The present clinical trial was conducted to determine the efficacy and tolerance of oxantel(CP-14, 445), one of pyrimidine derivative, in the treatment of Trichocephalus trichiurus infection. One hundred eighty two cases who harboured T. trichiurus were treated with oxantel in a single dose of 10 to 25 mg/kg of body weight. For the evaluation, the negative conversion rate and egg reduction rate were calculated before and 22 days after the treatment. The results obtained were as follows: The prevalence rate of T. trichiurus infection in present study was 64.2% by examining 1,536 fecal specimens collected. The overall negative conversion rate was 66.5%, while the highest rate(93.3%) was obtained in the group treated with 20 mg/kg of oxantel (Group III). The lowest rate(56.6%) was observed in Group I (10 mg/kg). The overall egg reduction rate on present study was 90.3%. The highest rate, 100% of egg reduction was also obtained in Group III (20 mg/kg). From the observation of 1,244 expelled worms, it was known that 45.0% of collected worms were expelled on the first of post-treatment day, and male and female worms were about the same in number(1.03 : 1). Average worm burden per capita was 11.1 in this observation. The medication was readily accepted and tolerated by all the treated cases. On the hemograms, urinalysis and liver function tests, no significant differences were noted before and after the drug administration. Side reactions were so mild and transient that none required specific treatment.
parasitology-helminth-nematoda ; Trichocephalus trichiurus ; oxantel ; chemotherapy-trichuriasis ; drug ; hematology ; liver ; urinalysis ; side reaction

OBJECTIVETo discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring.

METHODWork modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains.

RESULT AND CONCLUSIONAs there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short-term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.

Adverse drug reaction (ADR) causality judgement is a routine procedure in pharmacovigilance, no unified judgement standard and categories standard are established. Temporal relations, consistency, specificity, intensity of reaction are the basic principle of ADR causality jugement we should abide by. There are many ADR causality assessment methods, which classifies standard algorithms, expert judgement, bayesian approches. The implicit definitions of some categories standard, incomplete information from case reports coupled with vast differences in the application of clinical judgements are the major problems facing ADR evaluation. Almost every kind of method shares certain common feature, that is, causal relationship of ADR is classified about five categories. However, causality assessment methods differ in basic principle, evaluation standard, specificity and sensitivity. There are some advantages and disadvantages among methods, but no causality assessment method can be applied to all ADR evaluation to date.
Adverse Drug Reaction Reporting Systems ; standards ; China ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Pharmaceutical Preparations ; administration & dosage

Along with the general improving of public consciousness on drugs' safety and the increasing of new Chinese drugs' manufacture and application, the safety of Chinese drugs has become a more prominent concern and a focus of attention. The scientific identification, analysis and evaluation of this affairs greatly impacts the scientific decision-making for ensuring the public use of drugs in security, also influences the healthy development of Chinese medicine industry. In this paper, the different meanings of "adverse reaction" and "adverse events" of Chinese drugs were introduced from pharmacovigilance idealistic view, and the influencing factors on safety of Chinese drugs were analyzed from the perspective of pharmacovigilance. The authors proposed that "Chinese medicine safety monitoring and evaluation" is a much more practical concept in consistency with the current situation. They pointed out that introducing sufficiently the concept of pharmaco vigilance idea into the safety monitoring and evaluation process is the basis for overall evaluation and effective risk controlling of Chinese drugs.
Adverse Drug Reaction Reporting Systems ; Drug Evaluation ; standards ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects

This research based on the analysis of spontaneous reporting system (SRS) data which the 9 601 case reports of Shuxuening injection adverse drug reactions (ADR) in national adverse drug reaction monitoring center during 2005-2012. Apply to the association rules to analysis of the relationship between Shuxuening injection's ADR and the characteristics of ADR reports were. We found that ADR commonly combination were "nausea + breath + chills + vomiting", "nausea + chills + vomiting + palpitations", and their confidence level were 100%. The ADR and the case reports information commonly combination were "itching, and glucose and sodium chloride Injection, and generally ADR report, and normal dosage", "palpitation, and glucose and sodium chloride injection, and normal dosage, and new report", "chills, and generally ADR report, and normal dosage, and 0.9% sodium chloride injection", and their confidence level were 100% too. The results showed that patients using Shuxuening injection occurred most of ADRs were systemic damage, skin and its accessories damage, digestive system damage, etc. And most of cases were generally and new reports, and patients with normal dosage. The ADR's occurred had little related with solvent. It is showed that the Shuxuening injection occurred of ADR mainly related to drug composition. So Shuxuening injection used in clinical need to closely observation, and focus on the ADR reaction, and to do a good job of drug risk management.
Adverse Drug Reaction Reporting Systems ; Drug-Related Side Effects and Adverse Reactions ; diagnosis ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Male

