Research progress of exosome delivery vehicles in tumor phototherapy / 药学学报

Exosome is a self-secreted phospholipid bilayer nanovesicles, and has shown great potential in drug delivery field due to the important advantages of low immunogenicity and homologous targeting. Phototherapy, mainly includes photodynamic therapy (PDT) and photothermal therapy (PTT), utilize light to activate photoactive drug for tumor cell killing. The advanced therapeutic strategy shows low toxic side-effect and non-invasion precise advantages, and thus has made great progress in tumor treatment over the past few years. Therefore, using exosomes as a drug delivery system to deliver phototherapeutic agents can improve therapeutic performances with a reduced side-effect, and further enhance their application potential for clinical tumor therapy. This review focus on the rising cross-subjects field involving exosomes and phototherapy, and mainly introduce the research progress and relative case of exosomes-based delivery system for cancer phototherapy. Additionally, the advantages and challenges of exosome-based phototherapy are also discussed and proposed.

Meta analysis on acceptance rate of HIV pre-exposure prophylaxis among men who have sex with men in China / 中华预防医学杂志

Objective: To systematically evaluate the acceptance of pre-exposure prophylaxis (PrEP)among men who have sex with men (MSM) in China, so as to provide reference for the promotion of preventive drug use before human immunodeficiency virus exposure in China. Methods: By searching the databases of China national knowledge infrastructure, VIP database, Wanfan knowledge service platform, PubMed, Web of Science, Embase and The Cochrane Library with key words of "men who have sex with men" "pre-exposure prophylaxis" "PrEP" and "MSM". The literature on the willingness of Chinese MSM population to accept PrEP was systematically collected, and the data of the literature meeting the inclusion criteria were extracted for Meta analysis. Results: A total of 12 articles were selected in this study, including 6 articles in English and 6 in Chinese. The score of bias risk assessment of eligible articles was 14-18, which was more than 70% of the total score. The total number of samples was 11 269. The overall acceptance rate of PrEP was 0.77(95%CI:0.71-0.82). In subgroup analysis, the acceptance rates of different nationalities, marriage, household registration, age, education background, income, sexual orientation, sexual behavior and awareness of PrEP were statistically significant. Conclusion: In general, the acceptance rate of PrEP in MSM population is higher, but the awareness rate is low. There are differences in the acceptance rate among different groups.

Impact of Low Frequency Electro-acupuncture on Glucose and Lipid Metabolism in Unmarried PCOS Women: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To explore the effect of electro-acupuncture (EA) on glucose and lipid metabolism in unmarried patients with polycystic ovary syndrome (PCOS).@*METHODS@#Fifty-four PCOS patients were equally randomized into true acupuncture group and sham acupuncture group (control) for totally 16 weeks of treatment by random method with a computerized randomization program. Patients in true acupuncture group accepted traditional acupuncture methods with EA and two sets of acupoint groups were used alternatively. The first set consisted of Zhongji (CV 3), Qihai (CV 6), Guilai (ST 29), Sanyinjiao (SP 6), Yinlingquan (SP 9), Hegu (LI4) and Baihui (GV 20), and the second set consisted of Tianshu (ST 25), ST 29, CV 3, CV 6, SP 6, Taichong (LR 3), Neiguan (PC) 6 and GV 20. Patients in the sham acupuncture group accepted shallow acupuncture methods through EA without electricity at 4 non-meridian points in each shoulder and upper arm. Outcome measures included body mass index (BMI), waist-hip-ratio (WHR), oral glucose tolerance test (OGTT), insulin release test, glucose and lipid metabolism indicators such as total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, adiponectin, leptin, visfatin, resistin, and interleukin (IL-6).@*RESULTS@#Twenty-six subjects in the true acupuncture group and 20 subjects in the sham group completed the clinical trial. After 16 weeks of treatment, no significant difference in the outcome measures were observed between the two groups (P>0.05). However, as compared with baseline data, a reduction in weight, BMI, hipline, WHR, fasting glucose, homeostatic model assessment of insulin sensitivity, visfatin and HDL-C, and an increase in resistin and IL-6 were observed in the true acupuncture group (P<0.05). In addition, a reduction in visfatin and an increase in TC were also observed in the sham group (P<0.05).@*CONCLUSIONS@#Acupuncture may have a beneficial effect in the treatment of PCOS by improving glucose and lipid metabolism. Moreover, the sham acupuncture may be not completely ineffective. Sham acupuncture may improve some of the aspects of the glucose and lipid metabolism of PCOS patients through a placebo effect. (Registration Nos. ChiCTR-TRC-12002529 and NCT01812161).

