“胃瘫外敷方”穴位贴敷治疗消化系统肿瘤术后胃瘫（寒证）的临床试验
发布时间：2018-08-03 09:51
【摘要】：[研究背景]消化系统肿瘤术后胃瘫综合征(Postsurgicalgastroparesis Syndrome, PGS)指消化系统肿瘤手术后以胃流出道非机械性梗阻为主要特征的一种功能性疾病,也是一种胃动力缺乏性疾病。其发病率有上升趋势,胃瘫发病率国内报道为0.6%-7%,国外报道为5%-10%。消化系统肿瘤在中国的发病率逐年升高,同时医学技术的进步也使得早期消化系统肿瘤患者手术后获得了较长的生存期,不适的症状和漫长的术后并发症降低了患者的生活质量,对患者术后生活信心的恢复造成不良影响。现代医学治疗PGS的疗效有限。传统中医药治疗PGS的国内报道较多,不管采用中药内治法还是外治法,其治疗有效率普遍在80%以上,中医与西医治疗该病有效率差异明显。通过检索CNKI文献库与Pubmed文献库发现,尽管中药治疗PGS的中文报道较多,其缺点是诸多的研究结论缺乏高级别循证医学证据支持,仅为病例回顾分析研究或简单的病例对照研究；而Pubmed上目前仍检索到外用中药治疗PGS的任何研究报道。因此,设计一个具有较高级别循证医学证据的临床试验来证实中药治疗PGS的临床疗效,将有助于改善PGS的治疗现状,更好的发挥中医药的优势。课题组前期对消化系统肿瘤术后胃瘫患者的中医证型规律进行研究,局部辨证以“寒证”为主,以“温阳散寒、行气化瘀”为治法自拟“胃瘫外敷方”,采用前瞻性、多中心、随机双盲、安慰剂平行对照的RCT临床课题设计治疗消化系统肿瘤术后PGS,以期为中医中药治疗肿瘤术后PGS增加高级别的循证医学证据,继而使国内外更多的患者受益。[研究目的]1.探讨“胃瘫外敷方”治疗消化系统肿瘤术后PGS的临床疗效；2.评价“胃瘫外敷方”治疗消化系统肿瘤术后PGS安全性。[研究方法]本课题应用前瞻性、多中心、随机双盲、安慰剂平行对照的临床研究设计,并且整个研究过程接受课题管理部门北京市科委所安排的北京岐黄药品临床研究中心进行第三方实时监察。在多次方案论证会后确定最终研究方案,完成患者招募前的准备工作,同时通过四个研究中心的伦理审查,进行国际临床试验注册,培训四个分中心的研究者,统一安排药物购入,制剂室根据循证医学中心提前审定的盲底筹备制作药品(包括试验药和安慰剂药)。随后根据入组标准招募肿瘤术后PGS患者,完成入组前筛选,包括胃肠镜、消化道造影、胸腹部CT或腹部立位片、血常规、肝肾功能、尿常规、便常规+潜血检查、心电图等检查。根据患者入组次序分发每个中心已经完成设盲的药物,记录患者治疗第1、3、5、7、14天的胃动力恢复时间、胃瘫症状评分、胃引流及呕吐量,记录不良反应。患者治疗完成后进行出组检查(与入组时检查项目相同)后出组,同时按照患者愿望无偿领取2周的“胃瘫外敷方”真药继续治疗。所有病例数据录入后由北京中医药大学循证医学中心锁定数据,在课题负责人和循证医学中心、第三方岐黄研究中心监察人员三方在场下揭盲,完成数据统计分析。最后明确“胃瘫外敷方”治疗肿瘤术后PGS的临床疗效,并进行安全性评价。[研究结果]1.课题从启动、实施、完成到最后揭盲,均在严格的质量控制下完成,符合课题预期的质量控制标准。整个课题所开展并全部完成的质控项目有：伦理申报、上会讨论及审批、循证医学中心根据盲法要求设盲、药物统一购买、全程质量控制、制剂室根据研究项目书编写药品制备流程、在国际网站上进行临床试验登记注册、对内四个中心所有研究者进行培训、对外多渠道进行患者招募、第三方监察单位进行每月质量监察并出具报告、病例数达标后进行循证医学数据管理、两次标准化揭盲。细致规范的质控过程保证了该课题数据的客观性和准确性。2.本课题按要求招募120例肿瘤术后PGS患者入组,历时24个月,其中2例因不良反应事件提前终止试验,1例违背试验方案退出试验,12例受试者自动退出,共计105例患者完成本次研究,疗程为14天。基线分析示试验药组和安慰剂组在患者年龄、药物过敏史、术后留置鼻胃管、中药治疗史、术后胃瘫分级、胃瘫症状分级、肿瘤类型、肿瘤转移部位、手术名称、手术切口类型方面,P0.05,无统计学差异,两组在人口学特征方面具有可比性。入组检查包括两组病人在血常规、尿常规、便常规+潜血、肝功能、肾功能、离子水平和心电图等方面,疗效基线分析方面包括入组时是否留置鼻胃管与入组胃瘫症状评分,以上两组间无明显差异(P0.05)。因此,两组PGS患者在入组基线上具有可比性,符合随机设计。3.根据课题设定的临床有效标准,FAS集中60例试验组患者中41例为临床有效,有效率为68.33%；60例安慰剂组患者中25例临床有效,有效率为41.67%,FAS集中两组病人在有效率上有统计学差异,试验药组有效率高于安慰剂组(P=0.003)。PPS集为全部与试验方案相符、依从性好、试验期内未服禁止药、顺利完成研究方案规定的随访过程、同时完成CRF表规定填写内容的病例,试验药组为45例,安慰机组为43例,其中试验药组有效35例,无效10例,有效率为77.78%；安慰机组有效19例,无效24例,有效率为44.19%,PPS集中两组病人在有效率上有统计学差异,试验药组有效率高于安慰剂组(P=0.001)。扣除中心效应后分析发现“胃瘫外敷方”治疗PGS的临床疗效与安慰剂相比有统计学差异(P=0.002)。4.次要结局指标包括两组治疗有效时间、鼻胃管引流量变化、胃瘫主要症状前后变化程度、胃瘫症状评分变化,研究发现①治疗有效时间使用生存分析比较两组差异。FAS集(P=0.017)和PPS集(P=0.006)中两组病人在治疗有效所需时间上均有统计学差异,试验药组治疗有效所需时间小于安慰剂组。②鼻胃管引流量变化在治疗第1天、第3天、第5天、第7天、第14天的组间差异,FAS集和PPS集中两组病人在胃管引流量上无统计学差异。③胃瘫主要症状前后变化程度方面,FAS集和PPS集中两组病人在胃瘫主要症状(不能正常量的进餐、餐后极度饱胀感)前后变化上有统计学差异,其余症状无统计学差异。④胃瘫症状评分变化方面,FAS集和PPS集中不同时间的胃瘫症状评分有统计学差异,两组病人在胃瘫症状评分上无统计学差异。5.试验药组发现3例不良反应患者,不良反应在53例试验药患者(不含脱落的7例)中发生率为5.66%；安慰剂组未发现不良反应中止治疗的患者。试验药组皮肤不良反应发生率,与安慰剂组比较无统计学差异(P=0.244)。患者经过治疗后的血尿便常规、肝肾功能、电解质水平和心电图等检查出现异常值的发生率在两组中无明显差别(P0.05)。[研究结论]1.在试验研究前充分论证的基础上,完成本次前瞻性、多中心、随机双盲、安慰剂平行对照的临床试验,课题设计严密、实施过程严谨,第三方监管严格,为循证医学提供高级别证据,结论真实可靠。2.主要结局指标分析发现,寒热理论指导下的中药外敷能够提高消化系统肿瘤术后PGS患者的临床有效率,胃瘫外敷方与安慰剂治疗PGS的临床有效率有显著差别,胃瘫外敷方疗效确切。3.次要结局指标分析发现,胃瘫外敷方治疗有效所需时间小于安慰剂,且具有统计学差异；在治疗第1天、第3天、第5天、第7天、第14天的鼻胃管引流量变化方面,两组无统计学差异；两组在胃瘫主要症状(不能正常量的进餐、餐后极度饱胀感)改善方面有统计学差异,胃瘫外敷方优于安慰剂,而在“恶心、干呕、呕吐、胃部胀满、没有食欲、腹部胀大、胃或腹部明显增大”这7个症状方面,两组无统计学差异。两组在不同时间的胃瘫症状评分有统计学差异,但两组病人在胃瘫症状评分上无统计学差异。因此,在治疗后的鼻胃管引流量变化方面、治疗后“恶心、干呕、呕吐、胃部胀满、没有食欲、腹部胀大、胃或腹部明显增大”7个症状控制方面以及治疗后的胃瘫症状评分改善方面,不能认为胃瘫外敷方优于安慰剂。4.中药外敷治疗方式可以引起皮肤的过敏反应,使用“胃瘫外敷方”治疗PGS患者时皮肤过敏反应(1例中度干性脱皮水疱瘙痒,1例轻度皮肤瘙痒)发生率为5.66%,与安慰剂组比较未发现显著性差异(P=0.244)。与安慰剂相比,未发现“胃瘫外敷方”治疗PGS患者时增加患者血常规、生化检查(肝功能、肾功能、离子)、尿常规、便常规+潜血、心电图、胃镜、肠镜、消化道造影、腹部立位片、CT检查等指标的恶化风险。5.本研究证实“胃瘫外敷方”治疗消化系统肿瘤术后PGS的临床有效率高于安慰剂,治疗有效所需时间小于安慰剂,“胃瘫外敷方”可以让消化系统肿瘤术后属“寒证”的PGS病人获益。
