Risk signal mining of adverse event related to adalimumab based on FAERS / 中国药房

OBJECTIVE To provide reference for clinical safe and rational use of adalimumab by mining the risk signals of adverse event （AE）. METHODS AE reports related to adalimumab were collected from FDA adverse event reporting system （FAERS）from Jan. 1st，2015 to Dec. 31th，2021. The reporting odds ratio （ROR）method and the Medicines and Healthcare Products Regulatory Agency （MHRA） method were adopted to mine the AE risk signals related to adalimumab ，AEs were classified and described by using the preferred system organ class （SOC）and preferred term （PT）of Medical Dictionary for Regulatory Activities （23.0）. RESULTS A total of 149 203 AE reports related to adalimumab were screened ，among which 65 218 cases（43.71％）were severe AE reports. A total of 2 660 PTs were mined ，involving 27 SOCs. PTs related to primary disease （arthralgia，Crohn’s disease ，rheumatoid arthritis ，abdominal pain ，osteoarthritis，intestinal obstruction ，psoriasis，joint swelling ， arthritis，etc.）were more frequently reported ，followed by PTs related to inflammation and pain （procedural pain ，inflammation， etc.）. The main SOC included musculoskeletal and connective tissue diseases （68 227 cases），gastrointestinal diseases （50 682 cases），injury，poisoning and procedural complications （32 404 cases），infections and infestations （15 651 cases），general disorders and administration site conditions （15 424 cases），etc. CONCLUSIONS It is suggested to pay attention to the possible occurrence of paradoxical psoriasis and lupus-like syndrome related to the autoimmune system when using adalimumab clinically ； at the same time ，the attention should be paid to serious infection ，tuberculosis，malignant tumors ，demyelination，congestive heart failure and other AEs. If related AEs occurs ，intervention measures should be taken in time. Great importance should be paid to intracranial aneurysms ，ovarian cysts ，coronary artery occlusion ，thyroid masses and other AEs not mentioned in the instrcution ，to ensure the medication safety of patients.

ADE Risk Signal Mining Related to Belimumab Based on the FARES Database / 中国药房

OBJECTIVE：To prov ide referen ce for clinical safe and rational use of belimumab by mining the risk signals of adverse drug event （ADE）. METHODS ：ADE reports related to belimumab were collected from FDA adverse event reporting system（FAERS）from the first quarter of 2015 to the first quarter of 2021. The reporting odds ratio （ROR）method and the Medicines and Healthcare Products Regulatory Agency （MHRA）method were adopted to mine the ADE risk signals related to belimumab，setting the threshold as the number of reports ＞3 and the lower limit of 95％ CI ＞1（ROR method ）and the proportional reporting ratio （PRR）＞2，and χ2 ＞4（MHRA method ）. ADEs were counted and classified by using the preferred system organ class （SOC）and preferred term （PT）of Medical Dictionary for Regulatory Activities （MedDRA）. RESULTS & CONCLUSIONS：A total of 3 529 ADE reports with belimumab as the primary suspicious drug were screened ，in which female patients（90.31％）were much more than male patients （6.15％）；age distribution was concentrated in 18-59 years old （41.80％）. There were 1 234 cases（34.97％）of severe ADE reports ，mainly involving hospital or prolonged hospital stay. Most of the reporters were consumers or other non-medical professionals （81.84％）. North America reported the most （70.39％）and the main reporting country was the United States （2 029 reports）. A total of 180 PTs were mined from 3 529 reports，in addition to PTs associated with primary disease （systemic lupus erythematosus ，pain，arthralgia，pyrexia，weight decreased ，swelling，oropharyngeal pain ， etc.），PTs related to medication error （product dose omission ，inappropriate schedule of product administration ，underdose， product availability issue ，etc.）and PTs related to infection （influenza，urinary tract infection ，infection，sinusitis，etc.）were reported in a large number of cases. Twenty-six SOCs were involved ，the top 10 SOC in ADE reports were all kinds of injuries ， poisoning and surgical complications （2 225 reports），infections and infectious diseases （1 247 reports），general disorders and administration site conditions （1 196 reports），musculoskeletal and connective tissue disorders （1 195 reports），surgical and medical procedures（515 reports），etc. PTs in SOC in the first place （all kinds of injuries ，poisoning and surgical complications ）of ADE reports were all related to medication error ；herpes zoster ，kidney infection and cellulitis in SOC in the second place （infections and infectious diseases ）of ADE reports were not included in the drug instruction of belimumab ；most PTs in SOCs such as various nervous system diseases ，immune system diseases ，mental diseases ，benign，malignant and unknown tumors （including cystic and polypoid）which were taken attention in clinic were not included in the drug instruction of belimumab. It is suggested to avoid medication errors as far as possible in clinical use of belimumab ，and to guard against adverse reactions such as herpes zoster ， kidney infection ，cellulitis and various nervous system diseases ，immune system diseases and mental diseases. In addition ，the patients with malignant tumor or related history should use belizumab carefully.

Analysis of adverse reactions risk signal of Xinyuan Capsules based on national ADR monitoring spontaneous reporting system / 中国中药杂志

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.

Quantitative Evaluation on Adverse Drug Reaction Signal in FDA and Its Illumination / 中国药房

OBJECTIVE: To analyze and evaluate the quantitative evaluation of ADR signals in FDA and to provide a reference for ADR evaluation in China. METHODS: By means of literature review,contrasting analysis and data reduction,ADR signal evaluation in FDA was investigated. RESULTS&CONCLUSION: In USA MGPS method is used for the quantitative evaluation of ADR signal, which can earlier obtain ADR signal and effectively promote the risk warning ability of ADR information. This is practical in our country and we should learn from them. Combined with various data analyzing methods, we can set up a high-quality evaluation database for ADR signals. The importance of pharmacoepidemiology and statistics in ADR evaluation should be highly recognized and the methods for ADR signals evaluation should be gradually shifted from qualitative to quantitative evaluation.

Monitoring of Adverse Drug Reaction in Netherlands and Quantitative Evaluation on ADR Signal / 中国药房

OBJECTIVE:To provide reference for ADR evaluation in China.METHODS:The ADR signal evaluation method adopted by the pharmacovigilance center in Netherlands was analyzed by means of literature review,contrasting analysis and data reduction etc.RESULTS & CONCLUSION:We should draw experience from the pharmacovigilance center in Netherlands about the evaluation method on ADR signal and establish ADR evaluation databases of high quality;furthermore, we should attach great importance to the application of pharmacoepidemiology and statistics in ADR evaluation and gradually replace the qualitative evaluation with quantitative one for ADR signal.