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目的:研究葛根素注射剂(GGS)引起的药物不良反应(ADR)发生率、ADR类型,探索GGS引起的溶血性贫血(HemolyticAnemia,HA)的发生机制。方法:利用北京市ADR监测网络,选择32家医疗单位参加本课题研究。课题以使用GGS的1319例病例为暴露组,同期使用丹参/复方丹参注射液(DS)的541例病例为对照组,进行队列研究。并将暴露组中临床拟诊为HA的6例患者作为病例组,设立正常对照组进行血液免疫学临床试验研究,以探索GGS引起的HA的发生机制。结果:GGS的ADR发生率3.34%,与DS(3.14%)相比两组差并无统计学意义(P>0.05)。暴露组ADR以转氨酶升高、药疹和HA最为多见;对照组ADR以药疹为主,两组ADR表现形式的构成差异呈高度显著(P<0.001)。暴露组中、重度病例15.9%,死亡2例。GGS引起的HA属于Ⅱ型变态反应。结论:GGS与DS的ADR发生率差异无显著性,但对GGS引起的严重ADR应给予特别关注。对于使用GGS的患者应定期监测相关指标,特别是对于体内已存在抗葛根素药物性抗体(GGS-Ab)的患者应避免再次使用该药。
Objective: To study the incidence of adverse drug reactions (ADR) and ADR types caused by puerarin injection (GGS) and explore the mechanism of hemolytic anemia (HA) caused by GGS. Methods: Using the Beijing ADR surveillance network, 32 medical units were selected to participate in the study. Subjects used 1319 cases of GGS as the exposure group, while 541 cases of Danshen/Danshen Danshen Injection (DS) were used as the control group for the cohort study. Six patients with clinically diagnosed HA in the exposed group were used as the case group. A normal control group was set up to conduct a clinical study of hematological immunology to explore the mechanism of HA induced by GGS. RESULTS: The incidence of ADR in GGS was 3.34%, which was not statistically different from that in DS (3.14%) (P>0.05). The highest levels of transaminase, drug eruption, and HA were found in exposure group ADR. Drug rash was the main component of ADR in the control group. The composition of ADR in the two groups was highly significant (P<0.001). In the exposed group, 15.9% of severe cases and 2 died. GGS-induced HA belongs to type II allergy. Conclusion: There is no significant difference in the incidence of ADR between GGS and DS, but special attention should be given to severe ADR caused by GGS. Patients with GGS should regularly monitor the relevant indicators, especially for patients already in the body of anti-Puerarin antibiotic drug (GGS-Ab) patients should avoid using the drug again.