Analysis and evaluation of the application of polymyxin B in inpatients based on clinical guidelines and consensuses / 中国药房

OBJECTIVE To evaluate the rationality of clinical application of polymyxin B in the inpatients of a third grade class A hospital，so as to provide evidence for the optimization of clinical scheme of the drug. METHODS A retrospective method was conducted on the electronic medical records of inpatients treated with Polymyxin B sulfate for injection from January 2020 to March 2022 to collect the basic information of patients， inpatient departments and time， infection diagnosis， results of pathogenic bacteria test， laboratory test indicators， usage and dosage， and combined medication，etc. Based on the drug instructions， according to relevant guidelines and consensus， the rationality， efficacy and safety of polymyxin B in inpatient were evaluated. RESULTS & CONCLUSIONS A total of 101 inpatients were included， respiratory system infection was the main cause （62.4%）. All patients had received the etiological examination， and the pathogen with the highest detection rate was carbapenem‑resistant Acinetobacter baumannii （40.6%）. One hundred patients were treated by intravenous drip， and 4 patients were treated by combination of aerosol inhalation or intrathecal injection； 99 patients were given the dose of 500 thousand units by continuous intravenous infusion， q12 h. Totally 51.5% of patients were treated for 7-14 days； and 77 patients were treated with other anti-Gram-negative drugs. There were unreasonable phenomena including too short time of medication （29.7%）， no combination of medication （23.8%）， and no indication of medication （17.8%）. The clinical effective rate of 101 patients treated with polymyxin B was 49.5%， and 16 patients （15.8%） had acute kidney injury during the treatment. Clinical pharmacists should actively participate in the clinical treatment of polymyxin B， formulate individualized treatment plans according to the guidelines/consensus and in combination with the patient’s condition and infection status to improve the rationality of clinical medication.

Study on the mechanism of Taohong siwu decoction improving peripheral nerve injury induced by paclitaxel in rats / 中国药房

OBJECTIVE To explore the mechanism of Taohong siwu decoction （THD） improving peripheral nerve injury induced by paclitaxel （PTX） in rats. METHODS The effects of THD （1 g/mL drug-containing serum） and PTX （0.1 μmol/L） alone or in combination on the proliferation rate of Schwann cells line RSC96 as well as the expressions of lysosomal-associated membrane protein-2 （LAMP2）， autophagy marker protein yeast Atg 6 homolog （Beclin1）， phosphatidylinositol 3-kinase （PI3K）， protein kinase B （Akt）， and mammalian target of rapamycin （mTOR） were investigated， and then compared with autophagy promoter rapamycin and autophagy inhibitor 3-methyladenine （3-MA）. The effects of high-dose and low-dose THD on the expressions of myelin basic protein （MBP） and myelin protein zero （MPZ）， S100 calcium-binding protein （S100）， LAMP2， Beclin1， PI3K， Akt and mTOR were tested at the end of the experiment. RESULTS After treatment of THD+PTX， the proliferation rate of RSC96 cells was significantly higher than those treated with PTX alone. After treatment of THD+PTX or THD+ 3-MA， the protein expressions of LAMP2 and Beclin1 in RSC96 cells were significantly higher than those treated with PTX or 3- MA alone， while the protein expressions of PI3K， Akt and mTOR were significantly lower than those treated with PTX or 3-MA alone （P＜0.05）. Compared with model group， the protein expressions of MBP， MPZ， S100， LAMP2 and Beclin1 in sciatic nerve of rats were increased significantly in THD high-dose and low-dose groups， while the protein expressions of PI3K， Akt and mTOR were significantly decreased （P＜0.05）. CONCLUSIONS THD may activate Schwann cell autophagy by inhibiting the PI3K/Akt/ mTOR signaling pathway， thereby improving peripheral nerve injury caused by PTX.

