美国有324种生物技术类新药处于研发阶段

根据美国药品研究与制造商协会(PhRMA)的最新调查，共有324种应用生物技术新近开发的药品和疫苗目前正在接受针对近150种疾病的疗效测试。

Microbiome and pancreatic cancer: A comprehensive topic review of literature

To review microbiome alterations associated with pancreatic cancer, its potential utility in diagnostics, risk assessment, and influence on disease outcomes.METHODSA comprehensive literature review was conducted by all-inclusive topic review from PubMed, MEDLINE, and Web of Science. The last search was performed in October 2016.RESULTSDiverse microbiome alterations exist among several body sites including oral, gut, and pancreatic tissue, in patients with pancreatic cancer compared to healthy populations.CONCLUSIONPilot study successes in non-invasive screening strategies warrant further investigation for future translational application in early diagnostics and to learn modifiable risk factors relevant to disease prevention. Pre-clinical investigations exist in other tumor types that suggest microbiome manipulation provides opportunity to favorably transform cancer response to existing treatment protocols and improve survival.

Development and validation of a simple and multifaceted instrument,GERD-TEST,for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms

To evaluate the psychometric properties of a newly developed questionnaire, known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), in patients with GERD.METHODSJapanese patients with predominant GERD symptoms recruited according to the Montreal definition were treated for 4 wk using a standard dose of proton pump inhibitor (PPI). The GERD-TEST and the Medical Outcome Study Short Form-8 Health Survey (SF-8) were administered at baseline and after 4 wk of treatment. The GERD-TEST contains three domains: the severity of GERD and functional dyspepsia (FD) symptoms (5 items), the level of dissatisfaction with daily life (DS) (4 items), and the therapeutic efficacy as assessed by the patients and medication compliance (4 items).RESULTSA total of 290 patients were eligible at baseline; 198 of these patients completed 4 wk of PPI therapy. The internal consistency reliability as evaluated using the Cronbach’s α values for the GERD, FD and DS subscales ranged from 0.75 to 0.82. The scores for the GERD, FD and DS items/subscales were significantly correlated with the physical and mental component summary scores of the SF-8. After 4 wk of PPI treatment, the scores for the GERD items/subscales were greatly reduced, ranging in value from 1.51 to 1.87 and with a large effect size (P < 0.0001, Cohen’s d; 1.29-1.63). Statistically significant differences in the changes in the scores for the GERD items/subscales were observed between treatment responders and non-responders (P < 0.0001).CONCLUSIONThe GERD-TEST has a good reliability, a good convergent and concurrent validity, and is responsive to the effects of treatment. The GERD-TEST is a simple, easy to understand, and multifaceted PRO instrument applicable to both clinical trials and the primary care of GERD patients.

ACL reconstruction with BPTB autograft and irradiated fresh frozen allograft

Objective： To analyze the clinical outcomes of arthroscopic anterior cruciate ligament （ACL） reconstruction with irradiated bone-patellar tendon-bone （BPTB） allograft compared with non-irradiated allograft and autograft. Methods： All BPTB allografts were obtained from a single tissue bank and the irradiated allografts were sterilized with 2.5 mrad of irradiation prior to distribution. A total of 68 patients undergoing arthroscopic ACL reconstruction were prospectively randomized consecutively into one of the two groups （autograft and irradiated allograft groups）. The same surgical technique was used in all operations done by the same senior surgeon. Before surgery and at the average of 31 months of follow-up （ranging from 24 to 47 months）, patients were evaluated by the same observer according to objective and subjective clinical evaluations. Results： Of these patients, 65 （autograft 33, irradiated allograft 32） were available for full evaluation. When the irradiated allografl group was compared to the autograft group at the 31 -month follow-up by the Lachman test, the anterior drawer test （ADT）, the pivot shift test, and KT-2000 arthrometer test, statistically significant differences were found. Most importantly, 87.8% of patients in the autograft group and just only 31.3% in the irradiated allograft group had a side-to-side difference of less than 3 mm according to KT-2000. The failure rate of the ACL reconstruction with irradiated allograft （34.4%） was higher than that with autograft （6.1%）. The anterior and rotational stabilities decreased significantly in the irradiated allograft group. According to the overall International Knee Documentation Committee （1KDC）, functional and subjective evaluations, and activity level testing, no statistically significant differences were found between the two groups. Besides, patients in the irradiated allograft group had a shorter operation time and a longer duration of postoperative fever. When the patients had a fever, the laboratory examinations of all patients were almost normal. Blood routine was normal, the values of erythrocyte sedimentation rate （ESR） were 5-16 mm/h and the contents of C reactive protein （CRP） were 3-10 mg/L. Conclusion： We conclude that the short term clinical outcomes of the ACL reconstruction with irradiated BPTB allograft were adversely affected. The less than satisfactory results led the senior authors to discontinue the use of irradiated BPTB allografl in ACL surgery and not to advocate using the gamma irradiation as a secondary sterilizing method.