Real-world treatment patterns and outcomes for patients with advanced hepatocellular carcinoma initially treated with PD-1 inhibitors.

BACKGROUND: Programmed cell death protein-1 (PD-1) inhibitors have shown promising clinical efficacy in treating advanced hepatocellular carcinoma (HCC). However, little evidence exists regarding their treatment patterns and outcomes in real-world practice in China. This study aimed to investigate real-world treatment patterns and outcomes of PD-1 inhibitors as first-line therapies for patients with advanced HCC in China. METHODS: The study population included adult patients with advanced HCC who were initially treated with PD-1 inhibitors from April 2020 to November 2022 in China. Descriptive statistics were used to report first-line treatment patterns and associations between patient characteristics and the most frequently used treatment patterns. The effectiveness of first-line treatment with PD-1 inhibitors was also evaluated according to survival and tumor response. RESULTS: The analyses enrolled 480 patients. The four most frequently used first-line treatment patterns of camrelizumab, tislelizumab, camrelizumab + TACE, and tislelizumab + TACE showed statistical differences in patient characteristics of gender, HBV infection, liver cirrhosis, BCLC stage, and portal vein tumor thrombus (all P < 0.05). However, there was no significant difference in median progression-free survival among the first-line treatments of tislelizumab, camrelizumab, and tislelizumab + TACE (not reached vs. 4.4 months vs. 3.6 months, P = 0.5178). The three groups had similar objective response rates (25.0 % vs. 28.6 % vs. 28.6 %, P = 0.927), and disease control rates (73.1 % vs. 78.6 % vs. 64.3 %, P = 0.573) with no statistical significance. CONCLUSIONS: Our findings provided insights into potential therapeutic strategies of PD-1 inhibitors in first-line settings for advanced HCC in real-world practice in China. It was recommended to consider patient characteristics associated with therapeutic options when making clinical decisions. Prospective randomized controlled studies with larger sample sizes and longer follow-up times were warranted further to verify the potential clinical benefits of PD-1 inhibitors.

Pharmacoeconomic evaluation of anti-obesity drugs for chronic weight management: a systematic review of literature.

Introduction: Pharmacological therapy is recommended as a second-line alternative to reverse obesity. Currently, five anti-obesity drugs (AODs) have been approved by the U.S. Food and Drug Administration (FDA) for chronic weight management. The aim of this paper is to investigate the pharmacoeconomic evaluation of AODs through a systematic review with a special focus on methodological considerations. Methods: We searched the general and specific databases to identify the primary pharmacoeconomic evaluation of AODs. Results: A total of 18 full-text articles and three conference abstracts were included in this review. Most of the economic assessments were still about Orlistat. And the observations we could make were consistent with the previous systematic review. A few studies were on the combined therapies (i.e. PHEN/TPM ER and NB ER) compared to different comparators, which could hardly lead to a generalized summary of the cost-effectiveness. Most recently, pharmacoeconomic evidence on the newest GLP 1 RA approved for the indication of obesity or obesity with at least one comorbidity emerged gradually. Modelling-based cost-utility analysis is the major type of assessment method. In the modelling studies, a manageable number of the key health states and the state transitions were structured to capture the disease progression. In particular, the principal structure of the decision model adopted in the three studies on the newly approved drug was nearly the same, which enables more in-depth comparisons and generalizations of the findings. Conclusion: This study provided an up-to-date overview of the strengths and areas for improvement in the methodological design of the pharmacoeconomic evaluation of the licensed drugs for chronic weight management. Future modelling evaluations would benefit from a better understanding of the long-term weight loss effects of the current therapeutic options and the weight rebound process after the discontinuation of treatment. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302648, identifier CRD42022302648.

Digital Medical Information Services Delivered by Pharmaceutical Companies via WeChat: Qualitative Analytical Study.

