耳尖放血治疗风热感冒发热的临床研究
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摘要
目的
观察耳尖放血治疗风热感冒发热的临床疗效。
方法
本研究采用随机对照试验方法进行临床试验,共有合格受试者64例。治疗组32例；对照组32例。治疗组耳尖放血,治疗方法：选穴、耳尖穴：耳尖穴的部位将耳轮转向耳屏对折时,耳廓上尖端处即是。操作方法：按摩耳尖部使其充血,常规75%酒精棉球消毒皮肤,左手拇、食指夹捏,固定耳廓上端,右手指三棱针,对准耳尖穴迅速点刺,针尖刺入约1-3毫米深,以双手拇、食指轻挤针眼四周,使之出血如豆大,以棉球吸去,如此反复放血8滴。对照组：中成药：感冒退热冲剂。药物组成：大青叶、板蓝根、连翘、拳参。用法用量：冲剂,袋装每袋10克。每日2-3次,每次1袋；6岁以上儿童用1/2袋,每日2次；6岁以下儿童用1/3袋,每日2次,温开水冲服。试验期间均不得使用有治疗作用的其他药物治疗。治疗组与对照组疗程均为5天。
结果
两组治疗前各指标比较,差异均无统计学意义。提示影响两组预后的主要因素具有均衡性。
总疗效比较：两组总疗效比较,治疗组近期临床痊愈率为50%,显效率为31.3%,有效率为9.4%,近期临床痊愈率及显效率为81.3%,总有效率为90.6%；对照组近期临床痊愈率为28.1%,显效率为28.1%,有效率为25%,近期临床痊愈率及显效率为56.2%,总有效率为81.2%。两组比较(z=2.14,P=0.03),差异有统计学意义。
两组治疗5天后咳嗽改善程度(z=1.97，P=0.04)、口渴改善程度比较(z=2.89,P=0.00),差异有统计学意义。
两组治疗5天后恶寒、汗出、发热、、改善程度比较,差异无统计学意义。
两组治疗5天后咳嗽(χ2=4.14，P=0.041)、恶寒(χ2=7.27，P=0.007)、发热(χ2=6.34,P=0.01)、口渴(χ2=4.51,P=0.03)、咽痛(χ2=4.46，P=0.03)、咽部充血(χ2=4.14,P=0.04)、胸透肺纹理增粗(χ2=4.66，P=0.03)等消失率比较,差异有意义性意义。两组治疗5天后胸闷、汗出、鼻塞、喷嚏、便干、尿短赤、肺部听诊呼吸音较粗或少许干湿啰音、扁桃体红肿等消失率比较,差异无统计学意义。
不良事件观察,治疗组治疗后无不良反应。对照组用药后无不良反应。
结论
通过以上的临床研究和文献分析,可以得出如下结论：
两组中医证候疗效比较,治疗组疗效优于对照组。耳尖刺血疗法的损伤极小、痛苦小、安全无任何副作用,患者易于接受,放血微量,经济实惠,操作简单、极易掌握运用和推广；显效快,一些急性症状常出现即时效果；适用范围广,具有一法多病,一穴多病的特点。
Objective
To evaluate objectively efficacy of clinical therapeutic effect and safety of Erjian(HX6,7i) bloodletting therapy for exogenous fever, a randomized controlled trial was undertaken.
Methods
All study objects were patients with exogenous fever. Cases source:64 patients from You Sheng Chinese clinic were selected June,2008 to December, 2009. Therapeutic methods:for group of Erjian (HX6,7i) bloodletting: selection points and Erjian(HX6,7i) points allocation:at the superior apex of anteriority folded part of helix. Operation methods:massage the apex satyri to hyperemia, use routine cotton ball of 75% alcohol to disinfect the skin, knead and clip the skin of apex satyri with left thumb and forefinger, fix the superior extremity of auricle, use the three-edged needle by right fingers, aim at the Erjian point and prick fast to the point, about 1-3 mm, then press gently with both thumbs and forefingers circumference of pinpoint to make the blood volume as bean, and use the cotton ball to draw the blood away, repeat exsanguinations until bleeding of 8 drops.
Control group:Chinese patent medicine:Ganmaotuire Chong Ji. Herb Composition:Daqingye、Banglangen、Lianqiao、Quanshen. Usage and dosage:Chong Ji,10 g medicine was packed into each pouch. Adult take one pouch each time and two to three times everyday; child who older than six years use half pouch each and two times everyday; child who younger than six years use 1/3 pouch each time and two times everyday. Take medicine after mixing with warm water. Patients with syndrome of deficiency and cold of spleen and stomach are forbidden to take the medicine. The medicine was manufactured by Yuehua pharmaceutical factory in Guang Zhou. Any other drugs that have therapeutic effect are forbidden to take during the trial. The course is 5 days of both groups.
