Background Health-related quality of life (HRQoL) in kidney transplant recipients (KTRs) is a key concern influenced by physiological, social, and cultural factors. However, yet commonly used assessment tools in previous studies do not adequately capture the unique sociocultural context of Chinese populations. The objective of this study was to assess the HRQoL in KTRs using the CQ-11D questionnaire and analyze factors associated with HRQoL to enhance the HRQoL of KTRs. Methods We conducted a cross-sectional study. Data were collected from two tertiary hospitals in Beijing and Changsha, China. Demographic and clinical data were collected using a structured questionnaire. The CQ-11D was used to measure HRQoL. Other scales, including the Constitution in Chinese Medicine Questionnaire (CCMQ), the Hospital Anxiety and Depression Scale (HADS), and the Pittsburgh Sleep Quality Index (PSQI), were used to assess TCM constitution, psychological distress, and sleep quality, respectively. Data were analyzed using IBM SPSS 26.0, including bivariate analysis, generalized linear models, and multiple regression analysis. Results A total of 215 KTRs were enrolled. The median CQ-11D health utility value was 0.918. There were differences across the 11 dimensions of the CQ-11D in KTRs. After the age of 40, the proportion of reported problems generally increased with age. This trend was particularly evident in dimensions such as SY, SM, and JS, where individuals over 50 reported significantly more problems than other age groups. The biased constitutions and poor sleep quality were associated with a higher likelihood of reporting problems in most CQ-11D dimensions. Factors such as sleep quality, TCM constitution, and regular exercise were significantly associated with HRQoL. Conclusion Sleep quality, TCM constitution, and regular physical activity were associated with HRQoL of KTRs. Healthcare professionals should prioritize interventions targeting these factors, especially in older KTRs and those with a biased constitution, to improve their HRQoL.

OBJECTIVE:Integration of traditional Chinese and modern medicine (TCM-MM) aids rehabilitation of muscle strength among ischemic stroke (IS) survivors. However, it faces statistical challenges (e.g., multicollinearity, small sample) in the real-world setting. This study tried to provide an analytical framework for investigating linear causality with a retrospective small-sample case series. METHODS:Original data was sourced from hospital information system and processed by many means. Wilcoxon signed-rank test was utilized to execute a self-controlled before-and-after comparison, before multiple linear regression (MLR) models were established for exploring prognostic factors of muscle strength improvement. Afterward, Bayesian networks (BN), mediation analysis and between-subjects effects tests were undertaken the detection of underlying multicollinearity sources progressively. Both clinical interpretability and model performance, containing R2 and mean squared error (MSE), served as the indices for modelling comparison. RESULTS:Muscle strength was significantly improved among 112 post-IS patients after accepting TCM-MM therapies (p < 0.01). Initially, MLR analysis with 11 explanatory variables (EVs) (MLR_1) revealed a probable multicollinearity-driven bias, resulting in reduced interpretability. Consequently, we traced collinearity among EVs using a BN structure that provided clues to mediating and mutual effects for establishing MLR with interactions embracing 11 EVs (MLR_2). Eventually, MLR_2 demonstrated superior model performance (ΔR2 = 0.097, ΔMSE = -0.004), and better clinical interpretability. Whereas, we cannot deny a 1/3 probability of diminished statistical efficacy due to the small sample size. CONCLUSION:Our study proposed a practically hybrid approach for exploring linear causality under multicollinearity using real-world small-sample data, which suggested that balancing model performance with clinical interpretability can resolve statistical trade-offs in modelling optimization.

