| 施有琴,杨丽宁,吴玉琼,王明霞,张文杰,金永新,张鑫,郑彤,要林青.地芪固本口服液对慢性丙型病毒性肝炎抗病毒治疗不良反应的影响研究[J].中国药事,2018,32(4):567-574 |
| 地芪固本口服液对慢性丙型病毒性肝炎抗病毒治疗不良反应的影响研究 |
| Effect of Diqi Guben Oral Solution on Adverse Drug Reactions in Antiviral Therapy for Chronic Hepatitis C |
| 投稿时间：2017-11-14 |
| DOI：10.16153/j.1002-7777.2018.04.024 |
| 中文关键词: 地芪固本口服液 慢性丙型病毒性肝炎 抗病毒治疗 不良反应 |
| 英文关键词: Diqi Guben oral solution chronic hepatitis C antiviral therapy adverse drug reactions |
| 基金项目:甘肃省中医药管理局项目（编号GZK201314） |
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| 中文摘要: |
| 目的：探讨地芪固本口服液对慢性丙型病毒性肝炎（CHC）患者抗病毒治疗中不良反应（ADR）的影响。方法：参照2004年《丙型肝炎防治指南》诊断标准，将189例CHC患者随机分为2组，治疗组95例，对照组94例。两组均给予聚乙二醇干扰素α-2a 180 μg，1周1次，皮下注射和按体重口服利巴韦林1000 mg·d-1（体重< 75 kg）或1200 mg·d-1（体重> 75 kg），疗程48周，治疗结束后随访24周。治疗组加用地芪固本口服液，一次50 mL，一日2次。监测两组患者治疗期间ADR发生情况。结果：治疗组共发生ADR 701例次，对照组发生894例次。从整体看，发生了至少一次ADR的患者及人均发生例次数两组差异有统计学意义（P ≤ 0.05）。在疲乏、白细胞减少、中性粒细胞减少、体重减低、血小板减少、贫血、精神异常发生率上，两组差异具有统计学意义（P ≤ 0.05），治疗组均低于对照组。两组ADR的严重程度均以1级和2级为主，两组严重程度的百分率经秩和检验Z=8.030，P<0.05，差异有统计学意义。治疗组SDS评分均低于对照组，尤其是治疗12、24周（P ≤ 0.05）。结论：地芪固本口服液能够有效减少和减轻抗病毒治疗引起的ADR。 |
| 英文摘要: |
| Objective: To discuss the effect of Diqi Guben oral solution on adverse drug reactions (ADR) in antiviral therapy in patients with chronic hepatitis C (CHC). Methods: 189 patients with CHC were randomly divided into two groups according to the diagnostic criteria of Guidelines for the Prevention and Treatment of Hepatitis C issued in 2004, with 95 patients in the treatment group and 94 patients in the control group. Both groups were administrated peginterferon alfa-2a 180μg, once a week by subcutaneous injection and orally administrated ribavirin 1000 mg·d-1 (body weight<75 kg) or 1200 mg·d-1 (body weight>75 kg) for 48 weeks and were followed up for 24 weeks afterwards. The treatment group was given 50 mL Diqi Guben oral solution, twice a day. The ADR was monitored during the treatment in the two groups. Results: 701 cases of ADR occurred in the treatment group and 894 cases of ADR occurred in the control group. There was statistically signifcant difference of the patients having at least one ADR and the times of ADR per capita between the two groups (P ≤ 0.05). There was statistically signifcant difference in the incidence of the fatigue, leucopenia, neutropenia, weight loss, thrombocytopenia, anemia and mental abnormalities between the treatment group and the control group (P ≤ 0.050) and the incidences of the treatment group were lower than those of the control group. The severity of ADR of the two groups was mainly grade 1 and grade 2. The difference of percentage of the severity of the two groups was statistically signifcant by rank sum test (Z=8.030, P<0.05). The SDS score of the treatment group was lower than that of the control group, especially at 12, 24 weeks after the treatment of (P ≤ 0.05). Conclusion: Diqi Guben oral solution can effectively reduce and alleviate the ADR caused by antiviral therapy. |
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