Receiving Drug Treatment Research Articles

PACIENTES EM HEMODIÁLISE COM DIAGNÓSTICO DE ENFERMAGEM VOLUME DE LÍQUIDOS EXCESSIVO: ASPECTOS SOCIOECONÔMICOS E CLÍNICOS

Objetivou-se descrever aspectos socioeconômicos e clínicos de pacientes renais crônicos em hemodiálise com o diagnóstico de enfermagem Volume de líquidos excessivo. Estudo transversal, realizado em hospital universitário e clínica de hemodiálise do Nordeste do Brasil, com amostra de 100 pacientes. A coleta de dados em formulário abrangeu os dados clínicos e socioeconômicos, entre dezembro de 2012 a abril de 2013. A maioria dos pacientes com diagnóstico era do sexo feminino, raça parda, aposentado, possuíam companheiro, professavam religião, tinham média de idade de 50,4 anos, 6,5 anos de estudo e dois salários mínimos. Ainda, apresentava hipertensão, azotemia e hipercalemia, com mediana de 37 meses com doença renal e 33,5 meses em hemodiálise. Em terapia medicamentosa com cloridrato de sevelamer, ácido fólico, eritropoietina humana recombinante e anti-hipertensivos. Identificar aspectos socioeconômicos e clínicos contribuiu para o conhecimento da equipe de enfermagem acerca do contexto em que os pacientes renais crônicos estão inseridos.

Impact of the International Association of Diabetes and Pregnancy Study Groups criteria for gestational diabetes

AimsTo evaluate the diagnostic criteria of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and alternative criteria in terms of resultant prevalence of gestational diabetes mellitus (GDM) and measures of diagnostic impact. MethodsThe Brazilian Gestational Diabetes Study (EBDG) is a cohort of pregnant women enrolled consecutively in prenatal care clinics of the Brazilian National Health Service from 1991 to 1995, a time and setting in which those with lesser than diabetes hyperglycemia rarely received drug treatment. Eligibility criteria were age ≥20 years, gestational age 20–28 weeks and no history of diabetes outside pregnancy. After interview and anthropometric measurements, a standardized 2h 75g OGTT was scheduled. Women were followed through early postpartum. ResultsPrevalence of GDM defined by IADPSG criteria was 18.0% (95% CI 16.9–19.0), ranging from 2.7 to 17.0% with the alternative criteria. Relative risks for large for gestational age (LGA) and preeclampsia were generally small. The diagnostic impact assessed by pre- to post-test gain in the probability of an outcome was also small (3.6% for LGA and 0.5% for preeclampsia). Alternative criteria reached maximum gains of 9.7% and 5.3%, respectively. The fractions of LGA births and preeclampsia attributable to GDM by the IADPSG criteria were small, 6.7% and 3.5%, respectively. ConclusionsThe IADPSG criteria identify more women as having GDM but their diagnostic and population impacts with respect to adverse outcomes are small. Alternative definitions, although also presenting small diagnostic and population impacts, showed advantages which may be useful in specific settings.

Short-term cessation of sex work and injection drug use: Evidence from a recurrent event survival analysis

ObjectiveThis study quantitatively examined the prevalence and correlates of short-term sex work cessation among female sex workers who inject drugs (FSW-IDUs) and determined whether injection drug use was independently associated with cessation. MethodsWe used data from FSW-IDUs (n=467) enrolled into an intervention designed to increase condom use and decrease sharing of injection equipment but was not designed to promote sex work cessation. We applied a survival analysis that accounted for quit–re-entry patterns of sex work over 1-year stratified by city, Tijuana and Ciudad Juarez, Mexico. ResultsOverall, 55% of participants stopped sex work at least once during follow-up. Controlling for other characteristics and intervention assignment, injection drug use was inversely associated with short-term sex work cessation in both cities. In Ciudad Juarez, women receiving drug treatment during follow-up had a 2-fold increase in the hazard of stopping sex work. In both cities, income from sources other than sex work, police interactions and healthcare access were independently and significantly associated with shorter-term cessation. ConclusionsShort-term sex work cessation was significantly affected by injection drug use. Expanded drug treatment and counseling coupled with supportive services such as relapse prevention, job training, and provision of alternate employment opportunities may promote longer-term cessation among women motivated to leave the sex industry.

