目的 觀察鼻淵舒口服液對慢性鼻竇炎/鼻息肉鼻內(nèi)窺鏡手術(shù)(FESS)后臨床癥狀和體征的改善情況以及對鼻竇粘膜創(chuàng)傷愈合時間的影響,并對其有效性做出評價.
方法 將340例臨床確診的慢性鼻竇炎、鼻息肉患者按單純隨機化方法分為試驗組170例和對照組170例.試驗組手術(shù)后除常規(guī)抗生素(喹諾酮類抗生素7 d)、局部類固醇激素等治療外還給予鼻淵舒口服液治療,每次10ml,每天3次,共20d;對照組手術(shù)后僅給予常規(guī)抗生紊和局部類固醇激素等治療20d,而后比較兩組療效.
結(jié)果 試驗組綜合療效的總有效率ITT人群為94.1%,即人群為96.4%;對照組綜合療效的總效率中,ITT人群為75.3%,PP人群為79.0%,經(jīng)秩和檢驗,試驗組和對照組綜合療效的總有效率有顯著性差異(ITT:Z=5.635,P=0.018,Z=4.279,P=0.039).
結(jié)論 鼻淵舒口服液不僅可以提高鼻竇手術(shù)的療效,而且可以減少抗生素、激素等藥物的療程,無毒副作用及不良反應(yīng).
引用本文： 梁傳余,溫蓓,鄭艷,何剛,范敏,黎萬榮,唐嗣泉,彭濤,梁國慶,王杰,張玉萍. 鼻淵舒口服液改善慢性鼻竇炎/鼻息肉鼻內(nèi)窺鏡手術(shù)預(yù)后的多中心隨機對照試驗. 中國循證醫(yī)學(xué)雜志, 2004, 04(6): 377-381. doi: 復(fù)制
| 1. | ［1］Zhang NZ, Xia LJ. Observe after FESS for adult and children who suffer from chronic sinusitis by using Bi Yuan Shu Liquid[J ]. China J Otolaryngol Ingegrat Trad&West Medi (special publication), 2001; 12(9): 10-12. |
| 2. | 張念祖,夏立軍.鼻淵舒對成人、兒童慢性鼻竇炎與內(nèi)窺鏡鼻竇手術(shù)后的應(yīng)用觀察[J].中國中西醫(yī)結(jié)合耳鼻咽喉科雜志,2001;12(9?？?:10～12. |
| 3. | ［2］Multi-center, random,parallel and contrast Clinical research staard for treating nose-Antral inflammation with GG ( glucocorticoid) and evaluating its effect and safty [ R]. ENT department of CMA (China Medical Association). 2001. |
| 4. | 鼻用糖皮質(zhì)激素治療鼻--鼻竇炎療效和安全性評價之多中心、隨機、平行對照臨床研究標準[R].中華醫(yī)學(xué)會耳鼻咽喉科分會.2001. |
| 5. | ［3］ENT department of CMA ( China Medical Association), Editorial Committee of China J Otolaryngol Medi. Clinical type and period of chronic sinusitis and nasal polyp &stadard of FESS (functional endoscopic sinus surgery) evaluation [J]. China J Otolaryngol Medicine, 1998; 33 (2): 133. |
| 6. | 中華醫(yī)學(xué)會耳鼻咽喉科分會,中華耳鼻咽喉科雜志編輯委員會.慢性鼻竇炎鼻息肉臨床分型分期及內(nèi)窺鏡鼻竇手術(shù)療效評定標準[J].中華耳鼻咽喉科雜志,1998;33(2):133. |
| 7. | ［4］Chen LQ. Curative effectual observation of rhinitis and sinusits by using Bi Yuan Shu Liquid [ J ]. China J Otolaryngol Ingegrat Trad&West Medi ( special publication), 2001; 12 ( 9 ):23-24. |
| 8. | 陳綠琦.鼻淵舒治療鼻炎鼻竇炎療效觀察[J].中國中西醫(yī)結(jié)合耳鼻咽喉科雜志,2001;12(9專刊):23～24. |
- 1. ［1］Zhang NZ, Xia LJ. Observe after FESS for adult and children who suffer from chronic sinusitis by using Bi Yuan Shu Liquid[J ]. China J Otolaryngol Ingegrat Trad&West Medi (special publication), 2001; 12(9): 10-12.
- 2. 張念祖,夏立軍.鼻淵舒對成人、兒童慢性鼻竇炎與內(nèi)窺鏡鼻竇手術(shù)后的應(yīng)用觀察[J].中國中西醫(yī)結(jié)合耳鼻咽喉科雜志,2001;12(9?？?:10～12.
- 3. ［2］Multi-center, random,parallel and contrast Clinical research staard for treating nose-Antral inflammation with GG ( glucocorticoid) and evaluating its effect and safty [ R]. ENT department of CMA (China Medical Association). 2001.
- 4. 鼻用糖皮質(zhì)激素治療鼻--鼻竇炎療效和安全性評價之多中心、隨機、平行對照臨床研究標準[R].中華醫(yī)學(xué)會耳鼻咽喉科分會.2001.
- 5. ［3］ENT department of CMA ( China Medical Association), Editorial Committee of China J Otolaryngol Medi. Clinical type and period of chronic sinusitis and nasal polyp &stadard of FESS (functional endoscopic sinus surgery) evaluation [J]. China J Otolaryngol Medicine, 1998; 33 (2): 133.
- 6. 中華醫(yī)學(xué)會耳鼻咽喉科分會,中華耳鼻咽喉科雜志編輯委員會.慢性鼻竇炎鼻息肉臨床分型分期及內(nèi)窺鏡鼻竇手術(shù)療效評定標準[J].中華耳鼻咽喉科雜志,1998;33(2):133.
- 7. ［4］Chen LQ. Curative effectual observation of rhinitis and sinusits by using Bi Yuan Shu Liquid [ J ]. China J Otolaryngol Ingegrat Trad&West Medi ( special publication), 2001; 12 ( 9 ):23-24.
- 8. 陳綠琦.鼻淵舒治療鼻炎鼻竇炎療效觀察[J].中國中西醫(yī)結(jié)合耳鼻咽喉科雜志,2001;12(9專刊):23～24.