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.
目的 探討剋拉黴素治療慢性鼻-鼻竇炎(chronic rhinosinusitis,CRS)的臨床療效.方法 採用前瞻、開放、自身對照的臨床試驗方式,給予伴鼻息肉(17例)或不伴鼻息肉(33例)的CRS患者剋拉黴素250 mg,每日1次,連續治療3箇月,觀察其療效.評估指標包括視覺模擬量錶評分(visual analogue scale,VAS)、醫學結跼研究簡錶36項(medical outcomes study short-form 36-items, SF-36)、鼻腔鼻竇結跼測量20條(the sino-nasal outcome test-20,SNOT-20)以及鼻內鏡(Lund Kennedy)評分、鼻竇CT(Lund Mackay)評分、肝、腎功能檢查.患者在治療前需完成所有指標的評估,治療1箇月後隻進行VAS和鼻內鏡檢查評估,第2、3箇月後再次進行所有指標的評估(CT檢查隻在治療前和治療後第3箇月後做).採用SPSS 16.0軟件進行統計學分析.結果 50例CRS患者中45例完成瞭治療及隨訪,脫落5例.①33例不伴鼻息肉的CRS患者在治療後1、2、3箇月總體VAS評分分彆為(3.76±1.94)、(2.98±1.95)、(2.06±2.13)分,較治療前的(5.81±1.69)分,均明顯改善(t值分彆為5.910、8.090、8.932,P值均＜0.05);鼻內鏡評分在治療1、2、3箇月後分彆為(5.00±1.67)、(4.12±1.76)、(3.12±2.19)分,較治療前的(6.28±1.28)分,均明顯改善(t值分彆為6.662、9.161、9.936,P值均＜0.05);治療前後CT檢查評分分彆為(10.33±4.65)、(4.67±4.59)分,差異有統計學意義(t=7.226,P=0.000).②17例伴鼻息肉的CRS患者總體VAS評分在治療前、治療1、2、3箇月後分彆為(6.07±2.02)、(4.87±2.61)、(4.06±2.85)、(4.08±2.80)分,治療1箇月後未見明顯改善(t=1.846,P＞0.05),治療2、3箇月後有明顯改善(t值分彆為3.285、3.468,P值均＜0.05);鼻內鏡評分在治療1、2、3箇月後分彆為(9.35±1.93)、(8.65 ±2.76)、(8.47±2.76)分,較治療前的(10.65±1.77)分,均明顯改善(t值分彆為4.068、4.863、5.156,P值均＜0.05);治療前後CT檢查評分分彆為(13.82±4.94)、(11.41±5.12)分,差異有統計學意義(t=3.975,P=O.001).③試驗期間,用藥1箇月後l例患者訴全身乏力、頭痛,2箇月後1例有腹部疼痛,停止用藥後癥狀消失,其餘患者未見不適.40例患者治療前後肝、腎功能指標均無明顯變化.結論 長期、小劑量口服剋拉黴素治療伴和不伴鼻息肉的CRS,其主觀和客觀指標均能得到有效改善,但不伴鼻息肉的CRS患者療效更好.口服小劑量剋拉黴素3箇月對患者肝腎功能無影響.
목적 탐토극랍매소치료만성비-비두염(chronic rhinosinusitis,CRS)적림상료효.방법 채용전첨、개방、자신대조적림상시험방식,급여반비식육(17례)혹불반비식육(33례)적CRS환자극랍매소250 mg,매일1차,련속치료3개월,관찰기료효.평고지표포괄시각모의량표평분(visual analogue scale,VAS)、의학결국연구간표36항(medical outcomes study short-form 36-items, SF-36)、비강비두결국측량20조(the sino-nasal outcome test-20,SNOT-20)이급비내경(Lund Kennedy)평분、비두CT(Lund Mackay)평분、간、신공능검사.환자재치료전수완성소유지표적평고,치료1개월후지진행VAS화비내경검사평고,제2、3개월후재차진행소유지표적평고(CT검사지재치료전화치료후제3개월후주).채용SPSS 16.0연건진행통계학분석.결과 50례CRS환자중45례완성료치료급수방,탈락5례.①33례불반비식육적CRS환자재치료후1、2、3개월총체VAS평분분별위(3.76±1.94)、(2.98±1.95)、(2.06±2.13)분,교치료전적(5.81±1.69)분,균명현개선(t치분별위5.910、8.090、8.932,P치균＜0.05);비내경평분재치료1、2、3개월후분별위(5.00±1.67)、(4.12±1.76)、(3.12±2.19)분,교치료전적(6.28±1.28)분,균명현개선(t치분별위6.662、9.161、9.936,P치균＜0.05);치료전후CT검사평분분별위(10.33±4.65)、(4.67±4.59)분,차이유통계학의의(t=7.226,P=0.000).②17례반비식육적CRS환자총체VAS평분재치료전、치료1、2、3개월후분별위(6.07±2.02)、(4.87±2.61)、(4.06±2.85)、(4.08±2.80)분,치료1개월후미견명현개선(t=1.846,P＞0.05),치료2、3개월후유명현개선(t치분별위3.285、3.468,P치균＜0.05);비내경평분재치료1、2、3개월후분별위(9.35±1.93)、(8.65 ±2.76)、(8.47±2.76)분,교치료전적(10.65±1.77)분,균명현개선(t치분별위4.068、4.863、5.156,P치균＜0.05);치료전후CT검사평분분별위(13.82±4.94)、(11.41±5.12)분,차이유통계학의의(t=3.975,P=O.001).③시험기간,용약1개월후l례환자소전신핍력、두통,2개월후1례유복부동통,정지용약후증상소실,기여환자미견불괄.40례환자치료전후간、신공능지표균무명현변화.결론 장기、소제량구복극랍매소치료반화불반비식육적CRS,기주관화객관지표균능득도유효개선,단불반비식육적CRS환자료효경호.구복소제량극랍매소3개월대환자간신공능무영향.
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.
