Background: Insomnia often responds to the orexin receptor antagonist suvorexant. This study aimed to evaluate the efficacy and adverse events of suvorexant for Chinese patients with primary insomnia over 6 months. Methods: A total of 120 patients with primary insomnia were assigned randomly to two groups that received placebo or suvorexant (40 mg) for 6 months. The primary outcomes were the total sleep time (sTST), time to sleep onset (sTSO), and sleep quality (sQUAL). The secondary outcomes were the Insomnia Severity Index (ISI) score and adverse events. Results: A total of 111 patients completed the study and all of them were included in the final analysis. Suvorexant showed greater efficacy than the placebo in enhancing sTST, sTSO, sQUAL and ISI score at months 1 and 6. Serious adverse events were documented in 2 patients (3.3%) in the suvorexant group and 1 patients (1.7%) in the placebo group. The most common adverse event was somnolence, which occurred in 7 patients (11.7%) in the suvorexant group and 2 patients (3.3%) in the placebo group. No death related to suvorexant treatment was recorded. Conclusions: Suvorexant was efficacious and well-tolerated in a group of Chinese patients with primary insomnia over 6 months.
Sleep Initiation and Maintenance Disorders

BACKGROUND: Acetabular cup orientation using a standard radiograph of the pelvis is quite common method to assess artificial hip replacement nowadays. Non-standardization of pelvic orientation affected accuracy of measurement results, and it is difficult to compare. OBJECTIVE: To make sure how pelvis tilting affect the anteveration of the cup and to elevate clinical accuracy and compare study comparability. METHODS: Designed a simulated acetabular cup with serial concentric circles which pass through the same polars and represent anteveration of 0°, 10°, 20°, 30°, 40°, Loaded the simulated acetabular cup at an inclination of 35°, 40°, 45°, 50°, 55° to6 cadaver pelves, Made the pelves tilt around the frontal axis and sagittal axis with 5° each time in a scope of+30°. Takestandard radiograph of the pelvis accordingly. Radiograph was photographed end frontal angle of dip was measured. RESULTS AND CONCLUSION: Pelvic tilt of about 1° causes measuring errors of anteveration 0. 61 °-0. 73°. The anteveration decreased at both acetabular cups when pelvic posterior tilt and at the acetabular cup that near the X-ray source as pelvic lateral tilt. The anteveration rose at both acetabular cups when pelvic anterior tilt and at the acetabular cup that away from the X-ray source as pelvic lateral tilt. During clinical evaluation, pelvic orientation effects on measurement results should be considered.

Objective To elucidate the clinical characteristics and coronary angiographic findings of patients underwent PCI before and after drug-eluting stents(DES).Methods DESIRE(Drug-Eluting Stent Impact on revascularization) was a retrospective registry of patients who received revascularization therapy during July,2001 through June,2002(non-DES era) and July,2003 through February,2004(DES era).In this analysis,we used the DISIRE data to examine the clinical and angiographic features of patients who received PCI in the different era.Results Among 3763 patients in the registry,2180 patients were analyzed(763 were in the non-DES era and 1417 were in the DES era).In the DES era,more diseased vessels(1.31?0.54 vs 1.39?0.61,P

