Research about clinical comprehensive evaluation methods of pediatric drugs ：taking pediatric anti-allergic drugs as an example / 中国药房

OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.

Clinical efficacy of an integrated traditional Chinese and Western medication regimen on depression in the elderly / 中华老年医学杂志

Objective:To evaluate the clinical efficacy of an integrated traditional Chinese and Western medication regimen on depression in the elderly.Methods:Sixty elderly patients with depression were randomly divided into two groups.The integrated traditional Chinese and Western medicine group was treated with an in-house preparation composed of traditional Chinese medicine ingredients plus Escitalopram oxalate for 4 weeks, and the control group was treated with Escitalopram oxalate for 4 weeks.The clinical efficacy was assessed by the Hamilton depression(HAMD)scale.Adverse drug reactions were assessed by the treatment emergent symptoms scale(TESS).Results:After 4 weeks of treatment, HAMD scores in both groups were decreased compared with those before treatment, with a greater reduction in HAMD scores in the integrated traditional Chinese and Western medicine group than in the control group(0.71±4.36 vs. 0.52±3.45, t=2.54, P=0.03). TESS scores were lower in the integrated traditional Chinese and Western medicine group than in the control group after 4 weeks of treatment(8.42±5.30 vs.16.01±7.02, t=3.25, P=0.02). Conclusions:Compared with Western medicine therapy alone, the integrated traditional Chinese and Western medication regimen has better efficacy and fewer adverse drug reactions for the treatment of depression in the elderly.

Value of PLR in efficacy and prognosis of targeted therapy for NSCLC with EGFR mutation / 实用医学杂志

Objective To explore the value of PLR in peripheral blood in the efficacy and prognosis of targeted therapy for NSCLC with EGFR-mutated. Methods Ninety patients with EGFR-mutant of NSCLC were selected, and the PLR was calculated before targeted therapy. The PLR median was used as a cut-off point for grouping, and they were assigned to group A (low PLR group) and group B (high PLR group). All patients were treated with EGFR-TKIs. Relationship between PLR and clinicopathological features was analyzed. Objective efficacy, ORR, DCR, PFS and OS between the two groups were compared. Results Before EGFR-TKIs therapy, median PLR was 139, and there were 44 patients in group A, and 46 in group B. There were statistical differences regarding smoking, tumor location, histological differentiation, T staging, and clinical staging between group A and B (P <0.05). The rates of PR, ORR and DCR in group A were higher than those in group B, and the PD rate was lower than that in group B (P < 0.05). Log-rank test showed that median OS and median PFS in group A were longer than those in group B (P= 0.001). Conclusions PLR in peripheral blood has certain reference value for therapeutic effect and prognosis evaluation on NSCLC with EGFR-mutation. Low PLR of NSCLC patients with EGFR-mutation has higher efficacy and longer survival time after targeted therapy, and it is an independent and prognostic factor.

Simulation analysis of 9033 cases of second trimester maternal serum screening for Down's syndrome / 解放军医学杂志

Objective To reduce the screening positive rate (SPR) and improve clinical efficiency of maternal serum screening for Down's syndrome.Methods Nine thousand and thirty-three cases of second trimester maternal serum screening for Down's syndrome were included from Apr.2013 to Apr.2014 in the present study.The screening results,all basic data and equation curves were analyzed retrospectively.Based on the data from the authors' laboratory,the important adjustment parameters were simulated.Combined with postnatal follow-up results,the quality and clinical performance of second trimester serum screening for Down's syndrome were evaluated.Results The SPR of second trimester serum screening for Down's syndrome was 6.69％(604/9033),the detection rate (DR) was 75％(3/4),and FPR was 6.65％(601/9033).The median multiple of median (MOM) of alpha-fetoprotein (AFP) was low and SPR was high,and MOM of free human chorionic gonadotropin β subunit (free hCGβ) were high and SPR was high,while MOM of unconjugated estriol (uE3) were a little bit low,and SPR was slightly high.Considering these three factors,it is believed that the screening positive rate is high.By the simulation adjustments of MOM value equations (AFP and free hCGβ) and weight correction equation,the SPR reduced to 4.11％(371/9033) after recalculating the risk,FPR declined to 4.07％(368/9033),and no more Down's syndrome fetus were missed compared with postnatal follow-up results.Conclusion Based on a localized setting depending on the local laboratory data,we suggest that the MOM value distributions(AFP,free hCGβ and uE3) and maternal weight should be regularly adjusted since it is a useful way to reduce the false-positive rate and improve clinical efficiency of maternal serum screening for Down's syndrome.

Advances in BET bromodomain protein inhibitors / 中国药科大学学报

@#Recognizing acetyl-lysine of histone is a key process of epigenetic regulation that is mediated by a protein module called bromodomain(BRD). The bromodomain inhibitors of the bromodomains and extra-terminal(BET)family have shown great potential in anti-inflammatory and antiproliferative effects. Through a review of diseases and structures about BET bromodomain, different kinds of inhibitors were analyzed and their structure-activity relationships were summarized. Herenin, the recent advances reported are reviewed for discovering more excellent small molecule inhibitors.