BACKGROUND: Social media has become one of the primary information sources for medical professionals and patients. Pharmaceutical companies are committed to using various social media platforms to provide stakeholders with digital medical information services (DMISs), which remain experimental and immature. In China, WeChat tops the list of popular social media platforms. To date, little is known about the service model of DMISs delivered by pharmaceutical companies via WeChat. OBJECTIVE: This study aims to explore the emerging service model of DMISs delivered by pharmaceutical companies via WeChat in China. METHODS: This study applied a qualitative research design combining case study and documentary analysis to explore the DMISs of 6 leading pharmaceutical companies in China. Materials were collected from their official WeChat platforms. Thematic analysis was conducted on the data. RESULTS: The DMISs of 6 pharmaceutical companies were investigated. Themes emerged regarding 2 essential information services delivered by pharmaceutical companies via WeChat: business operation services and DMISs (ie, public information services, professional services, science and education services, and e-commerce services). Business operation services mainly function to assist or facilitate the company's operations and development trends for general visitors. Public-oriented information services are realized through health science popularization, academic frontiers, product information, and road maps to hospitals and pharmacies. Internet hospital and pharmacy services are the main patient-oriented professional services. Medical staff-oriented science and education services commonly include continuing education, clinical assistance, academic research, and journal searching. Public-oriented e-commerce services include health products and health insurance. CONCLUSIONS: Pharmaceutical companies in China use WeChat to provide stakeholders with diversified DMISs, which remain in the exploratory stage. The service model of DMISs requires more distinct innovations to provide personalized digital health and patient-centric services. Moreover, specific regulations on the DMISs of pharmaceutical companies need to be established to guard public health interests.

Comparative analysis of disease modelling for health economic evaluations of systemic therapies in advanced hepatocellular carcinoma.

BACKGROUND: The objective of this study was to systematically analyse methodological and structural assumptions utilised in model-based health economic evaluations of systemic advanced hepatocellular carcinoma (HCC) therapies, discuss the existing challenges, and develop methodological recommendations for future models in advanced HCC. METHODS: We performed literature searches using five databases (Embase, PubMed, Web of Science, Econlit, and CNKI) up to December 4, 2022. Technology appraisals from Canada, England, Australia, and the United States were also considered. Model-based full economic evaluations of systemic advanced HCC therapies in English or Chinese met the eligibility criteria. The reporting quality was assessed by using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. RESULTS: Of 12,863 records retrieved, 55 were eligible for inclusion. Markov model (n = 29, 53%) and partitioned survival model (n = 27, 49%) were the most commonly used modelling techniques. Most studies were based on health-state-driven structure (n = 51, 93%), followed by treatment-line-driven structure (n = 2, 4%) and combination structure (n = 1, 2%). Only three studies (5%) adopted external real-world data to extrapolate the overall survival or calibrate the extrapolation. Few studies reported the assumptions of transition probabilities. Utility modelling approaches were state-based (n = 51, 93%) and time-to-death (n = 1, 2%). Only 13 studies (24%) reported five types of model validation. Economic evaluation results of specific treatment strategies varied among studies. CONCLUSIONS: Disease modelling for health economic evaluations of systemic therapies in advanced HCC has adopted various modelling approaches and assumptions, leading to marked uncertainties in results. By proposing methodological recommendations, we suggest that future model-based studies for health economic evaluation of HCC therapies should follow good modelling practice guidelines and improve modelling methods to generate reliable health and economic evidence.

Gate-controlled Sb2S3 thin film photodetectors for logic switches.

Antimony sulfide (Sb2S3) photodetectors (PDs) have great potential in commercial applications. The performances are affected by photocarrier distribution and recombination. Here, the gate-controlled Sb2S3 thin film PD is fabricated on the TiO2/SiO2/Si substrate by the vacuum method. The p-channel Sb2S3 transistor obtained a threshold voltage of 0.6 V and a switching ratio of 1064, achieving an effective regulation by gate voltages. A negative gate voltage can enhance conductivity and can suppress recombination. The responsivity and detectivity of the PD reach 1.6 A/W and 1.2 × 1011 Jones, respectively. The device realizes logic outputs by the signal inputs of illumination and gate voltage.

Electric Control of Helicity-Dependent Photocurrent and Surface Polarity Detection on Two-Dimensional Bi2O2Se Nanosheets.

Bismuth oxyselenide (Bi2O2Se) is a two-dimensional (2D) layered semiconductor material with high electron Hall mobility and excellent environmental stability as well as strong spin-orbit interaction (SOI), which has attracted intense attention for application in spintronic and spin optoelectronic devices. However, a comprehensive study of spin photocurrent and its microscopic origin in Bi2O2Se is still missing. Here, the helicity-dependent photocurrent (HDPC) was investigated in Bi2O2Se nanosheets. By analyzing the dependence of HDPC on the angle of incidence, we find that the HDPC originates from surface states with Cs symmetry in Bi2O2Se, which can be attributed to the circular photogalvanic effect (CPGE) and circular photon drag effect (CPDE). It is revealed that the HDPC current almost changes linearly with the source-drain voltage. Furthermore, we demonstrate effective tuning of HDPC in Bi2O2Se by ionic liquid gating, indicating that the spin splitting of the surface electronic structure is effectively tuned. By analyzing the gate voltage dependence of HDPC, we can unambiguously identify the surface polarity and the surface electronic structure of Bi2O2Se. The large HDPC in Bi2O2Se nanosheets and its efficient electrical tuning demonstrate that 2D Bi2O2Se nanosheets may provide a good platform for opto-spintronics devices.

Policy analysis of system responses to addressing and reversing the obesity trend in China: a documentary research.

BACKGROUND: The obesity epidemic and its established consequences on population health and the economy call for a vigorous fight against excess weight. The primary aim of this study is to investigate China's responses to address and reverse the obesity trend by analysing the official documents and guidelines issued or coordinated by the central government through the lens of the WHO Health System Six Building Blocks. METHODS: This study is based on the method of document research. We screened the official documents obtained through the initial search on databases. The basic information of the included documents was tabulated, and the relevant content was mapped onto the analytical framework for further analysis. RESULTS: The screening process finally rendered 55 out of 152 official documents. The temporal distribution of these documents issued between 2003 and 2022 concentrated in the period starting 2016 until now. The State Council and its affiliated ministries were found to play an instrumental role in the efforts to tackle the obesity epidemic. The results from further analysis based on the framework revealed that the current government responses to the obesity epidemic were mainly oriented towards strengthening governance, promoting healthcare delivery to prevent obesity, and improving access to interventions. The components of financing, information system, and workforce are currently absent in the relevant documents. CONCLUSIONS: Our analysis indicated that China's health system has taken action in response to the unprecedented obesity prevalence in recent years. In preventing and managing obesity and overweight in the population, the government affirmed its central place in governing and coordinating different recourses. The promotion of healthcare service delivery and access to medical products and technologies have been reflected gradually in the relevant policy documents. An integrated endeavour should be made in the future from all six aspects of the health system to halt the further rise in overweight and obesity.

Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design.

BACKGROUND: Non-alcoholic steatohepatitis (NASH) is a liver disease currently lacking an approved therapy, resulting in significant clinical demand. Traditional Chinese medicines (TCMs) have been commonly used to manage NASH. This study aimed to systematically analyse the randomised controlled trials (RCTs) using TCMs for NASH management. METHODS: A systematic literature review was performed by following PRISMA guidelines 2020 in six electronic databases: PubMed, Web of Science, Scopus, Embase, the Cochrane Library, and China National Knowledge Infrastructure, from inception until August 2022. RCTs using TCMs for NASH were included in the analysis, irrespective of language or blinding. RESULTS: 112 RCTs were included in this review, with 10,573 NASH participants. 108 RCTs were conducted in China, and 4 RCTs were in other countries. Herbal medicine decoction was the major dosage form used for treating NASH (82/112). 11 TCMs products have been approved for NASH treatment (8 in China, 2 in Iran, and 1 in Japan). Classic prescriptions, such as "Huang Lian Jie Du decoction", "Yin Chen Hao decoction", and "Yi Guan Jian" were used in some studies. The TCMs treatment of NASH involved the use of 199 different plants, with the top 5 herbs being Salviae Miltiorrhizae Radix Et Rhizoma, Alismatis Rhizoma, Bupleuri Radix, Poria, and Curcumae Radix. "Salviae Miltiorrhizae Radix Et Rhizoma + Bupleuri Radix/Alismatis Rhizoma" were the mostly common drug-pair in the herbs network analysis. Nowadays, "Bupleuri Radix/Alismatis Rhizoma + Atractylodis Macrocephalae Rhizoma" are increasingly applied in herbal formulas for NASH. Based on the PICOS principles, the included studies varied in terms of the population, intervention, comparator, outcomes, and study design. However, some studies reported unstandardised results and failed to report diagnostic standards, inclusion or exclusion criteria, or sufficient patient information. CONCLUSION: Adopting Chinese classic prescriptions or drug-pair may provide a basis for developing new drugs of NASH management. Further research is needed to refine the clinical trial design and obtain more convincing evidence for using TCMs to treat NASH.

