摘要
目的
本临床对照研究探讨俞募与原络配穴为主治疗胃溃疡虚证的临床疗效；拟在导师已有的研究基础上,通过随机对照的研究方法,采用多学科同步观察分析,客观观察评价俞募与原络配穴为主治疗胃溃疡虚证的临床疗效及其安全性。期望进一步胃溃疡虚证的规范临床疗效,获得较好的社会效益。为中医药防治胃溃疡的临床研究及其新药开发建立必备的评估系统和提供严谨的科研资料。
本研究采用“俞募配穴”和“原络配穴”为主的针刺方法,对这两种取穴方案进行研究并与普通针刺配穴比较,通过检测一定的客观治标观察该配穴的疗效,并试图解释其机制。
方法
研究对象来源于台湾光晟中医门诊就诊病人。胃溃疡者腹痛常发生于中上腹部,隐痛或刺痛,有时为胀痛或烘灼痛可放射到腰背部。腹痛可因饮食不调、劳累、精神紧张或气候骤变而诱发。伴有泛酸、嗳气、恶心或呕吐。大便潜血试验阳性或阴性。纤维内窥镜对胃检查可见溃疡者。胃溃疡者需做活体组织检查或脱落细胞检查排除癌变。胃溃疡者具体的西医诊断标准如下(参考叶任高等主编《内科学》第六版。胃溃疡虚寒证中医证候诊断标准是：主症：①胃脘痛隐隐,喜暖喜按；②每遇冷或劳累而发作或加重；③空腹痛重,得食痛减,食后腹胀；④舌质淡嫩,边有齿痕,苔薄白,脉沉细或迟。次症：①倦怠乏力,神疲懒言；②肢寒肢冷；③大便溏薄；④呕吐清涎。
本研究共有合格受试者83例,试验组(试验组)46例,其中男性30例,女性16例；对照组(对照组)37例,其中男性24例,女性13例,两组均为门诊病人。合格受试者用随机对照试验方法,分配至试验组(俞募配穴组+原络配穴组)与对照组(常规穴位组)。病例分组采用简单随机的方法。具体的随机化分配方法由临床研究研究人员通过操作SAS(统计分析系统)软件得出随机数字,并制成随机分配卡片,加信封密封,信封序号与卡片序号相同。合格病例进入试验时,按其进入的先后次序,拆开号码相同的信封,按信封内卡片规定的分组进行治疗。随机数字表按要求进行保存。取穴方法根据丘茂良主编《高等医药院校教材·针灸学》俞募配穴组主穴：中脘、胃俞；原络配穴组主穴：冲阳、公孙(均双侧)；常规穴位组主穴：足三里、内关、上脘。配穴：胃痛甚加梁丘,胃寒甚加灸中脘,腹胀甚加天枢,反酸多加太冲,乏力加气海。以上穴位交替使用。操作方法：75%酒精严格消毒皮肤,选取华佗牌1寸或1.5寸豪针,进针得气后行平补平泻手法,留针30分钟,每日1次,5次为一个疗程,每疗程间休息2天,共9个疗程。试验期间均不得使用其他有治疗作用的药物治疗。疗程均为二个月。隔日1次,5次为一个疗程,每疗程间休息2天,9个疗程(即2个月)后胃镜复查。疗效标准：临床痊愈：主症与次症全部消失。胃镜下溃疡病灶亦基本愈合。显效：主症与次症均有明显改善；或个别主症轻度改善,但其他主症症状全部消失。胃镜下溃疡病灶有所好转。有效：主症与次症均有改善,或主症未有改善,但次症全部消失。胃镜下溃疡病灶无变化。无效：主症与次症状均无改善。临床研究结束后,临床资料及时汇总,输入计算机,建立数据库,进行数据管理,用EpiData3.0软件录入数据。用统计软件对两组治疗后临床总疗效、临床症状、体征疗效等进行统计分析、比较,最后客观评价临床疗效及其安全性。统计方法：分类资料用χ2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。统计计算采用SPSS17.0统计软件完成统计分析。
结果
本研究共有合格受试者83例,试验组46例,其中男性30例,女性16例；对照组37例,其中男性24例,女性13例。
两组可比性检查：两组年龄构成情况、性别分布情况、病情反复发作情况、病情近期发作情况、胃痛时间(分钟／每日)、上腹痛程度、上腹痛次数、上腹喜按、喜热、食入痛减出现率、上腹刺割痛、隐隐作痛、痛连两胁的出现率比较,差异均无显著性意义(P>0.05)。两组治疗前主要症状反酸、恶心、嗳气、腹胀、食少出现率比较,差异均无显著性意义(P>0.05)。两组治疗前主要症状口淡、口苦、便干结、体倦出现率比较,差异均无显著性意义。两组治疗前便溏比较,差异有显著性意义(P<0.05)。两组治疗前溃疡面积比较,差异无统计学意义(P>0.05)。两组治疗前溃疡数目比较,差异无统计学意义(P>0.05)。两组治疗前溃疡分期比较,差异无显著性意义(P>0.05)。两组治疗前舌质、舌苔、脉象比较,差异有显著性意义。两组治疗前幽门螺曲杆菌检测比较,差异无显著性意义(P>0.05)。
综上所述,治疗前两组性别、年龄、病程、中医证候、病种及两组治疗前上腹痛性质、次数程度、、溃疡面积、溃疡分期、溃疡数目、舌象、脉象等主要症状(除便溏外),胃镜检查结果等比较,差异均无显著性意义(P>0.05),说明上述各项因素在两组间具有齐同性,表明试验组与对照组具有可比性。
疗效比较：两组中医证候疗效比较,试验组临床痊愈率为56.52%,显效率21.74%,显效及临床痊愈率为77.2%；对照组临床痊愈率为29.73%,显效率为37.84%,显效及临床痊愈率为67.5%。两组中医证候总疗效比较,差异有显著性意义(P<0.05)。两组治疗前后上腹痛改善程度比较,差异有显著性意义(P<0.05)。
