Background Acute pancreatitis is one of the most severe acute abdominal conditions. Recently with the understanding of pathophysiology and pathogenesis of acute pancreatitis, cytokines, especially platelet-activating factor (PAF), have been shown to play an important role. Lexipafant is a potent inhibitor of PAF. It has shown exiting results in the animal experiments, so randomized controlled studies are needed to assess the impact of lexipafant for acute pancreatitis. Objectives To determine whether lexipafant can alter the course, prevent or treat organ failure and reduce mortality in acute pancreatitis. Search strategy Electronic databases were searched and reference lists from included studies were also handsearched. Published abstracts from conference proceedings and ten kinds of Chinese medical journals were handsearched for additional citations. Personal contaction with colleagues and experts in the field of pancreatitis was performed to identify potentially relevant trials. Selection criteria Randomized, controlled trials, In which participants went in hospital within 72 hours of belliache episode, comparing lexipafant to placebo or other interventions on organ failure rate or mortality of acute pancreatitis. Data collection and analysis Data related to the clinical outcomes were extracted by two reviewers independently, if there was any divarication, they would have a discussion. Main Results Three studies meet the inclusion criteria up to 2001. Compared with control group, lexipafant had the tendency of reducing the early deaths (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.23 to1.38, P=0.2), accelerating the recovery of organ failure (OR 0.40, 95%CI 0.12 to 1.32, P=0.13) and reducing the occurrence of new organ failure OR 0.34, but these results had no statistical significance. A large-scale multicentre randomized controlled trial including 1 500 patients has been completed in America, but the result has not been published. Reviewers’ Conclusions Current evidence couldn’t draw the final conclusion. So the large-scale of randomized controlled trials is required.
Objective To appraise the current situation of randomized controlled trials (RCTs) on information of common-used digestive-related medicines afforded by medicine-salesmen. Methods RCTs on digestive-related medicines were assessed according to clinical epidemiologic standard. Results 60 medicines containing 252 therapeutic articles were searched and 75 RCTs were identified and assessed. Conclusion The qualities and quantities of RCTs of information on digestive-related medicines were of large difference, the RCTs afforded by the joint pharmaceutical enterprises are much better than those of foreign ones and domestic ones.
Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.
Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy.Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Clinical trials were searched from Cochrane Controlled Trials Register (Issue 4, 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1980 to January 2004), the Chinese Biological Medicine Database (1978 to January 2004), the Chinese Science and Technology Journal Full-text Database (1989 to January 2004) and references of all included trials. The selection of studies, data extraction and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quality of the most included trials was of low level. The "funnel plot" of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of meta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period.Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not b because of the low quality of most trials. Rigorously designed, randomized, double-blinded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
摘要:目的: 探讨益活清下法早期联用用丙氨酰谷氨酰胺二肽治疗重症急性胰腺炎(severe acute pancreatitis, SAP)的疗效。 方法 :依据纳入和排除标准,选取我院中西医结合科收治的SAP80例,按1︰1随机分成早期组(40例)和晚期组(40例),早期组入院时便应用丙氨酰谷氨酰胺二肽治疗;晚期组入院5 d后加用丙氨酰谷氨酰胺二肽治疗。 结果 :两组入院时Ranson评分、CT评分、APACHEⅡ评分无统计学差异(P ＞005),治疗15 d后早期组APACHEⅡ评分(497±239分)明显低于晚期组(863±357分)(P ＜001);两组并发ARDS、肾功能衰竭、休克、肝功能不全、心功能衰竭、脑病及肠麻痹的发生率无统计学差异(P ＞005);早期组ARDS、肾功能衰竭、休克、肝功能不全、脑病及肠麻痹持续时间及住院病程短于晚期组(P＜005 );早期组感染率、手术中转率及病死率低于晚期组(P＜005 )。 结论 :益活清下法早期应用丙氨酰谷氨酰胺二肽治疗SAP,可缩短并发症的持续时间及病程,降低病死率和手术中转率。Abstract: Objective: To compare the effects of integrated basal treatment of Chaiqin Chengqi Decoction with alanylglutamine Dipeptide giving in different times for sever acute pancreatitis. Methods : The randomized parallel control was adopted. 80 patients of SAP were randomized to earlytreated group (40 cases were treated by AlaGln as soon as who entered hospital) and latetreated group (40 cases were treated by AlaGln after 5 days from who had entered hospital). The mortality, incidences of complication, operation and mortality,the duration of complication and the course of diseases, hospitalization were compared. Results : The mortality shown that in earlytreated group was lower than the latertreated group, there was statistically significantly difference. Ranson score, CT score, Acute Physiology and Chronic Heath EvaluationⅡscore (APACHEⅡ score) and the incidences of complications were no statistical differencein the two groups(P ＞005)in the early stage of hospitalization. But the APACHEⅡ score (497±239)in earlytreated group was lower than those in latetreated group(863±357)after 15 days(P ＜001 The duration of acute respiratory distress syndrome(ARDS ),renal failure, shock, hepatic failure, encephalopathy and enteroplegia were shorter in earlytreated group than those in latetreated group(P＜005 . The incidence of infection, operation and mortality were lower in earlytreated group than those in latetreated group(P＜005 . The course of diseases of earlytreated group was shorter than that of latetreated group (P＜005 . Conclusion : SAP treated by (CQCQD) and AlaGln in early stage can shorten the duration of complications and the hospitalization period, and reduce the incidences of infection, operation rates and mortality rate.