[Abstract]:[background] Postsurgicalgastroparesis Syndrome (PGS) after digestive system tumor operation refers to a functional disorder characterized by the non mechanical obstruction of the gastric flow after the operation of the digestive system, and also a kind of gastric motility deficiency. The incidence of the disease has a rising trend, and the incidence of gastroparesis is reported to be 0.6%-7% at home. It is reported that the incidence of 5%-10%. digestive system tumor in China is increasing year by year, and the progress of medical technology has also made the early digestive system tumor patients get a longer survival period. The symptoms of discomfort and the long postoperative complications reduce the quality of life of the patients and the recovery of life confidence after the operation of the patients. The effect of modern medical treatment of PGS is limited. There are many domestic reports on traditional Chinese medicine for the treatment of PGS. The effective rate of the treatment is more than 80%, and the effective rate of the treatment of the disease is more than 80%. The Chinese medicine and the western medicine treatment of the disease have obvious difference. The Chinese Medicine Library and the Pubmed literature database have been found, although the Chinese medicine is used to treat PGS in Chinese There are many reports, its shortcomings are that many research conclusions lack the support of high level evidence-based medicine, only a retrospective case study or a simple case control study, and Pubmed is still retrieving any research report on the treatment of PGS by external use of traditional Chinese medicine. Therefore, a clinical trial with a higher level of evidence-based medical evidence is designed. The clinical effect of traditional Chinese medicine in the treatment of PGS will help to improve the status of the treatment of PGS and give full play to the advantages of traditional Chinese medicine. A prospective, multicenter, randomized, double blind, placebo-controlled, parallel controlled RCT clinical project was designed for the treatment of PGS after the operation of digestive system tumor, in order to increase the level of evidence-based medical evidence for PGS after the treatment of tumor surgery in traditional Chinese medicine, and then benefit more patients at home and abroad. [Objective]1. to explore the treatment of digestive system with the external compress of gastroparesis The clinical effect of PGS after tumor operation; 2. evaluate the PGS safety after the treatment of digestive system tumor after the treatment of digestive system tumor. [research method] this subject applies prospective, multicenter, double-blind, placebo parallel control clinical research design, and the whole research process accepts the Beijing Qi Huang arranged by the Beijing municipal science and Technology Commission of the subject management department. The center for drug clinical research conducted the third party real-time monitoring. After several plans, the final research plan was determined, the preparatory work was completed before the recruitment of the patients. At the same time, the international clinical trial registration was carried out through the ethical review of the four research centers, the four sub centers were trained, the drug purchase was arranged in a unified way, and the preparation room was based on evidence-based evidence. Drugs (including test drugs and placebo drugs) were prepared by the medical center in advance. Then PGS patients after tumor surgery were recruited according to the criteria of entry group, and pre group screening was completed, including gastrointestinal endoscopy, digestive tract angiography, thoracic and abdominal CT or abdominal orthostatic tablets, blood routine, liver and kidney function, urine routine, routine + Occult examination, electrocardiogram examination. According to the order of the patients, each center had been dispensed with a blind drug, the recovery time of gastric motility, the score of gastroparesis, gastric drainage and vomiting were recorded, and the adverse reactions were recorded. After the treatment was completed, the