在结核病控制中应用固定剂量复合剂（FDC）的相关研究
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摘要
研究目的
掌握深圳市耐药肺结核病的诊断、治疗、管理以及耐药结核菌的流行趋势现状,为制定耐药肺结核病防治对策提供参考依据。
通过国产FDC(实验组)与目前使用的板式组合药(对照组)的对比研究,探讨固定剂量复合制剂在区域内推广的适用性、可行性和技术措施。
研究方法
抽取1999-2005年深圳市耐药监测资料,调查耐药结核病管理现状;采用非劣效性随机对照临床试验和社区对照试验探讨FDC治疗肺结核的疗效、不良反应、病人的依从性和耐受性,医务人员对FDC制剂的接受性以及经济学的可行性;
应用Epi Data 3.10建立数据库,SPSS13.0软件进行统计学分析与处理。
研究结果
深圳市1999-2005年结核病细菌耐药监测结果发现:总耐药率28.5%,其中初始总耐药率27.4%、获得性总耐药率40.7%,耐多药率5.1%。目前仅对户籍人口推行DOTS-PLUS策略,治愈率可达68.75%。
非劣效性随机对照临床试验结果显示:实验组与对照组2月末痰菌阴转率分别为88%、84%,6月末痰菌阴转率提高到98%、97%,两组6月末结核空洞闭合率分别为58.33%、48.65%,痰菌阴转率和空洞闭合率均无显著性差异(P>0.05);胸片X线明显改善,实验组6月末胸片病灶的显收率(78%)高于对照组(65%),差别有显著意义(P<0.05);实验组与对照组临床症状和实验室检测的结果均无显著性差异(P>0.05)。实验组与对照组病人两年内的复发率无显著差异(P>0.05)。
社区对照试验的研究结果发现:实验组与对照组完成治疗率分别为95.3%与92.6%,差异不具有统计学意义(P>0.05),但实验组治愈率高于对照组(P<0.05);两组副反应发生率无显著性意义(P >0.05);更多的实验组病人认为服药方式可以接受,药片大小合适,药片数适中(P<0.05);两组病人因肝损伤停药率接近,分别为8.9%与5.8%,差异无显著意义(P>0.05);更多的实验组督导管理医生认为发放药物的难度大、药品的量化管理困难、目前药物管治病人不方便、目前药物不/说不清能增加病人的依从性(P<0.05);对照组药物的成本效果分析优于实验组。实验组与对照组病人两年内的复发率无显著差异(P>0.05)。
研究结论
1、国产FDC制剂与板式组合药的治疗效果、不良反应发生率、安全性接近,无显著差异,同时,国产FDC制剂可以改善病人的接受性和依从性,提高治愈率,适于在深圳市全面推广。但是由于制作工艺、技术和市场等多方面原因,医务人员的接受性和成本效果方面比组合药差,在药物组合、药物剂量和每周服药次数等方面有待进一步改进。
2、目前,板式组合药具有一定的价格优势,适于在发展中地区推广应用。
3、目前深圳市耐药率较高,尤其二线药物出现较高的耐药率,应引起重视,规范二线药物使用;DOTS不能彻底解决耐药结核问题,应增加投入,全人口推行DOTS-PLUS策略,是解决耐药结核的关键。
Objectives
To determine the diagnosis、treatment、management and epidemic situation of drug-resistant tuberculosis patients in Shenzhen in order to provide evidences for policy makers on tuberculosis control.
To study between Fixed-dosed combination and assembled drugs in Anti-tuberculosis Chemotherapy, evaluate the effects、safety、patients’acceptability and technique measures.
Methods
Researching on the management status of drug resistance of mycobacterium tuberculosis by drug resistance monitoring from 1999-2005.
Randomized non-inferiority study and community-controlled study was conducted to explore the treatment effects、adverse effects、patients’adherence and medical personnel acceptability and economy feasibility.
Epi Data 3.10 was used to build up the data-base, and all data were analyzed by SPSS 13.0.
Results
The result of drug-resistance from 1999 to 2005: rate of total DR is 28.5%,rate of initial total DR is 27.4%,rate of acquired total DR is 40.7%, rate of MDR-TB is 5.1%. DOTS-PLUS strategy was implemented in resident population, the cure rate was 68.75%.
