| Objective:Re-evaluationon the safetyof three kinds of traditional Chinese medicine injection such as Danhong injection, Xiyanping injection and tanreqing injection by using Pharmacoepidemiology Nested case-control study, statistical analysis on the type performance and related factors ofadverse reactions ofeachtraditional Chinese medicine injection. Clear the type performance and related factors of adverse reactionsof three kinds of traditional Chinese medicine injection such as Danhong injection, Xiyanping injection and tanreqing injection,and explore the scientificand feasibilityof Nested case-control study used in adverse factors researchof traditional Chinese medicine injection.Methods:①Centralized monitoring on hospitalized patients which using Danhong injectionfrom the April 1, 2009 to August 31, 2013 six provinces 37 general hospitals, by using Pharmacoepidemiology Nested case-control study, select a control by using 1: 4 matching method, overall analyze on centralized monitoring data the existing 30,888 cases of Danhong injection. When a case of Danhong injection adverse reaction occur, match with the related factors which cases using Danhong injection from the queue in the information case did not occur adverse reactions,Determine factors of matching pair and extract the control group. ② Collect all inpatients HIS data of Xiyanping and Tanreqing injection and all reported data of Xiyanping injection adverse reactions from January 2012 to January 2014 in hree top three general hospitals of Zhengzhou. Above all extracted data of Hospital HIS system of Xiyanping injection and tanreqing were analyzed using 1: 4 matching method to select controls. Such as Xiyanping injection, When a case of Xiyanping injection adverse reaction occur, match with the related factors which cases using Xiyanping injection from the queue in the information case did not occur adverse reactions,Determine factors of matching pair and extract the control group. ③ According centralized monitoring data of Danhong injection and HIS hospital informationsystem acquisition and analysis results of Xiyanping, Tanreqing injection, clear the clinical safety related factors of Danhong injection, Xiyanping injection and tanreqing injection such three kinds of traditional Chinese medicine injections.Results:①The male and female patients proportion of 30,888 cases which using Danhong injection was close, men slightly more than women, the proportion of elderly people over 60 was larger, accounting for 59.93%. In which, 6577 cases have no weight and height information, the r emaining 24,311 cases have complete data of body mass index. Normal body mass index accounted for 41.80%. No bad habits accounted for 80.9%. Deny individual drugs, food allergies account for 84.06%, have personal medications and food allergies account for 15.94%. Denied family history of allergies accounted for 94.07%, with a fami ly history of allergies account for 0.31%, which unknowned account for 5.62%. Denied a history of allergic diseases 99.13%, have a history of allergic disease account for 0.87%. Consisting with indications of its instructions account were 17,853 cases, accounting for 57.80%. Beyond its indications were 13,035 cases, accounting for 42.20%, involving disease were diabetes, deep vein thrombosis, purpura, hypertension, nephrotic syndrome, arthritis, fractures, lumbar disc herniation, chronic obstructive pulmona ry disease, cardiac arrhythmias and other diseases. In addition, the vast majority(95.4%) patients had no more than three medication indications, 4.6% patients had three or more indications. Included cases had syndrome were 12,290 cases, accounting for 39.79%, compared with the West Hospital, differentiation rate of Traditional Chinese Medicine Hospital reached 95.0%. Patient of first time using Danhong injection accounted 51.44%. The patients which combined use 1-4 kinds of Chinese traditional medicine were most, accounted 50.5% of the total number of cases, fllowed by patients of combined using 5-9 kinds of drugs, accounted 33.3% of the total number of cases, the patients combined using over 15 kinds of drugs were least, only 1.2%. Ultimately determine Danhong injection ADR cases collected by centralized monitoring method were 108 cases, the rate was 3.50 ‰. Adverse reactions found involving damage multiple systems, in which the skin and its appendages, the central and peripheral nervous system damage, ca rdiac vascular damage were more common, accounting for 68.35%. Adverse reactions new discovered have 18 species, manifested as sweating, clammy skin, superficial phlebitis, purpura, vasodilation / relaxation, eye hemorrhage, periorbital edema, weakness, chest pain, anxiety, restlessness, flatulence, stomach ulcers bleeding, cyanosis, hypotension, hypertension, local numbness, joint disease, tinnitus. Danhonginjection adverse reactions were rapid onset, often seen within one hour. Shortest medication appears after one minute. Factors of Univariate analysis eventually enter in the Logistic Regression Model with Group design of adverse reactions risk factors have gender, personal food allergy medication history, personal history of allergic diseases, TCM, the first use of Danhong, medication for several days and vehicle types 7 kinds. P value of these seven analysis results reached significant level(P <0.05), with statistical significance. Factors of Univariate analysis eventually enter in the Logistic Regression Model with Individual match of adverse reactions risk factors have personal food allergies medications, family history of allergies, personal history of allergic diseases, TCM differentiation, whether for the first time using Danhong, medication for several days, vehicle types such 7 items. In seven of the analysis results P <0.05 have food allergies indi vidual drugs, personal history of allergic diseases, TCM, medication for several days, with statistical significance. ② Only two cases were found related with Xiyanping injection ADR / ADE in 27,773 cases of patients using Xiyanping injection, not enough to make a nested case-analysis. ③ 23,441 cases in this study, 2 cases of tanreqing related ADR / ADE were discovered, not enough to make a nested case-analysis.Conclusions: ① ADR occurrence of Danhong injection with Hospital acquired centralized monitoring method: ADR incidence of Danhong injection was 3.50 ‰, belong occasionally level, clinical use was safety; the ADR performance of damage to the skin and its appendages were largest share; ADR severity mostly was moderate or mild which had a good prognosis; ADR occurred within one hour, and mostly were rapid onset. ② The ADR related factors of Danhong injection mainly were sex, personal history of drug allergy food, personal history of allergic disease, whether for the first time using Danhong and vehicle types, the clinical use of the process should be closely watched. ③ The study results of Danhong injection utilizing hospital centralized monitoring method caring out nested case-control were most comprehensive and detailed, the comprehensive of using hospital HIS system extracting data was slightly less than above. In this study, the ADR information of the remaining two kinds of traditional Chinese medicine injections obtained through spontaneous reporting was missing and lag, unable to communicate with hospital HIS effective combination of extracted data. ④ Hospitals centralized monitoring could timely collect adverse reactions information of Danhong injection, related data were comprehensive, and in favour of promoting the progress of clinical safetyre-evaluation researching on traditional Chinese medicin e injections. If the adverse reaction information using spontaneous reporting method can be timely and effectively combined with the information extracted by hospital HIS system, we can carry out its clinical safety re-evaluation study using nested case-controlstudy.⑤Nested case-control method can be applied to researching on clinical safety re-evaluation of traditional Chinese medicine injections, and has better to find statistical power of ADR factors deserve, it is worth further application. |
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