Objective To assess the effectiveness and safety of nine lipid-lowing agents in the national essential drug list (2000) and provide evidence for the adjustment and selection of essential drugs. Methods Based on principles of health technology assessment (HTA) and evidence-based medicine, we searched for all published clinical studies about these drugs from the following databases: MEDLINE (1966-2002.8), The Cochrane Library, EMBASE (1974-2002), CBMdisk (1979-2002.8) and VIP (1989-2002.8), the database of National Center for Adverse Drug Reaction(ADR) Monitoring of China and the database of WHO Uppsala drug monitoring center. Included studies were appraised, analyzed and compared for the reduction of triglyceride (TC) or low density lipoprotein (LDL-C), the prevention for the coronary events and the incidence of ADR. Results The results from comparative trials for lipid-lowing agents showed that the equivalent dose of statins for 25% reduction of LDL-C was atorvastatin 10 mg/d, simvastatin 20 mg/d, pravastatin 40mg/d, lovastatin 40 mg/d, cerivastatin 0.3 mg/d and fluvastatin 80 mg/d. It was difficult to compare fenofibrate with gemfibrozil, acipimox with statins or fibrates based on available data. The study on the primary and secondary prevention of cardiovascular events showed that pravastatin and lovastatin were effective in primary prevention, and long-term use could reduce the incidence of cardiovascular disease.Gemfibrozil could reduce the mortality from coronary heart disease (CHD) but the overall mortality was not changed. Pravastatin, simvastatin, atorvastatin, fluvastatin, gemfibrozil and fenofibrate had a confirmed effect in secondary prevention. Data from large-scale clinical trials and the reports from ADR monitoring center of England, America, Canada and Australia suggested that the statins which had rare ADR were safe and tolerated. Rhabdomyolysis was rare but had a serious adverse reaction associated with statins. The rate of fatal rhabdomyolysis related to cerivastatin was the highest among 6 statins. The safety of simvastatin, lovastatin and atorvastatin was lower than cerivastatin but higher than simvastatin and atorvastatin. The number of ADR reports of fenofibrate was fewer than that of gemfibrozil. Conclusions At present, the best evidence focused on pravastatin, simvastatin and lovastatin are widely used and have a confirmed safety and efficacy. Atorvastatin, fluvastatin and fenofibrate still need more data to confirm their effects on coronary heart disease prevention. The drugs which were shown to be inferior or insufficient evidence are cerivastatin, gemfibrozil and acipimox.
ObjectiveTo evaluate the efficacy, safety, and economics of omalizumab for the treatment of pediatric asthma through a rapid health technology assessment (HTA). MethodsThe search was conducted on INAHTA website and databases such as PubMed, Embase, Cochrane Library, SinoMed, CNKI, VIP, and WanFang Data from inception to August 2024. Literature screening, quality evaluation, and data extraction were conducted independently by two investigators. An interview was conducted to consult the medication and treatment opinions of doctors and patients to investigate its clinical application. ResultsA total of 28 articles, including HTA articles (4), SR/Meta analyses (18), and pharmacoeconomics articles (6) were included. Omalizumab could reduce the incidence of clinical exacerbations, decrease the number of asthma attacks/days with asthma symptoms, and improve the quality of life. The results of the safety evaluation showed that omalizumab could reduce the rate of serious adverse events, especially those related to worsening asthma. Foreign pharmacoeconomic studies showed ICER ranging from £30 109 to £78 009. A pharmacoeconomic study in China found an ICER of $211 217/QALY for omalizumab, which were both above the pre-set thresholds. ConclusionOmalizumab is a treatment for patients who suffer from moderate to severe persistent allergic asthma or moderate to severe allergic asthma. It has been found to improve disease symptoms without increasing serious adverse events. However, it is not considered cost-effective due to its high price.
