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.
Objective To assess efficacy of a mouthwash containing 0.1% cetylpiridinium on gingivitis and plaque and its safety. Methods Multi-center randomized double-blind trial with positive control and split-mouth comparison was designed. Scaling on teeth of left side were conducted at do then on those of right side at D8. The cases rinsed five times a day in same way with assigned agents. Efficacy was measured using before-after differences of clinical and microbial variables. Re-examinations were scheduled at D4 and D8. Brushing was refrained between D0 and D4, resumed between D4 and D8. Results There were 144 patients with gingivitis included, 4 lost follow up. Data of 69 cases in test group and 71 in control group could be analyzed. Baseline data analysis showed that distributions of sex, age and values of clinical and microbial variables in both groups were well comparable. At D4 plaque accumulations of the scaled side in both groups were in same level, and Gingival index (GI), sulcus bleeding index (SBI) and VAS for halitosis were significantly reduced. At D8 the measurements of plaque index (PI), GI, SBI and VAS of halitosis decreased significantly more than those of D4. More than half of the suspected pathogenic strains were eliminated and log value of its CFU/ml decreased significantly but at same level in both groups. The balance of intra-oral bacterial flora was not disturbed. Seventeen cases in test group (24.6%) had minor and transient adverse reactions related to the mouthwash. Antimicrobial tests in vitro confirmed that the test agent could kill or inhibit growth of the pathogenic bacteria involving with oropharyngeal infection, gingivitis, periodontal diseases and caries. Conclusion The mouthwash containing cetylpiridinium could inhibit plaque, reduce severity of gingivitis and halitosis, with acceptable minor adverse reactions, similar to those of the marketed cetylpiridinum solution.
Objective To systematically review the effectiveness of different therapies for chronic periapical lesion (CPL), such as different root canal surgeries and conventional root canal obturation. Methods The following databases such as The Cochrane Library, MEDLINE, EMbase, VIP, CNKI, CMB and WanFang Data were searched to collect the randomized controlled trials (RCTs) and concurrent controlled trials (CCTs) on CPL treated by both conventional root canal obturation and different root canal surgeries such as periapical curettage, retrograde obturation and apicoectomy. The references of the included studies were also retrieved, and the retrieval time was from inception to October 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality. Then after cross-checking, the meta-analyses were performed by using RevMan 5.0 software. Results A total of 7 RCTs and 11 CCTs involving 1 663 patients were included. Among all 1 727 teeth, 1 661 met the inclusion criteria which contained 1 151 in the root canal surgeries groups, and 510 in the conventional groups. The methodological quality of all included studies was low. The results of meta-analysis showed that, in general, different root canal surgeries plus conventional root canal obturation were more effective than root canal obturation alone (RR=1.12, 95%CI 1.08 to 1.18, Plt;0.000 01). The results of sub-group analysis revealed that, the total effective rate of both retrograde obturation (RR=1.3, 95% CI 1.15 to 1.46, Plt;0.000 1) and apicoectomy (RR=1.23, 95% CI 1.04 to 1.46, P=0.02) was superior to that of periapical curettage, with significant differences in both sub-groups. But retrograde obturation took similar effect as apicoectomy did, without a significant difference (RR=0.96, 95% CI 0.83 to 1.11, P=0.61). Conclusion This systematic review suggests that, root canal obturation plus root canal surgeries is superior to root canal obturation alone in treating chronic periapical lesions. The comparison among different root canal surgeries reveals that, both apicoectomy and retrograde obturation are superior to periapical curettage. For the quantity and quality limitation of the included studies, additionally, the possibly existing bias because it is difficult to conduct surgeon and patient blind methods in root canal obturation and root canal surgeries in clinic, so the above conclusion has to be further proved by performing more well-designed and high quality RCTs.
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.
