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ObjectiveTo evaluate the clinical safety of Naoxintong （NXT） capsules after marketing， find out the potential risk factors of the drug as soon as possible， and reveal the incidence， nature， and clinical manifestations of the adverse events （ADE） and adverse reactions （ADR） of NXT capsules， so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective， large-sample， multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018， with at least one follow-up. The demographic characteristics， disease type， NXT medication， ADR occurrence， characteristics， and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients （79.40%） aged ≥60 years and 3 153 patients （49.27%） with body mass index （BMI） exceeding the normal standard. There were 344 （5.38%） patients with a history of allergy to medicines and food， 9 （0.14%） patients with a family history of allergy， and 52 （0.81%） patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients， with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases， involving 10 organs/systems， of which gastrointestinal system damage was the most common （17， 54.84%）. All ADRs were mild or moderate. Most ADRs （19， 86.36%） occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.
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ObjectiveTo achieve high-dimensional prediction of class imbalanced of adverse drug reaction（ADR） of traditional Chinese medicine（TCM） and to classify and identify risk factors affecting the occurrence of ADR based on the post-marketing safety data of TCM monitored centrally in real world hospitals. MethodThe ensemble clustering resampling combined with regularized Group Lasso regression was used to perform high-dimensional balancing of ADR class-imbalanced data， and then to integrate the balanced datasets to achieve ADR prediction and the risk factor identification by category. ResultA practical example study of the proposed method on a monitoring data of TCM injection performed that the accuracy of the ADR prediction， the prediction sensitivity， the prediction specificity and the area under receiver operating characteristic curve（AUC） were all above 0.8 on the test set. Meanwhile， 40 risk factors affecting the occurrence of ADR were screened out from total 600 high-dimensional variables. And the effect of risk factors on the occurrence of ADR was identified by classification weighting. The important risk factors were classified as follows：past history， medication information， name of combined drugs， disease status， number of combined drugs and personal data. ConclusionIn the real world data of rare ADR with a large amount of clinical variables， this paper realized accurate ADR prediction on high-dimensional and class imbalanced condition， and classified and identified the key risk factors and their clinical significance of categories， so as to provide risk early warning for clinical rational drug use and combined drug use， as well as scientific basis for reevaluation of safety of post-marketing TCM.
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To study the adverse reactions' factors to Danhong injection in the real world. A multi-center, large sample and prospective hospital centralized monitoring method was adopted, and 30 888 cases of Danhong injection from 37 national 3A hospitals were collected to carry out a nested case control design study. These cases were divided into adverse reaction group and non-adverse group. Single factor logistic regression and multiple factor logistic regression were used to analyze data, and investigate the correlation between adverse reaction and gender, allergy history, methods of administration, and combined drug use. One hundred and eight cases of adverse reactions in 30 888 patients were determined, with an incidence of 0.35%. The results showed that Danhong injection combined with other medication(potassium mendoxine magnesium, thymic peptide, celecoxib, fumarate bisoprolol) with history of adverse reactions including scephalosporin allergy and proprietary Chinese medicine allergies had more adverse reactions than the control group(<0.05, estimated coefficient>0), indicating that these six factors were the risk factors for the adverse reaction of Danhong injection. The adverse reaction of Danhong injection combined with the aspirin was less than that in the control group(<0.05, estimated coefficient<0), indicating that the aspirin was a non-risk factor for the adverse reaction of Danhong injection. All the above results indicate that the adverse factors to Danhong injection include scephalosporin allergy, patent Chinese medicine allergy, Danhong injection combined with medication(potassium mendoxine magnesium, thymic peptide, celecoxib, fumarate bisoprolol), suggesting special attention shall be paid in clinical application.