ObjectiveTo comprehensively review the status quo, contents, and problems of health technology assessments (HTAs) on cardiovascular and cerebrovascular diseases in Chinese rural. MethodsThe CNKI, VIP, WanFang Data and CBM databases were searched for the HTAs on cardiovascular and cerebrovascular diseases in Chinese rural up to October 31st, 2013. Two reviewers independently screened literatures and extracted data, and then the qualitative method was used to systematically analyze the literatures' information and results. ResultsA total of 34 studies were included. Of which, 23 were descriptive studies and 11 were experimental studies. The studied populations were patients and ordinary residents who had received the service of cardiovascular and cerebrovascular diseases health technology in rural, as well as the grassroots medical technical personnel and promotion staffs who had developed the health technologies. HTAs on cardiovascular and cerebrovascular diseases in rural mainly included western medicine health technologies and traditional Chinese medicine (TCM) health technologies. The contents of HTA of the included literatures mainly included:effectiveness, acceptability, requirements, economic characteristics, safety and technical specific property. The results of the included literatures showed that the type of diseases involved in cardiovascular and cerebrovascular diseases in rural were not widely enough, the fields involved in assessment contents were single, lack of rigorous and comprehensive study design. ConclusionWe need more HTAs of cardiovascular and cerebrovascular diseases in rural, we also need to strengthen early prevention, promote a wider range of cardiovascular and cerebrovascular diseases health technology, strengthen promotion and application of both TCM health technologies and the combination of TCM and western medicine health technologies in cardiovascular and cerebrovascular diseases.
Objectives About 12.9-50% patients of SARS (Severe Acute Respiratory Syndrome), require brief mechanical ventilation (MV) to save life. All the reported principles and guidelines for therapy SARS were based on experiences from clinical treatments and facts of inadequacy. Neither prospective randomized controlled trials (RCT) nor other high quality evidences were in dealing with SARS. Our objective is to seek safe and rational non-drugs interventions for patients with severe SARS by retrospectively reviewing clinical studies about MV all over the world, which include clinical guidelines, systematic reviews (SR), Meta-analysis, economic researches and adverse events. Methods To search MEDLINE and Cochrane Library with computer. According to the standards of inclucion or exclusion, the quality of the article which as assessed, and relevant data which were extracted double checked. The Meta-analysis was conducted if the studies had no heterogeneity. Results 14 papers were eligible. Due to the significant heterogeneity between these studies, further Meta-analysis could not be conducted, and the authors’ conclusions were described only. Conclusions The outcome of PPV is better than that of VPV. Patients who underwent PPV had a significantly lower mortality than that of VPV. Of course, the volutrauma should be watched. With low tidal volume and proper PEEP, or decreased FiO2, even permissive hypercapnia, the mortality and length of stay were cut down. Non-invasive mechanical ventilation (NIMV) was effective in treating haemodynamical stable patients, minimizing complications and reducing medical staff infection. Patients with serious dyspnea with PaO2/FiO2lt;200, no profit of NIMV, or couldn’t tolerance hypoxaemia were unlikely to benefit from this technique and needed ventilation with endotracheal intubation. Prone position could improve PaO2/FiO2, NO maybe increased pulmonary perfusion, improved V/Q, and raised oxygenation. Furthermore, Inhaled NO sequentially (SQA) was better than Inhaled NO continuouly (CTA). Some studies implied that practice of protocol-directed weaning from mechanical ventilation implemented by nurses excelled that of traditional physician-directed weaning.
Objective To investigate the feasibility of health technology permission (HTP) for widely used, high cost and risk technologies based on evidence of health technology assessment (HTA) from the perspective of Ministry of Health (MOH). Method With reference to experiences of HTA and evidence-based health administration in developed countries, four HTA and EBM entities have been established in China, which promoted and disseminated HTA. Three technologies-Bank of Haematopoietic Stem Cell from Umbilical Cord, Assisted Reproductive Technology (ART) and Sperm Bank-were piloted to assess, which provided quality evidence to assist MOH in formulating the Regulation for Permission on Health Technology. Results A set of technologies such as medical equipment, clinical techniques and screening technology for disease prevention and control have been assessed. Several regulations for permission on individual health technologies have been prepared to guide certification of professionals and health institutes. These include Regulation of Bank of Haematopoietic Stem Cell from Umbilical Cord, Regulation of Assisted Repreduction Technology and Management of Human Sperm Bank. Conclusions Although we have possessed a pre-requisite to establish a set of managing system for evidence-based permission of health technologies, an efficient infrastructure to run this system should be established and improved.
Objective To investigate present status of health care in peri-brain-death and analyze its effectiveness and health economic characteristics. Method Retrospective analysis of case series was conducted and a total of 940 patients from surgical intensive care unit (SICU) were reviewed on treatment and part of direct medical expenditure. The patients admitted from Jun. 1999 to Dec. 2000 and Nov. 2001 to Jun. 2002 were included in this study. Data were processed by SPSS 10.0. Results Patients were included if they had two of the three symptoms for at least one hour: deep coma, pupillar light reflex disappear, and no autonomic respiratory. Ultimately 115 patients were included, with a total cost of ￥2 515.9 per day for each case, whereas mortality was 99.10%. Mortality increased with the state of peri-brain-death prolonged. Eighty percent of patients included were dead within 72 hours after admission. Conclusions Attempts to resuscitate patients of peri-brain-death have been the most widely applied in China, however, it resulted in great unnecessary consumption of health resources. It is of great importance to promote legislation of brain death in China.