A comparison between endoscopic CO2 laser cauterization and open neck surgery in the treatment of congenital piriform fistula / 中华耳鼻咽喉头颈外科杂志

Objective: To compare the efficacy, advantages and disadvantages of endoscopic CO2 laser cauterization (ECLC) and open neck surgery in the treatment of congenital pyriform sinus fistula (CPSF). Methods: From September 2014 to March 2017, 80 cases with confirmed diagnosis of CPSF received initial treatment at Guangdong Provincial People's Hospital were prospectively analyzed, including 34 males and 46 females, aged 18 to 672 (194.17±141.18) months. They were consecutively divided into endoscopic group and open-surgery group, with 40 cases in each group. Both groups of patients received surgical treatment under general anesthesia. The endoscopic group was treated by endoscopic CO2 laser cauterization, and the open-surgery group underwent the following surgery: first, we performed suspension laryngoscopy examination to confirm the presence of fistula in the bottom of the piriform fossa, then open-neck resection of congenital piriform sinus fistula with recurrent laryngeal nerve and/or lateral branch of superior laryngeal nerve anatomy plus partial thyroidectomy were performed. The data between the two groups were compared, including the operative time, intraoperative blood loss, postoperative pain, average length of stay, neck cosmetic scores, complications and cure rates. All patients were followed up in outpatient clinics. Statistical analysis was performed using SPSS 20.0 software. P<0.05 indicates that the difference is statistically significant. Results: All patients were successfully completed the operation. The operative time, intraoperative blood loss, postoperative pain and average length of hospital stay in the endoscopic group were significantly less than those in the open group [(27.4±5.5) min to (105.8±52.5) min, (0.6±0.5) ml to (33.6±41.5) ml, (1.7±0.9) points to (4.6±0.7) points, (5.9±2.9)d to(8.9±3.3)d, t values were-9.400, -5.031, -16.199, -4.293, P values were all<0.01]; The neck cosmetic score in the endoscopy group was significantly greater than that of the open group [(9.9±0.4) against (5.8±0.9) points, t=25.847, P<0.01]. Compared with the open group (15.0%, 6/40), the complication rate of the endoscopic group (7.5%, 3/40) was not statistically significant (χ²=0.50, P>0.05). Three months after the first treatment, the cure rate in the endoscopic group (82.5%, 33/40) was significantly lower than that in the open-neck group (100.0%, 40/40), χ²=5.64, P<0.05. The follow-up time was 12 months after the last treatment. Eighty cases were followed up and none was lost to follow-up. During the follow-up period, the cure rate of the endoscopy group (97.5%, 39/40) was compared with that of the open group (100.0%, 40/40), and the difference was not statistically significant. Conclusions: In the treatment of CPSF, the two-surgical method each has their advantages. Compared with open-neck surgery, ECLC is simpler, repeatable. ECLC has shorter time in operation and hospital stay, less complications, and less postoperative pain and more precise cosmetic results. It could be preferred for the initial treatment of CPSF and relapsed cases after cauterization. But subject to relatively low cure rate of one-time cauterization and uncertain long-term efficacy, it cannot completely replace the open-neck surgery at present.