There are no drugs without the risk of potential adverse reactions. All pharmacologically active substances can cause adverse drug reactions (ADRs). This paper aims at introducing recent trends in pharmacosurveillance systems for ADRs, which can be broadly classified into type A and B reactions. Since type A reactions are associated with drug pharmacology, they are usually dose-dependent and predictable. Whereas, type B reactions occur in some susceptible individuals, regardless of the pharmacological action of drug. Drug hypersensitivity reactions are typical examples of type B reactions and are subclassified according to the underlying pathomechanism. Recent advancements in pharmacogenomics have enlightened the understanding of individual differences in drug efficacy and susceptibility to ADRs. Therefore, expectations for safe personalized medicines are higher than ever before. However, premarketing clinical trials are too small and too short to uncover rare but serious ADRs and detect long-standing ADRs. In the past, post-marketing surveillance systems mainly focused on passive ADR monitoring systems, based on spontaneous reports. Recently, the importance of active pharmacovigilance systems, which use big data, is growing with recent advancements in medical informatics. Thus, regarding ADRs, suspecting and detecting the causative drug using causality assessment based on data science may contribute to decrease suffering induced by ADRs.
Adverse Drug Reaction Reporting Systems ; Drug Hypersensitivity ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Individuality ; Medical Informatics ; Pharmacogenetics ; Pharmacology ; Pharmacovigilance

In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.
Adverse Drug Reaction Reporting Systems ; Bayes Theorem ; Capsules ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Neural Networks, Computer

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.
Adverse Drug Reaction Reporting Systems ; Books ; Drug-Related Side Effects and Adverse Reactions/epidemiology* ; European Union ; Humans ; Medicine, Chinese Traditional ; Pharmacovigilance

OBJECTIVE: To establish a new digital polymerase chain reaction (dPCR) system for the detection of BCR-ABL fusion gene in patients with chronic myeloid leukemia (CML), and explore its analytical performance and clinical applicability in the detection of BCR-ABL^p190/210/230. METHODS: A new dPCR system for detecting BCR-ABL^p190/210/230 was successfully developed, and its sensitivity difference with qPCR and improvement of drug side effects in patients with CML during drug reduction or withdrawal were compared. RESULTS: Among 176 samples, qPCR and dPCR showed high consistency in the sensitivity of detecting BCR-ABL (82.39%), and the positive rate of dPCR was about 5 times higher that of qPCR (20.45% vs 3.98%). During follow-up, blood routine (25% vs 10%), kidney/liver/stomach (25% vs 20%) and cardiac function (10% vs 0) were significantly improved after drug reduction or withdrawal in patients with initial dPCR negative compared with before drug reduction or withdrawal. CONCLUSIONS This new dPCR detection system can be applied to the detection of BCR-ABL^p190/210/230. It has better consistency and higher positive detection rate than qPCR. Drug withdrawal or dose reduction guided by dPCR has a certain effect on improving drug side effects.
Humans ; Fusion Proteins, bcr-abl/genetics* ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/diagnosis* ; Polymerase Chain Reaction ; Drug-Related Side Effects and Adverse Reactions ; Reverse Transcriptase Polymerase Chain Reaction

PURPOSE: Adverse drug reaction (ADR) is known to be a substantial reason for emergency departments (ED) visits. Additionally, it also is a frequent occurrence in ED. The aim of the study was to compare the characteristics between ADRs that occurred in ED and ADRs that occur elsewhere based on the spontaneous reporting system in a hospital. METHODS: In this retrospective observational study, the data was collected by the spontaneous ADR reporting system within an electronic medical record system during a 24-month period. ADR of patients aged more than 18 years were included in this study. RESULTS: Patients with ADR was older in ED (42.6±14.5 vs. 53.9±17.2, p<0.001) and they were administered with less medications (2.0±1.3 vs. 4.4±4.4, p<0.001). The proportion of ADR reported by doctors in ED was higher than that in non-ED (41.2% vs. 28.2%, p<0.001). The proportion of the severe ADR was not significantly different between the ED and non-ED groups (2.9% vs. 3.8%, p=0.701). The most common symptom of ADRs in ED and non-ED groups were cutaneous (52.9%) and gastrointestinal (42.2%), respectively; the most common implicated medication was analgesics (62.7%) and analgesics (41.5%), respectively. CONCLUSION: The characteristics of ADR in ED is different from that in non-ED locations. Further studies are needed to differentiate education and prevention strategies of ADR in ED from those in non-ED locations.
Adult* ; Adverse Drug Reaction Reporting Systems ; Analgesics ; Drug-Related Side Effects and Adverse Reactions* ; Education ; Electronic Health Records ; Emergencies* ; Emergency Service, Hospital* ; Humans ; Observational Study ; Retrospective Studies