A Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents

Purpose

The goal of this study was to explore the tolerability, safety, and treatment response of flexible doses of once-monthly paliperidone palmitate (PP) in the subset of nonacute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents in the PALMFlexS (Paliperidone Palmitate Flexible Dosing in Schizophrenia) study.

Methods

This was an interventional, single-arm, international, multicenter, unblinded, 6-month study performed in patients with schizophrenia. Patients were categorized according to reasons for switching. In patients switching because of lack of efficacy or for other reasons, primary efficacy outcomes were the proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to last-observation-carried-forward end point) and maintained efficacy (defined as noninferiority in the change in PANSS total score at end point versus baseline [Schuirmann’s test]), respectively.

Findings

A total of 593 patients (intention-to-treat population) were enrolled: 63.1% were male; their mean (SD) age was 38.4 (11.8) years; and 78.6% had paranoid schizophrenia. The main reasons for transition to PP were patient’s wish (n = 259 [43.7%]), lack of efficacy (n = 144 [24.3%]), lack of compliance (n = 138 [23.3%]), and lack of tolerability (n = 52 [8.8%]) with the previous oral antipsychotic medication. The recommended PP initiation regimen (150 milligram equivalents [mg eq] day 1 and 100 mg eq day 8) was administered in 93.9% of patients. Mean PANSS total score decreased from 71.5 (14.6) at baseline to 59.7 (18.1) at end point (mean change, –11.7 [15.9]; 95% CI, –13.0 to –10.5; P < 0.0001). Sixty-four percent of patients showed an improvement of ≥20% in PANSS total score, and the percentage of patients rated mildly ill or less in Clinical Global Impression–Severity increased from 31.8% to 63.2%. Mean personal and social performance total score (SD) increased (ie, improved) significantly for all patients from baseline to end point (58.1 [13.4] to 66.1 [15.7]; P < 0.0001).

Implications

The PALMFlexS study is a pragmatic interventional study compared with randomized controlled trials, conducted in a large, more representative sample of patients with schizophrenia, and designed specifically to mimic real-world clinical situations. The findings support the results from randomized controlled studies. They also demonstrate that a clinically relevant treatment response is possible in patients who are considered to be clinically stable by their physician, supporting the use of flexibly dosed PP in such patients. Clinical trials.gov number: NCT01281527.     

个案护理管理运用于棕榈酸帕利哌酮治疗精神分裂症患者的临床效果

目的 探讨个案护理管理运用于棕榈酸帕利哌酮治疗精神分裂症患者中的临床效果.方法 选取2015年2月～2016年2月在该院接受治疗的精神分裂症患者98例作为研究对象,随机分为两组,各49例.两组患者均应用棕榈酸帕利哌酮治疗,对照组患者接受常规护理,观察组患者给予个案护理管理.观察两组患者PSP评分、PANSS评分、MARS评分的变化.结果 两组治疗前PANSS评分相比,差异无统计学意义(P>0.05);观察组治疗后4、8、16、24、36、48周的PANSS评分低于对照组,差异有统计学意义(P<0.05).两组治疗前PSP评分相比,差异无统计学意义(P>0.05);观察组治疗后4、8、16、24、36、48周的PSP评分与MARS评分高于对照组,差异有统计学意义(P<0.05).结论 个案护理管理运用于棕榈酸帕利哌酮治疗精神分裂症患者中效果显著,可以显著减轻患者临床症状,改善患者社会功能,提高患者治疗依从性.     

Mycobacterium abscessus infection after facial injection of argireline: A case report

BACKGROUNDThe incidence of infection with Mycobacterium abscessus (M. abscessus) has increased in recent years. This increase is partly associated with invasive cosmetic procedures. CASE SUMMARYThe purpose of this case summary is to increase clinicians'' awareness of M. abscessus infection and reduce mycobacterial infection caused by cosmetic procedures. We report the case of a 45-year-old woman who received acetyl hexapeptide-8 (argireline) injections in the forehead and temples, and erythema, nodules, and abscesses appeared at the injection sites after one week. The pus specimens were examined by microbiological culture and confirmed to be positive for M. abscessus. Clarithromycin 500 mg twice daily and moxifloxacin 400 mg once daily were administered for 5 mo and the lesions gradually subsided. CONCLUSIONWe report here for the first time a case of infection with M. abscessus after argireline injection. This condition is easily misdiagnosed as a common bacterial infection. Microbiological examinations are helpful for diagnosis and standardized cosmetic procedures can prevent infection with M. abscessus.     

Rectal mature teratoma: A case report

BACKGROUNDRectal mature teratoma is rare and has been reported as a case report in this study. Herein, clinical presentation, magnetic resonance imaging findings, and immunohistochemistry showed a pelvic rectal mature teratoma. The case report and the surgical treatment procedure have been discussed below.CASE SUMMARYA 29-year-old Chinese female showed up with over a 1-mo history of perianal mass that emerged after defecation. Physical examination indicated that the mass was 4 cm × 3 cm × 3 cm. The intraoperative procedure involved ligation of the sigmoid colon 10 cm above the upper edge of the tumor, followed by ligation of the rectum 3.5 cm above the upper edge of the tumor, and subsequent complete removal of the mass. The histopathology confirmed the mature teratoma.CONCLUSIONThe tumor can be completely removed using surgery to prevent its recurrence.     

