Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were 1g for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable (15 in the triagroup and 15 in the control group). No significant differences were observed between the trial group and the control group with respect to the cure rate (40% vs. 27%), the effective rate (80% vs. 87%), the bacterial clearance rate (92% vs. 100%), and the incidence of adverse drug reactions (12.5% vs. 13%) (Pgt;0.05). Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.
Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
Heart failure affects quality of life and life expectancy of tens of millions of individuals. There are no available economic and effective treatments for end-stage heart failure. Hydrogels are novel tissue engineering materials, which have the potential to ameliorate myocardium remodeling, increase cardiac output, improve quality of life and prolong life span by implantation into myocardium. The preclinical experiments and clinical trials have greatly explored the function of hydrogels in heart failure. In this review, we summarized the approaches of implantation, mechanism and clinical outcomes of the hydrogels.
Objective To summarize the research progress of stem cell transplantation in treating spinal cord injury (SCI) at different stages based on the pathophysiological mechanism of SCI. Methods The relevant research literature at home and abroad was extensively reviewed to explore the impact of transplantation timing on the effectiveness of stem cell transplantation in treating SCI. Results Researchers performed different types of stem cell transplantation for subjects at different stages of SCI through different transplantation approaches. Clinical trials have proved the safety and feasibility of stem cell transplantation at acute, subacute, and chronic stages, which can alleviate inflammation at the injured site and restore the function of the damaged nerve cells. But the reliable clinical trials comparing the effectiveness of stem cell transplantation at different stages of SCI are still lacking. Conclusion Stem cell transplantation has a good prospect in treating SCI. In the future, the multi-center, large sample randomized controlled clinical trials are needed, with a focus on the long-term effectiveness of stem cell transplantation.
ObjectiveTo analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). MethodsThe website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. ResultsA total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. ConclusionThe number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.
Objective To investigate the safety and effectiveness of the operation of integrate subparagraph, fenestration, exclusion, cut expansion, seton, tube, and drainage (ISFECSTD) to cure complex anal fistula. Methods Using randomized comparison and multicenter parallel experiment, the total number was 240: 120 patients in study group treated by ISFECSTD, and 120 patients in control group treated by extended cutting and seton operation. Then compared the safety and effectiveness between two groups. Results The clinical recovery rate of the study group was significantly higher than that in the control group （Plt;0.05）. The operation time and wound healing time in study group were significantly less than those in control group, and the scar area after wound healing was smaller than that in control group （Plt;0.01）. The decreased extents of anorectal pressures and rectal capacity feeling function after operation in study group were smaller than those in control group (Plt;0.01). Rectal and anal reflex function and healing of the endostoma, stem, and branch in study group were better than those in control group (Plt;0.05, Plt;0.01). Incidence of anal incontinence after operation in study group was significantly less than that in of anus-rectum structure and function, and has the merits of higher cure rate, shorter time of healing, smaller scar, less pain, etc. The method of ISFECSTD is worth being a new standardized operation in the clinical application.
Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.
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.
Early and mid-stage esophageal cancer can achieve a particular effect through surgeries or comprehensive treatment based on surgery. Once the esophageal cancer progresses to the advanced stage, it is still lack of effective remedy for the disease, and the patient's prognosis is poor. Immunotherapy has developed rapidly in recent years, bringing dawn to patients with advanced esophageal cancer. On July 31, 2019, the US Food and Drug Administration (FDA) approved KEYTRUDA (Merck) for the treatment of esophageal squamous cell carcinoma, and it became the first milestone drug for esophageal squamous cell carcinoma. In the paper, we will review the progress of immunotherapy in the treatment of advanced esophageal cancer on the basis of current clinical researches, which might provide ideas for further studies in the immunotherapy for esophageal cancer.