[Systematic review and Meta-analysis of efficacy and safety of Ningmitai Capsules in treatment of urinary tract infection].

This study aims to evaluate the effectiveness and safety of Ningmitai Capsules in the treatment of urinary tract infection.To be specific, articles on the treatment of urinary tract infection with Ningmitai Capsules were retrieved from China National Know-ledge Infrastructure(CNKI), Wanfang, VIP, SinoMed, Cochrane Library, PubMed, EMbase, and Web of Science(from establishment to October 2021).Eligible randomized controlled trials(RCTs) were screened out, and ROB and RevMan 5.3 of Cochrane were employed for data integration and Meta-analysis.Finally, 17 articles were included, involving 1 972 cases, with 1 045 in the experimental group and 927 in the control group.The Meta-analysis results are as follows.Ningmitai Capsules combined with conventional antibiotics was superior to sensitive antibiotics alone in the treatment of acute pyelonephritis in aspects of clinical cure rate(RR=1.94, 95%CI[1.58, 2.37], P<0.000 01), reduction in the count of red blood cells in the urine(MD=-3.22, 95%CI[-3.23,-3.21], P<0.000 01), decrease in the count of white blood cells in the urine(MD=-2.34, 95%CI[-2.59,-2.10], P<0.000 01), and time for the disappearance of the symptoms(MD_(time for urinary tract irritation disappeared)=-2.19, 95%CI[-2.69,-1.68], P<0.000 01; MD_(time for waist aches disappeared)=-3.58, 95%CI[-4.20,-2.97], P<0.000 01; MD_(time for heating disappeared)=-0.57, 95%CI[-0.81,-0.33], P<0.000 01).The combination of either cephalosporin or quinolone with Ningmitai Capsules can improve clinical cure rate of acute pyelonephritis(RR_(combined with cephalosporin)=1.94, 95%CI[1.56, 2.42], P<0.000 01; RR_(combined with quinolone)=1.91, 95%CI[1.16, 3.15], P=0.01).The clinical cure rate(RR=1.91, 95%CI[1.47, 2.49], P<0.000 01) of diabetes complicated with urinary tract infection by Ningmitai Capsules was higher than that by quinolones.The clinical cure rate(RR=1.22, 95%CI[1.09, 1.37], P=0.000 5) of non-gonococcal urethritis by Ningmitai Capsules combined with conventional tetracycline and macrolide antibiotics was higher than that by conventional antibiotics.Ningmitai Capsules combined with conventional antibiotics/Ningmitai Capsules alone was superior to conventional antibiotics alone in the treatment of urinary tract infection in terms of the clinical cure rate(RR=1.35, 95%CI[1.17, 1.56], P<0.000 1) and incidence of adverse reactions(RR=0.32, 95%CI[0.15, 0.68], P=0.003), particularly the combination with quinolone antibiotics(RR=1.30, 95%CI[1.04, 1.61], P=0.02).The main adverse reactions were mild gastrointestinal discomfort, nausea, vomiting, and dry mouth.In summary, Ningmitai Capsules combined with conventional sensitive antibiotics/Ningmitai Capsules alone can improve the clinical cure rate of patients with urinary tract infection.Ningmitai Capsules combined with conventional sensitive antibiotics can significantly reduce the time for symptom disappearance of acute pyelonephritis and down-regulate the counts of red and white blood cells in the urine compared with antibiotics alone, and no serious adverse reactions have been found.However, in light of the low proportion of quality eligible articles, experiments with rigorous design, large sample size, and complete outcome in-dexes should be carried out in the future to verify the clinical efficacy and safety of Ningmitai Capsules in the treatment of urinary tract infection.

[Clinical comprehensive evaluation of Qilong Capsules in treatment of ischemic stroke with Qi deficiency and blood stasis syndrome].