Clinical and Bacteriological Analysis of Bacterial Bloodstream Infections in Patients with Acute Leukemial / 中国实验血液学杂志

OBJECTIVE@#To investigate the clinical characteristics, etiology and drug susceptibility of bacterial bloodstream infections in acute leukemia(AL) patients.@*METHODS@#Clinical data, etiology and drug susceptibility of acute leukemia patients with bacterial bloodstream infections from April 2009 to April 2018 were retrospectively analyzed.@*RESULTS@#A total of 376 strains were isolated, 76.9% was Gram-negative bacterial and 23.1% was Gram-positive bacteria. Escherichia coli, Pseudomonas aeruginosa and Klebsiella pneumoniae were listed as the top three of Gram-negative bacteria. The susceptibility of Escherichia coli to the tigacycline, imipenem and meropenem was 100.0%, 98.2% and 98.1%, respectively. The susceptibility of Klebsiella pneumoniae to the tigacycline, imipenem and meropenem were 100.0%, 98.3% and 94.4%, respectively. The adjustment rate for initial use of carbopenems was 3.8%, while the adjustment rate for initial use of noncarbopenems was 74.3% in patients with main Gram-negative bacterial blood stream infection. The susceptibility of Gram-positive bacteria to glycopeptide antibiotics, linezolid and tigacycline was 100.0%.@*CONCLUSION@#Gram-negative bacteria is the majority type of bacteria in AL patients with bacteria blood stream infections. The susceptibility of Gram-negative bacteria to the carbapenems is high, and the treatment adjustment rate is obviously low. The glycopeptide, linezolid and tigacycline are effective for Gram-positive bacteria infections..

Spatiotemporal analysis of esophageal cancer incidence in Huai’an: a study based on geographic information system / 中华疾病控制杂志

Objective To explore the spatiotemporal distribution pattern, and identify risk cluster of esophageal cancer in Huai’an City so as to provide evidence for control and prevention of esophageal cancer. Methods Data of esophageal cancer incidence at township level in Huai’an City from 2011 to 2015 was collected. Spatial autocorrelation and local indications of spatial autocorrelation (LISA) were implemented to evaluate the spatial pattern of esophageal cancer incidence. Spatial scan statistics was used to examine spatio-temporal clustering of risk areas. Results The average incidence of esophageal cancer in Huai’an from 2011 to 2015 was 67.12/10 million, the incidence of male was significantly higher than that of female. The results of Moran’s I values implyed the spatial autocorrelation at township level. The results of LISA indicated that there were local hot spots and cold spots. The significant high-risk clusters included townships in Huai’an County, Huaiyin County and Jinhu County. The low-risk clusters were located in the main urban area and Xuyi County. Conclusions There are significant spatio-temporal aggregation for the distribution of incidence of esophageal cancer in Huai’an City and same spatiotemporal high-risk clusters between male and female. Our findings have a foundation to explore the multi-factorial etiology of esophageal cancer and have vital practical value for health services and policies implementation.

Advancement of Salvia miltiorrhiza on reversing tumor resistance and chemotherapy sensitization / 中国药理学通报

At present, chemoresistance is one of the leading causes of chemotherapy failure but there is no effective drugs or strategies to reverse the resistance of chemotherapy. In recent years, the anticancer effect of Salvia miltiorrhiza receives wide attention of researchers. The major bioactive constituents in Sal-via miltiorrhiza can be divided into two groups: liposoluble com-ponents ( tanshinoneⅠ, tanshinoneⅡA, dihydrometanoneⅠ and cryptotanshinone, etc. ) and hydrophilic components (salvianol-ic acid A, salvianolic acid B and protocatechualdehyde, etc. ). Recent studies have found that these components not only play different anti-tumor activities, but showed significant reversal re- sistance effects on drug-resistant tumor cells. Besides, with the combination of chemotherapy drugs, they have significant attenu-ated toxicity and synergistic effect. In this paper, we summarize the researches pertaining to the effects of Salvia Miltiorrhiza on the reversal of drug resistance and chemotherapy sensitization in recent years, providing references for the development of Salvia miltiorrhiza as multidrug resistance reversal agents and its ration-al application in clinic.