Results
The research adapted methods of random and control to take clinical trial, and there were total 64 qualified patients including 32 cases in the trial group and 32 cases in the control group. Before treatment, all indices between two groups had no significant difference, indicating the main factors that would affect the prognosis between two groups are comparable. Total efficacy comparison:in the treatment group, the recent clinical recovery rate was 50%, excellence rate was 31.3%, and effective rate was 9.4%, recent clinical recovery plus excellence rate was 81.3% and total rate was 90.6%; while in the control group, the rate was 28.1%,28.1%,56.2% and 81.2% relatively. Comparison between two groups showed difference of significance (z=2.14, P=0.03). After five days'treatment, improvement degree of cough and thirsty symptoms had significant difference between two groups (z=2.89, P=0.00) however, improvement degree of aversion to cold, sweating and fever symptoms showed no significant difference. After treatment of five days, disappearance rate of cough (χ2=4.14,P=0.041), aversion to cold (χ2=7.27, P=0.007), fever (χ2=6.34, P=0.01), thirsty (χ2=4.51,P=0.03) pharyngalgia (χ2=4.46, P=0.03), hyperemia of pharyngeal portion (χ2=4.14, P=0.04), thick lung making by chest X-rays (χ2=4.66, P=0.03)between two groups had significant difference. While disappearance rate of chest distress, sweating, nasal obstruction, sneezing, dry stool, short and red urine, auscultation of lung breath sound showing fairly rough or a little of dry and moist rales, flare of tonsil, had no significant difference between two groups.
Safety test:pre-treatment and post-treatment, there were no abnormal changes of blood routine, urine routine, stool routine, function of liver and kidney, electrocardiogram in both groups. Adverse evens observation showed no adverse reaction in both groups.
Conclusions
By the above analysis of clinical research and literature, conclusions could come to as below:
Comparison with efficacy of Chinese medicine syndrome between two groups suggested the therapeutic effect of trial group is better than that in the control group. Erjian bloodletting Therapy had slight injury, suffering less, safe and without adverse effect, which could be accepted easily by patients, the method had other advantages such as microamount bleeding, economical and beneficial, simple operation and very easy to apply and popularize; the method could take effect fast and have immediately effect on some emergent symptoms; Erjian bleeding method's applicability was large and had characteristics of one method to treat multiple diseases and one point to therapy multiple diseases.
观察耳尖放血治疗风热感冒发热的临床疗效。
方法
本研究采用随机对照试验方法进行临床试验,共有合格受试者64例。治疗组32例；对照组32例。治疗组耳尖放血,治疗方法：选穴、耳尖穴：耳尖穴的部位将耳轮转向耳屏对折时,耳廓上尖端处即是。操作方法：按摩耳尖部使其充血,常规75%酒精棉球消毒皮肤,左手拇、食指夹捏,固定耳廓上端,右手指三棱针,对准耳尖穴迅速点刺,针尖刺入约1-3毫米深,以双手拇、食指轻挤针眼四周,使之出血如豆大,以棉球吸去,如此反复放血8滴。对照组：中成药：感冒退热冲剂。药物组成：大青叶、板蓝根、连翘、拳参。用法用量：冲剂,袋装每袋10克。每日2-3次,每次1袋；6岁以上儿童用1/2袋,每日2次；6岁以下儿童用1/3袋,每日2次,温开水冲服。试验期间均不得使用有治疗作用的其他药物治疗。治疗组与对照组疗程均为5天。
结果
两组治疗前各指标比较,差异均无统计学意义。提示影响两组预后的主要因素具有均衡性。
总疗效比较：两组总疗效比较,治疗组近期临床痊愈率为50%,显效率为31.3%,有效率为9.4%,近期临床痊愈率及显效率为81.3%,总有效率为90.6%；对照组近期临床痊愈率为28.1%,显效率为28.1%,有效率为25%,近期临床痊愈率及显效率为56.2%,总有效率为81.2%。两组比较(z=2.14,P=0.03),差异有统计学意义。
两组治疗5天后咳嗽改善程度(z=1.97，P=0.04)、口渴改善程度比较(z=2.89,P=0.00),差异有统计学意义。
两组治疗5天后恶寒、汗出、发热、、改善程度比较,差异无统计学意义。
两组治疗5天后咳嗽(χ2=4.14，P=0.041)、恶寒(χ2=7.27，P=0.007)、发热(χ2=6.34,P=0.01)、口渴(χ2=4.51,P=0.03)、咽痛(χ2=4.46，P=0.03)、咽部充血(χ2=4.14,P=0.04)、胸透肺纹理增粗(χ2=4.66，P=0.03)等消失率比较,差异有意义性意义。两组治疗5天后胸闷、汗出、鼻塞、喷嚏、便干、尿短赤、肺部听诊呼吸音较粗或少许干湿啰音、扁桃体红肿等消失率比较,差异无统计学意义。
不良事件观察,治疗组治疗后无不良反应。对照组用药后无不良反应。
结论
通过以上的临床研究和文献分析,可以得出如下结论：
两组中医证候疗效比较,治疗组疗效优于对照组。耳尖刺血疗法的损伤极小、痛苦小、安全无任何副作用,患者易于接受,放血微量,经济实惠,操作简单、极易掌握运用和推广；显效快,一些急性症状常出现即时效果；适用范围广,具有一法多病,一穴多病的特点。
Objective
To evaluate objectively efficacy of clinical therapeutic effect and safety of Erjian(HX6,7i) bloodletting therapy for exogenous fever, a randomized controlled trial was undertaken.
