Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medicat...Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medications. Methods: Sixty seven PIs for prescription—only medications were evaluated against a set of safety criteria published from the Ministry of Health. Results: Analyzed PIs showed many deficiencies with regard to the Ministry of Health (MOH) Investigation New Drug Application (INDA) requirements. Particularly of concern were side effects, warnings, use in pregnancy, lactation, and the storage conditions for the product. Conclusions: This study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend regulatory oversight and regulator audits from pharmaceutical company, followed by enhancement of regulations requiring companies to also create patient information leaflets.展开更多
目的探索药品说明书适老化的研究热点,为我国药品说明书适老化发展提供依据。方法在Web of Science核心合集数据库中检索2012-2022年发表的老年人使用药品说明书的相关英文文献,应用VOSviewer和CiteSpace软件进行文献计量学分析,探索该...目的探索药品说明书适老化的研究热点,为我国药品说明书适老化发展提供依据。方法在Web of Science核心合集数据库中检索2012-2022年发表的老年人使用药品说明书的相关英文文献,应用VOSviewer和CiteSpace软件进行文献计量学分析,探索该领域的研究热点,并总结该领域发展的障碍和解决措施。结果与结论本研究共收集到药品说明书适老化相关文献335篇,来自51个国家(地区)的819个研究机构,涉及2174位作者。近10年,药品说明书适老化研究发展趋缓,美国和日本等发达国家占该领域的主导地位,其中美国西北大学Wolf等学者的发文量最大(12篇)。老年人用药风险管理、药品说明书中老年用药信息的更新,以及老年人对药品说明书的理解和依从及其影响因素等是该领域的研究热点。药品说明书适老化发展中相关障碍的解决措施包括提高药品说明书的可视性、可读性,填补药品说明书中老年用药信息等。我国可借鉴其他国家的经验和方法,针对我国人口特点开展老年药品说明书影响因素的调查及老年用药的药动学研究,多维度提高老年患者用药的安全性。展开更多
Objective:To observe the therapeutic effect differences among five-knee-point acupuncture combined with Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction(身痛逐瘀汤 generalized p...Objective:To observe the therapeutic effect differences among five-knee-point acupuncture combined with Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction(身痛逐瘀汤 generalized pain stasis-expelling decoction),simple five-knee-point acupuncture and simple Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction in treating knee osteoarthritis(KOA).Methods:A total of 126 KOA patients were randomized into a five-knee-point acupuncture combined with Chinese medication package warm compress therapy group(combined treatment group),where there were 42 cases,including 28 cases of unilateral KOA and 14 cases of bilateral KOA,totally 56 affected knees involved,a Chinese medication package warm compress therapy group(medication package group,42 cases,including 22 cases of unilateral KOA,20 cases of bilateral KOA,totally 62 affected knees involved)and a five-knee-point acupuncture group(five-knee-point group,42 cases,including 27 cases of unilateral KOA,15 cases of bilateral KOA,totally 57 affected knees involved).The basic health education was provided in all of the groups.Additionally,in the combined treatment group,acupuncture was applied to the five knee points on the affected side for 30 min.The warm compress with herbal package of Shēntòng Zhúyū Decoction was given for 10 to 15 min.In the medication package group,the warm compress with Shēntòng Zhúyū Decoction was exerted on the affected area for 10 to 15 min.In the fiveknee-point group,acupuncture was applied to SP 10,ST 34,EX-LE 2,EX-LE 4 and ST 35 and the needles were retained for 30 min.The treatment in each group was given once a day,consecutively for 2 weeks.Before and after treatment,the visual analogue scale(VAS)and Lysholm knee scale were adopted to evaluate the pain degree and knee joint motor function in KOA patients.The clinical therapeutic effects were evaluated too.Results:A total of 121 cases accomplished the final observation and 5 cases were dropped out in the three groups,in which,2 cases(2 affected knees)were dropped out in the combined treatment group,1 case(2 affected knees)in the medication package group and 2 cases(3 affected knees)in the fiveknee-point group.VAS scores after treatment were all lower than those before treatment in the three groups and the scores of Lysholm knee scale were all higher than those before treatment,indicating the significant differences(all P<0.05).The total effective rate was 98.1%(53/54)in the combined treatment group,which was higher than 86.7%(52/60)in the medication package group and 92.6%(50/54)in the five-knee-point group,indicating the significant differences(all P<0.05).After treatment,VAS score(2.24±1.24)in the combined medication group was lower than(2.48±1.08)in the medication package group and(2.63 ± 1.44)in the five-knee-point group,presenting the significant difference(all P<0.05).The score of Lysholm knee scale was(60.50±13.76)in the combined medication group,higher than(52.23±11.65)in the medication package group and(52.14±11.77)in the five-knee-point group,indicting the significant differences(all P<0.05).Conclusion:Compared with the simple application of Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction or the five-knee-point acupuncture therapy,five-knee-point acupuncture combined with Shēntòng Zhúyū Decoction relieves the clinical symptoms of KOA patients more effectively and achieves a better clinical therapeutic effect.展开更多
文摘Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medications. Methods: Sixty seven PIs for prescription—only medications were evaluated against a set of safety criteria published from the Ministry of Health. Results: Analyzed PIs showed many deficiencies with regard to the Ministry of Health (MOH) Investigation New Drug Application (INDA) requirements. Particularly of concern were side effects, warnings, use in pregnancy, lactation, and the storage conditions for the product. Conclusions: This study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend regulatory oversight and regulator audits from pharmaceutical company, followed by enhancement of regulations requiring companies to also create patient information leaflets.
