加强药物治疗与功能性内镜鼻窦手术＋围手术期综合治疗慢性鼻-鼻窦炎疗效的多中心对照研究

A prospective multicenter clinical trial of medical and surgical treatment for chronic rhinosinusitis

目的探讨加强药物治疗（maximalmedicaltherapy，MMT）与功能性内镜鼻窦手术＋围手术期综合治疗（functionalendoscopicsinussurgery＋maximalmedicaltherapy，FESS＋MMT）两种方式治疗中一重度不伴鼻息肉的慢性鼻一鼻窦炎（chronicrhinosinusitiswithoutnasalpolyps，CRSsNP）的临床疗效，为临床治疗方式的选择提供参考。方法全国共8家大学附属医院协作的前瞻性、开放性、多中心对照研究，人组90例CRSsNP患者，分为MMT与FESS＋MMT两个治疗组，随访时间点为3、6个月，疗效评价指标包括视觉模拟量表评分（visualanaloguescale，VAS）、鼻腔鼻窦结局测试一20（sinonasaloutcometest-20，SNOT-20）、CT、手术后患者参考鼻内镜检查。以SPSS16．0软件进行数据统计分析。结果所有患者符合中一重度CRS，治疗前两组基线数据差异无统计学意义（P〉0．05）。①在治疗前、治疗后3、6个月3个时间点，总体症状VAS评分在MMT组分别为（6．52±2．61）、（2．66±2．10）、（2．40±1．56）分，治疗前后差异有统计学意义（t值分别为2．083、2．295，P值均〈0．05）；在FESS＋MMT组分别为（6．99±2．70）、（0．95±0．84）、（0．60±0．81）分，治疗前后差异有统计学意义（t值分别为3．582、5．196，P值均〈0．05）；SNOT-20评分在MMT组分别为（38．61±17．36）、（18．59±14．04）、（18．40±8．91）分，治疗前后差异有统计学意义（t值分别为2．737、2．657，P值均〈0．05），在FESS＋MMT组分别为（38．21±19．61）、（5．94±5．01）、（2．65±2．31）分，治疗前后差异有统计学意义（t值分别为4．538、3．791，P值均〈0．05）。②FESS＋MMT组比MMT组总体症状VAS评分、SNOT-20评分的改善时间更早，改善程度更为明显。③总体疗效显示，MMT组：病情完全控制14例（30．4％），病情部分控制31例（67．4％），病情未控制1例（2．2％）。FESS＋MMT组：病情完全控制17例（38．6％），病情部分控制26例（59．1％），病情未控制1例（2．3％）。④患者对治疗的满意度：对疗效非常满意的患者在FESS＋MMT组是MMT组的2倍。结论①对于中一重度CRSsNP的治疗，MMT与FESS＋MMT均可有效控制总体症状和分类症状，减少CT评分，并明显改善生活质量，无效患者的比例不超过5％。②FESS＋MMT对改善的时间和程度均优于MMT。③患者对治疗的满意度在FESS＋MMT组优于MMT组。因此建议对中一重度CRSsNP患者的治疗，可将FESS＋MMT作为首选方法。

Objective To demonstrate the clinical outcomes of maximal medical therapy （MMT） and functional endoscopic sinus surgery ＋ maximal medical therapy （ FESS ＋ MMT） for moderate to severe chronic rhinosinusitis without nasal polyps （CRSsNP） in China, to provide clinical evidence for treatment recommendation. Methods A prospective muhicentcr case control study consisting of 90 strictly selected CRSsNP patients were carried out by ENT Hospital of SUN Yet-sen university and 7 other university affiliated hospitals across China from March 2011 to October 2012. All patients were selected to MMT group or FESS ＋ MMT group followed by 3 months treatment and 6 months follow up. Treatment efficacy evaluation indicators included improvement of visual analogue scale （VAS） score, quality of life, CT score and post-operative nasal endoscopic evaluations. SPSS16. 0 software was used to analyze the data. Results All patients enrolled complied with moderate to severe CRSsNP evaluation criteria. There were no significant differences found in the baseline data between two groups （ P 〉 0. 05 ）. ①At the 3 time points （ pre-treatment, 3 months and 6 mongths after treatment）, VAS overall symptom score in MMT group were 6. 52±2. 61,2. 66 ±2. 10, 2. 40 ± 1.56, significant differences were found among them （ t value were 2. 083 and 2. 295, both P 〈 0.05）; in FESS ＋ MMT group the values were 6. 99 ±2.70, 0.95 ±0.84, 0.60 ±0.81, significant differences were found among them （ t value were 3. 582 and 5. 196, both P 〈 0. 05 ） ; SNOT-20 score in MMT group were 38.61±＋ 17.36, 18.59±14. 04, 18.40 ± 8.91, significant differences were found among them （t value were 2. 737 and 2. 657, both P 〈 0. 05 ） ; in FESS ＋ MMT group the values were 38.21 ± 19. 61, 5.94±5.01, 2. 65 ±2. 31, significant differences were found among them （t value were 3. 247, 3. 319,both P 〈0. 05）. ②FESS ＋ MMT group relative to the MMT group in VAS overall symptom score and quality of life improvements appeared earlier and were more pronounced. ③Overall treatment efficacy showed that in MMT group： complete control 14 cases （30.4%）, partially control 31 cases （67.4%）, uncontrolled 1 cases （ 2. 2% ） ; In FESS ＋ MMT group ： complete control 17 cases （ 38.6% ）, partially control 26 cases （59. 1% ）, uncontrolled 1 cases （2.3%）. ④Patients＇ satisfaction survey showed that the number of the patients who were very satisfied with the efficacy in the FESS ＋ MMT group were 2 times higher than the MMT group, Conclusions ①For moderate to severe CRSsNP, both MMT and FESS ＋ MMT treatment can effectively control the overall symptoms and classified symptoms, reduce CT scores and significantly improve the quality of life, the ineffective rate is less than 5%. ②FESS ＋ MMT group in terms of improving symptoms and the onset time are better than MMT group, especially in improving the stuffy nose, head and face fullness, and mental and physical symptoms are better than MMT group. ③FESS ＋ MMT group showed better results in patient satisfaction survey compared to the MMT group. Therefore for moderate to severe CRSsNP patients, FESS ＋ MMT therapy could be recommended as the preferred treatment.