首次复治耐多药肺结核采用短程与标准化疗方案的疗效分析

为探讨首次复治耐多药肺结核(MDR-PTB)患者行短程与标准化治疗的疗效并进行对比分析,作者收集了2009年3月至2014年3月广州市胸科医院门诊部诊治的既往有结核病病史、无基础疾病及严重并发症、曾仅给予常规一线抗结核药物治疗超过1个月、经实验室检测确诊的首次复治菌阳肺结核患者236例。将患者依就诊时间先后分为A、B组,各118例,两组患者分别进行耐多药筛查,共36例患者确诊为MDR-PTB,其中A组患者(21例)给予复治短程化疗方案[(2~3)H-R-Z-E-S/6H-R-E,简称“短程组”],B组患者(15例)给予耐多药结核病标准复治方案[6Am-Z-Lfx-PAS(Cs)-Pto/18Z-Lfx-PAS(Cs)-Pto,简称“标准组”]。分析两组患者治疗后的近远期临床疗效(包括痰菌阴转率、病灶吸收、药物不良反应及治疗转归)。两组间计数资料的比较采用Fisher确切概率法检验。结果显示,短程组治疗9个月末时的痰菌阴转率(85.7%,18/21)较标准组(46.2%,6/13)明显提高(P=0.017),但在疗程结束时短程组和标准组的痰菌阴转率[85.7%(18/21)和84.6%(11/13)]、病灶显著吸收率[47.6%(10/21)和23.1%(3/13)]、空洞闭合率[25.0%(3/12)和18.2%(2/11)]、治疗成功率[76.2%(16/21)和53.8%(7/13)]、失败率[23.8%(5/21)和46.2%(6/13)]差异均无统计学意义(P值分别为0.373、0.109、0.360、0.122、0.122)。两组患者治疗过程中均未发生严重药物不良反应而暂停治疗,标准组中有1例出现药物性肝损伤经保肝治疗后缓解,5例出现尿酸升高因无关节疼痛症状未予处理;短程组中有4例出现尿酸升高,仅1例因关节疼痛给予对症治疗后好转,2例患者出现胃肠道反应经调整服药次数后缓解。提示复治短程化疗方案治疗首次复治MDR-PTB的临床近期疗效优于耐多药结核病标准化疗方案,但远期疗效差异无统计学意义。基于前者具有疗程短、药品便宜且易获得、严重药物不良反应无增加等特点,建议对于首次复治MDR-PTB患者首选复治短程化疗方案。

Analysis of curative effect of short-term chemotherapy regimen and standard chemotherapy regimen on first-time retreated multidrug-resistant pulmonary tuberculosis patients

To explore and compare the curative effect of short-term chemotherapy regimen and standard chemotherapy regimen on first-time retreated multidrug-resistant pulmonary tuberculosis (MDR-PTB) patients, a total of 236 cases of first-time retreated MDR-PTB patients admitted to the Outpatient Department of Guangzhou Chest Hospital from March 2009 to March 2014 who had previous tuberculosis history, no basic disease, and no serious complications were enrolled in this study. These patients were diagnosed by the laboratory test and had only received regular first-line anti-tuberculosis drugs for more than one month. All these subjects were randomly divided into two groups, group A and group B, according to their visiting order. Each group had 118 cases. Multidrug screening was performed in both groups, respectively, and altogether 36 cases were diagnosed as MDR-PTB, among which 21 cases of group A received short-term chemotherapy regimen 2-3H-R-Z-E/6H-R-E (short-term group) and 15 cases of group B received multidrug-resistant standard retreatment regimen 6Am-Z-Lfx-PAS(Cs)-Pto/18Z-Lfx-PAS(Cs)-Pto (standard group). We analyzed the short and long-term clinical therapeutic effect of the two groups after treatment, including the sputum negative conversion rate, lesion absorption rate, adverse reactions, and prognosis. The Fisher’s exact probability statistics was used to compare the enumeration data between the two groups. The results showed that after being treated for 9 months the sputum negative conversion rate in the short-term group (85.7%, 18/21) was significantly higher than that in the standard group (46.2%, 6/13) (P=0.017).There was no statistically significant difference in the sputum negative conversion rate (85.7% (18/21) vs 84.6% (11/13), P=0.373), absorption rate of lesions (47.6% (10/21) vs 23.1% (3/13), P=0.109), cavity closure rate (25.0% (3/12) vs 18.2% (2/11), P=0.360), treatment success rate (76.2% (16/21) vs 53.8% (7/13), P=0.122), and treatment failure rate (23.8% (5/21) vs 46.2% (6/13), P=0.122) between the two groups after the termination of treatment. No suspension of treatment due to serious adverse reactions occurred in the two groups. One case in the standard group showed drug-induced hepatitis, the patient was relieved after being treated with hepatoprotective agents. Five cases in the standard group showed increased serum uric acid, since there was no symptom of joint pain, so no relevant treatment was performed in these patients. Four cases in the short-term group showed increased serum uric acid, while only one case was relieved after symptomatic treatment of joint pain, and two patients who showed gastrointestinal response were relieved after adjusting the frequency of medication. Our results indicated that the short-term clinical efficacy of short-term retreatment chemotherapy regimen was better than multidrug-resistant standard chemotherapy regimen in treating the first-time retreated MDR-PTB patients, but the long-term efficacy was not statistically significant. It is suggested that for the first-time retreated MDR-PTB patients the short-term retreatment chemotherapy regimen is a preferred choice, since the short-term retreatment chemotherapy regimen is short course with cheap and accessible drugs and no increased serious adverse reactions.