Reproducible Non-Volatile Multi-State Storage and Emulation of Synaptic Plasticity Based on a Copper-Nanoparticle-Embedded HfOx/ZnO Bilayer with Ultralow-Switching Current and Ideal Data Retention.

The multilevel properties of a memristor are significant for applications in non-volatile multi-state storage and electronic synapses. However, the reproducibility and stability of the intermediate resistance states are still challenging. A stacked HfOx/ZnO bilayer embedded with copper nanoparticles was thus proposed to investigate its multilevel properties and to emulate synaptic plasticity. The proposed memristor operated at the microampere level, which was ascribed to the barrier at the HfOx/ZnO interface suppressing the operational current. Compared with the stacked HfOx/ZnO bilayer without nanoparticles, the proposed memristor had a larger ON/OFF resistance ratio (~330), smaller operational voltages (absolute value < 3.5 V) and improved cycle-to-cycle reproducibility. The proposed memristor also exhibited four reproducible non-volatile resistance states, which were stable and well retained for at least ~1 year at 85 °C (or ~10 years at 70 °C), while for the HfOx/ZnO bilayer without copper nanoparticles, the minimum retention time of its multiple resistance states was ~9 days at 85 °C (or ~67 days at 70 °C). Additionally, the proposed memristor was capable of implementing short-term and long-term synaptic plasticities.

Efficacy and safety of monotherapy and combination therapy of immune checkpoint inhibitors as first-line treatment for unresectable hepatocellular carcinoma: a systematic review, meta-analysis and network meta-analysis.

BACKGROUND: Hepatocellular carcinoma (HCC) is one of the cancers with the highest morbidity and mortality. Sorafenib used to be the main treatment for unresectable HCC patients. However, regimens based on immune checkpoint inhibitors (ICIs) have attracted attention in recent years because of their reported benefits. This study aimed to evaluate the efficacy and safety of monotherapy and combination therapy of ICIs as first-line treatment for unresectable HCC patients by conducting a systematic review, meta-analysis, and network meta-analysis. METHODS: Studies published up to 11st August 2022 were searched from 4 commonly used databases, including PubMed, Web of Science, Embase, and Clinical trials.gov. All eligible clinical trials were included. Data about reported objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and treatment-related adverse events (TRAEs) were extracted. RESULTS: Of the 8579 studies retrieved, 24 met the inclusion criteria. In patients with unresectable HCC taking ICIs-based therapy as first-line treatment, the pooled result of median PFS and median OS was 5.76 months (95% CI 4.82-6.69) and 16.35 months (95% CI 15.19-17.51) The ORR and DCR were 25.1% (95% CI 20.8-29.5%) and 75.2% (95% CI 70.3-80.2%) measured by RECIST v1.1 or 40.2% (95% CI 31.7-48.6%) with 75.2% (95% CI 68.3-82.1%) measured by mRECIST v1.1. Compared to sorafenib, ICIs-based therapy significantly prolonged OS. The combination treatment of sintilimab plus IBI305 had the highest ORR, while atezolizumab plus bevacizumab had the highest DCR. The pooled incidence of any grade TRAEs was 82.3% (95% CI 73.9-90.7%), with highest incidence appeared in dysphonia. CONCLUSIONS: This study demonstrated that first-line ICIs-based therapies could provide survival benefits for patients with unresectable HCC, with manageable TRAEs. The potential of combination treatment to become the new treatment trend in clinical practice is promising.