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.
Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
Objective To assess the effectiveness and safety of tinidazole buccal tablets produced by China Associate Pharmaceutical Co. , Ltd. on periodontitis and pericoronitis. Methods A mukicenter randomized controlled doubleblind trial was designed. Three units from Shanghai, Hangzhou and Chengdu joined the study. The trial tablet oftinidazole was supplied by the mentioned Pharmaceuticals company. A marketed tinidazole produced by Zhejiang Hacon Marine BioPharmaceutical Co. Ltd. , was used as positive control. Both drugs were administered at a dose of 5 mg four times daily for 6 days. Outcomes measurement included symptoms, clinical signs of the patients with periodontitis or pericoronitis, and gingival index （GI）, bleeding index （BI）, plaque index （PI） and periodontal depth （PD） were measured for the patients with periodontitis. Subgingival bacterial samples taken from subgingival plaque of diseased teeth of the cases with periodontitis or from exudates of diseased wisdom teeth of the cases with pericoronitis were cultivated aerobically and anaerobically. Putative microorganisms were isolated and colony forming unit （CFU） were counted before and after treatments. All adverse drug reactions （ADIL） were observed, recorded, properly treated and followed. Results Altogether, 157 cases met the inclusion criteria and entered the study. Lost to follow-up happened in 14 cases with drop-out rate of 8.9%. In per-protocal cases there were 109 with periodontitis （57 in trial group and 52 in control group） and 34 with pericoronitis （17 in trial group and 17 in control group）. Basehne analysis demonstrated that the two groups were comparable. At the final examination, it was found that 85% of the cases in the periodontitis group showed significant）mprovement gingival bleeding, both gingival pain and biting pain subsided, PD, BI, GI and PI reduced with no significant difference between trial and control groups （P 〉0.05）. The symptoms of sixty percent of cases with pericoronitis were improved. More than 75% of the cases with pericoronal pus, the pus were ehminated. Over 60% of the cases with lymphadenitis, the node swelling was subsided. Mouth opening increased in all cases with pericoronitis. All improvements in the cases with pericoronitis showed no significant difference between trial and control groups （ P 〉0.05 ）. The effective rate only including cured and markedly improved cases reached 88.2% in both groups of pericoronitis. Various species of putative microorganisms were detected in patients with periodontitis or pericoronitis before treatment. A great proportion of the putative microorganisms eliminated or the quantity reduced after treatment, with no significant difference between trial and control groups （P 〉0.05 ）. Candida albicans was not detected before and after treatment. Nine patients developed ADRs, 5 （6.8% ）in trial group and 4 （5.8% ）in control group. All the ADRs were mild and transient, not interfering with drug administration. Conclusions This study showed the tinidozole buccal tablet with commercial name “Jinhe” supphed by China Associate Pharmaceutical Co. , Ltd. do inhibit the common putative microorganisms of periodontitis and pericoronitits, and do not influence balance of the local commensal microganisms. It reduces severity of the infectious inflammation and benefits improvement and/ or rehabilitation of periodontitis and pericoronitis, with only mild and transient ADRs. The trial and control tablets have similar efficacy and safety for patients with periodontits or pericoronitis.
ObjectivesThe aim of this meta-analysis was to evaluate the adjuvant efficacy of dendritic cell (DC) vaccines against advanced colorectal cancer.MethodsCNKI, CBM, WanFang Data, VIP, PubMed, Web of Science, The Cochrane Library and EMbase were searched to identify studies on dendritic cell vaccine for CRC up to August 13rd, 2017. After independently screening the literature and extracting data, two researchers evaluated the risk of bias in the studies, and used RevMan 5.3.5 software for meta-analysis.ResultsA total of 10 studies involving 2 050 patients were included. Meta-analysis showed that cellular immunotherapy based on DC vaccine treatment can improve the 2-year and 3-year overall survival rate of patients with advanced colorectal cancer (HR=0.33, 95%CI 0.17 to 0.27; 0.26, 95%CI 0.12 to 0.56, P<0.05), while there was no statistically significant difference in 1-year overall survival rate (HR=0.48, 95%CI 0.19 to 1.20, P=0.12); DC-CIK-based cellular immunotherapy could improve 2-year and 3-year overall survival rates (HR=0.27, 95%CI 0.10 to 0.75; HR=0.15, 95%CI 0.04 to 0.54, P<0.05), the difference of 1-year overall survival rate was not statistically significant (HR=0.39, 95%CI 0.13 to 1.13, P=0.08); DC combined with chemotherapy could improve 2-year and 3-year overall survival (HR=0.24, 95%CI 0.10 to 0.56; HR=0.22, 95%CI 0.04 to 0.54, P<0.05); the difference of 1-year overall survival rate was not statistically significant (HR=0.34, 95%CI 0.06 to 2.03, P=0.24); median overall survival in the DC vaccine group (MSR=1.25, 95%CI 1.16 to 1.34, P<0.05) and median progression-free survival (MSR=1.39, 95%CI 1.25 to 1.53, P<0.05) were superior to the control group. Fever was the most common adverse reaction and most patients could be relieved after treatment.ConclusionsDendritic cells vaccines-based immunotherapy can effectively improve the later overall survival rate and prolong median OS of patients with advanced colorectal cancer with mild adverse reactions, however the improvement of short term survival rate is not obvious.