Clinical symptoms and microbiological outcomes in tuberculosis treatment trials.
Clinical symptoms and microbiological outcomes in tuberculosis treatment trials.
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DOI：
10.1016/j.tube.2011.05.007
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发表时间：
2011-11
期刊：
影响因子：
--
通讯作者：
Johnson JL
中科院分区：
文献类型：
--
作者：
Bark CM;Dietze R;Okwera A;Quelapio MI;Thiel BA;Johnson JL
在最近的一次食品和药物管理局关于评估新结核病药物的临床试验的研讨会上，提出了关于使用细菌学终点（如治疗失败和复发）作为治疗后健康状况和长期结局改善的指标的问题。FDA的科学家询问了患者的临床体征和症状在治疗期间如何变化，并指出，虽然这些信息通常是在临床试验期间收集的，但并不经常报告。我们分析了一项国际3期结核病治疗试验的数据，该试验包括对症状的系统评估。基线时有自我报告症状的受试者百分比范围从30%的呼吸困难到81%的咳嗽，其中51%报告发烧。治疗期间，发热、出汗和呼吸困难下降最快，治疗结束时几乎消退。胸痛和咳嗽缓解较慢; 13%的受试者在6个月时报告咳嗽。治疗期间症状缓解在复发和未复发的受试者之间没有差异。在微生物学复发的受试者中，症状复发的比例显著增加，伴有发热、咳嗽和胸痛。在复发时，咳嗽是最常见的症状，75%的复发受试者发生咳嗽，但只有12%的未复发受试者发生咳嗽。我们的数据支持继续使用基于痰培养的细菌学终点作为结核病药物试验中症状缓解、健康状况改善和良好长期治疗结果的替代指标。
During a recent Food and Drug Administration workshop on clinical trials to evaluate new TB drugs, questions were raised regarding the use of bacteriologic endpoints such as treatment failure and relapse as measures of improvement in health status and long term outcome after treatment. FDA scientists asked how patients’ clinical signs and symptoms changed during therapy, noting that while such information is usually collected during clinical trials, it is not often reported. We analyzed data from an internationalphase 3 TB treatment trial that included systematic assessments of symptoms. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough, with 51% reporting fever. During therapy, fever, sweats, and dyspnea decreased most rapidly, with near resolution by the end of therapy. Chest pain and cough resolved more slowly; 13% of subjects reported cough at six months.Symptom resolution during treatment did not differ between those who relapsed and those who did not.Among those with microbiological relapse, symptoms returned with significant increases in the proportion with fever, cough, and chest pain. At the time of relapse, cough was the most frequent symptom, occurring in 75% of subjects who relapsed but only 12% of those who did not. Our data support the continued use of bacteriologic endpoints based on sputum culture assurrogate measures of the relief of symptoms, improvement in health status and favorable long term treatment outcome in TB drug trials.
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DOI：
10.1164/rccm.200904-0536oc
发表时间：
2009-09-15
影响因子：
24.7
作者：
Johnson, John L.;Hadad, David Jamil;Boom, W. Henry
通讯作者：
Boom, W. Henry
影响因子：
2.5
作者：
Dhuria, Meera;Sharma, Nandini;Ingle, Gopal Krishan
通讯作者：
Ingle, Gopal Krishan
影响因子：
9.6
作者：
Marra, Carlo A.;Marra, Fawziah;Fitzgerald, J. Mark
通讯作者：
Fitzgerald, J. Mark
DOI：
10.1016/0041-3879(79)90002-3
发表时间：
1979-01-01
期刊：
TUBERCLE
影响因子：
--
作者：
ALLAN, WGL;GIRLING, DJ;FOX, W
通讯作者：
FOX, W
影响因子：
11.8
作者：
HOPEWELL, P;CYNAMON, M;OBRIEN, R
通讯作者：
OBRIEN, R