To reduce the incidence of surgical site infection (SSI), perioperative antimicrobial prophylaxis has long been advocated for joint replacement and open reduction with internal fixation of long bones. Increasing health care costs have focused hospital interest on more cost-effective procedures. Although current literature indicates that single-dose antibiotic prophylaxis is comparable to a 3-dose regimen, there are no reports from lowincome countries. The primary aim of this study was to compare the infection rate following open reduction and internal fixation of long-bone fractures in groups with a single dose and 3 doses of prophylactic antibiotic. The secondary aim was to compare the costeffectiveness of both antibiotic regimens. This is a prospective randomized clinical trial (RCT) to compare the incidence of surgical site infection between the patients allocated randomly into two groups with different antibiotic prophylactic regimens: single dose or 3 doses 8 hourly of 1g ceftriaxone administered intravenously. 200 consecutive patients who underwent open reduction and internal fixation (ORIF) for closed long-bone fractures were enrolled in this study. The rate of postoperative SSI was 4.1% in the single-dose group and 2.2% in the 3-dose group; the overall SSI rate was 3.2%. The primary endpoint of this study, which is the incidence of SSI, showed no significant difference between the single-dose and 3-dose prophylactic antibiotic groups. Furthermore, there was no difference between groups regarding the length of hospital stay. Our randomized clinical trial affirmed that single-dose antibiotic prophylaxis in orthopaedic clean operations is not only a cost-saving practice but also is effective for SSI prevention, and should be incorporated in the development of clinical practice guidelines in tropical hospitals.
Clinical Trials as Topic- statistics & ; numerical data,

OBJECTIVEThe determination of non-inferiority margin is an important and confusing issue which directly influences the acceptability of a new medication. We reviewed the published literature, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines and Committee for Proprietary Medicinal Products (CPMP) papers on the selection of non-inferiority margin and the corresponding statistical tests in clinical trials, in order to provide practical recommendations and suggestions for establishing reference criteria for the non-inferiority margin in China. Data sources The literature on the selection of a non-inferiority margin and statistical tests was mainly extracted from relevant English articles on non-inferior clinical trials published from 1990 to 2007. The starting point (1990) was chosen due to lack of such papers published prior to 1990. This literature was searched via PubMed, Medline and Chinese Knowledge Information (CNKI). ICH guidelines and CPMP papers were downloaded from their official websites. The keywords "clinical trial", "non-inferiority" and "non-inferiority margin" were used. Study selection Forty-three original articles and critical reviews, ICH E10 guideline and CPMP papers were selected.

RESULTSThe non-inferiority testing with treatment difference and ratio are commonly used, where the non-inferiority margin is determined with and without historical data. Traditionally, this margin is treated as a fixed value, while developed methods take the variation into account in the determination of this margin, on which the test depends is more convincing. The mixed margin consisting of a margin based on treatment difference and a margin based on treatment ratio can exactly control the type I error at the desirable level and obtain a better power. In this review, we also provide some recommendations and suggestions for the selection of the non-inferiority margin in the western countries and China.

CONCLUSIONSBesides the magnitude and variability of the standard control and placebo effects, the determination of the margin depends on other factors, such as, the safety profiles of the two comparative therapies, method of administration and product cost. Hence the margin should be made specifically for a certain case. Reference criteria for different medications should be given to avoid the arbitrary conclusion.

Clinical Trials as Topic ; statistics & numerical data ; Models, Statistical ; Research Design

Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

OBJECTIVETo investigate the quality of reports of clinical results concerning burn injury, in order to raise the standard of clinical study of burn care in accordance to the standard of evidence-based medicine (EBM), with the aim of improving clinical research in burn care of this country.

METHODSAll the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard.

RESULTSThere were 89 papers about clinical trials published in the past 5 years, in which 43 (48.3%) of the studies were carried out with random control trials (RCT), and 46 (51.7%) were clinical control trials (CCT). RCT papers increased year by year, while the number of CCT papers fluctuated greatly. The disparity in the quality of research was found as follows. In all the RCT and CCT papers, blinded research was adopted only in 5 papers (5.6%). Strict diagnostic standard including inclusion and exclusion standards were reported in 53 articles (59.6%). The comparison with baselines was not provided in 64 articles (71.9%). P value was given in 10 papers but statistical method was not mentioned (11.2%). Follow-up visits and lost information were only recorded in 2 articles, but no detailed follow-up visiting data were provided. Side effects were reported in 10 articles (11.2%). There were analysis and explanation of mixed interfering factors only in 5 papers (5.6%). There was no explanation of the evaluation of sample size in any one paper.

