Clinical research progress of palbociclib in treatment of breast cancer / 中国临床药理学与治疗学

Palbocicril, the first cyclin-dependent kinases 4 and 6 inhibitors, is a crucial milestone in the development history of antineoplastic drugs. It combined with aromatase inhibitor or fulvestrant as first-line, second-line or post-line therapy has good efficacy and safety for hormone receptor-positive, human epidermal growth factor receptor-2 negative locally advanced or metastatic breast cancer, which has a good application prospect. This article summarizes the clinical trials and safety studies related to palbociclib.

Pharmacokinetic interaction study between sorafenib and dapagliflozin in rats / 中国临床药理学与治疗学

AIM: To explore the pharmacokinetic interactions between sorafenib and dapagliflozin in rats and to provide some theoretical basis for the rational clinical use of the two drugs. METHODS: An ultra -performance liquid chromatography-tandem mass spectrometry (UPLC / MS / MS) method was developed for the simultaneous determination of sorafenib and dapagliflozin. Male SD rats were randomly divided into 5 groups (6 rats in each group), including 100 mg / kg sorafenib group, 0.5 mg / kg dapagliflozin group, 1 mg / kg dapagliflozin group, and 100 mg/kg sorafenib combined with 0.5 mg/kg dapagliflozin group and 100 mg/kg sorafenib combined with 1 mg / kg dapagliflozin group, for sorafenib and dapagliflozin drug interaction study. All samples were analyzed using a validated UPLC/ MS/MS method, and the main pharmacokinetic parameters were calculated by compartment model. RESULTS: 1 mg/kg dapagliflozin increased the C

Research advances in signaling pathways associated with potential anti-liver fibrosis drugs and targets / 临床肝胆病杂志

Liver fibrosis is a key step in the progression of chronic liver diseases to liver cirrhosis and even liver cancer. In recent years， a large number of studies have shown the necessity of intervening in the process of liver fibrosis， and various anti-liver fibrosis drugs and active ingredients have been discovered. Non-coding RNAs also play an important role in the process of liver fibrosis， and searching for upstream non-coding RNAs that can regulate signaling pathways can provide new insights for anti-liver fibrosis treatment. This article introduces the process of liver fibrosis mediated by the TGF-β， Wnt/β-catenin， PI3K/Akt/mTOR， NF-κβ， Hippo， and MAPK signaling pathways， lists the latest anti-liver fibrosis drugs or active components in each signaling pathway， and summarizes the research advances in anti-liver fibrosis targets and drugs mediated by related non-coding RNAs， so as to provide new research ideas and treatment methods for anti-liver fibrosis treatment.

Literature analysis of compatible stability of commonly used intravenous drugs in ICU / 中国药房

OBJECTIVE To analyze the compatible stability of commonly used intravenous drugs in the intensive care units （ICU）， and to provide a reference for improving medication safety in clinic. METHODS The commonly used intravenous drugs in the ICU of Hebei General Hospital were investigated and confirmed in April 1-30， 2022， and used as keywords to retrieve the relevant literature about compatible stability from PubMed， CNKI， Wanfang Data and other databases， and manually filtered with Micromedex database at the same time. Then， the compatible stability results of the included literature were analyzed descriptively. RESULTS Totally 32 commonly used intravenous drugs and 39 mixed infusion combinations were collected from ICU of this hospital. A total of 40 studies were included， only 2 studies followed all quality requirements； 18 studies validated their methods to guarantee correct reproducibility； 33 studies evaluated physical stability， including precipitate formation and pH changes； 32 studies evaluated chemical compatibility， mainly content/concentration changes. A total of 666 possible two-drug combinations were obtained from the included literature， of which 254 combinations of stability data were available， including 176 were stable， 68 were unstable， and 10 were contradictory. Totally 412 combinations had no stability results. Among two-drug combinations in ICU of this hospital， 42 combinations were stable， 14 combinations were unstable， and 2 combinations were contradictory. CONCLUSIONS The pH， solvent， excipients and preparation concentration are the factors that affect the stability. There are drug combinations with unstable compatibility of commonly used intravenous drugs in ICU of this hospital. The stability study methods are limited， and the stability data cannot meet the actual clinical needs.

