Biocompatibility of bioprosthetic heart valve materials with a non-glutaraldehyde-based chemical treatment / 中国胸心血管外科临床杂志

@#Objective    To study the biocompatibility of bioprosthetic heart valve material with a non-glutaraldehyde-based treatment, and to provide the safety data for the clinical application. Methods    All the tests were conducted according to GB/T16886 standards. The in vitro cytotoxicity was determined by methyl thiazolyl tetrazolium assay. Fifteen guinea pigs were divided into a test group (n=10) and a control group (n=5) in the skin sensitization test. Three New Zealand white rabbits were used in the intradermal reactivity test. Five sites on both sides of the rabbit back were set as test sites and control sites, respectively. In the acute systemic toxicity test, a total of 20 ICR mice were randomly assigned to 4 groups: a test group (polar medium), a control group (polar medium), a test group (non-polar medium) and a control group (non-polar medium), 5 in each group. Forty SD rats were divided into a test group (n=20) and a control group (n=20) in the subchronic systemic toxicity test. Results    The viability of the 100% extracts of the bioprosthetic heart valve material with a non-glutaraldehyde-based treatment was 75.2%. The rate of positive reaction was 0.0%. The total intradermal reactivity test score was 0. There was no statistical difference in the body weight between the test group and control group in the acute systemic toxicity test. There was no statistical difference in the body weight, organ weight, organ weight/body weight ratio, blood routine test or blood biochemistry between the test group and control group in the subchronic systemic toxicity test. Conclusion    The bioprosthetic heart valve material with a non-glutaraldehyde-based treatment has satisfying biocompatibility, which conforms to relevant national standards. The material might be a promising material for application in valve replacement.

Discussion on safety of Xanthii Fructus and consideration on its rational use / 中国中药杂志

Xanthii Fructus is a traditional Chinese medicine for the treatment of sinusitis and headache,rich in medicinal materials and is widely used for more than 1 800 years. Modern pharmacological studies have showed that Xanthii Fructus has anti-inflammatory,analgesic,anti-tumor,anti-bacterial,hypoglycemic,anti-allergic,immunomodulatory and other pharmacological effects,which can be commonly used in the treatment of diseases relating to immune abnormalities,such as rheumatoid arthritis,acute and chronic rhinitis,allergic rhinitis,and skin diseases,with a high medicinal value. Toxicological studies have shown that Xanthii Fructus poisoning can cause substantial damage to organs,such as the liver,kidney,and gastrointestinal tract,especially to liver. Because of the coexisting of its efficacy and toxicity,Xanthii Fructus often leads to a series of safety problems in the clinical application process. This study attempts to summarize its characteristics of adverse reactions,analyze the root cause of the toxicity of Xanthii Fructus from such aspects as processing,dose,course of treatment and eating by mistake,discuss the substance of its efficacy/toxicity from chemical compositions,and put forward exploratory thinking about how to promote its clinical rational application from the aspects such as strict processing,reasonable compatibility,medication information,contraindication,strict control of the dose,and course of treatment,so as to promote the safe and reasonable application of Xanthii Fructus.

Discussion and consideration on safety of Sophorae Tonkinensis Radix et Rhizoma and its rational use / 中草药

Sophorae Tonkinensis Radix et Rhizoma is known as the important drug for treating sore throat and is widely used in clinic. Because of the coexisting of its efficacy and poison, Sophorae Tonkinensis Radix et Rhizoma often leads to a series of safety problems in the clinical application process. In this study, we attempt to analyze the ultimate cause of the toxicity of Sophorae Tonkinensis Radix et Rhizoma by reviewing nearly 20 years of literature, discuss the substance of its efficacy/toxicity from the point of view of chemical composition, and put forward exploratory thinking on its clinical rational application.

Observation of Fluorouracil Implants on the Intraperitoneal Chemotherapy Safety of Advanced Gastric Cancer Patients / 中国药房

OBJECTIVE:To investigate the effects of Fluorouracil implants on intraperitoneal chemotherapy safety of advanced gastric cancer patients. METHODS:The information of 264 patients with advanced gastric cancer were analyzed retrospectively. All patients were given Fluorouracil implants 800 mg,scattered into the mesenteric and surgical area,dose of each implantation site less than 200 mg,the distance of implantation range from incision and anastomosis more than 3 cm. All patients were given second generation cephalosporin 30 min before operation,at 3rd h during operation,1-3 d after operation. The occurrence of complications and ADR during hospitalization were observed after operation. RESULTS:After operation,6 patients suffered from complications, with incidence of 2.28%,including 3 cases of gastrointestinal reaction,2 cases of anastomotic bleeding and 1 case of anastomotic leakage. Routine blood test and liver and kidney function were rechecked 3 d after operation,mainly thrombocytopenia and liver function injury,with the incidence of 2.65%. CONCLUSIONS:Fluorouracil implants can be used for intraperitoneal chemotherapy of advanced gastric cancer patients. However,attention should be paid to thrombocytopenia and liver function injury.