Construction of evaluation system for clinical effectiveness of Drug Selection Guideline for Medical Institutions / 中国药房

OBJECTIVE To establish an evaluation syste m of clinical effec tiveness of Drug Selection Guideline for Medical Institutions，and to provide reference for drug selection in medical institution. METHODS Retrieved from relevant Chinese government websites ，PubMed，Embase，CBM and CNKI ，etc.，from the inception to Sept. 14th 2021，related contents of clinical effectiveness related to three secondary indicators ，such as “recommended level and strength of guideline ”“clinical pathway ”and “evidence and level of efficacy ”were extracted respectively ；evaluation system was construction for the clinical effectiveness. RESULTS A total of 5，4 and 17 policy documents or literatures were included according to “recommended level and strength of guideline”“clinical pathway ”and“evidence and level of efficacy ”，respectively.“The recommended level and strength of drug guideline”could reflect the clinical effectiveness of drugs ，and the evaluation content referred to the recommended level and strength of the selected drugs in the guidelines for corresponding indications. “Clinical pathway ”was the embodiment of drug effectiveness, and the evaluation content referred to the clinical path of whether the selected drugs were included in the corresponding indications. The evaluation contents of “evidence and level of efficacy ”were different between chemical medicine/ biological agent and Chinese patent medicine ；evidence and quality level of efficacy research for chemical medicine/biological agent referred to GRADE system ，while those for Chinese patent medicine referred to classic works or clinical experience inheritance. Therefore，the evaluation contents of this index system were the evidence and quality level of the efficacy research related to selected drugs. CONCLUSIONS The evaluation system of clinical effectiveness of drugs constructed from the perspective of drug selection in medical institutions can lay the foundation of evaluation system for the construction of Drug Selection Guideline for Medical Institutions ，and also provide reference for drug selection in medical institutions.

CHINA PH ARMACY Volume 33，Number 7，April 15，2022 Semimonthly Table of Contents Drug selection guideline for medical institutions / 中国药房

In order to promote the standardization of drug selection in medical institutions ，enhance the level of pharmaceutical affairs management of medical institutions and promote the safe ，effective，economical and appropriate use of drugs in the treatment of diseases ，the Drug Selection Guideline for Medical Institutions （hereinafter refer to as the Guideline ）is formulated. The development of the Guideline for medical institutions is following the latest definition of Institution of Medicine （IOM）， National Academy of Sciences and based on the methodology of WHO handbook for guideline development. During the construction of the Guideline ，the research points of the Guideline are constructed on the basis of Delphi method ；a drug selection and evaluation system with 10 primary indicators and 30 secondary indicators as the core is also designed. The evaluation indexes can be divided into research indexes and policy indexes according to their attributes and main sources of evidence. The GRADE method is used to evaluate the quality of the evidence system for research indexes ，while the policy indexes are graded according to the Legislation Law of the People ’s Republic of China . On this basis ，the evaluation methods of those indexes are constructed by using evidence-based medicine method ，the recommendation is formed through expert consensus method ，and finally a standard guideline for drug selection in medical institutions is formed.

Bibliometric analysis of status quo and hot spots of domestic and foreign pharmacovigilance research / 中国药房

OBJECTIVE To investigate th e status quo and hot spots of domestic and foreign pharmacovigilance research ，so as to provide reference for scientific evaluation of drug safety. METHODS Relevant literature were searched from Web of Science and CNKI during the inception to Mar. 31st，2021. Excel 2019 software and CiteSpace 5.7R2 software were used to visualize and analyze the co-occurrence ，clustering and burst of annual document volume ，researchers，countries/regions，institutions and keywords. RESULTS & CONCLUSIONS A total of 5 422 foreign literature and 966 domestic literature were included ，with an increasing trend year by year. The cooperation between foreign researchers was relatively close ，while the cooperation between domestic researchers was less. A close network of cooperation was set up ，mainly in Europe and the United States. China although the late start ，but since 2018，there was a relatively rapid development trend and has continued so far. In domestic literature ，the organizations with a large number of published literature were mainly national medicine regulatory authorities ，research institute ， colleges and universities ，the cooperation of them was relatively weak. ADR ，drug safety and relevant risk factors are the research hotspots of pharmacovigilance abroad ；the frontier mainly focuses on pharmacovigilance research for vaccines ，drugs and therapeutic methods. The current research hotspot in China is ADR ，and special attention is paid to the safety of traditional Chinese medicine. The establishment of pharmacovigilance system of “Drug Marketing Authorization Holders ”is the research frontier. In the process of drug safety evaluation ，attention should be paid not only to the monitoring and reporting of ADR ，but also to the evaluation and application of multi-link and multi-dimensional research evidence of pharmacovigilance ，so as to effectively promote safe and rational drug use.

