-two patients were randomly allocated to receive weekly massages with lavender essential oil and an inert carrier oil (aromatherapy group), an inert carrier oil only (massage group) or no intervention. Outcome measures included a Visual Analogue Scale (VAS) of pain intensity, the Verran and Snyder-Halpern (VSH) sleep scale, the Hospital Anxiety and Depression (HAD) scale and the Rotterdam Symptom Checklist (RSCL). We were unable to demonstrate any significant long-term benefits of aromatherapy or massage in terms of improving pain control, anxiety or quality of life. However, sleep scores improved significantly in both the massage and the combined massage (aromatherapy and massage) groups. There were also statistically significant reductions in depression scores in the massage group. In this study of patients with advanced cancer, the addition of lavender essential oil did not appear to increase the beneficial effects of massage. Our results do suggest, however, that patients with high levels of psychological distress respond best to these therapies.     

Pharmacogenomics guided versus standard antidepressant treatment in a community pharmacy setting: A randomized controlled trial

The literature on pharmacogenomics as a tool to support antidepressant precision is burgeoning. Recently, a more active role has been argued for pharmacists in pharmacogenomic testing, with both pharmacists and family physicians perceiving pharmacist‐led testing as a valuable method by which to scale this innovation for depression treatment. In this prospective, single‐blind randomized controlled design, we evaluated the impact of pharmacogenomics guided versus standard antidepressant treatment of depression and anxiety, implemented in three large community pharmacies. Participants were 213 outpatients diagnosed with major depressive disorder and/or generalized anxiety disorder, randomized to receive pharmacogenomics guided (n = 105) or standard antidepressant treatment (n = 108); participants were blinded to the study. Patient reported outcomes of depression, anxiety, disability, and treatment satisfaction were assessed at months 0, 1, 3, and 6. Hypotheses were investigated using mixed effect models on the full data. All clinical outcomes improved significantly. The primary outcome (depression) and two secondary outcomes (generalized anxiety and disability) exhibited significant time by group interactions indicating that they improved for participants who received pharmacogenomics guided treatment more so than they did for participants who received standard treatment. Treatment satisfaction improved similarly for both groups. Results contribute to a growing body of work evaluating the impact of pharmacogenomics testing to inform antidepressant medication treatment for depression and anxiety, and provides important initial evidence for the role of pharmacists in care delivery. Pharmacogenomic testing may be a valuable tool to allow pharmacists to more effectively collaborate in facilitating clinical treatment decisions. ClinicalTrials.gov registration: ({"type":"clinical-trial","attrs":{"text":"NCT03591224","term_id":"NCT03591224"}}NCT03591224).

Study Highlights

• WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?

Findings are mixed on whether pharmacogenomic testing as a tool to guide antidepressant treatment improves depression response, remission, and symptom severity.

• WHAT QUESTION DID THIS STUDY ADDRESS?

We evaluated the impact of pharmacogenomics guided versus standard antidepressant treatment of depression and anxiety as they occur in the real‐world, implemented by pharmacists in three large community pharmacies.

• WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?

Results from this study provide initial evidence in support of a pharmacist‐led pharmacogenomic testing program in the treatment of mental health difficulties, as well as evidence for the role of pharmacists in care delivery.

• HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?

In supporting the external validity of pharmacogenomic testing, this study has implications for how primary care clinicians may manage antidepressant medication use in their patients. In conjunction with measurement‐based care, pharmacogenomic testing may help pharmacists more confidently and effectively manage patients in a protocolized and evidence‐based manner.     

Evaluation of a community-based organization's intervention to reduce the incidence of sexually transmitted diseases: a randomized,controlled trial

BACKGROUND: The study objectives were to determine whether a community-based organization's intensive counseling intervention would reduce sexually transmitted disease (STD) acquisition among high-risk STD clinic patients and to determine whether a low-cost trial could be conducted in a community-based setting with passive follow-up. METHODS: Participants were randomly assigned to routine counseling or intensive counseling consisting of three 1-hour sessions. We reviewed clinic records to determine 1-year cumulative incidence of STD. RESULTS: From September 1994 through December 1995, we enrolled 581 high-risk black men. Among the intervention group, 38% did not attend any intervention session; 38% attended all three. The 1-year cumulative incidence of STD did not differ significantly between the intervention (16%) and control groups (12%) (P = 0.20). CONCLUSION: Our results suggest that the intensive counseling did not reduce STD acquisition. We encountered problems in conducting this low-cost trial, making results difficult to interpret Future trials should schedule follow-up STD assessments and will likely need more staff.     

