| Objects: To investigate the adverse drug reactions (ADRs) incidence rates of shuanghuanglian(SHL) injection, the ADRs types, the frequence of each type and the relevant influence factors of the ADRs,and to further explore a feasible post-marketing reevaluation method of drugs.Methods:1) Searched the published literatures about the ADRs of SHL by iv-dropping over the past 15 years (1989-2004). According to systematic review and ADRs study methods, classified those into 3 groups: the paralled control clinical trial group (Control trial group), the ADRs monitor and the case analysis group (Monitor and analysis group), the case report group(Case report group). Sorted out and quantitative analyzed those data.2) Selected the third class A grade hospital in Wuhan City Hubei Province, where ADR monitoring launched better. By cluster sampling, retrospective investigated the completive integrated cases that adopted SHL by iv-dropping during from January 1st, 2001 to December 31st, 2002.3) All results of the incidence, the types, and the frequence of each type of ADRs were statistically analysed by SPSS (version 11.0). On the basic of single factor unconditional logistic regression results and considering the interaction, multi-variate unconditional logistic regression adopted the enter, forward and backward methods respectively, and to calculate the odds ratio and it's 95% confidence interval of correlated study factors and ADRs happened.Results:1. References Systematic Review1) In Control trial group, there were 96 papers that referred to 'random' or 'balanced', 7445 cases in total were adopted SHL and 177 cases were reported ADRs. The average ADRs rates were 2.38%.The incidence rates of powder reagent (2.68%) weresignificantly higher than those of injection reagent (chi-square =9.362, P=0.002). The main ADRs of SHL were allergic reaction (56.99%) and digestive system reaction (28.49%). Rash was usual and phlebitis, fever, nausea or vomit were incidental.2) In Monitor and analysis group, 12 papers were selected. 407 cases were reported ADRs among 11 188 cases in total who adopted SHL. Similarly, allergic reaction (71.00%) and digestive system reaction (20.78%) were the most. Rash was usual andfever, diarrhea, nausea or vomit were incidental.3) In Case report group, Among 411 cases ADRs from 264 reports, sex selectivity was not significant (male 54.9% vs. female 45.1%, chi-square =1.966, P=0.161); ages covered from 2 months to 89 years old, average 28.6 years (median 28.0 years), 15-49 years age-group was the most, the proportions of each age-groups were not significant different (chi-square =2.138, P=0.710). The most ADRs was allergic reaction (63.48%), followed by digestive system reaction (12.63%) and respiratory system reaction (7.85%).2. Case Retrospective Investigation:1) 2 068 cases (95.8%) were investigated, among 1 175 males, 891 females and 2 others; average age was 9.7 years (from 2 days to 88.6 years, median was 4.0 years).2) Average intake days was 4.7 (median was 4 days) and 34.0% was less longer than 3 days due to fully recovery (21.9%), unsatisfied effect (10.5%), adverse events (6.3%) and other reasons (45.2%). 99.0% (2 047 cases) combined with other medicines, and 82.8% (1 712 cases) with antibiotics, 48.1% (973 cases) with over 5 kinds of medicines. ?3) 112 cases happened adverse events and 53 of them were identified as ADRs. The ADRs rates were 2.56%. The main types were allergic reaction (76.8%) and digestive system reaction (10.7%). We can find that the rash was usual and vomit, fever, diarrhea, oral ulcer and body disorder were incidental.The rare types were liver function abnormality and leucopoenia.4) The ADR rates in males were significantly higher than those of females (3.32% vs. 1.57%, chi-square=6.174, P=0.013). In the different age groups, they did not show asignificant difference (Fisher's exact, P=0.339). Single factor unconditional logistic regression demonstrated that the relevant factors to ADR involve in sexuality, cooperated with antibiotics, the kinds numbers of combined medicines. All methods of multi-variate unconditional logistic regression which adopted the enter, forward and backward methods showed that the relevant factors included sexuality and the number of combined medicines. The risk of ADRs to males is double than to females. Patients who adopted 11 kinds or more combined medicines would have 4 times danger to suffer ADR than those who adopt 0-4 kinds, and twice than those who adopt 5-10 kinds.Conclusion:1) Different research methods confirm that the ADR incidence rates of SHL are from 2.38 to 3.64%; the main ADRs are allergic reaction and digestive system reaction, as well as several kinds of reactions that do not report in the drug labeling.2) The published references demonstrate that ADRs are relevant to reagent kinds, the history of asthma and allergy. Cases retrospective investigation point out that ADRs are relevant to sexuality and the number of combined medicines.3) The utilizable rate of references is so poor that it is necessary to be improved. The reports of ADRs are not standard and thorough enough.4) To comprehensivelly study the ADR of literatures and case retrospective investigation are be suitable for drugs post-marketing reevaluation, especially in the safety field. And these methods could provide the evidence to further prospective survey.
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