大椎穴刺血治疗外感发热的效应规律研究
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摘要
研究目的:
     观察大椎穴刺络放血后治疗外感发热的临床疗效,初步探讨刺络放血与疗效的效应规律。
     研究方法:
     选取广州中医药大学第二附属医院急诊留观及发热门诊的符合纳入标准的受试者120例为研究对象,按病人就诊时间顺序采用随机对照方法,把患者按3:1的比例分为治疗组和对照组,其中治疗组依据刺血后拔罐放血量的多少分为小剂量组(<2ml)、中等剂量组(2-5ml)和大剂量组(>5ml),每组各30例。四组均接受基础治疗5%葡萄糖或5%葡萄糖氯化钠注射液500ml+Vit C 2. Og+Vit B6 100mg静滴4小时,每日1次,共治疗3天。治疗组在基础治疗的基础上接受大椎点刺放血治疗。方法:取大椎穴,局部常规消毒后,右手持注射针头在大椎穴上及其周围散在地点刺数针(一般3-5针),用投火法拨罐,留罐时间15分钟,用消毒干棉球擦去血迹即可,每日1次,共治疗3天。对照组在基础治疗的同时,若体温大于37.0℃时肌注柴胡注射液2ml,每天1次,共3天,4组患者每次分别于治疗前及治疗后0.5h、1h、2h、4h记录腋下体温值,并记录起效时间、解热时间、痊愈时间,同时在每次治疗结束时进行中医症候学积分评分。使用spss13.0进行统计学分析,通过比较各时点体温变化、起效时间、解热及痊愈时间,以及中医证候积分评分值,对刺血疗法治疗外感发热的时效关系进行评价。根据不同治疗组的出血量的多少与起效时间、解热及痊愈时间及有效率对刺血疗法治疗外感发热的量效关系进行评价。同时记录试验的不良反应和脱落情况,并分析原因。
     结果:
     1.治疗前一般资料比较:本研究共纳入120例,其中男性53例,女性67例。分为治疗组(小于2ml为小剂量组、2-5ml为中剂量组、大于5ml为大剂量组)和对照组(柴胡注射液组)。治疗前四组基线资料(年龄、病程、性别、体温、中医症候积分、白细胞计数等)方面比较,差异均无统计学意义(P>0.05),表明组间基线条件一致,具有可比性。
     2.疗效比较:
     2.1四组治疗前后各时点体温比较
     为观察刺血疗法的即时效应和延时效应,通过比较患者在治疗前体温,和第一次、第二次、第三次治疗后各四个不同时点(0.5h、1h、2h、4h)的腋下体温。统计分析结果表明,第一次治疗后体温疗效比较,大剂量组起效最快,中剂量组治疗后1h体温下降明显,总体疗效大剂量组与中剂量组相似,中剂量组疗效明显优于小剂量组,小剂量组与对照组疗效相当。但第二次治疗前四组体温无明显,说明虽经第一次治疗后体温下降明显,但病情未达稳定,体温有所反复。第二次治疗后体温疗效评价,大、中剂量组退热作用明显,大剂量组平均体温已降至正常。两次治疗后总体疗效比较,大剂量组优于中剂量组,中剂量组优于小剂量组,小剂量组与对照组疗效相当。第三次治疗前四组体温比较差异有统计学意义,大、中剂量组体温较小剂量组、对照组发热低,说明经过两次治疗后,大、中剂量组的延时疗效已较明显。总体疗效评价,大剂量组疗效与中剂量组相似,明显优于优于小剂量组和对照组,后两组疗效无统计学差异。
     2.2四组起效、解热、痊愈时间比较:
     四组起效时间比较:大剂量组的起效时间最快,明显短于中、小剂量组,而中剂量组短于小剂量组,小剂量组与对照组起效时间相似。
     四组解热时间比较:大剂量组优于中剂量组,中剂量组优于小剂量组,小剂量组与对照组无明显差别。
     四组痊愈时间比较:大剂量组与中剂量组痊愈时间相似,明显短于小剂量组,而小剂量组痊愈时间与对照组相似。
     2.3体温变化疗效评定:
     以腋下体温测量为观察指标的结果显示,治疗三组疗效总有效率高于对照组,其中大、中剂量组与小剂量组、对照组差异有统计学意义,但大、中剂量组之间比较差异无统计学意义,小剂量组与对照组差异无统计学意义,说明大剂量组和中剂量组疗效相似、小剂量组和对照组疗效相似,大、中剂量组疗效明显比小剂量组和对照组好。
     2.4四组疗程一疗效相关性比较:
     四组自身前后有效率疗效比较,各组均随着治疗时间的延长,有效率逐渐提高,差异无统计学意义。大、中剂量组总体疗效在三次治疗后达到最高疗效,说明经3个疗程的治疗后疗效达到最佳。
     2.5证候疗效评定
     2.5.1四组证候积分比较:
     2.5.1.1同组治疗前后自身比较:大、中剂量组在第1天治疗后与治疗前比较,差异有统计学意义,说明在改善中医证候方面,大、中剂量组的显效时间快。小剂量组和对照组的近期疗效不明显。
     2.5.1.2组间比较:治疗前四组症候积分组间比较无显著性差异,治疗第1天、第2天、第3天后组间比较,大、中剂量组在改善患者中医症候方面,明显优于对照组。小剂量组从第2次治疗起,显示出比对照组改善外感发热病人的中医症候方面治疗效果好。
     2.6四组中医证候总体疗效比较:
     总有效率:大剂量组>中剂量组>小剂量组>对照组,说明针刺在改善患者中医症候方面疗效比对照组好,而且放血剂量越大效果越明显。从痊愈率比较来看,四组比较差异无统计学意义,可能与样本量少有关。
     2.7四组中医证候各症状痊愈情况比较:
     两组在改善症状学方面比较,对外感发热的发热、恶寒、鼻塞、身痛、咽痛、流涕、汗出、头痛、咳嗽、口渴的改善四组比较均P>0.05,疗效差异无统计学意义,但在改善发热,恶寒、咽痛、头痛、口渴等症状方面治疗组有效率均高于对照组,但统计学无显著性差异,可能与病例数少有关。
     2.8四组病人中医辨证分型治疗情况比较:
     四组患者经中医辨证分型为风寒、风热两型,组间比较,风热证、风寒证分型各组治疗疗效相当,无明显差异。从组内两两比较来看,风热证的治疗有效率明显高于风寒证,但差异无统计学意义,可能与样本量不足有关。
     3.本研究共有2例病例脱落,中剂量组1例因不能坚持针灸而退出,对照组1人因工作繁忙不能坚持治疗,最后收集完整病例118例,其中治疗组89例,对照组29例,此2例按治疗无效统计。
     4.不良反应观察:在治疗过程中,治疗组中有2例出针后出现局部皮下肿胀,予以2-3天热敷后瘀血症状消失,考虑原因为针刺拔罐后皮下淤血。治疗组2例、对照组1例出现头晕乏力,经休息后缓解,余未发现不良反应。
     结论:
     大椎穴点刺放血治疗外感发热是一种安全、有效的治疗方法,随点刺后拔罐放血量的增大,退热的起效时间越快,解热、痊愈时间越短,中医症候学积分改善也越快,在治疗3次后总有效率可达96%,较对照组显著升高,退热的即时作用、远期疗效均较佳,时效、量效关系均呈现正相关性,故本研究认为大椎穴点刺后拔罐放血治疗外感发热的治疗疗程为每日1次,共3次,放血量以2ml以上为佳。大椎穴点刺后拔罐放血临床操作简单,患者的依从性高,值得临床推广应用。
Study objective:
     To observe the clinical effect of treating exogenous fever by blood letting puncturing and cupping on Dazhui and discuss its mechanism
     Method:
     120 cases from the fever clinics and observation room in the Second Affiliated Hospital of Guangzhou University of TCM, who were in accordance with the admission criteria, were chosen as study subjects. In relation to the time sequence, those patients were randomly divided into treatment group and control group, with the ratio of 3:1. Patients in treatment group were further divided into low dose group (<2ml), middle dose group(2-5ml) and high dose group (>5ml), according to the amount of blood let out by blood letting puncturing and cupping, with 30 cases in each group. All the four groups were given basic treatment:which referred to 4-hour intravenous infusion of 5% glucose injection or 5%Sodium Chloride Injection 500ml+Vit C+Vit B6 once a day, for three days. The treatment group also received blood letting puncturing and cupping on Dazhui in addition to basic treatment. Method:The operator firstly located Dazhui and disinfected the area, then pierced scatteredly on and around Dazhui with the right hand holding a needle (generally 3 to 5 pins), applied fire cupping on the pierced part last. The cupping time was 15 minutes and the blood was cleaned by disinfectant dry cotton balls. The treating course was carried out once a day for three days. In addition to basic treatment, the control group were given intramuscular injection of Bupleurum injection once a day for three days, when body temperature was≥37.0℃. For all four groups, temperatures before the treatment and 0.5h, 1h,2h,4h after treatment were recorded. The onset time, fever-relieving time and recovery time were also recorded and TCM syndrome score was evaluated after each treatment. Spss13.0 was utilized to analyze the temperature changes, working time, fever-relieving time and recovery time as well as TCM symptom scores so as to evaluate statistically the relationship between time and effect for the method of treating exogenous fever by blood letting puncturing and cupping on Dazhui. By analyzing the amount of blood let out, onset time, fever-relieving time and recovery time as well as effective rate, the relationship between bleeding amount and effect was evaluated for the method of treating exogenous fever by blood letting puncturing and cupping on Dazhui At the same time, all side effects and failing cases were recorded and analyzed.
     Results:
     1. Comparison of general information before the treatment:120 cases were included in this study, among whom 53 cases were male and 67 cases were female. Those patients were randomly divided into control group (Bupleurum injection) and treatment group (which was further divided into low dose group (<2ml), middle dose group(2-5ml) and high dose group (>5ml) based on the amount of bleeding). Comparing the basic data of four groups in terms of age, disease duration, gender, temperature, TCM syndrome scores and WBC count, the results showed no significant difference (P> 0.05), indicating that the groups were comparable.
