ObjectiveTo investigate the diagnostic value of serum cystatin-C (Cys-C) detection in hypertensive disorder complicating pregnancy patients. MethodsA hundred patients with pregnancy induced hypertension (PIH) were chosen as the research object from February 2012 to March 2013, and they were divided into mild group, moderate group and severe group according to the severity of the disease. The other 40 healthy pregnant women were selected as the controls (the control group). We compared the four groups in terms of Cys-C, serum urea nitrogen (BUN) and creatinine level, as well as the positive rate of Cys-C, BUN, and creatinine. ResultsCys-C, BUN, and creatinine in the PIH group were significantly higher than those in the control group (P<0.05). Cys-C and creatinine in preeclampsia mild group were significantly higher than those in the control group (P<0.05), but BUN level between the two was not statistically significant (P>0.05). Cys-C, BUN, and creatinine in the PIH moderate and severe groups were significantly higher than those in the control group (P<0.05). The abnormal rate of Cys-C in the PIH mild group was significantly higher than that of Cys-C and creatinine (P<0.05). ConclusionCys-C, BUN and creatinine can all show renal damage in PIH patients, but the Cys-C value in early diagnosis is better than that of BUN and creatinine. It can be used as a monitoring index of pregnancy-induced hypertension prevention and early treatment.
ObjectiveTo explore the clinical value of transthoracic echocardiography (TTE) in the diagnosis of infective endocarditis. MethodsWe retrospectively analyzed the transthoracic echocardiogram in 35 patients with infective endocarditis confirmed between September 2003 and September 2013. Patients underwent routine heart scan in all sections to measure sizes of all chambers and cardiac function, observe morphologies, activities and functions of all valves and ventricular walls, and diagnose whether underlying heart diseases exist, focusing on intracardiac vegetations and their distributions, morphologies, sizes, numbers, echoes and activities, and a full analysis of the blood culture findings was also conducted. ResultsOf the 35 patients undergoing initial TTE, 29 were positive, and 6 were negative (2 positive and 4 negative in the reexamination one week later). Vegetations were found in the mitral valve (8/35), aortic valve (15/35), tricuspid valve (5/35), pulmonary valve (1/35), pulmonary arterial wall (1/35) and right ventricle (1/35), respectively. There were 29 (8 and 21 with congenital and acquired heart diseases, respectively) and 6 patients with and without underlying heart diseases, respectively. Of the 35 blood cultures, 33 were positive and 2 were negative. ConclusionsTTE is rapid and accurate for early diagnosis of infective endocarditis, precise localization and rough quantification of vegetations, determination of whether valve damage occurs and what its severity is, and detection of whether complications exist. It is valuable for early diagnosis, treatment, follow-up and prognosis judgment.
Randomized double-blind controlled trials (RCTs) conduct researches in carefully selected populations to ensure results of RCTs are unaffected by external disturbances and provide evidence of safety and efficacy. Real-world researches further help to understand the real world effects of new technologies in different medical environments after-market authorization. RCTs are the evidence foundation of real-world researches, and real-world researches provide valuable complement to RCTs. Medical insurance database is one of the most important database in real-world researches. Now, China's national medical insurance is entering a new era and transits from passive payment and compensation into a value-based strategic purchase mechanism for its insured population to buy the most cost-effective services. It is necessary to establish a mature, well-organized and value-based mechanism. The core of such mechanism is values, which is the price/performance ratio of innovative medicines and technologies rather than looking at the price solely. Demonstrating innovative drug value is an essential part of health care assessment. The authors argue that the assessment of the overall value of innovative technologies or medicines should include and based on the following four dimensions: clinical value, economic value, patient value and society value.
Assessing the clinical value of pharmaceuticals is crucial for comprehensive evaluation in clinical practice and plays a vital role in supporting decision-making for drug supply assurance. Real-world data (RWD) offers valuable insights into the actual diagnosis and treatment processes, serving as a significant data source for evaluating the clinical demand, effectiveness, and safety of drugs. This technical guidance aims to elucidate the scope of application of RWD for the clinical value assessment of pharmaceuticals, as well as the key considerations for conducting value assessment research. These considerations include identifying the dimensions of clinical value that necessitate RWD and effectively utilizing RWD for evaluation purposes. Additionally, this guidance provides essential points for implementing pharmaceutical clinical value assessment based on real-world data, with a specific focus on study design and statistical analysis. By doing so, this guidance assists researchers in accurately comprehending and standardizing the utilization of real-world research in conducting pharmaceutical clinical research.
With the acceleration of global innovative drug development, selecting safe, effective, and cost-effective products from numerous drugs has posed new challenges for the decision-making process of medical insurance drug access and dynamic updating of insurance directory. Real-world data (RWD) provides a new perspective for evaluation of clinical and economic value of drugs, but there are still uncertainties regarding the scope, quality standards, and evidence categories of RWD that can be used. Based on the current status of domestic and international RWD supporting the assessment of the clinical and economic value of drugs, this paper, in collaboration with national RWD and healthcare experts, has developed the key considerations for using real-world data to evaluate the clinical and economic value of drugs. This paper first clarifies the scope of RWD that can be used to evaluate the clinical and economic value of drugs evaluate; secondly, provides specific requirements and guidance on data attribution, data governance, and quality standards for RWD; finally, summarizes the evidence categories of RWD supporting evaluate the clinical and economic value of drugs evaluate.