Advances in new fast-acting antidepressants / 中国临床药理学与治疗学

Antidepressants are mainly used to treat mental illnesses. Traditional antidepressants mainly target monoamine neurotransmitters, but these drugs are slow to be effective and cannot meet clinical needs. Recently, therapeutics have been developed that depart from the traditional monoamine hypothesis and focus on the glutamatergic, GABAergic, opioidergic, and inflammatory systems. In recent years, great progress has been made in the development of new antidepressants, some of which have been applied in clinical practice. This article mainly summarizes the research mechanisms and treatment programs of new antidepressants, and briefly reviews common rapid-acting antidepressants.

Advances in uridine diphosphate glucuronosyltransferase-mediated drug interactions with tyrosine kinase inhibitors / 中国临床药理学与治疗学

Drug-drug interactions (DDI) of tyrosine kinase inhibitors (TKIs) mediated by metabolic enzymes and transporters have become an important issue in clinical practice recently. In addition to CYP450 enzymes, uridine diphosphate glucuronidases (UGTs) are another class of metabolic enzymes involved in the metabolism of TKIs, and most TKIs can inhibit the UGTs in vitro. Potential clinically meaningful DDIs may occur with the co-administration of TKIs and substrates or inhibitors of UGTs. This paper will mainly focus on the UGTs-mediated drug-drug and the effect of UGT1A genotype on the drug interactions of TKIs and explores strategies to address, aiming to provide clinicians and pharmacists with references for the safe and rational application of TKIs.

Use of Severe ADR-inducing Drugs in Special Population in Our Hospital Guided by the Detailed Quantitative Scoring Rules of Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions / 中国药房

OBJECTIVE：To promote the safe use of severe ADR-inducing drugs in special population in our hospital. METHODS：According to detailed quantitative scoring rules of Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions，comprehensive evaluation database of drugs in our hospital was established. Drugs with ADR rating or ADE general terminology standard rating of 1，2，3 and 4 under the "safety" dimension were obtained from the database. According to the difference of the incidence of ADR ，4 kinds of severe ADR-inducing drugs ，such as very common （incidence≥10％），common （incidence 1％-＜10％），occasional（incidence 0.1％-＜1％）and rare （incidence ＜0.1％），were obtained. According to the quantitative scores of these 4 kinds of drugs in six special groups ，such as children ，pregnant women ，lactating women ，the elderly，patients with abnormal liver function ，and patients with abnormal kidney function ，the feasibility for special population to use drugs that cause severe ADR was analyzed. RESULTS ：Among 1 172 chemical drugs in drug comprehensive evaluation database of our hospital ，18，73，61，and 357 kinds can cause very common ，common，occasional and rare severe ADR ， respectively. Among them ，the incidence of severe ADR caused by tumor drugs was high ，so it was necessary to pay close attention to the use of tumor drugs in special populations. Totally 173 kinds of drugs were prohibited for children because the instructions clearly showed organ toxicity ，cytotoxicity and there were no guidelines recommending their use in children ，so the clinical medication should be used with extraordinary caution. There were 278 and 228 drugs prohibited for pregnant women and lactating women，which were prohibited for pregnant or lactating period due to embryonic toxicity and reproductive toxicity. There were 13 prohibited drugs for the elderly ，most of which were specialized drugs. Five kinds of drugs were prohibited in patients with abnormal liver function and seven were prohibited in patients with abnormal kidney function ，most of which were tumor drugs with strong hepatorenal toxicity. CONCLUSIONS ：Established quantitative score system can provide effective guidance for the safe use of severe ADR-inducing drugs among 6 special populations as children ，pregant women ，lactating women ，the elderly ，the patients with abnormal liver function and the patients with renal