A natural setting behavior management program for persons with acquired brain injury: a randomized controlled trial

OBJECTIVE: To investigate the efficacy of a behavior management program delivered in the natural community setting for persons with brain injury and their caregivers. DESIGN: Three-group randomized controlled trial. SETTING: Homes and other community settings. PARTICIPANTS: Thirty-seven persons with traumatic and other acquired brain injury and their caregivers. INTERVENTIONS: Natural Setting Behavior Management (NSBM) involving education and individualized behavior modification program versus education only versus control group. MAIN OUTCOME MEASURES: Changes in frequency of targeted problematic behaviors. Subscale in Questionnaire on Resources and Stress, Maslach Burnout Inventory, and the Neurobehavioral Functioning Inventory. RESULTS: While no significant effects were detected at termination of education only (P<.075) or of NSBM (P<.56), significant treatment effects were found at the main outcome point 3 months after termination of services (P<.002). Rates of disruptive or aggressive behaviors declined significantly in the NSBM group. Differences in caregiver-rated stress, burden, and aggression were not statistically significant. CONCLUSIONS: A program of caregiver education and individualized behavior management in natural settings can decrease the frequency of disruptive behavioral challenges. Larger studies are needed to clarify the duration and intensity of education and individualized treatment required to diminish behavioral challenges and to understand relationships with general stress and burden experienced by caregivers.     

Safety and efficacy of temafloxacin versus ciprofloxacin in lower respiratory tract infections: a randomized, double-blind trial.

Temafloxacin, a new fluoroquinolone with broad-spectrum anti-bacterial activity and a favourable pharmacokinetic profile, was evaluated in a prospective, randomized double-blind multicentre study in which 564 patients were enrolled. Ambulatory adults with lower respiratory tract infections were randomly assigned to receive temafloxacin 600 mg or ciprofloxacin 750 mg, each given every 12 h for 7-14 days. Cure or improvement occurred in 93.8% of temafloxacin patients and 93.1% of ciprofloxacin recipients (P greater than 0.05). Bacteriological eradication rates were higher in the temafloxacin group than in the ciprofloxacin group (99.5% vs 92.5%; P = 0.001) primarily because of the failure of ciprofloxacin to eradicate Streptococcus pneumoniae (P = 0.01). Both regimens were well tolerated. In patients who received concomitant theophylline, gastrointestinal and central nervous system disturbances occurred in a higher percentage of patients in the ciprofloxacin group than the temafloxacin group (36.4% vs 9.4%; P less than 0.05). This study indicates that temafloxacin would be suitable for the empirical treatment of lower respiratory tract infections, including high-risk groups such as the elderly and heavy smokers.     

A randomized controlled trial of intranasal fentanyl vs intravenous morphine for analgesia in the prehospital setting

Study Objective

The objective of the study was to compare intranasal fentanyl (INF) with intravenous morphine (IVM) for prehospital analgesia.

Methods

This was a randomized, controlled, open-label trial. Consecutive adult patients (n = 258) requiring analgesia (Verbal Rating Score [VRS] >2/10 noncardiac or >5/10 cardiac) were recruited. Patients received INF 180 μg ± 2 doses of 60 μg at ≥5-minute intervals or IVM 2.5 to 5 mg ± 2 doses of 2.5 to 5 mg at ≥5-minute intervals. The end point was the difference in baseline/destination VRS.

Results

Groups were equivalent (P = not significant) for baseline VRS [mean (SD): INF 8.3 (1.7), IVM 8.1 (1.6)] and minutes to destination [mean (SD): INF 27.2 (15.5), IVM 30.6 (19.1)]. Patients had a mean (95% confidence interval) VRS reduction as follows: INF 4.22 (3.74-4.71), IVM 3.57 (3.10-4.03); P = .08. Higher baseline VRS (P < .001), no methoxyflurane use (P < .01), and back pain (P = .02) predicted VRS reduction. Safety and acceptability were comparable.

Conclusions

There was no significant difference in the effectiveness of INF and IVM for prehospital analgesia.     

阿莫西林/舒巴坦钠治疗急性细菌性感染的随机对照多中心临床研究

目的评价阿莫西林/舒巴坦钠治疗急性细菌性感染的有效性和安全性.方法以氨苄西林/舒巴坦钠为对照,采用多中心随机对照临床试验治疗急性细菌性感染113例,其中试验组58例、对照组55例.阿莫西林/舒巴坦钠每日4.5-6.0g、氨苄西林/舒巴坦钠每日4.5-12.0g,两药均分次静脉滴注,疗程7-14日.结果试验组与对照组的痊愈率和有效率分别为75.86%与80.0%(P＞0.05)和94.83%与98.18%(P＞0.05).两组细菌产酶率分别为67.35%与69.57%(P＞0.05).细菌清除率分别为93.88%与95.65%.两组均未见严重不良反应.结论阿莫西林/舒巴坦钠治疗急性细菌性感染临床疗效确切,使用安全.     