Abstract Purpose This study aimed to assess the health-related quality of life (HRQoL) of the Chinese population by using the Chinese medicine quality of life-11 dimensions (CQ-11D) questionnaire and to identify factors associated with HRQoL. Methods The data was derived from a survey conducted by the Institute of Pharmacoeconomics Evaluation at Beijing University of Chinese Medicine on the quality of life of the Chinese population. The sex and age of respondents were considered through quota sampling. Demographic, socioeconomic, and health indicators were collected using the structured questionnaire. We performed bivariate analyses first to examine the associations between the above factors and the HRQoL of respondents measured by the CQ-11D. Multivariate linear regression and ordinal logistic regression models were established to analyze the factors (demographic, socioeconomic, and health indicators) differences in HRQoL, as well as the risk of each group reporting problems across the 11 dimensions of CQ-11D. Results From February 2021 to November 2022, a total of 7,604 respondents were involved and 7,498 respondents were included. The sample approximated the general adult Chinese population in terms of age, sex, and district of residence, and each geographic distribution ranged from 9.71 to 25.54%. Of the respondents, 45.84% were male, and 89.82% were Han ethnicity. The mean utility score ranged from 0.796 to 0.921 as age increased. According to the respondents, most health problems were identified in the PL (fatigue) (70.16%) and SM (quality of sleep) (63.63%) dimensions. The CQ-11D index scores varied with the demographic and socioeconomic characteristics of respondents, except for ethnicity (p > 0.05) and income (p > 0.05). The multivariate analysis revealed significant negative associations between health utility scores and various factors. These factors include sex (female), age over 65, belonging to ethnic minorities, rural household registration, being widowed or divorced, having a primary school education or below, being a student or unemployed, having a low income of 0–1,300, engaging in smoking or drinking, limited participation in physical activities, experiencing changes in self-perceived health status compared to the previous year, and having chronic diseases. The odds of respondents reporting problems in 11 dimensions varied among different socio-demographic groups. Conclusions This study reports the first Chinese population norms for the CQ-11D derived using a representative sample of the Chinese general population. Self-reported health status measured by the CQ-11D varies among different socio-economic groups. In addition to participation a physical activity and the presence of chronic disease, smoking and drinking also significantly influence HRQoL.

Objective: This research aims to evaluate the efficacy and safety of the Fuke Qianjin capsule combined with antibiotics in the treatment of chronic pelvic inflammatory disease, including the associated complications (endometritis and adnexitis). Methodology: We searched 4 Chinese and 3 English databases from their establishment to May, 2023. A randomized controlled trial (RCT) of the Fuke Qianjin capsule combined with antibiotics was included in the trial group. The meta-analysis used the RevMan 5.4 software provided by the Cochrane collaboration network. Results: A total of 103 RCTs were included, specifically 58 on chronic pelvic inflammatory disease, 6 on endometritis, and 39 on adnexitis (n= 9820, trial group n = 4925, control group n = 4895). The results of the meta-analysis demonstrated that the total effective rate of the Fuke Qianjin capsule combined with antibiotics in the treatment of chronic pelvic inflammatory disease (RR=1.21, 95%CI [1.18, 1.25], Z=14.86, p < 0.00001), endometritis (RR=1.22, 95%CI [1.13, 1.31], Z=5.31, p < 0.00001), and adnexitis (RR=1.26, 95%CI [1.23, 1.30], Z=16.49, p < 0.00001) was significantly better than that of antibiotics alone. Equally important, the relief time of clinical symptoms, the incidence of adverse reactions, and the recurrence rate (p < 0.05) were significantly lower than those of antibiotics alone. Conclusion: The Fuke Qianjin capsule combined with antibiotics was found to be superior to those in the antibiotic group alone. However, this conclusion necessitates further improvements, such as being supported by a greater number of high-quality and substantive research samples.

