摘要:目的: 探討益活清下法早期聯用用丙氨酰谷氨酰胺二肽治療重癥急性胰腺炎(severe acute pancreatitis, SAP)的療效。 方法 :依據納入和排除標準,選取我院中西醫結合科收治的SAP80例,按1︰1隨機分成早期組(40例)和晚期組(40例),早期組入院時便應用丙氨酰谷氨酰胺二肽治療;晚期組入院5 d后加用丙氨酰谷氨酰胺二肽治療。 結果 :兩組入院時Ranson評分、CT評分、APACHEⅡ評分無統計學差異(P ＞005),治療15 d后早期組APACHEⅡ評分(497±239分)明顯低于晚期組(863±357分)(P ＜001);兩組并發ARDS、腎功能衰竭、休克、肝功能不全、心功能衰竭、腦病及腸麻痹的發生率無統計學差異(P ＞005);早期組ARDS、腎功能衰竭、休克、肝功能不全、腦病及腸麻痹持續時間及住院病程短于晚期組(P＜005 );早期組感染率、手術中轉率及病死率低于晚期組(P＜005 )。 結論 :益活清下法早期應用丙氨酰谷氨酰胺二肽治療SAP,可縮短并發癥的持續時間及病程,降低病死率和手術中轉率。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 assess the effectiveness and safety of prulifloxacin in the treatment of urinary tract infection. Methods The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group (prulifloxacin , 4 tablets, bid) and the control group (levofloxacin, 4 tablets, bid). The randomization code was produced by computer. The treatment duration for both groups was from 7 to 10 days. Results Data were analyzed on the basis of full analysis sets (FAS) and per-protocol (PP) analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates (Pgt;0.05). Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates (Pgt;0.05). The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively. Conclusion Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.
Objective To investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.
In the late-breaking trials session of the American Heart Association’s Scientific Sessions 2021, which took place in November 2021, six clinical trials in cardiac surgery published their primary results. This review will look into three of them including the management of patients with moderate or less-than-moderate tricuspid regurgitation at the time of surgery for degenerative mitral regurgitation, timing of ticagrelor cessation before coronary artery bypass grafting, and long-term outcomes of ticagrelor-based antiplatelet therapy for secondary prevention of coronary artery bypass grafting.
ObjectivesTo systematically evaluate the efficacy and safety of 1 470 nm laser vaporization vs. transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) about the efficacy and safety of 1 470 nm laser vaporization vs. TURP for BPH from inception to October 22nd, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 RCTs and 4 non-RCTs were included. The results of meta-analysis showed that: 1 470 nm laser vaporization was superior to TURP in reducing intraoperative bleeding (MD=?103.87, 95%CI ?148.08 to ?59.65, P<0.000 01), hospital stay (MD=?3.82, 95%CI ?4.35 to ?3.28, P<0.000 01), postoperative indwelling catheter time (MD=?2.24, 95%CI ?3.45 to ?1.02, P=0.000 3), postoperative hemoglobin (MD=?1.63, 95%CI ?3.14 to ?0.12, P=0.03) and rate of secondary hemorrhage (OR=0.13, 95%CI 0.03 to 0.48, P=0.002). There were no significant differences in operative time, bladder irrigation time, transient urinary incontinence and urethral stricture, IPSS Score and Qmax at 3 months after operation between the two groups (P>0.05).ConclusionCurrent evidence shows that 1 470 nm laser vaporization is superior to TURP in reducing intraoperative bleeding and secondary hemorrhage. It may be more suitable for prostate surgery in anticoagulant or coagulative dysfunction patients. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible RCTs of lung cancer with 22 780 patients were included. The patients were mainly with non-small cell lung cancer (84.91%), with the median sample size of the included studies was 364.0 (160.5, 599.5) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies measured "health-related quality of life". Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25.00% to 93.00%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For every increment in sample size, the completeness of reporting increased by 27.5% (SE=0.00, t=2.040, P=0.046). Additionally, studies published after 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.
ObjectiveTo investigate the effects of two different oxygen therapies (oxygen time<4 h/d, oxygen flow>6 L/min versus oxygen time>4 h/d, oxygen flow<6 L/min) on conservative treatment of spontaneous pneumothorax by meta-analysis.MethodsThe following electronic databases as PubMed, The Cochrane Library, Web of Science, Chinese Biomedical Literature Database, WanFang Database and China National Knowledge Database were retrieved on computer for randomized controlled trials (RCTs) of comparing two different oxygen therapies (oxygen time<4 h/d, oxygen flow>6 L/min versus oxygen time>4 h/d, oxygen flow<6 L/min) on conservative treatment of spontaneous pneumothorax. The retrieval time was from inception of each database to December 2017. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of the included studies. Then data were analyzed by RevMan 5.3 software.ResultsA total of 4 RCTs involving 226 patients were included. The meta-analysis showed that compared with lower oxygen flow (oxygen time>4 h/d, oxygen flow<6 L/min), the higher oxygen flow (oxygen time<4 h/d, oxygen flow>6 L/min) could obviously decrease the degree of pulmonary compression after oxygen therapy for 5 days (MD=–2.81, 95%CI –4.18 to –1.44, P<0.05), shorten duration of hospital stay (MD=–3.26, 95%CI –6.05 to –0.47, P<0.05) and duration of recruitment maneuvers (MD=–2.78, 95%CI –5.27 to –0.28, P<0.05), but there was no significant difference in oxygen partial pressure after oxygen therapy for 5 days (MD=10.68, 95%CI –7.03 to 28.39, P=0.24).ConclusionThe higher oxygen flow (oxygen time<4 h/d, oxygen flow>6 L/min) can obviously decrease the degree of pulmonary compression after oxygen therapy for 5 days, shorten duration of hospital stay and duration of recruitment maneuvers, but the results are influenced by the number and quality of RCT.
