Ganoderma lucidum:a comprehensive review of phytochemistry,efficacy,safety and clinical study

Ganoderma lucidum,one of the most well-known edible fungi,is believed to be very beneficial for longevity and vitality.A long usage history suggests that G.lucidum has various clinical therapeutic effects.And experimental studies have confirmed that G.lucidum has multiple pharmacological effects,including antitumor,anti-microbial,anti-HIV protease,and antidiabetic activity and so on.With the deepening of research,more than 300 compounds have been isolated from G.lucidum.There is an increasing population of G.lucidum-based products,and its international development is expanding.Currently,G.lucidum has drawn much attention to its chemical composition,therapeutic effect,clinical value,and safety.This paper provides a comprehensive review of these aspects to enhance the global promotion of G.lucidum.

“Blind men and an elephant”:The need for animals in research,drug safety studies,and understanding civilizational diseases

Animal-based research and drug safety studies are essential to understanding the mysteries of nature and the long-term survival of humans.Due to the rapid increase in the global human population,conflict-and economically driven human migration,tourism-related activities,densely populated metropolitan areas,and local policies,humans will be affected by a multitude of novel disease-causing microorganisms and civilizational diseases.Despite disparities among countries,recent and planned changes in regulations concerning animal research and drug safety studies could have detrimental effects on both the animal research community and nations lacking sufficient social support systems.Based on existing scientific literature,I argue that we need animal research encompassing aspects such as animal development,behavior,drug safety studies,and for the understanding of future civilizational diseases.Depending on the nature of the research questions and local challenges,a suitable animal model organism should be made mandatory.

Efficacy and safety of Nafamostat mesylate in patients with endstage renal failure

BACKGROUND Recent studies on dialysis anticoagulation therapy in patients with renal failure have shown that Nafamostat mesylate,a broad-spectrum potent serine protease inhibitor,has strong anticoagulation and anti-fiber activity.AIM To evaluate the efficacy and safety of Nafamostat mesylate in patients with end-stage renal failure.METHODS Seventy-five patients with end-stage renal failure who received hemodialysis at our hospital between January 2020 and August 2021 were selected and divided into the observation group(Nafamostat mesylate for injection,n=33)and control group(heparin sodium injection,n=32).General patient data,indicators of clinical efficacy,dialyzer hemocoagulation parameters,coagulation function indices,and hemoglobin concentration and platelet count before and after treatment,and the occurrence of adverse reactions after treatment were compared between the two groups.RESULTS The two groups showed no significant differences in general patient data(P>0.05).The post-treatment effectiveness rate in the control group was lower than that in the observation group(P<0.05).The two groups showed no significant difference in the number of patients in grade I(P>0.05),while the number of patients in grade 0 was lower in the control group,and the number of patients in grades II and III was higher in the control group(P<0.05).The post-treatment prothrombin time,activated partial thromboplastin time,thrombin time,and international normalized ratio values in the control group were higher than those in the observation group,while the fibrinogen level in the control group was lower than that in the observation group(P<0.05).The two groups showed no significant difference in the platelet count and hemoglobin level before and after treatment(P>0.05).The total number of post-treatment adverse reactions in the observation group was lower than that in the control group(P<0.05).CONCLUSION Treatment of patients showing end-stage renal failure with Nafamostat mesylate can significantly improve therapeutic efficacy and has high safety and clinical value.

Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China

BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are etiological differences.This necessitates further real-world studies of lenvatinib across diverse populations,such as in China.AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy.Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1.Baseline characteristics and adverse events(AEs)were recorded throughout the entire study.RESULTS In total,54 HCC patients treated with lenvatinib monotherapy were included for final analysis.The objective response rate was 22%(n=12)with a progressionfree survival(PFS)of 168 d;however,AEs occurred in 92.8%of patients.Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage[hazard ratio(HR)0.465;95%CI:0.23-0.93;P=0.031],portal vein tumor thrombus(HR 0.38;95%CI:0.15-0.94;P=0.037)and Child-Pugh classifications(HR 0.468;95%CI:and specificity(83.3%)of decreasing serum biomarkers including alphafetoprotein were calculated in order to predict tumor size reduction.Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study.The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC.However,further analysis suggested that baseline characteristics,changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.