Neuroelectrophysiological characteristics of peripheral neuropathy in primary Sj?gren's syndrome:study protocol for a prospective case series and preliminary results / 中国组织工程研究

BACKGROUND: Sj?gren's syndrome (SS) is a chronic progressive autoimmune disease. The incidence of peripheral nervous system damage in patients with primary Sj?gren's syndrome (pSS) is 10%-30%. Previous studies have shown that there are multiple electrophysiological manifestations in patients with pSS presenting with peripheral neuropathy. However, there is no consensus on its neuroelectrophysiological manifestations. Peripheral neuropathy associated with pSS is easily confused with peripheral neuropathy caused by other etiologies. OBJECTIVE: To observe the neuroelectrophysiological manifestations of peripheral neuropathy associated with pSS to assist in the diagnosis of the disease. METHODS: A total of 100 pSS patients with peripheral neuropathy who receive treatment in the Department of Neurology, First Affiliated Hospital of Kunming Medical University, in China will be included in this study. Fifty-two patients included in the preliminary experiment presented with peripheral neuropathy associated with pSS. The primary outcome measure is the rate of abnormal motor nerve conduction velocity. The secondary outcome measures include the rate of abnormal terminal motor latency, the rate of abnormal compound muscle action potential amplitude, the rate of sensory nerve conduction velocity, the rate of abnormal sensory nerve action potential amplitude, the rate of abnormal F wave, and the rate of abnormal sympathetic skin response. RESULTS AND CONCLUSION: Results of 52 patients included in the preliminary study showed that the rate of each electrophysiological index was similar between upper and lower extremities; the rate of abnormal motor nerve conduction velocity was significantly higher than the rate of abnormal compound muscle action potential amplitude; the rate of sensory nerve conduction velocity was significantly higher than the rate of abnormal sensory nerve action potential amplitude; the rate of abnormal motor nerve conduction velocity was similar to the rate of abnormal sensory nerve conduction velocity; the rate of abnormal compound muscle action potential amplitude was similar to the rate of abnormal sensory nerve action potential amplitude; the rate of abnormal wave was significantly lower than the rate of abnormal motor nerve conduction velocity; the rate of abnormal sympathetic skin response was similar to the rate of abnormal motor nerve conduction velocity. Results from this study will reveal neuroelectrophysiological abnormality in peripheral neuropathy associated with pSS, which will help diagnose the disease.

Effect of Electroacupuncture on BiP and CHOP Expressions in the Substantia Nigra in a Rat Model of Parkinson Disease / 上海针灸杂志

Objective To investigate the effect of electroacupuncture on the expressions of endoplasmic reticulum stress-related proteins in the substantia nigra in a rat model of rotenone-induced Parkinson disease.Methods One hundred and twenty healthy male SD rats were randomized to normal, sham operation, model, electroacupuncture pretreatment, and 7-day, 14-day, 21-day and 28-day electroacupuncture treatment groups, 15 rats each. A model of Parkinson disease was made by subcutaneous injection of rotenone in the nape. The sham operation group received an injection of equal volume of sunflower oil emulsion. The normal, sham operation and model groups were not treated. The electroacupuncture treatment group received electroacupuncture at points Fengfu (GV 16)and Taichong (LR 3) after model making. The electroacupuncture pretreatment group received model making after 7 days of electroacupuncture treatment. TH and α-syn positive cells expressions in rat substantia nigra were determined by immunohistochemical method. BiP and CHOP expressions in rat substantia nigra were examined by Western blotting. Results The model group rats had obvious syndrome characteristic of PD and rat behavior score decreased significantly after electroacupuncture intervention (P<0.01).α-syn positive cells expression and BiP and CHOP expressions in rat substantia nigra increased significantly and TH positive cells expression in rat substantia nigra decreased significantly in the model group compare with the normal and sham operation groups (P<0.01).α-syn positive cells expression and BiP and CHOP expressions in rat substantia nigra decreased significantly and TH positive cells expression in rat substantia nigra increased significantly in every electroacupuncture treatment group compare with the model group (P<0.01).Conclusions The mechanism of electroacupuncture prevention and treatment of Parkinson disease may be related to its significant inhibition of the expressions of endoplasmic reticulum stress-related proteins and protection of dopaminergic neurons.