文摘目的探索药品说明书适老化的研究热点,为我国药品说明书适老化发展提供依据。方法在Web of Science核心合集数据库中检索2012-2022年发表的老年人使用药品说明书的相关英文文献,应用VOSviewer和CiteSpace软件进行文献计量学分析,探索该领域的研究热点,并总结该领域发展的障碍和解决措施。结果与结论本研究共收集到药品说明书适老化相关文献335篇,来自51个国家(地区)的819个研究机构,涉及2174位作者。近10年,药品说明书适老化研究发展趋缓,美国和日本等发达国家占该领域的主导地位,其中美国西北大学Wolf等学者的发文量最大(12篇)。老年人用药风险管理、药品说明书中老年用药信息的更新,以及老年人对药品说明书的理解和依从及其影响因素等是该领域的研究热点。药品说明书适老化发展中相关障碍的解决措施包括提高药品说明书的可视性、可读性,填补药品说明书中老年用药信息等。我国可借鉴其他国家的经验和方法,针对我国人口特点开展老年药品说明书影响因素的调查及老年用药的药动学研究,多维度提高老年患者用药的安全性。
文摘Objective:To observe the therapeutic effect differences among five-knee-point acupuncture combined with Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction(身痛逐瘀汤 generalized pain stasis-expelling decoction),simple five-knee-point acupuncture and simple Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction in treating knee osteoarthritis(KOA).Methods:A total of 126 KOA patients were randomized into a five-knee-point acupuncture combined with Chinese medication package warm compress therapy group(combined treatment group),where there were 42 cases,including 28 cases of unilateral KOA and 14 cases of bilateral KOA,totally 56 affected knees involved,a Chinese medication package warm compress therapy group(medication package group,42 cases,including 22 cases of unilateral KOA,20 cases of bilateral KOA,totally 62 affected knees involved)and a five-knee-point acupuncture group(five-knee-point group,42 cases,including 27 cases of unilateral KOA,15 cases of bilateral KOA,totally 57 affected knees involved).The basic health education was provided in all of the groups.Additionally,in the combined treatment group,acupuncture was applied to the five knee points on the affected side for 30 min.The warm compress with herbal package of Shēntòng Zhúyū Decoction was given for 10 to 15 min.In the medication package group,the warm compress with Shēntòng Zhúyū Decoction was exerted on the affected area for 10 to 15 min.In the fiveknee-point group,acupuncture was applied to SP 10,ST 34,EX-LE 2,EX-LE 4 and ST 35 and the needles were retained for 30 min.The treatment in each group was given once a day,consecutively for 2 weeks.Before and after treatment,the visual analogue scale(VAS)and Lysholm knee scale were adopted to evaluate the pain degree and knee joint motor function in KOA patients.The clinical therapeutic effects were evaluated too.Results:A total of 121 cases accomplished the final observation and 5 cases were dropped out in the three groups,in which,2 cases(2 affected knees)were dropped out in the combined treatment group,1 case(2 affected knees)in the medication package group and 2 cases(3 affected knees)in the fiveknee-point group.VAS scores after treatment were all lower than those before treatment in the three groups and the scores of Lysholm knee scale were all higher than those before treatment,indicating the significant differences(all P<0.05).The total effective rate was 98.1%(53/54)in the combined treatment group,which was higher than 86.7%(52/60)in the medication package group and 92.6%(50/54)in the five-knee-point group,indicating the significant differences(all P<0.05).After treatment,VAS score(2.24±1.24)in the combined medication group was lower than(2.48±1.08)in the medication package group and(2.63 ± 1.44)in the five-knee-point group,presenting the significant difference(all P<0.05).The score of Lysholm knee scale was(60.50±13.76)in the combined medication group,higher than(52.23±11.65)in the medication package group and(52.14±11.77)in the five-knee-point group,indicting the significant differences(all P<0.05).Conclusion:Compared with the simple application of Chinese medication package warm compress therapy of Shēntòng Zhúyū Decoction or the five-knee-point acupuncture therapy,five-knee-point acupuncture combined with Shēntòng Zhúyū Decoction relieves the clinical symptoms of KOA patients more effectively and achieves a better clinical therapeutic effect.