BackgroundRecent evidence indicates that Shexiang Baoxin Pill (MUSKARDIA), as an add-on treatment to standard therapy for stable coronary artery disease (CAD), is effective. Nevertheless, the cost-effectiveness of introducing the Shexiang Baoxin Pill (Abbreviation SBP) to the current standard treatment for patients with CAD in China remains unknown.ObjectiveThe objective of this study was to assess the cost-effectiveness of introducing SBP into the current standard treatment in China for patients with CAD.MethodThe effects of two treatment strategies-the SBP group (SBP combined with standard therapy) and the standard therapy group (placebo combined with standard therapy)-were simulated using a long-term Markov model. The simulation subjects might experience non-fatal MI and/or stroke or vascular or non-vascular death events. The study parameters were primarily derived from the MUSKARDIA trial, which was a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial. Furthermore, age-related change, event costs, and event utilities were drawn from publicly available sources. Both costs and health outcomes were discounted at 5.0% per annum. One-way and probabilistic sensitivity analyses were conducted to verify the robustness of the model. Based on the MUSKARDIA trial results, the risk with the events of major adverse cardiovascular events (MACE) was decreased (P < 0.05) in the female subgroup treated with SBP therapy compared with standard therapy. Consequently, a scenario analysis based on subgroups of Chinese females was conducted for this study. Incremental cost-effectiveness ratios (ICERs) were assessed for each strategy for costs per quality-adjusted life-year (QALY) saved.ResultsAfter 30 years of simulation, the SBP group has added 0.32 QALYs, and the cost has been saved 841.00 CNY. Compared with the standard therapy, the ICER for the SBP therapy was -2628.13 CNY per QALY. Scenario analyses of Chinese females showed that, after 30 years of simulation, the SBP therapy has been increased by 0.82 QALYs, and the cost has been reduced by 19474.00 CNY. Compared with the standard therapy, the ICER for the SBP therapy was -26569.51 CNY per QALY. Similar results were obtained in various extensive sensitivity analyses.ConclusionsThis is the first study to evaluate the cost-effectiveness of SBP in the treatment of CAD. In conclusion, SBP as an add-on treatment to standard therapy appears to be a cost-effective strategy for CAD in Chinese patients.

目的:儿童用药是当前全球临床需求面临的重要问题之一,推动儿童用药研发是监管方和工业界共同面对的问题.本文旨在进一步完善促进我国儿童用药的政策体系搭建并发挥其在药品注册体系中的作用.方法:通过总结当下国内儿童用药现状,梳理我国卫生相关部门已出台的针对性政策以及现阶段取得的成效,进一步提出我国儿童用药法规体系建设在药品研发领域的发展建议.结果与结论:我国儿童药物研发起步较晚,因药品研发成本高、周期长和利润回报率低等多重问题导致儿童用药在临床使用上存在问题.当前,在我国已出台的相关法规政策的促进下,儿童用药研发取得较好成果的同时还需加强相关积极政策的制订导向,建议相关部门结合我国特色,根据实际突显的问题及时进行法规政策体系调整优化.

Background China is facing an increasing number of chronic disease patients. Health-related quality of life (HRQoL) is an important indicator assessing the effect of prevention and treatment measures for chronic diseases, so it is important to select an appropriate HRQoL measurement tool for these patients. Objective To compare the validity, consistency and correlation of the Chinese Medicinal Quality of Life scale (CQ-11D) , Short-form 6-dimension version 1 (SF-6Dv1) , and the 3-level version of EQ-5D (EQ-5D-3L) in terms of utility values measuring HRQoL in chronic disease patients, and to identify a scale that is most applicable to Chinese chronic disease patients. Methods From February 2021 to April 2021, this study recruited the initial sample of Chinese people using quota sampling with quotas based on sex and age from a total of 28 representative provinces, autonomous regions or municipalities selected from seven geographical regions (north China, northeast China, east China, central China, southwest China, northwest China, and south China, with 2 to 6 selected from each of the regions) . A face-to-face survey was used to collect the sample people's basic demographic information and the situation of chronic diseases, and self-reported HRQoL measured using the CQ-11D, SF-6Dv1 and EQ-5D-3L, respectively, then according to the survey results, those with chronic diseases were selected, and the utility values of the three scales in them were analyzed. Bland-Altman chart and intraclass correlation coefficient (ICC) were used to analyze the consistency and correlation of the three scales. Kruskal-Wallis H test was used for univariate analysis to determine whether or not there is a statistically significant difference between the utility values of the scales across age or sex groups. Results A total of 692 chronic disease patients were finally included. The mean (standard deviation) of utility scores of CQ-11D, SF-6Dv1 and EQ-5D-3L scales were (0.855±0.168) , (0.793±0.132) and (0.876±0.136) , respectively. The top three prevalent chronic diseases were hypertension (n=275) , arthritis (n=128) and hyperlipidemia (n=124) . Histogram showed that EQ-5D-3L had obvious ceiling effect, and CQ-11D was more widely distributed. The Bland-Altman chart showed that the consistency between the three scales was relatively good, and the points within the 95% limits of agreement (LOA) were all about 95%. The strength of correlation between CQ-11D and visual analogue score (VAS) was the highest (P<0.001) . The ICC among the three scales ranged from 0.528 to 0.625, showing a moderate level of correlation (P<0.001) . Both Bland-Altman chart and ICC analysis showed that SF-6Dv1 and EQ-5D-3L had the best consistency. The results of analysis for the three chronic diseases in subgroups were similar to those in the total sample. Univariate analysis showed that male patients with hypertension or hyperlipidemia had higher utility scores of three scales than their female counterparts (P<0.05) . And the utility scores of three scales were the lowest in 60-year-olds and above among patients with hyperlipidemia. Conclusion The ceiling effect of EQ-5D-3L scale is obvious in patients with chronic diseases. CQ-11D demonstrated a wide range of distribution of utility values in measuring the three chronic diseases, which may be more suitable for measuring HRQoL in Chinese chronic disease population, as no ceiling effect was observed and its correlation with VAS was the strongest.

