Objective To evaluate the clinical efficacy and safety of pazufloxacin for the treatment of moderate and severe acute bacterial respiratory infections.Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin (500 mg twice daily for 7 to 10 days), and patients in the levofloxacin group were treated with levofloxacin (300 mg twice daily for 7 to 10 days). Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS). At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.
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.
ObjectiveTo evaluate the safety of shearing fracture ligation combining procedure for prolapse and hemorrhoids （PPH） in treatment for mixed hemorrhoids via a multicenter clinical study. MethodsTwo hundred and fortysix patients with mixed hemorroids were included from four a level of firstclass hospitals, which were averagely divided into shearing fracture ligation combining PPH group, PPH group, and shearing fracture ligation group according to the order of admission. The occurrence status of rectovaginal fistula, urethrorectal fistula, postoperative bleeding, acute urinary retention, anorectal stenosis, and anal incontinence were observed. And the anal function was evaluated by the anorectal pressure measurement. ResultsNo rectovaginal fistula or urethrorectal fistula happened among three groups. No anorectal stenosis happened in the shearing fracture ligation combining PPH group or the PPH group. The score of anorectal stenosis and anal incontinence in these two groups were lower than those in the shearing fracture ligation group (Plt;0.05). The rate of postoperative bleeding in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group (Plt;0.05). There were acute urinary retentions happened among three groups, but without significant differences among them (Pgt;0.05). The anal canal resting pressure after operation was lower than that before operation among three groups (Plt;0.01), which in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group after operation (Plt;0.05). There were no significant differences of the rectum feeling capacity or maximum rectum capacity between the shearing fracture ligation combining PPH group and PPH group before and after operation (Pgt;0.05), but compared with the level before operation in the shearing fracture ligation group, the rectum feeling capacity obviously decreased after operation (Plt;0.05), the maximum rectum capacity obviously increased (Plt;0.05). There were no significant differences of the maxinum anal canal systolic blood pressure between before and after operation in three groups and among three groups (Pgt;0.05). ConclusionsThe operation of shearing fracture ligation combined with PPH can protect the tissue of rectal cushion, remain the normal anatomy structure of anal canal. It has better clinical effect and is much safer than other methods.
Multicenter randomized controlled studies can recruit more subjects in a relatively short period of time, avoiding the bias of single research institution studies, resulting in reliable conclusions and providing strong guidance to clinical practice. They are the most scientific and most reliable methods to evaluate clinical researches. However, there are few multicenter clinical trials in China as Chinese doctors are often trapped in difficulties in clinical research, including imperfect research system, lack of experience, capital investment deficient, the tension in the doctor-patient relationship and so on. Although the above problems are related to medical system architecture of our country in a certain extent, compared with the overseas, we also have our own advantages, such as resource of our patients, doctors, and diseases type. Pay attention to discovering of new type of diseases, looking for genetics discipline, and exploring new medical technology is an important task of clinical research. We have plenty of high level ophthalmology centers at present, which provide favorable conditions for launching multi-center clinical trial studies. We have good reasons to believe that, if we can effectively exploit the resources in our hands, carefully observe and discover clinical problems, there will be more convincing clinical results present in the world after bring up hypothesis boldly while prove it conscientiously and carefully.
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, which may result in infertility. Because of the complicated etiology and high morbidity, it has attracted wild attention of researchers around the world. The large quantity of blood specimens that have been obtained from multicenter clinical trials (PCOSAct) are precious resources for clinical research. It could not only contain clinical data of the related diseases but also provide vital guidance for the diagnosis and treatment of the disease. This paper discusses the collection, processing, storage, and testing of blood specimens as well as the potential problems, and emphasizes the importance of specimen quality for high quality clinical research. The purpose of this paper is to provide experience and reference for the standardized construction of biobank in future and improve the management of blood specimen in clinical trials.
Objective To formulate a medical endoscopy service evaluation system, so as to guide the hospitals to select products, provide advices for manufacturers to improve the service, and finally improve the overall service capacity of medical endoscopy industry. Methods The whole study was conducted from January to December 2018. Firstly, Delphi method was used to establish the evaluation indexes, which helped to get the evaluation scenario. Secondly, the evaluation mechanism was established through the association of three central hospitals with their medical treatment partnerships and collaborative hospitals. Thirdly, the popular medical endoscopy brands in China were evaluated for a long time by means of information technology. Results Finally, more than 80% of the provinces of China were covered by the medical endoscopy services evaluation, and 51 hospitals participated in the evaluation. At the end of 2018, 1 450 valid data were collected, of which the annual average abnormal data was less than 5%. With the score ranking, the highest score was 4.45, the lowest score was 3.27, and the average score was 3.85. The preliminary evaluation results were sent to medical endoscopy manufacturers. Conclusions The " multi-center hospital” medical endoscopy service evaluation system established in this study has the characteristics that the indexes are scientific, and the evaluation is comprehensive and wide-coverage. It provides a feasible and effective solution for medical endoscopy service evaluation and plays an important role in improving the whole medical endoscopy service level and brand value.
ObjectiveTo understand the distribution of demographic sociological characteristics and co-morbidities among primiparous and multiparous pregnant women under the China's universal two-child policy, to provide baseline data for clinical high-risk management and medical resources allocation.MethodsWe included pregnant women from 24 hospitals in 16 provinces (municipality, autonomous region) of China and collected their demographic sociological characteristics and obstetrics information by questionnaires between September 19th, and November 20th, 2016. Then, we used descriptive analysis to present the distribution of demographic sociological characteristics and pregnancy co-morbidities among primiparous and multiparous women and compared differences between groups by t test or Chi-square test.ResultsAmong 12 403 investigated pregnant women, 8 268 (66.7%) were primiparous and 4 135 (33.3%) were multiparous, with highest proportion in East (931/2 008, 46.4%) and lowest in Northeast (385/2 179, 17.7%). Multiparous women, comparing to primiparous women, were more likely to be elderly than 35 years (accounting for 30.6% vs. 6.5%), lower educated with high school or below (29.7% vs. 16.9%), occupied in physical labor or unemployed (49.2% vs. 42.5%), non-local residents (12.7% vs. 10.5%), family annual income higher than 120 thousand yuan (41.3% vs. 33.3%), pre-pregnancy body mass index≥24 kg/m2 (13.6% vs. 9.9%), history of artificial abortions (44.9% vs. 24.0%), or pregnancies≥4 times (23.8% vs. 3.1%) and were less likely to receive assisted reproductive technology (2.3% vs. 4.7%). The most common co-morbidities were gynecology disease (5.5%), thyroid disease (5.4% in all women), blood system disease (5.0%), digestive system disease (4.2%) and hepatitis B infection (2.5%). Multiparous women, comparing to primiparous women, had higher proportions with blood system disease (5.7% vs. 4.7%), hepatitis B infection (3.1% vs. 2.2%) and chronic hypertension (0.6% vs. 0.2%), but lower proportions with thyroid diseases, polycystic ovary syndrome, and immune system diseases, whose distribution also showed regional differences.ConclusionThere existed distribution differences regarding demographic sociological characteristics and co-morbidities proportions between primiparous and multiparous women. Therefore, we should improve clinical risk management and medical resources allocation based on pregnant women’s baseline and gestational characteristics.