茧蜂克星对栗蚕寄生蜂病防治效果试验

栗蚕的盘绒茧蜂病大发生年份发病率高达60%以上,严重影响栗蚕的生产。采用0.05%的茧蜂克星在栗蚕2龄期施药,防治效果可达100%;栗蚕食药叶4d后疗效可达95.88%,且对栗蚕生长发育无不良影响。

Clinical Research into Ke Min Yin for Treatment of Persistent Allergic Rhinitis in Patients with Qi Deficiency and Blood Stasis

Persistent allergic rhinitis (PAR) is one of the common diseases at ear-nose-throat department. From August 1998 to May 2001, we randomly selected 60 cases of PAR with qi deficiency and blood stasis for a clinical observation. 30 patients in the treatment group were treated with Ke Min Yin (克敏饮), a herbal medicine, to supplement qi, expel wind, nourish blood and promote blood circulation; and the other 30 cases in the control group were treated with cetrine. Through systematic observation and statistical processing, the clinical research is summarized and reported in the following.

Pioneering drugs for overactive bladder and detrusor overactivity: Ongoing research and future directions

The ongoing research on pioneering drug candidates for the overactive bladder （OAB） aimed to overcome the limitations of currently licensed pharmacotherapies, such as antimuscarinics, β3-adrenergic agents, and botulinum neurotoxin, has been reviewed performing a systematic literature review and web search. The review covers the exploratory agents alternative to available medications for OAB and that may ultimately prove to be therapeutically useful in the future mana-gement of OAB patients based on preclinical and early clinical data. It emerges that many alternative pharmacological strategies have been discovered or are under investigation in disease-oriented studies. Several potential therapeutics are known for years but still fnd obstacles to pass the clinical stages of development, while other completely novel compounds, targeting new pharmacological targets, have been recently discovered and show potential to translate into clinical therapeutic agents for idiopathic and neurogenic OAB syndrome. The global scenario of investigational drugs for OAB gives promise for the development of innovative thera-peutics that may ultimately prove effective as first, combined or second-line treatments within a realistic timescale of ten years.

Therapy Response of Chinese Herbal Medicine in Advanced Liver Cancer： A Retrospective Observational Clinical Trial

Aiming at starting the ball rolling and contributing humble effort to promote CTM （Chinese traditional medicine）, we performed the present study to assess the therapy response of Chinese herbal decoction compared to conventional therapy on critical ill patients of advanced liver cancer. A total of 6 patients （1 female and 5 males） with histologically confirmed liver cancer were included in this retrospective observational clinical trial. We administered Chinese medicine （Gan Decoction, mixed with a variety of effective herbal components） to help them to recover from poor condition. In the meantime, conventional treatment of surgical resection and artery catheterization chemotherapy was applied in cases compared. In 3 cases of CTM combined treatment, the tumor marker level decreased. Residual intrahepatic metastatic sites reduced according to ultrasonography/CT imaging, and the patients felt free from the complaint of abdominal discomfort. The quality of life has been improved, we managed to have prolonged the PFS （Progression-Free-Survival） and TTP （Time-to-Progression） from the onset to date. While in 3 cases with conventional treatment only of surgical resection and artery catheterization chemotherapy, we were not able to decrease the level of tumor marker, metastatic lesions increased according to ultrasonography/CT imaging, and the patient＇s condition worsen more. We failed in having prolonged the PFS and TTP in the compared cases of conventional treatment only. The retrospective clinical study showed no OS （overall survival） benefit for liver cancer patients treated with Gan Decoction, while the QOL （quality of life） evaluation seemed to predict survival better. Chinese herbs might be an additional choice with its better benefits and tolerability in the treatment of primary liver cancer.

Efficacy of prokinetic drugs in combination with proton pump inhibitors versus proton pump inhibitors alone in the treatment of gastroesophageal reflux disease:a meta-analysis

In the present study,we aimed to systematically evaluate the efficacy of the combination therapy of prokinetics and proton pump inhibitors(PPIs)in patients with gastroesophageal reflux disease(GERD),and to provide an evidence-based reference for clinical use.The pertinent randomized controlled trials(RCTs)were retrieved from Pub Med and Embase.The quality of included studies was evaluated using the"risk of bias"tool for RCTs using the Rev Man 5.3.Related data were extracted according to the preset data collection forms.Meta-analysis was performed using Rev Man 5.3 and Stata 12.0 statistical software.Mean difference(MD)was used to describe the continuous variables,and relative ratio(RR)was used for classification variables.A total of 13 RCTs involving 1388 patients were included.Results of the meta-analysis showed that compared with PPI monotherapy,the combination therapy significantly improved the total response rate(RR=1.15,95%confidence interval(CI):(1.07,–1.24),P<0.001),gastroesophageal reflux disease questionnaire(GERD-Q)score(MD=–1.38,95%CI:(–2.12,–0.64),P<0.001),the frequency scale for the symptoms of gastroesophageal reflux(FSSG)score(MD=2.11,95%CI:(1.68,2.54),P<0.001)and visual analogue scale(MD=–0.69,95%CI:(–0.93,–0.45),P<0.001).However,the endoscopic response(RR=1.08,95%CI:(0.99,1.18),P=0.10)and symptomatic response(RR=1.22,95%CI:(0.94,1.59),P=0.13)were not significantly different between the two groups.For patients with GERD,the combination therapy could markedly improve the total response rate(symptomatic response and/or endoscopic response)and quality of life,while no benefits were found in symptomatic and endoscopic response.In view of the small number of participants included and some confounding factors in this study,the conclusion made in this study needs to be further confirmed by including a large number of participants and performing high-quality RCTs.

Minimally invasive plate internal fixation for calcaneal fractures

Objective： To assess the clinical efficacy of minimally invasive plate internal fixation for the treatment of calcaneal fractures. Methods： Manual reduction, rectification of deformity, and cold compress with traditional Chinese medicine were used preoperatively to relieve swelling and pain. A small incision was made to expose the articular facet and to perform anatomic reduction and plate fixation. Self-made traditional Chinese pharmaceutics were applied postoperatively on the surface of the wound to accelerate bony union. Results： All the 40 patients were followed up for at least 1 year postoperatively. According to the Maryland scoring system, the excellent and good rate was 87.5%. Conclusion： Minimally invasive plate internal fixation has the advantages of relatively mild injury, reliable fixation, good recovery, and rare complications in the treatment of intraarticular fractures.

Brief introduction for application of the USA national drug code

The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.

Preclinical efficacy of a novel cyclin-dependent kinase 9 inhibitor,QHRD107 against acute myeloid leukemia

QHRD107 is a specific inhibitor of cyclin-dependent kinase 9(CDK9).It is a highly potent antiproliferative agent against leukemia cells in vitro.Oral administration of QHRD107 to mice bearing acute myeloid leukemia tumors markedly inhibited tumor growth.In Molm-13 orthotopic model,QHRD107 resulted in remarkable prolongation of animal life span.After single oral administration of QHRD107 to Molm-13 xenograft model,QHRD107 was quickly absorbed and distributed to tumor with high concentration within 1 h.Tumor half-life time(T1/2)was three times longer compared with that of plasma.Under the high exposure of QHRD107 in tumor tissue,fast down-regulation of anti-apoptotic protein Mcl-1 mRNA was noted.Reduction of Ki-67 staining in tumor tissue further demonstrated the apoptosis of tumor cells.Therefore,the results provided evidence that QHRD107 at therapeutic dose had significant antitumor activity against AML cell lines.

Brief introduction for application of USA authorized generic drugs

The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.

Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.