| BackgroundTraditional Chinese Medicine Injections (TCMIs) is an important landmark of modernization and progress of Traditional Chinese Medicine (TCM), and have played an important role in medical practice since it born. However, with the widespread clinical applications, Adverse reactions of traditional Chinese medicine injection increased in recent years, which catch people's eyes. Some traditional Chinese medicine injection was forbbiden for severe adverse reaction, such as Acanthopanax senticosus, Shuanghuanglian and Yinzhihuang, security issues affecting the development of TCMIs, and against the masses on medicine confidence, affect the development of TCM. In order to develop these featured TCM formulations, the State Food and Drug Administration (SFDA) required in2009the reassessment of all existing TCMIs on aspects such as safety, effectiveness and drug combination, to control the safety risks of TCMI and ensure the safety, stability and effectiveness.Shen Mai injection is rooted from the ShenMaiYin in<Zhen Ying Mai Zhi>, it is extract prepared by an equal amount of ginseng, Ophiopogon japonicus, The effective constituents include Ginseng saponins of Ophiopogon japonicus, Ophiopogon japonicus saponin, flavone and trace of ginseng polysaccharide and polysaccharide of Ophiopogon japonicus, that it have the efficacy of increase Qi to prevent passing away, nourishing Yin and Generating pulse. Shen Mai injection was applied to the medicine practice since Nineteen seventies, it was list as the one of the first batch essential medicine in emergency department (room) in1992, as one of national medicine protections and one of essential medicines in emergency of traditional Chinese medicine. Since listing, Shenmai injection was used widely in clinic, for the treatment of pulmonary heart disease, coronary heart disease, neutropenia and other diseases, and achieved good results, but some adverse reactions happened. It made great importants to re-evaluation the safety of Shen Mai injection in order to provide reference Specifications of clinical rational drug use and reduce the occurrence of adverse reactions.ObjectivesTo evaluate the safety of Shen Mai injection, find out the incidence of adverse reactions of Shenmai injection and adverse reactions related factors in the crowd, learn the adverse reactions in cancer patients, and learn the allergic reaction of Shenmai injection in tumor-bearing mice.MethodsThe study includes clinical research and experimental study. The hospitalized patients treated by Shenmai injection were observed in the tumor section in first hospital of Guangzhou University of Traditional Chinese Medicine, in the internal medicine departments in Baoan District Chinese medicine hospital, Shenzhen City, and in the tumor section in ZhongShang hospital of Traditional Chinese Medicine, Using a cohort study with case-control study research design method in clinical study. Through the statistical analysis of data and summary, to make clear the incidence rate of adverse reactions, adverse reaction forms and influencing factors of Shenmai injection, and to clear incidence rate of adverse drug reactions of Shenmai injection in tumor patient. Experimental study with tumor-bearing mice as the object, it includes active systemic anaphylaxis test, passive cutaneous anaphylaxis test. The experiment used a randomized controlled method, divided into four groups, including low dose group of Shenmai injection, high dose group of Shenmai injection, negative group and positive group. outcome measures include allergic reactions, skin and blue plaques and IgE. If positive symptoms appear in active systemic anaphylaxis, Supplementary test should be tood in order to identify anaphylactoid reactions.ResultsThe clinical research:The541cases of hospitalized patients were observed during2011January to2011December, including male250, female291, age range from15to97years old, average age is61.23years old, have food or drug allergy the history of a total of37, with a hi story of allergic disease in5patients, primary disease include cardiovascular system, malignant tumor, respiratory system, etc; all patients used0.9%sodium chloride injection or5%glucose injection as solvent, single dose of40ml majority in Shenmai injection.One adverse reaction case, the incidence rate of adverse reactions was0.18%, the case with adverse reactions was a63female patients with coronary heart disease. The patient had no history of drug allergy or a history of allergic disease. The adverse reaction occurred in the first use of Shenmai injection for10minutes, the main clinical manifestations was fever and chills, the symptoms dissappeared after stop Shenmai injection and vein injection of dexamethasone injection.This clinical observation, includes267cases of cancer patients,that accounting for49.35%of the observed cases.135cases were male and132cases were female, the average age was62.82years of age, including lung cancer, colon cancer, liver cancer and other common tumors, and also including mesothelioma, renal cell carcinoma and other rare tumors,14patient had a history of drug allergy, but adverse reactions not found in the tumor patients The Experimental study:(1) active systemic anaphylaxis:40tumor-bearing mice were randomly divided into4groups for active systemic anaphylaxis,10rats in each group, high dose group, low dose group and positive group showed symptoms, while in the complementary tests, the three groups had no allergy symptoms. So it could be identified, symptoms in the three groups were because or allergic reaction, but not anaphylactoid reactions. By statistical analysis, we learnd that it hat significant differences among the four groups at the point of allergic reactions.Positive group:the adverse reactions incidence rate was100%, the mortality rate was20%. The high dose group:the the adverse reactions incidence rate was60%, the mortality rate was20%. The low dose group the incidence of adverse reactions was11.11%, mortality is0. The adverse reactions was more serious in high dose group than in low dose group,with significant difference. IgE performed that high dose group>low dose group> negative group of Shenmai injection, with significant difference.(2) passive cutaneous anaphylaxis:36tumor-bearing mice were randomly divided into4groups for passive cutaneous anaphylaxis,9rats in each group,5rats showed blue plaques in positive group,3rats showed blue plaques in low dose group, and2rats showed blue plaques in both high dose group and negative group, but diameter of most blue spot was less than5mm, evaluation was negative; the diameter of blue spot which was more than5mm only appeared in only2cases, respectively,one in the positive group and the other in low dose group. Allergic reaction positive rate were not significantly different among high dose group, low dose group and negative group.IgE in high dose and low dose group were significantly higher than that in the negative group, but there was no significant difference between the high dose group and the low dose group.ConclusionShenmai injection safety is better when used in the prescribed dose, from clinical and experimental results, the tumor groups also has good security. There was no case with over-dose Shenmai injection in the clinical research, it had not yet been found in Shenmai injection adverse reactions associated with patient age, gender, underlying diseases, drug and food allergy history, history of allergic disease, familial history, not found the adverse reactions associated with solvent, dose dependency. So, we considered that the clinical of Shenmai injection adverse reactions may be associated with individual differences, transfusion related. The safety of Shenmai injection was good in tumor-bearing mice, low adverse reactions incidence rate in low dose group, capared with low group, allergic reactions incidenct rate increased in high dose group, allergic reaction and the IgE had certain correlation. To sum up, Shenmai injection is safe in the crowd, and also in tumor patients when used in the prescribed dose. When it was used according to the instructions, the proper dosage, the incidence of adverse reactions to low risk; but if not, the occurrence of adverse reactions to higher risk. The occurrence of adverse reactions, may be related to dose, individual differences and infusion operation. |
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