目的 基于系统评价对胆舒胶囊治疗慢性胆囊炎的有效性、安全性和经济性进行成本-效果评价.方法 检索中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、The Cochrane Library和Web of Science数据库中,关于胆舒胶囊的随机对照试验(RCT),检索时间为自建库起至2022年11月.使用RevMan 5.4软件对胆舒胶囊的有效性进行Meta分析,采用成本-效果分析法进行药物经济学评价,使用Treeage Pro软件对其经济性结果进行敏感性分析.结果 共纳入23项RCTs,其中8项RCTs为慢性胆囊炎,15项RCTs为慢性结石性胆囊炎.系统评价分析结果,胆舒胶囊比金胆片[RR=1.26,95％CI(1.10,1.45),P=0.000 9]、消炎利胆片[RR=1.26,95％CI(1.10,1.45),P=0.000 9]和熊去氧胆酸片[RR=1.29,95％CI(1.08,1.55),P=0.006]治疗慢性胆囊炎的总有效率更高;胆舒胶囊比消炎利胆片[RR=1.33,95％CI(1.24,1.42),P＜0.000 01]和胆宁片[RR=1.24,95％CI(1.06,1.44),P=0.006]治疗慢性结石性胆囊炎的总有效率更高.胆舒胶囊比消炎利胆片治疗慢性结石性胆囊炎的不良反应发生率更低[RR=0.24,95％CI(0.15,0.39),P＜0.000 01].成本-效果分析结果,胆舒胶囊与消炎利胆片、金胆片和熊去氧胆酸片相比治疗慢性胆囊炎的增量成本-效果比(ICER)分别是-0.64、0.31、-41.75;胆舒胶囊与消炎利胆片和胆宁片相比治疗慢性结石性胆囊炎的ICER分别是-43.96和-0.97.胆舒胶囊治疗慢性胆囊炎较对照药相比增加的成本完全值得,敏感性分析证实了结果的稳定性.结论 胆舒胶囊粒治疗慢性胆囊炎具有较好的有效性、安全性和经济性,可进一步通过开展前瞻性临床试验佐证研究结论.

罕见病用药是当前全球临床需求面临的重要问题之一,推动罕见病用药研发是监管方和工业界共同面对的问题.当前我国药品监管机构已出台了诸多政策,在实践中已取得了切实的成果,但我国罕见病药物研发整体起步较晚,在供给侧改革中尚需完善相关制度.本文对当下国内罕见病用药现状以及目前研发注册方面的激励政策进行了总结,结合部分法规中的薄弱环节提出相关建议,为未来我国罕见病用药政策制定提供参考.