磷霉素氨丁三醇与环丙沙星随机对照治疗121例泌尿道细菌性感染临床评价

目的 :评价磷霉素氨丁三醇与环丙沙星随机对照治疗泌尿道细菌性感染的疗效和安全性。方法 :以环丙沙星为对照 ,采用随机化开放试验方法 ,观察试验药磷霉素氨丁三醇组 6 1例 ,对照药环丙沙星组 6 0例。结果 :磷霉素氨丁三醇与环丙沙星治疗泌尿系统感染的临床痊愈率分别为 85 .2 %和 83.3% ,有效率分别为 95 .1%和 95 .0 % ,细菌清除率分别为 92 .3%和92 .2 %。经统计学检验 ,上述两组结果差异无显著性 (P >0 .0 5 )。从分离到的 10 3株致病菌药敏试验结果分析发现 ,93株(90 .3% )致病菌对磷霉素氨丁三醇敏感 ,81株 (78.6 % )致病菌对环丙沙星敏感 ,经统计学处理两组的差异有显著性 (P =0 .0 2 1)。两药不良反应发生率分别为 4 .8%与 7.7%。结论 :磷霉素氨丁三醇对多数革兰阳性菌、阴性菌引起的泌尿道感染的治疗是安全有效的     

头孢哌酮-三唑巴坦与头孢哌酮-舒巴坦治疗急性细菌性感染随机对照研究

目的：评价国产头孢哌酮-三唑巴坦治疗急性细菌性呼吸道感染、泌尿道感染以及其他系统感染的有效性与安全性。方法：采用区组随机、平行对照、开放研究设计，头孢哌酮-三唑巴坦和头孢哌酮一舒巴坦均为每次给药2．0g，静脉滴注30～60min，每日2次或3次，疗程7～14d。结果：本试验共入选病例57例，因各种原因淘汰4例，进入疗效分析的病例数为53例，其中头孢哌酮-三唑巴坦组27例，头孢哌酮-舒巴坦组26例，治疗结束头孢哌酮-三唑巴坦与头孢哌酮-舒巴坦临床有效率分别为96．3％与92．3％，各种致病菌清除率分别为95．8％与90．9％，两组不良反应发生率分别为7．1％与7．4％，上述结果经统计学处理，差异均无显著性。结论：头孢哌酮-三唑巴坦与头孢哌酮-舒巴坦在治疗临床常见的敏感细菌引起的细菌性感染均有效、安全。     

Multidisciplinary rehabilitation for chronic back pain in an outpatient setting: a controlled randomized trial

Based on existing models for pain chronicity and effective treatment strategies for patients with chronic low back pain, a multidisciplinary rehabilitation programme for an outpatient group setting was developed. The main treatment components address the patient's physical functional capacity (functional restoring), cognitive and affective processes (pain management strategies), and behavioural and ergonomical aspects (back school elements). Short-term (immediately after intervention) and long-term effects (at 6-months follow-up) of the intervention were assessed in a randomized controlled study. Dependent variables were pain measures, functional capacity, disability, muscular strength and endurance, pain and posture-related self-efficacy, attitudes, depression, well-being, behavioural habits and posture assessed by a standardized behavioural observation method. Immediately after the intervention, patients in the treatment group (n=36) showed significant improvement over patients in the control group (n=29) in all variables except depression and muscular strength and endurance. At 6-months follow-up, compared to pretreatment scores, patients continued to show beneficial effects in pain intensity and frequency, posture, posture-related self-efficacy and well-being. In contrast to post-treatment results, there were also significant improvements in strength and endurance. Overall results testify to the effectiveness of the intervention programme. Future studies (with larger sample sizes) should aim at a further improvement of functional capacity and disability perception, an analysis of differential treatment effects, and strategies for an improved long-term maintenance of the changes induced by the programme.     

A randomized controlled trial testing the efficacy of an HIV/AIDS symptom management manual

This study investigates whether using an HIV/AIDS symptom management manual with self-care strategies for 21 common symptoms, compared to a basic nutrition manual, had an effect on reducing symptom frequency and intensity. A 775-person, repeated measures, randomized controlled trial was conducted over three months in 12 sites from the United States, Puerto Rico, and Africa to assess the relationship between symptom intensity with predictors for differences in initial symptom status and change over time. A mixed model growth analysis showed a significantly greater decline in symptom frequency and intensity for the group using the symptom management manual (intervention) compared to those using the nutrition manual (control) (t = 2.36, P = 0.018). The models identified three significant predictors for increased initial symptom intensities and in intensity change over time: (1) protease inhibitor-based therapy (increased mean intensity by 28%); (2) having comorbid illness (nearly twice the mean intensity); and (3) being Hispanic receiving care in the United States (increased the mean intensity by 2.5 times). In addition, the symptom manual showed a significantly higher helpfulness rating and was used more often compared to the nutrition manual. The reduction in symptom intensity scores provides evidence of the need for palliation of symptoms in individuals with HIV/AIDS, as well as symptoms and treatment side effects associated with other illnesses. The information from this study may help health care providers become more aware of self-management strategies that are useful to persons with HIV/AIDS and help them to assist patients in making informed choices.     

