Objective To evaluate therapeutic drug monitoring and efficacy of meropenem in patients with continuous renal replacement therapy(CRRT) and patients with renal insufficiency but without CRRT,and to evaluate the effect of CRRT on the clearance of meropenem. Methods Patients with renal insufficiency receiving meropenem treatment and therapeutic drug monitoring in the Affiliated Suzhou Hospital of Nanjing Medical University from January 2019 to June 2021 were collected retrospectively.They were divided into the CRRT group and the non-CRRT group.Dosage regimen,blood trough concentration,and clinical efficacy were compared between the two groups. Results A total of 74 patients were included and divided into the CRRT group(21 cases)and the non-CRRT group(53 cases).The blood trough concentration of CRRT group was higher than that of non-CRRT group(P<0.01).The blood trough concentration of the CRRT group in dose of 1 g,q8h was higher than that of the non-CRRT group(P<0.05).The rate of clinical efficacy in the non-CRRT group was higher than that in the CRRT group(P<0.05).The clearance rate of gram-negative bacteria in the group with blood trough concentration>4MIC was higher than that of another group with blood trough concentration<4MIC(P<0.01).The linear regression analysis results indicated a certain correlation between blood trough concentration and ultrafiltration rate(r=-0.454,P<0.05). Conclusion Patients with CRRT had higher blood trough concentration and less clearance of meropenem than patients with renal insufficiency but without CRRT.There was a certain correlation between blood trough concentration and ultrafiltration rate in CRRT patients.For patients with Multi-resistant pathogens,keep blood through concentration>4MIC can obtain better clearance of gram-negative bacteria.

With the gradual promotion of drug selection and evaluation in some provinces and cities in China,it is urgent for medical institutions to establish a complete and quantifiable drug selection and evaluation system. Based on the development of pharmacy and the adjustment of national drug policies in recent years,this guideline has revised and refined the evaluation indicators of drug evaluation and selection in medical institutions on the basis of the first version,so that the quantitative scoring can better reflect the priority of drugs in medical institutions,and also more fulfill the requirements of the national policy. Moreover,the scoring items are more detailed,clear and easy to use. In this guideline,five dimensions of pharmaceutical properties (28 points),effectiveness (27 points),safety (25 points),economy (10 points) and others (10 points) were quantified and scored,so as to objectively conduct selection and evaluation of drugs in medical institutions.

Pharmacists play an irreplaceable role in the development process of global chronic disease management.Foreign pharmacists provide pharmacy services such as medication therapy management,chronic disease prevention and screening,and medication use review in social pharmacies,community hospitals,and home environments,and have achieved significant results.In China's hierarchical medical system,relevant policies have been introduced to promote the development of grassroots pharmacy services.However,community pharmacy services are still at an early stage and need more experience to learn from.This article provides a summary of the working models and service content,policy documents,pharmacist qualifications,and pharmacy service payment mechanisms of community pharmacists in the United States,United Kingdom,Australia,and Japan,providing a reference for the practice of community pharmacists and the development of community pharmacy in China.

Objective To provide medical institutions with expert recommendations for the rational off-label use of key monitored drugs and to guide healthcare professionals in further standardizing the application of national monitored drugs. Methods The research design for reaching expert consensus on the rational clinical use of national monitored drugs beyond their approved indications followed the guidelines of the World Health Organization (WHO).A systematic search was conducted to extensively collect common issues related to the off-label use of the second batch of national monitored drugs in various provinces.The Delphi method was used to survey experts and identify common off-label use items for the key monitored drugs.Literature research and expert experience were utilized to collate and form relevant body of evidence,and quality evaluation was carried out in accordance with the GRADE approach.Consensus was reached again through the Delphi method regarding the recommended advice and evidence level,which ultimately led to the formation of the “Expert Consensus on the Rational Clinical Use of Nationally Monitored Drugs Beyond Their Approved Indications.” Results A survey questionnaire was conducted among 60 experts through an online survey,and a consensus on off-label use items was reached using the Delphi method,covering drug categories such as proton pump inhibitors,antibiotics,glucocorticoids,and other medications.A total of 37 clinical issues were identified,resulting in a total of 38 recommended pieces of advice. Conclusion This consensus provides a reference and supplement for medical institutions to develop clinical application norms and prescription (medical order) review rules for national monitored drugs,to ensure the effectiveness and safety of their use.It further improves the quality of medical services,reduces the risk of adverse events related to national monitored drugs,promotes rational drug use.

