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2H3R323E3S3／6H3R3E3。（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（X^2值分别为2．39724、0．82142、1．354777、0．82958；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（x^2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（x^2值分别为2．58962、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（X^2=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（X^2=4．58429，P〈．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 2H3R323E3S3/6H3R3E3 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＋Lfrd6-9R （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 （ x^ 2=2.397 24, x^ 2=0.821 42, x ^2=1.354 777, x ^2=0.829 58,P〉0.05）. 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 （ x ^2=0.191, x ^2=0.511 ,P〉0.05 ）. 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 （ x^ 2=2.589 62, x^ 2=0.861, P〉0.05） . （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 （ x^ 2=3.81 ,P〈0.05） ; 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 （ x ^2=4.584 29, P〈0.05 ） ; 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） . Conclusions 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.