RESUMO
OBJECTIVE: To put forward a method of construction of the safety evaluation platform related to formula-medicine dose of TCM because of the lack of the dose-effect relationship research and the insufficient of safety monitoring in Chinese medicine. METHODS: Under the guidance of Chinese medicine theory, an ADR (adverse drug reaction)/ADE (adverse drug event) monitoring scale with TCM characteristics was developed based on patients reporting, thus to promote positive and prospective evaluation researches related to formula-medicine dose. On the basis of the ADR/ADE data base, the safety monitoring module will be formed then. RESULTS AND CONCLUSION: The safety evaluation platform related to formula-medicine dose is supposed to be structured.
RESUMO
BACKGROUND: This study was carried out in Mahasarakham Primary Healthcare Center, Mahasarakham province in the area of Northeastern of Thailand. The experiment was randomized control trial clinical study in order to examine the side effects of Areca catechu Linn., Thai traditional formulae medicine, mebendazole in the treatment of anti-helmintic activity of mixed worms infection in human. MATERIALS AND METHODS: The experimental group consisted of 15 patients and 5 patients for control group with inclusion and exclusion criteria, which were screened by parasitologist with the selection of mixed worm infection patient samples. The investigation of side effects was recorded after the treatment of each group of patient with different kinds of 4 group of medicine. RESULTS: The percentage of side effects was collected by nurses and confirmed by the physician at Mahasarakham Health Center, which were diarrhea and nausea side effects. The percentage of side effects by the treatments of Areca catechu Linn., Thai traditional formulae medicine, mebendazole were investigated by the physician and the pharmacist, which the result showed 20% of diarrhea in Areca catechu Linn., 20% of nausea in Areca catechu Linn, 20% in side effect of diarrhea in mebendazole treatment, and no side effects were found by the treatment of TTFM. The result showed that Areca catechu Linn. had higher side effects among the 3 anti-helmintic drugs. CONCLUSION: The findings indicate to increase the numbers of samples of worm-infected patients, which the samples can be identified with the specification of helminthes genus and species in order to obtain the efficacy by the treatment using Areca catechu Linn and also indicates to increase various forms of dosage preparations and various demographic locations in Thailand.
