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OBJECTIVE To evaluate the effectiveness， safety and economics of Aidi injection combined with first-line chemotherapy for non-small cell lung cancer （NSCLC）， and to provide evidence-based reference for clinical drug use and decision. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CNKI， Wanfang databases， VIP and Health Technology Assessment （HTA） related websites， HTA reports， systematic evaluation/meta-analysis and economic evaluations about Aidi injection combined with first-line chemotherapy for NSCLC were collected from the inception to Aug. 2022. After data extraction and quality evaluation， descriptive analysis was performed for the results of included studies. RESULTS A total of 16 pieces of literature were included， involving 1 piece of systematic review， 13 pieces of meta-analysis， 2 pieces of pharmacoeconomic studies. Compared with first-line chemotherapy， Aidi injection combined with first-line chemotherapy could improve response rate and disease control rate， prolonged survival time， improved survival quality， reduced the incidence of nausea and vomiting， leukocytopenia and thrombocytopenia， and improved immune function， but had controversial effects on liver and kidney function. With the payment threshold set by 3 times the national per capita GDP in 2019， Aidi injection combined with first-line chemotherapy had a more economical probability. CONCLUSIONS Aidi injection combined with first-line chemotherapy for NSCLC has good efficacy and safety， and has certain economic benefits. However， given the limited pharmacoeconomic studies included， the economic conclusions obtained need to be carefully interpreted.
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OBJECTIVE To mine the safety signals of FOLFOX scheme and FOLFIRI scheme-induced hepatotoxicity， and to provide reference for the selection of clinical rational treatment plan and the prevention and treatment of drug adverse reaction （ADR）. METHODS Reporting odds ratio method and proportion report ratio method were used to analyze adverse drug event （ADE） reports of FOLFOX scheme and FOLFIRI scheme in FDA adverse event reporting system during January 1， 2004-June 30， 2022. The potential safety signals of FOLFOX scheme and FOLFIRI scheme-induced hepatotoxicity were mined. RESULTS The amounts of ADE reports related to FOLFOX scheme and FOLFIRI scheme were respectively 3 454 and 1 359； the proportions of male and female patients involved were 1.50∶1 and 1.67∶1 in these two schemes， respectively. The top five countries with the largest number of reports were the United States， Japan， France， Italy and the United Kingdom， respectively accounting for 58.48% and 53.79% of the total reported cases. More than 90% of patients took no more than 5 drugs in combination， the proportion of patients receiving FOLFOX scheme and FOLFIRI scheme combined with anti-angiogenic drugs or epidermal growth factor receptor inhibitors was 45.45% and 86.82%， respectively. Totally 443 ADE reports of FOLFOX scheme-induced hepatotoxicity were collected， and 22 ADR signals were generated， including hepatic sinusoidal obstruction syndrome， nodular regenerative hyperplasia， drug-induced liver injury， blood bilirubin increased， etc. Totally 128 ADE reports of FOLFIRI scheme- induced hepatotoxicity were reported， and 9 ADR signals were generated， including blood bilirubin increased， hepatotoxicity， steatohepatitis， hepatic steatosis， etc. CONCLUSIONS FOLFOX scheme and FOLFIRI scheme can cause different types of hepatotoxicity. Clinical drug monitoring should be strengthened to guarantee drug safety.
