Drug safety has always been a global focus. Discovery and accurate information acquisition of adverse drug reaction have been the most crucial concern. Terminology of adverse drug reaction makes adverse reaction medical report meaningful, standardized and accurate. This paper discussed the domestic use of the terminology WHOART and MedDRA in terms of content, structure, and application situation. It also analysed the differences between the two terminologies and discusses the future trend of application in our country
Dictionaries, Medical ; Drug-Related Side Effects and Adverse Reactions ; Terminology as Topic ; World Health Organization

Animals ; Apoptosis ; radiation effects ; Electromagnetic Fields ; adverse effects ; Hippocampus ; pathology ; radiation effects ; Male ; Maze Learning ; radiation effects ; Rats ; Rats, Wistar

There are few articles or reports collecting evidence about Kudiezi injection from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about Kudiezi injection. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data), and literature analysis. All the four aspects build an evidence body for Kudiezi injection in order to inform its safety use in clinical practice and further study.
Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Hospital Information Systems ; Humans ; Injections

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.
Biomedical Research ; China ; Clinical Trials as Topic ; Databases, Factual ; Humans ; Medicine, Chinese Traditional ; United States

International clinical trials register is one of the global measures to realize transparency in clinical trials and also one of a powerful measure to improve the quality of clinical trials. Many scholars studying the quality of TCM clinical trials find that they are poor in quality and lack transparency. Furthermore, they find that TCM clinical trial registry has many problems. We must base on the successful experiences of WHO and international clinical trial registry to establish technical specifications for registry of traditional Chinese medicine clinical study of their own. Then, it can effectively improve the overall level of TCM clinical studies. We have suggested some concrete and feasible measures to establish technical specifications for registry of traditional Chinese medicine clinical study of their own based on the problems of TCM clinical trial registry.
Biomedical Research ; Humans ; Medicine, Chinese Traditional ; standards ; Registries

Exercise Test ; Female ; Heart Sounds ; physiology ; Humans ; Male ; Phonocardiography ; methods ; Pregnancy ; Stress, Physiological ; physiology ; Young Adult

OBJECTIVETo investigate the bond strengths of customized titanium bracket manufactured by selective laser melting.

METHODSEighty human premolars which had been extracted for orthodontic purpose were collected and divided randomly (by random table) into two groups (customized bracket group and 3M bracket group, 40 molars in each group). The 35% phosphoric acid was used for etching and the brackets were bonded with 3M Unitek bonding adhesive. All bonded specimens were placed in saline for 24 hours at room temperature and were tested on DWD3050 electronic testing machine to determine the shear bond strength and tensile bond strength. After debonding, the adhesive remnant indexes (ARI) were recorded.

RESULTSThe shear bond strengths of customized brackets was 6.80 (6.20, 8.32) MPa, which was significantly lower than that of the 3M brackets [10.46 (9.72, 11.48) MPa] (Z = -3.463, P < 0.05). And the tensile bond strengths of customized brackets was (6.93 ± 1.21) MPa, which was significantly higher than that of the 3M brackets [(5.88 ± 1.23) MPa] (t = 2.81, P < 0.05). No significant difference was found in the ARI between two different kinds of the brackets.

CONCLUSIONSThe shear bond strength and tensile bond strength of both kinds of brackets were enough for clinic application.

Acid Etching, Dental ; Adolescent ; Bicuspid ; Child ; Composite Resins ; chemistry ; Dental Bonding ; methods ; Dental Debonding ; Dentin-Bonding Agents ; chemistry ; Humans ; Lasers ; Orthodontic Brackets ; Phosphoric Acids ; chemistry ; Random Allocation ; Shear Strength ; Tensile Strength ; Titanium

AIMTo investigate the effect of benzyltetrahydropalmatine (BTHP) on the rapidly activating component of delayed rectifier K+ current (Ikr) in single guinea pig ventricular myocytes.

METHODSWhole-cell patch clamp technique was used to record Ikr.

RESULTSIkr was blocked by 1-100 mumol.L-1 BTHP in concentration-, voltage-, and specifically frequency-dependent fashion, with IC50 of 13.5 mumol.L-1 (95% confidence range: 11.2-15.8 mumol.L-1). 30 mumol.L-1 BTHP reduced Ikr and Ikr.tail by (31 +/- 4)% and (36 +/- 5)% (n = 6, P < 0.01), respectively. The time constant for deactivation (tau') of the tail current was decreased by 30 mumol.L-1 BTHP from (238 +/- 16) ms to (196 +/- 14) ms, while drug had no any effect on the time constant for activation (tau) of Ikr,tail.

CONCLUSIONBTHP inhibited Ikr in a frequency-dependent fashion.

Animals ; Anti-Arrhythmia Agents ; pharmacology ; Berberine Alkaloids ; pharmacology ; Cell Separation ; Delayed Rectifier Potassium Channels ; Female ; Guinea Pigs ; Heart Ventricles ; cytology ; metabolism ; Male ; Myocytes, Cardiac ; drug effects ; metabolism ; Patch-Clamp Techniques ; Potassium Channels ; drug effects ; metabolism ; Potassium Channels, Voltage-Gated

OBJECTIVETo evaluate the effects of Rbl on action potentials and force of contraction in guinea pig ventricular papillary muscles.

METHODThe ventricular papillary muscles of guinea pig were isolated regularly and immersed with Tyrode, s solution. The effects of Rbl (purified saponins of panaxnotoginseng) on the action potentials (AP), the slow action potentials and the force of contraction (FC) of the muscles were studied. The AP and FC were measured synchronously.

RESULTRbl shortened the duration of AP, including APD2O and APD90, and reduced the FC(n = 5, P < 0.01), but didn't affect the rest potential (RP), the amplitude of action potential (APA), overshot (OS) and maximal upstrok velocity (Vmax). Rbl also decreased the APA of slow action potential, but quinidine had no such effects.

CONCLUSIONRbl may be a channel blocker.

Action Potentials ; drug effects ; Animals ; Calcium Channel Blockers ; pharmacology ; Drugs, Chinese Herbal ; isolation & purification ; pharmacology ; Female ; Ginsenosides ; isolation & purification ; pharmacology ; Guinea Pigs ; Male ; Myocardial Contraction ; drug effects ; Panax ; chemistry ; Papillary Muscles ; physiology

OBJECTIVETo create an integrated digital maxillodental model and to apply it in computer aided design (CAD) of individualized lingual brackets in order to align both crowns and roots without fenestration and dehiscence.

METHODSCone-beam computerized tomography (CBCT)-based maxillodental model and laser-scanned dental model were integrated by auto registration in 10 patients with malocclusions. The registration error was calculated automatically. Three observers tested the method independently. The inter-observer difference was investigated. An integrated model was selected randomly and the setup was created with roots and jaws in good relationship without fenestration and dehiscence. The individualized lingual brackets were designed by CAD on the setup.

RESULTSNo significant difference was found in inter observers (P > 0.05). The registration errors of maxilla and mandible were (0.144 ± 0.020) mm and (0.141 ± 0.022) mm, respectively. The digital individualized lingual brackets based on the virtual treatment in integrated digital maxillodental model were produced.

CONCLUSIONSAn integrated digital maxillodental model was created in good accuracy. By applying the integrated model, individualized lingual brackets were designed.

Adolescent ; Adult ; Child ; Computer-Aided Design ; Cone-Beam Computed Tomography ; Dental Models ; Dentition ; Female ; Humans ; Imaging, Three-Dimensional ; Male ; Malocclusion ; therapy ; Mandible ; diagnostic imaging ; Maxilla ; diagnostic imaging ; Orthodontic Brackets ; Young Adult