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OBJECTIVE:To explore the incidence,clinical manifestations and influential factors of ADR induced by Xuebi-jing injection,and to provide reference for safe and rational use of it. METHODS:The inpatients who used Xuebijing injection in our hospital during Jan. 2012 to Dec. 2016 was registered and monitored centrally,and analyzed statistically in respects of clinical characteristics,occurrence time of ADR,clinical manifestation,outcome,etc.RESULTS:A total of 3 300 patients records were in-cluded,involving 81 ADR cases with incidence of 2.45%. There was no correlation between ADR and gender. The incidence of ADR was in high level in the patients with age over 60 years(6.53%),history of allergy(72.84%),original diseases as respirato-ry disease(3.33%),blood system disease(3.11%)and central nervous system disease(3.03%),and receiving combination of TCM injection(34.57%),antibiotics(25.93%)and immune enhancer(14.81%). Single-day culmulative amount with no more than 50 mL had relatively higher proportion(36.67%),and there was no statistical significance in the ADR with different sin-gle-day culmulative amounts(P>0.05). 38.27% of ADR occurred within 30 min after first medication. Organs/systems involved in ADR were mainly skin and its appendants(37.04%),cardiovascular system(19.75%)and gastrointestinal system(14.81%). To-tally 15 cases had severe ADR,which were mainly anaphylactic shock(33.33%,5/15)and systemic rash(20.00%,3/15). All ADR were recovered after drug withdrawal or symptomatic treatment. CONCLUSIONS:ADR induced by Xuebijing injection are mainly anaphylactic type. The incidence of ADR is higher in patients with primary respiratory disease,blood system disease,drug combination,allergic history and advanced age. The part of them are not mentioned in drug package inserts.Manufacturers are sug-gested to collect ADR information and improve drug package insets in time.
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OBJECTIVE:To explore the incidence,clinical manifestations and influential factors of ADR induced by Xuebi-jing injection,and to provide reference for safe and rational use of it. METHODS:The inpatients who used Xuebijing injection in our hospital during Jan. 2012 to Dec. 2016 was registered and monitored centrally,and analyzed statistically in respects of clinical characteristics,occurrence time of ADR,clinical manifestation,outcome,etc.RESULTS:A total of 3 300 patients records were in-cluded,involving 81 ADR cases with incidence of 2.45%. There was no correlation between ADR and gender. The incidence of ADR was in high level in the patients with age over 60 years(6.53%),history of allergy(72.84%),original diseases as respirato-ry disease(3.33%),blood system disease(3.11%)and central nervous system disease(3.03%),and receiving combination of TCM injection(34.57%),antibiotics(25.93%)and immune enhancer(14.81%). Single-day culmulative amount with no more than 50 mL had relatively higher proportion(36.67%),and there was no statistical significance in the ADR with different sin-gle-day culmulative amounts(P>0.05). 38.27% of ADR occurred within 30 min after first medication. Organs/systems involved in ADR were mainly skin and its appendants(37.04%),cardiovascular system(19.75%)and gastrointestinal system(14.81%). To-tally 15 cases had severe ADR,which were mainly anaphylactic shock(33.33%,5/15)and systemic rash(20.00%,3/15). All ADR were recovered after drug withdrawal or symptomatic treatment. CONCLUSIONS:ADR induced by Xuebijing injection are mainly anaphylactic type. The incidence of ADR is higher in patients with primary respiratory disease,blood system disease,drug combination,allergic history and advanced age. The part of them are not mentioned in drug package inserts.Manufacturers are sug-gested to collect ADR information and improve drug package insets in time.
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Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.
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The safety of TCM injection triggered attentions and hotspots in recent years in China.The centralized monitoring of TCM injection provided important evidence for analyzing the safety risk of TCM injections,recognizing adverse reactions and contraindications and perfecting the instructions.This study aimed at exploring the ethical problems on centralized monitoring.In this paper,we retrieved and screened the ethical issues of TCM injections over hospital centralized monitoring in China National Knowledge Infrastructure (CNKI,1979-Ju1.,2016).Issues over it were put forward and addressed.It is found that the current ethical issues related to hospital centralized monitoring lacks sufficient attentions,corresponding norms and requirements.Based on the ethical issues reflected from the literatures,suggestions should be pressed ahead with the ethical review of centralized surveillance,signing of informed consents,registration of research programs,data statistics and reporting stages,for the better protection of the rights and interests of subjects and improvement of research quality.
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Safety hospital centralized monitoring is one of the important methods for evaluating the medication safety of TCM injections in clinic.It is critical to warrant research quality by reasonable statistical analysis.However,universally accepted standards and guidelines for the statistical analysis of hospital centralized monitoring of TCM injections have not been issued so far,which would probably reduce the research quality of safety hospital centralized monitoring of TCM injections since the unreasonable use of statistical analysis methods.Combined with previous practical experience and understanding,we put forward the problems of statistical analysis of hospital centralized monitoring of TCM injections with the provision of some advice in this paper based on the analysis of the preceding studies,laying a foundation for the same kind of researches.