Economic Burden and Quality of Life of Hepatocellular Carcinoma in Greater China: A Systematic Review.

Background: Hepatocellular carcinoma (HCC) accounts for more than 85%-90% of primary liver cancer globally, and approximately 45% of deaths from HCC occur in greater China. This disease poses a significant economic burden for patients, payers and society and significantly affects patients' quality of life (QoL). However, such impact of HCC in greater China has not been well characterized. This review was conducted to analyze the current evidence about the economic and humanistic impact of HCC in greater China for informing national disease management and identifying clinical gaps yet to be resolved. Methods: A systematic search literature using seven databases (Web of Science, PubMed, Medline, Cochrane Central, China National Knowledge Infrastructure, Wanfang, and Weipu) was performed to identify interventional and observational studies that reported the impact of HCC on cost or QoL and published before April 6, 2021. The focus population included adult patients with HCC in greater China. This review excluded any studies that focused on any specific treatment. Study quality was assessed using the Effective Public Health Practice Project tool. Results: Of 39,930 studies retrieved, 27 were deemed eligible for inclusion. The methodologies, perspectives and data sources used in studies were heterogeneous. In greater China, while few studies reported the health expenditures of HCC patients and investigations about economic burden at national level was lacking, the significant economic impact of HCC on patients and their families had been reported. Health-related costs increased as the disease deteriorated. Additionally, HCC also has a negative impact on the QoL of patients, mostly in terms of physical, cognitive, social functioning and severe symptoms. Conclusions: HCC has brought significant economic and QoL burden to patients in greater China. Both physical and psychological factors predicted QoL in patients with HCC in greater China. Future studies should explore the disease-related economic effects on Chinese patients and their families, the effects of physical and psychological factors on QoL and the relationships of physical and psychological factors in the region.Systematic Review Registration: www.crd.york.ac.uk/prospero/display_record.php?RecordID=278421, PROSPERO: CRD42021278421.

10.24% Efficiency of Flexible Cu2 ZnSn(S,Se)4 Solar Cells by Pre-Evaporation Selenization Technique.

Flexible Cu2 ZnSn(S,Se)4 (CZTSSe) solar cells show great potential due to non-toxicity and low cost. The quality of CZTSSe absorber suffering from the high-temperature selenization process is the key to overcoming open-circuit voltage (VOC ) deficit and obtaining high efficiency. In this work, the authors develop a selenization technique to improve the quality of the CZTSSe layer by pre-evaporation selenization. This method provides saturated selenium vapor at the beginning of the selenization process to promote the crystallization process. The oversaturated selenium source greatly shortens the annealing time at high temperatures. The prepared CZTSSe films have larger grains and fewer voids. The measurement of the space charge limited current shows that the defect density of the CZTSSe absorber is significantly reduced from 4.43 × 1013  cm-3 to 3.46 × 1013 cm-3 . Electrical tests show that the devices have better charge separation at the interface, resulting in a charge recombination lifetime, increasing from 133 to 197 µs. The power conversion efficiency of the flexible CZTSSe solar cell reaches 10.24% with VOC and the fill factor enhances to 463 mV and 62%, respectively. The safe non-toxicity and efficient selenization method is expected to provide a new strategy for high-efficiency flexible CZTSSe solar cells.

Giant photoinduced inverse spin Hall effect of the surface states in three dimensional topological insulators Bi2Te3 with different thickness.

