Evaluation of Effectiveness of Integrated Intervention Program in Improving Drug Addicts' Psychological Health

Objective To investigate the social mental state of drug addicts in a compulsive drug abuse treatment center; evaluate the effectiveness of integrated program for the prevention of abuse relapse and improvement of drug addicts＇ psychological health. Methods The study subjects were addicts from the Wuhan Compulsive Drug Abuse Treatment Center between October 2003 and June 2004, who satisfied the inclusion criteria. A non-randomized control-intervention study design was adopted. Volunteers willing to take part in intervention were put into the intervention group with their full awareness and willingness to prevent drug abuse relapse. The control group was composed of the addicts who were willing to prevent relapse and to be followed up after their discharge. Results The effectiveness of the integrated intervention program in promoting addicts＇ psychological health： before the intervention, the scores of Self-Rating Anxiety Scale （SAS）, the positive and negative dimensionalities of Simple Coping Style Questionnaire （SCSQ） and Chinese Perceived Stress Scales （CPSS） had no significant differences between the intervention group and the control group. After the intervention, except that the SCSQ＇s positive dimensionality in the intervention group was significantly higher than that in the control group, other indices in the intervention group were lower. Before and after the intervention, the psychological health level in both the groups was lower than that in the normal population; there were significant differences between addicts and normal subjects in regards with all of the indices above. Conclusion Drug abuse was associated closely with addicts＇ social mental factors. The integrated intervention program can alleviate anxiety and stress, reduce co-morbid mental disorders and effectively improve their coping style. In conclusion, the program can promote addicts＇ psychological health significantly.

Household Disposal and Recycling of Medication in Saudi Arabia: A Call for Introducing Drug Take-Back Programs

Background: Inappropriate disposal practices of medicinal products by households can harm nature. Alternatively, passing unused medications to friends and family members can have undesirable consequences as the quality of the product is in question. Objective: To investigate the disposal and recycling practices of medicinal products by households in Saudi Arabia. Methods: A cross-sectional questionnaire designed to investigate disposal and recycling practices aimed at households in Saudi Arabia. Phone interviews were conducted with healthcare providers from hospitals and community pharmacies as well as medical charity representatives. A thorough search (Jun-September 2020) for disposal and recycling policies was performed on the Saudi Food and Drug Authority (SFDA) and the Ministry of Health websites. Results: More than 900 participants were included in this study. Approximately 40% of respondents claimed to follow the SFDA recommendations for the disposal of unwanted medications in the wastebasket, whilst ≥6% preferred disposal via the toilet. On the other hand, 10% and 5% of households donated their unwanted over-the-counter and prescription-only medication products, respectively, to a person in need, without referring to healthcare professionals. Interviews with healthcare providers and medical charities revealed no drug take-back programs were currently available for households. The SFDA website provides a brief guide on the disposal of unwanted or expired medication. Conclusions: The absence of a clear drug disposal policy for households has created a gap allowing incorrect disposal practices that may lead to harming patients and/or the environment. The launching of drug take-back programs may lead to the provision of a clear consensus of governing bodies and healthcare providers on patient guidance for a safe drug disposal policy.

An Evaluation Synthesis of US AIDS Drug Assistance Program Policy

US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a federally-funded but state-maintained and managed program primarily concerned with providing medication for low-income HIV/AIDS patients. While ADAP programs across the country reached one-third of all patients in 2007, these programs are now in budgetary danger due to the economic recession, state budgetary constraints, the rising cost of healthcare generally, and longer life expectancies associated with current highly active antiretroviral therapy (HAART). This paper first evaluates the current state of ADAP, its strengths and weaknesses, and examines its sustainability in the short term if short-term measures are taken. Concluding that such measures would not lead to long-term sustainability, this paper then argues for a long-term solution to ADAP’s current problems, namely a national, centralized ADAP standard for budgetary and administrative matters. Such a program would increase the long-term sustainability and effectiveness of current ADAP programs by employing more efficient, standard policies and allowing larger, wholesale purchases of costly HAART medications. Moreover, a national policy would address the disparity that currently exists in ADAP programs today with regard to both minorities and those on the waiting lists for treatment. The institution of a national ADAP program would certainly face many political hurdles. Consequently, this paper also looks to a recent political dispute, the enactment of the Affordable Care Act (ACA), for guidance. Using the passage of the ACA as an example could light the path for passage of a national ADAP standard. Ultimately, this would lead to a more effective and sustainable program for HIV/AIDS patients in the United States.