group was examined (the same as that in the group), and the patient's desire was unpaid in accordance with the patient's desire. After 2 weeks of "gastroparesis external compress" to continue the treatment, all case data were recorded by the evidence based medicine center of Beijing University of Chinese Medicine, in the subject and evidence-based medical center, the third Fang Qi Huang Research Center, three party inspectors under the presence of blindness, completed the statistics and analysis. Finally, the "gastroparesis external compress" treatment. The clinical efficacy of PGS after the treatment of tumor and the evaluation of safety. [results]1. subjects from starting, implementing, completing to final blindness are all completed under strict quality control, conforming to the expected quality control standards of the subject. The whole project carried out and completed the quality control items: ethical declaration, discussion and approval, evidence-based medicine The center should be blind according to the requirements of the blind law, the drug purchase, the whole quality control, the preparation process of the drug preparation room based on the research project, the registration of clinical trials on the international website, the training of all the four centers in the inner center, the recruitment of patients in the foreign channels, and the monthly quality supervision of the third party supervision units. The data management of evidence-based medicine and two standardized blindness were carried out after the number of cases reached the standard. The objective and accuracy of the detailed standard quality control process ensured the objective and accuracy of the data..2. this subject was recruited in 120 cases after the operation of the tumor for 24 months, of which 2 cases were terminated in advance because of adverse events and 1 cases were violated. The back test scheme withdrew from the test. 12 subjects were automatically withdrawn. A total of 105 patients completed the study for 14 days. The baseline analysis showed the age of the drug group and the placebo group in the patient's age, the history of drug allergy, the retention of the nasogastric tube after operation, the history of Chinese medicine treatment, the classification of gastroparesis, the classification of gastroparesis symptoms, the type of tumor, the site of tumor metastasis, and the name of the operation. There were no statistical differences between the two groups. The two groups were comparable in demographic characteristics. The group examination included two groups of patients in the blood routine, urine routine, routine + occult blood, liver function, renal function, ion level and electrocardiogram, including whether the nasogastric tube was indwelling with the group of gastroparesis when the group was entered. There was no significant difference in symptom score between the two groups (P0.05). Therefore, two groups of PGS patients were comparable in the baseline of the entry, which accorded with the randomized design of.3. according to the clinical effective criteria set according to the subject. 41 of the 60 patients in the FAS concentration test group were clinically effective and effective at 68.33%; 25 of the 60 placebo group were clinically effective and had an effective rate of 4. 