治疗后反酸、恶心、嗳气、食少、腹胀、口淡、口苦、便溏、便干结、体倦等主要临床症状及体征等消失率比较,差异均无显著性意义。胃镜疗效比较,试验组临床痊愈率为52.17%,显效率21.74%,显效及临床痊愈率为73.8%；对照组临床痊愈率为32.43%,显效率为37.84%,显效及临床痊愈率为70.2%。两组胃溃疡胃镜检查疗效比较,差异无显著性意义(P>0.05)。两组治疗后缩短胃痛时间比较(分钟／日)比较,差异无统计学意义(P>0.05)。
安全性检测：试验组治疗前共检测了46例血常规、大便常规、尿常规、肝功能(GPT)、肾功能(BUN),治疗后复查均未见异常变化。试验组治疗前共检测了46例心电图,治疗后复查了44例,未见异常变化。对照组治疗前共检测了37例血常规、大便常规、尿常规、肝功能(GPT)、肾功能(BUN)、心电图,治疗后复查均未见异常变化。
不良事件观察,本试验过程中,试验组与对照组的血常规、尿常规、大便常规、肝功能(GPT)、肾功能(BUN)、心电图等治疗前后检查结果,均未发现明显损害。
结论
本研究采用随机对照试验方法进行临床试验,本试验共有合格受试者83例,其中试验组46例,对照组37例。
安全性检测表明,治疗前血、尿、大便常规、肝肾功能、心电图正常者,治疗后未见异常改变,表明该疗法临床应用安全。
两组治疗前性别、年龄、病程、中医证候、病种及主要症状等各项经可比性检测,两组均衡性较好,在观察治疗过程中未发现明显不良反应。
本研究是治疗胃溃疡属虚寒证的患者。其试验组中医证候疗效的总有效率为96.5%,对照组中医证候疗效的总有效率为83.78%,差异有显著性意义(P<0.05)；胃镜总疗效,试验组总有效率为86.96%,对照组总有效率为83.78%,差异有显著性意义(P<0.05)。两组中医证候疗效比较,差异有显著性意义(P<0.05),试验组疗效优于对照组。
本试验严格按照临床试验方案实施,采用随机对照试验方法进行观察,尽可能避免一些可能由观察者、受试者带来的偏倚,因而研究结论有较好的客观性与真实性。综上所述,治疗胃溃疡属虚寒证有较好的疗效且较安全。
Objective
This randomized controlled clinical trial intended to observe the clinical effect of combination Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts Method in treating deficiency syndrome of gastric ulcer. Based on the previous research of the tutor, by randomized controlled study and simultaneously multidisciplinary observation, we objectively assessed the clinical effect and safety about the combination of Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts Method in treating deficiency syndrome of gastric ulcer. Looking forward to further standardize the clinical effect of Deficiency Syndrome of gastric ulcer and get better social benefits. To establish an essential/necessary system and provide rigorous scientific reaearch data for Chinese medicine clinical research on Gastric ulcer prevention and treatment, as well as new drug development.
In this study, adopting Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts Method to study these two acupoints methods and compare with ordinary acupuncture acupoints by detecting certain objective indicators to observe the effect of acupoints, and attempt to explain its mechanism.