Mini Health Technology Assessment of Repaglinide and Naglinide / 中国药房

OBJECTIVE：To provid e reference for hospital decision-maker to select and use repaglinide and naglinide reasonably. METHODS ：Through reviewing literautre ，guideline and instruction ，full score system was estalished for comunni- cation between pharmacists and physicians ；from the aspects of clinical necessity ，effectiveness，safety，economy，medical insu- rance attribute ，essential medicine attribute ，original research attribute ，drug packaging attribute ，drug market and enterprise attributes，the Mini health technology assessment （Mini HTA ）was carried out for repaglinide and nateglinide ，and scored on the basis of weight value. RESULTS ：Repaglinide and naglinide ’s final score were 77 and 74，respectively. For type 2 diabetes，both of them could reduce postprandial blood glucose ，and had less side effect and good safety. They were both included in the medical insurance list. Both of them were original varieties ，easy to store and had a long period of validity. Although they were expensive in the treatment of type 2 diabetes，their manufacturers had a good reputation and were widely used in the world ，which was a good choice for patients with type 2 diabetes. But they were different to certain extent ；repaglinide could be used in patients with poor renal function [eGFR ＜30 mL/min] without dose adjustment ；nateglinide should be adjusted according to eGFR for renal excretion. Repaglinide was essential medicine but nateglinide wasn ’t；repaglinide didn ’t need shading storage but nateglinide did. In addition ， a variety of liver drug enzyme inducers or inhibitors may interact with the two drugs ，and special groups should be used with. CONCLUSIONS ：Mini HTA provide reference for the selection and rational use of repaglinide and nateglinide ；patients with type 2 diabetes can select suitable drug according to their own conditions and needs. When combined with other drugs ，blood glucose should be closely monitored to prevent the occurrence of hypoglycemia.

Meta-analysis of the Effects of Sh enqi Fuzheng Injection Combined with Conventional Chemotherapy on the Immune Function of Patients with Advanced NSCLC / 中国药房

OBJECTIVE： To systematically evaluate the effects of Shenqi fuzheng injection combined with conventional chemotherapy on the immune function of patients with advanced non-small cell lung cancer （NSCLC）， and provide evidence-based reference for clinical medication. METHODS： Retrieved from Cochrane Library， PubMed， Medline， Embase， CNKI， Wanfang database， VIP and CBM， Shenqi fuzheng injection combined with conventional chemotherapy （trial group） versus conventional therapy （control group） for advanced NSCLC were collected. After literature screening， data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0 risk evaluation tool， Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS： A total of 16 literatures were included， involving 1 324 cases. Results of Meta-analysis showed that there were no statistical significance in the difference of objective remission rate （ORR） [RR＝1.14， 95％CI（0.91，1.43）， P＝0.25] and the level of  CD8+ [MD＝－1.26，95％CI（－4.10， 1.59），P＝0.39] between 2 groups. The levels of CD3+ [MD＝17.48， 95％CI（13.40， 21.56）， P＜0.000 01 ]， CD4+[MD＝12.26， 95％CI（8.39 16.13）， P＜0.000 01]， CD4+/CD8+ [MD＝0.33，95％CI（0.27， 0.39），P＜0.000 01] and the percentage of NK cells [MD＝9.33， 95％CI（5.72， 12.94）， P＜0.000 01] in trial group were significantly higher than control group. Results of subgroup analysis for medication duration of Shenqi fuzheng injection showed that after 1-14 d treatment of Shenqi fuzheng injection， the levels of CD3+ [MD＝17.11， 95％CI（12.37 ，23.17），P＜0.000 01]， CD4+[MD＝13.28，95％CI（8.33， 18.23），P＜0.000 01]， CD4+/CD8+[MD＝0.36，95％CI（0.28，0.43），P＜0.000 01] and the percentage of NK cells [MD＝12.06，95％CI（7.52，16.61），P＜0.000 1] in trial group were significantly higher than control group. After 21 d treatment of Shenqi fuzheng injection， the levels of CD3+[MD＝14.88， 95％CI（7.51，22.26），P＜0.000 01]， CD4+[MD＝10.56，95％CI（5.57，15.56），P＜0.000 01]， CD8+[MD＝3.02， 95％CI（1.80， 4.23），P＜0.000 01]， CD4+/CD8+[MD＝0.29，95％CI（0.23， 0.35），P＜0.000 01] and the percentage of NK cells [MD＝5.58，95％CI（2.49， 8.67），P＝0.000 4] in trial group were significantly higher than control group. There was no statistical significance in the level of CD8+ between 2 groups after 7-14 d treatment of Shenqi fuzheng injection [MD＝－4.26，95％CI（－12.60， 4.09），P＝0.32]. The incidence of leukopenia， nausea and vomiting， and renal dysfunction in trial group were significantly lower than control group. There was no statistical significance in the incidence of hemoglobin decreased and thrombocytopenia between 2 groups. The results of publication bias showed that there was a greater possibility of publication bias in this study. CONCLUSIONS： Shenqi fuzheng injection combined with conventional chemotherapy may improve the immune function of patients with advanced NSCLC and improve the safety after chemotherapy. But more large-scale， milltiple-center and high-quality RCT are needed to validate this conclusion.