Effectiveness of Family-Based Behavioral Treatment Based on Medication Behavior Barkley Compared with Drug Therapy in Reducing the Symptoms of Children with Attention Deficit Disorder-Hyperactivity

Children with attention deficit and hyper activity disorder have various problems such as low academic performance, social and communication problems, anxiety, depression, aggression, conduct disorder and delinquency, and also when they become adults, they have problems in social relationships that these problems can increase or decrease in dealing with family. Hence, this study was performed in order to examine the impact of family-based behavioral treatment compared with Barkley behavior therapy in reducing symptoms of children with attention deficit disorder—ADHD. To meet the aim, 20 of children with age range of 7 to 12 years old with attention deficit disorder—hyperactivity were selected in both experimental and control groups, and exposed to the treatment of behavioral family therapy groups and changes in behavior Barkley. Before and after the treatment, they were evaluated according to the scale of the Conner’s Parent Rating Scale-Revised Short Form (CPRS-R: S). Results of multivariate analysis of covariance indicated that there were significant differences between the experimental group who had received family-based behavioral treatments based on changes in behavior Barkley and a control group who had received drug treatment in variables, including conduct problems, learning problems, psychosomatic symptoms, and signs of impulsive hyperactivity, anxiety and hyperactivity (p < 0.01). These results could be guidance for counsel or sand therapists for children with attention deficit disorder—ADHD.

Modulatory Role of Morphine and Gabapentin as Anti-inflammatory Agents Alone and on Coadministration with Diclofenac in Rat Paw Edema

Objective: To evaluate the anti- inflammatory effects of Morphine and Gabapentin alone and as adjuvant with diclofenac by using formalin induced paw edema model. Methods: After acclimatization of one week, adult Sprague-Dawley rats were divided into two groups: control and treatment (n=6). Treatment group received diclofenac (10 mg/kg), gabapentin (150 mg/kg), morphine (15 mg/kg), gabapentin (150 mg/kg) + diclofenac (10 mg/kg) and morphine (15 mg/kg) + diclofenac (10 mg/kg), respectively. Paw edema was produced by injecting 0.2ml of 2% formalin subcutaneously on the dorsal surface of right hind paw. Animals received drug treatment 30 minutes before injection of formalin and paw volume was measured at 0, 30, 60, 120 and 240 minutes after formalin challenge with help of mercury plethysmometer. Results: Both morphine and gabapentin alone and in combination with diclofenac caused a significant reduction (p< 0.01) in rat paw edema when compared to group given saline only. Reduction in paw edema with gabapentin and diclofenac was significantly superior when compared with either drug alone. Conclusions: Combination of gabapentin and diclofenac showed synergistic anti-inflammatory effect as compared to either drug alone or combination of morphine + diclofenac groups.

Safety of recombinant human granulocyte-macrophage colony-stimulating factor in healing pediatric severe burns.

We explored the safety of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) for healing burns in children. Subjects were randomly assigned to two groups: the experimental group received external rhGM-CSF gel, and the control group received rhGM-CSF gel matrix components, applied to the burn surface. Neither group was given any other drugs that promote wound healing. Each day we recorded the pulse, body temperature, and respiration status in the two groups. We detected the blood routine, urine routine, and hepatic and renal function before the patients received drug treatment and after 72 h. The wound scab and healing states in the two groups were recorded every 4 days to evaluate wound healing rate and time taken for complete healing. Adverse reactions and their rate of occurrence were also recorded. The median time of healing was 15 days in the experimental group and 19 days in the control group (log-rank χ(2) = 5.139, P < 0.05). After 10 days, the experimental group healing rate was consistently higher than that of the control group (significantly different using intuitive analysis), suggesting the experimental group method was more effective. There were no obvious adverse reactions. There was no significant difference between the blood routine, urine routine, and liver and kidney function in the two groups before the treatment and after 3 days (P > 0.05). Compared with saline treatment of severe burns, rhGM-CSF can effectively shorten the healing time without significant adverse reactions, and is an effective and safe treatment for burns in children.

Decreased variability of the 6-minute walk test by heart rate correction in patients with neuromuscular disease.

