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克拉霉素治疗慢性鼻窦炎患者的临床疗效

[Clinical effect of clarithromycin therapy in patients with chronic rhinosinusitis].

作者信息

Luo Qing, Deng Jie, Xu Rui, Zuo Kejun, Li Huabin, Shi Jianbo

机构信息

Department of Otorhinolaryngology Head and Neck Surgery, First Affiliated Hospital of Nanchang University, Nanchang 330006, China.

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出版信息

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Feb;49(2):103-8.

Abstract

OBJECTIVE

To evaluate the efficacy of clarithromycin (CAM) treatment in adult Chinese patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP).

METHODS

A prospective, open and self-controlled clinical trial on patients with CRS was conducted. Fifty patients met inclusion criteria. Of 50 patients, there were 33 patients with CRSsNP and 17 patients with CRSwNP. CAM was administered at 250 mg/d and the duration of administration was 12 weeks. Outcome measures included assessments of visual analogue scale (VAS), the sino-nasal outcome test-20(SNOT-20), the medical outcomes study short-form 36 items(SF-36), Lund-Kennedy endoscopy score, and Lund-Mackay computed tomography score. Before starting the treatment, 2 months after treatment and at the end of treatment, each patient had to complete all the measures except Lund-Mackay computed tomography score, which was only conducted before and after treatment. In order to evaluate the safety of CAM, liver function and renal function in all patients were detected before and after treatment. SPSS 16.0 software was used to analyze the data.

RESULTS

Forty-five patients completed 3 months follow-up and 5 patients withdrew due to different reasons. The results were as follows: (1) Thirty-three patients with CRSsNP's VAS scores of four time point were 5.81 ± 1.69, 3.76 ± 1.94, 2.98 ± 1.95, 2.06 ± 2.13, respectively, there were statistically significant improvements in turn (t values were 5.910, 8.090, 8.932, all P < 0.05). Endoscopy score of four time point were 6.28 ± 1.28, 5.00 ± 1.67, 4.12 ± 1.76, 3.12 ± 2.19, respectively, there were statistically significant improvements in turn compared with before treatment (t values were 6.662, 9.161, 9.936, all P < 0.05). The CT scores before and after treatment were 10.33 ± 4.65 and 4.67 ± 4.59, respectively (t = 7.226, P = 0.000) . (2) Seventeen patients with CRSwNP's VAS scores of four time point were 6.07 ± 2.02, 4.87 ± 2.61, 4.06 ± 2.85, 4.08 ± 2.80, respectively, there were statistically significant improvements after 2 or 3 months (t values were 3.285, 3.468, both P < 0.05) except after one month (t = 1.846, P > 0.05). Endoscopy score of four time point were 10.65 ± 1.77, 9.35 ± 1.93, 8.65 ± 2.76, 8.47 ± 2.76, respectively, there were statistically significant improvements in turn(t values were 4.068, 4.863, 5.156, all P < 0.05). The CT scores before and after treatment were 13.82 ± 4.94 and 11.41 ± 5.12, respectively (t = 3.975, P = 0.001). (3) During the period of CAM treatment, 1 patient reported a tolerable headache and weakness and 1 patient had abdominal pain after two months treatment, all the symptoms disappeared while they were asked to stop the drug. Liver function and renal function were detected in 40 patients, the differences before and after treatment were not significant statistically.

CONCLUSIONS

Long-term, low-dose CAM treatment is effective in the treatment of CRSsNP and CRSwNP in Chinese patients. Meanwhile, the efficacy of CAM is more significant in polyp-free group compared with polyp group. Low does CAM therapy is safe, and the liver function and renal function does not worsen after 3 months treatment.

摘要

目的

评估克拉霉素(CAM)治疗成年中国慢性鼻窦炎伴鼻息肉(CRSwNP)或不伴鼻息肉(CRSsNP)患者的疗效。

方法

对慢性鼻窦炎患者进行一项前瞻性、开放性、自身对照临床试验。50例患者符合纳入标准。其中,CRSsNP患者33例,CRSwNP患者17例。CAM给药剂量为250mg/d,给药持续时间为12周。观察指标包括视觉模拟量表(VAS)、鼻窦结局测试-20(SNOT-20)、医学结局研究简表36项(SF-36)、Lund-Kennedy内镜评分以及Lund-Mackay计算机断层扫描评分。治疗前、治疗2个月后及治疗结束时,每位患者均需完成除Lund-Mackay计算机断层扫描评分外的所有测量指标,该评分仅在治疗前后进行。为评估CAM的安全性,在治疗前后对所有患者检测肝功能和肾功能。采用SPSS 16.0软件进行数据分析。

结果

45例患者完成3个月随访,5例患者因不同原因退出。结果如下:(1)33例CRSsNP患者四个时间点的VAS评分分别为5.81±1.69、3.76±1.94、2.98±1.95、2.06±2.13,依次有统计学显著改善(t值分别为5.910、8.090、8.932,均P<0.05)。四个时间点的内镜评分分别为6.28±1.28、5.00±1.67、4.12±1.76、3.12±2.19,与治疗前相比依次有统计学显著改善(t值分别为6.662、9.161、9.936,均P<0.05)。治疗前后CT评分分别为10.33±4.65和4.67±4.59(t=7.226,P=0.000)。(2)17例CRSwNP患者四个时间点的VAS评分分别为6.07±2.02、4.87±2.61、4.06±2.85、4.08±2.80,除1个月后外(t=1.846,P>0.05),2或3个月后有统计学显著改善(t值分别为3.285、3.468,均P<0.05)。四个时间点的内镜评分分别为10.65±1.77、9.35±1.93、8.65±2.76、8.47±2.76,依次有统计学显著改善(t值分别为4.068、4.863、5.156,均P<0.05)。治疗前后CT评分分别为13.82±4.94和11.41±5.12(t=3.975,P=0.001)。(3)在CAM治疗期间,1例患者报告有可耐受的头痛和乏力,1例患者在治疗2个月后出现腹痛,停药后所有症状消失。对40例患者检测肝功能和肾功能,治疗前后差异无统计学意义。

结论

长期、低剂量CAM治疗对中国CRSsNP和CRSwNP患者有效。同时,CAM在无息肉组的疗效比息肉组更显著。低剂量CAM治疗安全,治疗3个月后肝功能和肾功能未恶化。

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