Systemic study on the safety of immuno-deficient nude mice treated by atmospheric plasma-activated water

Cold atmospheric-pressure plasma is a new technology, widely used in many fields of biomedicine,especially in cancer treatment. Cold plasma can selectively kill a variety of tumor cells, and its biological safety in clinical trials is also very important. In many cases, the patient’s immune level is relatively low, so we first studied the safety assessment of plasma treatment in an immunocompromised animal model. In this study, we examined the safety of immuno-deficient nude mice by oral lavage treatment of plasma-activated water, and studied the growth status, main organs and blood biochemical indexes. Acute toxicity test results showed that the maximum dose of plasma treatment for 15 min had no lethal effect and other acute toxicity. There were no significant changes in body weight and survival status of mice after 2 min and 4 min of plasma-activated water(PAW)treatment for 2 weeks. After treatment, the major organs, including heart, liver, spleen, lung and kidney, were not significantly changed in organ coefficient and tissue structure. Blood biochemical markers showed that blood neutrophils and mononuclear cells were slightly increased, and the others remained unchanged. Liver function, renal function, electrolytes, glucose metabolism and lipid metabolism were not affected by different doses of PAW treatment. The above results indicate that PAW treatment can be used to treat immuno-deficient nude mice without significant safety problems.

Assessment of knowledge,cultural beliefs,and behavior regarding medication safety among residents in Harbin,China

BACKGROUND Medication misuse or overuse is significantly associated with poor health outcomes.Information regarding the knowledge,cultural beliefs,and behavior about medication safety in the general population is important.AIM To conduct a survey on medication habits and explored the potential factors impacting medication safety.METHODS The current survey included adults from 18 districts and counties in Harbin,China.A questionnaire on medication safety was designed based on knowledge,cultural beliefs,and behavior.Both univariate and multivariate analyses were used to explore the factors that impacted medication safety.RESULTS A total of 394 respondents completed the questionnaires on medication safety.The mean scores for knowledge,cultural beliefs,and behavior about medication safety were 59.41±19.33,40.66±9.24,and 60.97±13.69,respectively.The medication knowledge score was affected by age(P=0.044),education(P<0.001),and working status(P=0.015).Moreover,the cultural beliefs score was significantly affected by education(P<0.001).Finally,education(P=0.003)and working status(P=0.011)significantly affected the behavior score.CONCLUSION The knowledge,cultural beliefs,and behavior about medication safety among the general population was moderate.Health education should be provisioned for the elderly,individuals with a low education level,and the unemployed to improve medication safety in Harbin,China.

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven&#174) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.

Safety Observation Study on Haemophilus Influenza Type B Conjugate Vaccines Injected at Different Sites in Chinese Infants

In the present study, the safety of Hoemophilus influenza type b conjugate vaccines inoculated in the upper arm deltoid and vastus lateralis muscle was evaluated. 680 infants aged 2-5 months and 6-12 months were selected to be the research subjects in whom the Hib conjugate vaccines were inoculated by injection in the upper arm deltoid and vastus lateralis muscle, respectively. The safety analysis indicated that there were no statistic differences in the incidence rates of adverse reactions when the Hib conjugate vaccines were inoculated at different sites. So we concluded that the safety of inoculation injection of Hib conjugate vaccines in vastus lateralis muscle was the same as that inoculated in the upper arm deltoid.