The negative conversion rates of sputum at the 2nd month and 6nd month in the FDC group and the control group were 88% and 84% vs 98% and 97% respectively;Chest radiography showed remarkable improvement.The cavity closure rates at the 6nd month were 58.33% in the FDC group and 48.65% in the control group.No significant difference could be found between them.The resolution of pulmonary lesion at the 6nd month in the FDC group and the control group were 78% and 65% respectively,the resolution rate of FDC was higher than controlled group(P<0.05);No significant difference could be found between the rate of clinical symptoms adverse reactions and laboratory test result. No significant difference could be found between the relapse rates of two groups within two years.
The rates of complement treatment between fixed-dosed combination group and assembled drugs group were 95.3% and 92.6%, there is no difference, but the cure rate of FDC was higher than controlled group. No significant difference could be found between two groups about adverse reactions.Compared with controlled group, less patients in treatment group complained about the procedure of taking medicine, the size and number of pills (P<0.05).Stopping treatment rates because of liver damage in two groups are similar (8.9% and 5.8% respectively, P>0.05);More monitoring doctors in treatment group felt inconvenience in pills distribution, quantity management of pills and patients supervision. In their viewpoint, there was almost no advantage in increasing patients’adherence (P<0.05);The cost-effective of the controlled group showed a remarkable advantage over FDC. No significant difference could be found between the relapse rates of two groups within two years.
Conclusions
The treatment outcomes、adverse reactions and satefy between fixed-dosed combination and assembled drugs were nearly similar,there was no significant difference. National fixed-dose combination can improve the patients’compliance、acceptability and cure rate of chemotherapy, the expanded use of FDC is promising in Shenzhen.But acceptability of doctors and cost-effective analysis are inferior to controlled group due to manufacture technique, market and some other factors.
Assembled drugs has the advantage of price in tuberculosis control which could be recommended for wider use in developing district.
The rate of drug resistance in Shenzhen was high, especially the rate of secong-line drugs resistance was much higher, so the use of second-line drugs should be standarded. DOTS could not solute multidrug-resistant tuberculosis problem, investment should be increased. Implementing DOTS-PLUS strategy in whole population is the key to reduce epidemic situation of multidrug-resistant tuberculosis.
掌握深圳市耐药肺结核病的诊断、治疗、管理以及耐药结核菌的流行趋势现状,为制定耐药肺结核病防治对策提供参考依据。
通过国产FDC(实验组)与目前使用的板式组合药(对照组)的对比研究,探讨固定剂量复合制剂在区域内推广的适用性、可行性和技术措施。
研究方法
抽取1999-2005年深圳市耐药监测资料,调查耐药结核病管理现状;采用非劣效性随机对照临床试验和社区对照试验探讨FDC治疗肺结核的疗效、不良反应、病人的依从性和耐受性,医务人员对FDC制剂的接受性以及经济学的可行性;
应用Epi Data 3.10建立数据库,SPSS13.0软件进行统计学分析与处理。
研究结果
深圳市1999-2005年结核病细菌耐药监测结果发现:总耐药率28.5%,其中初始总耐药率27.4%、获得性总耐药率40.7%,耐多药率5.1%。目前仅对户籍人口推行DOTS-PLUS策略,治愈率可达68.75%。
非劣效性随机对照临床试验结果显示:实验组与对照组2月末痰菌阴转率分别为88%、84%,6月末痰菌阴转率提高到98%、97%,两组6月末结核空洞闭合率分别为58.33%、48.65%,痰菌阴转率和空洞闭合率均无显著性差异(P>0.05);胸片X线明显改善,实验组6月末胸片病灶的显收率(78%)高于对照组(65%),差别有显著意义(P<0.05);实验组与对照组临床症状和实验室检测的结果均无显著性差异(P>0.05)。实验组与对照组病人两年内的复发率无显著差异(P>0.05)。
社区对照试验的研究结果发现:实验组与对照组完成治疗率分别为95.3%与92.6%,差异不具有统计学意义(P>0.05),但实验组治愈率高于对照组(P<0.05);两组副反应发生率无显著性意义(P >0.05);更多的实验组病人认为服药方式可以接受,药片大小合适,药片数适中(P<0.05);两组病人因肝损伤停药率接近,分别为8.9%与5.8%,差异无显著意义(P>0.05);更多的实验组督导管理医生认为发放药物的难度大、药品的量化管理困难、目前药物管治病人不方便、目前药物不/说不清能增加病人的依从性(P<0.05);对照组药物的成本效果分析优于实验组。实验组与对照组病人两年内的复发率无显著差异(P>0.05)。
研究结论
1、国产FDC制剂与板式组合药的治疗效果、不良反应发生率、安全性接近,无显著差异,同时,国产FDC制剂可以改善病人的接受性和依从性,提高治愈率,适于在深圳市全面推广。但是由于制作工艺、技术和市场等多方面原因,医务人员的接受性和成本效果方面比组合药差,在药物组合、药物剂量和每周服药次数等方面有待进一步改进。
2、目前,板式组合药具有一定的价格优势,适于在发展中地区推广应用。
3、目前深圳市耐药率较高,尤其二线药物出现较高的耐药率,应引起重视,规范二线药物使用;DOTS不能彻底解决耐药结核问题,应增加投入,全人口推行DOTS-PLUS策略,是解决耐药结核的关键。
Objectives
To determine the diagnosis、treatment、management and epidemic situation of drug-resistant tuberculosis patients in Shenzhen in order to provide evidences for policy makers on tuberculosis control.