药学服务体系是健康中国建设不可或缺的组成部分,该体系建设是医疗保障管理精细化与可持续发展的有力保证,药学服务是符合国情且世界通行的医保支付服务。《推进药学服务体系建设和医疗保障协同发展专家共识》从药学服务项目、内涵与支付标准三个方面阐述了药学服务体系建设的社会价值和意义。药学服务体系与医疗保障体系二者相互依存、相互促进,该共识旨在明确二者的协同发展是当今大众健康的重要保障,同时厘清医保支付体系下的药学服务付费的社会发展需求和实施路径。

Chronic diseases pose a serious threat to human health and impose a serious burden on national healthcare systems.The United States of America,Germany,Japan,the United Kingdom and Australia have studied chronic disease management earlier,and a number of management strategies have been formulated,such as the American community plan,the German disease management programs,Japanese specific health examination and guidance,the British general practice-centered management model,and the general practitioner management plan launched in Australia.The chronic disease management strategies in these countries have achieved good results after years of practice.This paper reviewed the subjects,strategies and effects of chronic disease management in these countries,and provided reference for the formulation of chronic disease management strategies in China.

Noncommunicable chronic diseases (NCDs) pose a significant risk to human health,which accounts for 60% of global mortality.Patients with NCDs often require lifelong treatment.Effective self-care contributes to optimizing treatment outcomes,reducing complications and saving treatment costs for patients with NCDs.In the developed countries,such as the United States of American,Japan,Australia,and the United Kingdom,pharmacists are involved in the self-care of patients with NCDs through medication guidance,education,monitoring,follow-up,and referral.Their works encourage healthy lifestyles,reasonable use of medications,improved medication adherence,and the management of NCDs risk factors.In order to provide examples for the work of pharmacists in China,this article reviewed the current status of pharmacists' involvement in self-care of patients with NCDs in foreign countries.Their works in diabetes,cardiovascular diseases,cancer,chronic respiratory diseases,mental diseases,and mental health were introduced as examples.

With the deepening of modern drug research,traditional computer simulation can not meet the needs of future drug design experiments.As a classic technology of standard computer simulation,molecular simulation can construct and analyze complex molecular models to study the dynamic processes of molecular motion.However,the simulation results are easy to be affected by human factors.In recent years,the integration of artificial intelligence and molecular simulation has become a new method of drug design research.Artificial intelligence technology uses big data to screen out the corresponding compounds for molecular simulation and feedback on the simulation results to the artificial intelligence system to optimize the artificial neural network.The combination of artificial intelligence and molecular simulation technology improves the efficiency of drug design research,reduces the influence of human factors on simulation results,and increases the credibility of simulation results.In this review,we summarized the progress of artificial intelligence and molecular simulation technology in drug design to provide a reference for the change from computer assisted drug design (CADD) to artificial intelligence-aided drug design (AIDD) in future pharmaceutical development.

Objective To investigate the relationship between PAI-1 4G/5G gene polymorphisms and venous thromboembolism (VTE) in tumor patients and to provide reference for early identification of high-risk groups of VTE and prevention of VTE. Methods ① Comparison of genetic differences: malignant tumors patients were enrolled by His system of our hospital and divided into a venous thromboembolism group (30 cases) and a non-venous thromboembolism control group (118 cases) according to whether VTE occurred or not. PAI-1 4G/5G gene screening was performed on both groups of patients, and the differences in gene distribution frequency and Hardy-Weinberg genetic balance test were compared between the two groups. ② Gene intervention study:malignant tumor patients without VTE were randomly divided into the gene guidance group (n=30) and the non-gene guidance group (n=30) by a single-blind randomized number table method. The gene guidance group took VTE preventive measures according to the results of gene testing, while the non-gene guidance group did not take VTE preventive measures without gene screening. The number and incidence of venous thromboembolism events were compared between the two groups. Results The gene distribution frequency of the VTE group and the non-venous thromboembolism control group was statistically different (P<0.05) and all were in consistent with Hardy-Weinberg genetic balance;The number of venous thromboembolism events in the gene guidance group was 0, and that in the non-gene guidance group was 4 (13.33%), the difference was statistically significant (P<0.05). Conclusion The 4G/5G polymorphism of PAI-1 gene can be used as a risk-discriminating factor for VTE in tumor patients, and at the same time, it can provide certain guidance for early identification of high-risk groups of VTE and intervention measures.