Applications and safety of gold nanoparticles as therapeutic devices in clinical trials

Use of gold nanoparticles(GNPs)in medicine is an emerging field of translational research with vast clinical implications and exciting therapeutic potential.However,the safety of using GNPs in human subjects is an important question that remains unanswered.This study reviews over 20 clinical trials focused on GNP safety and aims to summarize all the clinical studies,completed and ongoing,to identify whether GNPs are safe to use in humans as a therapeutic platform.In these studies,GNPs were implemented as drug delivery devices,for photothermal therapy,and utilized for their intrinsic therapeutic effects by various routes of delivery.These studies revealed no major safety concerns with the use of GNPs;however,the number of trials and total patient number remains limited.Multi-dose,multicenter blinded trials are required to deepen our understanding of the use of GNPs in clinical settings to facilitate translation of this novel,multifaceted therapeutic device.Expanding clinical trials will require collaboration between clinicians,scientists,and biotechnology companies.

Study and Countermeasures on Safety Control of Traditional Chinese Medicines Industry Chain

I'm very grateful to Chinese Pharmaceutical Association and DIA for their elaborate organization,so that we are able to participate in the Sino-Europe Symposium.Yesterday and today,several professors have talked about various aspects.It is true that the effectiveness of traditional Chinese medicine is important,and safety is equally important.For this reason,our laboratory works on the effective test,and at the same time,since 2001,we have been focusing on the safety of traditional Chinese medicines,especially the research on exogenous pollution.Today,I would like to share with you some of the quality control of the whole industry chain of traditional Chinese medicine and some of our thoughts.

Clinical Evaluation of the Safety and Efficacy of the Phytomedicine APIVIRINE Based on Aqueous Extracts of Dichrostachys glomerata (Forssk.). Chiov. (D. cinerea) in COVID-19 Patients without Signs of Severity

Background: Since the appearance of the COVID-19 pandemic, several drugs have also been proposed for the treatment of the COVID-19, but the therapeutic effectiveness of those drugs is not satisfactory. This situation has led to the search for therapeutic solutions based on recipes from traditional medicine. Aims: This study aimed to evaluate the clinical safety, efficacy and tolerability of the phytomedicine APIVIRINE in patients with non-severe COVID-19. Methods: Patients were included following defined criteria and followed on an outpatient basis until recovery in accordance with national guidelines for the management of single cases of COVID-19 in Burkina Faso. Vital signs, anthropometric parameters as well as electrocardiographic, hematological and biochemical examinations were measured on D4, D7, D14 and D21. Adverse events were recorded during maintenance. Results: The present study included 45 patients. The clinical signs present at inclusion were mostly cough (44.44%), asthenia (42.22%), headache (40%), and anosmia (35.55%). Dyspnoea and chest pain were less represented in 05 (11.11%) and 06 (13.33%) patients. Cough, dyspnoea, chest pain, fever, sore throat, headache, and nasal obstruction present at inclusion disappeared before Day 4 of treatment. Anosmia and asthenia disappeared before Day 7. At the inclusion visit (Day 1), CRP, WBC, and blood glucose were abnormal in 15 (33.33%), 13 (28.89%), and 11 (24.44%) patients respectively. In addition, 3 (6.66%) patients had elevated creatinine levels. Transaminases Alanine aminotransferase (ALAT) were elevated in 05 (11.11%) patients while Aspartate aminotransferase (ASAT) was elevated in 04 (8.89%) patients. After 4 days of treatment, the cure rate was 33.33% of patients and 48.89% after 7 days. The cumulative cure rate was 86.67% after 14 days of treatment. Conclusion: No serious side effects or allergic reactions were observed during treatment. No clinical complications were observed and all symptoms present resolved on the 7th day of treatment.

Analysis of Stopping Behavior at Rural T-Intersections Using Naturalistic Driving Study Data