Effects of Wuzhi Capsules on in vivo Pharmacokinetic Behavior of Apatinib Mesylate in Rats / 中国药房

OBJECTIVE： To establish a method for the concentration determination of apatinib mesylate in plasma of rats， and to investigate the effects of single and multiple administration of Wuzhi capsules on the pharmacokinetic behavior of apatinib mesylate in rats. METHODS：  LC-MS/MS method was used to detect the plasma concentration of apatinib mesylate in rats. Using carbamazepine as internal standard， the determination was performed on Waters XBridge BEH C18 column with mobile phase consisted acetonitrile-0.1％ formic acid solution （45 ∶ 55，V/V） at the flow rate of 0.3 mL/min. The column temperature was 40 ℃. The temperature of injector was 15 ℃， and the sample size was 2 μL. ESI was used for positive ion scanning in MRM mode. The ion pairs m/z used for quantitative analysis were 398.1→212.1 （apatinib mesylate） and  237.2→194.2 （internal standard）. The rats were randomly divided into control group Ⅰ， observation group Ⅰ， control group Ⅱ， observation group Ⅱ， with 6 rats in each group. Control group Ⅰ were given single administration of apatinib mesylate intragastrically （50 mg/kg， similarly hereinafter）. Observation group Ⅰ was given Wuzhi capsules intragastrically （450 mg/kg， similarly hereinafter）， and then 10 min later given apatinib mesylate intragastrically. Control group Ⅱ was given normal saline intragastrically， once a day， for consecutive 7 d， and then were given single administration of apatinib mesylate. Observation group Ⅱ was given Wuzhi capsules intragastrically， once a day， for consecutive 7 d， and then 10 min later were given single administration of apatinib mesylate. The blood samples were collected from intraocular canthus vein plexus and determined 0.25， 0.5， 1.0， 2.0， 2.5， 3.0， 4.0， 6.0， 8.0， 12.0， 24.0 h after intragastric administration， respectively. Pharmacokinetic parameters were apatinib mesylate were calculated and compared among those groups by using DAS 2.1 software and t-test. RESULTS： The linear range of apatinib mesylate were 2-2 000 ng/mL. The lower limit of quantitation was 2 ng/mL. RSDs of intra- day and inter-day were all lower than 10％， and the accuracy were 94.93％-104.68％. Matrix effect did not affect the quantitative analysis of the substance to be measured. Compared with control group Ⅰ， cmax， AUC0-24 h and AUC0-∞ of observation group Ⅰ were increased significantly， CLZ was decreased significantly （P＜0.05）. Compared with control group Ⅱ， AUC0-24 h and AUC0-∞ of observation group Ⅱ were increased significantly， and CLZ was decreased significantly （P＜0.05）. Compared with observation group Ⅰ， AUC0-24 h and AUC0-∞ of observation group Ⅱ were decreased significantly （P＜0.05）. CONCLUSIONS： Established LC-MS/MS method is sensitive and specific， and can be used for the concentration determination of apatinib mesylate in plasma of rats. Wuzhi capsules can influence in vivo pharmacokinetic behavior of apatinib mesylate in rats. The effect of multiple administration of Wuzhi capsules is weaker than that of single administration.