Objective To explore the clinical application value of percutaneous kyphoplasty ( PKP ) under the guidance of G arm X ray machine in the treatment of osteoporotic vertebral compression fracture (OVCF). Methods The medical records of eighty-two patients (94 vertebral bodies) with OVCF treated with PKP were collected retrospectively. Thirty-nine cases ( 44 vertebral bodies ) were guided by G-arm X-ray machine to implement PKP,which were recorded as G-arm group. Forty-three cases (50 vertebral bodies) were guided by C-arm X-ray machine to carry out PKP,which were recorded as C-arm group. The operation time, intraoperative fluoroscopy times, bone cement leakage cases, preoperative and postoperative anterior height of injured vertebrae,Cobb angle of injured vertebrae,visual analogue scale scores and Oswestry disability index of the two groups were recorded. Results There was significant difference in operation time and intraoperative fluoroscopy times between the G-arm group and C-arm group (the operation time:(31. 6±5. 2) vs. (45. 8±6. 7) min,the intraoperative fluoroscopy times: (9. 5±2. 3) times vs. (18. 7±3. 5) times,t=-10. 64,-13. 91,P<0. 05) ,while there was no significant difference in the number of bone cement leakage ( P>0. 05) . Compared postoperative and preoperative anterior height of injured vertebrae, Cobb angle of injured vertebrae, visual analogue scale scores and Oswestry disability index scores of G-arm group and C-arm group respectively, the differences were significant ( t=-3. 41 vs. -3. 28, 6. 67 vs. 7. 66, 26. 63 vs. 25. 75 and 10. 41 vs. 11. 90, P<0. 05). There was no significant difference between the two groups (P>0. 05). Conclusion The treatment of OVCF with PKP guided by G-arm X-ray machine could significantly shorten operation time, reduce the intraoperative fluoroscopy times and the operative difficulty,and increase operation safety than PKP guided by traditional C-arm X-ray machine.

Objective:To report a SPTLC2 gene mutation in a family with a phenotype of Charcot-Marie-Tooth disease.Methods:To screen the family of patients with pathogenic mutations of SPTLC2 gene from the database of hereditary peripheral neuropathy in the Department of Neurology, Peking University First Hospital, and to collect their clinical data, peripheral nerve conduction examination, nerve ultrasound examination, pathological examination of the peroneal nerve and whole exome sequencing results of prohand.Results:One family was screened, the proband was a 16-year-old female with 4 years of sensory loss and anhidrosis of both lower limbs and 16 months of walking difficulty who admitted to Peking University First Hospital in January 2022. Physical examination showed sensory loss, dry skin and weakness in distal limbs. Her father had numbness and dry skin in the distal lower limbs from childhood,weakness and atrophy of his lower limbs in adulthood. He died at age of 52 years old. The nerve conduction study revealed no action potentials of the sensory and motor nerves of the lower limbs in the proband. The amplitude of the compound muscle action potential of the motor conduction of the bilateral ulnar nerve and median nerve decreased, and the nerve conduction velocity of the bilateral median nerve were 32 m/s and 24 m/s. Neurosonography showed thickening of peripheral nerves. Sural biopsy revealed severe loss of myelinated and unmyelinated nerve fibers with onion bulbs formation. SPTLC2 gene showed a known heterozygous p.G435V mutation. The lower limb weakness was improved after oral L-serine.Conclusions:SPTLC2 gene mutation can lead to an intermediate Charcot-Marie-Tooth disease phenotype. L-serine can improve the limb weakness.

OBJECTIVETo evaluate the efficacy and safety of itraconazole for secondary prophylaxis of previous proven or probable invasive fungal infection (IFI) in patients undergoing chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) in agranulocytosis state.

METHODSA phase IV prospective, open-label, multicenter trial was conducted to evaluate itraconazole (200 mg q12h intravenously d1-2, 200 mg/d) as secondary antifungal prophylaxis in patients (18-65 years old) undergoing chemotherapy or HSCT with previous proven or probable IFI. Itraconazole was started when patients' neutrophils＜1.5 × 10⁹/L, and stopped when chemotherapy patients' neutrophils ＞0.5 × 10⁹/L and stem cell transplant recipients' neutrophils＞1.0 × 10⁹/L. The primary end-point of the study was the incidence of proven, probable or possible IFI.

RESULTSSeventy one patients from November 2008 to September 2010 were enrolled in the trial. The median duration of itraconazole prophylaxis was 14 (4-35) days. No patients died of drug-related toxicity within trial. Five cases occurred IFI during the trial. The cumulative incidence of invasive fungal disease was 7.0%. One patient was withdrawn from the study due to treatment-related adverse events (liver malfunction and severe phlebitis).

CONCLUSIONItraconazole appears to be safe and effective for secondary prophylaxis of systemic fungal infection after chemotherapy and allogeneic HSCT. The observed incidence of 7.0% is considerably lower than the relapse rate reported in historical controls, suggesting that itraconazole is a promising prophylactic agent in this population.

Adolescent ; Adult ; Aged ; Antifungal Agents ; therapeutic use ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Itraconazole ; therapeutic use ; Male ; Middle Aged ; Mycoses ; prevention & control ; Prospective Studies ; Treatment Outcome ; Young Adult

BACKGROUNDPeople with metabolic syndrome are at higher risk for developing coronary artery disease (CAD). The effect of the metabolic syndrome on outcomes in patients with preexisting CAD has not been well studied. This study was conducted to assess the prevalence, characteristics, in hospital and long term prognosis of CAD with metabolic syndrome and to determine the factors influencing the prognosis of the disease.

METHODSThe DESIRE registry contains data of 3696 patients with CAD between 2001 and 2004. Mean long term followup was (829 +/- 373) days. Diagnosis of metabolic syndrome was based on modified International Diabetes Federation (IDF) Worldwide Definition of the Metabolic Syndrome, using body mass index (BMI) instead of waist circumference.

RESULTSOf 2596 patients with complete records of height, weight, and so on, 1280 (49.3%) were identified with metabolic syndrome. The patients with metabolic syndrome had higher level of body mass index, systolic blood pressure, diastolic blood pressure, fasting glucose and disordered blood lipid (all P < 0.0001), with higher creatinine [(10.5 +/- 4.3) mg/L vs (9.9 +/- 2.9) mg/L, P < 0.0001] and the number of white blood cells [(7.49 +/- 2.86) x 10(9)/L vs (7.19 +/- 2.62) x 10(9)/L, P = 0.008) compared with those without metabolic syndrome. The patients with metabolic syndrome showed severer coronary angiographic alterations (left main artery and/or > or = 2-vessel) (73.6% vs 69.6%, P = 0.031). There were no significant differences of major adverse cardiac and cerebral events (MACCE) or mortality in hospital between the two groups. During followup, the ratio of MACCE in CAD with metabolic syndrome patients increased significantly (11.8% vs 10.0%, P = 0.044). Fasting blood glucose (> or = 1000 mg/L) and triglyceride (TG, > or = 1500 mg/L) were responsible for most of the increased risk associated with the metabolic syndrome (adjusted OR 1.465, 95% CI 1.037 - 1.874, P = 0.032; OR 1.378, 95% CI 1.014 - 1.768, P = 0.044).

CONCLUSIONSThe prevalence of metabolic syndrome was very high in CAD patients. The metabolic syndrome confers a higher risk of long term MACCE in patients with CAD, and dysglycaemia and hypertriglycaemia appear to be responsible for most of the associated risk.

Adult ; Aged ; Blood Glucose ; analysis ; Coronary Artery Disease ; complications ; physiopathology ; therapy ; Female ; Humans ; Lipids ; blood ; Male ; Metabolic Syndrome ; complications ; epidemiology ; Middle Aged ; Myocardial Revascularization ; Prognosis

BACKGROUNDCatheter ablation for atrial fibrillation (AF) has been demonstrated to be effective in a subsets of patients with AF. However, very few data are available in regard to patients with prior history of stroke undergoing catheter ablation. This study aimed to investigate the outcome of catheter ablation in AF patients with prior ischemic stroke.

METHODSBetween January 2008 and December 2011, of 1897 consecutive patients who presented at Beijing An Zhen Hospital for treatment of drug-refractory AF, 172 (9.1%) patients in the study population had a history of ischemic stroke. All patients underwent catheter ablation and were followed up to assess maintenance of sinus rhythm and recurrence of symptomatic stroke.

