注射用盐酸柔红霉素的质量评价

目的 按照国家计划抽验要求，评价国内不同企业生产的注射用盐酸柔红霉素的质量。方法 按国家标准检验与探索性研究相结合，对抽验样品进行检验，对检验结果进行统计分析。结果 共抽取样品17批次，按国家标准检验合格率100.0%。探索性研究对主要杂质的来源与结构进行了研究；建立溶液的澄清度检查方法；对包材相容性及稳定性进行了考察。结论 目前国内注射用盐酸柔红霉素总体质量较好；现行标准有待进一步提高，建议现行标准修订有关物质检查方法，增加特定杂质的控制，增加溶液的澄清度检查；建议企业优化生产工艺，以提高产品质量。     

Simeprevir added to peginterferon and ribavirin lessens time with fatigue,depressive symptoms and functional limitations in patients with chronic hepatitis C compared with peginterferon and ribavirin: results from 1161 patients in the QUEST‐1, QUEST‐2 and PROMISE studies

The value of adding simeprevir (SMV) vs placebo (PBO) to peginterferon and ribavirin (PR) for treatment of chronic hepatitis C virus infection was examined using patient‐reported outcomes (PROs); further, concordance of PROs with virology endpoints and adverse events (AEs) was explored. Patients (n = 768 SMV/PR, n = 393 PBO/PR) rated fatigue (FSS), depressive symptoms (CES‐D) and functional impairment (WPAI: Hepatitis C Productivity, Daily Activity and Absenteeism) at baseline and throughout treatment in three randomised, double‐blind trials comparing the addition of SMV or PBO during initial 12 weeks of PR. PR was administered for 48 weeks (PBO group) and 24/48 weeks (SMV group) using a response‐guided therapy (RGT) approach. Mean PRO scores (except Absenteeism) worsened from baseline to Week 4 to the same extent in both groups but reverted after Week 24 for SMV/PR and only after Week 48 for PBO/PR. Accordingly, there was a significantly lower area under the curve (baseline–Week 60, AUC₆₀) and fewer weeks with clinically important worsening of scores in the SMV/PR group at any time point. Incidences of patients with fatigue and anaemia AEs were similar in both groups, but FSS scores showed that clinically important increases in fatigue lasted a mean of 6.9 weeks longer with PBO/PR (P < 0.001). PRO score subgroup analysis indicated better outcomes for patients who met the criteria for RGT or achieved sustained virological response 12 weeks post‐treatment (SVR12); differences in mean PRO scores associated with fibrosis level were only observed with PBO/PR. Greater efficacy of SMV/PR enabled reduced treatment duration and reduced time with PR‐related AEs without adding to AE severity.     

Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized,double-blind pilot study

Flavocoxid (Limbrel), a proprietary mixture of flavonoid molecules (baicalin and catechin), was tested against a traditional nonsteroidal anti-inflammatory drug, naproxen, for the management of the signs and symptoms of moderate osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either flavocoxid [500 mg twice daily (BID)] or naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both flavocoxid and naproxen showed significant reduction in the signs and symptoms of knee OA (P ≤ .001). There were no statistically detectable differences between the flavocoxid and naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of edema and nonspecific musculoskeletal discomfort in the naproxen group. In this short-term pilot study, flavocoxid was as effective as naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.     

Zolpidem induced nocturnal sleep‐related eating disorder (NSRED) in a male patient

Nocturnal Sleep‐Related Eating Disorder (NSRED) is a well‐documented sleeping disorder where the person is reported to experience bizarre eating behavior during sleep. Although various causes are implicated in this disorder, role of drugs cannot be ruled out. Here we narrate an interesting rare case report of a drug‐induced new onset NSRED, where a 45‐year‐old man on zolipdem performed an unexpected and bizarre eating behavior during somnambulistic state, type of which has not been reported earlier in the literature. The case falls under even rarer category as such behavior in sleep is reported mainly in woman. © 2008 by Wiley Periodicals, Inc. Int J Eat Disord 2009     

