Clinical Application Analysis of Andrographolide Total Ester Sulfonate Injection,a Traditional Chinese Medicine Licensed in China

Andrographolide total ester sulfonate（ATES） injection is one of the products of traditional Chinese medicine（TCM） currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-world clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86% were contraindicated.Irregular medication of adults and children accounted for 1.91% and 23.38%,respectively.Improper choice of solvent accounted for 3.18%.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events（AEs） was observed in the monitoring period,and the incidence of adverse drug reaction（ADR） of ATES injection was 0.12%.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.

Rapid detection of Mycoplasma Pneumoniae in Clinical Samples by the Polymerase Chain Reaction Technique.

The polymerase chain reaction (PCR) technique was used to detect mycoplasma pneumoniae in clinical samples

Comparison of result judgment algorithm of test for interfering factors in the bacterial endotoxins test among Chinese, Japanese, European, American, and Indian pharmacopeias

Background The bacterial endotoxins test （BET） is a method used to detect or quantify endotoxins （lipo-polysaccharide,LPS） and is widely used in the quality control of parenteral medicines/vaccines and clinical dialysis fluid.It is also used in the diagnosis of endotoxemia and in detection of environment air quality control.Although BET has been adopted by most pharmacopoeias,result judgment algorithms （RJAs） of the test for interfering factors in the BET still differ between certain pharmacopoeias.We have evaluated RJAs of the test for interfering factors for the revision of BET described in the Chinese Pharmacopoeia 2010 （CHP2010）.Methods Original data from 1 748 samples were judged by RJAs of the Chinese Pharmacopoeia 2010,the Japanese Pharmacopoeia 2011 （JP2011）,the European Pharmacopoeia 7.0 （EP7.0）,the United States Pharmacopoeia 36 （USP36）,and the Indian Pharmacopoeia 2010 （IP2010）,respectively.A SAS software package was used in the statistical analysis.Results The results using CHP2010 and USP36,JP2011,EP7.0,and IP2010 had no significant difference （P=-0.7740）.The results using CHP2010 of 1 748 samples showed that 132 samples （7.6%） required an additional step; nevertheless there was no such requirement when using the other pharmacopeias.The kappa value of two RJAs （CHP2010 and EP7.0） was 0.6900 （0.6297-0.7504） indicating that the CHP2010 and other pharmacopoeias have good consistency.Conclusions The results using CHP2010 and USP36,JP2011,EP7.0,and IP2010 have different characteristics.CHP2010 method shows a good performance in Specificity,mistake diagnostic rate,agreement rate,predictive value for suspicious rate,and predictive value for passed rate.The CHP2010 method only had disadvantages in sensitivity compared with other pharmacopeias.We suggest that the Chinese pharmacopoeia interference test be revised in accordance with the USP36,JP2011,EP7.0,and IP2010 judgment model.

Five simple models for interfering factors test of bacterial endotoxins test

Endotoxins have been credited for over 50% of sepsis cases, with significantly greater mortality.1 A literature indicates wide-spread agreement that early detection of endotoxemia, endotoxin in the bloodstream, is the major key for patient survival from sepsis.2 Today the most popular endotoxin detection system is bacterial endotoxins test （BET）, adopted by most pharmacopoeias. Interference test is a part of the bacterial endotoxin inspection method, used to judge whether the sample can be applied in BET. However, Limuloid resources are exhausted in China, which is an important source for LAL. Here, we reported 5 simple models for interfering factors test in the BET, and compared new models with the United States Pharmacopoeia 36 （USP36）.