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.
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.
Objective To evaluate the efficacy and safety of genus Phyllanthus for chronic HBV infection. Design a systematic review of randomized clinical trials. Methods Randomized trials comparing genus Phyllanthus versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assesses, by the Jadadscale plus allocation concealment. Results Twenty-two randomized trials (n=1 947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95%C1 1.85 to 17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBeAg, HBeAg, HBV DNA, and liver enzyme normalization. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum (1.56, 1.06 to 2.32) and HBV DNA (1.52, 1.05 to 2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Phyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not b due to the general low methodological quality and the variations of the herb. Further large trials are needed.
Objective To provide an overview of the main anti-tumor mechanisms of attenuated Salmonella typhimurium（ST） and explore potential reasons for the limited clinical application of attenuated ST. Methods The literatures related to clinical and basic research on attenuated ST tumor treatment and virulence at home and abroad in recent years were reviewed and the relevant mechanisms of attenuated ST tumor treatment were summarized. And then, analyses were made regarding the failure of clinical application experiments of attenuated ST based on the characteristics of attenuated ST and the human immune microenvironment. Results Attenuated ST could inhibit the growth of primary tumors and reduce the metastasis of secondary tumor due to its effect of tumor-targeting, its property of facultative anaerobic and its characteristic of being able to carry plasmids. On the other hand, the toxicity of wild strains to hosts had been reduced through biotechnology. In terms of clinical application, the anti-tumor effect of attenuated ST was far lower than expected due to excessive detoxification of ST, the elimination effect of foreign substances by the human immune system, and the inactivation effect of various proteases in the body. Conclusion As an emerging bacterial mediated anti-tumor therapy, attenuated ST will provide a new treatment option for precise treatment of cancer patients once its clinical application problems are solved.
Objective To assess efficacy of mepivacaine on local anesthesia in dentistry and oral surgery and its safety. Methods Parallel group, stratified randomization, double blinded, muti-center clinical trial was designed. Two percent lidocaine with adrenaline in same cartridge was as control. Healthy patients with deep decay, pulpitis needed operative dentistry, or indication for extraction of the teeth, which located in the maxilla or front part of the mandible were included. Results Except 17 cases, 127 patients fulfilled inclusion criteria: 66 in treatment group and 61 in control group, dental filling for 60 and extraction for 67 cases, male 55 and female 72, average at 38.84 + 12.06 years. Submucous infiltration of 1.5 ml mepivacaine at labial or buccal side of the alveolar process produced onset of anesthesia in the median of 60 seconds which was same as that of lidocaine, anesthesia duration for 146.7 minutes with the median of 125 minutes, permitting painless filling or extractions. In the treatment group 81.82% freed of pain, while 15.15% had slight pain but received no extra local anesthetic for implementation of the treatment procedures, making the successful rate of 96.97%. In the mepivacaine group, 13.64% of the cases had transient elevation of the systolic pressure to the level of 145-162 mmHg, 8.33% diastolic pressure to the level of 91-93 mmHg. Only one case had transient palpitation in half minute after one minute injection of the drug with no medical care needed. All the cardiovascular reactions might result from adrenaline containing in the injections. Conclusion Mepivacaine is an effective, safe and reliable anesthetic agent for dentistry and oral surgery.
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.
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 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.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To assess the safety and effect of different intravenous chemotherapic regimens in patients with gastric carcinomas who had received gastrectomy. Method A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from Medline and Embase (1980-2001.4), Chinese Bio-medicine Database (1990-2001.1). Literature references were checked at the same time. We included randomized andquasi-randomized trials in patients with confirmed gastric carcinomas who had received gastrectomy comparing the effect of intravenous chemotherapy after gastrectomy with that of gastrectomy alone.Results Twenty trials involving 4 171 patients were included. Meta-analysis was done with fixed effects model. Heterogeneity analyses was performed also. The effects of intravenous chemotherapy with 5FU + MCCNU, 5FU + MMC, 5FU + BCNU or FAM after gastrectomy were failed to show have better effects than that of surgery alone. There were eleven trials which detailed the side effects according to the toxicity grade by WHO standard. The side effects halting treatment were haematologic and biochemical toxicity, debilitating nausea and vomiting. There were twenty-two patients died of chemotherapic toxicity. Conclusions Based on the review, there is no enough evidence to show that intravenous chemotherapy after gastrectomy have positive treatment effect on gastric cancer.