Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

Heart Diseases ; genetics ; Humans ; Proteomics

Objective To investigate the effects of diclofenac sodium suppositories on emergence agitation after sevoflurane maintenance in children undergoing adenotonsilleetomy. Methods Forty-five patients selected for adenotonsillectomy were randomly divided into three groups (n=15). Patients in group 1 were given diclofenac sodium suppositories 12.5 mg right after intubation, those in group 2 were given diclofenac sodium suppositories 12.5 mg immediately after operation, while those in control group were not treated with diclofenac sodium suppositories before or after operation. The extubation time and time spent in post-anesthctic ICU (PACU) were recorded, the modified Aldrete score and pain score were assessed after entrance into PACU, and pediatric anesthesia emergence delirium (PAED) scale was administered 10, 20 and 30 rain after entrance into PACU. Results There was no significant difference in extubation time and time spent in PACU among three groups(P>0.05). Ten minutes after entrance into PACU, the PAED score of group 1 was significantly lower than those of group 2 and control group(P<0.05), while there was no significant difference between the latter two groups(P>0.05). Twenty and thirty minutes after entrance into PACU, the PAED scores of group 1 and group 2 were significantly lower than that of control group(P<0.05). There was no significant difference in the modified Aldrete score right after entrance into PACU among three groups. The pain scores of group 1 and group 2 were signifiantly lower than that of control group(P< 0.05). Conclusion Diclofenac sodium suppositories can decrease the incidence and severity of emergence agitation after sevoflurane maintenance in children undergoing adenotonsillectomy.

″Herb-Pairs″, also known as pair drugs, refers to a prescription consisted of two relatively fixed traditional Chinese medicine, is the most basic, most simple and most common form of medication prescription in traditional Chinese medicine compound compatibility. It is not a random combination of two herbs, nor is the simple accumulation of efficacy, but the simple and delicate experience of ancient Chinese medicine practitioners. As a bridge between single drug and prescriptions, it is the embodiment of the regular and dialectical connotation. Therefore, research on Herb-Pairs has always been the most basic and most important entry point for compound compatibility studies. However, the interaction between herbs and herbs is an effect with a downside as well as benefits. The beneficial herb-herb interaction in Herb-Pairs include mutual promotion, mutual enhancement, mutual restraint between two drugs and counteract toxicity of another drug. And the harmful herb- herb interaction in Herb- Pairs includes mutual inhibition and antagonism. All of these interactions areby means of affecting the metabolism of components to play a therapeutic effect. Using the pharmacokinetic-pharmacodynamic (PK-PD) binding model, the combination of drug metabolism and pharmacodynamics can further elucidate the influence on effect caused by drug concentration and metabolism, which can help elucidate the mechanism of drug action. Consequently, in this review, the herb-herb interactions in terms of pharmacokinetic were summarized to elucidate rule of TCM compatibility.

Adult ; Brucellosis ; epidemiology ; Case-Control Studies ; China ; epidemiology ; Female ; Humans ; Male ; Occupational Exposure ; Risk Factors

Objective To observe the changes of respiratory and hemodynamic functions in children with different age undergoing laparoscopic Nissen's fundoplication(LNF). Methods Thirty-three children with LNF were divided into three groups according to the age: group Ⅰ,1 to 12 months,n=13;group Ⅱ,1 to 3 years old,n=10;and group Ⅲ,4 to 7 years,n=10.Heart rate(HR),mean arterial pressure,Ppeak,compliance of the respiratory system(CRS) and end-tidal carbon dioxide pressure(PETCO2) were recorded 5 min before pneumoperitoneum(T0),10 min(T1),60 min(T2) after pneumoperitoneum and 10 min after deflation(T3),and parameters of blood gas analysis such as PaCO2 were measured at the same time. Results Compared with those at T0,HR,Ppeak,PETCO2 and the difference between PaCO2 and PETCO2(Pa-ETCO2)were significantly increased at T1 and T2,while CRS was significantly decreased.The most significant changes were found in group Ⅰ. Conclusion The changes of respiratory and hemodynamic functions are observed in children undergoing LNF,and anesthesia management should be enhanced for those within 1 to 12 months old who experience the most significant changes.