碱性成纤维细胞生长因子（bFGF）加速猪背部创伤修复的实验研究

实验采用猪背部创伤模型，观察重组的碱性成纤维细胞生长因子（ｂＦＧＦ）对创伤修复的作用。在无菌条件下用特制打孔器在猪背部切割皮肤，形成２．５ｃｍ２的园型创面。将１５０个创面分成５组，分别以ｂＦＧＦ（６０ｕ／ｃｍ２创面），ｂＦＧＦ（（６０ｕ／ｃｍ２创面）加ＳＤ－Ａｇ、ＳＤ－Ａｇ、生理盐水以及不治疗等方法处理，每间隔一天换药一次。实验结果表明，ｂＦＧＦ具有显著促进肉芽组织生长、加速创面再上皮化率以及增加创面愈合组织抗张力强度等作用。ＦＧＦ显著促修复效应的确切机制尚不完全清楚，可能包括直接与间接效应两方面。     

Non-HIV-Related Progressive Multifocal Leukoencephalopathy (PML): A Tertiary Cancer Center Experience

In the course of 1 year at a tertiary cancer center, 3 patients (2 men; 1 woman; age 51-75 years) were seen in neurological consultation (1.5% of all consultations). Clinical course in all patients was of a progressive neurologic disorder not consistent with either a primary or secondary malignancy. Magnetic resonance (MR) imaging was most informative with respect to diagnosis and subsequent management. Brain biopsy was performed in all patients to assist in both diagnosis and prognostication. All patients were determined to have progressive multifocal leukoencephalopathy (PML) by brain biopsy.     

About the centrality of mood lowering in mood disorders : Plenary Lecture ECNP Congress, Monte Carlo, October 1991

5-HT disturbances in depression (as exemplified by lowered CSF 5-HIAA) are not syndrome specific but related to components of the depressive syndrome, specifically to increased anxiety and aggression. These 5-HT disturbances are probably core pathogenetic processes not derivative features. I hypothesized that in this subtype of depression, i.e. in “5-HT related depression”, the key psychopathological disturbances are dysregulation of anxiety and aggression, while mood lowering is a “by-product”. Based on this hypothesis it was predicted that agents which ameliorate anxiety and/or aggression via harmonization of 5-HTergic transmission will, in addition, exert overall antidepressant effect in “5-HT related depression”. The study of the relative “weight” of the various psychopathological components of depression is a basic exercise in understanding the nature of that condition and could, as such, greatly facilitate the goal-directed search for new and innovative antidepressants.     

Outcome of live related and live unrelated renal transplants

Summary: This study compares the outcomes of 229 renal transplants, of which 156 were live related renal transplants done at our centre and 73 unrelated transplants done at other centres but followed up at our centre. All the patients were on triple immunosuppression for periods varying between 9 months and 1 year. Patient characteristics, rejections, infections and 1 and 5 years patient and graft survival were analyzed in the two groups. the outcome of patients who continued on cyclosporine beyond 1 year was compared to those who discontinued cyclosporine at 1 year. Males predominated (191 vs 38) in both groups, while younger patients (<50 years) predominated in live related group (152 vs four). There was no difference in the incidence of infection, rejection, graft dysfunction, graft loss or death between the two groups. the 1 and 5 year patient survival in the related and unrelated group, (93.7% and 71.4% vs and 85% and 66%) and graft survival (90.4% and 69.4% vs 83.3% and 65.4%) were similar. However, in the unrelated group, patients who discontinued cyclosporine had a higher incidence of rejections (38% vs 14%) and graft loss (43% vs 11.8%), while in the related group no such difference was found. It is concluded that 1 and 5 year patient and graft survival is comparable between live related and live unrelated transplantation. However, in the unrelated group it is necessary to continue cyclosporine beyond 1 year in order to achieve comparable results.