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Paclitaxel is the first-line chemotherapy drug for a variety of cancers. However， the paclitaxel resistance greatly reduced the efficacy in the later treatment stage， which seriously increased the mortality and recurrence rate of cancer and limited the clinical application of paclitaxel. At present， Chinese medicine compound prescription， proprietary Chinese medicine， and Chinese medicine injection are widely used as the adjuvant chemotherapy drugs for the treatment of cancer in clinic. Chinese medicine has shown unique advantages in improving the efficacy of chemotherapy drugs and the prognosis of chemotherapy， and reducing the toxic and side effects. However， the specific mechanism and effective monomer composition of Chinese medicine for reversing the resistance of chemotherapy drugs are unclear， and the application of Chinese medicine in different types of cancer is also limited， which are worthy of further exploration. This review summarized the composition of Chinese medicine monomer with synergistic antitumor effect combined with paclitaxel in recent years. The specific mechanism and pharmacological activities of Chinese medicine monomer reversing paclitaxel resistance were classified. This review found that through acting on the membrane transport protein， Chinese medicine monomer promoted the accumulation of paclitaxel in tumor cells， inhibited the expressions of protein and metabolic enzyme related to multidrug resistance and the metabolism of paclitaxel， and regulated the levels of apoptosis genes and factors and apoptosis-related pathways to promote the inhibitory effect of paclitaxel on cell proliferation. Chinese medicine monomer also significantly improved paclitaxel chemotherapy sensitivity by regulating the expression levels of micro ribonucleic acid （microRNA） and long non-coding ribonucleic acid RNA （lncRNA）， inhibiting the characteristics of tumor stem cells and tumor metabolic reprogramming， improving tumor microenvironment， and triggering tumor cell death autophagy and oxidative stress response. This review provides a theoretical basis for clarifying the specific anti-tumor mechanism of Chinese medicine monomer combined with paclitaxel， which is of great significance for the development of new Chinese medicine and the clinical research of the drugs combined with paclitaxel， and has certain value for the application of Chinese medicine combined with other chemotherapy drugs.
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OBJECTIVE：To provide reference for pharmacists ’participation in the integrated outpatient treatment in China. METHODS：Using“Pharmacist”“Clinical pharmacist ”“Integrated outpatient ”“Combined outpatient ”“Outpatient department ”as Chinese and English retrieval words ，the related literatures were retrieved from Embase ，PubMed，CNKI，Wanfang and VIP ， retrieval time limit was from the construction of database to July 24，2019. The type ，research method ，service content and the evaluation indexes of the service effectiveness of pharmacists ’participation in the integrated outpatient treatment at home and abroad were compared. RESULTS ：A total of 848 related literatures were retrieved ，including 30 valid ones. From respective of research method ，main foreign method was retrospective research （42.86％），followed by self-control trial （21.43％） and questionnaire survey/telephone research （14.29％）；main domestic method was descriptive research （37.50％），followed by case control（25.00％）and self-control trial （25.00％）. From respective of the types of pharmacists ’participation in the integration of outpatient services ，there were 9 types of pharmacists ’participation in the foreign integrated outpatient treatment ，including cancer or palliative outpatient department ，geriatric outpatient department ，lipid management outpatient department ，AIDS outpatient department， hypertension outpatient department ， etc. Among them ， the proportion of pharmacists participating in cancer orpalliativeoutpatient department was the highest ，being 42.86％. There were 11 types of pharmacists ’participation in the domestic integrated outpatient treatment ， including anticoagu lation （No.ZYCC2019017） outpatient department ， diabetes outpatient department and epilepsy out patient department ，Parkinson’s disease outpatient 38297155。E-mail：lydaishu@163.com department， etc. Foreign pharmacists provided in-depthservices in cancer or palliative outpatient department ， including treatment suggestions ，classification and resolution of drug-related problems ，provision of drug information and pharmacist intervention ，etc.；the contents of pharmaceutical care provided by domestic pharmacists in anticoagulant outpatient department was more in-depth ，including dosage adjustment of anticoagulants，pharmaceutical care ，medication consultation ，medication guidance and education ，etc. For the evaluation of service effect，foreign researches involved 13 kinds of outcome indexes ，including the improvement of clinical indexes ，the reduction of medical cost ，reduction of drug used ，etc. Domestic researches involved 11 kinds of outcome indexes ，including the improvement of medication compliance ，clinical indexes and ADR ，etc. CONCLUSIONS ：The participation of pharmacists in integrated outpatient at home and abroad are mainly chronic diseases ，but also different in their emphasis . The domestic pharmacists and related scholars can improve the research methods ，the types of integrated outpatient services ，service contents and the evaluation indexes of effectiveness of pharmacists.
