摘要
研究背景:急性病毒性上呼吸道感染是人类的常见、多发病,约80%以上由病毒引起,我国流行病学调查结果显示,城区儿童患病率为86.8%,学生病假的73.0%均是由其造成的,因此急性病毒性上呼吸道感染的防治意义重要。目前西医西药对急性病毒性上呼吸道感染治疗多对症处理;中医中药在退热和抗病毒方面有一定优势,临床研究报道颇多。但对岭南具有兼挟湿证特点的外感发热证候却鲜有深入系统的研究报道。本课题根据名老中医周仲瑛教授治疗病毒性高热的经验结合岭南气候特点以清热解表祛湿为法选药研制成新香冲剂,对其方证毒效的相关性进行研究。
研究目的:观察新香冲剂治疗岭南急性病毒性上呼吸道感染辩证属湿热郁表证、风热袭表证的临床疗效,探讨效关系;通过实验室病毒抗体检测,分析证型与病毒分布相关性。
研究方法:按纳入和排除标准,选取广东省中医院急诊科门诊、留观及发热门诊患者120例,西医临床诊断为病毒性上呼吸道感染,中医诊断为湿热郁表、风热袭表证患者,采用随机单盲法(就诊卡号末尾数奇偶)分为治疗组和对照组,每组60例,两证型按1:1纳入各组。治疗组予新香冲剂口服(1袋/次,3次/日,共2日),对照组予抗病毒口服液(1支/次,3次/日,共2日),观察体温开始下降时间、首次降至正常时间、完全降至正常时间以及恶寒、汗出、咳嗽、咽痛、鼻塞、头痛、身困重、身酸痛、口渴等临床症状和体征变化:并对其中108例患者进行血清病毒抗体检测。
研究结果:
1.总体疗效:新香冲剂组对恶寒、鼻塞、头身困重、身酸痛症状改善优于对照组(P＜0.05);但抗病毒口服液组退热较新香冲剂组迅速(P＜0.05);两组体温首次降至正常时间、完全退热时间、体温改善程度、总有效率、其他伴随症状改善比较无显著性差异(P＞0.05)。
2.证效关系:新香冲剂对热郁表证总有效率(86.7%)明显高于风热袭表证(73.3%),但两证型总有效率差异无显著性。治疗后湿热郁表证在开始退热时间,头身困重、身酸痛等伴随症状的改善优于风热袭表证(P＜0.05)。
3.方效关系:湿热郁表证型内新香冲剂组与抗病毒口服液组间总有效率差异无显著性(P＞0.05);新香冲剂组在开始退热时间、体温首次降至正常时间较抗病毒口服液组短,但无统计学意义:新香冲剂组对身酸痛、头身困重症状改善优于抗病毒口服液组(P＜0.05)。
4.证毒关系
湿热郁表证型与风热袭表证中病毒频数分布差异无显著性(P＞0.05)。
5.药物安全性
临床观察过程中,两组均未见局部以及全身性不良反应或严重的毒副作用。
结论:
1.新香冲剂对急性病毒性上呼吸道感染辨证属湿热郁表证有良好的临床效果,退热迅速,可以明显改善头痛、鼻塞、头身困重、身酸痛等症状,且安全性和耐受性较好。
2.湿热郁表证与风热袭表证中流感A/B、副流感、呼吸道合胞等病毒频数分布无显著性差异。
Background
Acute upper respiratory tract infection is the most common multiple human diseases,about 80 percent caused by a virus,China's epidemiological investigation showed that the prevalence rate for urban children 86.8%, 73.0%of the sick students are caused by the diseases,focus on prevention of acute upper respiratory tract infection control is important significance.Symptomatic treatment is a main method of Western Medicine Chinese medicine in the cooling and anti-virus advantage has a certain extent recently as research gradually depth,clinical efficacy has been continually enhanced.But for the Lingnan region unique Exogenous fever syndrome and more damp and heat evil in exterior syndrome has little in-depth research reports.According to the old topic of the Chinese Professor Zhou Zhongying's treatment of the viral fever experience、Lingnan climatic characteristics,Xinxiang granule was made and to research relationship of prescription and effect,to discuss relationship of Syndromes、Virus.
