小儿病毒性肺炎痰热闭肺证中医治疗研究
|
摘要
目的
应用清肺口服液治疗小儿病毒性肺炎的主要证型痰热闭肺证，并以利巴韦林注射液为对照进行临床研究，从而评价清肺口服液的有效性和安全性，揭示开肺化痰解毒法治疗小儿病毒性肺炎痰热闭肺证的科学性。
方法
遵循盲法、分层区组随机、平行对照的原则，在南京军区南京总医院住院病例中，选择符合西医小儿病毒性肺炎和中医小儿肺炎喘嗽痰热闭肺证证候珍断标准的患儿90例，按电脑随机化2：1分为试验组(Ⅰ组)和对照组(Ⅱ组)，建立随机密码表。填写统一的病历报告表，进行治疗前后对照比较观察研究。Ⅰ组为试验组，口服具有开肺化痰解毒功用的清肺口服液，加用不含抗病毒抗菌药物的澄清静滴液；Ⅱ组为对照组，用利巴韦林注射液静脉滴注，加用不含药物成分的口服液安慰剂。观察疗程为10天。
结果
研究前的一般资料、主症、次症和理化检查结果，除性别、舌质两项外，两组间均无显著性差异，说明两组具有可比性。研究结束后，符合方案集试验组58例、对照组29例，两组痊愈、显效、进步、无效例数分别为：50、5、3、0，15、14、0、0。经秩和检验，Z=4.63，P＜0.0001，试验组疗效非常显著优于对照组。症状、体征、理化检查结果：咳嗽、鼻煽，肺部湿啰音，紫绀、恶心呕吐、小便、四肢，X线全胸片等指标好转情况，试验组均优于对照组；发热、痰鸣(咯痰)、气促、恶寒、面色、精神、出汗、口渴、大便，血常规，鼻咽部分泌物呼吸道病毒学检查，两组疗效无显著性差异。临床安全性指标研究结果，清肺口服液未显示对于重要脏器有毒副作用。
结论
清肺口服液治疗小儿病毒性肺炎痰热闭肺证是安全有效的，开肺化痰解毒法治疗小儿病毒性肺炎痰热闭肺证具有科学性和实用性。
Objective
To study on the treatment of accumulation of phlegm-heat in lung syndrome of children's virus pneumonia with Qing Fei oral liquid, controlled by ribavirin injection. To assess the efficacy and safty of Qing Fei oral liquid and to discover that the therapy of clearing lung to resolve phlegm and removing toxical material in treating accumulation of phlegm-heat syndrome of children's virus pneumonia is scientific. Methods
According to the rule of stratified randomization, equal control, blind, multicent clinical study, in Nanjing Military Area Central Hospital, 90 cases had been carefully chosen as study subjects according to the western medicine s diagnostic criterion of children's virus pneumonia and the TCM diagnostic criterion of accumulation of phlegm-heat syndrome of children's virus pneumonia. According to the rule of randomization, all subjects were divided into two groups, test group(group I ) and controlled group(group II ).The ration was 2:1.The randomized code form was also created by computer. The unified lists about cases were filled to study the difference between the status before cases being cured and after cases being cured.Group I was given Qingfei oral liquid, which has the function to resolve phlegm and removing toxical material, and infusion liquid without any antivirus and antibiotics. Group II was infused
ribavirin injection and oral placebo. The observing course was 10 days.
Results
There are, prior to the study, no significant differences between the two groups general information, the leading symptoms and signs, secondary symptoms and signs and physical examinations and laboratory tests except for the sex and texture of tongue. It means that the two groups can be compared. 58 cases of test group and 29 cases of controlled group accorded with the project. The cured, significant effective, improved and ineffective cases of group I were 50, 5, 3, 0. The cured, significant effective, improved and ineffective cases of group II were 15, 14, 0, 0. With rank sum test ,it showed that Z=4.63 , P< 0.0001 .The effect of test group was much better than of the controlled group. Compared with the controlled group, the indexes of test group of the symptoms, signs, physical examinations and laboratory tests including cough, flaring of nares, auscultation on lung, cyanopathy, urine, limb, X-ray of chest were much better. There are no significant differences between the two groups in treating fever, sputum, short breath, aversion to cold, feces, vitality, sweating, thirst, nausea, blood routine test and the virus test of the secretion of nose and throat. The study of clinical safety showed that Qingfei oral liquid had not any harms and side effects on important organs.