Objective To analyze the efficacy and safety of hepatic artery infusion chemotherapy(HAIC)based therapy in patients with unresectable hepatocellular carcinoma. Methods Participants who underwent HAIC-based therapy from October 2020 to November 2021 were evaluated retrospectively by the conversion rate of surgery,objective response rate(ORR),disease control rate(DCR),overall survival(OS),and safety. Results In total,29 patients were included(HAIC-monotherapy,n=9;HAIC-multitherapy,n=20). A proportion of 10.34% of patients received surgery after HAIC-based therapy were all HAIC-multitherapy group. OS,ORR,and DCR of all patients were 15.9 months [95%CI=(11.4,20.3)],34.45% and 89.66%,respectively.There was no significant difference in OS,ORR,and DCR between HAIC-monotherapy and HAIC-multitherapy groups.Subgroup analysis showed that patients with CNLC Ia-IIa,initial treatment,and AFP≤200 ng · mL^-1 had higher ORR significantly(Ⅰa-Ⅱa vs. Ⅱb-Ⅲa 80.00% vs. 25.00%,P=0.036;initial treatment vs. non-initial treatment 52.94% vs. 8.33%,P=0.019;AFP≤200 ng·mL^-1 vs. AFP>200 ng·mL^-1 58.33% vs.16.67%,P=0.045).The most common HAIC-related adverse reaction was anorexia. And the grade 3-4 adverse reactions accounted for 19.35%,which mainly manifested as liver injury and thrombocytopenia. Conclusion HAIC-based therapy for patients with unresectable hepatocellular carcinoma has satisfactory efficacy and acceptable adverse reactions.

Objective To understand changes in the treatment cost of anti-Parkinson's disease drugs in clinic and to explore differences of the clinical efficacy and cost between monoamine oxidase B inhibitors (MAO-BI) and dopamine receptor agonists (DAs) in delaying the progression of Parkinson's disease. Methods The prescriptions of medicines for Parkinson's disease in outpatients of 30 hospitals in China from 2014 to 2019 were statistically analyzed,and the per capita yearly drug payment amount,per capita yearly drug intake,and average daily treatment cost of anti-Parkinson's disease drugs were summarized.In addition,the typical treatment schemes of two medications for delaying the progression of Parkinson's disease (DAs and MAO-BI) were analyzed for cost-effectiveness. Results A total of 8420 patients with Parkinson's disease were included in this study;prescription analysis results showed that the per capita yearly drug intake and the per capita yearly drug payment amount decreased by 14.0% and 18.2% from 2014 to 2019,respectively.On the other hand,the proportion of prescription payment and the ratio of drug selegiline intake increased by 268.8% and 317.2%,respectively,and the average daily treatment cost was 3.68 CNY/day.The results of the cost-effectiveness analysis showed that compared with the control group,the average time of adding the third class of drugs into the compound levodopa combined with the MAO-BI group was prolonged by 60.57 days,and the average daily treatment cost was reduced by 16.20 CNY per day (P<0.05). Conclusion The per capita treatment cost of anti-Parkinson's disease drugs in patients decreased continuously from 2014 to 2019,and the proportion of prescription payment and drug intake of MAO-BI are increasing.Meanwhile,the average daily treatment cost is decreasing.The addition of MAO-BI to the compound levodopa has apparent advantages over the addition of dopamine receptor agonists in delaying the use of the third anti-Parkinson's disease drug and reducing the average daily treatment cost.

Objective To summarize the packaging standard system and its development in European Pharmacopoeia, and to provide reference for the establishment and optimization of the pharmaceutical packaging standard system in China. Methods The structure of the packaging standard system and the contents of the standards in European Pharmacopoeia were analyzed, the relationship between the standards was compared,and the applicability of the relevant strategy was evaluated. Results The packaging standard system in European Pharmacopoeia has remained relatively stable and been continuously improved in line with the needs of development.The standards of materials were of distinctive characteristics, and the suitability and operability of the standards are reasonably balanced. Conclusion The expectation management of packaging standards and the management policy of materials and accepted additives in European Pharmacopoeia are of great reference value to the construction of the pharmaceutical packaging standard system in our country.

