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中国防痨杂志 ›› 2007, Vol. 29 ›› Issue (2): 111-116.

• 论著 •    下一篇

固定剂量复合剂在国家结核病防治规划中的应用研究

成诗明1；钟球2；郑金凤3；谢艳光4；李晓凤5；王伟6；陈诚1；徐敏1；杜昕1；   

  1. 1中国疾病预防控制中心结核病预防控制中心 北京 100050；2广东省结核病防治研究所 广州 510630；3福建省疾病预防控制中心 福州 350007；4黑龙江省结核病防治所 哈尔滨 150500；5陕西省咸阳市疾病预防控制中心 咸阳712000；6重庆华邦制药股份有限公司 重庆 400041；
  • 出版日期:2007-02-10 发布日期:2007-11-03
  • 基金资助:
    世界银行贷款/英国赠款(WB/DFID)中国结核病控制项目(NO.2003004)

Operational research of use Fixed-Dose Combination in national tuberculosis programme in China

Cheng Shiming1,Zhong Qiu,Zheng Jinfeng.et al.   

  1. 1.National Center for Tuberculosis Control and Prevention,Chinese Centerfor Disease Control and Prevention,Beijing 100050,China
  • Online:2007-02-10 Published:2007-11-03

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摘要： 目的研究固定剂量复合剂(FDC)在国家结核病防治规划中对肺结核患者治疗的可行性,为制定国家药品供用政策提供依据。方法选择4省17个县,采用固定剂量复合剂与抗结核板式组合药,对初治涂阳肺结核患者治疗效果、不良反应、治疗依从性及药品用量的对照研究。结果研究组484例初治涂阳肺结核患者中,治疗2个月和3个月末痰涂片阴转率为91.1%和95.0%,治愈率为94.6%,对照组482例初治涂阳肺结核患者中,治疗2个月和3个月末痰涂片阴转率为90.2%和92.9%,治愈率为89.4%,治愈率研究组高于对照组(P<0.05);研究组不良反应病例数90例(18.6%),对照组89例(18.5%),在不良反应病例数中,因严重不良反应中断和停止治疗病例数37例,其中,研究组10例,占研究病例总数的2.1%,对照组27例,占对照组病例总数的5.8%(P<0.05);患者在不同时期与治疗依从性有关因素的问卷调查中,反应例数不一;各省患者不同等级体质量不一。按照两种制剂用量方法计算患者口服药片数,966例患者用FDC药片数与板式组合药片数比,强化期少29.0%,继续期少8.5%。结论用FDC对初治涂阳肺结核患者治愈率达到国家结核病防治规划要求,因降低了严重药物不良反应所造成的患者中断治疗,以及患者药品片数比组合药减少,为减少耐药结核病人的发生和降低的药品成本具有重要作用,值得进一步推广应用。

关键词: 结核,肺/药物治疗, 固定剂量复合剂, 可行性研究

Abstract: Objective To explore the feasibility of treating new smear positive TB patient with Fixed-Dose Combination(FDC) in NTP in China,to provide evidence for the decision-maker to develop the policy on FDC use and supply. Methods Case-control study was conducted in 17 DOT counties in 4 provinces,with the case group using FDC and control group using the blister pack.The treatment outcome,side-effect and patient’s compliance were compared and the demand of the drug was calculated according to the weight of the patients in different area. Results For the new smear positive patients treated with FDC,the conversion rate at the end of 2nd and 3rd month were respectively 91.1% and 95.0% and the cure rate was 94.6%,the conversion rate at the end of 2nd and 3rd month in control group were respectively 90.2% and 92.9% and cure rate was 89.4%.Cure rate was higher in case group than control group(P<0.05).90 of 484 occurred side-effect of all kinds of drug and its frequency was 18.6% in case group.89 of 482 occurred side-effect of all kinds of drug and its frequency was 18.5%in control group. 37 of the total number of patient stopped the treatment due to the side-effect and among which 10(2.1%) was in case group and 27(5.8%) was in control group(P<0.05).According to the survey in different time of the treatment,patient’s compliance was different.The percentage of the patient with the weight was different between provinces.The number of drug tablets used in FDC was fewer than that of blister pack. Conclusion By using FDC,the cure rate of new smear positive patient has achieved the target of NTP,as the defaulted cases due to severe adverse side effect was less in case group than the control group and the number of drug tablet was fewer in case group than in control group.Therefore,FDC can play an important role in reducing MDR-TB and the cost of the drugs.The use of FDC should be further expanded in next step.

Key words: Pulmonary tuberculosis/drug therapy, Fixed-Dose Combination(FDC), Feasibility research

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