Rural intersections account for around 30% of crashes in rural areas and 6% of all fatal crashes, representing a significant but poorly understood safety problem. Crashes at rural intersections are also problematic since high speeds on intersection approaches are present which can exacerbate the impact of a crash. Additionally, rural areas are often underserved with EMS services which can further contribute to negative crash outcomes. This paper describes an analysis of driver stopping behavior at rural T-intersections using the SHRP 2 Naturalistic Driving Study data. Type of stop was used as a safety surrogate measure using full/rolling stops compared to non-stops. Time series traces were obtained for 157 drivers at 87 unique intersections resulting in 1277 samples at the stop controlled approach for T-intersections. Roadway (i.e. number of lanes, presence of skew, speed limit, presence of stop bar or other traffic control devices), driver (age, gender, speeding), and environmental characteristics (time of day, presence of rain) were reduced and included as independent variables. Results of a logistic regression model indicated drivers were less likely to stop during the nighttime. However presence of intersection lighting increased the likelihood of full/rolling stops. Presence of intersection skew was shown to negatively impact stopping behavior. Additionally drivers who were traveling over the posted speed limit upstream of the intersection approach were less likely to stop at the approach stop sign.

Attitudes and actions of hospitalized patients on management of their safety：a cross-sectional study

背景与目的：患者参与在预防医疗实践相关不良反应和伤害中有举足轻重的作用,积极且成功的患者参与可有效降低不良反应与伤害的发生率.患者安全管理机构及卫生行政部门一致认为,患者参与自我医疗管理可显著预防医疗差错.然而住院患者对这一观点的态度和想法的实践转化情况仍然存争议.本研究旨在探析患者对参与自我医疗管理所持的态度及采取实际行动的情况,以及态度积极的患者是否更愿意将想法转化为实践.方法：本项横断面研究采用便利抽样法从汕头大学医学院两所附属教学医院招募了2052名患者.我们采用了包含7个条目的调查问卷调查研究对象对参与自我医疗活动所持的态度及采取实际行动的情况.本研究采用描述性分析和独立t检验比较分析了持积极和消极态度的患者采取实际行动的差异.结果：调查结果显示,多数患者对参与自我安全管理活动持积极态度,但较少将想法付诸实践.持积极态度的患者更有可能采取实际行动,但持不同态度的患者在诸如“嘱医生或护士洗手”与“嘱护士或医生确认您的身份”等方面的差异无统计学意义.结论：对参与自我安全管理活动持积极态度是提高患者参与自我医疗活动的重要因素.基于本次研究结果,我们认为需要采取针对性的干预措施以改变患者参与自我安全管理的态度,并学会如何实现想法的实践转化.此外,在制定干预策略时,还需要考虑患者的文化背景.

On the Danger of Threats Underestimating and the Resulting Unreliable Assessment of Building Fire Safety

The paper gives an example showing that the utilization of prescriptive rules in some situations can lead to strong underestimation of the real risks and inadequate fire safety assessment of buildings.The issue seems to be very important as the prescriptive rules in many European countries are the only allowed and acceptable by the authority’s method of building fire safety assessment.The building presented in this paper is an exemplary bakery plant consisting of several premises of a different purpose and method of use,e.g.:technical facilities,production depot,distribution and storage spaces,long-term storage cool rooms,etc.The whole building that consists of single-story technological(production and storage)part and(located on two stories)office parts was approved as a singular fire zone with a total usable area of 6280 m2.The technological area includes production facilities,storage depots of raw materials,packages and finished products,as well as cold stores and a number of auxiliary function rooms.In the second(having two stories)part of the building some social rooms,administrative areas and offices are localized.The total height of the building(at the highest point)does not exceed 10.5 m.Due to the Polish regulations the parameters determining the fire-related requirements of individual structural elements of the building(especially in terms of their fire resistance)are the surface area,the average value of the fire-load density and the presence of the risk of possible explosion.The building was designed based on the assumption that the average fire-load density does not exceed the level of 1000 MJ/m2.The analysis and calculations carried out during the exploitation phase of the building confirmed the compatibility with the assumptions adopted,but the actual volume,estimated at the level of 974 MJ/m2 proved to be very close to the limit value.Exceeding of the limit value of 1000 MJ/m2-due to provisions given in a state regulations-would automatically double the formal requirements for the resistance of the structural elements from R30 to R60.When assessing the real risk,especially in case of the large-surface-area buildings with varying ways of use of the premises,the average values of fire-load density may not properly reflect the real threat of fire.This is confirmed in the present facility,where in approximately 47%of the total area of the building the fire-load density doesn’t exceed 100 MJ/m2.Surfaces for which the fire load density exceeds 4000 MJ/m2(in extreme cases,it’s 5644 MJ/m2)represent only about 11%of the total area.It is worth mentioning that the fire-load density exceeding 4000 MJ/m2 due to the national regulations and codes of design would increase the criterion of structural resistance to R240.A completely separate issue is the fact that the oldest part of the building was completed in violation of some basic technical and construction requirements,so that the structure of this part of the building currently does not meet any criteria for fire resistance.This prompted the owner to implement some solutions that will not only lead the property to become fully consistent with the state regulations but also raise the level of security over the required standards,especially in the areas particularly vulnerable to fire.Presented case study shows that the adopted method of determining the requirements for fire resistance,especially based on the average value of fire-load density,in selected cases can lead to significant underestimations and result in incorrect assessment of a building fire safety.