Conclusions:
T therapy of clearing lung to resolve phlegm and removing toxical material herapy of clearing lung to resolve phlegm and removing toxical material is effective in treating accumulation of phlegm-heat syndrome of children's virus pneumonia.
应用清肺口服液治疗小儿病毒性肺炎的主要证型痰热闭肺证，并以利巴韦林注射液为对照进行临床研究，从而评价清肺口服液的有效性和安全性，揭示开肺化痰解毒法治疗小儿病毒性肺炎痰热闭肺证的科学性。
方法
遵循盲法、分层区组随机、平行对照的原则，在南京军区南京总医院住院病例中，选择符合西医小儿病毒性肺炎和中医小儿肺炎喘嗽痰热闭肺证证候珍断标准的患儿90例，按电脑随机化2：1分为试验组(Ⅰ组)和对照组(Ⅱ组)，建立随机密码表。填写统一的病历报告表，进行治疗前后对照比较观察研究。Ⅰ组为试验组，口服具有开肺化痰解毒功用的清肺口服液，加用不含抗病毒抗菌药物的澄清静滴液；Ⅱ组为对照组，用利巴韦林注射液静脉滴注，加用不含药物成分的口服液安慰剂。观察疗程为10天。
结果
研究前的一般资料、主症、次症和理化检查结果，除性别、舌质两项外，两组间均无显著性差异，说明两组具有可比性。研究结束后，符合方案集试验组58例、对照组29例，两组痊愈、显效、进步、无效例数分别为：50、5、3、0，15、14、0、0。经秩和检验，Z=4.63，P＜0.0001，试验组疗效非常显著优于对照组。症状、体征、理化检查结果：咳嗽、鼻煽，肺部湿啰音，紫绀、恶心呕吐、小便、四肢，X线全胸片等指标好转情况，试验组均优于对照组；发热、痰鸣(咯痰)、气促、恶寒、面色、精神、出汗、口渴、大便，血常规，鼻咽部分泌物呼吸道病毒学检查，两组疗效无显著性差异。临床安全性指标研究结果，清肺口服液未显示对于重要脏器有毒副作用。
结论
清肺口服液治疗小儿病毒性肺炎痰热闭肺证是安全有效的，开肺化痰解毒法治疗小儿病毒性肺炎痰热闭肺证具有科学性和实用性。
Objective
To study on the treatment of accumulation of phlegm-heat in lung syndrome of children's virus pneumonia with Qing Fei oral liquid, controlled by ribavirin injection. To assess the efficacy and safty of Qing Fei oral liquid and to discover that the therapy of clearing lung to resolve phlegm and removing toxical material in treating accumulation of phlegm-heat syndrome of children's virus pneumonia is scientific. Methods
According to the rule of stratified randomization, equal control, blind, multicent clinical study, in Nanjing Military Area Central Hospital, 90 cases had been carefully chosen as study subjects according to the western medicine s diagnostic criterion of children's virus pneumonia and the TCM diagnostic criterion of accumulation of phlegm-heat syndrome of children's virus pneumonia. According to the rule of randomization, all subjects were divided into two groups, test group(group I ) and controlled group(group II ).The ration was 2:1.The randomized code form was also created by computer. The unified lists about cases were filled to study the difference between the status before cases being cured and after cases being cured.Group I was given Qingfei oral liquid, which has the function to resolve phlegm and removing toxical material, and infusion liquid without any antivirus and antibiotics. Group II was infused
ribavirin injection and oral placebo. The observing course was 10 days.
