Correlation Factors Study Of Adverse Reaction In Apitherapy

BackgroundApitherapy is a therapy combined fold bee-sting therapy and acupuncture, which is widely used in many diseased of different systems, such as respiratory system, nervous system, locomotor system, digestive system and urinary system.Gradully apitherapy was accepted by the patients due to its unique clinical effect, but its adverse reaction was concerned by lots of people. Adverse reactions often happen in apitherapy, sometimes they are very light and sometimes they are too serious to prevent. Various adverse reactions in the clinical practice call enough attention to this special therapy. Objective, scientific and realistic evaluation of adverse reactions and the risks can immensely prevent and reduce the patients'damage caused by apitherapy. At present, such concerned adverse reactions were appeared in case reports, while the law and correlation factors of apitherapy were rarely investigated.Objective1. Document research:search, compile and analyze the documents concerning adverse reactions after apitherapy or bee sting of the past11years by means of bibliometrics to direct clinical study.2. Clinical research:observe the specific manifestation and incidence of adverse reaction, then investigate the correlation factors to offer reliable evidence and reduce the risk.Methods1. Document research:take "bee sting" OR "apitherapy" OR "bee venom" AND "adverse reaction" OR "allergic response" as the retrieval terms, search CBM, CNKI, VIP from1,2001to12,2011. Then use Microsoft Excel software to record, extract and analyze.2. Clinical research:randomly divide all the cases into three groups:group1, group2and group3respectively. The whole study is composed of tow steps. The first step begins from the first week to the fifth week, called reactive period. The initial amount is one bee, twice a week. Observe and record the adverse reactions in these five weeks, then summarize the law and filter the correlation factors. The second step begins from the sixth week to the twentieth week, is called tolerance observation. The three groups increase different amount of bees, and at the same time, investigate and record vital signs, blood routine examination, routine urine test, hepatonephric function, immune-markers and adverse event at different time.Results1. document researchA total of1427documents have been searched. There are23CCTs and5RCTs. In the past11years, there are lots of studies regarding adverse reaction of apitherapy and bee-sting, but it can not be denied that most of the studies were in a low level without reliable data and result. Jadad score has revealed that the number of clinical random research which score is equal to2or higher than2is very few. Meta analysis revealed that combined treatment of blood purification has better therapeutic effect in BUN, Cr and death rate than single blood purification and hemofiltration.2. clinical research2.1All the patients in the three groups emerged different adverse chief complaints and signs, mainly include three aspects:symptoms of digestive system, such as abdominal pain and diarrhea; local cutaneous symptoms, such as pain, cutaneous induration, pigmentation, flare, pruritus, rubella, petechia, blister, facial rubeosis; systemic symptoms, such as aversion to cold, fever, debilitation, muscle soreness, hydrosis, dizziness. Their incidences have huge difference.2.2The statistical analysis revealed that no significant difference (P＞0.05) exist between different sex, age and weight in group1, group2and group3repectively. There is no significant difference (P＞0.05) exist between three groups.2.3The statistical analysis revealed that in group1, the cases who emerged adverse reactions between different diseases and the difference shows statistical significance(P＜0.05); group2and group3shows similar condition with group1(P＜0.05); but there is no significant difference (P＞0.05) exist between three groups. The number of disease enterned into the study maybe intervened the result, so this factor can not be excluded.2.4The statistical analysis revealed that in group1, the cases who emerged adverse reactions with accumulative bees of3-8are much higher than1-2bees and9-10bees, and the difference shows statistical significance (P＜0.05); group2and group3shows similar condition with group1(P＜0.05); but there is no significant difference (P＞0.05) exist between three groups.2.5Different accumulative amount of bees has positive relationship with the occurrence of local cutaneous symptoms (r=0.494, p＜0.01); Different accumulative amount of bees has negative relationship with the occurrence of systemic symptoms (r=-0.214, P=0.03); Different accumulative amount of bees has positive relationship with the occurrence of digestive symptoms (r=0.672, p＜0.01)2.6Logistic regression have showed that abdominal pain, pruritus, petechia, blister, pigmentation, flare, aversion to cold, fever and lymphadenectasis are related to accumulative amount of bees, while the emergence of diarrhea, rubella, facial rubeosis, debilitation, muscle soreness, hydrosis and dizziness have not showed correlative factors. Cutaneous induration is related to age, weight and accumulative amount of bees, while pain has showed no relationship with any factors.2.7The tolerance research showed that all the patients in the three groups reveals normal vital signs. Although blood and urination examination, hepatonephric function, immune-markers have changed after treatment, all of them in the normal scope. Apitherapy is safe. In group3, two cases showed recurrence of adverse reaction, which are light and determined related to apitherapy, while the rest one emerged fever, but can not be excluded influence by other medicines.Conclusion1. Document research:there are too many document research, clinical research, theoretic investigation and case report concerned to apitherapy or bee-sting; clinical researches mainly focus on descriptive study, rarely focus on RCT or CCT. The reliability and validity of RCT weakened because of writing. So the clinical research should be enforced through the angle of evidence-based medicine to increase the quality.2. Adverse chief compliants and signs has close relationship with age and weight, especially the accumulative amount of bees; most patients revealed better tolerance and highter safety.