Objective: The study aimed to examine the dose–response associations between night-sleep duration and depression risk in middle-aged and older adults.Methods: We searched PubMed, Embase, Web of Science, CNKI, VIP, and the Wanfang data knowledge service platforms from inception to 31 July 2022. Cohort and case–control studies assessing the relationship between night-sleep duration and depression were selected. We used the Newcastle–Ottawa scale to assess the quality of the published research. Two researchers carried out data extraction and quality assessment. The restricted cubic spline function and generalized least squares method were used to establish dose–response relationships between sleep duration and depression. We aimed to analyze the estimated effect size presented as the risk ratio (RR) and its 95% confidence interval (CI) using Stata 12.0.Result: Six cohort studies with 33,595 participants were included in this meta-analysis. A U-shaped association between sleep duration and depression risk was revealed. On one hand, compared with 7-h of night sleep, both shorter and longer sleep duration were associated with an increased risk of depression (5 h: risk ratio = 1.09, 95% confidence interval = 1.07–1.12; 6 h: RR = 1.03, 95% CI = 1.02–1.04; 8 h: RR = 1.10, 95% CI = 1.05–1.15; 9 h: RR = 1.31, 95% CI = 1.17–1.47; 10 h: RR = 1.59, 95% CI = 1.31–1.92; non-linear test p < 0.05). On the other hand, an increased risk of depression with shorter sleep duration was observed in middle-aged and older people among the non-Asian population (5 h: RR = 1.09; 95% CI = 1.02–1.17), while both shorter and longer sleep duration can increase the risk of depression among an Asian population (5 h: RR = 1.10, 95% CI = 1.07–1.13; 6 h: RR = 1.04, 95% CI = 1.02–1.05; 8 h: RR = 1.09, 95% CI = 1.05–1.14; 9 h: RR = 1.35, 95% CI = 1.18–1.53; 10 h: RR = 1.70, 95% CI = 1.36–2.12).Conclusion: The lowest-risk onset of depression occurred among middle-aged and older people with 7 h of night sleep, which suggested that shorter and longer night-sleep duration might lead to an increased incidence of depression.Clinical Trial Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=344052, identifier 344052

Objective To explore generating a health utility value set for the Chinese medicine Quality of life-11 Dimensions (CQ-11D), a utility instrument designed to assess patients’ health status while receiving TCM treatment, among the Chinese population. Methods The study was designed to recruit at least 2400 respondents across mainland China to complete one-to-one, face-to-face interviews. Respondents completed ten discrete choice experiment with survival duration (DCE TTO ) tasks during interviews. The conditional logit models were used to generate the health utility value set for the CQ-11D using the DCE TTO data. Results A total of 2,586 respondents were invited to participate in the survey and 2498 valid interviews were completed (a completion rate of 96.60%). The modified conditional logit model with combing logically inconsistent levels was ultimately selected to construct the health utility value set for the CQ-11D instrument. The range of the measurable health utility value was -0.868 ~ 1. Conclusion The study provides the first utility value set for the CQ-11D among the Chinese population. The CQ-11D and corresponding utility value set can be used to measure the health utility values of patients undergoing traditional Chinese medicine interventions, and further facilitate relevant cost-utility analyses. The application of the CQ-11D can support TCM resource allocation in China.

目的 探讨我国2018-2022 年中成药的药物经济学研究现状,分析其中存在的问题并提出针对性建议.方法 对2018-2022 年已发表的国内外中成药药物经济学文献进行系统分析,根据制定的纳排标准对纳入的研究文献进行系统评估和质量评价.结果 共纳入中成药药物经济学评价文献 164 篇,大部分研究文献角度不明确、评价方法较为单一;成本测算较为局限;敏感性分析不合理;总体质量较低.结论 我国中成药药物经济学评价文献质量总体偏低,在研究角度、评价方法和成本测算等各方面均存在一定的问题,提示目前中成药药物经济学的研究水平亟待提高.