ObjectiveThe 6-minute walk test is widely used to assess functional status in neurological disorders. However, the test is subject to great inter-test variability due to fluctuating motivation, fatigue and learning effects. We investigated whether inter-test variability of the 6MWT can be reduced by heart rate correction.MethodsSixteen patients with neuromuscular diseases, including Facioscapulohumeral muscular dystrophy, Limb-girdle muscular dystrophy, Charcot-Marie-Tooths, Dystrophia Myotonica and Congenital Myopathy and 12 healthy subjects were studied. Patients were excluded if they had cardiac arrhythmias, if they received drug treatment for hypertension or any other medical conditions that could interfere with the interpretation of the heart rate and walking capability. All completed three 6-minute walk tests on three different test-days. Heart rate was measured continuously.ResultsSuccessive standard 6-minute walk tests showed considerable learning effects between Tests 1 and 2 (4.9%; P = 0.026), and Tests 2 and 3 (4.5%; P = 0.020) in patients. The same was seen in controls between Tests 1 and 2 (8.1%; P = 0.039)). Heart rate correction abolished this learning effect.ConclusionA modified 6-minute walk test, by correcting walking distance with average heart rate during walking, decreases the variability among repeated 6-minute walk tests, and should be considered as an alternative outcome measure to the standard 6-minute walk test in future clinical follow-up and treatment trials.

Effect of spiritual therapy on blood pressure, anxiety and quality of life in patients with high blood pressure

Background: High blood pressure is the most important risk factor of cardiovascular diseases. This study was conducted to evaluate the efficacy of spiritual therapy on blood pressure, anxiety and quality of life in patients with high blood pressure. Method: This study was quasi-experimental with a pretest-posttest and control group design. The sample consisted of 30 patients with high blood pressure refering to Kangavar Healthcare center that were selected through convenience sampling and randomly divided into two experimental and control groups. The instrument for data collection included Cattel’s Anxiety Scale, the World Health Organization Quality of Life and a manometer. After assigning the sample into two groups, the experimental group received spiritual therapy in addition to pharmaceutical therapy, while control group only received drug treatment. Results: Analysis of covariance showed spiritual therapy reduced the systolic blood pressure and anxiety of patients. Also, it increased the patients’ quality of life, however, it did not have a significant effect on the diastolic blood pressure of patients. Conclusion: It is concluded that spiritual therapy as a useful method to improve the anxiety, quality of life and blood pressure of patients with high blood pressure.

Perceptions of professional drug treatment staff in England about client barriers to narcotics anonymous attendance

A growing body of research evidence shows that Twelve Step Group (TSG) attendance confers a consistent moderate beneficial effect on substance use. Clinicians potentially represent a major referral pathway to TSG. This qualitative study aimed to explore staff perceptions of the barriers to Narcotics Anonymous (NA) group attendance in a population receiving drug treatment, and potential strategies to increase attendance. A cross-sectional survey of substance misuse treatment professionals was conducted between January and April 2012 in Birmingham, England. Fifty-eight members of staff working within statutory community drug treatment teams were interviewed using qualitative research methods. The overarching themes within the staff accounts are described and the importance of these themes explored. Perceived objections to core elements of the 12 step programme (religious nature of the programme, powerlessness, surrender, desire to stop using drugs) were major obstacles to recommending NA attendance. However, a perception that the client would object to any form of group process, and concerns about risk both to the client and the TSG members were also important. Increased education about TSG practices and procedures was a commonly cited strategy for increasing levels of TSG referral, and in particular ensuring that clinicians attend open meetings themselves. An increased understanding and familiarity with the process and principles of TSGs may be necessary to increase promotion of TSG within drug treatment services in line with recent national policy promoting recovery from drug use.

Willingness to pay for ovulation induction treatment in case of WHO II anovulation: a study using the contingent valuation method.

