ObjectiveTo explore the clinical effect of keeping the pancreatic capsule in radical gastrectomy for early stage of gastric cancer.
MethodsTwo hundreds and seven patients with early stage of gastric cancer who were treated in our hospital from Jan 2011 to December 2011 were enrolled prospectively, and were divided into experimental group (n=95) and control group (n=112). Patients in experimental group kept the pancreatic capsule in radical gastrec-tomy, but patients in control group didn't keep the pancreatic capsule. Comparison of the clinical effect between the 2 groups was performed.
ResultsThe blood loss[(134.1±5.3) mL vs. (150.3±3.7) mL] and operation time[(76.4±5.7) min vs. (87.5±9.1) min]of experimental group were all lower or shorter than those of control group (P<0.05), but there were no significant difference between the 2 groups in incidence of total complication[7.37% (7/95) vs. 10.71% (12/112)], stomal leak[3.16% (3/95) vs. 4.46% (5/112)], and anastomotic stenosis[4.21% (4/95) vs. 6.25% (7/112)], P>0.05. All of the 207 patients were followed-up for 1-36 months, with the median time of 17.5 months. During the follow-up period, in experimental group, there were 30 patients suffered from recurrence, 23 patients suffered from metastasis, and 44 patients died, and the 1-and 3-year survival rates was 84.21% (80/95) and 53.68% (51/95) respectively, 1- and 3-year disease free survival rates was 80.00% (76/95) and 48.42% (46/95) respectively; in control group, there were 37 patients suffered from recurrence, 23 patients suffered from metastasis, and 49 patients died, and the 1-and 3-year survival rates was 85.71% (96/112) and 56.25% (63/112) respectively, 1-and 3-year disease free survival rates was 81.25% (91/112) and 49.11% (55/112) respectively. There were no significant difference in the 1-and 3-year survival rate, 1-and 3-year disease free survival rate (P>0.05). In addition, there were no significant difference in the survival and disease free survival situation (P>0.05).
ConclusionsSurvival and disease free survival situation of keeping the pancreatic capsule in radical gastrectomy is similar with traditionally radical gastrectomy, but surgery of keeping the pancreatic capsule in radical gastrectomy has the advantages of less bleeding and shorter operation time, which is worthy of further study.
Different from modern medicine, traditional Chinese medicine (TCM) has its unique thought patterns and decision methods. In the process of developing TCM clinical practice guidelines, not only the modern clinical researches should be included, but also the TCM ancient books which had influenced TCM for thousands of years should be included. As an important carrier of TCM, the characteristics of researches in TCM ancient books are different from modern clinical researches. In this paper, we introduced the present situation of the TCM guidelines and how to use TCM ancient books for developing TCM clinical guideline with the guidance of evidence-based method. We used the example of developing of headache TCM guideline to explain how to use TCM ancient books as evidence source for guideline development and explored the application of evidence-based research of TCM ancient books to promote TCM clinical guidelines development.
Objective To compare the efficacy of one kind of modified De Vega technique and traditional De Vega technique. Methods From January 2002 to August 2005, 70 patients were treated with tricuspid valve plasty. These patients were divided into modified De Vega annuloplasty group and traditional De Vega annuloplasty group randomly before operation. The tricuspid regurgitation (TR) were functional and secondary in all patients. The grade of TR and New York Heart Association(NYHA) functional class of two groups were analyzed by Ridit analysis. The changes of right ventricular end-diastolic dimension of two groups were analyzed by paired-sample t test. Results There was no statistically difference between two groups about preoperative characteristics. The follow-up time of modified De Vega annuloplasty group was 12.91±8.84 months and that of traditional De Vega annuloplasty group was 13.61±11.21 months. There was no significant difference between two groups. The outcome of follow-up was satisfactory. In modified De Vega annuloplasty group, there were 12 patient with no TR, 17 patient with mild TR, and 6 patients with moderate TR. There was no patient with severe TR. In traditional De Vega annuloplasty group, 7 patients were observed with no TR, 19 patients mild TR, 7 patients moderate TR and 2 patients severe TR. In modified De Vega annuloplasty group, 32 patients were in NYHA class Ⅰ, 2 patients in NYHA class Ⅱ and only 1 patient in NYHA class Ⅲ. As for traditional De Vega annuloplasty group, 31 patients were in NYHA class Ⅰ, 2 patients in NYHA class Ⅱ and 2 patients in NYHA class Ⅲ. The Ridit analysis showed that there was no significant difference about NYHA class between two groups. However, the difference of TR between two groups was statistically significant (P〈0.05). The outcome of modified De Vega annuloplasty was superior to that of traditional De Vega technique. Paired-sample t test demonstrated that the modified De Vega annuloplasty could reduce the right ventricular end-diastolic dimension significantly (P〈0.05). However, the right ventricular end-diastolic dimension of traditional De Vega annuloplasty groups did not change significantly (P 〉 0.05). Conclusion The efficacy of modified tricuspid De Vega technique is superior to that of traditional De Vega technique in patients with secondary TR.