Results
There are, prior to the study, no significant differences between the two groups general information, the leading symptoms and signs, secondary symptoms and signs and physical examinations and laboratory tests except for the sex and texture of tongue. It means that the two groups can be compared. 58 cases of test group and 29 cases of controlled group accorded with the project. The cured, significant effective, improved and ineffective cases of group I were 50, 5, 3, 0. The cured, significant effective, improved and ineffective cases of group II were 15, 14, 0, 0. With rank sum test ,it showed that Z=4.63 , P< 0.0001 .The effect of test group was much better than of the controlled group. Compared with the controlled group, the indexes of test group of the symptoms, signs, physical examinations and laboratory tests including cough, flaring of nares, auscultation on lung, cyanopathy, urine, limb, X-ray of chest were much better. There are no significant differences between the two groups in treating fever, sputum, short breath, aversion to cold, feces, vitality, sweating, thirst, nausea, blood routine test and the virus test of the secretion of nose and throat. The study of clinical safety showed that Qingfei oral liquid had not any harms and side effects on important organs.
Conclusions:
T therapy of clearing lung to resolve phlegm and removing toxical material herapy of clearing lung to resolve phlegm and removing toxical material is effective in treating accumulation of phlegm-heat syndrome of children's virus pneumonia.
引文
1．国家中医药管理局。中华人民共和国中医药行业标准·中医病症诊断疗效标准。第1版。南京：南京大学出版社，1995
2．吴瑞萍、胡亚美、江载芳主编，实用儿科学．北京：人民卫生出版社，1996
3．中华人民共和国卫生部。《中药新药临床研究指导原则》1997
4．阎田玉．小儿腺病毒肺炎血．瘀症的临床证治体会．中医杂志，1981：22(12)：27
5．中华人民共利国卫生部．小儿肺炎防治方案．中华儿科杂志，1987；25(1)：47
6．汪受传，任现志，朱先康，等．小儿病毒性肺炎病原病机证候探讨．辽宁中医杂志，1999，26(1)：67
7．徐美龄，虞坚尔，潘新，等．肺炎方治疗柯萨奇病毒性肺炎的临床和实验研究．上海中医约杂志，2000：34(8)：28-30