Development and Validation of a Model for Predicting Diabetic Nephropathy in Chinese People / 生物医学与环境科学（英文）

<p><b>OBJECTIVE</b>To develop a risk model for predicting later development of diabetic nephropathy (DN) in Chinese people with type 2 diabetes mellitus (T2DM) and evaluate its performance with independent validation.</p><p><b>METHODS</b>We used data collected from the project 'Comprehensive Research on the Prevention and Control of Diabetes', which was a community-based study conducted by the Jiangsu Center for Disease Control and Prevention in 2013. A total of 11,771 eligible participants were included in our study. The endpoint was a clear diagnosis of DN. Data was divided into two components: a training set for model development and a test set for validation. The Cox proportional hazard regression was used for survival analysis in men and women. The model's performance was evaluated by discrimination and calibration.</p><p><b>RESULTS</b>The incidence (cases per 10,000 person-years) of DN was 9.95 (95% CI; 8.66-11.43) in women and 11.28 (95% CI; 9.77-13.03) in men. Factors including diagnosis age, location, body mass index, high-density-lipoprotein cholesterol, creatinine, hypertension, dyslipidemia, retinopathy, diet control, and physical activity were significant in the final model. The model showed high discrimination and good calibration.</p><p><b>CONCLUSION</b>The risk model for predicting DN in people with T2DM can be used in clinical practice for improving the quality of risk management and intervention.</p>

Effects of intensive therapy program on gross motor function of children with spastic cerebral palsy / 医用生物力学

Objective To explore the effects of intensive therapy program on gross motor function of children with spastic cerebral palsy. Methods Thirty 3-15 year old children with spastic cerebral palsy and level I-III in gross motor function classification system (GMFCS) were randomly divide into 2 groups. The trial group adopted intensive therapy program for treatment, including functional dynamic suit and universal exercise unit combined with functional movement training. The control group adopted core stability training for treatment. Children in two groups took a 1-month training program for 3 hours per day and 5 days per week. The pediatric evaluation of gross motor function measure (GMFM-66) and peabody developmental motor scale (PDMS-2) were administered before and after treatment. Results The scores of GMFM-66 as well as the stationary and locomotion scores of PDMS-2 in both groups showed significant differences within group (P<0.01) after treatment. For the scores of GMFM and PDMS-2 between two groups, no significant differences were found. Conclusions The intensive therapy program can improve the gross motor function of children with spastic cerebral palsy and gain the same effects as core stability training, which can provide a novel and effective intervention for children with cerebral palsy.

Effects of intensive therapy program on gross motor function of children with spastic cerebral palsy / 医用生物力学

Objective To explore the effects of intensive therapy program on gross motor function of children with spastic cerebral palsy.Methods Thirty 3-15 year old children with spastic cerebral palsy and level Ⅰ-Ⅲ in gross motor function classification system (GMFCS) were randomly divide into 2 groups.The trial group adopted intensive therapy program for treatment,including functional dynamic suit and universal exercise unit combined with functional movement training.The control group adopted core stability training for treatment.Children in two groups took a 1-month training program for 3 hours per day and 5 days per week.The pediatric evaluation of gross motor function measure (GMFM-66) and peabody developmental motor scale (PDMS-2) were administered before and after treatment.Results The scores of GMFM-66 as well as the stationary and locomotion scores of PDMS-2 in both groups showed significant differences within group (P ＜ 0.01) after treatment.For the scores of GMFM and PDMS-2 between two groups,no significant differences were found.Conclusions The intensive therapy program can improve the gross motor function of children with spastic cerebral palsy and gain the same effects as core stability training,which can provide a novel and effective intervention for children with cerebral palsy.

Development of inflatable and multi-function medicine chest / 医疗卫生装备

Objective To develop a new type of muhifunctional inflatable medicine chest to execute medical service at special conditions.Methods The chest was made of Hypalon rubber,and composed of multi facets of air cells.Each air cell was divided into several independent columns to enhance the stability and anti-leakage performance of the chest.Results The chest realized the function of medicine storage,and the air cell could be used for rescue when applied separately and used as floating stretcher when collectively.The problems of the original medicine chest were solved in withdrawal,volume,transportation and etc.Conclusion The chest gains advantages in compactness,closure,moisture resistance,floating,stability,reliability,practicability,safety,anti shock and multi function,and thus is worthy promoting in emergency rescue and field training.