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Objective To investigate the mechanism of Qinggan-Huoxue recipe in the treatment of alcoholic liver disease by observing its function on alcoholic liver disease rat fibroblast growth factor -21 (FGF21). Methods The rats were randomly divided into the blank group (n=10), the carbon tetrachloride group (n=10), the model group (n=11), the Qinggan-Huoxue recipe group (n=10), the Qinggan recipe group (n=9) and the Huoxue recipe group (n=10). Except for the blank group and the carbon tetrachloride group, the other rats were given 10 ml/kg alcohol, corn oil and pyrazole mixture (4.5 ml: 2 ml: 25 mg), once a day, 0.3 ml/kg carbon tetrachloride olive oil solution (carbon tetrachloride: olive oil =1: 3) intraperitoneally, and twice a week for 12 weeks to prepare the alcoholic liver disease model. In the ninth week, the Qinggan-Huoxue recipe group was treated with 4.75 g/kg of Qinggan-Huoxue recipe, the Qinggan recipe group was treated with 1.5 g/kg of Qinggan recipe, and the Huoxue recipe group was treated with 3.25 g/kg of Huoxue recipe, once a day, and 28 d for continuous administration. The pathological changes of liver tissue were observed by HE staining and Masson staining. The serum levels of AST and ALT were detected in rats. The changes of FGF21 protein and mRNA expression were detected by immunohistochemistry, Western blotting and fluorescence quantitative PCR. Results Compared with the model group, the liver weight and liver body ratio in the Qinggan recipe group, Qinggan-Huoxue recipe group and Huoxue recipe group were significantly lower (P<0.01). Compared with the model group, the serum ALT (41.95 ± 26.78 U/L, 46.63 ± 21.00 U/L, 37.57 ± 27.85 U/L vs. 138.34 ± 43.35 U/L), AST (102.74 ± 23.55 U/L, 111.50 ± 21.26 U/L, 83.72 ± 37.57 U/L vs. 257.41 ± 162.31 U/L) in the Qinggan recipe group, Qinggan-Huoxue recipe group and Huoxue recipe group significantly decreased (P<0.01 or P<0.05). Compared with the model group, the expression of FGF21 protein (1.19 ± 0.07, 1.24 ± 0.12 vs. 0.92 ± 0.04) in Qinggan recipe group and Qinggan-Huoxue recipe group significantly increased (P<0.05), and the expression of FGF21 mRNA (1.25 ± 0.08 vs. 0.95 ± 0.05) in Qinggan-Huoxue recipe group significantly increased (P<0.05). Conclusions FGF21 plays an important role in the alcoholic liver disease. During the process of liver injury, FGF21 increases continuously. Qinggan-Huoxue recipe can improve the content of FGF21 in the treatment of alcoholic liver disease.
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Objective: To investigate the entry points of traditional Chinese clinical pharmacists participating in multidisciplinary team (MDT) to provide reference for more peers and subject development. Methods: According to the daily work of traditional Chi-nese clinical pharmacists in joint multidisciplinary clinic and combining with patients' medication characteristics, traditional Chinese clinical pharmacists carried out works from three aspects including doctors, patients and peers. Results: After the medication was guided by traditional Chinese clinical pharmacists, the effect of medicinal treatment was improved, the patients' medication compliance increased and the incidence of adverse reactions was reduced. Moreover, it brought more ideas to the peers within the discipline in our hospital. Conclusion: Traditional Chinese clinical pharmacists can exploit their advantages to the full to find clinical demands and more entry points in works. At the same time, traditional Chinese clinical pharmacists should enhance related knowledge, professional qualities, and cooperation and communication ability comprehensively.