Objective To study on the pharmaceutical packaging standard system and the latest progress in the United States Pharmacopoeia (USP),and to provide reference for the establishment and optimization of the pharmaceutical packaging standard system in China. Methods The structure of the pharmaceutical packaging standard system in USP and their contents were analyzed,the relationship among the packaging products standards,method standards,guidance for pharmaceutical packaging in USP were compared and analyzed. Results The pharmaceutical packaging standard system in USP is relatively complete,and the evaluation standards for pharmaceutical packaging materials have distinctive characteristics.The applicability of the standards is more comprehensively throughout the entire life cycle of pharmaceutical packaging material and pharmacopoeia forum updates periodically. Conclusion The relatively complete standards for pharmaceutical packaging materials in USP,mutually-supporting product standards plus evaluation standards throughout the entire life cycle of pharmaceutical packaging material are of great reference value to the construction of Chinese pharmaceutical packaging standard system.

Through literature review,questionnaire surveys,medical case analysis and other methods,Chinese Hospital Association Pharmaceutical Specialized Committee conducted research on the current status and development direction of pharmacy administration and pharmacy practice in healthcare institutions,summarized systematically the key issues in the fields of pharmacy practice,pharmaceutical supply services and pharmacy administration in healthcare institutions,studied relevant domestic and foreign literature in recent years,referenced existing domestic laws,regulations and rules,as well as domestic and foreign standards,and ultimately established a group standard system framework.The group standard system was named “Pharmacy administration and Pharmacy practice in Healthcare institutions”,and included 51 volumes in four parts,which were general principles,pharmacy practice,pharmaceutical supply services and pharmacy administration.

Objective To formulate a pharmaceutical service pathway to standardize the pharmacists' whole process of pharmaceutical services for breast cancer patients in medical institutions,promote the standardization of pharmacists' work and improve the rationality of drug use for breast cancer patients in medical institutions. Methods The editorial committee aimed at several challenging problems in the whole process of pharmaceutical services for breast cancer patients in medical institutions through systematic search,referring to the latest domestic and international guidelines and expert consensus of breast cancer and under the relevant drug administration regulations in China,collected and sorted out the professional opinions of doctors,pharmacists,and methodological experts,developed questionnaires and held two rounds of expert argumentation meetings,and finally screened out the most valuable results.The whole process management pathway of pharmaceutical care for breast cancer patients was formulated,and the referral principles of hospitals at different levels and the contents of pharmacist training and assessment were clarified. Results The whole process management pathway of pharmaceutical services for breast cancer patients was developed,including information collection,analysis,evaluation,development implementation of intervention plans,and follow-up. Conclusion This pharmaceutical service pathway can standardize and guide pharmacists in hospitals at different levels to carry out pharmaceutical services for breast cancer patients,achieve the whole process of monitoring drug use,and ensure rational drug use and treatment effectiveness for patients.

Tumor-associated macrophages (TAMs) are essential parts of the tumor microenvironment and play a vital role in the occurrence and development of tumors.TAMs-targeted immunotherapy is one of the frontiers and hotspots of tumor therapy.Nano-drug-loaded systems provide new ideas and directions for targeted regulation of TAMs due to their enhanced permeability and retention(EPR ),intelligent response,targeted modification,and co-delivery of different drugs.This article briefly reviewed the new drug-loaded nanosystems for targeting TAMs.

自2019年末新型冠状病毒肺炎(COVID-19)暴发以来,世界各国政府和科学工作者全力以赴,致力于开发各种防控疫苗、生物制剂和化学治疗药物,但随着新型冠状病毒(SARS-CoV-2)基因突变后新病毒株的不断涌现,其毒力和传播能力比最初的病毒株更加强劲,成为危害全球人类身心健康的严重传染疾病。当地时间2021年11月22日,美国食品药品管理局(FDA)紧急授权批准美国辉瑞制药公司治疗COVID-19新药奈玛特韦(nirmatrelvir)片联用病毒蛋白酶增强药利托那韦(ritonavir)片共包装盒Paxlovid^®上市,用于治疗SARS-CoV-2轻至中度成人和≥12岁、体质量≥40 kg的儿童,及具有较高重症风险的患者人群。Ⅲ期临床试验初步结果显示,与安慰药相比,在症状出现3 d内接受治疗的患者,任何原因导致住院和死亡的风险可降低89%。该文对奈玛特韦片合用利托那韦片共包装盒Paxlovid^®的非临床和临床药理毒理学、临床研究、不良反应、适应证、剂量与用法、用药注意事项及知识产权状态和国内外研究进展等进行介绍。