Developing a school-based drug prevention program to overcome barriers to effective program implementation: The CLIMATE schools: Alcohol module

Although effective school-based alcohol prevention programs do exist, the overall efficacy of these programs has been compromised by implementation failure. The CLIMATE Schools: Alcohol Module was developed to overcome some of the obstacles to high fidelity program implementation. This paper details this development of the CLIMATE Schools: Alcohol Module. The development involved two stages, both of which were considered essential. The first stage, involved reviewing the literature to ensure the program was based on the most effecttive pedagogy and health promotion practice and the second stage involved collaborating with teachers, students and specialists in the area of alcohol and other drugs, to ensure these goals were realised. The final CLIMATE Schools: Alcohol Module consists of computer-driven harm minimisation program which is based on a social influence approach. The program consists of six lessons, each with two components. The first component involves students completing an interactive computer-based program, with the second consisting of a variety of individual, small group and class-based activities. This program was developed to provide an innovative new platform for the delivery of drug education and has proven to be both feasible and effective in the school environment. The success of this program is considered to be testament to this collaborative development approach.

美国食品监管架构改组情况分析及对我国特殊食品监管的启示

目的:拓宽国际视野,从国外食品安全监管实践中,寻找对我国具有参考价值和借鉴意义的经验和做法。方法:对美国食品药品监督管理局的食品监管职能概况、人类食品计划情况进行整理和介绍,重点就2022年“奶粉供应危机”导致的食品监管架构改组情况和改进措施开展分析,并结合我国特殊食品监管情况进行比对。结果:从我国特殊食品监管架构和法律要求切入,探讨对加强特殊食品监管的几点启示。结论:从强化有效协作、提升战略管理水平、加强技术支撑能力建设和信息化建设等几方面发力,有助于进一步提升特殊食品安全监管的现代化与科学化水平。

Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China

In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for U.S. pharmaceutical manufacturers as described in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug registration stages. Finally, some suggestions and implications are proposed to strengthen the construction of compliance management for Chinese drug registration applicants based on the former practical experience.

急性髓系白血病患儿柔红霉素耐药与PD-L1蛋白表达相关

目的研究急性髓系白血病(AML)患儿柔红霉素(DNR)耐药与程序性死亡受体配体-1(PD-L1)蛋白表达的相关性。方法选取2016年1月至2022年12月郑州大学附属儿童医院收治的110例AML患儿骨髓样本作为研究组,以50名骨髓正常供体骨髓样本作为对照组。培养人AML细胞系HL60、THP-1、U-937、Molm-13,Western blot检测PD-L1蛋白表达量。构建LV-PD-L1-shRNA、LV-PD-L1-WT-OE慢病毒载体,分析PD-L1对Molm-13细胞DNR耐药的影响及机制。结果研究组PD-L1蛋白表达量高于对照组,AML细胞系中PD-L1蛋白表达量高于健康骨髓单个核细胞(BMMC)(P<0.05),PD-L1表达与AML患儿白细胞计数、骨髓原始细胞比率、预后危险分层、两个标准化学治疗方案后疾病缓解情况有关(P<0.05)。PD-L1高表达组总生存率低于PD-L1低表达组(P<0.05)。与LV-PD-L1-WT-OE组比较,LV-PD-L1-shRNA组PD-L1 mRNA表达量降低、细胞增殖活性降低、凋亡率升高(P<0.05),LV-PD-L1-shRNA可提高Molm-13细胞对DNR的敏感性。TCGA数据库分析显示,6-磷酸葡萄糖脱氢酶(G6PD)可能为PD-L1潜在的目标基因。结论PD-L1在儿童AML中高表达,与患儿化疗耐药有关,其可能通过调控G6PD引起DNR耐药。

Estimating the Size of an Injecting Drug User Population

This article describes a sampling and estimation scheme for estimating the size of an injecting drug user (IDU) population by combining classical sampling and respondent-driven sampling procedures. It is designed to use the information from harm reduction programs, especially, Needle Exchange Programs (NEPs). The approach involves using respondent-driven sampling design to collect a sample of injecting drug users who appear at site of NEP in a certain period of time and to obtain retrospective self-report data on the number of friends among the IDUs and number of needles exchanged for each sampled injecting drug user. A methodology is developed to estimate the size of injecting drug users who have ever used the NEP during the fixed period of time, and which allows us to estimate the proportion of injecting drug users in using NEP. The size of the IDU population is estimated by dividing the total number of IDUs who using NEPs during the period of time by the estimated proportion of IDUs in the group. The technique holds promise for providing data needed to answer questions such as “What is the size of an IDU population in a city?” and “Is that size changing?” and better understand the dynamics of the IDU population. The methodology described here can also be used to estimate size of other hard-to-reach population by using information from harm reduction programs.

