复治肺结核化疗新方案与原复治方案的临床对照研究

Controlled clinical studies comparing the new chemotherapeutic regimens with the primary regimens for retreatment pulmonary tuberculosis patients

目的探讨复治肺结核化疗新方案的疗效和安全性。方法依照药物敏感试验将345例患者分为复治敏感患者161例(试验组85例,对照组76例);复治耐药患者184例(试验组124例,对照组60例)。治疗方案:(1)复治敏感患者试验组2HRZES/6-10HRE(非糖尿病患者疗程8个月,糖尿病患者12个月);对照组采用原复治方案2H3R3Z3E3S3/6H3R3E3。(2)复治耐药患者试验组3R(H)ZES±Lfx/6-9R(H)ZE±Lfx(耐H或R者,分别以R或H相互替代;耐S以Am替代;耐HS或RS均以Am或Lfx替代);对照组采用原复治方案:2-3HRZES/6HRE(同地,同情况,历史对照)。结果 (1)复治敏感患者试验组和对照组,疗程结束时痰Mtb培养阴转率分别为77.6%(66/85)、88.2%(67/76);病灶显效率分别为63.5%(54/85)、55.3%(42/76);有效率分别为96.5%(82/85)、90.8%(69/76);空洞闭合率分别为68.3%(28/41)、56.1%(23/41);差异均无统计学意义(χ2值分别为2.397 24、0.821 42、1.354 777、0.829 58;P值均>0.05)。伴糖尿病患者试验组和对照组痰Mtb培养阴转率分别为66.7%(16/24)、73.3%(11/15);病灶显效率分别为58.3%(14/24)、46.7%(7/15);差异均无统计学意义(χ2值分别为0.191、0.511;P值均>0.05)。不伴糖尿病患者试验组和对照组上述各项指标分别为82.0%(50/61)、91.8%(56/61);65.6%(40/61)、57.4%(35/61);差异均无统计学意义(χ2值分别为2.589 62、0.861;P值均>0.05)。(2)复治耐药试验组疗程结束时痰Mtb培养阴转率为79.8%(99/124),对照组为66.7%(40/60);两组比较差异有统计学意义(χ2=3.81,P<0.05)。病灶显效率分别为62.9%(78/124)和45.0%(27/60),两组差异有统计学意义(χ2=4.584 29,P<0.05),不良反应的发生率敏感患者试验组和对照组分别为1.1%(1/92)、1.2%(1/82);耐药患者试验组不良反应的发生率为2.8%(4/142)。结论复治敏感患者无论是否伴有糖尿病,均可采用原复治方案治疗;复治耐药患者采用新方案治疗疗效优异,新方案不良反应发生率较低。

Objective To evaluate the efficacy and safety of new chemotherapeutic regimens for retreatment pulmonary tuberculosis. Methods A total of 345 cases were enrolled,according to the results of drug susceptibility testing,161 cases with drug-sensitive results were assigned to a test group（85 cases） and a control group（76 cases）,184 with drug-resistant results assigned to the test group（124 cases） and the control group（60 cases）.The chemotherapeutic regimens were as follows：（1）For the drug-sensitive group,new chemotherapeutic regimen with 2HRZES/6-10HRE was used in the test group and primary regimen with 2H_3R_3Z_3E_3S_3/6H_3R_3E_3 was used in the control,respectively（8 months for PTB but no diabete cases,12 months for PTB with diabete cases）.（2）For the drug-resistant group,3R（H）ZES±Lfx/6-9R（H）ZE±Lfx was used in the test group.R or H could be replaced each other for R or H resistant patients.Am could be used in the case of S resistance.Am and Lfx could be used in HS or RS resistant cases.2-3HRZES/6HRE regimen was used in the control（We selected the control subjects in the same place,same situation but historical controls）. Results （1）In drug sensitive group,the sputum conversion rate was 77.6%（66/85） and 88.2%（67/76）,radiographic improvement rate was 63.5%（54/85） and 55.3%（42/76）,effective rate was 96.5%（82/85） and 90.8%（69/76）and cavity closing rate was 68.3%（28/41） and 56.1%（23/41）,there was no statistically significant difference between the test group and the control group（χ2=2.397 24,χ2=0.821 42,χ2=1.354 777,χ2=0.829 58,P0.05）.Also in drug sensitive group complicated with diabetic,the sputum conversion rate was 66.7%（16/24） and 73.3%（11/15）,radiographic improvement rate was 58.3%（14/24） and 46.7%（7/15）,there was no statistically significant difference between the test group and control group complicated with diabetic（χ2=0.191,χ2=0.511,P0.05）.Meanwhile,the sputum conversion rate was 82.0%（50/61） and 91.8%（56/61）,radiographic improvement rate was 65.6%（40/61） and 57.4%（35/61）in the test group but no diabetes and control group but no diabetes.There was no statistically significant difference between the two groups（χ2=2.589 62,χ2=0.861,P0.05）.（2）In the drug resistant group,at the end of treatment,the radiographic improvement rate was 79.8%（99/124）in the test group and 66.7%（40/60） in control.There were statistically significant difference between the test group and control（χ2=3.81,P0.05）;Radiographic improvement rate was 62.9%（78/124） in test group and 45.0%（27/60） in the control,there were statistically significant difference between the test group and the control（χ2=4.584 29,P0.05）;The Incidence of adverse reactions were 1.1%（1/92） and 1.2%（1/82） in the test and control groups in drug sensitive group,respectively,and the Incidence of adverse reaction in the test group of drug-resistant cases was 2.8%（4/142）. Conclusion For retreatment drug-sensitive cases,whether or not complicated with diabetes,can receive the primary chemotherapeutic regimen.New chemotherapeutic regimens had got good effect in the retreatment drug-resistant cases and the Incidence of adverse reactions were lower and no sever adverse reactions developed.