| Objective:use of evidence-based medicine approach to carry out evaluation of the efficacy and safety of alprostadil clinical application, and through 2014 in a hospital in-patients alprostadil clinical usage and adverse reactions carried out survey, to clarify various clinical factors unreasonable used for clinical safe, effective and rational use of alprostadil reference.Method:Database retrieval:PubMed database, Embase CD database, MEDLINE, The Cochrane Library, Chinese Journal Full-text data (CNKI), Articles digitization of full text journals, Chinese Biomedical Literature Database, Chinese scientific and technical journals full-text databases. Retrieving coverage period:each database built Library-September 2015. According to inclusion and exclusion criteria, included randomized controlled trials of alprostadil (Randominzed Controlled Trail, RCT), Meta analysis (Meta-Analysis) and systematic review of the literature, its Meta data extraction and statistical analysis of Lipo Seoul clinical efficacy and safety of a reasonable evaluation.Randomly selected from a hospital in 2014 patients in the hospital use alprostadil complete medical records of 300 parts of retrospective research, questionnaire design, according to the sample of cases carefully fill out the form, the contents of the questionnaire included:patient’s basic information, drug use, clinical and laboratory data and medication rationality evaluation. Fill in the table of contents based on the comprehensive evaluation of the reasonableness of alprostadil in clinical use.Results:A total of 53 randomized controlled trials,15 of which English literature, Chinese literature 38. Alprostadil comparison with the control group divided into: compared with placebo, compared with the monotherapy and combination therapy treatment comparison. (1) In the total efficiency, the total effective rate alprostadil therapy over placebo monotherapy group and the combination group. The total efficiency is obviously superior to cinepazide alprostadil, low molecular weight heparin, aspirin, and other breviscapine having antithrombotic medicine and dilation of blood vessels and improve microcirculation of proprietary Chinese medicines, such as Xueshuantong Shuxuetong, Yinxingdamo and safflower injection; but there are no differences in overall efficiency comparison of alprostadil and its lipid microspheres injectable dosage form between; the total efficiency of alprostadil combined use of these drugs was also significantly higher in a separate drug group. (2) Improved after treatment in ankle-brachial blood pressure index (ABI), the alprostadil placebo monotherapy group and combined treatment group there were significant differences before and after treatment in improving the ABI value, with statistical significance. (3) Improvement in painless walking distance, the alprostadil group and the placebo in improving painless walking comparative statistical difference between the distance aspect, and with other comparative monotherapy and combination therapy due to incomplete data it can not be Systematic Review.In the safety evaluation of clinical drug alprostadil:there are 30 reports of adverse reactions/event of alprostadil (ADR/ADE). The drug major ADR/ADE are infusion reactions, nervous system and digestive system reaction, its mainly performance is:the injection site pain, phlebitis, rash, headache, dizziness, nausea, vomiting and other symptoms were mild, symptomatic treatment discontinuation were better, no any serious ADR/ADE occurs. Wherein alprostadil and placebo groups, alprostadil injection group, Shuxuetong group and safflower group there were significant differences in the occurrence of contrast ADR/ADE of rates was statistically significant; ADR combination comparison group/ADE there is no difference between the incidence rate was not statistically significant.According to a hospital 300 cases survey analysis show that:alprostadil in clinical departments is the highest utilization rate of cardiovascular department, which is consistent with the instructions mentioned indications of mention indications, but there are still 4.67% of patients with drug indications improper phenomenon.22.33% syndrome refers to the phenomenon of improper medication of patients over manual dosage; the presence of inappropriate dosing frequency phenomenon 0.67% of the patients; inappropriate choice of solvent phenomenon accounted for 4.00% of the total; there are 1.67% of patients after treatment for longer than one month; administration concentration is not in line with the requirements of the specification accounted for 46.00% of the total; in addition, there is the presence of 1.00% of the patients with joint drug incompatibility.300 cases of adverse reactions occurred in the reported rate of 2.67%, including one patient developed anaphylactic shock, symptomatic improvement after immediate withdrawal treatment, serious adverse reaction/event occurred.Conclusion:The system of evaluation results show:alprostadil have in the treatment of arteriosclerosis obliterans, before and after treatment to improve the value of ABI significant effect, and a lower incidence of adverse reactions, better safety, clinical value. However, due to the limited number of included studies of literature, quality evaluation is not high, so for the clinical evaluation of the reasonableness of alprostadil for further in-depth study in order to obtain a more comprehensive and reliable evaluation system. Because alprostadil has a variety of biological activities, clinical application more widely, therefore, lead to more serious clinical phenomenon of irrational use by hospital patients in a hospital in case investigation, analysis in the clinical alprostadil on the use of irrational factors, to guide the clinical medication. |
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