广州市“十二五”与“十三五”期间利福平耐药肺结核患者发现与治疗情况分析

目的:分析广州市“十二五”与“十三五”结核病防治规划期间利福平耐药肺结核(RR-PTB)患者发现与治疗情况,为进一步制定本地区RR-PTB防治规划提供科学依据。方法:通过“中国疾病预防控制信息系统”子系统“结核病信息管理系统”,按照登记时间导出2011年1月1日至2020年12月31日,即“十二五”(2011—2015年)和“十三五”(2016—2020年)规划期间广州市登记的肺结核患者耐药病案数据(包括性别、年龄、民族、职业、户籍、耐药类型、治疗分类等相关信息),筛选出利福平耐药患者病案,分析患者登记、人群特征、耐药筛查和治疗转归情况。结果:2011—2020年,RR-PTB患者年均登记率为0.71/10万(1152/16286.08万),从2011年的0.31/10万(42/1346.32万)上升至2015年的0.38/10万(60/1594.95万)和2020年的0.97/10万(182/1874.03万),呈逐年上升趋势(χ_(趋势)^(2)=256.395,P<0.001)。其中,“十二五”期间年均登记率为0.34/10万(250/7358.06万),不同年份登记率的差异无统计学意义(χ_(趋势)^(2)=4.674,P=0.322);“十三五”期间年均登记率为1.01/10万(902/8928.02万),不同年份登记率的差异有统计学意义(χ_(趋势)^(2)=38.439,P<0.001)。1152例患者中,以男性(851例,73.87%)、25~34岁青壮年(257例,22.31%)和家政家务及待业(364例,31.60%)为主;流动人口、初治、RR-PTB(除异烟肼耐药)、广泛耐药肺结核比例分别从“十二五”的8.80%(22/250)、11.20%(28/250)、0.00%(0/250)和0.00%(0/250)上升到“十三五”的54.43%(491/902)、37.14%(335/902)、19.84%(179/902)和0.78%(7/902),差异均有统计学意义(χ^(2)=91.370、298.740、97.915、34.096,P值均<0.001)。广州市耐药肺结核高危人群筛查率由2017年的60.91%(148/243)上升至2020年的98.95%(568/574),新发/初治病原学阳性肺结核耐药应筛查率由2018年的83.93%(1410/1680)提高到2020年的94.99%(3222/3392),差异均有统计学意义(χ_(趋势)^(2)=425.043、269.670,P值均<0.001)。纳入治疗、完成治疗和治疗成功的患者比例分别从“十二五”的81.20%(203/250)、2.46%(5/203)和45.81%(93/203)提高到“十三五”的91.02%(821/902)、33.62%(276/821)和67.48%(554/821),治疗失败患者比例从17.73%(36/203)降低至2.68%(22/821),差异均有统计学意义(χ^(2)=19.112、86.809、46.636、58.572,P值均<0.001)。结论:在“十二五”与“十三五”规划期间,广州市RR-PTB的防治工作取得了显著的成效。下一步工作中需继续坚持政府主导、多部门合作和全社会共同参与的原则,切实落实结核病防治规划要求,加强结核病防治服务体系建设。

生物制药(中外合作办学)专业药物代谢课程思政教育的探索

药物代谢课程是南京中医药大学生物制药(中外合作办学)专业的一门重要专业课,主要介绍药物在多种代谢酶的作用下化学结构发生改变的情况、影响药物代谢的因素以及药物代谢的研究方法。为了进一步落实高校立德树人的根本任务,本文从教学内容与学情分析、课程思政的建设和教学实施、课程考核与教学效果评价这三个方面,阐述了围绕药物代谢课程开展课程思政建设的概况以及在教育教学过程中的探索和实践。