     2. Efficacy comparison:
     2.1 comparison of temperature changes before and after treatment In order to observe immediate effect and delay effect, we compared temperatures recorded before treatment and 0.5h、1h、2h、4h after treatment. The results indicated that after the first treatment, the high dose group had the fastest onset time, the middle dose group had significant temperature decrease 1h after treatment, the overall effect of high dose group and middle dose group were similar. Middle dose group had better effect than low dose group and low dose group had similar effect with control group. However, the comparison of temperature changes before the second treatment showed no statistical difference, indicating that though temperature decreased significantly after the first treatment, the patients'conditions were not stable, and fever relapsed. After the second treatment, high dose group and middle dose group had significant antipyretic effect, and average temperature in high dose group had dropped to normal level. The overall effect after two treatments showed high dose group had better effect than middle dose group while middle dose group was superior to low dose group, and low dose group had commensurate effect to control group. The comparison of temperature changes before the third treatment showed statistical difference and temperatures in high dose group and middle dose group were lower than that of low dose group and control group, indicating the delay effect of high dose group and middle dose group began to appear after two treatments. Assessment of overall effect showed that high dose groups and middle dose group had similar effect, but superior to low dose group and control group and the comparison between the later two groups showed no statistical difference.
     2.2 Comparison of onset time, fever relieving time and recovery time: Comparison of the onset time between four groups showed that high dose group had the fastest onset time, and was significantly shorter than middle dose group and low dose group, and middle dose group had shorter onset time. But the difference between small dose group and middle dose group was not statistically significant.
     Comparison of the fever-relieving time between four groups showed that high dose group had better effect than middle dose group and middle dose group was superior to low dose group. But the difference between small dose group and middle dose group was not statistically significant.
     Comparison of recovery time between four groups showed that high dose group had considerable effect with middle dose group and their recovery time was significantly shorter than low dose group. But the difference between small dose group and middle dose group was not statistically significant.