Objective
To discuss relationship of prescription and effect of Xinxiang Granules in treating the Acute viral upper respiratory infection from Observing its treatment of the people with damp and heat and with wind and heat syndrome;to analysis relationship of distribution of the virus by laboratory detection.
Methods
A total of 120 qualified patients were randomly divided into treatment and controlled groups(By clinics numbers at the end of card).The people with damp and heat syndrome,and with wind and heat was into the group by 1:1.Treatment group was treated by Xinxiang granule,and the control group was treated by Anti-virus oral liquid,to observe the time of the temperature beginning to droping,the first time to normal,fully droping to normal, and Wuhan,Han Chu,cough,pharyngodynia,stuffy nose,headache,body weight hardship,body pain,thirst,and other clinical signs and symptoms of change;of which 108 cases of patients was through laboratory virus antibody detection.
Results
1.Overall curative effect:Xinxiang granule group was superior to the Anti-virus oral liquid group on the improvement of the symptom of the chill, stuffy nose,body weight hardship,the body soring(P＜0.05);But the Anti-virus oral liquid group brought down a fever faster than the Xinxiang granule group(P＜0.05);Two groups had a non-significance difference on the time of the temperature beginning to droping,the first time to normal, of fully droping to normal,the other symptoms' improvement(P＞0.05).
2.Relationship of syndrome and effect:There was no significant in the difference of the two syndromes of the total efficiency.The damp and heat syndrome group was superior to the wind and heat syndrome group at the beginning of the cooling time,headache,stuffy nose,body weight hardship, body soring(P＜0.05).
3.Relationship of prescription and effect:There was no significant in the difference of the total efficiency of the the Xinxiang granule and Anti-virus oral liquid on the damp and heat syndrome.There was no significant on the time of the temperature beginning to droping,the first time to normal the symptom of two groups.Xinxiang granule group was superior to the Anti-virus oral liquid group on the improvement of the symptom of the body weight hardship,the body soring(P＜0.05)
4.Relationship of syndromes and virus:There was no significant in the frequency distribution of the virus of the damp and heat,wind and heat syndrome(P＞0.05).
5.Drug Safety
No obvious or serious side effects were observed in the test drug.
Conclusion
1.Xinxiang Granules treating people with damp and heat syndrome had a good clinical effect,a rapidly cooling,and significantly improved stuffy nose、headache、body weight hardship、body soring,and had a better safety and tolerance
2.There was no significant in the frequency distribution of the virus of the damp and heat,wind and heat syndrome.
引文
[1]奚小土,罗翌急性病毒性上呼吸道感染的治疗现状甘肃中医2004年第17卷第11期.
[2]姜良铎,张文生,从毒论治初探(J).北京中医药大学学报,1998,21(5):2.
[3]焦扬,姜良铎中医热病学的临床研究述评中国中医急症2006年9月第15卷第9期.
[4]任继学,张志强,毒邪肺热病辨证论治.中医药通报.名医精华2005年12月第4卷第6期.
[5]张京安,苗青.外感热病初起辨治的探讨[J].中国中医基础医学杂志,2001,7(6):408.
[6]黎敬波.外感病因及其致病特点探讨[J].上海中医药大学学报,1999,13(4):9-10.
[7]柯雪帆,赵章忠,王育群.中医外感病治[M].北京:人民卫生出版社出版,1993,9-11.
[8]李继明.论中医外感致病因素[J].成都中医药大学学报,2004,27(2):51-53.
[9]唐农.从火郁证的病机论感染性发热辨治思路(J).江苏中医。2000。21(7):6-7.
[10]杨钦河,彭胜权.伏气学说及其对外感热病的临床意义[J].山东中医药大学学报,1998,22(6):412.
[11]胡金咏,金雪明…中国中医急症2006年6月 第15卷 第6期.
[12]金雪明等.简明中医外感病证治[M].北京:人民军医出版社,2004:1,2,9.
[13]董建华,杜怀棠,周平安等.急性热病临床研究的初步设想[J].中医杂志,1985,26(1):62.
[14]刘兰林,杨进,倪嫒嫒.构建外感热病辨证体系的探讨2005,20(1):20.