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments. Based on the evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, and pharmacoeconomics, the qualitative and quantitative evaluation of "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility, as well as characteristics of traditional Chinese medicine(TCM) was performed with multi-criteria decision analysis(MCDA) mo-del using the information, such as public data, literature data, pharmaceutical research, and questionnaire survey, and CSC v2.0 was used to calculate the clinical value of Qilong Capsules. The evaluation results were grade A, B, C, or D. Spontaneous reporting system(SRS) monitoring data, literature reports, clinical trials, and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth, nausea, and rash, and no severe adverse reactions was found. The evidence was sufficient with small and controllable known risks, and the safety was grade A. Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits, clinical total response rate, patients' activities of daily living, and hemorheological indexes. The level of evidence was high with manifest clinical significance, and the effectiveness was grade A. The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone, but the incremental effect was not significant. The quality evaluation results of the economic report were comparatively clear, and the economy was grade B. Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM, Qilong Capsules focused on the inheritance of classics and scientific and technological innovation, and innovation was grade B. The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients, and the suitability was grade B. The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income. The drug accessibility was good with a wide range of drug sales, sufficient production capacity, and sustainable medicinal materials resources, and was grade B. This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application, which could regulate Qi and blood circulation, and the section of TCM characteristics was grade B. Based on the evidence evaluation results of "6+1" dimensions of Qilong Capsules, the comprehensive evaluation of clinical value was class A. It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.

[Systematic evaluation and Meta-analysis of Xiao'er Chaigui Tuire Granules in treating hand, foot and mouth disease].

The efficacy and safety of Xiao'er Chaigui Tuire Granules for the treatment of hand, foot and mouth disease were syste-matically evaluated. Four Chinese databases of CNKI, CBM, WanFang, VIP and four English databases of PubMed, Cochrane Library, EMbase, Web of Science were retrieved by computers. With Chinese and English words "Xiao'er Chaigui Tuire Granules" "hand, foot and mouth disease" as the subject and keywords, randomized controlled trials(RCT) for the effect of Xiao'er Chaigui Tui-re Granules alone and combined with Western medicine in the treatment of hand, foot and mouth disease were retrieved, and the retrieval time was generally from the establishment of the database to January 20, 2020. Then all the relevant documents that meet the requirements and be included in the quality evaluation standard were screened out, relevant baseline data information was extracted, and a final evaluation was conducted for the quality of relevant literatures. The quality evaluation was conducted by the latest RevMan 5.3 software version-based tools. The reliability of the data relating to the results of the literatures was analyzed by statistical data. A total of 7 RCTs were included. The total sample size was 619, including 321 in the experimental group and 298 in the control group. Meta-analysis results show that: Xiao'er Chaigui Tuire Granules could improve the total clinical effectiveness(RR=1.28, 95%CI[1.11, 1.46], P=0.000 4; RR=1.62, 95%CI[1.06, 2.48], P=0.02); Xiao'er Chaigui Tuire Granules combined with Western medicine could significantly shorten the healing time of oral ulcers in children with hand, foot and mouth disease(MD=-1.11, 95%CI[-1.44,-0.78], P<0.000 01; MD=-2.13, 95%CI[-2.37,-1.89], P<0.000 01; MD=-1.10, 95%CI[-1.38,-0.82], P<0.000 01); on the basis of conventional treatment, Xiao'er Chaigui Tuire Granules combined with Western medicine could reduce the fever time(MD=-1.21, 95%CI[-2.15,-0.27], P=0.01; MD=-1.93, 95%CI[-2.35,-1.51], P<0.000 01; MD=-2.00, 95%CI[-2.60,-1.40], P<0.000 01), with no serious adverse reaction. The results showed that, in the treatment of hand, foot and mouth disease, compared with the conventional treatment method of Western medicine alone, the combined use of Xiao'er Chaigui Tuire Granules had more obvious advantage in effectively shortening the healing time of oral ulcers in children and effectively reducing the antipyretic time. Moreover, it had a better clinical efficacy in treating the patients with hand, foot and mouth disease in the early stage in terms of the improvement and control of symptoms and pathology, with a significantly increased effectiveness and no serious adverse reaction. It could be considered to be combined with therapies based on syndrome differentiation. However, due to the small sample size of clinical studies currently included, and the low quality of clinical studies further included, the quality of the studies included was low, which affected the scientific reliability and quality of the conclusions of the study. Therefore, further clinical results are still required for further confirmation.