ObjectiveTo measure the willingness to pay (WTP) of women aged 18–45 years to receive drug treatment for ovulation induction (ie, the social value of normal cycles of ovulation for a woman of childbearing age) in order to feed the debate about the funding of fertility cares.SettingAn anonymous questionnaire was used over the general population of Quebec.ParticipantsA total of 136 subjects were recruited in three medical clinics, and 191 subjects through an online questionnaire.MethodThe questionnaire consisted of three parts: introduction to the problematic, socioeconomic data collection to determine factors influencing the formation of WTP, and a WTP question using the simple bid price dichotomous choice elicitation technique. The econometric estimation method is based on the “random utility theory.” Each subject responding to our questionnaire could express her uncertainty about the answer to our WTP question by choosing the answer “I do not know.”Outcome measureThe WTP in Canadian dollars of women aged 18–45 years to receive drug treatment for ovulation induction.ResultsResults are positive and indicate an average WTP exceeding 4,800 CAD, which is much more than the drug treatment cost. There is no evidence of sample frame bias or avidity bias across the two survey modes that cannot be controlled in econometric estimates.ConclusionMedical treatment for ovulation induction is highly socially desirable in Quebec.

Morphological and immunohistochemical analysis in ovaries and fallopian tubes of tamoxifen, letrozole and clomiphene-treated rats.

Ovarian and tubal dysplasia may be precursors to ovarian cancer. The goal of this study was to check whether these histopathological lesions would be found after ovulation induction using tamoxifen, clomiphene citrate and letrozole. Seventy-two rats were divided into four groups. In the first group, 24 rats received normal saline. The second group (16 rats) received clomiphene citrate for six cycles. The third group, divided into two sub-groups of eight rats each, were stimulated with tamoxifen for six cycles, with a dosage, respectively, of 0.4 and 0.8mg/kg/day. In the last group, eight rats received letrozole 0.1mg/kg/day and eight other rats received letrozole 0.5mg/kg/day, for six cycles. Once the six cycles had been completed the rats were killed in order to remove ovaries and tubes for histopathological analysis (morphological, p53 and Ki67 immunohistochemical assessment). Histopathological lesions were found in both ovaries and tubes. The mean ovarian dysplasia score was significantly higher in the tamoxifen group whatever the dosage (p=0.006 and 0.0002) and in the letrozole group with 0.5mg/kg/day (p=0.0002) compared with the control group. The mean tubal dysplasia score was significantly higher in all groups that received drug treatment compared with the control group, whatever the dosage used. The proliferation index (Ki67) was significantly higher in the tamoxifen and letrozole groups while no significant difference was found for apoptosis marker p53. Ovulation induction may induce histopathological abnormalities in ovaries and tubes with a different immunohistochemical profile in comparison with salpingo-oophorectomies for genetic risk.

Effect of group psycho-game therapy on patient with neurosis

Objective To observe the clinical effect of group psycho -game therapy on patient with neurosis .Methods 72 cases of patient with neurosis were randomly divided into the study group and the control group, each with 36 cases.Both groups received drug treatment and psychological health education , and the study group was given 10 weeks of group psycho-game therapy in addition .MMPI, group psycho-therapy factor questionnaire , NOSIE were used to evaluate the effect before and after treatment .Results There was no statistically significant difference of MMPI and NOSIE between two groups before treatment （P>0.05）.After treatment, the score of Hs, D, Hy, Pt, Si dimension of MMPI was respectively （10.53 ±177;4.55）,（27.23 ±177; 5.02）,（23.26 ±177;5.12）,（18.25 ±177;7.21）,（35.26 ±177;5.81）in the study group, which was significantly different from that in the control group （t=2.951,3.261,3.116,3.146,2.116, respectively; P<0.05）.There was statistically significant difference of Hs , D, Hy, Pd, Pa, Pt, Sc, Si dimension of MMPI before and after treatment in the study group （P〈0.05）.There was statistically significant difference of Hs , D, Hy, Pa, Pt dimension of MMPI before and after treatment in the control group （P〈0.05）.After treatment, the total score of NOSIE was （ 218 .84 ±177;10 .26 ） in the study group , and （ 195 .30 ±177;21 .35 ） in the control group , with statistically significant difference （t=5.958,P<0.05）.There was statistically significant difference of every dimension of NOSIE except personal cleanliness between two groups after treatment （P<0.05）.There was statistically significant difference of all factors except identity and family recurrence of group psycho -therapy factor questionnaire （P <0.05）.Conclusions Group psycho-game therapy is effective to control clinical symptoms of patient with neurosis , improve their personality defects and promote their psychological growth . Key words: Neurosis; Group psycho-game therapy; Personality defect; Psychological growth