Clinical Observation of Tegafur Gimeracil Oteracil Potassium Combined with 3D-CRT and Microwave Hy-perthermia in the Treatment of Elderly Patients with Local Advance Esophageal Cancer / 中国药房

OBJECTIVE:To observe clinical efficacy and safety of tegafur gimeracil oteracil potassium combined with 3D-CRT and microwave hyperthermia in the treatment of elderly patients with local advance esophageal cancer. METHODS:48 cases of local advance esophageal cancer were divided into group A,B and C according to random number table method,with 16 cases in each group according to random number table method. Group A was given 3D-CRT with total dose of 60-66 Gy totnlly for 6-7 weeks;group B was additionally given tegafur gimeracil oteracil potassium 60 mg/(m2·d),bid,on the basis of group A 3 weeks for a course of treatment,until the end of radvotherapy;group C was additionally given thermotherapy on the basis of group B 3 weeks for a course of treatment,until the end of radvotherapy. Clinical efficacy,1-year survival rate,dysphagia,weight and KPS score were compared among 3 groups,and the occurrence of toxic reactions(radioactive esophagitis,radioactive pneumonia, bone marrow suppression and gastrointestinal reaction) were observed in 3 groups. RESULTS:Total effective rate,1-year survival rate and the remission rate of dysphagia of group C were 93.75%,87.50% and 93.75%,which were significantly higher than those of group A(50.00%,50.00% and 56.25%)and B(68.75%,68.75% and 68.75%),with statistical significance(P0.05). The incidence of radioactive esophagitis and radioactive pneumonia in group C were significantly lower than in group A and B,with statistical significance(P0.05). CONCLUSIONS:Tegafur gimeracil oteracil potassium combined with 3D-CRT and microwave hyperthermia in the treat-ment of elderly patients with local advance esophageal cancer further improves clinical efficacy and survival rate,but shows low inci-dence of toxic reaction.

Relationship Between Serum Concentration at 48 h and Pharmacokinetic Characteristics and Toxic Reactions at Terminal Elimination Phase After Starting High Dose Methotrexate Infusion / 医药导报

Objective To recheck the reliability of methotrexate ( MTX) serum concentration at 48 h ( C48 h ) in predicting the pharmacokinetic characteristics and toxic reactions at terminal elimination phase after high dose MTX infusion and to provide a reference for determination of rational rescue regimen in clinic practice. Methods In total,114 cases of children with acute lymphoblastic leukemia (ALL) received 176 courses of high dose MTX chemotherapy treatment. The regimen was continuous infusion of MTX[3 -5 g·( m2 ) -1 ] in 24 h. Plasma samples were treated with solid phase extraction and serum concentrations of MTX were determined by HPLC at 24,48 and 72 h (C24 h ,C48 h and C72 h ) after starting MTX infusion. All data were divided into C48 h≥1 μmol·L-1 group and C48 h<1 μmol·L-1 group. The pharmacokinetic parameters of the two groups at elimination phase were estimated by residual method and the toxic reactions after MTX infusion of two groups were compared by Ridit analysis. Results The C72 h and AUC48-∞ were significantly higher in C48 h ≥1 μmol · L-1 group than in C48 h <1 μmol·L-1 group (P<0. 01). The MTX toxicities to the blood,digestive and hepatic systems were significantly higher in C48 h≥1 μmol·L-1 group than in C48 h < 1 μmol · L-1 group ( P < 0. 05). Conclusion C48 h can predict the pharmacokinetic characteristics and toxic reactions at ther terminal elimination phase. Therefore,C48 h≥1 μmol·L-1 can be used as a marker of MTX elimination delay event to guide later rescue regimen.

Pneumococcal Vaccination-Induced Localized Cutaneous Toxic Reaction Mimicking Fixed Drug Eruption on a Nearby Vaccination Injection Site in an Infant / 대한피부과학회지

Pneumococcus is a very important pathogen for children and elderly people, and causes considerable morbidity and mortality in these groups. Pneumococcal vaccination is relatively safe, and is being increasingly used for the prevention of pneumococcal disease, such as meningitis, pneumonia, otitis media, and bacteremia. Mild adverse reactions of pneumococcal vaccination are relatively common, and include erythema, pain, fever, myalgia, and headaches. However, adverse skin reactions are very rare. Here, we present a case of pneumococcal vaccination-induced localized toxic reaction mimicking fixed drug eruption on a nearby vaccination injection site in an infant, which has not previously been documented in Korea.

Clinical Observation of Shen-fu Injection on Toxic Reaction Relief in the Chemotherapy for Moderate to Advanced NSCLC / 中国药房

OBJECTIVE:To investigate the effect of shen-fu injection on toxic reaction relief in the chemotherapy for moderate to advanced non-small cell lung cancer(NSCLC).METHODS:130 patients of NSCLC were randomly divided into treatment group and control group,2 groups both received the second-generation regimen for chemotherapy,the major chemotherapeutic agents included vinorelbine,gemcitabine and paclitaxel,the treatment group was given intravenous shen-fu injection 60ml/d for continuous2weeks plus chemotherapy.RESULTS:The toxic reactions in treatment group significantly decreased compared to that in the control group(P

The toxic reactions of all-trans retinoic acid occuring in the treatment of acute promyelocytic leukemia / 中国癌症杂志

Purpose:To observe the toxic reactions of all trans retinoic acid in the treatment of acute promyelocytic leukemia. Methods:Analysis of toxic reaction was done for 38 patients who suffered from acute promyelocytic leukemia treated with all trans retinoic acid. Results:In the treatment of acute promyelocytic leukemia with all trans retinoic acid, the common toxic reactios are dry mouth, skin desiccation, desquamation, rhagadia (100%). 19 patients had gastro intestinal symptoms with higher ALT(50%),18 patients had hyperleukocytosis syndrome (47.5%), 16 patients had headache and dizziness (42.4%),8 patients had pain in muscle and joint (21.2%). The rare toxic reactions included 4/38 who had intracranial hypertension syndrome, 2/38 had hyperglycemia, 1/38 and hyperhistaminemia syndrome. Conclusions:The toxic reactions of all trans retinoic acid in the treatment of acute promyelocytic leukemia usually have dry mouth ,skin desiccation, desquamation, rhagadia, gastro intestine symptom with higher ALT, and hyperleukocytosis syndrome ets. THe treatment with lower dose of all trans retinoic acid(20～30 mg/d)for acute promyelocytic leukemia could decrease the toxic reactions without influencing its effectiveness.