Objective To provide medical institutions with occupational exposure risk prevention and control strategies for cytotoxic drugs.Enhance the protective awareness of medical personnel and reduce potential occupational exposure risks. Methods The World Health Organization (WHO) guideline formulation manual was used to study and design the guidelines for the hierarchical control and protection of occupational exposure to cytotoxic drugs.Guide writing group collect exposure risk problems in various links such as the allocation and use of cytotoxic drugs after entering the hospital retrieval through systematic retrieval.The Delphi method was used to construct identify clinical issues, and evidence-based research methods were used to develop relevant evidences.The Delphi method was used to survey experts and identify clinical issues.Literature research and expert experience methods were utilized to compile relevant evidences.Quality evaluation was conducted using the GRADE method, and consensus was reached on the recommendation opinions and evidence levels through Delphi method.Ultimately,the “Guidelines for Prevention and Control of Occupational Exposure Risks to Cytotoxic Drugs in Medical Institution” was formulated. Results Through the online questionnaire survey of 143 experts, the Delphi method was used to reach a consensus on the guidelines.By combining engineering control, administrative control and personal protective equipment at different levels, a graded control approach was established.A total of 37 clinical issues were finally determined through hierarchical management and control, resulting 36 recommendations. Conclusion The guidelines covers seven steps after cytotoxic drugs enter the hospital, including transportation, reception, storage, unpacking, dispensing, finished product use, and waste treatment,which provide reference for medical institutions to develop cytotoxic drugs related prevention and control measures.Therefore, the possibility of occupational exposure to cytotoxic drugs could be reduced and the safety of medical personnel could be protected.

Objective To analyze the current status of medication therapy management (MTM) against the background of “Internet+” in China,to reveal its research hotspots and development trend through visual methods,and to provide a firm reference for promoting innovative pharmaceutical development and the transformation of pharmacists. Methods Using CiteSpace 6.2 R2,368 Chinese studies from the CNKI,CBM,and VIP databases were collected and analyzed. Relevant graphs were drawn,and the results were analyzed through post-trend,cooccurrence,cluster,and burst analysis. Results The number of articles issued in China's “Internet+” MTM field is on the rise. However,the cooperation network between authors and research institutions is relatively scattered. The research team led by tertiary hospitals has played an essential role in this field,but the medical consortium has not fully utilized its advantages. In addition,informatization and pharmacists are the research objects of continuous concern,while quality of life and diabetes are recent research hotspots. Conclusion “Internet+” MTM is a new medical service model involving multiple disciplines and fields.In this paper,CiteSpace 6.2 R2 performed a visual analysis of the literature on “Internet+” medication therapy management in China,revealing the research status,concerns,and development trends in this field,which has specific reference value for relevant policy formulation and research.

Objective By analyzing the evolution of China's national pharmaceutical packaging material standards,the significance of pharmaceutical packaging material standards in ensuring drug safety,effectiveness,and accessibility is summarized,providing a reference for constructing the national pharmaceutical packaging material standard system. Methods Through reviewing the development process of national pharmaceutical packaging standards in China's pharmaceutical industry at different stages and under different regulatory models,the experience and shortcomings of establishing a national pharmaceutical packaging standard system in China were summarized. Results The national pharmaceutical packaging materials standard system in China has been closely followed by the development and regulatory needs of the pharmaceutical industry,continuously enhancing its connotation and sublimated its concept;The national pharmaceutical packaging material standard is an important guarantee for promoting the high-quality development of the pharmaceutical packaging material industry.The standard system of pharmaceutical packaging materials can effectively improve the quality of pharmaceutical packaging materials and ensure the safety,effectiveness,and accessibility of drugs only if it follows the changes of the new situation and constantly improves itself. Conclusion Drawing on the development trend of domestic and foreign pharmaceutical packaging materials and related field standard systems,establishing risk management concepts and full process management concepts based on ensuring drug safety and effectiveness,and accelerating the construction of a scientific,advanced,practical,and standardized national pharmaceutical packaging material standard system is an important task in the construction of Chinaese national pharmaceutical packaging material standard system.