CONCLUSIONIn summary, the literature concerning clinical studies published in CJB in the past five years has become more extensive. However, the present study indicates that many clinical trials are not designed and ethical consideration is often missing. Therefore, it is deemed imperative to improve the quality of the clinical studies by improving the planning of the protocols of the study and statistical analysis of the research results in future.

Burns ; therapy ; Controlled Clinical Trials as Topic ; standards ; statistics & numerical data ; Evidence-Based Medicine ; standards ; Humans ; Periodicals as Topic ; statistics & numerical data

Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.
Clinical Trials as Topic ; Cost-Benefit Analysis ; Economics, Pharmaceutical ; Guidelines as Topic ; Humans ; Pharmaceutical Preparations ; economics ; Product Surveillance, Postmarketing ; economics ; Statistics as Topic

A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
Biostatistics ; Clinical Trials as Topic ; statistics & numerical data ; Data Collection ; standards ; Quality Control ; Research Design ; standards

The papers regarding moxibustion published in science citation index (SCI) journals for the recent 5 years were searched to explore the international tendency of moxibustion researches, which provided references for moxibustion to have a better internationalization. With methods of internet search and database search, a total of 116 papers regarding moxibustion were included. These papers were published in 40 kinds of journals, mostly in Britain and the United States. The journal with the highest impact factor was Stroke, which had 5729 points. The number and impact factor of these journals were inferior to those of acupuncture journal. Compared among these journals, the depth and width of moxibustion research were increasing year by year. The category of diseases related with moxibustion is mainly digestive system diseases, motor system diseases and urinary-genital system diseases. The type of papers was characterized with clinical observation and mechanism research. Researches related with moxibustion included moxibustion dose and safety. It was believed that the international recognition of moxibustion effectiveness, standardization of moxibustion manipulation, standardization research, etc. were needed to be solved in the further.
Bibliometrics ; Clinical Trials as Topic ; Humans ; Journal Impact Factor ; Moxibustion ; Publications ; statistics & numerical data

Colorectal cancer (CRC) remains one of the major causes of cancer death worldwide. In recent years, the development of new and effective management options, such as fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET), total mesorectal excision (TME) and monoclonal antibody novel "targeted" therapies has led to a considerable improvement in the outcome of this disease. In China, studies on CRC using integrative medicine (IM) have made remarkable progress. We therefore review the recent developments in CRC treatment through IM and Western medicine, including research studies such as the exploitation of Chinese herbs for the disruption of the tumor cell cycle or inhibition of tumor cell proliferation, induction of tumor cell apoptosis, improvement of the immune system, and the curative effect of chemotherapy. We also examine clinical studies such as those on special prescriptions and medicines and IM in anti-cancer therapy. Particularly, we analyze the advantages and disadvantages of management with IM, and propose a suggestion for the management of colorectal cancer with IM, such as screening for effective prescriptions. We also analyze Chinese medicine, studying the pharmacologic mechanism of its anti-cancer effect, further strengthening the study of IM on CRC.
Antineoplastic Agents ; therapeutic use ; Clinical Trials as Topic ; Colorectal Neoplasms ; drug therapy ; therapy ; Humans ; Integrative Medicine ; statistics & numerical data

OBJECTIVEUndertake analysis of the pragmatic use of Shuxuening injection, in order to understand the drug's characteristics and risks. This will provide the basis for a deeper understanding for risk management.

METHODTwenty general hospitals using Shuxuening injections were selected nationwide. Data analysis of their hospital information systems (HIS), comprising 48 445 inpatients of which 13 936 had received Shuxuening injections, took place. Analysis of patient demographics, drug use, drug combinations and patient deaths was carried out.

RESULTMore than 79% of patients were over 45 years old. Clinical use of the injection was for the treatment of cerebral infarction (equivalent to the Chinese medicine category of zhongfeng), coronary heart disease (equivalent to the Chinese medicine category of xiongbi), diabetes and hypertension. However, only 37.66% of Western medicine diagnoses are in accordance with recommendations and only 49.09% of Chinese medicine diagnoses follow the guidelines. The injection is administered intravenously, with most patients receiving a dosage of 15-20 mL per dose for between 3 and 7 days. It is always combined with aspirin in clinical practice.

CONCLUSIONShuxuening injection is primarily used for older patients. Several clinical risk factors have been identified including administering the wrong dose for inappropriate conditions and failure to follow guidelines. Appropriate risk management is required to protect patients.

Aged ; Aged, 80 and over ; Drug Therapy ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic