Diabetic macular edema (DME) is one of the main reasons causing blindness in patients with diabetic retinopathy. In recent years, with the recognition of the pathogenic role of vascular endothelial growth factor (VEGF) in DME, many clinical trials of intravitreal injection of anti-VEGF drugs have been carried out at home and abroad, proving that it has significant effects in improving visual acuity and reducing macular edema, and has become the first-line treatment of DME. However, there are still many challenges in routine clinical application of anti-VEGF drugs, such as frequent injections, insensitivity to treatment, and it is unclear whether repeated injections will cause damage to retina. The pathophysiological process of DME is very complicated, in addition to VEGF, there are many inflammatory factors and growth factors involved. Clinical trials of long-acting anti-VEGF agents, drugs of other targets and gene therapy are also being carried out. It is believed that with the in-depth research and progress of clinical trials, the gradual application of anti-VEGF drugs, other drugs and therapy in clinical practice are just around the corner, which is expected to provide more convenient and effective treatments for DME patients in the future.
Dyspnea is the most common symptom in patients with acute heart failure syndrome (AHFS), and relieving dyspnea is an important goal in clinical practice, clinical trials and new drug regulatory approval. However, in clinical and scientific research, there is still no consensus on how to evaluate dyspnea, and there is still a lack of unified measurement methods. This article introduces the pathophysiological mechanism of dyspnea in acute heart failure, the measuring time of dyspnea, the posture of patients during measurement, the measuring conditions, and the common measurement methods of dyspnea in clinical trials and their advantages and disadvantages, so as to provide references for the selection of measurement methods of dyspnea in clinical trials of acute heart failure.
Evidence-based medicine database is a type of digital resource, which is based on principles of evidence-based medicine. It collects clinical evidence as a major content to serve clinical decision-making. This paper focused on various types of evidence-based databases, such as clinical practice guidelines, systematic reviews, and clinical trials. After collecting some representative databases, it analyzed and compared their contents, functions and characteristics, in attempt to enhance understanding of the current situation and trends of development of evidence-based medicine databases.
Clinical practice is very important in clinical pharmacology education. However, there are some deficiencies in this field in China. Clinical trial institutions in China are medical institutions that are qualified to undertake drug clinical trials. There are hardware and software for clinical pharmacology practice, and high-quality teaching personnel with medical, teaching, and scientific research backgrounds in the clinical trial institutions, which can be used as clinical pharmacology teaching practice bases. Therefore, this article discusses the practice of clinical pharmacology teaching reform using clinical trial institutions as a practical platform, and aims to put forward teaching reform ideas that combining students’ clinical pharmacology research practice on the basis of theoretical teaching.
Clinical research reports are the main form of clinical evidence. Based on the requirements of clinical research reports and the characteristics of clinical research on traditional Chinese medicine, it is an important basic systematic project to construct a standardized system of clinical curative effects study report on Chinese medicine. This article elaborates existing problems, focus of attention and construction process in order to help promote the improvement of clinical curative effects research report on Chinese medicine, provide more high-quality evidences for clinical decision-making and promote the development of Chinese medicine.
In recent years, CRO has developed rapidly in China, and has played an important role in improving the level of Chinese clinical trials and drug development. However, the development of CRO industry also has problems. This paper discusses the beneficial factors of the main problems and the future direction of CRO, in attempt to attract the attention of government supervision and management departments and CRO industries.
Based on the conclusion of recent clinical research conducted by foreign countries, there is no statistical difference in outcomes between real and placebo acupuncture. This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture, striving for a new way to test for the placebo effect; a way that is more scientific, more suitable for the current conditions of China, while at the same time capable of being recognized internationally. This paper describes a new acupuncture placebo-controlled method. Under the condition of complete patient trust, we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group. From the actual clinical practice, by randomized controlled trial comparing acupuncture and medicine, using the concept as the double-dummy clinical trail, this paper explores the “double-dummy – non-specific sites – random sampling” method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.
Objective To analyze the methodological quality of clinical trails on butylphthalide for cerebral ischemic stroke. Methods We collected all of the published clinical studies on butylphthalide for cerebral ischemic stroke in the world, and evaluated the methodological quality of the included studies according to clinical epidemiologic standard. The search time was from the establishment of each database to December, 2009. Results A total of 62 studies involving 5 762 patients were included. In all included studies, there were 56 randomized controlled trials (RCTs). A total of 8 studies described the method of random assignments. There were 4 multi-center randomized double-blind placebo-control trials. A total of 55 reported diagnosis criteria, 40 reported included criteria, 28 reported excluded criteria; 36 reported the curative efficacy at the end of the treatment, 51 assessed the neurological deficit score of patients before and after the treatment, 27 evaluated the ADL scores; 32 studies reported the side effects; 6 trials did not conduct intention-to-treat analysis even though some people withdrew the treatment because of the side effects or poor tolerance, etc. Conclusion Except for several high quality RCTs, current quality of some clinical trials on butylphthalide for ischemic stroke should be improved. We recommend that researchers should use internationally accepted consolidate standards of reporting trials (CONSORT) in future studies.
Objective To introduce the use of Central Randomization System in clinical trials. Methods We discussed the application of Central Randomization System in clinical trials from object management, drug management and user management, and made a brief description of minimization method. Results Central Randomization Systems can guarantee the nnplementation of the scheme of randomization, and can be used in clinical trials with minimization. Conclusion Central Randomization Systems are feasible in clinical trials especially in traditional Chinese medicine and open clinical trials.
Objective To evaluate the efficacy and safety of safflower yellow pigment lyophilized power amp; dripping solution in the treatment of patients with angina, by using parenteral solution of Dan-shen root extraction as control, we designed the nonferiority clinical trial phase Ⅲ. Method 784 patients with stable angina pectoris Ⅰ, Ⅱ, Ⅲ degree and occurred more than twice per week were selected. They were randomly, stratified and blindly assigned into 5 parallel groups including one control. They were treated by using safflower yellow pigment lyophilized power (SYPLP) 80 mg + 0.9% NS 250ml, intravenously guttae, daily (trial group 1); SYPLP 160 mg + 0.9% NS 250 ml, intravenously guttae, daily (trial group 2); safflower yellow pigment lyophilized dripping solution (SYPLDS) 200 ml (160 mg), intravenously guttae, daily (trial group 3); SYPLDS 100 ml (80 mg), intravenously guttae, daily (trial group 4) and parenteral solution of Dan-shen root extraction 20 ml + 0.9% NS 250 ml, intravenously guttae, daily (control group) respectively. Efficacy and safety were evaluated after 14 days of continuous treatment. Results The angina efficacy (per-protocol population, PP): The notable effective rates of trial groups 1 to 4 and control group were 53.27%，69.44%，70.09%，55.09% and 26.00% respectively, and the effective rates were 88.79%，92.59%，93.46%，89.81% and 73.00% respectively。There was significant differences between trial group 1 and 2, trial group 3 and 4. All trial groups showed significant different effect when compared with control (P＜0.05). The effect of trial group 2 was better than those of trial group 1, and trial group 3 better than trial group 4, the four trial groups better than control group. The intention-to-treat (ITT) analysis result was almost the same to PP analysis, but trial group 3 showed no significant difference to trial group 4. In trial group 2, 3 and 4, each occurred one adverse effect, while the number was 10 in control group.Conclusion SYPLP amp; SYPLDS have certain effect on angina. They are more effective than parenteral solution of Dan-shen root extraction. No toxic side effect has been found in clinic tests.