中医药调控程序性细胞死亡干预肝纤维化的研究进展

肝纤维化(HF)是一种由于慢性肝损伤导致的肝组织结构异常修复的病理过程,其发病机制尚未完全阐明。相关研究表明,程序性细胞死亡可能与HF的发生有关,而中医药在调控程序性细胞死亡干预HF方面有着显著疗效。本文概述了程序性细胞死亡影响HF的主要机制,并从中医角度出发探讨中医药调控程序性细胞死亡改善HF的可能机制,为中医药防治肝纤维化提供新思路。

艾司西酞普兰联合运动方案对苯二氮[艹卓]类药物依赖焦虑症患者睡眠质量的影响

目的:探讨艾司西酞普兰联合运动方案对苯二氮[艹卓]类(BDZ)药物依赖焦虑症患者睡眠质量的影响。方法:选取2021年9月至2023年2月泉州市第三医院收治的BDZ类药物依赖焦虑症患者120例作为研究对象,按照抛掷法随机分为对照组(n=58)和观察组(n=62)。对照组仅予以艾司西酞普兰治疗,观察组予以艾司西酞普兰联合运动方案治疗。比较2组睡眠质量、失眠程度、负性情绪以及生命质量。结果:治疗后,观察组匹兹堡睡眠质量指数(PSQI)中主观睡眠质量、入睡时间、睡眠效率、睡眠障碍、日间功能5个维度评分及总分均低于对照组,差异均有统计学意义(均P<0.05),失眠严重程度指数(ISI)评分低于对照组,差异有统计学意义(P<0.05);观察组汉密尔顿焦虑抑郁量表(HADS)评分均较对照组低,差异有统计学意义(P<0.05),健康调查简表(SF-36)评分较对照组高,差异有统计学意义(P<0.05)。结论:艾司西酞普兰联合运动方案能明显提高BDZ类药物依赖焦虑症患者的睡眠质量,改善失眠症状,缓解负性情绪,提高生命质量。

程序性死亡受体1抑制剂治疗恶性黑色素瘤的不良反应及其影响因素分析

目的:分析程序性死亡受体1(PD-1)抑制剂治疗恶性黑色素瘤(malignant melanoma,MM)引起的不良反应临床特点及其危险因素,为安全用药提供参考。方法:采用回顾性分析法,收集我院126例MM患者使用PD-1抑制剂的临床资料,观察性别、年龄、疾病分期及有无基础疾病等一般资料对不良反应的影响,并对发生不良反应累及器官、临床表现、严重程度、发生时间、处理情况及转归等情况进行分析总结。结果:126例患者中有81例发生不同严重程度的不良反应,1~2级有64例(50.8%),3级以上有17例(13.5%),中位发生年龄56岁(6~84岁)。年龄、有无基础疾病、既往有无不良反应发生史及是否合并抗肿瘤药物增加了不良反应的发生,差异有显著意义(P<0.05)。发生率前5位的不良反应临床表现为甲状腺功能减退(27.78%)、三酰甘油(TG)升高(15.08%)、谷丙转氨酶(ALT)升高(13.49%)、恶心(11.90%)、瘙痒(11.90%)。不良反应发生时间较分散,其中肝毒性发生较早,甲状腺功能减退发生较晚。81例不良反应中有59例(73%)症状好转,24例(29.6%)患者接受糖皮质激素等免疫抑制剂处理,6例(7.41%)加用了其他免疫抑制剂。结论:PD-1抑制剂相关性不良反应多为轻度的,3级以上不良反应发生率低,可通过类固醇激素治疗后得到改善或治愈。高龄、合并基础疾病以及既往有药品不良反应史的患者可增加不良反应的发生,临床使用中应重点关注。

PD-1抑制剂及抗血管生成药物联合TACE治疗原发性肝癌的效果

目的探究程序性死亡受体-1(PD-1)抑制剂及抗血管生成药物联合经动脉化疗栓塞术(TACE)治疗原发性肝癌的效果。方法纳入原发性肝癌患者58例,均于2019年1月至2022年12月在河南省肿瘤医院就诊,按治疗方法将患者分为对照组(抗血管生成药物联合TACE治疗,30例)与研究组(PD-1抑制剂及抗血管生成药物联合TACE治疗,28例)。两组均治疗9周,比较其疗效、肝功能[碱性磷酸酶(ALP)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆红素(TBIL)]、血管内皮生长因子(VEGF)、可溶性血管细胞黏附因子1(sVCAM1)、免疫指标及不良反应。结果研究组疾病控制率(85.71%)较对照组(60.00%)高(P<0.05);两组治疗后ALP、ALT、AST、TBIL较治疗前低,且研究组较对照组低(P<0.05);两组治疗后VEGF、sVCAM1较治疗前低,且研究组较对照组低(P<0.05);研究组治疗后CD3^(+)、CD4^(+)、CD8^(+)较对照组高,CD4^(+)/CD8^(+)较对照组低(P<0.05);两组总不良反应发生率比较,差异无统计学意义(P>0.05)。结论PD-1抑制剂及抗血管生成药物联合TACE治疗原发性肝癌效果确切,可减少患者肝损伤,改善其免疫功能,且安全性较好。

