平消胶囊(片)的不良反应文献分析

Literature analysis of adverse reactions induced by Pingxiao Capsules or Pingxiao Tablets

目的统计平消胶囊(片)致不良反应(ADR)的相关文献,为临床该制剂的安全应用提供参考。方法检索在万方数字化期刊全文库、中国生物医学文献数据库、中国学术期刊(网络版)、中国科学引文数据库、中文科技期刊全文数据库(维普)、读秀学术搜索数据库以及Pubmed数据库并筛选出涉及平消胶囊(片)ADR的文献,统计分析所有服用平消胶囊(片)产生ADR的病例。结果共检索并筛选得到平消胶囊(片)致ADR的相关文献74篇,相应ADR病例共计1 168例;产生ADR的患者年龄集中在41～60岁,总计645例,占总数的55.22%;发生ADR的时间主要是在一周之内;产生ADR的患者就诊时诊断的疾病主要为乳腺增生等乳腺疾病、肺癌,分别占总病例的31.16%、21.58%;累及的系统主要为消化系统和生殖系统,其次为免疫系统;发生ADR的患者中多数在服用平消胶囊(片)的同时还联合使用其他西药或中成药,其中联用频率最高的西药是氟尿嘧啶和顺铂,而联用频率较高的中成药是长春地辛和莲芪胶囊;大部分文献未说明服用平消胶囊(片)产生ADR应如何应对,而文献有报道的针对服用平消胶囊(片)产生ADR的应对措施主要是饭后服药或减少服药量,或是针对不良反应对症加服其他药物。结论无论单独使用平消胶囊(片)还是联用其他药物均未见严重的不良反应,在不影响治疗效果的前提下可适当对症服用其他药物或是改变服药方式来缓解服用平消胶囊(片)所产生的ADR,后期临床应用中仍应记录其他新出现的ADR,为临床安全用药提供依据。

Objective To investigate the literature about adverse drug reaction（ADR） induced by Pingxiao Capsules or Pingxiao Tablets for rational clinical drug use. Methods Wangfang Database, China Biology Medicine disc, Chinese Academic Journal（online）, Chinese Science Citation Database, Chinese Science, and Technology Journal Full-text Database（VIP）, Duxiu Knowledge Search Database, and PubMed Database were retrieved, and related literatures about ADR induced by Pingxiao Capsules or Pingxiao Tablets were collected, summarized and analyzed. Results A total of 74 literatures related to adverse reactions（ADR） caused by Pingxiao Capsules or Pingxiao Tablets were searched and screened. The corresponding ADR cases totaled 1 168 cases. Most patients with ADR were 41 — 60 years old, a total of 645 cases, accounting for 55.22% of the total. ADR occurred mainly within a week. Patients with ADR were diagnosed with breast diseases such as breast hyperplasia and lung cancer, accounting for 31.16% and 21.58% of the total cases, respectively. The systems involved by ADR were mainly digestive and reproductive systems, followed by the immune system. Most of patients taking Pingxiao Capsules（Tablets） also used other western medicines or proprietary Chinese medicines in combination. Among them, western medicines with the highest frequency of combination were fluorouracil and cisplatin, while Chinese medicines with higher frequency of combination were vinorelbine and Lianqi Capsules. Most literatures did not explain how to handle ADR induced by taking Pingxiao Capsules（Tablets）. However, there are reports in the literature that the countermeasures for ADR were mainly taking medication after meals, reducing the dosage, or treating other drugs against adverse reactions. Conclusion No serious adverse reactions are found in Pingxiao Capsules（Tablets） alone or in combination with other drugs. They can be appropriately symptomatic to take other drugs or change the way of taking medicines to ease the effects without affecting the therapeutic effect. Other emerging ADR produced by Pingxiao Capsules（Tablets） in later clinical applications should be recorded, to provide evidence for clinical safe drug use.