Application and Practice of Drug Quantitative Scoring Table in the Temporary Drug Purchase of Our Hospital / 中国药房

OBJECTIVE： To standardize the management of temporary drug purchase， and to provide reference for drug selection in Hospital Pharmaceutical Administration and Drug Treatment Committee （Pharmaceutical Association）. METHODS： Clinical pharmacists set up drug quantitative scoring table according to the 10 attributes of drugs as effectiveness， safety， economy， etc. 15 temporary purchased drugs submitted by departments in Oct. 2018 were graded according to the rules of the scoring table， and the evaluation results were fed back to Pharmaceutical Association. A retrospective evaluation of 20 temporary purchased drugs which were discussed at the Pharmaceutical Association from Jul. to Sept. 2018 was made according to previous approval model without using drug quantitative scoring table. The effect of pre-intervention was evaluated after using drug quantitative scoring table. RESULTS： Among 15 temporary purchased drugs， 2 of them scored below 60， and the unqualified rate was 13.3％. It suggested that 2 drugs could not be discussed at the meeting. Among 20 temporary purchased drugs that have been discussed at the meeting， 9 of them scored below 60， with the unqualified rate of 45.0％， suggesting that 9 drugs may have wasted the workload of the Pharmaceutical Association. CONCLUSIONS： Drug quantitative scoring table can play a pre-intervention role in the scoring of temporary purchased drugs to a certain extent. At the same time， the table can also be used as a relevant reference for hospital drug evaluation. It is helpful to optimize hospital drug use list and improve the level of rational drug use in clinic.

Determination of Fluconazole in Human Plasma by UPLC-MS/MS with Isotopes Dilution / 中国药房

OBJECTIVE： To establish a method for determination of fluconazole concentration in human plasma. METHODS： UPLC-MS/MS method was adopted to determine plasma after precipitated with acetonitrile. Using isotope fluconazole-d4 as internal standard， the determination was performed on ACQUITY UPLC BEH C18 column with mobile phase consisted of 0.1％ formic acid-acetonitrile （gradient elution） at the flow rate of 0.3 mL/min. The column temperature was 40 ℃， and the sample size was 3 μL. ESI was used for positive ion scanning by multiple reaction monitoring mode. The ion pairs for quantitative analysis were m/z 307.1→220.0 （fluconazole） and m/z 311.1→223.0 （internal standard）. RESULTS： The linear range of fluconazole was 10-5 000 ng/mL （r＝0.998 1）. The limits of quantitation was 10 ng/mL. RSDs of intra-day and inter-day were less than 8％； accuracy ranged 95.8％-106.7％. The extraction recovery ranged 97.3％-107.3％ （RSD＜5.0％， n＝6）， and matrix effect， dilution effect and residual effect didn’t influence quantitative analysis of the substance to be measured. CONCLUSIONS： The method is simple， rapid， specific and accurate， which can be used for therapeutic drug monitoring and pharmacokinetic study of fluconazole.

Stability Study of Ginkgo Biloba Extract Injection from Three Manufacturers in Two Varieties of Infusions / 中国药师

Objective:To determine and investigate the stability of ginkgo biloba extract injection from three different manufactur-ers respectively in 0.9% NaCl infusion and 5% glucose infusion under different conditions (room temperature, high temperature and light). Methods:Ginkgo biloba extract injection was mixed with the two kinds of infusions,and then divided into the normal tempera-ture group,the high temperature group and the light group. The appearance,insoluble particles,pH and content of flavonoids after the relevant treatment were investigated. The appearance and insoluble particles were tested according to the characteristics of the inspec-tion method described in Chinese Pharmacopoeia(2015 edition,volume IV,the general rule),and the content of flavonoids was detec-ted by HPLC-UV. Results:All the mixed solutions were yellow. No significant changes were found in the appearance,pH value,in-soluble particles and contents of quercetin and isorhamnetin in all the mixed solutions in 24 h. The pH value of the mixed solution with 5% glucose infusion was lower than that with 0.9% NaCl infusion,and all the pH values met the standard in Chinese Pharmacopeias. The kaemphenol content in the injection from Shenwei pharmaceutical company was higher than that from the other manufacturers, while the content of kaemphenol in all the injections was within the standard range. Conclusion:The quality of Ginkgo biloba extract injection from the three different manufacturers is stable under different conditions.