BACKGROUND:An increasing number of women suffer from perimenopausal syndrome (PMS) and the global burden of this disease has been steadily rising. Acupoint application therapy and Chinese herbal medicine (CHM) are widely used as effective methods for treating PMS, but the efficacy was inconsistent and the evidence should be summarized by quantitively analysis.OBJECTIVE:The purpose of this systematic review and meta-analysis was to evaluate the clinical efficacy and safety of the acupoint application combined with the CHM for the treatment of PMS.METHODS:We searched eight databases from their inception to August 2022 to identify relevant studies. Only randomized controlled trials (RCTs) focusing on acupoint application combined with CHM for the treatment of PMS were included in this study. To assess the clinical efficacy and safety, meta-analysis was used to quantitively synthesize the effect estimates. Subgroup analysis, publication bias assessment and sensitivity analysis were also performed. We further assessed whether the included studies had reported on the purity and potency of the CHM used in their trials.RESULTS:A total of 8 RCTs with 560 participants were included in the systematic review and meta-analysis, of which none of them included a description of an independent testing of purity or potency of the CHM product used. There were significant differences between the acupoint application combined with CHM and CHM alone in terms of Kupperman Menopausal Index (KMI) score (MD = -2.91, 95%CI: -3.91 to -1.91), total effective rate (RR = 1.22, 95% CI: 1.11-1.34), Pittsburgh Sleep Quality Interview (PSQI) score (MD = -2.86, 95% CI: -3.61 to -2.10) and reduction in the serum level of luteinizing hormone (LH) (MD = -2.52, 95% CI: -4.70 to -0.34), whereas there were no differences between the two groups regarding lowering serum level of follicle-stimulating hormone (FSH) (MD = -1.66, 95% CI: -3.98-0.67) and elevating serum level of oestradiol (E2) (MD = 2.41, 95% CI: -0.70-5.52). For the comparation between the acupoint application combined with CHM and western medicine (WM), the KMI score (MD = -6.80, 95%CI: -7.95 to -5.65) was substantially different, while the PSQI score (MD = -0.60, 95% CI: -1.88-0.68) was not substantially different. The total effective rate in the combined group (91.7%) was higher than the western medicine group (83.49%).CONCLUSION:Acupoint application combined with CHM may enhance the efficacy and safety of patients with PMS. However, due to the lack of description of an independent testing of purity or potency of the CHM product used in the trials, as well as blinding of participants and investigators, these results should be interpreted with caution.

专利是保护药品创新最重要的方式,药品专利制度深刻影响着药品产业的发展.目前,在我国现行的药品管理制度以及专利法规中,已经正式引入了药品专利链接制度的规定,本文以我国首个药品专利链接诉讼案件为例,探求解析目前药品专利链接制度在我国的试行效果及对仿制药行业的影响,从而对仿制药企业在专利声明类型的抉择和资料的真实性方面给予建议,原研药企业则需要把握维权时机并在专利纠纷解决路径上谨慎选择,并基于我国国情的民行二元分立体制对专利纠纷早期解决途径的束缚和专利声明类型中尚需解决的问题,提出需要适时回顾分析专利链接制度的实施情况,提高行政裁决的法定地位,使其具有一定的确权属性,以及需要适当进一步细化专利声明类型,对不同情况的侵犯专利情形应加以规范等.