护士高警示药品用药安全影响因素的质性研究

目的 :了解护士对高警示药品用药安全影响因素的认知体验,为护士更加安全有效地管理高警示药品提供参考。方法 :采用目的抽样法,选取不同科室的13名临床护士和护理管理者,以临床事件分析模型为理论框架,采用描述性质性研究方法对研究对象进行半结构式访谈和关键事件访谈,采用内容分析法对资料进行分析。结果 :构建了防止高警示药品错误实践的描述性模型——高警示药品用药安全:组织、护理与合作影响,提炼出组织因素、护士能力与责任、沟通合作3个主题和8个亚主题。结论 :护士高警示药品用药安全受到组织文化、自身知识与能力、医护患间沟通合作等因素影响。本研究为高警示药品用药安全管理实践提供了概念框架,同时也为医疗机构安全有效地管理高警示药品提供理论依据。

SAFETI在LPG储罐事故后果评价中的应用

分析了LPG危险特性及LPG储罐潜在的火灾爆炸危险性,运用SAFETI软件对某LPG储罐区的各类重大事故后果进行了定量评价,建立了针对性强的事故后果模型。该模型能客观准确地模拟与预测重大事故后果,获得事故危害程度的计算机模拟图表和报告等结果,可提供预测、预防事故发生的措施。

合并血小板减少症的非心源性轻型脑卒中患者早期抗血小板治疗的安全性研究

目的:探讨合并血小板减少症的非心源性轻型脑卒中患者早期接受抗血小板治疗的安全性。方法:从多中心登记数据库中纳入基线美国国立卫生研究院卒中量表评分3分及以下且血小板计数低于100×10^(9)/L的急性缺血性脑卒中患者,并排除需要抗凝治疗或存在其他抗血小板治疗禁忌证者。短期安全性结局为院内出血事件,长期安全性结局为1年全因死亡,短期神经功能结局使用出院时改良Rankin量表(mRS)评分进行评价。采用二元logistic回归分析模型分析抗血小板治疗对患者临床结局的影响。结果:最终共1868例合并血小板减少症的非心源性轻型脑卒中患者纳入本研究。多因素回归分析显示,相比未接受抗血小板治疗,单抗治疗可以显著提高患者出院时mRS评分0~1分的比例(OR=1.657,95%CI:1.253~2.192,P<0.01),且不增加颅内出血的风险(OR=2.359,95%CI:0.301~18.503,P>0.05)。而相比于单抗治疗,双抗治疗并没有带来更多的神经功能获益(OR=0.923,95%CI:0.690~1.234,P>0.05),反而增加了胃肠道出血风险(OR=2.837,95%CI:1.311~6.136,P<0.01)。对于血小板计数75×10^(9)/L及以下和90×10^(9)/L以上的患者,抗血小板治疗显著改善了神经功能结局(均P<0.05),而对于血小板计数为(>75~90)×10^(9)/L的患者,抗血小板治疗显著改善了1年生存曲线(P<0.05)。即使患者同时存在凝血功能异常,单抗治疗也未增加各种类型出血风险(均P>0.05),且能改善神经功能结局(均P<0.01)。对于单抗药物的选择,无论使用阿司匹林还是氯吡格雷,在各类出血事件、1年全因死亡风险以及神经功能结局上差异均无统计学意义(均P>0.05)。结论:对于合并血小板减少症的非心源性轻型脑卒中患者,抗血小板治疗仍是合理的,且单抗治疗相比双抗治疗神经功能结局改善效果相当、胃肠道出血风险更低。