[15]周仲瑛,金妙文.中医药治疗病毒感染性高热临床研究(J).中国中医急症,1994,3(1):5-8.
[16]高雅,李更生.论益气扶正法在外感热病中的应用[J].中医研究,2002,15(4):49.
[17]陈建章.“温凉并用"治疗外感热病的认识与临床实践[J].使用中西医结合临床,2004,4(1):55.
[18]罗翌,等.柴莪退热栓抗病毒实验研究,中医药学刊,第23卷第3期2005年3月.
[19]Kobayashi,中药银翘散对小鼠流感A2病毒感染的抗病毒作用,国外医学中医中药分册,2000,22(5):292-293.
[20]王殿俊,金妙文,罗宇慧等“清气凉营”注射液对病毒和微循环的药理作用J.of Chinese Microcimulation Aug.2003,Vol.7,No,
[21]李文,王少军,严敏,等,鱼腥草提取液抗流感、腮腺炎病毒效果观察,预防医学文献信息,1999,5(4):347-348.
[22]NagaiT,Moriguchi R,Suzuki Y,et al,Mode of action of the anti-influenza Virus activity of plant flavonoid 5,7,4'-trihydroxy-8-methoxyflavone,from the roots of Scutellaria baicalensis Antiviral Res,1995,26(1):11-25.
[23]ZhangGG,Song SJ,Ren J,et al A new compoundfrom Forsythia suspensa (Thunb.)Vahl with antiviral effect on RSV.J Herb Pharmacother,2002,2(3):35-40.
[24]周军,李沧海,霍海如,等.桂枝汤对发热大鼠下丘脑蛋白质组影响初探[J].中国实验方法学杂志,2003,9(:):31-34.
[25]李守拙,李沈明,范书铎.黄芩茎叶中野黄芩甙含量测定[J].中草药,2000,31(12):910.
[26]赵红艳.中国医科大学学报,2003,32(12):115-117.
[27]吴少云.柴银白虎汤加减治疗外感发热152例.福建中医药,2002,33(6):35-36.
[28]喻小和,周醒之.小柴胡汤加减治疗小儿外感发热150例.浙江中医学院学报,1997,21(5):37.
[29]尤兢.柴胡注射液治疗小儿上呼吸道感染132例.人民军医.1997,第40卷第12期.
[30]李瑛,邝荣贵.清开灵注射液治疗外感高热症186例临床观察.九江医学.2000,(1):47.
[31]罗翌,等.柴莪退热液灌肠治疗外感高热40例临床观察,中国中医急症.2000,9(1):12.
[32]耿庆云.中药直肠点滴的临床应用经验.云南中医学院学报.1998,(4):43-44.
[33]赵法新等.退热速肛注剂治疗外感高热症107例.中医研究.1999,(6):20-22.
[34]胡晓蕙,江涛,蒋莲泓.中药雾化剂对上呼吸道感染的影响及实验研究.中医药学刊2003年6月第21卷第6期.
[35]刘晓东,朱颖,陈广玲,“热立清擦剂”对小儿外感发热退热疗效的观察附:90例病例报告,成都中医药大学学报,2003;26(4):8-9.
[36]黄文玉,刘力,张咏梅.小儿退热贴穴位外敷治疗风热外感发热患儿61例.中国中医药科技,2003:10(6):282.
[37]范瑞林,民间草药熏洗治疗外感发热,中国民间疗法,2003;11(11):23.
[38]石昌熙,药浴治疗小儿外感发热30例,中国民间疗法,1999;5(10):23.
[39]夏粉仙.针刺加拔罐治疗外感发热37例.浙江中医学院学报.2001,(6):50.
[40]王占慧 耳尖放血加大椎拔罐治疗感冒发热35例 Shanghai J Acu-mox,2005February,Vol 24,No.2.
[41]白雪嫒,卢凤彩中国针灸2003年8月第23卷第8期.
[42]叶任高,内科学,北京:人民卫生出版社,2001,第5版:11.
[43]陈主初,病理生理学,北京:人民卫生出版社,2001,第1版:172-181.
[44]李沧海,周军,霍海如等.前列腺素EP3受体激动剂诱导发热及其机制初探.中国病理生理杂志,2004;20(4):664-665,672.