To analyze the regularity in combined medication with Xiyanping injection (Xiyanping for short) in the real world by as- sociation rules. Totally 5 822 patients using Xiyanping injection was collected from the 18 Class III Grade I hospitals nationwide to study the combined medication information of the patient with lung infection and make the analysis by using association rules and Apriori. According to the results, major drugs combined with Xiyanping in treatment of lung infection included compound amino acid, inosine, coenzyme A, cytidine triphosphate, vitamin C. Common drugs combined with Xiyanping can be divided into 5 categories: nutrition support therapy (vitamin C, compound amino acid) , coenzymes (coenzyme A, cytidine triphosphate, inosine), expectorants and antiasthmatics (ambroxol, salbutamol, doxofylline), hormones (dexamethasone, budesonide), antibiotics (mainly cefminox). The main combined medicines mostly conformed to the regularity for drugs treating lung infection. In addition, there were two most common medical combination models: the model for Xiyanping combined a single medicine is Xiyanping + nutrition support therapy, while the model for Xiyanping combined two or more than two medicines is Xiyanping + nutrition support therapy + coenzyme. Pharmacologically, Xiyanping is mostly combined with western medicines with similar pharmacological effects to substitute or supplement the antibiotic effect in treating lung infection. However, further studies shall be conducted for the safety and rationality of the combined medication based on clinical practices, in order to provide reference for clinical medication.
Adult ; Anti-Bacterial Agents ; administration & dosage ; Ascorbic Acid ; administration & dosage ; Cephamycins ; administration & dosage ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; Humans ; Lung Diseases ; drug therapy ; Male ; Middle Aged ; Young Adult

Biomedical Research ; China ; Freeze Drying ; Hepatitis A Vaccines ; adverse effects ; immunology ; Humans ; Safety ; Vaccines, Attenuated ; adverse effects ; immunology

A complex disease is rarely a consequence of abnormality in a single gene. It is known that many drugs exhibit a therapeutic effect by acting on multiple targets, produce synergies to intervene the occurrence and development of diseases. Unlike the traditional methods which act on single molecule or pathway, this disease-drug target network constructed with high throughput data vividly showed the complex relationship between drugs, their targets and diseases. However, the networks are usually extremely complex. In order to reduce the complexity, it is necessary to deconstruct the network and identify module structures. In this study, framework of module analysis was summarized from four aspects: module concept, structure and identification methods, importance of disease-drug module identification, and its application. Module-based analysis provides a new perspective for deciphering the drug intervention mechanisms for complex diseases, and provides new ideas and pathways to reveal the mechanisms of multi-target and multi-component drugs.
Drug Delivery Systems ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Gene Regulatory Networks ; drug effects ; Humans ; Molecular Targeted Therapy

Objective To evaluate the role of contrast-enhanced ultrasound (CEUS) on the the detection of hepatic metastases in comparison with conventional ultrasonography (US) and contrastenhanced computed tomography (CECT).MethodsNinety-seven patients with hepatic metastases underwent US,CEUS and CECT images.Their detection of hepatic metastases were compared.Results Hepatic metastases showed five enhancement patterns with CEUS,including bolus hyper-enhancement,peripheralrimenhancement,inhomogeneousenhancementwithnecrosis,hypo-enhancement,isoenhancement with liver parenchyma,all hepatic metastases showed dark defects in portal and delayed phase.The mean number of metastases at CEUS was greater than that of US (2.6±1.9 vs 1.6 ±1.2,P＜0.05).The detection of hepatic metastases was 53.4％ and 87.1％ respectively(P＜0.05).CEUS and CECT have no statistically significant difference in the detection of hepatic metastases (P＞0.05).ConclusionsCEUS can improve detection of hepatic metastases.