Protective estrogen-like properties and mechanism of quercetin in rat cerebral cortex neurons / 中国药理学与毒理学杂志

OBJECTIVE To investigate the effect of quercetin on primary cultured newborn rat cortex neuron cell which is estrogen depletion, and discuss the possible mechanism, to provide new ideas and strategies for developing a drug of neurodegenerative disease. METHODS Rat cortex neurons were isolated from one day old Sprague Dawley rats and treated with estrogen, quercetin and estrogen receptor antagonists (ICI182,780). Cell viability was determined by MTT assay, neurite outgrowth was measured by fluorescent microsope and estrogen receptors were determine by Western blot. RESULTS Quercetin functions like estrogen to increase cortex neuronal cell viability, the Que (50, 100 μmol·L-1) group compared with the control group could significantly improve the activity of the cortical neurons(P<0.05). It can also increase neurite out growth, the Que (50,100 μmol·L-1) group significantly promoted the formation of synapse, most of the neurons were full, and the synapses of neurons became thick, growth, and connect to a dense neural network. And in the Western blot experiments, Que (50, 100 μmol·L-1) group could obviously increase the expression of estrogen receptor alpha protein, in addition, the neural protective effect of quercetin can be inhibited by ICI182,780. CONCLUSION Quercetin like estrogen can protected cortex neuronal and the effect of quercetin on cortex neuronal cells was mediated by estrogen receptor alpha.

The effect of methyl jasmonate on Zea mays tassel development / O efeito de methyl jasmonato sobre o devolvimento do pendão de Zea mays

Methyl jasmonate (MeJA) is a lipid-derived plant hormone that mediates diverse biological phenomena. Application of MeJA onto rice spikelet could exhibit abnormal floral organ development. Although jasmonic acid (JA) has been proved to be involved in maize tassel sex determination process, the roles of JA and its precursor MeJA in maize tassel development still remain obscure. In this study, we found that tassel development was decelerated by application of 2 mM MeJA. Exogenous MeJA also influenced the number of palea and stamens of tassel spikelets. Exogenous MeJA increased the expression level of some key regulator genes, which may responsible for the phenotypic change in MeJA-treated tassel, and may mediate the crosstalk between MeJA and other hormones.

jasmonate (MeJA) é um derivado lipídico vegetal hormônio que medeia Diversos fenómenos biológicos.Aplicação de MeJA para arroz spikelet poderá apresentar Desenvolvimento anormal DOS órgãos florais.Apesar de Ácido jasmónico (Ja), precursor de MeJA, mostrou ser envolvido no processo de determinação do sexo de milho tassel, OS papéis DOS dois compostos de milho tassel Desenvolvimento ainda permanecem obscuros.No presente estudo, descobrimos que o Desenvolvimento FOI desacelerada pelo pedido do tassel de 2 mm MeJA.MeJA exógeno também influenciou o número de palea e estames de tassel spikelets.MeJA aumentou o nível de expressão exógena, um regulador chave genes, o que Pode o responsável PELA alteração fenotípica EM MeJA tratados tassel, e podem mediar a interferência entre MeJA e outras hormonas.

Optimization of Supercritical Fluid Extraction and Rapid Resolution LC-MS/ESI Identification of Chromones from Saposhnikoviae Radix through Orthogonal Array Design / 中草药·英文版