To study between Fixed-dosed combination and assembled drugs in Anti-tuberculosis Chemotherapy, evaluate the effects、safety、patients’acceptability and technique measures.
Methods
Researching on the management status of drug resistance of mycobacterium tuberculosis by drug resistance monitoring from 1999-2005.
Randomized non-inferiority study and community-controlled study was conducted to explore the treatment effects、adverse effects、patients’adherence and medical personnel acceptability and economy feasibility.
Epi Data 3.10 was used to build up the data-base, and all data were analyzed by SPSS 13.0.
Results
The result of drug-resistance from 1999 to 2005: rate of total DR is 28.5%,rate of initial total DR is 27.4%,rate of acquired total DR is 40.7%, rate of MDR-TB is 5.1%. DOTS-PLUS strategy was implemented in resident population, the cure rate was 68.75%.
The negative conversion rates of sputum at the 2nd month and 6nd month in the FDC group and the control group were 88% and 84% vs 98% and 97% respectively;Chest radiography showed remarkable improvement.The cavity closure rates at the 6nd month were 58.33% in the FDC group and 48.65% in the control group.No significant difference could be found between them.The resolution of pulmonary lesion at the 6nd month in the FDC group and the control group were 78% and 65% respectively,the resolution rate of FDC was higher than controlled group(P<0.05);No significant difference could be found between the rate of clinical symptoms adverse reactions and laboratory test result. No significant difference could be found between the relapse rates of two groups within two years.
The rates of complement treatment between fixed-dosed combination group and assembled drugs group were 95.3% and 92.6%, there is no difference, but the cure rate of FDC was higher than controlled group. No significant difference could be found between two groups about adverse reactions.Compared with controlled group, less patients in treatment group complained about the procedure of taking medicine, the size and number of pills (P<0.05).Stopping treatment rates because of liver damage in two groups are similar (8.9% and 5.8% respectively, P>0.05);More monitoring doctors in treatment group felt inconvenience in pills distribution, quantity management of pills and patients supervision. In their viewpoint, there was almost no advantage in increasing patients’adherence (P<0.05);The cost-effective of the controlled group showed a remarkable advantage over FDC. No significant difference could be found between the relapse rates of two groups within two years.
Conclusions
The treatment outcomes、adverse reactions and satefy between fixed-dosed combination and assembled drugs were nearly similar,there was no significant difference. National fixed-dose combination can improve the patients’compliance、acceptability and cure rate of chemotherapy, the expanded use of FDC is promising in Shenzhen.But acceptability of doctors and cost-effective analysis are inferior to controlled group due to manufacture technique, market and some other factors.
Assembled drugs has the advantage of price in tuberculosis control which could be recommended for wider use in developing district.
The rate of drug resistance in Shenzhen was high, especially the rate of secong-line drugs resistance was much higher, so the use of second-line drugs should be standarded. DOTS could not solute multidrug-resistant tuberculosis problem, investment should be increased. Implementing DOTS-PLUS strategy in whole population is the key to reduce epidemic situation of multidrug-resistant tuberculosis.
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