The photoinduced inverse spin Hall effect (PISHE) has been studied in three dimensional (3D) topological insulator (TI) Bi2Te3 thin films with different thicknesses (3, 5, 12 and 20 quintuple layer (QL)). The sign of the PISHE current flips only once in the 3- and 20-QL Bi2Te3 films, but it flips three times in the 5-, 7- and 12-QL samples. The three-times sign flip is due to the superposition of the PISHE current of the top and bottom surface states in Bi2Te3 films. By analyzing the x-ray photoelectron spectroscopy (XPS) of the Bi2Te3 films, we find that the top surface of the 3- and 20-QL Bi2Te3 films are severely oxidized, leading to only one sign flip in the PISHE. The PISHE contributed by the top and bottom surface states in Bi2Te3 films have been successfully separated by fitting a theoretical model to the PISHE current. The impact of the bulk states on PISHE current has been determined. The PISHE current is also measured at different light powers, and all the measurement results are in good agreement with the theoretical model. In addition, it is found that the PISHE current in Bi2Te3 films grown on Si substrate is more than two orders larger than that grown on SrTiO3 substrates, which can be attributed to the larger absorption coefficient for Bi2Te3/Si samples. It is revealed that the PISHE current in 3D TI Bi2Te3 is as large as 140 nA/W in the 3-QL Bi2Te3 film grown on Si substrate, which is more than one order larger than that reported in GaAs/AlGaAs heterojunction (about 2 nA/W) and GaN/AlGaN heterojunction (about 1.7 nA/W). The giant PISHE current demonstrates that the TIs with strong SOC may have good application prospects in spintronic devices with high spin-to-charge conversion efficiency.

Self-Powered Sb2S3 Thin-Film Photodetectors with High Detectivity for Weak Light Signal Detection.

Photodetectors (PDs) for weak light signal detection have wide applications for optical communication and imaging. Antimony sulfide (Sb2S3) as a nontoxic and stable light-sensitive material becomes a promising candidate for weak light PDs, which are developing in the direction of high response, high speed, and low cost. Herein, a self-powered Sb2S3 PD with the structure of FTO/TiO2/Sb2S3/Au is developed to achieve weak light detection for 300-750 nm visible light. We control the Sb2S3 thickness with about 460 nm to match depletion region width (438 nm) and obtain an excellent photoresponsivity and 3 dB bandwidth. Furtherly, we prepare pyramid structure polydimethylsiloxane (PDMS) on the illuminating surface to enhance the performance of weak light detection by light-trapping effects. The photocurrent of Sb2S3 PD with 20 µm-sized PDMS texture achieves 13.6% improvement compared with the control one. Under weak 530 nm light illumination of 1 µW cm-2, the self-powered Sb2S3 PD with PDMS achieves high responsivity (3.41 A W-1), large detectivity (2.84 × 1013 Jones), and ultrafast speed (15 µs). The present Sb2S3 PD and light-trapping strategy are expected to provide an alternative to future commercial weak light detection applications.

Epidemiology and disease burden of non-alcoholic steatohepatitis in greater China: a systematic review.

BACKGROUND: Non-alcoholic steatohepatitis (NASH) is a progression of non-alcoholic fatty liver disease. The increasing burden of NASH has become a major concern of public health in greater China. This study aimed to characterize the epidemiology, disease burden, and treatment of NASH in greater China to better inform national disease management and delivery of health services. METHODS: We conducted a systematic review searching four English databases (Web of Science, PubMed, Medline, and Cochrane Central) and three Chinese databases (CNKI, Wanfang, and VIP). We identified articles published from database inception to October 10, 2020 which reported NASH epidemiology, disease burden, and/or intervention in Chinese adults. RESULTS: Of 44,115 articles retrieved, 33 were eligible for inclusion. Overall prevalence of NASH ranged from 2.4 to 6.1% in greater China, with a more substantial burden among males, the aged, and those in Hong Kong and Taiwan. Most NASH patients suffered from several comorbidities, including obesity, diabetes, and cardiovascular conditions. PNPLA3 rs738409 G allele and haptoglobin 2-2 genotype drove the fibrosis progression in NASH. Increasingly prevalent cases of cirrhosis and hepatocellular carcinoma caused a higher NASH-related mortality. Compared with normal population, NASH patients experienced markedly poorer quality of life and heavier costs. CONCLUSION: This is the first comprehensive overview of NASH among Chinese population that revealed an overwhelming impact of social and healthcare burden associated with the condition. Further high-quality studies are needed to improve the understanding and management of NASH in greater China.

Market access of Chinese patent medicine products to healthcare security system in China: implications for international integration of traditional medicine into health systems.

