克拉霉素治疗慢性鼻-鼻窦炎的疗效观察

Clinical effect of clarithromycin therapy in patients with chronic rhinosinusitis

目的 探讨克拉霉素治疗慢性鼻-鼻窦炎（chronic rhinosinusitis,CRS）的临床疗效.方法 采用前瞻、开放、自身对照的临床试验方式,给予伴鼻息肉（17例）或不伴鼻息肉（33例）的CRS患者克拉霉素250 mg,每日1次,连续治疗3个月,观察其疗效.评估指标包括视觉模拟量表评分（visual analogue scale,VAS）、医学结局研究简表36项（medical outcomes study short-form 36-items, SF-36）、鼻腔鼻窦结局测量20条（the sino-nasal outcome test-20,SNOT-20）以及鼻内镜（Lund Kennedy）评分、鼻窦CT（Lund Mackay）评分、肝、肾功能检查.患者在治疗前需完成所有指标的评估,治疗1个月后只进行VAS和鼻内镜检查评估,第2、3个月后再次进行所有指标的评估（CT检查只在治疗前和治疗后第3个月后做）.采用SPSS 16.0软件进行统计学分析.结果 50例CRS患者中45例完成了治疗及随访,脱落5例.①33例不伴鼻息肉的CRS患者在治疗后1、2、3个月总体VAS评分分别为（3.76±1.94）、（2.98±1.95）、（2.06±2.13）分,较治疗前的（5.81±1.69）分,均明显改善（t值分别为5.910、8.090、8.932,P值均＜0.05）;鼻内镜评分在治疗1、2、3个月后分别为（5.00±1.67）、（4.12±1.76）、（3.12±2.19）分,较治疗前的（6.28±1.28）分,均明显改善（t值分别为6.662、9.161、9.936,P值均＜0.05）;治疗前后CT检查评分分别为（10.33±4.65）、（4.67±4.59）分,差异有统计学意义（t=7.226,P=0.000）.②17例伴鼻息肉的CRS患者总体VAS评分在治疗前、治疗1、2、3个月后分别为（6.07±2.02）、（4.87±2.61）、（4.06±2.85）、（4.08±2.80）分,治疗1个月后未见明显改善（t=1.846,P＞0.05）,治疗2、3个月后有明显改善（t值分别为3.285、3.468,P值均＜0.05）;鼻内镜评分在治疗1、2、3个月后分别为（9.35±1.93）、（8.65 ±2.76）、（8.47±2.76）分,较治疗前的（10.65±1.77）分,均明显改善（t值分别为4.068、4.863、5.156,P值均＜0.05）;治疗前后CT检查评分分别为（13.82±4.94）、（11.41±5.12）分,差异有统计学意义（t=3.975,P=O.001）.③试验期间,用药1个月后l例患者诉全身乏力、头痛,2个月后1例有腹部疼痛,停止用药后症状消失,其余患者未见不适.40例患者治疗前后肝、肾功能指标均无明显变化.结论 长期、小剂量口服克拉霉素治疗伴和不伴鼻息肉的CRS,其主观和客观指标均能得到有效改善,但不伴鼻息肉的CRS患者疗效更好.口服小剂量克拉霉素3个月对患者肝肾功能无影响.

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）,Lunid-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.O0 ± 1.67,4.12 ± 1.76,3.12 ±2.19,respectively,there were statistically significant improvements in tum 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.