| ObjectiveTo observe whether a number of traditional Chinese medicine factors are associated to the reaction after administration of aconite, whether the reaction after administration of aconite (dizziness reaction) is regular actually and in a certain extent is controllable, whether the reaction after administration (dizziness reaction) is different from drug adverse reactions, and whether the aconite medication is effective and safe with enough decoction time, proper compatibility of medicines, clinical drug selection, and drug regimens through the clinical retrospective study of the large sample of patients treated in Traditional Chinese Medicine Clinical Practice Base of Guangdong Province Traditional Chinese Medical Hospital in 2013-2015. The conclusion and data of the study can be used as objective basis of controlling the reaction after administration of aconite according to clinical requirements, and provide research ideas and data support for future similar aconite safety research.MethodsRetrospective analysis was used in this study. The patients treated by prescription containing aconite and suffered the reaction after administration (dizziness reaction) during hospitalization in Traditional Chinese Medicine Clinical Practice Base of Guangdong Province Traditional Chinese Medical Hospital in 2013.1-2015.12 were researched to analyze the characteristics of the traditional Chinese medicine factors, strictly complying with the relevant norms of clinical trials and experimental operation. Hospitalization time, age, gender, first diagnosis of western medicine were chosen as baselines, and control group (1:1 match) was selected from patients hospitalized in the department (without the reaction after administration), traditional Chinese medicine factors used in the two groups were analyzed, in order to assess the potential impact of various factors related to taking traditional Chinese medicine on the occurrence of the reaction after administration. The factors included:aconite species, dosage, compatibility of drugs, decoction time, and drug regimens in the prescription used by the patients. The data collected were analyzed using statistical software for chi-square test, t test, and logistic regression analysis to assess whether the above factors are related to or have effects on the patient’s reaction after administration.Results and conclusion1. Between 2013 January and 2015 December, there were 2960 patients hospitalized in Traditional Chinese Medicine Clinical Practice Base of Guangdong Province Traditional Chinese Medical Hospital in 2013-2015, in which, 154 patients appeared reaction after administration after taking Traditional Chinese Medicine prescription containing aconite,152 patients turned better and leaved hospital,1 people transferred to other hospital department due to the illness situation, and one patients died due to serious basic diseases. For the descriptive analysis of the rest data, see below.2. Comparing the prescriptions of responders group and non responders group, the dosages of raw aconite, rhizoma zingiberis, pinellia tuber, asarum, dark plum, astragalus root, ephedra, white atractylodes rhizome, cassia twig, peony, ginger, prepared rhizome of rehmannia, angelica and aconitum in prescriptions have obvious statistical significance, shows that the amounts of the above drugs have obvious effect on the occurrence of dizziness reaction.3. In responders and non responders groups, whether using raw aconite, roasted lateral tuber of A. carmichaeli. Aconitine, cooked aconite, asarum, raw cornus officinalis, dark plum, ginseng, Poria, ginger, amomum villosum, Vessel-Freeing Counterflow Cold Decoction, and Wen bentun soup in prescriptions are statistically significant. It suggests that above drugs and prescriptions have obvious influence on the occurrence of dizziness reaction.4 The decoction time and methods of taking medicine in responders and non responders groups are statistically significant, suggesting these factors have obvious influence on the occurrence of dizziness reaction.5 In responders and non responders groups, assess the drug used in two groups and drug factors of prescription using logistic regression analysis, the results showed that:the usage of raw aconite, dark plum, raw cornus officinalis, Vessel-Freeing Counterflow Cold Decoction increases the occurrence of dizziness reaction, and rhizoma zingiberis is a protective factor of dizziness reaction.6. In responders and non responders groups, assess the drug dosage using logistic regression analysis, the results showed that:the dosages of raw aconite, dark plum, raw cornus officinalis increase the occurrence of dizziness reaction, and prepared licorice root is a protective factor of dizziness reaction. |
PDF Full Text Request