BACKGROUND: China has introduced a series of polices and practice to manage the market access of Chinese patent medicine (CPM) products into its healthcare security system, which is less analyzed and reported in current literature. Therefore, this paper aimed to investigate the mechanisms managing market access of CPM products into healthcare security system in China, expecting to provide implications for international integration of traditional medicine products into health systems. METHOD: This paper used a documentary analysis approach as a qualitative research method. Data were collected from four sources and analyzed in a thematic way. RESULTS: Four mechanisms to manage entry, price adjustment, and exit of innovative brand and generic CPM products are identified, including: (1) price negotiation, mechanism of new entry of innovative brand CPM products into the national reimbursement list; (2) price re-negotiation, mechanism of price adjustment of innovative brand CPM products within the national reimbursement list; (3) mass procurement, mechanism of generic CPM products to healthcare security system; and (4) direct removal, mechanism of removal from the national reimbursement list. CONCLUSIONS: China has established market access framework of CPM products by focusing on price negotiation for innovative brand CPM products and mass procurement for generic CPM products. Further studies of CPM products based real-world data are needed to provide clinical and pharmacoeconomic evidence to support market access of CPM products into healthcare security systems.

Clinical and economic analysis of Gastrodin injection for dizziness or vertigo: a retrospective cohort study based on electronic health records in China.

BACKGROUND: Dizziness and vertigo are common clinical symptoms. Gastrodin injection has shown clinical effects on dizziness or vertigo. However, little is known about the effectiveness and costs of combining Gastrodin injection with conventional treatment on dizziness or vertigo in daily practice. This study aimed to analyze the clinical and economic effects of Gastrodin injection for patients with dizziness or vertigo in comparison to Extract of Ginkgo Biloba Leaves injection in real-world practice. METHODS: Data was collected from the Hospital Information System of 131 hospitals across China from January to December 2018. Patients whose primary discharge diagnosis was dizziness or vertigo according to ICD-10 diagnostic coding were included and divided into two samples: sample of dizziness or vertigo; sample of dizziness or vertigo, with the complication of cerebral infarction. Comparative analysis of the medical cost per hospitalization, hospitalization duration, effective rates, and cure rates between the group of Gastrodin injection and the group of Extract of Ginkgo Biloba Leaves injection was conducted. Propensity Score Matching was used to control potential confounding factors. RESULTS: In the sample of dizziness or vertigo, although there was no significant differences on hospitalization duration (P = 0.080), the group of Gastrodin injection was significantly better than the group of Extract of Ginkgo Biloba Leaves injection (P < 0.001) in terms of treatment effect and the per capita hospitalization cost. In the sample of dizziness or vertigo, with the complication of cerebral infarction, there was no significant difference (P = 0.371) in terms of hospitalization duration, but the group of Gastrodin injection was significantly better than the group of Extract of Ginkgo Biloba Leaves injection (P = 0.009) in terms of treatment effect, and significant difference regarding the per capita hospitalization cost (P < 0.001). CONCLUSIONS: Gastrodin injection showed advantages for inpatients with dizziness or vertigo compared with Extract of Ginkgo Biloba Leaves injection. Future studies using prospective pragmatic controlled trials can test and explore more about the effects of Gastrodin injections on dizziness or vertigo.

Efficacy and Safety of First-Line Targeted Treatment and Immunotherapy for Patients with Biliary Tract Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: Biliary tract cancer is one of the most aggressive and fatal tumours. Gemcitabine with cisplatin chemotherapy has long been the first-line treatment, but the prognosis is poor. In recent years, targeted treatment and immunotherapy have produced encouraging outcomes requiring a thorough review and meta-analysis. METHOD: For this systematic review and meta-analysis, we searched four databases, starting from the inception dates of databases to 11 January 2022. This study comprised randomised clinical trials and cohort studies that used immunotherapy or targeted treatment as the first line of treatment for patients with biliary tract cancer. RESULTS: From the 888 studies extracted, 33 trials were examined and found to meet the criteria. These included 3087 patients, 16 single-arm trials, 13 RCTs, one nRCT, a prospective single-arm pilot study, and a clinical setting in the real world. From 2010 to 2020, 33 studies were conducted using targeted treatment or immunologic therapies as first-line treatments for BTC patients, and 18 of those studies had positive outcomes. CONCLUSION: This study demonstrates that immunotherapy combined with chemotherapy as first-line treatment can provide survival benefits by improving the objective response rate for patients with unresectable biliary tract cancer. The potential for combination therapy to become a new trend in clinical treatment is promising but needs further clinical evaluation.