8．杨端芬．增液承气汤治疗小儿病毒性肺炎88例．四川中医，2001，19(3)：60
9．杨振汉．活血化瘀法治疗病毒性肺炎36例临床观察．新中医，1996，(5)：25
10．郭迪．儿科基础与临床．上海：上海科学技术出版社，1988；533．
11．阎田玉，侯安存，郑企静，等．小儿呼吸道合胞病毒肺炎的中医治疗和体会．中医杂志，1987，28(1)：32
12．陆秀华，闫田玉．活血化瘀法治疗小儿病毒性肝炎100例．江苏中医，1998，19(9)：31．
13．万伟祖，袁磊，朱健，等．肺毒清冲剂治疗小儿病毒性肺炎30例疗效观察．新中医，2001．33(4)：17．
14．宋铁玎，王雪平，张宏伟，等．小儿清肺饮治疗小儿病毒性肺炎144例．辽宁中医杂志，2001．28(2)：94．
15．温振英，李秋英，佘继林．扶正祛邪法治疗小儿病毒性肺炎的临床与实验研究，中医杂志1991，32(10)：41．
16．刘传珍，周丽华，水正．清肺扶正祛瘀法治疗小儿病毒性肺炎的临床报道．中国医约学报，1993，8(4)：32．
17．汪受传，任现志，朱先康，等．开肺化痰解毒法治疗小儿病毒性肺炎痰热壅肺证临床观察．南京中医药大学学报，1999，15(1)：14．
18．刘怡湘，沈洁，王荣珍．莨菪消喘膏穴位贴敷促进小儿肺炎罗音吸收80例观察．中医杂志，1994，35(10)：620．
19．李杰，广凌，王雪峰．中药内外合治小儿病毒性肺炎的临床研究．辽宁中医杂志
1999，26(6)：261．
20．石是峰，宋革利．中药小儿清热合剂灌肠疗效观察．中医杂志，1989，30(6)：339．
21．崔现军，孙钦迎，邵秀梅，等．扶正抗毒液灌肠治疗小儿病毒性肺炎临床观察．中医杂志，1999，40(11)：678．
22．师晶丽，吴倩倩，刘树青，等．中药雾化合剂治疗小儿腺病毒肺炎的临床研究．中医杂志，1999，40(1)：36．
23．怀有为，宋学枋，张公惠，等．比较穿琥宁与利巴韦林治疗小儿病毒性肺炎的疗效．中国新药与临床杂志，1999，18(1)：55．
24．范荣刚，张惠珍．双黄连治疗小儿病毒性肺炎41例疗效分析．苏州医学院学报，1997，17(3)：572．
25．王慕逖．儿科学．第4版．北京：人民卫生出版社，1997：247．
26．吴瑞萍，胡亚美，江载芳．诸福棠实用儿科学．第6版．北京：人民卫生出版社，1996：1157
27．丁韵珍．1993～1998年上海地区4941例婴幼儿肺炎患儿的呼吸道病原检测．199 8年宜昌小儿呼吸会议文集
28．杨明光，王晓刚，刘渝．急性毛细支气管炎病毒病原分析．四川医学，1998：19(5)：410
29. Berner R, Schwoerer F, Schumacher RF, Meder M,, Forster J· Community and nosocomially acquired respiratory syncytial virus infection in a German paediatric hospital from 1988 to 1999. Eur J Pediatr 2001 Sep;160(9):541
30．李建平，陈劲松．桥联酶标法检测小儿呼吸道病毒病原156例报告．中国厂矿医学，1999：12(3)：164
31．李江全，任现志，汪受传等．清肺口服液在组织培养上对常见呼吸道病毒抑制作用的研究[J]．辽宁中医学院学报，2002：4(2)：153-154。
32．李江全，任现志，汪受传．清肺口服液对免疫功能影响的实验研究[J]．中国实验方剂学杂志，2003：9(4)：47-48．
33．何丽，汪受传，王明艳等．开肺化痰解毒法对人胚肺成纤维细胞Fas表达的影响[J]．江苏中医药，2004；[1]：35-38．
34．任现志，汪受传，李江全等．清肺口服液治疗小儿病毒性肺炎药效学实验研究．中国中医基础医学杂志，2002，8(101．22-24
2．吴瑞萍、胡亚美、江载芳主编，实用儿科学．北京：人民卫生出版社，1996
3．中华人民共和国卫生部。《中药新药临床研究指导原则》1997
4．阎田玉．小儿腺病毒肺炎血．瘀症的临床证治体会．中医杂志，1981：22(12)：27
5．中华人民共利国卫生部．小儿肺炎防治方案．中华儿科杂志，1987；25(1)：47
6．汪受传，任现志，朱先康，等．小儿病毒性肺炎病原病机证候探讨．辽宁中医杂志，1999，26(1)：67