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Andrographolide total ester sulfonate (ATES) injection is one of the products of traditional Chinese medicine (TCM) currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-word clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86％ were contraindicated.Irregular medication of adults and children accounted for 1.91％ and 23.38％,respectively.Improper choice of solvent accounted for 3.18％.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events (AEs) was observed in the monitoring period,and the incidence of adverse drug reaction (ADR) of ATES injection was 0.12％.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.
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The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.
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Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.
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According to the related requirements of safety reevaluation of TCM injections,hospital centralized monitoring of the safety of TCM injection was consecutively pressed ahead.Centralized security monitoring was a large-scale real world research involving numerous data acquisition,transmission,verification and analysis.The quality of data acquisition and data verification directly affected the authenticity and reliability of research data and results.Therefore,data management played a significant role in the safety monitoring of TCM injections.Based on the analysis of previous researches,this paper discussed the implementation content,links and the frequent problems and corresponding solutions of data management during the safety monitoring of TCM injections,combining with the experience in the implementation of projects.
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OBJECTIVE: To investigate the clinical use of ornidazole injection in a wide patient population by the post-marketing hospital centralized monitoring method in order to regulate and guide its rational use, improve the drug specification, and provide a basis for the drug therapy. METHODS: A prospective, multi-center, large sample hospital centralized monitoring method was adopted. Five sentinel hospitals in Hubei Province were selected, and hospitalized patients who received ornidazole injection treatment from July 1, 2015 to October 31, 2015 were observed. The basic information of the patients was recorded, as well as the drug use and adverse events, and then statistical analysis was made. RESULTS: A total of 4396 cases were enrolled in this study, most of them were middle-aged female patients. Ornidazole injection was mainly used before surgeries to prevent infections and after surgeries for treatment of anaerobic infections, abdominal infections and pelvic infections. Irrational drug use existed in clinic, mainly concentrating at unreasonable dosing frequency, excessive dripping speed, and long duration of use. Eleven cases of adverse reactions were collected during the monitoring, indicating an incidence of adverse drug reactions of 2.5‰, and most of the adverse drug reactions occurred within 30 min post drug administration. CONCLUSION: The manufacturers should make further investigation on the dripping speed and quality standard of ornidazole injection to further improve the information in the package insert and regulate the clinical use.
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To assess the clinical use and occurrence of adverse reactions of Xiyanping injection, and to provide reference for rational drug use in the clinic. Based on hospital central monitoring method, the clinical data of Xiyanping injection in our hospital in 2014 was tracked and analyzed. A total of 848 inpatients were enrolled in this study. Among them, 39.9% were not in accordance with the medication purpose. In practice, the dose more than the limits prescribed by the instructions of child and adult were accounted for 1.72% and 6.62%, respectively; improper choice of solvent, accounting for 3.18%; both the choice of versus intravenous drip and aerosol inhalati administration route were reasonable; mixed with other drug, accounting for 2.24%. The incidence of ADR of Xiyanping injection was 0.12%, which showed good safety. Irrational use of Xiyanping injection existed in clinics, and the use should be strengthened and regulated. The manufacturer should improve the drug instruction of usage and dosage.
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Objective To re-evaluate Danhong injection and analyze the rationality of medication. Methods 400 patients treated with Danhong injection in Taiyuan Centre Hospital from February to August, 2010 were monitored centralizedly.Their medication and the results were analyzed and evaluated. Results The improvement rate was 95.1%, and the incidence of adverse reaction was 0.5%. The problems showed in the use of the drug were non-indication medication,inappropriate selection of solvent, and unsuitable compatibility with other drugs. Conclusion Danhong injection has the advantages of perfect effects and safe. The mode of medication monitoring by clinical pharmacist is worth promoting.
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OBJECTIVE:To establish a computer monitoring system for ADRs so that a centralized supervision can be carried out in hospital.METHODS:Based on the hospital HIS system,the information of medication was retrospectively analysed and the real-time monitoring of the information was carried out.RESULTS:This system made early warning and monitoring of ADRs become easier and simpler,and provided a proper condition for large-scale ADR monitoring.CONCLUSION:The application of real-time supervision and drug safety evaluation system provides a new and timely way to guarantee the rational and safe use of drugs in clinical practice.