Impact of ethics consultations in the intensive care setting: a randomized, controlled trial

OBJECTIVE: To determine the following: a) whether ethics consultations in the intensive care setting reduce nonbeneficial treatments, defined as days in the intensive care unit (ICU) and treatments delivered to those patients who ultimately fail to survive to hospital discharge; and b) whether physicians, nurses, social workers, and patients/families agree that ethics consultations in the ICU are beneficial in addressing treatment conflicts. DESIGN: Prospective, randomized, controlled trial of ethics consultations. SETTING: Medical and pediatric ICUs in a university medical center. PATIENTS: Seventy-four patients in whom value-based treatment conflicts arose during the course of treatment. INTERVENTIONS: The patients were randomly assigned to an intervention (ethics consultation offered) or nonintervention (ethics consultation not offered) arm of the trial. MEASUREMENTS: Medical data and ICU hospital days were compared between the intervention and control groups before and after the randomization. Likert scale and commentary responses were recorded to structured and open-ended interviews with the responsible physicians, nurses, social workers, and families of patients assigned to the intervention arm within 1 month after the patient's death or hospital discharge. Interviewees were asked whether ethics consultations helped with the following: a) to identify ethical issues; b) to analyze ethical issues; c) to resolve ethical issues; d) to educate about ethical issues; and e) to present personal views. MAIN RESULTS: There were no differences in overall mortality between the control patients and patients receiving ethics consultations. However, ethics consultations were associated with reductions in ICU hospital days and life-sustaining treatments in those patients who ultimately failed to survive to discharge. Also, ethics consultations were regarded favorably by most participants. CONCLUSIONS: Ethics consultations seem to be useful in resolving conflicts that may be inappropriately prolonging futile or unwanted treatments and are perceived to be beneficial.     

A pilot study for a randomized controlled and patient preference trial of buprenorphine versus methadone maintenance treatment in the management of opiate dependent patients

Aims: To assess the feasibility of conducting an RCT comparing buprenorphine and methadone maintenance therapy in Norfolk.

Design: Forty‐two opiate dependent patients were given the option of being randomized or choosing between open label buprenorphine or methadone maintenance treatment for 6 months. Dosage was assessed individually using a flexible regime.

Findings: No subjects agreed to randomization. At 6 months more methadone patients were retained (68 vs. 55% for buprenorphine), however, after adjustment for baseline differences between the groups results favoured buprenorphine, but were not statistically significant (odds ratio for retention BMT vs. MMT = 1.57, 95% CI, 0.30–8.29, p = 0.60). The buprenorphine group showed a non‐significant advantage in illicit opiate use (45 vs. 66% p = 0.43) and CHRISTO scores at 6 months (?0.85 units lower score, 95% CI, ?4.93 to +3.23, p = 0.67). In this study, predictors of retention in treatment at six months were lower (better) CHRISTO score (p = 0.01), age below 29.5 years (p = 0.02) and of borderline statistical significance was being married or cohabiting (p = 0.06).

Conclusions: A local RCT is not feasible. As a pilot this study lacked power but the results suggest that, in practice, in the UK, buprenorphine may be more able to retain patients in treatment, suppress illicit opiate use and improve functioning. Given the significantly higher cost of buprenorphine a larger study is needed to answer these questions.     

Vaginal leukocyte counts for predicting sexually transmitted infections in the emergency department

BackgroundThe use of vaginal white blood cell (WBC) counts to predict sexually transmitted infections (STIs) in the emergency department (ED) is incompletely characterized.ObjectivesOur objective was to assess the relationship between vaginal wet preparation WBC counts and STIs and to determine whether WBC counts of at least 11 WBCs per high-power field (HPF) could be useful for identifying STIs in women in the ED.MethodsFemale ED patients 18 years or older who were evaluated in a single health system between April 18, 2014, and March 7, 2017, and had a genital wet preparation WBC result were retrospectively examined using univariable and multivariable analysis.ResultsVaginal wet preparation WBC counts were examined for 17,180 patient encounters. Vaginal WBC counts of at least 11 WBCs/HPF were associated with increased odds of having gonorrhea, chlamydia, or trichomoniasis. When this threshold was used for the diagnosis of each STI, sensitivity ranged from 48.2% to 53.9%, and specificity ranged from 67.2% to 68.8%.ConclusionWomen with STIs are more likely to have higher vaginal WBC counts. However, higher vaginal wet preparation WBC counts in isolation have limited diagnostic utility for gonorrhea, chlamydia, and trichomoniasis. Incorporation of age, urine leukocyte esterase results, and vaginal WBC counts provided a better predictor of an STI than vaginal WBC counts alone.