Definition of Core Competitiveness of Drug Manufacturing Enterprises and Construction of Its Evaluation System / 中国药房

OBJECTIVE：To define the core competitiveness of drug manufacturing enterprises ，and build its evaluation system. METHODS ：With“core competitiveness ”and“pharmaceutical”as Chinese and English keywords ，the laws ，policies and interpretation documents published on relevant Chinese government websites （from the inception/establishment of the database to June 2020，the same below ）were retrieved. Related literatures were collected from PubMed ，Embase，CBM，Wanfang database ， CNKI，VIP databases. The evidence-based research method was adopted to define the core competitiveness and elements of drug manufacturing enterprises. Based on above elements and retrieval method ，guideline database （National Guideline Clearinghouse ， Guidelines International Network ，Trip database ，The National Institute for Health and Care Excellence ）and systematic review ， health technology assessment （HTA），health economics evaluation research databases （NHS Economic Evaluation Database ，the Cochrane Library ，HTA，etc.）were retrieved. The output indexes of the core competitiveness of drug manufacturing enterprises were extracted ；according to the principles of scientificity ，hierarchy，comparability and comprehensiveness ，the evaluation system of core competitiveness of drug manufacturing enterprises was constructed. RESULTS & CONCLUSIONS ：The definition of core competitiveness of drug manufacturers is proposed as the strategic needs of the enterprises ，actively undertaking major national science and technology projects ，introducing top scientific and technological talents at home and abroad ，having independent intellectual property rights ，enhancing the ability of scientific and technological support ，strengthening original innovation ， increasing R&D investment ， strengthening key technology breakthrough ， perfecting the innovation mechanism of enterprises-univerisities-researches integration with enterprises as the main body. The elements included original innovation ， 60362951。 R&D investment and scientific and technological talents. Atotal of 25 original innovation output indexes [including two aspects of innovation system （such as national science and technology innovation base ，national laboratory ），innovation achievements （such as National Natural Science Award ， National Technological Invention Award ）]，1 R&D input-output indicator （R&D amount ），7 scientific and technological talent output indicators of production enterprises （such as those selected in the “National Million Talent Project ”，“National Outstanding Scientific and Technological Talents ”award） were extracted. The evaluation system composed of original innovation ，R&D investment and scientific and technological talents is constructed ，which can provide objective evaluation for core competitiveness of pharmaceutical manufacturing enterprises.

Efficacy and Safety of Rivaroxaban versus Low Molecular Weight Heparin in the Prevention of Venous Thromboembolism in Patients with Hip Fracture ：A Meta-analysis / 中国药房

OBJECTIVE： To systematically evaluate the efficacy and safety of rivaroxaban versus low molecular weight heparin in the prevention of venous thromboembolism （VTE） in patients with hip fractures， and to provide evidence-based reference for clinical application. METHODS： Retrieved from Cochrane library， PubMed， Embase， CNKI， VIP and Wanfang database， randomized controlled trials （RCTs） about rivaroxaban （test group） versus low molecular weight heparin （control group） in the prevention of VTE in patients with hip fracture were collected during database establishment to Jun. 2018. After data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0， Meta-analysis was performed by using Rev Man 5.3 statistical software for the incidence of  deep venous thrombosis （DVT）， postoperative discharge， activated partial thromboplastin time （APTT）， prothrombin time （PT） and the incidence of ADR. RESULTS： Totally 8 RCTs were included， involving 949 patients. Results of Meta-analysis showed that compared with low molecular weight heparin， rivaroxaban could significantly decreased the incidence of DVT [RR＝0.55， 95％CI （0.36， 0.83）， P＝0.004]. There was no statistical significance in postoperative discharge [MD＝－0.24， 95％CI （－5.27， 4.8）， P＝0.93]， APTT [MD=0.56， 95％CI （－0.75， 1.86）， P＝0.40]， PT [MD＝0.04， 95％CI（－0.03， 0.11）， P＝0.25] or the incidence of ADR [RR=1.73，95％CI（0.15，20.48）， P＝0.66] between 2 groups. CONCLUSIONS： Rivaroxaban has a better preventive effect on VTE in patients with hip fracture than low molecular weight heparin， and has a similar safety as low molecular weight heparin.