目的 系统评价妇科千金胶囊联合抗菌药治疗慢性宫颈炎的有效性和安全性.方法 计算机检索中文学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)、万方数据库(Wanfang Data)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、Embase和Web of Science数据库中妇科千金胶囊联合抗菌药治疗慢性宫颈炎的临床随机对照试验(RCT),检索时间从各数据库建库至2023年1月.采用Cochrane协作网提供的RevMan 5.4软件进行Meta分析.结果 共纳入18项RCTs,共计1 946例患者(试验组972例、对照组974例).Meta分析结果显示,妇科千金胶囊联合抗菌药治疗慢性宫颈炎的临床总有效率明显高于单独使用抗菌药[RR=1.23,95％CI(1.18,1.27),P＜0.000 01];白细胞介素-6水平[MD=-2.60,95％CI(-3.32,-1.88)]、超敏C反应蛋白(hs-CRP)水平[MD=-3.78,95％CI(-4.46,-3.09)]均明显低于单独使用抗菌药(P＜0.000 01);分泌物评分[MD=-0.74,95％CI(-1.05,-0.43)]、宫颈病变评分[MD=-0.89,95％CI(-1.07,-0.72)]均明显低于单独使用抗菌药物(P＜0.000 01);不良反应发生率与单独使用抗菌药物相比,组间差异无统计学意义[RR=0.78,95％CI(0.34,1.77),P=0.55].结论 妇科千金胶囊联合抗菌药物治疗慢性宫颈炎的临床疗效较好,在血清学指标、治疗后评分方面也有较好表现,亚组分析认为该结果稳健.但纳入文献较少,其中血清学指标、治疗后评分结局指标存在显著异质性,尚需要更多高质量、大样本、多中心RCT进一步验证.

This study was conducted to evaluate the efficacy and safety of Simotang Oral Liquid in the treatment of functional dyspepsia in adults. "Simotang Oral Liquid" "Simotang" "Si Mo Tang" "Si Mo Tang Oral Liquid" were used for retrieval of the relevant papers from CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Springer Link, and Web of Science from database inception to June 2021. Randomized controlled trial(RCT) of Simotang Oral Liquid in the treatment of functional dyspepsia in adults was screened out for Meta-analysis which was conducted in RevMan 5.3. A total of 16 RCTs were included. Meta-analysis showed that compared with the control group, Simotang Oral Liquid increased the total response rate and lowered the traditional Chinese medicine syndrome scores, serum cholecystokinin(CCK), serum nitric oxide(NO), and incidence of adverse reactions. However, the serum substance P(SP) had no statistical difference between the two groups. Simotang Oral Liquid is effective and safe in the treatment of functional dyspepsia in adults. However, this study has evidence and limitations, so the conclusions need to be further verified by large sample and multicenter clinical studies.

Purpose To measure health-related quality of life in the Chinese population using three universal health utility scales (CQ-11D, EQ-5D-5L, and SF-6D) and to compare the differences in the results obtained by the different scales to provide a reference for future utility on health-related quality of life in the Chinese population. Methods According to the Chinese population's distribution area, gender, and age, quota sampling was conducted. Three scales, CQ-11D, EQ-5D-5L, and SF-6D, whose results were self-reported, were collected in succession after collecting respondents' demographic information. The health utility value and floor/ceiling effect were explained. Bland–Altman was used to evaluate the consistency, the intraclass correlation coefficient was used to evaluate the correlation, and the receiver operating characteristic curve was used to evaluate the discriminative validity of the scale. Results The mean utility values of the CQ-11D, EQ-5D-5L, and SF-6D scales, respectively, were 0.891, 0.927, and 0.841. The floor effect did not appear in any of the three scales, but the ceiling effect did, and the EQ-5D-5L ceiling effect was the most severe. The limits of the agreement interval for CQ-11D versus EQ-5D-5L in the total sample population were (-0.245,0.172); for CQ-11D versus SF-6D, they were (− 0.256,0.354); and for EQ-5D-5L versus SF-6D, they were (-0.199,0.371). The consistency of the three scales is satisfactory overall. In the total population, the intraclass correlation coefficient between CQ-11D and EQ-5D-5L was 0.709, while EQ-5D-5L and SF-6D were 0.0.565 and that between EQ-5D-5L and SF-6D was 0.472. According to the subject operation curve results, the area under the curve for the total sample population of CQ-11D was 0.746, EQ-5D-5L was 0.669, and SF-6D was 0.734. Conclusion The CQ-11D is inferior to the EQ-5D-5L, but superior to the SF-6D. There is a strong correlation between the health utility values of the total population as measured by the three scales and those of the healthy population. The CQ-11D scale is the most sensitive to differences between populations and diseases.

