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.
Objective To assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
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 assess the efficacy and safety of corticosteroid and antiviral agents for idiopathic facial nerve paralysis (IFNP) by network meta-analysis.MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WangFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of corticosteroid and antiviral agents for IFNP from inception to January 31th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. The meta-analysis was performed by R 3.3.3 and Stata 13.0 software.ResultsA total of 16 RCTs involving 3 061 patients were included. The results of network meta-analysis showed that: for the facial function recovery rates, corticosteroid plus antiviral agents was superior to placebo and antiviral agents alone at 3-month follow-up. Corticosteroid plus antiviral agents was superior to placebo, antiviral agents or corticosteroid alone at 6-month follow-up (if the satisfactory recovery was defined as a House-Brackmann grade class Ⅱ or below). When the follow-up exceeded 6 months, corticosteroid alone was superior to placebo and antiviral agents alone, corticosteroid plus antiviral agents was superior to placebo and antiviral agents alone. All of the differences above were statistically significant. For the sequelae, corticosteroid plus antiviral agents and corticosteroid alone were superior to placebo and antiviral agents alone. Corticosteroid plus antiviral agents was superior to corticosteroid alone. The differences were statistically significant. For the adverse events, there were no significant differences between any other pairwise comparisons of these different interventions.ConclusionConsidering the efficacy and safety, patients with IFNP treated corticosteroid plus antiviral agents are more likely to have a better recovery of facial function and less likely to develop sequelae, followed by corticosteroid alone. More high-quality, large scaled and multicenter RCTs are required to verify the conclusions above, and focus on the treatment of children and patients with severe facial paralysis.
Objective To determine the effects recombinant human growth hormone (GH) and hypocaloric nutrition on postoperative convalescence, we performed a placebo-controlled randomized double-blind trial in 18 patients after elective gastrectomy or colectomy. Methods The subjects received parenteral nutrition containing 20 calories/kg per day and 1 g protein/kg per day. Daily injections of drug or placebo were given during the first postoperative week. Result The nine control subjects lost 3.3 kg (5.9% of preoperative weight) and had a cumulative nitrogen loss of 32.6 ± 4.2 g nitrogen at eight days. The patients receiving GH lost significantly less weight (1.3 kg) and nitrogen loss was 7.3 ± 3.1 g at eight days (Plt;0.001). Kinetic studies demonstrated that anabolic effects of GH were associated with increased protein synthesis, and amino acid flus studies across the forearm revealed increased uptake of amino acid nitrogen in the GH-treated patients. Body composition analysis revealed that the patients receiving GH maintained their lean body mass despite the major surgical procedure. Conclusion We conclude that the postoperative catabolic response can be modified with GH and hypocaloric nutrition. The metabolic and physiologic effects should now be studied in a larger number of patients to determine if this approach can reduce morbidity, mortality, and length of hospital stay for surgical patients.
Virtual clinical trials are clinical trials conducted through computer simulation technology, which breaks through the limitations of traditional clinical trials and has the advantages of saving time, reducing costs, and reducing the risk of human trials. With the application of new computer technologies such as population pharmacokinetics, physiologically-based pharmacokinetics, quantitative systems pharmacology, and artificial intelligence, the field of virtual clinical trials in healthcare has become an important development direction. This article will give a preliminary review of the connotation, methods and future development trends of virtual clinical trials, aiming to provide reference for the application of new technologies and methods in clinical trials.
Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were 1g for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable (15 in the triagroup and 15 in the control group). No significant differences were observed between the trial group and the control group with respect to the cure rate (40% vs. 27%), the effective rate (80% vs. 87%), the bacterial clearance rate (92% vs. 100%), and the incidence of adverse drug reactions (12.5% vs. 13%) (Pgt;0.05). Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.
Since the outbreak of the coronavirus disease (COVID-19), more than 200 interventional clinical trials have been registered in Chinese Clinical Trial Registry (www.chictr.org.cn) and the US Clinical Trials Registry (www.clinicaltrials.gov), testing or going to test treatments of COVID-19 in China from January 23rd, 2020 to March 5th, 2020. This situation has drawn attentions from various sectors of society. This article summarizes the basic design features of 249 registered COVID-19 clinical trials in China, compares them with National Clinical Trials Network practices in the USA, and describes a concept of national clinical trials network as a strategy to enhance quality and efficiency of clinical research in cases like COVID-19 outbreak as well as other disease fields.
Objective To evaluate the efficacy and safety of amoxicillin/sulbactam (AMX/SBT) in the treatment of acute bacterial infections. Method A multicentre randomized controlled clinical trial was conducted. Ampicillin/sulbactam (AMP/SBT) was chosen as the control drug. 113 patients were enrolled in the study (58 cases in test group and 55 cases in control group). AMX/SUL and AMP/SUL were administered 4.5-6.0 g and 4.5-12.0 g every day respectively. Both drugs were given intravenously for 7-14 days. Results The cure rates and the efficacy rates of the two groups were 75.86%, 80.0% and 94.83%, 98.18% respectively. The β-lactamase producing rates were 67.35% , 69.57% and the bacterial clearance rates were 93.88%, 95.65%.There were no significant differences of the above results between the two groups (Pgt;0.05). There was no serious adverse drug reaction in AMX/SBT groups. Conclusion This study suggests that AMX/SBT is an effective and safe drug for treating acute bacterial infections.
Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second- line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