ObjectivesTo systematically review the efficacy and safety of hydrotalcite in the treatment of reflux esophagitis (RE).MethodsCBM, CNKI, WanFang Data, VIP, PubMed, EMbase, The Cochrane Library, Web of Science and Scopus databases were searched online to collect randomized clinical trials (RCTs) of hydrotalcite or hydrotalcite plus PPI versus PPI alone in the treatment of RE from inception to June 30th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed by RevMan 5.3 software.ResultsA total of 15 RCTs involving 1 655 patients were included. The results of meta-analysis showed that: after 4-8 weeks of treatment, there was no significant difference between hydrotalcite vs. PPI regarding RE healing rates (RR=0.87, 95%CI 0.76 to 1.00, P=0.05). However, there were significant increases in RE healing rate (RR=1.22, 95%CI 1.14 to 1.31, P<0.001) and symptom relief rate (RR=1.36, 95%CI 1.12 to 1.66,P<0.01) between hydrotalcite plus PPIvs. PPI alone. Similar increases of RE healing rate (RR=1.16, 95%CI 1.08 to 1.25, P<0.001) and symptom relief rate (RR=1.12, 95%CI 1.04 to 1.20,P<0.01) were seen in patients with refractory RE. No increase of adverse effect rate was shown with hydrotalcite or hydrotalcite plus PPI compared to PPI alone.ConclusionsCompared with PPI alone, hydrotalcite plus PPI confers a statistically significant improvement of healing rate and symptom relief rate, while it does not increase adverse effect rate. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.
Objective To evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic cor pulmonale. Design A systematic review of randomized clinical trials. Method Randomized trials comparing Salviae miltiorrhizae Injection plus routine treatment versus muting treatment alone were identified by electronic and manual searches. No blinding and language limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n=2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1.15 to 1.26). Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not b. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Injection may have positive effect on symptom scores in patients with chronic cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, there is no reliable conclusion. However, the evidence is not b due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important markers. Further large trials are needed.
With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.
Objective To review the current progress of clinical and experimental research of vascularized lymph node transfer for lymphedema. Methods The domestic and abroad literature about vascularized lymph node transfer in treatment of lymphedema was reviewed and analyzed. Results Experimental studies in animal model indicate that vascularized lymph node transfer can improve lymph node survival and show a promising effectiveness in reducing lymphedema. " Lymphatic wick” and " lymph pump” were the two main hypotheses proposed to explain the potential functional mechanism of vascularized lymph node transfer in treatment of lymphedema. Improvement in lymphedema symptoms are reported in most of the clinical trials, but the level of evidence to advocate this procedure in the treatment of lymphedema remains low because of the small number of the cases and problems in their methodologies. Conclusion Based on current evidence, vascularized lymph node transfer seems to be a promising treatment for lymphedema, but long-term well-designed studies are required to further explore the effectiveness of this procedure.
Objective To evaluate the effect of perioperative period clinical care mode through fast-track (FT) under nonminimal invasive operation on the inflammatory response of colorectal cancer resection. Methods Fifty-five patients underwent elective colorectal cancer resection were randomized divided into two groups: FT group (n=29) in which patients were performed FT perioperative care and tradition group (n=26) in which patients were received traditional perioperative care. The nonminimal invasive operations were performed in this study. The venous blood samples were respectively collected at 24 h before operation, at 24 h, 72 h, and 7 d after operation, and were used to detect the concentrations of serum C-reactive protein (CRP) and serum amyloid A protein (SAA).Results There was no complication such as infection, fistula of stoma and inflammatory ileus that was potential to influence the study results in two groups, and no patient died. The trend of changes in the concentrations of CRP and SAA of patients was accordant in each group. The peak concentrations of CRP and SAA of patients in FT group were respectively observed at 24 h after operation 〔CRP: (72.36±60.94) mg/L; SAA: (328.97±267.20) mg/L〕, while which were respectively delayed to 72 h after operation in tradition group 〔CRP: (112.71±63.92) mg/L; SAA: (524.18±331.03) mg/L〕. At the same time, the concentrations of CRP and SAA in FT group began to descend 〔CRP: (57.21±30.42) mg/L; SAA: (237.43±215.66) mg/L〕. The peak concentrations of CRP and SAA in tradition group were significantly higher than that in FT group (Plt;0.001) and the concentrations of CRP and SAA in FT group were significantly lower than those in tradition group at 72 h after operation (Plt;0.001). On 7 d after operation, the concentrations of CRP and SAA further decreased, but the difference between two groups was not significant (Pgt;0.05). Likewise, the concentrations of CRP and SAA at 7 d after operation were significant higher than those 24 h and 72 h after operation (Plt;0.001), lower than that 24 h before operation (Plt;0.001), respectively. Conclusion This study demonstrates that perioperative period clinical care mode through FT under non-minimal invasive operation can reduce the inflammatory response of colorectal carcinoma resections and scientific clinical care is an important means to promote quick rehabilitation.