RESULTSAmong these 1897 patients, 1768 (93.2%) who had complete follow-up information for a minimum of six months were included in the final analysis. Patients in the stroke group (group I) and the no-stroke group (group II) were similar in regards to gender, body mass index (BMI), history of diabetes, type of AF, and left atrial size. The patients in group I were older than those in group II, and had a higher incidence of hypertension, chronic heart failure, lower left ventricular ejection fraction (LVEF), and higher CHADS2 scores. Six months after ablation, 107 (68.6%) patients in group I and 1403 (87.1%) in group II had discontinued warfarin treatment (P < 0.001). During a median follow-up of (633 ± 415) days, 65 patients in the group I and 638 in group II experienced AF recurrence, and five patients in group I and 28 in group II developed symptomatic stroke. The rates of AF recurrence and recurrent stroke were similar between group I and group II (41.7% vs. 39.6%, P = 0.611; 3.2% vs. 1.7%, P = 0.219; respectively).

CONCLUSIONCatheter ablation of AF in patients with prior stroke is feasible and efficient.

Aged ; Atrial Fibrillation ; surgery ; Catheter Ablation ; methods ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Stroke ; surgery

Three prime repair exonuclease 1 (TREX1), also known as DNase IE, is a major 3'-5' restriction exonuclease in most of tissues and cell types of the mammals. The exonuclease activity of TREX1 plays an essential role in maintaining the immune tolerance of the innate immune system, which avoids the excessive activation of the innate immune system and massive production of auto-antibodies induced by the abnormal accumulation of cytosolic DNA. cGAS-STING signaling was identified as an important innate immune response to pathogens and maintained cellular environmental homeostasis. TREX1 prevents occasional leakage of nuclear DNA into the cytosol, which activates cGAS and triggers the downstream type I interferons cascade. Mutations of human TREX1 cause a series of autoimmune diseases, such as Aicardi-Goutieres syndrome (AGS), Familial chilblain lupus (FCL), Systemic lupus erythematosus (SLE) and Leukodystrophy-related retinopathy (RVCL). Besides, TREX1 inhibits the innate immune response to human immunodeficiency virus type 1 (HIV-1) and plays an important role in mediating the viral immune evasion. Moreover, TREX1 acts as an upstream regulator of the DNA sensing pathway, which maintains tumor immune tolerance and prevents cell senescence. Here, we focus on the immune regulation of TREX1 and demonstrate the role of TREX1 in autoimmune diseases, HIV-1 infection, cancer and cell senescence to provide the basic theoretical guidance for human disease therapy.

Objective To explore the safety and efficacy of neoadjuvant chemotherapy(NAC)combined with immunotherapy before radical cystectomy plus pelvic lymph nodes dissection(RC-PLND)for muscle-invasive bladder cancer(MIBC).Methods The clinical data of 101 patients with MIBC who underwent neoadjuvant therapy followed by RC-PLND in the Department of Urology,the First Affiliated Hospital of Xi'an Jiaotong University during Jan.2019 and Dec.2023 were retrospectively analyzed,including 71 patients(70.3％)who received NAC(NAC group)and 30(29.7％)who received NAC combined with immunotherapy(NAC combine immunotherapy group).The clinical and pathological data and adverse events during neoadjuvant therapy were compared.Logistic regression analysis was used to explore the independent predictors of pathological complete response(pCR)and pathological partial response(pPR).Results There were no significant differences in the baseline data between the two groups(P＞0.05).However,the proportion of multiple tumors in patients receiving NAC before surgery was significantly higher than that in the NAC combined immunotherapy group(69.0％vs.46.7％,P=0.034).Compared with NAC group,NAC combined with immunotherapy group had significantly improved rate of pathological downstaging and pPR(60.6％vs.83.3％,P=0.026;45.1％vs.70.0％,P=0.022).Furthermore,the rate of pCR in patients undergoing NAC combined immunotherapy was higher than those undergoing NAC,but the difference was not significant(53.3％vs.33.8％,P=0.067).Logistic regression analysis revealed that clinical T-stage and tumor diameter were independent predictors of pCR and pPR(P＜0.05).In addition,the most common adverse events during neoadjuvant therapy were anemia,decreased white blood cells,nausea,and vomiting,but most of them were grade 1-2 and could be relieved through symptomatic treatment.Conclusion NAC combined with immunotherapy is safe and effective,which can improve the rate of pathological downstaging,pPR and pCR,without increasing the incidence of adverse reactions.