参连滴耳液治疗慢性化脓性中耳炎的临床和实验研究

Clinical and Experimental Study on Treatment of Chronic Pyogenic Tympanitis with Shenlian Ear Drops

目的：探讨中药复方参连滴耳液治疗慢性化脓性中耳炎的疗效和机制。方法：选择２０１例慢性化脓性中耳炎患者，随机分为治疗组（用参连滴耳液滴耳，每日３次）和对照组（用氧氟沙星滴耳液滴耳，每日３次），观察其各症状和体征以及细菌培养等方面的变化；进行抗炎消肿、皮肤粘膜刺激试验等动物实验以及抑菌试验。结果：治疗组在疗效、平均用药时间、改善患者症状、体征方面均明显优于对照组（Ｐ＜００５或Ｐ＜００１），且参连滴耳液有明显的抗炎消肿作用，对慢性化脓性中耳炎常见致病菌均有明显的抑菌作用，无对外耳道和中耳腔皮肤、粘膜的刺激性和耳毒作用等副作用。

Objective: To study the effect and mechanism of Shenlian Ear Drops (SLED), a composite preparation of Chinese herbal medicine, in treating chronic pyogenic tympanitis (CPT). Methods: The 201 patients of CPT enrolled were divided randomly into two groups. The treated group were treated with SLED, three times per day, and the control group treated with ofloxacin ear drop, three times per day. The changes in symptoms, signs and bacterial culture after treatment were observed. Experimental studies on anti inflammatory, detumescent effect and skin mucosa irritation test, and bacteriostasic activity of SLED were also conducted. Results: The curative effect in the treated group was higher than that in the control group with shorter time of medication. The improvement of symptoms and signs in the former was also better than that in the latter (P<0 05 or P<0 01). Experimental study showed SLED had obvious anti inflammatory and detumescent effect, apparent bacteriostasic activity against often encountered pathogens of CPT, and with no side effect such as irritation on skin, mucosa of external acoustic meatus or tympanic cavity, and was non ototoxic. Conclusion: SLED has good curative effect in treating CPT.