Objective To conduct data mining on adverse events (AEs) of lorlatinib, and to explore the risk factors of serious AEs. Methods The FAERS database was searched,and the openFDA data platform was used to collect the report information of AEs induced by lorlatinib from listing to March 31,2022.Grouped according to severity,the risk factors of severe AEs caused by lorlatinib were analyzed by univariate analysis and a modified Poisson regression model. Results A total of 1 986 lorlatinib AEs were reported,including 1 468 serious AEs (73.92%).One hundred and three AEs signals were detected.According to the frequency of occurrence,the number of edema reports was the most (49 cases),and according to the signal intensity,the signal of migratory superficial thrombophlebitis was the strongest [ROR=214.689,95%CI=(88.065,523.376)],moreover,none of them was mentioned in drug instructions.Modified Poisson regression analysis showed that the risk factors for the development of severe AEs were the combination of drugs with CYP3A enzyme system interactions [RR=1.148,95%CI=(1.009,1.305)],and low body weight [RR=0.997,95%CI=(0.994,1.000)],however,other symptomatic medications were the protective factors [RR=0.680,95%CI=(0.493,0.938)]. Conclusion It was recommended that clinicians and pharmacists should pay more attention to the signals not mentioned in the instructions of lorlatinib,strengthen the management of patient combination drugs and nutrient metabolism,avoid the occurrence of serious AEs,and ensure the safety of the patient's medication.

Objective To analyze the problems of review of anti-tumor drug prescriptions and medical orders assisted by an information system to improve the review rules,and to provide a reference for improving review quality of anti-tumor drug prescription. Methods The problem with the pre-review of anti-tumor drug prescriptions and medical orders assisted by the information system in Sichuan Cancer Hospital during 2020-2022 were collected.The data came from the MEDICOM PASS system in Sichuan Cancer hospital.Clinical pharmacists made comments on relevant problems and analyzed the results. Results A total of 9 325 antitumor drug pre-approval problems,including 6 279 outpatient prescriptions (67.3%) and 3 046 inpatient orders (32.7%),among which 6 153 (66.0%) were unsuitable indications,1 933 (20.7%) were drug contraindications,449 (4.8%) were problematic routes of administration,345 (3.7%) were unsuitable drug compatibility,177 (1.9%) were inappropriate drug frequency,133 (1.4%) were problematic drug populations,74 (0.8%) were unsuitable single doses,39 (0.4%) were unacceptable drug interactions,22 (0.2%) were unsuitable drug total.The results of clinical pharmacists' comments were 4 459 reasonable cases,with a false positive rate of 47.8%.The false positive problems included 2 264 (50.8%) cases of unsuitable indications,1 933 (43.3%) cases of drug contraindications,231 (5.2%) cases of problematic routes of administration,and 31(0.7%) cases of unsuitable populations. Conclusion The review of anti-tumor drug prescriptions assisted by an information system can effectively intercept irrational drug use and improve the review quality of prescriptions and medical orders.However,the evidence-based medicine date of antitumor drugs is updated quickly.Pharmacists should constantly improve the prescription review rules based on the latest evidence-based medicine data.

2021年11月26日,世界卫生组织(WHO)召开紧急会议向全世界通报,一种令人担忧的新型冠状病毒(SARS-CoV-2)变异株正在世界各地传播,各国亟需采取应对措施。WHO定性为最高级别的、值得关切的“变异株”(variants of concern,VOC),并命名为奥密克戎(omicron),距离该变异株被发现仅2 d时间。已观察到奥密克戎在支气管中感染速度和繁殖速度比SARS-CoV-2德尔塔变异株及SARS-CoV-2原始毒株快70倍,传播力为德尔塔的3~4倍。至2022年2月24日,时隔3个月,WHO最新实时统计指出,自SARS-CoV-2暴发以来,已扩散至全球各个角落,累计确诊新型冠状病毒肺炎病例4.30亿例,死亡近97万人,95%以上是由德尔塔和奥密克戎变异株感染引起的。全球范围内已有超过100多个国家发现奥密克戎新变异毒株BA.2,其传染性比奥密克戎高30%,患者临床症状更严重,成为危害全球人类身心健康的严重传染疾病的病原体,可使多种疫苗的防疫机制失效。美国当地时间2021年11月23日,美国食品药品管理局(FDA)紧急授权,批准美国默克制药集团公司(除美国和加拿大外,均称为默沙东制药公司)与美国Ridgeback公司合作开发的第3款治疗COVID-19新药:莫努匹韦(molnupiravir)胶囊上市,商品名lagevrio^®。根据Ⅲ期临床试验研究的中期分析,莫努匹韦胶囊治疗SARS-CoV-2轻至中度成人和≥12岁,体质量≥40 kg的儿科患者,及具有较高重症风险的住院人群,推荐剂量为每12小时口服莫努匹韦胶囊800 mg(4粒),连续服用5 d。可使住院率或死亡风险率减低约50%。该文对莫努匹韦(商品名:lagevrio^®)胶囊的非临床和临床药理毒理学、临床研究、不良反应、适应证、剂量与用法、用药注意事项及知识产权状态和国内外研究进展等进行介绍。