Health Technology Assessment International (HTAi), in conjunction with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), initiated a joint Task Force and published guideline and a checklist for deliberative processes for health technology assessment (HTA). Currently, there is a lack of guidance for designing and implementing deliberative processes of HTA in China, so this paper performs a detailed interpretation of the guideline and checklist, with a view to providing a reference for China's HTA and deliberative process, in order to promote the dissemination and application of the HTA methodology, and advance the construction of domestic HTA deliberative processes capacity and institutional mechanism.
Objective According to health technology assessment (HTA) methodology, to assess the efficacy and safety of different doses of metoprolol in the treatment of atrial fibrillation (AF). Methods Based on the principles of HTA, we searched some important medical databases including MEDLINE, EMBASE, The Cochrane Library and CMCC, as well as several national special heart disease databases and side effect centers. We selected eligible studies based on the inclusion and exclusion criteria and critically assessed their quality. Results Intravenous metoprolol 10 mg - 15 mg could control rapid ventricular rate in patients with chronic AF. On either rest or exercise, oral metoprolol 150 mg/d had a better control of rapid ventricular rate than 50 mg/d in patients with chronic AF. For preventing postoperative AF (POAF), the intravenous metoprolol 20 mg group and the 30 mg group could decrease the incidence of POAF compared to the 10 mg group. Oral metoprolol 150 mg/d was more effective than 100 mg/d in preventing POAF. In addition, intravenous metoprolol therapy was well-tolerated and more effective than oral metoprolol therapy in preventing atrial fibrillation after cardiac surgery. Results from several national side effect centers demonstrated that the incidence of adverse reactions associated with metoprolol was low. Conclusion Present evidence showed that high dose of metoprolol was superior to low dose in treating AF, however, the evidence available is insufficient. It is suggested that adequate evidence through further studies are needed. The safety profile of different doses of metoprolol is similar.
Objective To evaluate the clinical effectiveness, safety, cost-effectiveness of eight angiotensin converting enzyme inhibitors (ACEIs) in order to provide evidence for adjustment of Essential Drug List in China. Method Collecting all clinical trials by searching Medline, Cochrane Library, Embase and Chinese Biomedical Database and conducting critical appraisal. High quality randomized controlled trials and systematic reviews were included to assess the effectiveness of ACEIs. Non-randomized controlled trials were also included to evaluate the safety and cost-effectiveness. Results New generation of ACEIs are better than enalapril and captopril in antihypertension and endurance. Meta-analysis showed that T/P ratio was less than 50% in prindopril, benazepril and captopril. Enalapril and captopril had the most adequate evidence in the treatment of chronic heart failure. The effects of lisinopril, prindopril, benazepril and cilazapril positive influence on heart failure were assessed by surrogates. Captopril, lisinopril could reduce the total death rate of acute period (during 36 hours of AMI). Enalapril, captopril, ramipril and prindopril had the effect of heart protection in late period of AMI (3 days after AMI). Only ramipril, lisinopril and prindopril had evidence to support the protective effect on cerebral vessels. The available evidence, though not adequate, showed all the ACEIs except benazepril could diminish proteinuria and delay the renal failure. The new generations of ACEIs were similar in adverse reactions to enalapril and captopril, while incidences were lower than enalapril and captopril. Few evidence on cost-effectiveness of ACEIs were identified. The available evidence showed enalapril was cost-effective in treating heart failure. However, it compromised to lisinopril. The studies on ethics were not available. Conclusions It was difficult to generally rank the eight ACEIs according to available evidence. Not all eight ACEIs had adequate evidence in organs protection. It was suggested that clinicians should select ACEIs with adequate evidence to treat patients on states.
Hospital-based health technology assessment (HB-HTA) refers to the practice of health technology assessment for hospital management decision-making based on the actual situations in hospitals. It includes processes and methods of health technology assessment carried out in and for hospitals. Under the background of comprehensively promoting the reform of public hospitals in China, HB-HTA is undoubtedly an important scientific method to enhance the fine management of public hospitals and implement the policy of medical reform. This paper introduced the concept, the international and domestic development status, the characteristics of HB-HTA, and put forward the scheme of development of HB-HTA macroscopically, so as to promote the popularization and applications of HB-HTA in China.