Methods
Study objects were patients from Taiwan GuangSheng Chinese Medicine Clinic. Patients with Gastric ulcer mostly had abdominal pain occurred in upper abdomen, like dull or stabbing pain, sometimes like stending or burning pain;It may radiate into the small of the back. Unregular diet, tiredness, nervousness, or sudden change in the climate may cause abdominal pain to happen, accompanied by sour regurgitation/acid regurgitation, belching, nausea or vomiting. Fecal occult blood test was positive or negative. Gastroscopy showed ulcer. Patients with gastric ulcer were required to do biopsy or exfoliative cells to exclude Canceration. Western gastric ulcer diagnostic criteria was as follows (refer to Internal medicine Sixth Edition edited by Ye Rengao. Traditional chinese deficiency syndrome of ulcer diagnostic criteria was:main symptoms:①dull stomachache, likes being pressed and warmed;②it Occures or even gets worse when cold or tiredness;③severe pain when empty stomach, less pain while eating, distention after eating;④tongue is pale and tender with teeth marks in edges and thin white coating, the pulse is deep thin or slow. Secondary symptoms:①lack of strenth, tiredness dislike talking;②cold body and limbs;③loose stools;④vomit clear saliva.
In this study, a total of 83 cases of qualified volunteers, the test group (test group) 46 cases, male 30 and female 16; the control group (control group) 37 cases, male 24 and female 13. They were all outpatients. Equally randomized controlled test with 83 qualified volunteers that met the criteria,divided them into test group(Back-Shu Front-mu & Yuan-(source) Luo-(connecting) pionts group) and control group (conventional acupoints group). Allocation of specific random was designated to the clinical study researchers, by operating SAS (Statistical Analysis System) software to get the random number, and making random distribution of cards, adding sealed envelopes, card number and serial number of the same. According to the order of Patients entry who had passed into this trial, opening the same number of envelopes to give patients treatment stated group by card in envelopes. Random number tables for preservation are in accordance with the requirements. According to "Medical institutions of higher learning materials·Acupuncture" edited by Qiu Maoliang, Method of selecting points:Back-Shu & Front-mu points group with main points:RN12, BL21;Yuan-(source) & Luo-(connecting) points group, mian point:ST42, SP4 (both sides). Conventional acupoints group with main piont:ST36, PC6, RN13;matched pionts:severe stomachache ST34, cold stomach apply moxibustion to Rnl2, abdominal distension ST25, sour regurgitation/acid regurgitation LR3, lack of strength RN6. Alternate to use the above points. Methods of acupuncture:use 75% ethanol to sterilize the skin, select 1 inch or 1.5 inch needleof the Huatuo brand, after needling and getting Qi,select the equally reinforcing and reducing method at all points, remain the needles for 30 minutes, once a day,5 times for a course of the treatment, each 2 days off between treatments, a total of 9 courses. During the trial period, the other therapeutic drugs were not allowed to be used. The Course of treatment for 2 months. Once every other day,5 times for a course, 2 days off between each course of treatment. After 9 courses (i. e.2 months), had gastroscope rechecked.
Effect standard/indicator:Clinical cure:the main and secondary symptoms disappeared. Ulcer was basically healed in gastroscope. Excellence/Markedly effective:the main and secondary symptoms were significantly improved, or individual main symptoms improved slightly, but the other main symptoms had disappeared. Ulcer lesions were improved in gastroscope. Effective:main and secondary symptoms were improved, or main symptoms had not improved, but all the minor symptoms had disappeared. Ulcer lesions had no change in gastroscope. Ineffective/Void:main and secondary symptoms were not improved. After the clinical study, clinical data was promptly collected, entered into the computer, then set a database and managed the data. Using EpiData 3.0 software to operate data entry. After the treatment, using statistical software to analyze and compare the overall clinical effect, clinical symptoms and signs effect, to have an objective evaluation on clinical effect and its safety. Statistical methods:categorical data using Chi-Square test, ranked data using two-samples compared Wilcoxon rank sum test (adjusted), compare means of two samples using T-test or Wilcoxon rank sum test, before and after itself using paired-samples T-test or Wilcoxon paired rank sum test. Statistics calculated by using statistical software SPSS17.0 to complete statistical analysis.
Results
In this study, a total of 83 cases of qualified volunteers, the test group 46 cases, male 30 and female 16; the control group 37 cases, male 24 and female 13.
Testing the comparability of the two groups:the age composition, gender distribution, recurrent pathogenetic condition,the recent occurrence of disease, stomachache time (minute/day), the extent of abdominal pain, frequency of upper abdominal pain, abdomen likes being pressed & heated.frequency of pain reduction after eating, abdominal stabbing pain, vague pain, frequency of accompaied pain in both costal part, there was no statistically significant difference(P>0.05). Before treatment, the two groups main symptoms of sour regurgitation, nausea, belching, abdominal distension, frequency of less ingestion, there was no statistically significant difference(P>0.05).