Simultaneous Determination of 3 Kinds of Saponins in Marsdenia tenacissima by UPLC-MS/MS / 中国药房

OBJECTIVE:To establish the method for simultaneous determination of tenacissoside A,tenacissoside H and tenacissoside I in Marsdenia tenacissima. METHODS:UPLC-MS/MS method was adopted. The determination was performed on a Phenomenex Kinetex XB-C18column with mobile phase consisted of 0.1% formic acid solution-acetonitrile(gradient elution)at the flow rate of 0.2 mL/min. The column temperature was set at 40 ℃,and sample size was 5 μ L. Multiple reaction monitoring (MRM)mode was adopted with electrospray ion source as ion source,using positive ion scanning. Source jet voltage was 5 500 V,nebulizer pressure was 60 psi,heating pressure was 60 psi,curtain pressure was 20 psi and cone temp was set at 600 ℃. RESULTS:The linear ranges of tenacissoside A,tenacissoside H and tenacissoside I were 0.1-10 ng/mL(r=0.999 7),0.025-10 ng/mL(r=0.999 5),0.025-10 ng/mL(r=0.998 9),respectively;limited of quantation were 0.1,0.025,0.025 ng/mL,limited of detection were 0.05,0.012 5,0.012 5 ng/mL,respectively;RSDs of precision,stability and reproducibility tests were<4.0%. The recoveries were 97.67%-99.00%(RSD=0.47%,n=6),95.00%-101.67%(RSD=2.59%,n=6),96.67%-103.33%(RSD=2.83%, n=6). CONCLUSIONS:The method is simple,precise,stable and reproducible,and can be used for simultaneous determination of tenacissoside A,tenacissoside H and tenacissoside I in M.tenacissima.

Study on Compatible Stability of Calcium Folinate for Injection Mixed with Glucose Injection and Sodium Chloride Injection / 中国药房

OBJECTIVE:To investigate the compatible stability of Calcium folinate for injection mixed with Glucose injection and Sodium chloride injection. METHODS:Referring to clinical common concentration,each 3 Calcium folinate for injection (each injection was equal to calcium folinate 100 mg)were respectively mixed with Glucose injection 250 mL or Sodium chloride injection 250 mL. At room temperature,under light or dark condition,the appearance of mixtures,pH value and the number of in-soluble particles were investigated 0,1,2,3,4,6,8,12,24,36,48 h. The contents of calcium folinate in mixtures were deter-mined by HPLC. RESULTS:Under above condition,the color of the mixtures had no change,and no gas,precipitation and turbid-ity was found;there was no evident change in pH values(RSD<2%,n=11). 0 h after mixing,there was large number of parti-cles≥10 μm in mixtures,but the number of particle was decreased as time;within 48 h,the number of particles ≥10 μm and ≥25 μm in mixtures were all in line with the standard of Chinese Pharmacopeia(2015 edition). Under the protection from light con-dition,relative contents of calcium folinate in mixtures had no significant change(RSD<2%,n=11). Under light condition,rela-tive contents of calcium folinate in mixtures decreased significantly,decreasing to 94.5%(mixed with Glucose injection) and 88.4%(mixed with Sodium chloride injection). CONCLUSIONS:Calcium folinate for injection is more stable in Glucose injec-tion,and the stability of compatibility can be affected by light conditions. After mixed with Glucose injection and Sodium chloride injection,Calcium folinate for injection should be kept away from light and used as soon as possible

Efficacy and Safety of Total Glucosides of Paeony in Treatment of Patients with Sjogren Syndrome :A Meta-analysis / 医药导报