Methods
All study objects were patients with exogenous fever. Cases source:64 patients from You Sheng Chinese clinic were selected June,2008 to December, 2009. Therapeutic methods:for group of Erjian (HX6,7i) bloodletting: selection points and Erjian(HX6,7i) points allocation:at the superior apex of anteriority folded part of helix. Operation methods:massage the apex satyri to hyperemia, use routine cotton ball of 75% alcohol to disinfect the skin, knead and clip the skin of apex satyri with left thumb and forefinger, fix the superior extremity of auricle, use the three-edged needle by right fingers, aim at the Erjian point and prick fast to the point, about 1-3 mm, then press gently with both thumbs and forefingers circumference of pinpoint to make the blood volume as bean, and use the cotton ball to draw the blood away, repeat exsanguinations until bleeding of 8 drops.
Control group:Chinese patent medicine:Ganmaotuire Chong Ji. Herb Composition:Daqingye、Banglangen、Lianqiao、Quanshen. Usage and dosage:Chong Ji,10 g medicine was packed into each pouch. Adult take one pouch each time and two to three times everyday; child who older than six years use half pouch each and two times everyday; child who younger than six years use 1/3 pouch each time and two times everyday. Take medicine after mixing with warm water. Patients with syndrome of deficiency and cold of spleen and stomach are forbidden to take the medicine. The medicine was manufactured by Yuehua pharmaceutical factory in Guang Zhou. Any other drugs that have therapeutic effect are forbidden to take during the trial. The course is 5 days of both groups.
Results
The research adapted methods of random and control to take clinical trial, and there were total 64 qualified patients including 32 cases in the trial group and 32 cases in the control group. Before treatment, all indices between two groups had no significant difference, indicating the main factors that would affect the prognosis between two groups are comparable. Total efficacy comparison:in the treatment group, the recent clinical recovery rate was 50%, excellence rate was 31.3%, and effective rate was 9.4%, recent clinical recovery plus excellence rate was 81.3% and total rate was 90.6%; while in the control group, the rate was 28.1%,28.1%,56.2% and 81.2% relatively. Comparison between two groups showed difference of significance (z=2.14, P=0.03). After five days'treatment, improvement degree of cough and thirsty symptoms had significant difference between two groups (z=2.89, P=0.00) however, improvement degree of aversion to cold, sweating and fever symptoms showed no significant difference. After treatment of five days, disappearance rate of cough (χ2=4.14,P=0.041), aversion to cold (χ2=7.27, P=0.007), fever (χ2=6.34, P=0.01), thirsty (χ2=4.51,P=0.03) pharyngalgia (χ2=4.46, P=0.03), hyperemia of pharyngeal portion (χ2=4.14, P=0.04), thick lung making by chest X-rays (χ2=4.66, P=0.03)between two groups had significant difference. While disappearance rate of chest distress, sweating, nasal obstruction, sneezing, dry stool, short and red urine, auscultation of lung breath sound showing fairly rough or a little of dry and moist rales, flare of tonsil, had no significant difference between two groups.
Safety test:pre-treatment and post-treatment, there were no abnormal changes of blood routine, urine routine, stool routine, function of liver and kidney, electrocardiogram in both groups. Adverse evens observation showed no adverse reaction in both groups.
Conclusions
By the above analysis of clinical research and literature, conclusions could come to as below:
Comparison with efficacy of Chinese medicine syndrome between two groups suggested the therapeutic effect of trial group is better than that in the control group. Erjian bloodletting Therapy had slight injury, suffering less, safe and without adverse effect, which could be accepted easily by patients, the method had other advantages such as microamount bleeding, economical and beneficial, simple operation and very easy to apply and popularize; the method could take effect fast and have immediately effect on some emergent symptoms; Erjian bleeding method's applicability was large and had characteristics of one method to treat multiple diseases and one point to therapy multiple diseases.
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