The Effect of Indirect Gentle Moxibustion on Serum IL-1 and TNF-? Contents in Patients with Knee Osteoarthritis / 上海针灸杂志

Objective To investigate the effect of indirect gentle moxibustion on serum IL-1 and TNF-?contents in patients with knee osteoarthritis and explore the mechanism of its action. Method A randomized controlled trial was conducted according to the patient's condition. Besides acupuncture as basic treatment, the treatment group received indirect gentle moxibustion and the control group, thermotherapy plus cupping. Pre-treatment and post-treatment serum IL-1 and TNF-?contents and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were analyzed in the patients and compared between the two groups. Result There were statistically significant pre-/post-treatment differences in serum IL-1 and TNF-? contents and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score in the two groups (P<0.05). After treatment, serum IL-1 and TNF-?contents and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score were lower in the treatment group than in the control group. Conclusion Indirect gentle moxibustion can effectively decrease serum IL-1 and TNF-?contents in patients with knee osteoarthritis. That provides a certain molecular cytobiological and bio tissue engineering basis for the mechanism of its action in reducing inflammatory stimulation.

Producing and quality control of fecal-derived microbiota enteric capsules / 中华消化杂志

Objective To initially explore the feasibility and quality control of producing fecal-derived microbiota enteric capsules.Methods Fecal-derived microbiota was put into double layered enteric capsules.The bacteria colony numbers of fresh prepared glycerol containing fecal-derived microbiota liquid,glycerol containing and glycerol free fecal-derived microbiota after stored at -80 ℃ for 72 h were counted with standard plate count methods in order to investigate the stability after frozen.Methylene blue was taken as the standard,resistance to acid and release rate of capsules was evaluated.The t test was performed for statistical analysis.Results The preparation process of double layered microbiota capsules was simple and practicable.The data of 12 plates of each microbiota were acquired.The number of bacteria colony of fresh prepared glycerol containing fecal-derived microbiota ((5.08 ±1.37)×107 colony-forming units (cfu)/mL)was significantly more than that of the group without glycerin ((1.73±0.64)×107 cfu/mL)at -80 ℃for 72 h (t = 7.621 ,P <0.01).There was no significant difference in the number of bacteria colony between glycerin containing frozen fecal-derived microbiota ((4.67±1 .56)×10 7 cfu/mL)and fresh fecal-derived microbiota (t = 0.694,P = 0.495).Regression equations were achieved with fecal-derived microbiota containing methylene blue,and there was a good linear relation between 0.5 μg/mL and 8.0 μg/mL.Three fecal-derived microbiota enteric capsules containing methylene blue were prepared.Their resistance to acid was 96.0%,99.1 %,and 95 .5 %,while the release rate was 88.6%,95 .1 % and 86.5 %, respectively.All met the requirement of Chinese Pharmacopoeia to enteric capsules.Conclusion The preparation of double layered fecal-derived microbiota enteric capsules had feasible technology and stable quality,which could provide reference in prevention and treatment of diseases related with colonic microbiota imbalance.

Analysis on Application of Antimicrobials in Hepatic Disease Inpatients in Our Hospital from Mar. 2007 to Mar. 2008 / 中国药房

OBJECTIVE:To investigate the use of antimicrobials in hepatic disease inpatients. METHODS:In retrospective study,200 cases of hepatic disease in our hospital from Mar. 2007 to Mar. 2008 were randomly collected and utilization of antimicrobials was analyzed. RESULTS:136 inpatients treated with antimicrobials accounted for 68.00%. 76.47% were injected by intravenous. 35 cases were performed bacteria culture (25.74%). 7 categories (24 kinds) of antimicrobials were used. The DUI of top 10 antimicrobials in the list of DDD were below 1,which indicated drug use was basically appropriate. CONCLUSION:Great importance should be attached to application management of antimicrobials in patients with hepatic disease in our hospital to reduce irrational use of drug.