仿制与原研左乙拉西坦注射用浓溶液疗效、安全性与经济性比较的真实世界研究

目的 比较国家集中带量采购中标药品左乙拉西坦注射用浓溶液仿制药与原研药的疗效、安全性与经济性。方法 回顾性收集带量采购政策实施后(2021年11月—2022年3月)首都医科大学宣武医院使用原研的左乙拉西坦注射用浓溶液的住院患者病历资料(原研药组)和皖南医学院第一附属医院(弋矶山医院)使用仿制的左乙拉西坦注射用浓溶液的住院患者病历资料(仿制药组),比较2组在预防和治疗癫痫方面的疗效、安全性及经济性。结果 原研药组和仿制药组治疗用药的患者分别纳入18,17例,有效率为50.00%和58.82%,均未发生药品不良反应,原研药组与仿制药组日均费用的中位数(四分位数间距)分别为255.00(255.00,510.00)元和131.78(131.78,131.78)元。倾向性评分匹配后,原研药组和仿制药组预防用药的患者各76例,有效率分别为97.37%和100.00%(P> 0.05),药品不良反应发生率均为0%,原研药组与仿制药组日均费用的中位数(四分位数间距)分别为170.00(170.00,170.00)元和131.78(131.78,131.78)元,差异有统计学意义(P <0.01)。结论 仿制与原研左乙拉西坦注射用浓溶液在预防癫痫方面的临床疗效基本一致,安全性相当,经济性优于原研药;治疗癫痫时,两药的有效率相近,但需进一步扩大样本量,验证结果。

仿制与原研注射用头孢呋辛钠治疗儿童支气管肺炎疗效、安全性及经济性比较

目的比较注射用头孢呋辛钠的仿制药与原研药治疗支气管肺炎患儿的疗效、安全性及经济性。方法通过医院信息系统档案数据库提取合肥市第二人民医院2019年1月至2022年12月收治的使用注射用头孢呋辛钠的支气管肺炎患儿的基本信息及临床资料,按用药的不同分为仿制组和原研组,以临床有效率和细菌清除情况评估疗效,以不良反应发生率评估安全性,将头孢呋辛钠费用视为药物治疗费以计算成本,并计算成本-效果比。结果采用倾向性评分匹配法按1∶2匹配后仿制组和原研组分别纳入104例和208例,两组的临床有效率、细菌清除情况及不良反应发生率均无显著差异(P>0.05);仿制组成本-效果比为2.26,远低于原研组的11.41。结论注射用头孢呋辛钠仿制药和原研药的疗效与安全性具有临床一致性,仿制药经济性更具优势。

基于真实世界的派安普利单抗临床应用及安全性分析

目的 探讨基于真实世界派安普利单抗的临床应用及安全性。方法 收集某肿瘤专科医院2022年4月至12月使用派安普利单抗的患者13例,回顾性分析其基本信息、临床诊断、用药信息等临床应用情况及安全性。结果 13例患者中,男女性别比为1∶1.6,年龄(61.1±14.5)岁,53.85%的患者合并慢性疾病。派安普利单抗在临床使用中存在超适应证(100.00%)、联用其他抗肿瘤药物(76.92%)等超药品说明书用药情况;药品不良反应(ADR)发生率为23.08%,其中,3级ADR 2例,分别为腹泻和肝功能损伤。结论 派安普利单抗发生的ADR与药品说明书中的ADR类似,应进一步扩大样本量,把握使用指征,确保安全、合理用药。