Eficacia de la infiltración de ozono paravertebral lumbar y en puntos gatillos como coadyuvante del tratamiento en pacientes con dolor lumbar crónico y lumbociatalgia crónica en el síndrome doloroso miofascial aislado o acompañado de otras patologías

Background: After the first episode of low back pain, recurrence persists for a year or more in 25 to 60 %, affecting economically active population, causing disability and 80 % absenteeism. Objective: To evaluate the effectiveness of the use of ozone injection technique with paravertebral lumbar and trigger points along the drug treatment and rehabilitation in patients with chronic low back pain and sciatica due to chronic pain syndrome myofascial isolated or accompanied other pathologies. Methods: A non-probability, experimental type double-blind controlled. We studied 43 patients (22 experimental and 21 control). The experimental group received lumbar paravertebral ozone trigger points and more drug treatment and rehabilitation. The control group received drug treatment and rehabilitation. Was applied in both groups VAS, Oswestry and measuring the degrees of flexion of the trunk at the beginning, two and four weeks after initiation of therapy. Results: The application of ozone and lumbar paravertebral and trigger points along the drug treatment and rehabilitation in the management of patients with chronic low back pain and sciatica, compared to just drug treatment and rehabilitation, was more effective, with statistical significance (p < 0.05) to decrease the intensity of pain (90.5 %), functional disability (90.5 %) and increased degrees of trunk flexion (85.7 %) versus 40.0, 70 and 75 %, respectively, at four weeks after initiation of treatment. It is evident improvement in patients with MDS or accompanied isolated lateral recess syndrome, facet syndrome, disc herniation varying degrees except the central extrusion. Conclusions: The ozone infiltration paravertebral lumbar and trigger points along the drug treatment and rehabilitation was more effective, to reduce pain and functional disability and increase the degrees of trunk flexion early in patients with chronic low back pain and sciatica due to chronic isolated or accompanied by other conditions that cause back pain.

Analysis on Reverse of Atypical Endometrial Hyperplasia by Drugs in Patients with Polycystic Ovary Syndrome

Objective To analyze the efficacy and safety of drugs on reverse of atypical endometrial hyperplasia in patients with polycystic ovary syndrome (PCOS). Methods Seventeen patients with PCOS complicated by atypical endometrial hyperplasia (9 patients who were treated with progestin but not reversed were considered as group A; 8 patients who were untreated were considered as group B) were retrospectively analyzed. Both groups received oral glucose tolerance test (OGTT) and insulin release test, to check whether the patients had insulin resistance (IR) or hyperinsulinemia. The 17 patients were treated with oral contraceptives combined with metformin. Results After the 17 patients with PCOS complicated by IR and hyperinsulinemia received drug treatment for 3–6 cycles, atypical endometrial hyperplasia was successfully reversed. Conclusion Oral contraceptives combined with metformin is a clinically practical and effective method for treatment of PCOS complicated by atypical insulin-resistant endometrial hyperplasia.

Offenders as victims: post-traumatic stress disorder and substance use disorder among male prisoners

Background: Comorbid substance use disorder(s) and post-traumatic stress disorder (SUD-PTSD) is common among prisoners and linked to an increased risk of criminal recidivism; however, little is known about the characteristics of prisoners with this comorbidity. Aim: This study provides a preliminary examination of the clinical and criminal profile of male inmates with symptoms of SUD-PTSD, and examines whether this profile differs according to whether a person has experienced a trauma while in prison. Methods: Thirty male inmates from two correctional centres in Sydney, Australia, were recruited and assessed using a structured interview. Results: The sample reported extensive criminal, substance use and trauma histories. A history of substance dependence was almost universal (90%) and 56.7% met diagnostic criteria for PTSD with the remainder experiencing sub-threshold symptoms. Forty-three per cent reported a traumatic event while in prison. Those who had experienced trauma in prison, compared to those who had not, were more likely to nominate heroin as their main drug of concern and to be receiving drug treatment in prison. There was also a trend toward inmates who had experienced a trauma in prison being more likely than inmates who had no prison trauma to have experienced a physical assault. Conclusion: Male prisoners with SUD-PTSD are a high-needs group yet treatment responses are poor. Further research examining treatment options for this comorbidity may improve prisoner well-being and reduce recidivism.