Objective To evaluate the effectiveness and safety of different injection sites for collagenase chemonucleolysis for lumbar intervertebral disc protrusion (LIDP). Methods We searched for randomized controlled trials (RCTs) and quasi-RCTs in the following electronic databases: Pubmed (1966 to May 2006), EMBASE(1966 to May 2006), The Cochrane library (Issue 2, 2006), CRD(Center for Reviews and Dissemination),York University, CBM (1978 to May 2006 ), CNKI(1994-2006)and VIP(1989-2006). Quality assessment and data extraction were conducted by two reviewers independently. Disagreement was resolved through discussion. Results Eight studies involving a total of 1035 participants met the inclusion criteria. Meta-analysis was not carried out because of apparent heterogeneity. Four studies made comparisons among intradisc, extradisc, and combined intra- and extra-disc injection. One study (62 participants) showed that intradisc injection was superior to extradisc injection (RR 3.71, 95% CI 1.19 to 11.58, Plt;0.05). Another study (240 participants) showed that intradisc injection was superior to combined intra- and extra-disc injection after 3 months and 6 months of follow-up (RR 0.88, 95% CI 0.80 to 0.98, Plt;0.05). The other two studies showed no significant difference among intradisc, extradisc, and combined intra- and extra-disc injection. Four studies (436 participants in total) showed that amongst three extradisc injections, both anterior epidural space injection and lateral epidural space injection were superior to posterior epidural space injection (Plt;0.05). Although one study indicated that anterior epidural space injection was superior to lateral epidural space injection (RR 1.24, 95% CI 1.03 to 1.51, Plt;0.05), no statistical significance was found between anterior epidural space injection and lateral epidural space injection in two other studies (Pgt;0.05). Conclusions There is insufficient evidence to identify which injection site for collagenase is the most effective for lumbar intervertebral disc protrusion. The included studies showed that both anterior and lateral epidural space injection were superior to posterior epidural space injection. However, these studies are too small and poor quality, and have different diagnostic criteria, follow-up time points, outcome measures and efficacy parameters. Thus, more high quality and large-scale RCTs are needed.
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 systematically evaluate the efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately or highly emetogenic chemotherapy. Methods Searched PubMed, Embase, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biological Medical Database, Wanfang Database and VIP Chinese Science and Technology Journal Database to find domestic and abroad published literatures of palonosetron used to control CINV associated with moderately or highly emetogenic chemotherapy. Two reviewers independently selected literatures, extracted data and assessed quality of the included studies by the Cochrane handbook 5.1. Meta-analysis was performed using RevMan 5.3 software. Results Twenty trials involving 4 919 patients were included. The results of meta-analysis showed statistically significant differences between palonosetron and first-generation 5-hydroxytryptamine3 receptor antagonists (5-HT3RAS) in prevention of acute〔RR=1.09, 95%CI (1.40, 1.14),P=0.000 4〕, delayed 〔RR=1.26, 95%CI (1.15, 1.37),P＜0.000 01〕, and overall phase of CINV 〔RR=1.19, 95%CI (1.10, 1.30),P＜0.000 1〕. Subgroup analyses indicated that there were no statistical significances between palonosetron and granisetron (P=0.09) or ondansetron (P=0.08) in prevention of acute CINV, as well as between palonosetron and first-generation 5-HT3RAS in prophylaxis of moderately CINV (P=0.18), while there was statistical significance in favor of palonosetron in prophylaxis of delayed and overall phase of CINV. Compared with first-generation 5-HT3RAS, there were different in prophylaxis of highly chemotherapy-induced acute〔RR=1.10, 95%CI (1.02, 1.18),P=0.01〕, delayed〔RR=1.20, 95%CI (1.06, 1.36),P=0.005〕, and overall phase〔RR=1.18, 95%CI (1.04,1.33),P=0.008〕of CINV. In terms of safety, such as headache, constipation, diarrhea and dizziness, there were no statistical differences between two groups. Conclusions Palonosetron hydrochloride injection showed efficacy in prophylaxis of moderately or highly CINV, and didn't increase adverse events. Palonosetron hydrochloride injection is more better than first-generation 5-HT3RAS, especially in prevention of highly CINV, and can significantly improve the control rate of acute, delayed, and overall phase of CINV.