Objective To establish a rapid and effective supercritical fluid extraction (SFE) and rapid resolution liquid chromatography method coupled with diode-array detector (RRLC-DAD) to quantify the chromones in a species. Methods The effects of four parameters including ethanol concentration (50%–90%), pressure (25–45 MPa), temperature (40–60 oC), and time (30–90 min) on the chromones yields, namely prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisammioside, and sec-O-gluco-sylhamaudol, were investigated using SFE system with orthogonal array design (OAD). Furthermore, the extracts were analyzed using rapid resolution liquid chromatography coupled with diode-array detector (RRLC-DAD) system to confirm the results. Results Under the optimized conditions, i. e., 35 MPa of pressure, 60 °C of temperature, 70% ethanol, and 60 min of time, the yields of prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisammioside, sec-O-glucosylhamaudol, and total chromones were 3.514, 0.132, 6.242, 0.342, and 10.231 mg/g, respectively. In comparison with ultrasonic assisted extraction (UAE), SFE was able to yield a 20.7% increase in the total chromones from Saposhnikoviae Radix. Conclusion SFE is an alternative and promising method to extract chromones from this species, and the established RRLC-DAD method could serve as a rapid and effective method for the identification of chromones from Saposhnikoviae Radix.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015, the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti-ties single or compounds and 15 biologics license applications, a total of 35 which record number of approved innovative drugs. Ac-cording to the prescription information for professionals, this article briefly describes the description, mechanism of action and clinical studies, the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and criti-cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA’ s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016, the U.S. food and drug administration (FDA) approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

New drugs approved by the U.S. FDA (2007-2016): A review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“ Journal of International Pharmaceutical Research ”for ten years. However, new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated, such as the indications and purposes change, supplement of the modified efficacy, clinical data and the important new indications, constant improvement of the dosage, form and mode of administration, and the emergence of new, serious and even fatal adverse reactions urge the supplements of contraindications, warnings and precautions, or even the black box warnings. In brief, 6 entries of the introductions all may be modified, supplemented or canceled. More importantly, ten years of general analyses also find some prominent events, such as the amount of new molecular entity (NME)and new biological products come to an obvious peak in 2015. With regard to this, this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Effect of Wenyang Huazhuo Tongluo Recipe on Peripheral Blood Thl7/Treg Cell Balance in Systemic Sclerosis Patients / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the effect of Wenyang Huazhuo Tongluo Recipe (WYHZTLR) on the proportion of T helper 17 cells (Thl7)/regulatory T cells (Treg), and serum levels of IL-17 and IL-10 in peripheral blood of systemic sclerosis (SSc) patients with yang qi insufficiency and turbidity induced collaterals blockage syndrome (YQITICBS).</p><p><b>METHODS</b>Totally 82 SSc patients were randomly assigned to the Western medicine group (as the control group) and the integrated Chinese and Western medicine group (as the treatment group), 41 cases in each group. All patients took methotrexate (MTX) tablet and prednisone tablet. Patients in the treatment group additionally took WYHZTLR. The treatment course for all was six consecutive months. Besides, another 70 healthy volunteers were recruited as a healthy control group (as the healthy group). Percentages of Th17 and Treg in peripheral blood were detected by flow cytometry. Serum levels of IL-17, IL-10, von Willebrand factor (vWF), aminoterminal propeptide of type l procollagen (PIIINP), and cross-linked carboxyterminal telopeptide of type I collagen ( I CTP) were measured by double antibody sandwich ELISA. The correlations between Th17/Treg and levels of vWF, PIIINP, I CTP, skin score, and disease activity index were observed by Pearson correlation analysis.</p><p><b>RESULTS</b>The percentage of Th17 in peripheral blood, ratios of Th17/Treg, and the serum level of IL-17 were significantly higher, but the percentage of Treg and the serum level of IL-10 were significantly lower in SSc patients, when compared with those of the healthy group (P <0. 05, P <0. 01). Compared with the same group before treatment, the percentage of Thl7, ratios of Thl7/Treg, and levels of IL-17, vWF, and PIIINP all decreased in the two groups after treatment (P <0.05, P <0.01), but the percentage of Treg and the IL-10 level increased (P <0. 05, P <0. 01). Meanwhile,the level of I CTP was higher in the treatment group after treatment (P <0. 05). The improvement of all indices except the percentage of Th17 was more obvious in the treatment group than in the control group (P <0. 05, P <0. 01). The ratio of Th17/Treg was positively correlated with levels of vWF, PIIINP, skin score, and disease activity index before and after treatment respectively (P <0. 01), but with no obvious correlation with the level of I CTP (P >0. 05).</p><p><b>CONCLUSION</b>WYHZTLR could achieve its therapeutic effect on SSc patients by regulating Th17/Treg imbalance, lowering levels of vWF and PIIINP, and elevating the level of I CTP.</p>