Primary maxillary chondrosarcoma: A case report

BACKGROUND Sarcomas of the head and neck region are rare tumors,constituting less than 1%of malignant neoplasms in this area,of which few cases(20%)originate from bone or cartilage.Chondrosarcoma is a malignant neoplasm that develops in bone,with a predilection for the pelvis,chest wall,and scapula,and is uncommon in the maxilla and jaw.Although this type of lesion has locally aggressive behavior,destroying the affected bone,it can metastasize when it is not diagnosed early and compromise the patient's life.CASE SUMMARY On intraoral examination of a 32-year-old female with a tumor in the middle third of the face,a well-defined rise in volume of approximately 3 cm in diameter was observed.Computed tomography with 3-dimensional reconstruction was performed,and we observed that the osteolytic lesion affected the vestibular cortex as the palatal bone.Hematoxylin and eosin staining revealed an appearance that was similar to mature hyaline cartilage,hypercellularity,nuclear and cellular pleomorphism,and multinucleated cells,with significant vacuolization.CONCLUSION Determination of the clinical and histopathological characteristics of rare neoplasms in the maxillofacial region,such as chondrosarcomas,allows the pathologist and surgeon to make the appropriate therapeutic decisions,optimizing the patient’s prognosis.     

Pregnancy-induced leukocytosis: A case report

BACKGROUNDPregnancy is a complex physiological process. Physiological leukocytosis occurs often and is mainly associated with increased neutrophil counts, especially in the third trimester of pregnancy. Non-congenital leukocytosis with white blood cell counts above 20 × 10⁹/L lasting 13 wk during pregnancy is rare and has been reported occasionally. Herein, we present a case of pregnancy-induced leukocytosis. CASE SUMMARYWe present the case of a 33-year-old Chinese woman at 27 wk of gestation who had a leukocytosis complication. No abnormalities were detected in the examinations before pregnancy or in the first trimester. From the third trimester of pregnancy, the patient began to suffer from asymptomatic leukocytosis. We administered antibiotics to treat the patient; however, the complication persisted until the patient underwent a cesarean section after 40⁺³ wk of gestation. One day after the cesarean section, the patient’s neutrophil count returned to normal. After 2 years of follow-up, we found that the patient and baby were healthy.CONCLUSIONPregnancy-induced leukocytosis seems to be associated with immunoregulation and pregnancy termination may be the most effective treatment approach for pregnancies complicated with malignant leukocytosis.     

Progressive disfiguring facial masses with pupillary axis obstruction from Morbihan syndrome: A case report

BACKGROUNDMorbihan syndrome is a rare illness, which presents with recurrent pitting edema on the upper two thirds of the face causing facial contour deformities, and Morbihan syndrome obstructing the pupillary axis with ptosis was seldomly reported.CASE SUMMARYA 59-year-old woman presented with a 15-year history of facial swelling that progressively invaded bilaterally from the inner canthus and eyelids outwards. Imaging examination indicated that the bilateral periorbital and the left temporal soft tissues had swelling without cranium invasion. Histopathological analysis showed a large amount of lymphocyte infiltration, and immunohistochemistry showed positive expression of CD68 in clear-cut granulomas and D2-40 in the lymphatic endothelium. Finally, the clinical diagnosis of Morbihan syndrome was confirmed.CONCLUSIONMorbihan syndrome is an infrequent and refractory disease, which is characteristic with recurrent woody facial edema on the upper two thirds of the face. Solid facial edema is persistent and non-pitting, causing facial contour deformities and even vision field impairment. The diagnosis of Morbihan syndrome depends on clinical features, imaging information, and pathology. Blepharoplasty is optional to improve the visual field for these patients with severe pupillary axis obstruction.     

Retroperitoneal parasitic fetus: A case report

BACKGROUNDFetus-in-fetu (FIF) is an extremely rare congenital abnormal mass, in which a normal fetus’s vertebral axis frequently connected with malformed fetus around this axis. Here, we report the case of a male infant aged 26 d presenting with retroperitoneal parasitic fetus. CASE SUMMARYIn a prenatal examination, we first detected an abdominal mass measuring 7.8 cm × 5.1 cm × 6.8 cm in a mother’s abdomen at 25 gestational weeks and teratoma was suspected. After the fetal was born, we did a magnetic resonance imaging (MRI) and ultrasonography on him and saw a distinctive limb with five-toes. According to the result of MRI, ultrasonography and postoperative pathology, he finally was diagnosed with FIF. CONCLUSIONA laparotomy was performed at 26 d of age with excision of the retroperitoneal cystic tumor, which measured about 10 cm in diameter. According to the result of imaging and histological test, FIF was confirmed.     

Multiple gastric angiolipomas: A case report

BACKGROUND Angiolipoma is a benign tumor and is generally found in subcutaneous tissues.Angiolipomas are rare in the gastrointestinal tract,including the stomach.Preoperative diagnosis of the tumor is difficult,although there are several radiological examinations such as computed tomography and endoscopic ultrasound.CASE SUMMARY We report a 24-year-old Chinese man with multiple gastric angiolipomas,with a positive stool occult blood examination. Endoscopic biopsy only showed nonspecific inflammation. Histological examination of the specimen by endoscopic snare resection showed that the tumor consisted of adipose tissues and blood vessels. We also performed a literature review. After the use of proton pump inhibitor,the fecal occult blood test was negative. Due to the difficulty of resecting multiple lesions in the stomach completely and the benign characteristics of angiolipoma,we chose to have regular upper gastrointestinal endoscopy evaluation of the lesion. No evidence of significant change in lesion size was detected after 3-years follow-up.CONCLUSION Gastric angiolipoma is rare,and benign neoplasm should be considered when lesions occur submucosally in the gastrointestinal tract.