[45]齐云,杨镇珲,发热及低体温大鼠下丘脑腺苷酸环化酶和磷酸二酯酶活性的经时变化,中国病理生理杂志,2001;7(12):1202-1204.
[46]吴晓岚,赵书芬,IL-1β致热机制的研究进展,解剖科学进展,2004;10(3):267-270.
[47]刘凌云,于瑞雪,苏昕等,血清C—反应蛋白测定及其在小儿上呼吸道感染中的临床价值.济宁医学院学报,2000;3:51-53.
[48]孙丽雯,黄敬孚,呼吸道病毒检测与临床意议,中国医学工程,2005;13(3):325-326.
[49]赵林清,钱渊,王之梁,等.呼吸道合胞病毒检测方法比较,临床儿科杂志,2003;21(1):20-24.
[50]LI FP,LIU MS,LI P,et al.Rapidly making digoxigenin labelled mycolacterium tuberculosis DNA probe by one step method of PCR.China Journal of Modern Medicine,1997;7(3):8-80.
[51]朱汝南,钱渊,刘成贵等.用逆转录聚合酶链反应鉴别甲型和乙型流感病毒感染中华儿科杂志,2000;38(9):536-539.
[52]胡逢蛟,张姝等,摇床吸附治微量细胞板短期培养快速检测流感病毒,中国卫生检验杂志,2005,5,15(5):522-523.
[53]何明俭.病毒唑治疗病毒性上呼吸道感染30例疗效观察,广州医药.1996,27(5):62-63.
[54]武建国.病毒唑滴鼻治疗病毒性上呼吸道感染疗效观察,陕西医学杂志.1997,26(12):734.
[55]陆关珍.阿昔洛韦治疗非疱疹病毒性上呼吸道感染14例.泰山医学院学报,1997,18(1):60-61.
[56]王雷.α-干扰素滴鼻治疗病毒性上呼吸道感染疗效观察.职业与健康,2000,16(12):151.
[57]宋立刚,袁哗,闵昌敏磷酸奥司他韦(达菲)的安全使用天津药学Tianjin Pharmacy 2006年1月第18卷第1期.
[58]刘慧芳 用达菲治流感临床疗效观察 中国初级卫生保健 2005年6月第19卷第6期(总第232期).
[59]杨荣,曹岩,郑红王小燕HIV蛋白酶抑制剂临床应用及评价 药学服务与研究Pharm Care&Res 2006 Oct:6(5).
[60]史志云.刘仕昌教授对岭南温病研究.新中医,1991,6:16-17.
[61]史志云.以“三维空间”思维方法研究岭南温病[J].国医论坛,2000,15(2):21.
[62]刘德传,吴仕九.中医湿热证的研究进展及其方向.中国中医急症,2000,9:43-44.
[63]罗翌,严夏等 急性上呼吸道感染发热2502例中医证侯分析 浙江中医杂志2005年第40卷第5期
[64]李赛美,林培政 岭南温病学研究概况及发展趋势[J],广州中医药大学学报,2005,22(4):329
[65]黄一梅.常见呼吸道疾病湿热兼证临床分析.湖北中医杂志,1994,16(5):39.
[66]樊移山.病毒性疾病从湿论治浅谈.云南中医学院学报,1990,2:5.
[67]段国玉.浅谈病毒与湿邪的关系.中国中医药信息杂志,2002,9(11)31-32.
[68]李赛美,林培政 岭南温病学研究概况及发展趋势[J],广州中医药大学学报,2005,22(4):329.
[69]陆木兴,江西与岭南地区温邪特性与证治差异[J].浙江中医杂志,2002(8):327.
[70]任存霞.试论《伤寒论》和温病学对温邪的讼治[J].光明中医,2004,19(4):10.
[71]吕冠华.脾胃湿热证与温病湿热证关系辨析[J].中医药学刊,2004,22(3):517.
[72]彭胜权.中医药治疗病毒性感染性疾病的优势和特色[J].广州中医药大学学报,2004,21(5):336.
[73]王孟昭,张波.流行性感冒的抗病毒药物治疗.中国医院用药评价与分析.2003,3(4):250-252.