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Objective To investigate the inhibitory effect of Xiaoaiping injection (XAP) combined with paclitaxel (PTX) on human ovarian cancer SK-OV-3 cells .Methods In vitro anti-proliferation activity study of XAP combined with PTX on hu-man ovarian cancer SK-OV-3 cells was performed using optical microscope and MTT assay .Human ovarian cancer SK-OV-3 cells were treated with PTX ,XAP ,PTX combined XAP or vehicle control .Each group of cells was treated with drugs for 24 h or 48 h .SK-OV-3 cell morphology was observed with optical microscope .MTT assay was used to detect the A value and cell vi-ability was calculated .In vivo effect of XAP combined with PTX on the growth of SK-OV-3 cells was determined in nude mice . In our study ,thirty-six mice were randomly divided into six groups :G1 (NS) ,G2 (PTX ,10 mg/kg) ,G3 (XAP ,20 ml/kg) , G4 (XAP ,50 ml/kg) ,G5 (PTX 10 mg/kg+XAP 20 ml/kg) and G6 (PTX 10 mg/kg+XAP 50 ml/kg) .Animals were trea-ted for 18 days .Body weight ,tumor volume and tumor inhibition rate were recorded and calculated .The results were analyzed by the SPSS 19 .0 software .Results In vitro study showed that SK-OV-3 cell viability decreased significantly in PTX com-bined XAP group compared to PTX group or XAP group ,in a time and dose-dependent manner .In vivo study showed that the combination of PTX and XAP resulted in decreased tumor weight significantly compared to the control or the PTX alone . Conclusion The combination of XAP and paclitaxel exhibited a synergistic effect both in vitro and in vivo in nude mouse tumor xenograft model .
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OBJECTIVE:To provide reference for promoting rational use of essential medicines. METHODS:Combined with the actual situation of our hospital,a set of risk prevention and control system on essential medicine was constructed on the basis of relevant laws and regulations and support of information,and then implemented. RESULTS:The implementation of the system greatly promoted cognition of all medical staffs on reasonable,economical and safe use of essential drugs,standardized medication behavior and improved essential medicine use more reasonable. After the implementation of risk prevention and control system on essential medicines,medicine ratio of whole hospital decreased from 34.62% to 32.64%,inpatient medicine ratio decreased from 33.02% to 27.89%;essential medicine ratio of whole hospital rose from 31.22% to 43.34%,inpatient essential medicine ratio in-creased from 23.46%to 39.17%;the proportion of outpatient antibiotics prescriptions decreased from 15.04%to 13.46%,the utili-zation of inpatient antibiotics decreased from 62.11% to 48.47%. Various early warning were sent out 104 times in total,and 23 medical staff were punished due to irrational drug use. The prescription form and rationality of drug use were improved gradually. CONCLUSIONS:The construction of risk prevention and control system on essential medicine is one of the keys to the success of health care reform. It is suggested to make full use of thesystem+technologymeans,establish long-term mechanism for risk pre-vention and control,and constantly improve the system.
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Objective To introduce the working experience of clinical pharmacists who provide pharmaceutical service in participating integrated diabetes out-patient.Methods Review and analyze the patients' clinical features and the clinical pharmacists' working model and effect in integrated diabetes out-patient of the Sixth People's Hospital Affiliated to Shanghai Jiaotong University.Results Among these patients who got pharmaceutical service in integrated diabetes out-patient, 81.7% were 40 to 70 years old, 51.7% had diabetes for 5 to 10 years, 50.0% were taking oral antidiabetic drugs to control blood glucose, and 90.0% were having complications.After the medication guide by clinical pharmacists,patients' medication compliance was increased from the percentage of 30.0% to 80.0%, the good control rate of blood glucose was increased from the percentage of 8.3% to 41.7%, and the incidence rate of adverse reaction was reduced from 10.0% to 3.3%.Conclusion Clinical pharmacists who actively participate in integrated diabetes out-patient could ensure the effective and safe treatment to diabetic patients.Therefore, this model is worth to be popularized due to professional value of clinical pharmacists.