Comparing the main symptoms of tasteless, bitter taste of mouth, firm stools, frequency of tiredness in both groups before treatment, There was no significant difference (P<0.05). Comparing ulcer area of the two groups before treatment, there was no statistically significant difference (P>0.05). Comparing the number of ulcers of two groups before treatment, there was no statistically significant difference (P>0.05). Comparing ulcer stage of the two groups before treatment, there was no statistically significant difference (P>0.05). Comparing texture and coating of tongue, pulse in the two groups before treatment, there was statistically significant difference. Comparing the detection of HP in the two groups before treatment, there was no statistically significant difference (P>0.05).
In summary, comparing sex, age, duration, syndrome of TCM, entity and the nature of abdominal pain, frequency, extent, ulcer area, ulcer stage, the number of ulcers, tongue demonstration, pulse and other major symptoms (except for loose stools), gastroscopy results in the two group before treatment, here was no statistically significant difference (P>0.05), meaning that the above factors between the two groups has homogeneity and the test was comparable between test group and control group.
Effect comparison:comparing Chinese medicine syndromes of two groups, the clinical curative rate of the test group was 56.52%, markedly effective rate was 21.74%, markedly effective and clinical curative rate was 77.2% in total;clinical curative rate of control group was 29.73%, markedly effective rate was 37.84%, markedly effective and clinical curative rate was 67.5% in total. The total effect of Chinese medicine syndromes of two groups, there was statistically significant difference (P<0.05). Improvement of abdominal pain before and after treatment between the two group, there was statistically significant difference (P<0.05).
After treatment, comparing the disappearance rate of sour regurgitation/acid regurgitation, nausea, belching, less ingestion, abdominal distension, tasteless, bitter taste of mouth, loose stools, firm stools, tiredness and other main clinical symptoms and signs, there was no statistically significant difference (P>0.05). Comparing effect of gastroscopy in test group, the clinical curative rate was 52.17%, markedly effective rate was 21.74%, markedly effective and clinical curative rate was 73.8% in total; in control group, clinical curative rate was 32.43%, markedly effective rate was 37.84%, markedly effective and clinical curative rate was 70.2% in total. Comparing Gastroscopy effects of gastric ulcer, there was no statistically significant difference (P>0.05) between the two groups. After treatment, Comparing reducing time of stomachache (minutes/day), there was no statistically significant difference (P>0.05).
Safety Testing:the test group were detected 46 cases of blood before and after the treatment, and the results showed no abnormal changes.The test group were detected 46 cases of stool before treatment and after the treatment,and the results showed no abnormal changes. the test group were detected 46 cases of urine before treatment and after the treatment, and the results showed no abnormal changes. The test group were detected 46 cases of liver function(GPT)/renal function (BUN) before and after the treatment, and the results showed no abnormal changes. The test group were detected 46 cases of ECG before treatment, rechecked 44 cases after treatment, and the results showed no abnormal changes.
The control group were detected 37 cases of blood before and after the treatment, and the results showed no abnormal changes. The control group were detected 37 cases of stool before treatment and after the treatment, and the results showed no abnormal changes. The control group were detected 37 cases of urine before treatment and after the treatment,and the results showed no abnormal changes.The control group were detected 37 cases of liver function(GPT)/renal function (BUN) before and after the treatment, and the results showed no abnormal changes. The control group were detected 37 cases of ECG before and after the treatment, and the results showed no abnormal changes.
Observation on adverse events in this trial, the test group and control group of blood, urine and stool regular test,liver function (GPT), renal function (BUN), ECG and other test results before and after treatment,no obvious damage was found.
Conclusion
This clinical trial adopted randomized controlled test methods, a total of 83 patients/qualified subjects/qualified volunteers,46 cases in test group,37 cases in control group.
Safety testing showed that blood, urine and stool regular test, liver and kidney function, ECG were normal before treatment and no abnormal changes after treatment, indicating that the clinical application of this therapy was safe.
Testing the comparability between the two groups before treatment in sex, age, duration, syndrome of TCM, entity and the main symptoms was in a good equitability. No obvious adverse reactions were found during the course of treatment.
In this study, patients with gastric ulcer received this treatment had a deficiency and cold syndrome. The effect of syndrome of TCM:the total effective rate was 96.5% in test group,83.78% in control group, there was statistically significant difference(P<0.05);total effect of gastroscopy:the total effective rate was 86.96% in test group, and 83.78% in contaol group, there was statistically significant difference (P<0.05). The effect of Chinese medicine syndromes between the two groups, there was statistically significant difference(P<0.05).The test group was better than the control group in clinical effect.
This test was in strict accordance with the implementation of clinical trials, observing through randomized controlled test method, as far as possible to avoid bias possibly brought by observers or volunteers, so the result had better objectivity and authenticity.To sum up, this treatment for deficiency and cold syndrome of gastric ulcer has a better effect and more security.
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