德曲妥珠单抗治疗转移性乳腺癌的效果及安全性

目的探讨德曲妥珠单抗二线及以上治疗晚期乳腺癌患者的有效性及安全性。方法选取中国科学技术大学附属第一医院(安徽省立医院)肿瘤化疗科2023年3月至2024年3月收治的采用德曲妥珠单抗治疗的34例人表皮生长因子受体2(HER-2)阳性或低表达晚期乳腺癌患者的临床资料,回顾性分析患者的临床病理特征、客观缓解率、疾病控制率和不良反应发生情况。采用Fisher确切概率法比较组间差异。结果共入组女性34例,中位年龄55.5岁;25例为HER-2阳性,9例为HER-2低表达;治疗线数为2~10线,中位4线,客观缓解率为35.29%(12/34),疾病控制率为58.82%(20/34);其中三线以上及内脏危象的患者较早线和无内脏危象患者疾病控制率下降,差异有统计学意义(P<0.05)。不良反应主要为恶心、乏力、天冬氨酸氨基转移酶升高及骨髓抑制等,其中3级以上不良反应主要为血液学毒性包括白细胞减少、粒细胞缺乏、血小板减少、淋巴细胞减少及腹泻,其余均为1或2级不良反应。结论德曲妥珠单抗在晚期HER-2阳性或低表达乳腺癌中疗效确切,安全性较好,建议早期应用德曲妥珠单抗。

纳武利尤单抗药品不良反应文献分析

目的为及时识别与处理纳武利尤单抗所致药品不良反应(ADR)提供参考。方法检索PubMed、中国知网、万方、维普数据库中有关纳武利尤单抗ADR的个案报道,检索时限为各数据库自建库起至2021年12月。汇总分析出现ADR患者的临床信息(包括患者的一般情况、原患疾病,纳武利尤单抗使用剂量,ADR出现时间、累及系统/器官、临床表现、最终结局等)。结果共纳入文献600篇,涉及患者649例(发生ADR 679例次),其中男444例(68.41%),女205例(31.59%);患者年龄(63.41±12.63)岁;涉及原患疾病以非小细胞肺癌最多(219例、33.74%),其次为黑色素瘤(203例、31.28%)。纳武利尤单抗单药治疗505例(77.81%),用量高于或低于药品说明书要求的分别有4例和59例;联合用药144例(22.19%)。ADR主要发生在用药后6个月内,主要累及内分泌系统(105例次)、神经系统(95例次)、皮肤及其附件(84例次)等。临床症状自行缓解8例次(1.18%),对症处理后改善576例次(84.83%),发生致死性ADR 72例次(10.60%,主要累及心血管系统、神经系统、肌肉骨骼系统等)。结论纳武利尤单抗ADR发生以男性、60~79岁患者居多,多发生在用药后6个月内。其ADR累及多个系统,多数程度较轻,经临床治疗后可改善,但应特别注意心肌炎、重症肌无力、肌炎、移植排斥反应、免疫相关性肺炎等ADR,防止发生致死性ADR。

基于低代码开发平台构建药品盘点程序的实践与效果分析

目的 基于低代码开发平台构建药品盘点程序,利用信息化手段提升药品盘点工作效率。方法 利用低代码开发平台“简道云”,通过需求分析、建立表单、仪表盘、数据关联、配置角色和权限、移动端适配等步骤构建药品盘点程序。经过测试与优化后,以药品盘点时间和盘点误差率对系统应用后的效果进行评价分析。结果 基于低代码开发平台构建的药品盘点程序能够实现扫码录入、无纸化盘点、实时汇总等功能。程序应用后,药品初盘时间由(60.88±6.51)min缩短至(42.75±3.10)min(t=6.37,P<0.05),盘点误差率由7.16%下降至3.80%(χ^(2)=7.444,P<0.05)。结论 基于低代码开发平台构建的药品盘点程序能够简化药品盘点流程、缩短盘点时间、提高盘点准确率,有效提升了药品盘点工作效率。