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Objective: To explore the in vitro inhibition effect of Zuojin pills on 6 cytochrome P450 isoenzymes ( CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4) in human liver microsomes. Methods:The water extract of Zuojin pills, Cop-tidis Rhizoma and Euodiae Fructus was respectively incubated with human liver microsomes in the presence of seven probe substrates of CYP450 isoenzymes, and seven metabolites of cytochrome P450 probe substrate ( paracetamol/CYP1A2, 6α-hydroxypaclitaxel/CYP2C8, 4-hydroxydiclofenac/CYP2C9, 4-hydroxymephenytoin/CYP2C19, dextrorphan/CYP2D6, 6β-hydroxytestosterone/CYP3A4 and 1-hydroxymidazolam/CYP3A4) were simultaneously measured by LC-MS/MS, and the inhibitory effects were evaluated with IC50 value. Results:The IC50 value of Zuojin pills on CYP2D6, CYP1A2 and CYP3A4_T was 11. 6, 77. 4 and 97. 0 μg·ml-1 , respec-tively. The other IC50 values were from 334 to 690μg·ml-1 on CYP2C8, CYP2C9, CYP2C19 and CYP3A4_M isoenzymes. The IC50 value of Coptidis Rhizoma on CYP2D6, CYP1A2 and CYP3A4_T was 5. 8, 36. 8 and 59. 2 μg·ml-1 , respectively. The other IC50 values were from 163 to 476 μg·ml-1 on CYP2C8, CYP2C9, CYP2C19 and CYP3A4_M isoenzymes. The IC50 value of Euodiae Fructus on CYPs was over 107 μg·ml-1 . Conclusion:Zuojin pills shows notable inhibitory effect on CYP2D6, and weak inhibitory effects on CYP1A2 and CYP3A4_T. Coptidis Rhizoma has similar effects on CYPs and may be the main herbal medicine in the formu-la. Therefore, much attention should be paid to the combination of Zuojin pills and the drugs metabolized by human CYP2D6 in clin-ics.
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OBJECTIVE:To investigate the satisfaction degree of outpatients on policy of separation of clinical pharmacy from 4 third grade hospitals in Shanghai,and provide reference for promoting medical reform policy. METHODS:Parts of outpatients in the 4 new suburb third grade hospitals were investigated by the questionnaire and interview in Shanghai city,and the data was sta-tistically analyzed by Excel software and SPSS 19.0 software. RESULTS:Totally 400 questionnaires were sent out and 368 were valid with effective recovery of 94.3%. The awareness rate of medical separation policy was 81.3% in the outpatients;55.5% of outpatients thought that medicine cost savings effect was not obvious;the overall satisfaction of patients was 91.6%,and the high-est of satisfaction was the service attitude and the lowest was medical expenses. CONCLUSIONS:Policy of separation of clinical pharmacy has reduced the medical expenses,guided the triage treatment of patients partly and improved the satisfaction of patients. It is suggested to shorten the waiting time by optimizing examination process,strengthen price regulation in drug,standardize pro-duction and distribution process,improve use rate of essential medicines and promote clinical rational drug use for further improve-ment of satisfaction.
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This study was aimed to observe the antipyresis and cholagogue effect of theFructus Gardeniae-Fructus Forsythiaeherb couple in order to explore the possible pharmacodynamic mechanism. Dry yeast suspension was subcutaneously injected into the back of rat to establish the fever model. The freeze-dried powders ofF. Gardeniae,F. Forsythiae, andF. Gardeniae-F. Forsythiaeherb couple were prepared. They were dissolved in the water for intragastric administration. SD rats were randomly divided into the normal group, model group, positive control group and Chinese medicine group. The Chinese medicine group was subdivided into the group ofF. Gardeniae,F. Forsythiae, andF. Gardeniae-F. Forsythiaeherb couple. The concentration of herbal water extract was 10 mL·kg-1 (which equaled to 3 g·kg-1 of a single crude herb). The concentration of positive control was 10 mL·kg-1. Intragastric administration of equal amount of normal saline was given to the blank group and the model group. Except rats in the normal group, rats in other groups were subcutaneously injected with 10 mL·kg-1 of 15% dry yeast suspension on the back of to establish the fever model. Electronic thermometer was used to record the body temperature of rats at 0, 1, 4, 5, 6, 7 and 8 h after the injection, respectively. Meanwhile, bile was collected from 1-1, 1-2, 2-4, 4-6, 6-8, 8-12, 12-24 h, respectively. Observation was given on changes of body temperature and bile amount of rat. The results showed thatF. Gardeniae,F. Forsythiae, andF. Gardeniae- F. Forsythiaeherb couple had certain effect to reduce the body temperature of rats. The temperature-reducing effect of the combination of both herbs was better than a single herb. TheF. Gardeniae -F. Forsythiae herb couple can reduce the body temperature of fever rat (P < 0.05, orP < 0.01). It had a little effect on the body temperature of normal rat. TheF. Gardeniae - F. Forsythiaeherb couple can promote the bile secretion, which was better than the single using of F. Gardeniae (P < 0.05). It was concluded that theF. Gardeniae - F. Forsythiaeherb couple had better temperature-reducing effect than the using of a single herb; however, there was no significant difference. But it had obvious effect on the promotion of bile secretion, which indicated the strengthening of cholagogue effect.