Clinical Outcomes Associated with Monotherapy and Combination Therapy of Immune Checkpoint Inhibitors as First-Line Treatment for Advanced Hepatocellular Carcinoma in Real-World Practice: A Systematic Literature Review and Meta-Analysis.

BACKGROUND: Immune checkpoint inhibitors (ICIs)-based therapy has recently been demonstrated to greatly ameliorate survival outcomes in advanced hepatocellular carcinoma (HCC). We aimed to evaluate clinical outcomes of ICIs-based monotherapy and combination therapy as first-line treatment of adults with advanced HCC in real-world practice by conducting a systematic literature review and meta-analysis. METHODS: PubMed, Web of Science, and Embase were searched up to 25 April 2022. Retrospective or prospective real-world studies evaluating progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs) of patients with advanced HCC receiving first-line ICIs-based therapy were included. RESULTS: Of 7805 studies retrieved, 38 were deemed eligible for inclusion. For patients receiving first-line ICIs-based therapy in real-world practice, the pooled median PFS and OS were 7.03 (95% CI: 5.55-8.51) and 14.39 (95% CI: 10.91-17.86) months. The ORR and DCR were 0.432 (95% CI: 0.327-0.538) and 0.756 (95% CI: 0.677-0.836), according to mRECIST 1.1, 0.317 (95% CI: 0.218-0.416) and 0.740 (95% CI: 0.644-0.835), judged by RECIST 1.1. The best outcomes of survival and response rate were observed in ICIs-based combination therapy of ICIs, TKIs, plus LRTs. Furthermore, ORR, DCR judged by mRECIST 1.1, and PFS could be potential prognostic factors for OS. CONCLUSIONS: This research revealed diversified first-line ICIs-based therapies for advanced HCC in real-world practice. Future studies are needed to adopt prospective, multicentric and comparative designs to test the ICIs-based combination therapies, especially triple therapies of ICIs, TKIs, plus LRTs.

Budget Impact Analysis of Diabetes Drugs: A Systematic Literature Review.

Background: Budget impact analysis (BIA) is an economic assessment that estimates the financial consequences of adopting a new intervention. BIA is used to make informed reimbursement decisions, as a supplement to cost-effectiveness analyses (CEAs). Objectives: We systematically reviewed BIA studies associated with anti-diabetic drugs and assessed the extent to which international BIA guidelines were followed in these studies. Methods: We conducted a literature search on PubMed, Web of Science, Econlit, Medline, China National Knowledge Infrastructure (CNKI), Wanfang Data knowledge Service platform from database inception to June 30, 2021. ISPOR good practice guidelines were used as a methodological standard for assessing BIAs. We extracted and compared the study characteristics outlined by the ISPOR BIA Task Force to evaluate the guideline compliance of the included BIA. Results: A total of eighteen studies on the BIA for anti-diabetic drugs were identified. More than half studies were from developed countries. Seventeen studies were based on model and one study was based on real-world data. Overall, analysis considered a payer perspective, reported potential budget impacts over 1-5 years. Assumptions were mainly made about target population size, market share uptake of new interventions, and scope of cost. The data used for analysis varied among studies and was rarely justified. Model validation and sensitivity analysis were lacking in the current BIA studies. Rebate analysis was conducted in a few studies to explore the price discount that was required for new interventions to demonstrate cost equivalence to comparators. Conclusion: Existing studies evaluating budget impact for anti-diabetic drugs vary greatly in methodology, some of which showed low compliance to good practice guidelines. In order for the BIA to be useful for assisting in health plan decision-making, it is important for future studies to optimize compliance to national or ISPOR good practice guidelines on BIA. Model validation and sensitivity analysis should also be improved in future BIA studies. Continued improvement of BIA using real-world data is necessary to ensure high-quality analyses and to provide reliable results.