Objective To assess the effects and possible adverse reactions of traditional Chinese medicine (TCM) in treating arteriosclerosis obliterans. Methods Materials were collected with both electronic retrieval including EMbase (1978 to October 2009), OVID-MEDLINE (1950 to October 2009), Cochrane Controlled Trials Register (Issue 3, 2009), Current Controlled Trials, The National Research Register, CBM (1983 to September 2009), CNKI (1995 to September 2009), Wanfang Data (1994 to 2009), and VIP Data (1989 to 2009), and manual retrieval of related journals. All the retrievals were published before November 10, 2009 without limitation of languages. The quality of included studies was evaluated, and meta-analysis was conducted with RevMan 5.0.2 software. Results A total of 10 included studies were all randomized controlled trials, including 837 patients, and the sample size of each study was from 36 to 260 cases. Because both Chinese medicines and control drugs used in studies were different from each other, the effect size of each study can only be singley described and newly calculated. Most included studies showed that, the effects of TCM on cure rate, total effective rate and decrease of TC and TG were similar to that of aspirin, acipimox, prostaglandin E1; a few studies showed the effect of TCM was much better; one study on side effect showed that, TCM was less than western medicine. Conclusion The evidences of TCM effects in treating arteriosclerosis obliterans is quite limited, which has to be strengthened by more studies of high quality.
Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine (TCM) for non-alcoholic steatohepatitis (NASH). Methods Such databases as CNKI, VIP, CBM, and PubMed (from the date of their establishments to November 2009) were searched. Randomized controlled trials of TCM treatment of NASH were included. According to the principle of ZANG-fu Differentiation, the method recommended by the Cochrane Collaboration was applied to evaluate the quality of the studies and to conduct meta-analysis. Results Twenty-two studies were included, of which 18 were of low quality and 4 of high quality. The results of meta-analyses showed: there was no difference between liver-oriented TCM treatment and western medicine treatment in terms of the recovery rate, total effective rate, liver function, and blood lipid; the liver and spleen oriented TCM treatment was better than the western medicine treatment in terms of the recovery rate, total effective rate, liver function, and blood lipid, but similar to that of western medicine on TG and HDL-C; the liver, spleen and kidney oriented TCM treatment was better than the western medicine in terms of the recovery rate, total effective rate, liver function, lipids, but showed no difference on HDL-C; the liver and kidney oriented TCM treatment was better than the western medicine treatment in terms of the recovery rate, total effective rate, liver function, LDL-C, and HDL-C, but showed no differences on TC and TG. Conclusion The TCM has significant effects on NASH. The liver, spleen and kidney oriented TCM treatment is significantly better than the western medicine treatment in terms of the recovery rate, total effective rate, and liver function. TCM has no serious adverse reactions.
Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
ObjectivesTo investigate the citation status of systematic reviews (SRs)/meta-analyses in clinical practice guidelines and consensuses of traditional Chinese medicine (TCM).MethodsWe electronically searched PubMed, CBM, WanFang Data and CNKI databases to collect TCM guidelines and consensus from January 1st, 2009 to December 31st, 2018. Two reviewers independently screened literature and extracted data. Citation analysis method was used to analyze the citation status of SRs/meta-analysis in TCM guidelines and consensuses.ResultsA total of 142 TCM guidelines and consensuses were included, of which 39 (26.5%) failed to provide relevant citations. Of the 103 (72.5%) TCM guidelines and consensuses providing citations, 48 (34.3%) cited SRs/meta-analyses, and 43 cited outdated SRs/ meta-analyses. Four TCM guidelines and consensuses cited Cochrane reviews. In terms of citations, the average citations of guidelines and consensuses were 35.1 and 42.2, respectively; and the average SRs/meta-analyses citations of guidelines and consensuses were 3.8 and 5.5, respectively.ConclusionsTCM guidelines and consensuses citation report rates and the proportion of citation SRs/meta-analyses still require increase. TCM guidelines developers should strengthen the role and significance of SRs, especially Cochrane reviews, in supporting recommendations.
ObjectiveTo compare the similarities and differences in procedures between Western medicine (WM) and traditional Chinese medicine (TCM) guidelines. MethodsWe systematically searched China National Knowledge Infrastructure, WanFang Data, China Biology Medicine disc and PubMed from inception to May 17, 2022. Supplementary search of reputable medical institutions and organizations, as well as retrospective references were conducted and screened. We extracted and analyzed the basic information and guideline development procedure of the included handbooks. ResultsA total of 10 handbooks published from 2013 to 2022 were included, with four WM handbooks and six TCM handbooks. The median completeness of handbooks was 53.3%, with a maximum of 93.3% and a minimum of 43.3%. There are six handbooks with less than 60.0% completeness. The median reporting rate of the key steps was 65.0%, and the reporting rate of 5/8 of the key steps was more than 80.0%. Among the key reporting steps, role of funders, update methods, and conflict of interest management were reported at a low rate. Compared with WM handbooks, TCM handbooks reflected TCM characteristics in the procedure of topic selection, working groups, conflict of interest declaration and management, clinical questions, evidence, recommendations, report guideline, and external review. ConclusionThe completeness and reporting rate of the key steps need to be improved. TCM characteristics need to be further integrated when developing TCM guideline handbooks. We highly recommend that guideline stakeholders actively participate in handbook development to promote the quality of handbooks.
Image fusion currently plays an important role in the diagnosis of prostate cancer (PCa). Selecting and developing a good image fusion algorithm is the core task of achieving image fusion, which determines whether the fusion image obtained is of good quality and can meet the actual needs of clinical application. In recent years, it has become one of the research hotspots of medical image fusion. In order to make a comprehensive study on the methods of medical image fusion, this paper reviewed the relevant literature published at home and abroad in recent years. Image fusion technologies were classified, and image fusion algorithms were divided into traditional fusion algorithms and deep learning (DL) fusion algorithms. The principles and workflow of some algorithms were analyzed and compared, their advantages and disadvantages were summarized, and relevant medical image data sets were introduced. Finally, the future development trend of medical image fusion algorithm was prospected, and the development direction of medical image fusion technology for the diagnosis of prostate cancer and other major diseases was pointed out.