Objective Objective To evaluate the effects and safety of total glucosides of paeony (TGP) in the treatment of patients with Sjogren syndrome.Methods The Cochrane Library,PubMed,EMBASE,CBM,VIP,CNKI,Wanfang databases were searched from their establishments up to September 30,2015.We used the method recommended by the Cochrane collaboration to perform a meta-analysis of randomized controlled trails (RCTs) of total glucosides of peony in the treatment of patients with Sjogren syndrome.Two reviewers analyzed these data independently.The Cochrane Collaboration's software RevMan 5.3 was used for meta-analysis.Results A total of 573 patients in 10 studies were finally included,and were divided into different subgroups.The results of subgroup-analysis showed that:①Schimer test:TGP group had a higher effective rate than the blank control group [MD=2.41,95%CI (0.08,4.74)],lower effective rate than Chinese herbal medicine [MD=-2.55,95%CI (-3.88,-1.22);②Salivary flow:TGP group had a lower effective rate than the control group [SMD=-0.87,95%CI (-1.20,-0.54)].③Rheumatic factors (RF):TGP group had a higher effective rate than Chinese herbal medicine [SMD=0.44,95%CI (0.06,0.82)] and Chinese patent drug [SMD=0.74,95%CI (0.36,1.12)],lower effective rate than the blank control group [SMD=2.23,95%CI (-2.79,-1.67);④ C-reactive protein (CRP):TGP group had a higher effective rate than the control group [MD=4.51,95%CI (1.75,7.26)];⑤IgG:TGP group had a higher effective rate than Chinese patent drug group [MD=2.73,95%CI (1.63,3.84)],lower effective rate than the blank control group [MD=-3.90,95%CI (-5.67,-2.13),but no statistical difference was noted when compared with Chinese herbal medicine and Western medicine groups;⑥ESR:TGP group had a higher effective rate than Chinese herbal medicine group [MD=12.73,95%CI (3.62,21.84)] and Chinese patent drug group [MD=7.82,95%CI (5.39,10.24)],lower effective rate than the blank control group [MD=-7.13,95%CI (-12.70,-1.56) and Western medicine group [MD=-12.19,95%CI (-24.19,-0.19)];⑦Safety:8 studies reported adverse effects in 41 patients.TGP group had a higher adverse reaction rate than the control group [OR=3.23,95%CI (1.60,6.50)].Conclusion Current evidence demonstrates that TGP can effectively improve CRP,but its effects on Salivary flow,Schimer test,IgG,ESR,RF were not significant.However,the heterogeneity and high risk of bias in the reports involved in this study limits the reliability of this conclusion.

Bibliometric Analysis of Metabolomics / 中国药房

OBJECTIVE:To investigate the present situation of domestic and foreign metabolomics study,and to preliminarily discuss research hotspots and development rules. METHODS:By using bibliometric methods and GoPubMed literature analysis tool,usingMetabolomicsas subject,all literatures were retrieved from PubMed database up to Jul. 31,2016. Those literatures were ranked and analyzed in respects of publication amount,countries and cities,journal sources,research topics,core authors and authors collaborative networks. UsingMetabolomicsMetabonomicsas subjects,all literatures were retrieved from Web of Science database up to Aug. 1,2016. The literatures with high citation frequency were analyzed during 2007-2016 by using the sort-ing function of citation frequency. RESULTS:A total of 15449 domestic and foreign metabolomics literatures were retrieved. The researchers of 2189 literatures came from China,and the amount of published literatures showed a rising trend. 15449 literatures were distributed in 129 countries and regions;10 countries,such as the United States,China,Britain and Germany,were the core countries,and the total number of literatures issued was 12847(83.16%). The United States held the largest share of world publi-cations(4288 literatures,27.76%),and the following was China in order(2189 literatures,14.17%). The city with the largest amount of publications was London(467 literatures),followed by Shanghai,Beijing. A total of 2168 periodicals were involved, and there were 7.1 published literatures averagely. All of the top 20 periodicals were from the United States and European countries (4377 literatures,28.33%). The first 3 subjects with the highest frequency of occurrence were metabolomics,metabolome and me-tabolism;related researches mainly focused on metabolic processes,metabolic networks and pathways,biological markers,pro-teome and genome;main research methods included spectrum analysis and magnetic resonance spectroscopy. Main 6 groups of au-thors were involved,mainly Nicholoson JK,Holmes E,Lindon J and other researchers. None of Chinese researchers had been found among the core authors and author groups. The literatures with high citation frequency mainly focused on the association of metabolism with disease,metabolomics database,metabolomics research methods and biological markers related to disease predic-tion. CONCLUSIONS:Metabolomics has aroused worldwide interest among researchers,and metabolic pathways and biological markers are the focuses in this field. Our researchers have published a large amount of literatures on metabolomics,but there are not high quality periodical carrier or enough cooperation between researchers. It is suggested to enhance the cooperation between various research institutions or grasp the frontier and hotspots of the research in this field so as to push forward the development di-versification and depth of metabolomics research in China.

Study on Compatible Stability of Xiao'aiping Injection Combined with 3 Kinds of Injections / 中国药房

OBJECTIVE:To investigate the compatible stability of Xiao'aiping injection combined with 3 kinds of common in-jections. METHODS:Referring to package inserts,Xiao'aiping injection 40 mL was compatible with 5% Glucose injection,10%Glucose injection or 0.9% Sodium chloride injection 160 mL,respectively. At room temperature(about 25 ℃)and high tempera-ture(40 ℃),the appearance of mixtures were observed at 0,1,2,4,8,12,24,48 h;pH value and the number of insoluble particles were detected. The contents of tenacissoside A and tenacissoside Ⅰ in mixtures were determined by HPLC. RESULTS:Un-der above condition,the mixtures were brownish yellow liquid within 48 h after Xiao'aiping injection was compatible with 5%Glucose injection or 10% Glucose injection;24 h after mixed with 0.9% Sodium chloride injection,the mixture changed from brownish yellow to reddish brown,but no precipitation was found. The pH value of mixtures had no significant change(RSD<1%,n=8). The number of particles ≥25 μm was in line with the requirements of Chinese Pharmacopeia(2015 edition). For-ty-eight hours after mixing,the number of particles ≥10 μm in the mixtures exceeded the pharmacopoeia limits. Within 48 h after mixing,the relative contents of tenacissoside A and tenacissoside I in mixtures had no significant change(RSD<2%,n=8). CON-CLUSIONS:The mixture should be used up within 24 h after Xiao'aiping injection combined with 5% Glucose injection,10%Glucose injection or 0.9% Sodium chloride injection.

Application Effects of DS8000 Intelligent Sorting System in the PIVAS of Our Hospital / 中国药房

OBJECTIVE:To improve the automation and information level of Pharmacy intravenous admixture service (PIV-AS),and provide reference for the PIVAS development. METHODS:Related functions of DS8000 intelligent sorting system and its effect of PIVAS were introduced;work environment,workflow,work efficiency,labor intensity and sorting error before and af-ter the system application were compared. RESULTS:The application of intelligent sorting system achieved the automation of multi-ple links including reviewing,sorting,automatically counting,automatically generating hand-over lists of departments,statistical inquiring for related information in finished soft bag infusion sorting. Compared with manual sorting,it only covered less area, working environment was neat and orderly,workflow links was reduced (6 vs. 10),work time was shortened (average time for sorting per bag of infusion 13.53 s vs. 3.11 s),labor intensity was decreased,and work error rate was reduced (0.128‰ vs. 0.013‰);meanwhile,it improved the management for shading drugs,and achieved data analysis of PIVAS and management infor-mation. CONCLUSIONS:The application of DS8000 intelligent sorting system has improved the automation and information of PI-VAS,and promoted the construction and development of PIVAS.

Stability of Compound Kushen Injection in Two Kinds of Infusion Solution / 中国药师

Objective:To study the stability of compound Kushen mixed liquid to provide reliable evidence for safe clinical drug application.Methods:Compound Kushen injection was mixed respectively with 0.9% sodium chloride injection and 5% glucose injection,and then placed under the different conditions for 0,1,2,4,8,12,24 and 48 h.HPLC was conducted to determine the content changes of four components in compound Kushen mixed liquid,and the appearance,pH and insoluble particles were observed as well.Results:The mixed liquid of compound Kushen with 0.9% sodium chloride injection was stable in 48 h without the influence of light and temperature.However,the mixed liquid of compound Kushen with 5% glucose injection had poorer stability with storage time shorter than 12 h at room temperature and 2 h at high temperature.Conclusion:The stability of the mixed liquid of compound Kushen is closely related to the pH value of solvent.0.9% Sodium chloride injection is recommended as the solvent,and the mixed liquid should be used up in 48 h.