ABSTRACT
To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.
Subject(s)
Aged , Female , Humans , Middle Aged , Adverse Drug Reaction Reporting Systems , Bayes Theorem , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Pharmacovigilance , Risk ManagementABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of different operation time for acute spinal cord injury(SCI) based on systematic review.</p><p><b>METHODS</b>PubMed database, EMBASE database, Cochrane Library, ISI Web of knowledge, CBM database, VIP database, CNKI database and Wanfang database were searched from their start year up to February 2017 for relevant randomized clinical trials on the treatment of acute spinal cord injury with different intervention times.</p><p><b>RESULTS</b>Four randomized clinical trials of total 156 cases were included. Early surgical intervention for the patients with incomplete spinal cord injury can improve the ASIA motor function score [MD=3.29, 95%CI(-7.90, 14.49), =0.56] and overall Frankel score[=7.65, 95%CI(2.69, 21.74), =0.000 1]. There was no significant difference in the improvement of the overall Frankel score[=4.88, 95%CI(0.74, 32.09), =0.10] for the patients with complete spinal cord injury between the early surgery and delayed surgery group. There was no significant difference in hospitalization time[MD=-3.4, 95%CI(-8.12, 1.32), =0.16], death rate [=1.07, 95%CI(0.21, 5.56), =0.93]and incidence of decubitus[=1.07, 95%CI(0.17, 6.69), =0.94] between the early surgery and delayed surgery group.</p><p><b>CONCLUSIONS</b>Early surgical intervention can promote the nerve function recovery after spinal cord injury, whithout further incidence of complications, but random control trails with higher quality are still required for this conclusion.</p>
Subject(s)
Humans , Randomized Controlled Trials as Topic , Recovery of Function , Spinal Cord Injuries , General Surgery , Time FactorsABSTRACT
Corneal astigmatism includes anterior astigmatism (AA) and posterior astigmatism (PA).According to the hterature,85.0％-96.1％ PA ranging from-0.01 to-1.10 D refers to astigmatism against the rule.With the age increasing,PA shows a significant trend from astigmatism against the rule to with the rule,while AA shows toward against-the-rule astigmatism.Therefore,PA often leads to partially decrease of total astigmatism (TA) in young adults,but the increase of TA in aged elderly.Clinically,ignorance of PA will lead to a false estimate of TA,thereby affecting visual quality after refractive cataract surgery.And this article aims to introduce the measurement of PA and its clinical significance for providing the reference in clinical practices.
ABSTRACT
To prepare the intrauterine slow release silicone rubber bar made of Panax notoginseng and Rubia cordifolia, and finish its preliminary evaluation of in vitro releasing properties. The open mill method was used for plasticating of silicone rubber. The process parameters of the silicone rubber and drugs mixing were optimized by orthogonal test. The parameters of silicone rubber vulcanization was optimized by single factor test. The preliminary evaluation of in vitro release performance of the silicone rubber bar was conducted with ginsenoside Rg₁, ginsenoside Rb₁, notoginsenoside R₁, purpurin and rubimaillin as the indexes. The results showed that optimum technologic parameters for silicone rubber and drugs mixing：the roller spacing 2 mm; speed ratio 1∶1.2; front roller temperature 55-60 ℃; rear roll temperature 50-55 ℃; and mixing time 20 min. The optimum parameters for silicone rubber vulcanization：temperature 90 ℃, and time 60 min. The studies on release process in vitro revealed that the release process of silicone rubber bar was in line with the Higuchi equations. After 90 days, the cumulative release of ginsenoside Rg₁, ginsenoside Rb₁ and notoginsenoside R₁ was 46.7%, and the cumulative release of purpurin and rubimaillin was 51.9%. The preparation method can be applied to the preparation of silicone rubber bar, with slow release characteristics.
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the association of hepatic lipase -250G/A gene promoter polymorphism with type 2 diabetes mellitus combining with coronary heart disease.</p><p><b>METHODS</b>Using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), we detected the genotypes of the hepatic lipase gene promoter -250G/A, the effect of this polymorphism on plasma lipids, lipoproteins and apolipoproteins in 364 patients with type 2 diabetes mellitus and coronary heart disease(T2DM+CHD), 357 patients with type 2 diabetes mellitus alone(T2DM) and 356 healthy controls.</p><p><b>RESULTS</b>The frequencies of alleles and genotypes in the T2DM group were not significantly different from that of controls. However, the AA and GA genotypes in the T2DM+CHD group were lower than those in controls (0.431vs 0.618, P=0.031). The frequencies of both allele and genotype were not related to gender, family history, smoking and BMI. When adjusted by factors such as gender, age, BMI, history of smoking, family history of coronary atherosclerosis and systemic hypertension, Spearmanos correlation and linear regression analyses showed that the A allele is related positively to the levels of HDL-C and apoA1 in T2DM and T2DM+CHD patients. However, logistic regression analysis showed that the A allele is one risk factor for the presence of coronary heart disease.</p><p><b>CONCLUSION</b>The hepatic lipase gene promoter -250G/A polymorphisms is associated with type 2 diabetes mellitus with coronary heart disease, its polymorphisms may affect the levels of HDL-C and apoA1.</p>