Angioplasty and stenting for severe vertebral artery orifice stenosis: effects on cerebellar function remodeling verified by blood oxygen level-dependent functional magnetic resonance imaging.

Vertebral artery orifice stenting may improve blood supply of the posterior circulation of the brain to regions such as the cerebellum and brainstem. However, previous studies have mainly focused on recovery of cerebral blood flow and perfusion in the posterior circulation after interventional therapy. This study examined the effects of functional recovery of local brain tissue on cerebellar function remodeling using blood oxygen level-dependent functional magnetic resonance imaging before and after interventional therapy. A total of 40 Chinese patients with severe unilateral vertebral artery orifice stenosis were enrolled in this study. Patients were equally and randomly assigned to intervention and control groups. The control group received drug treatment only. The intervention group received vertebral artery orifice angioplasty and stenting + identical drug treatment to the control group. At 13 days after treatment, the Dizziness Handicap Inventory score was compared between the intervention and control groups. Cerebellar function remodeling was observed between the two groups using blood oxygen level-dependent functional magnetic resonance imaging. The improvement in dizziness handicap and cerebellar function was more obvious in the intervention group than in the control group. Interventional therapy for severe vertebral artery orifice stenosis may effectively promote cerebellar function remodeling and exert neuroprotective effects.

Prevalence of central sleep apnea among heart failure patients with preserved ejection fraction

Introduction Central sleep apnea (CSA) is common among patients with chronic heart failure (CHF) and has been associated with increased morbidity and mortality. However, scarce data about CSA prevalence in heart failure patients with preserved ejection fraction (EF) are available. The aim of the study was to determine the prevalence of CSA among ambulatory heart failure patients with preserved ejection fraction (HFPEF). Materials and methods Thirty-three ambulatory patients with HFPEF were recruited and subjected to full-night polysomnography. The presence of sleep-disordered breathing (SDB) was based on apnea-hypopnea index (AHI) – 5–15 – mild, 15–30 – moderate, >30 – severe. Preserved ejection fraction was defined as EF > 45%. All patients received drug treatment in concordance with the latest guidelines. Results The mean age was 65.8 ± 8.5 years and the mean left ventricular ejection fraction was 55.4 ± 6.4%. Among the 33 patients, 27 (81.8%) had SDB – 11 (33.3%) CSA, 4 (12.1%) obstructive sleep apnea and 12 (36.4%) mixed sleep apnea. Moderate or severe SDB was present in 24 of them (72.3%). No statistically significant differences between CHF patients with CSA and CHF patients without SDB were found regarding main anthropometric parameters (body-mass index (BMI) = 28.5 ± 6.9 vs 25.6 ± 8.7, NS, age = 70.2 ± 9.9 vs 63.3 ± 8.1, NS) and excessive daytime sleepiness (Epworth score = 8.7 ± 6.1 vs 7.2 ± 2.6). Conclusion CSA demonstrates very high prevalence in patients with HFPEF. Those patients should also be considered for screening for SDB and consequent therapy. Acknowledgement The study was financed by the Bulgarian Ministry of Youth and Science.

Prevalência e impacto da incontinência urinária na qualidade de vida da mulher

Objectives: Urinary incontinence is a health problem with many negative effects on the quality of life of women. It is often under-diagnosed and untreated. This is a study of the prevalence of urinary incontinence, its impact on quality of life, and its association with demographic factors. Study Design: analytical cross-sectional Setting: The family health units of the authors Participants: A sample of 1918 women over age 40 Methods: The variables studied were age, marital status, education, body mass index, number of children, type of incontinence, duration, referral the problem to the doctor and treatment. The impact on quality of life was assessed using the CONTILIFE© questionnaire. The level of significance was set at (p < 0,05). Results: Of the 1291 women responding (mean age 60 years), 23% had urinary incontinence. Their quality of life score was 6.7 points out of a possible 10. The impact on quality of life increases (p < 0.05) with illiteracy, body mass index, and the number of births. 38% of women with urinary incontinence have addressed this issue with their doctor. 66% received either drug treatment or referral. Reporting the problem to the family doctor was associated with greater impact of incontinence on quality of life. (p< 0,001) Conclusions: This study found a high prevalence of urinary incontinence in this population with significant impact on quality of life. Only one third of women with urinary incontinence addressed this problem with their doctor and two thirds of these women received drug treatment or referral.

Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial

We aimed to investigate the efficacy and tolerability of empagliflozin, an oral, potent, and selective inhibitor of sodium-glucose co-transporter 2, in patients with type 2 diabetes who had not received drug treatment in the preceding 12 weeks. In our multicentre, randomised, placebo-controlled, phase 3 trial, we enrolled adults (aged ≥18 years) who had not received oral or injected anti-diabetes treatment in the previous 12 weeks. Eligible patients had HbA1c concentrations of 7-10%. We randomly allocated patients (1:1:1:1) with a computer-generated random sequence, stratified by region, HbA1c, and estimated glomerular filtration rate at screening, to placebo, empagliflozin 10 mg, empagliflozin 25 mg, or sitagliptin 100 mg once daily for 24 weeks. Patients and investigators were masked to treatment assignment. The primary endpoint was change from baseline in HbA1c at week 24 by ANCOVA in all randomly allocated patients who were treated with at least one dose of study drug and had a baseline HbA1c value. This study is completed and registered with ClinicalTrials.gov, number NCT01177813. Between Aug 12, 2010, and March 19, 2012, we randomly allocated 228 patients to receive placebo, 224 to receive empagliflozin 10 mg, 224 to receive empagliflozin 25 mg, and 223 to receive sitagliptin. Compared with placebo, adjusted mean differences in change from baseline HbA1c at week 24 were -0·74% (95% CI -0·88 to -0·59; p<0·0001) for empagliflozin 10 mg, -0·85% (-0·99 to -0·71; p<0·0001) for empagliflozin 25 mg, and -0·73% (-0·88 to -0·59; p<0·0001) for sitagliptin. 140 (61%) patients in the placebo group reported adverse events (four [2%] severe and six [3%] serious), as did 123 (55%) patients in the empagliflozin 10 mg group (eight [4%] severe and eight [4%] serious), 135 (60%) patients in the empagliflozin 25 mg group (seven [3%] severe and five [2%] serious), and 119 (53%) patients in the sitagliptin group (five [2%] severe and six [3%] serious). Empagliflozin provides a tolerable and efficacious strategy to reduce HbA1c in patients with type 2 diabetes who had not previously received drug treatment. Boehringer Ingelheim and Eli Lilly.

Clinical analysis of primary tracheobronchial amyloidosis

Objective To discuss the clinical features,diagnosis,treatment and prognosis of primary tracheobronchial amyloidosis.Methods We retrospectively studied 50 primary tracheobronchial amyloidosis cases reported in Chinese literature during 1989-2012 and one in our hospital.The clinical information,symptoms,imaging findings,endoscopic manifestations and treatment were analyzed.Results The patient in our hospital was admitted due to "short breath".Chest CT,bronchoscopy and pulmonary function examination were done;bronchoscopy biopsy specimen confirmed the diagnosis of PTA;and the patients responded to cyclophosphamide treatment.The main clinical symptoms of the 50 patients included cough(96%,48/50),short breath(70%,35/50),sputum(66%,33/50),fever(24%,12/50),and hemoptysis(22%,11/50).Thickening of lung markings(45.5%,15/33)was the most common chest X-ray finding;airway wall thickening and stenosis(76.2%,32/42) was the most common CT manifestation;and the most common endoscopic finding was also airway wall thickening and stenosis(40.8%,20/49),followed by mucosal congestion and edema(32.7%,16/49).Obstructive ventilatory dysfunction was found to be the major problem during pulmonary function tests.The diagnoses in 47(94%) patients were confirmed by bronchoscopic biopsy.Twenty-one literatures reported complications in 3 cases and misdiagnosis in 24 cases.Forty-two of the 50 patients received drug treatment,bronchoscopic interventional therapy,external beam radiation therapy and surgical treatment,and they responded well. Conclusion Primary tracheobronchial amyloidosis is rare and is prone to be misdiagnosed.Correct diagnose needs pathological examination and currently there is no specific treatment for it.