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<p><b>OBJECTIVE</b>Qingkailing injection (QKLI), Jinnaduo injection (JNDI), Shuxuetong injection (SXTI), Shenmai injection (SMI) and Kangai injection (KAI) are widely used in China. To predict the herb-drug interactions in clinical application, they were evaluated for their in vitro inhibition effect on CYP3A in rat liver microsomes.</p><p><b>METHOD</b>The rat liver microsomes were incubated with different doses of 5 kinds of traditional Chinese medicine injections (TCMIs) in the present of testosterone, a specific substrate of CYP3A. 6beta-hydroxytestosterone, the metabolite of testosterone, was monitored by HPLC to compare the inhibition effect of 5 TCMIs on CYP3A in rat liver microsomes. Ketoconazole was used as a positive control.</p><p><b>RESULT</b>10% QKLI reduced the formation of 6beta-hydroxytestosterone by approximately 93.0%, which is more significant than other four TCMIs. The half maximal inhibitory concentration (IC50) and the enzyme-inhibitor constant K(i) were 1.0% and 0.7% respectively.</p><p><b>CONCLUSION</b>QKLI showed much stronger inhibition activity against CYP3A, comparing to other 4 TCMIs. The results revealed that QKLI may be involved in herb-drug interactions by inhibition of CYP3A.</p>
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Animals , Male , Rats , Cytochrome P-450 CYP3A Inhibitors , Injections , Medicine, Chinese Traditional , Microsomes, Liver , Rats, Sprague-DawleyABSTRACT
OBJECTIVE:To study the relative bioavailability,pharmacokinetics and bioequivalence of domestic nisoldipine tablets in healthy volunteers.METHODS:A single oral dose of 10 mg test and reference nisoldipine tablets were given to 24 male healthy volunteers in an open randomized 2?2 latin square design.The plasma concentrations of nisoldipine at different time points were determined by LC-MS and the pharmacokinetic parameters of the two kinds of tablets were computed and their bioequiavailability was evaluated.RESULTS:The main pharmacokinetic parameters of the test vs.reference formulations of nisoldipine in 24 healthy volunteers were as follows:Cmax(2.94?2.78)ng?mL-1 vs.(3.22?2.16)ng?mL-1,tmax(1.70?1.00)h vs.(1.40?1.00)h,t1/2(6.81?4.11)h vs.(5.55?2.35)h,AUC0～24(10.60?7.70)ng?h?mL-1 vs.(9.90?6.76)ng?h?mL-1,AUC0～∞(11.30?7.90)ng?h?mL-1 vs.(10.20?7.00)ng?h?mL-1.The relative bioavailability of domestic nisoldipine tablets was(110.3?30.8)%.CONCLUSION:The reference preparation and the test preparation of nisoldipine tablets were proved to be bioequivalent.
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OBJECTIVE:To prepare jumazhitong film and establish its quality control method.METHODS:The jumazhitong film former was made with PVOH-124 as the base,the content of the principal agent-dyclonine hydrochloride was determined by HPLC.RESULTS:Good linear relation was achieved when the detection concentration range of dyclonine hydrochloride was 40.8～408?g/ml(r=0.9 998),the average recovery was 101.3%(RSD=1.3%,n=6).CONCLUSION:The preparing technique of jumazhitong film former is simple,its quality is stable and the control method is feasible.