[Systematic review on efficacy and safety of Lanqin Oral Liquid in treatment of hand, foot and mouth disease].

Lanqin Oral Liquid is a Chinese patent medicine which contains Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Phellodendri Chinensis Cordex and Sterculiae Lychophorae Semen. It is known for the pharmaceutical effect on the upper respiratory tract infection as it is beneficial for relieving the swelling of pharyngeal. In terms of Chinese medicine, it offers a clearing action on heat and toxic materials. According to the principle of Chinese medicine, different diseases can be treated by the same therapy as long as they have the same syndrome. Based on this unique diagnosis and treatment approach, Lanqin Oral Liquid was applicable to diseases with syndrome of excessive heat in lung and stomach. It was therefore commonly be used in the therapeutic approach towards hand, foot and mouth disease as well. However, no systematic evaluation had yet been done to verify this Chinese patent medicine on the efficacy and clinical safety for the disease. In order to achieve the manner of evidence-based medicine, this study had adopted a systematic review and Meta-analysis to evaluate the efficacy and safety of Lanqin Oral Liquid in the treatment of hand, foot and mouth disease. All related randomized controlled trials(RCT) were searched in the following data bases: CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed. Based on the method provided by the Cochrane collaboration, the study assessed the quality of papers selected and RevMan 5.3 software was used to perform Meta-analysis. Totally 24 studies were included with 3 491 sample size, which 1 826 cases were treatment group and 1 665 cases were control group. From the results of Meta-analysis, the total effective rate of combination of Lanqin Oral Liquid and Western medicines shown better than Western medicine alone in the treatment for hand, foot and mouth di-sease, but mild adverse event were also found(RR=1.20,95%CI[1.16,1.23],P<0.000 01). Incidence of adverse reaction between experimental and control group was statistically insignificant(RR=1.16, 95%CI[0.79, 1.70], P=0.45). No conclusion was able to made in terms of the remission time of clinical symptoms, as the studies included were not qualified for Meta-analysis. As a matter of fact, the number of existing studies related to the Lanqin Oral Liquid were limited with poor quality as well. In other words, high quality studies were essential to further evaluate the efficacy and safety of Lanqin Oral Liquid.

The Uptake and Distribution Evidence of Nano- and Microplastics in vivo after a Single High Dose of Oral Exposure.

Objective: Tissue uptake and distribution of nano-/microplastics was studied at a single high dose by gavage in vivo. Methods: Fluorescent microspheres (100 nm, 3 µm, and 10 µm) were given once at a dose of 200 mg/(kg∙body weight). The fluorescence intensity (FI) in observed organs was measured using the IVIS Spectrum at 0.5, 1, 2, and 4 h after administration. Histopathology was performed to corroborate these findings. Results: In the 100 nm group, the FI of the stomach and small intestine were highest at 0.5 h, and the FI of the large intestine, excrement, lung, kidney, liver, and skeletal muscles were highest at 4 h compared with the control group ( P < 0.05). In the 3 µm group, the FI only increased in the lung at 2 h ( P < 0.05). In the 10 µm group, the FI increased in the large intestine and excrement at 2 h, and in the kidney at 4 h ( P < 0.05). The presence of nano-/microplastics in tissues was further verified by histopathology. The peak time of nanoplastic absorption in blood was confirmed. Conclusion: Nanoplastics translocated rapidly to observed organs/tissues through blood circulation; however, only small amounts of MPs could penetrate the organs.

Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial.

BACKGROUND: Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD). METHODS: One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups. RESULTS: At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05). CONCLUSIONS: The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.