2023年美国与我国批准新药的对比分析

目的:对2023年美国FDA批准的新药进行分析,并与我国2023年新药审批相关情况进行对比分析,以供业界参考。方法:通过查阅美国FDA CDER发布的《2023年新药审批总结报告》、我国药品审评中心发布的《2023年度药品审评报告》、Drugs@FDA数据库、国家药品监督管理局发布的药品批件及药品审评中心公开的上市药品信息,结合相关文献,收集并统计分析2023年FDA批准的新药信息,并与我国的相关情况做对比分析。结果与结论:2023年,FDA批准了55个新药,涵盖肿瘤、遗传/罕见病、神经系统疾病等多个疾病领域。51%的新药获得了孤儿药认定,36%的新药被认定为“first-in-class”,65%的新药审批至少使用了一种加速审评程序。获批新药的企业涵盖广泛,从大型制药巨头到中小型生物技术公司均有不同数量的新药获批。我国批准新药74个,疾病领域广泛性和多样性与FDA不相上下,但新药创新性及罕见病药物的开发有待提升。38%的新药审批至少使用了一种加速上市程序。新药审评用时比2022年减少,但一次性通过率降低,反映了监管的趋严性。药企需提升申报资料质量。监管部门需完善药品监管法规,加强药品监管人员的培训和教育,提升其专业水平和国际视野。

通过钉钉小程序分析肿瘤医院药品质量数据及对策讨论

目的加强肿瘤医院药品质量管理,提高药库管理药品质量的效率,确保患者用药安全。方法通过钉钉小程序的药品质量信息管理平台导出医院2023年药品质量信息反馈表,按药品种类、厂家性质、剂型、药品质量问题类型和科室进行归纳分析。结果出现质量问题最多的药品种类依次为消化系统药物、营养药和调节水、电解质和酸碱平衡用药。国产药品出现质量问题多于进口药品。出现质量问题最多的前3个剂型依次为注射液、小水针、粉针。出现质量问题最多的前3个类型依次为破损、漏液、变色。出现质量问题排名前3的科室依次为药学部、放疗科、生物治疗中心。结论应用钉钉小程序分析肿瘤医院药品质量数据,有效提升了医院的管理水平,后续药库需建立完整药品质量管理制度,确保药品质量安全,保障肿瘤患者治疗效果。

PD-1抑制剂联合抗血管生成药物治疗晚期NSCLC的疗效及安全性分析

目的探讨程序性死亡蛋白-1(PD-1)抑制剂联合抗血管生成药物治疗晚期非小细胞肺癌(NSCLC)的疗效及安全性。方法选取我院2019年1月至2021年11月收治的137例晚期NSCLC患者作为研究对象,按治疗方法分为两组。PD-1抑制剂联合抗血管生成药物治疗者81例(联合组),PD-1抑制剂单药治疗者56例(单药组)。统计分析两组客观缓解率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)、总生存时间(OS)、血管内皮生长因子(VEGF)、肿瘤体积(TV)、预后生存曲线及毒副反应相关数据。结果联合组ORR和DCR显著高于单药组,差异有统计学意义(χ^(2)=4.219,3.583;P=0.040,0.045);联合组PFS和OS均显著长于单药组,差异有统计学意义(Z=7.017,5.778;P<0.001);两组治疗后VEGF和TV水平均明显下降(P<0.001),且治疗1、2个周期后联合组VEGF和TV水平均显著低于单药组,差异有统计学意义(P<0.001);两组Kaplan-Meier预后生存曲线比较差异有统计学意义(χ^(2)_(L)=5.338,P=0.027);两组患者恶心呕吐、头疼、疲劳、腹泻、皮疹、贫血、便秘、呼吸困难及关节痛发生率和Ⅲ级以上毒副反应发生率比较,差异无统计学意义(P>0.05)。结论PD-1抑制剂联合抗血管生成药物可抑制肿瘤微血管增生,缩小TV,提高ORR和DCR,延长PFS和OS,Ⅲ级以上毒副反应发生率低,毒副反应总体安全可控,有助于增加晚期NSCLC患者获益。