7．徐美龄，虞坚尔，潘新，等．肺炎方治疗柯萨奇病毒性肺炎的临床和实验研究．上海中医约杂志，2000：34(8)：28-30
8．杨端芬．增液承气汤治疗小儿病毒性肺炎88例．四川中医，2001，19(3)：60
9．杨振汉．活血化瘀法治疗病毒性肺炎36例临床观察．新中医，1996，(5)：25
10．郭迪．儿科基础与临床．上海：上海科学技术出版社，1988；533．
11．阎田玉，侯安存，郑企静，等．小儿呼吸道合胞病毒肺炎的中医治疗和体会．中医杂志，1987，28(1)：32
12．陆秀华，闫田玉．活血化瘀法治疗小儿病毒性肝炎100例．江苏中医，1998，19(9)：31．
13．万伟祖，袁磊，朱健，等．肺毒清冲剂治疗小儿病毒性肺炎30例疗效观察．新中医，2001．33(4)：17．
14．宋铁玎，王雪平，张宏伟，等．小儿清肺饮治疗小儿病毒性肺炎144例．辽宁中医杂志，2001．28(2)：94．
15．温振英，李秋英，佘继林．扶正祛邪法治疗小儿病毒性肺炎的临床与实验研究，中医杂志1991，32(10)：41．
16．刘传珍，周丽华，水正．清肺扶正祛瘀法治疗小儿病毒性肺炎的临床报道．中国医约学报，1993，8(4)：32．
17．汪受传，任现志，朱先康，等．开肺化痰解毒法治疗小儿病毒性肺炎痰热壅肺证临床观察．南京中医药大学学报，1999，15(1)：14．
18．刘怡湘，沈洁，王荣珍．莨菪消喘膏穴位贴敷促进小儿肺炎罗音吸收80例观察．中医杂志，1994，35(10)：620．
19．李杰，广凌，王雪峰．中药内外合治小儿病毒性肺炎的临床研究．辽宁中医杂志
1999，26(6)：261．
20．石是峰，宋革利．中药小儿清热合剂灌肠疗效观察．中医杂志，1989，30(6)：339．
21．崔现军，孙钦迎，邵秀梅，等．扶正抗毒液灌肠治疗小儿病毒性肺炎临床观察．中医杂志，1999，40(11)：678．
22．师晶丽，吴倩倩，刘树青，等．中药雾化合剂治疗小儿腺病毒肺炎的临床研究．中医杂志，1999，40(1)：36．
23．怀有为，宋学枋，张公惠，等．比较穿琥宁与利巴韦林治疗小儿病毒性肺炎的疗效．中国新药与临床杂志，1999，18(1)：55．
24．范荣刚，张惠珍．双黄连治疗小儿病毒性肺炎41例疗效分析．苏州医学院学报，1997，17(3)：572．
25．王慕逖．儿科学．第4版．北京：人民卫生出版社，1997：247．
26．吴瑞萍，胡亚美，江载芳．诸福棠实用儿科学．第6版．北京：人民卫生出版社，1996：1157
27．丁韵珍．1993～1998年上海地区4941例婴幼儿肺炎患儿的呼吸道病原检测．199 8年宜昌小儿呼吸会议文集
28．杨明光，王晓刚，刘渝．急性毛细支气管炎病毒病原分析．四川医学，1998：19(5)：410
29. Berner R, Schwoerer F, Schumacher RF, Meder M,, Forster J· Community and nosocomially acquired respiratory syncytial virus infection in a German paediatric hospital from 1988 to 1999. Eur J Pediatr 2001 Sep;160(9):541
30．李建平，陈劲松．桥联酶标法检测小儿呼吸道病毒病原156例报告．中国厂矿医学，1999：12(3)：164
31．李江全，任现志，汪受传等．清肺口服液在组织培养上对常见呼吸道病毒抑制作用的研究[J]．辽宁中医学院学报，2002：4(2)：153-154。
32．李江全，任现志，汪受传．清肺口服液对免疫功能影响的实验研究[J]．中国实验方剂学杂志，2003：9(4)：47-48．
33．何丽，汪受传，王明艳等．开肺化痰解毒法对人胚肺成纤维细胞Fas表达的影响[J]．江苏中医药，2004；[1]：35-38．
34．任现志，汪受传，李江全等．清肺口服液治疗小儿病毒性肺炎药效学实验研究．中国中医基础医学杂志，2002，8(101．22-24
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址：北京市海淀区学院路29号 邮编：100083 电话：办公室：(+86 10)66554848；文献借阅、咨询服务、科技查新：66554700 |