目的:采用CQ-11D、EQ-5D-3L和SF-6Dv1 共3 种普适性健康效用量表,测量中国一般人群的健康相关生命质量并比较不同量表所得测量结果的差异,为中国人群健康相关生命质量研究提供参考.方法:依据中国一般人群分布区域、性别、年龄进行配额抽样,通过面对面调查收集受访者人口学特征信息,并依次收集CQ-11D、EQ-5D-3L和SF-6Dv1 共3 种量表的自报结果.选取其中未自报患慢性病的人群,描述其健康效用值情况,采用Tobit回归对健康效用值与主要人口学信息进行回归分析.结果:CQ-11D、EQ-5D-3L和SF-6Dv1 量表的效用值均值分别为0.926、0.951 及0.858.3 种量表测量结果两两比较的一致性可信区间分别为(-0.1096,0.1593)、(-0.0827,0.1523)及(-0.0691,0.1626),组内相关系数分别为0.503、0.329 和0.275.Tobit回归表明,性别与体育锻炼或健身活动均为3 种量表的显著影响因素,但目前家庭与婚姻状况、吸烟等特征对3种量表的影响均有区别.结论:CQ-11D量表测量值总体低于EQ-5D-3L量表,但高于SF-6D v1 量表.3 种量表测量所得一般人群健康效用值间的一致性较好,但相关性较低,不同量表间影响因素存在一定差异.

目的 基于Meta分析评价四磨汤口服液治疗小儿功能性消化不良、早产儿喂养不耐受和新生儿黄疸的有效性和经济性.方法 根据纳排标准进行文献筛选,通过适应证进行归类整理;利用RevMan 5.3软件进行Meta分析,采用成本-效果分析和最小成本分析法进行经济学评价.结果 共纳入18篇随机对照试验(RCT)文献;Meta分析结果显示,相对于对照组,四磨汤口服液组治疗小儿功能性消化不良、新生儿黄疸的临床效果更优;相对于常规治疗,四磨汤口服液联合常规治疗早产儿喂养不耐受的呕吐停止或缓解时间更短,住院时间更短,体重增长更优,差异均有统计学意义(P<0.05).经济性评价结果显示,与多潘立酮混悬液比较,四磨汤口服液治疗小儿功能性消化不良总有效率的增量成本-效果比(ICER)为0.35元;与常规治疗联合茵栀黄口服液比较,四磨汤口服液联合常规治疗联合茵栀黄口服液治疗新生儿黄疸总有效率的ICER为1.70元;与常规治疗相比,四磨汤口服液联合常规治疗早产儿喂养不耐受呕吐停止或缓解时间、住院时间的ICER分别为15.07元、2.70元.结论 四磨汤口服液治疗小儿功能性消化不良、早产儿喂养不耐受和新生儿黄疸有较好的有效性和经济性.

目的 探索构建中成药防治重大慢性病的药物经济学评价体系.方法 分析中成药防治重大慢性病药物经济学评价存在的问题,以问题为导向,探索可用于系统评价中成药防治重大慢性病的药物经济学理论、工具和方法,构建相关药物经济学评价体系.结果 与结论中医药防治重大慢性病有优势,这种独特优势需要在药物经济学评价中得到挖掘、体现和证明.中成药的药物经济学评价近年来获得了一定发展,但是中成药防治重大慢性病优势的药物经济学评价仍存在理论和方法学方面的不足,简单套用化学药的经济学评价指标及技术很难真实、全面地体现中成药的价值.应该围绕中成药药物经济学特有属性,挖掘中成药"治未病"和发挥人体自身调节作用的经济学价值指标,统筹考虑中成药药物经济学在研究设计、研究角度、目标人群、干预措施和对照选择、研究时限、评价方法等方面的特殊性,并通过系统建模、真实世界研究以及建立体现中医药特点的中医生命质量评价量表,全面、综合地反映中成药防治重大慢性病的经济学价值,从而更好地体现中成药防治重大慢性病的优势.