Since the U.S.FDA approved the first deuterated drug,deuterated drugs have gradually become a research hotspot,because they can reduce metabolic efficiency,effectively prolong drug half-life,reduce the frequency of drug use and improve compliance.And they have the advantages of short research time,low cost and patent recognition.The problem that has long restricted the development of deuterated drugs is the detection method.Therefore,this paper summarized the detection methods and prospected the future development of the deuterated drug.

Objective To provide a comprehensive evaluation framework for assessing the value of clinical pharmacy services, and to offer guidance for improving and optimizing the provision of clinical pharmacy services. Methods The World Health Organization (WHO) handbook for guideline development were used for the research design of the evaluation system guidelines. The Delphi method was used to identify clinical questions. The secretariat conducted systematic searches and collected existing evidence for the identified questions. Systematic reviews and evidence grading were performed,and evidence summaries were created. Based on the analysis report from the secretariat,the writing group developed specific guidelines. The Australian Joanna Briggs Evidence Level System, and the Grading of Recommendations Assessment,Development,and Evaluation (GRADE) system recommended by the World Health Organization in 2004 were used to grade the quality of evidence for this guideline. Consensus on recommendations and evidence grading was reached through a Delphi process. Finally,the practice Guidelines for the Value Evaluation of Clinical Pharmacy Services (First Edition) were established. Results More than 100 experts participated in the voting process by the Delphi method,and 23 value indicators for assessing the value of clinical pharmacy were included in the guidelines. The included indicators were searched and relevant systematic reviews,meta-analyses,network meta-analyses,and original studies were identified following the PICO principle. The Guideline Development Committee reviewed each search strategy. Consensus was reached on the definition and content of the included indicators,and 20 recommendations for the value assessment of clinical pharmacy were determined. Conclusion This guideline provides a set of indicators for measuring the quality and effectiveness of clinical pharmacy services,which is of great significance for improving the quality of clinical pharmacy services.

Objective To construct the Internet+ intelligent pharmaceutical care pathway management model in the Pharmacist-managed cough and wheeze clinic of pulmonary and critical care medicine (PCCM) and evaluate its work result. Methods A total of 300 patients with asthma and COPD diagnosed in the outpatient clinic of PCCM in the First Affiliated Hospital of Soochow University from September 2020 to March 2021 were selected, and randomly divided into a control group and intervention group with 150 cases in each group.The control group received routine pharmacy services;The intervention group was included in the Internet+ intelligent pharmaceutical care pathway management in the pharmacist-managed cough and wheeze clinic of PCCM,including patient information filing and consultation,pharmacy evaluation,pharmacy intervention(human intervention and intelligent intervention),medication education,patient follow-up,Internet+ pharmaceutical care.The study period was six months.The scores of inhalation device usage,medication compliance (MMAS-8),and clinical effective control rate were compared between the two groups in the third and sixth months after enrollment.After six months of enrollment,the number of acute attacks/exacerbations,incidence of adverse drug reactions,satisfaction with pharmacy services,and willingness to pay for the pharmaceutical care in the pharmacy clinic were compared between the two groups. Results At the third and sixth months after enrollment,the inhalation device usage score,and MMAS-8 score of the intervention group were significantly higher than those at the time of enrollment and the control group during the same period (P<0.05);The clinically effective control rate was significantly higher than the control group during the same period (P<0.05).After six months of enrollment,the number of acute attacks/exacerbations in the intervention group was significantly less than those at the time of enrollment,and in the control group during the same period (P<0.05),the incidence of adverse reactions was reduced by 9.87%,the satisfaction of the work quality and the patient experience were 91.83%,96.64%,and the proportion of patients willing to pay was 67.12%. Conclusion The Internet+ intelligent pharmaceutical care pathway management in the pharmacist-managed cough and wheeze clinic of PCCM could provide effective,safe,and professional pharmaceutical care for the patients,which is a beneficial exploration to develop high-quality pharmaceutical care in a standardized and homogeneous manner.