     2.3 Assessment of effect by observing temperature changes
     Choosing axillary temperature as the observation index, the results showed that the total effect of three treatment groups were higher than that of control group. Comparing high dose group and middle dose group with low dose group and the control group, the difference was statistically significant, but the difference between high dose group and middle dose group showed no significant difference and the difference between low dose group and control group showed no significant difference, indicating high dose group and middle dose group had similar efficacy, and low dose group had considerable effect with control group. The effect of high dose group and middle dose group was better than low dose group and control group.
     2.4 Relationship between treatment duration and effect Comparison of effect before and after treatment of four groups showed the effective rate increased gradually in accordance with treatment time, the difference was not statistically significant. The overall effect of high dose group and middle dose group reached its top after the third treatment, indicating that after 3 courses of treatment, the best effect could be achieved.
     2.5 Assessment of effect on TCM syndromes
     2.5.1 Comparison of TCM syndrome scores in four groups:
     2.5.1.1 Comparison within each group before and after treatment:high dose group and middle dose group had significant difference after the first treatment, which suggested high dose group and middle dose group worked faster on the improvement of syndromes while low dose group and control group had no significant short-term effect.
     2.5.1.2 Comparison between groups:Before treatment, there was no significant difference between four groups on TCM syndrome scores. But 1 day,2 days, and 3 days after treatment, comparison between groups showed high dose group and middle dose group were superior to control group in improving syndromes of patients. Low dose treatment group started to show its advantage in improving symptoms of patients exogenous fever from the second treatment.
     2.6 Comparison of overall effect of TCM syndrome in four groups:
     The total effect:high dose group> middle dose group> low dose group> control group, indicating blood letting puncturing was better than control group in the improvement of TCM syndrome, and the better the result was, the more the blood was let out. Comparison of recovery rate showed no statistical difference between four groups, and it may be because the sample was too small.
     2.7 Comparison of recovery in terms of symptoms of TCM syndrome between four
     groups:
     Comparison between two groups in terms of fever, aversion to cold, stuffy nose, body aches, sore throat, runny nose, sweating, headache, cough and thirst showed no statistical difference (P>0.05), but the treatment group had higher effective rate in improving the above symptoms than the control group, the difference was not statistically significant, maybe it was due to the small size of the sample.
     2.8 Comparison of four groups on differential Diagnosis of TCM: Patients in four groups were diagnosed as two syndromes by differential diagnosis of TCM which were wind-cold and wind-heat. Comparison between two groups, the differences were not statistically significant. But within a group, the effective rate of treating wind-heat syndrome was apparently higher than that of wind-cold syndrome, but the difference was also not statistically significant, maybe it was due to the small size of the sample.
     3 In this study,2 cases failed to finish the treatment.1 case in middle dose group dropped out because of not being able to keep puncturing treatment.1 case in control group was not available for being too busy. Therefore, the above two cases were excluded. Finally,118 cases finished the treatment, with 89 cases in treatment group and 29 cases in control group.
     4 Observation of side effects:in the course of treatment, two cases in the treatment group had local subcutaneous swelling after the puncturing, and the swelling disappeared after hot compress therapy for 2 to 3 days. We thought it was subcutaneous ecchymosis caused by acupuncture and cupping.2 patients in treatment group and 1 patient in control group had dizziness and fatigue, but the symptoms were relieved after rest, we thought it was caused by the patients'being too nervous. No other side effects were found.
     Conclusion:
     Treating exogenous fever by blood letting puncturing and cupping on Dazhui was a safe and effective method. With the increase of bleeding after puncturing and cupping, the onset time was faster, fever-relieving time and recovery time became shorter, and the improvement of TCM syndrome score was faster. After three times'treatment, the total effective rate was up to 96%, significantly higher than that of the control group. The immediate effect of relieving fever and long-term effect were both better. Relationship of time-effect and dose-effect was positively correlated. Therefore, this study suggested that the treating course of treating exogenous fever by blood letting puncturing and cupping on Dazhui was once per day, three days, and the bleeding amount should be more than 2ml. Treating exogenous fever by blood letting puncturing and cupping on Dazhui is simple and has high patient's compliance, should be recommended clinically.
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