1.67%, FAS concentration of two groups of patients in the effective rate of statistical difference, the effectiveness of the test group is higher than the placebo group (P=0.003).PPS set is all consistent with the test plan, compliance is good, in the test period did not take the prohibition drug, the smooth completion of the follow-up process prescribed by the research program, the same time the CRF table completed the contents of the cases, the test drug group is 45 For example, the consolation unit was 43 cases, of which 35 cases were effective in the experimental group, 10 cases were invalid, the effective rate was 77.78%, the consolation unit was 19 cases, 24 cases were invalid, the effective rate was 44.19%, the effective rate of the PPS concentration two groups was statistically different, the effective rate of the experimental group was higher than that of the placebo group (P=0.001). After deducting the central effect, the analysis found "the external application side of gastroparesis". The therapeutic effect of PGS was statistically different from placebo (P=0.002).4. secondary outcome indicators including two groups of effective time, changes in nasal gastric tube flow, changes in the main symptoms of gastroparesis, and the change of gastroparesis symptom score. The study found that two groups of difference.FAS set (P=0.017) were compared with the analysis of effective time use survival analysis (P=0.017). In the PPS set (P=0.006), two groups of patients were statistically different in the time required for effective treatment. The time required for effective treatment in the experimental group was less than that in the placebo group. (2) the variation in the flow of nasal gastric tube at first days, third days, fifth days, seventh days and fourteenth days, and there was no statistical difference between the FAS set and the PPS concentration group in the gastric tube flow rate. (3) the change degree of the main symptoms of gastroparesis before and after the main symptoms of FAS and PPS, there were statistical differences between the two groups of the main symptoms of gastroparesis (not the normal meal, the postprandial satiety feeling), and the other symptoms were not statistically different. (4) the score of gastroparesis symptom score, FAS set and PPS concentration in different time scores of gastroparesis symptom score Statistical differences, there was no statistical difference between the two groups in the score of gastroparesis, and 3 cases of adverse reactions were found in the.5. test group, and the incidence of adverse reactions was 5.66% in 53 cases (7 without shedding); the placebo group did not find the patients with ADR treatment. The incidence of ADR in the experimental group and the consolation of the placebo group. There was no statistical difference between the two groups (P=0.244). There was no significant difference in the incidence of abnormal values in the two groups (P0.05). [conclusion]1., based on sufficient demonstration before the test, completed this prospective, multicenter, randomized, double blindness. The clinical trials of consolation parallel control were strictly designed, the implementation process was rigorous, the third party supervision was strict, and the evidence based on the evidence-based medicine was provided. The conclusion of the true and reliable.2. main outcome indicators found that the external application of Chinese medicine under the guidance of the cold and heat theory could improve the clinical efficiency of the PGS patients after the digestive system tumor operation, and the external application of gastroparesis. The clinical efficiency of PGS with placebo was significantly different. The effective.3. secondary outcome index analysis showed that the time required for the treatment of gastroparesis external application was less than that of placebo, and the difference was statistically significant. There was no statistical difference between the two groups in the first days, the fifth days, the seventh days, and fourteenth days of the nasal gastric tube flow. Differences in the two groups were statistically different in the main symptoms of gastroparesis (not normal food intake, postprandial satiety feeling). The external application of gastroparesis was superior to placebo, while in "nausea, vomiting, vomiting, stomach distention, no appetite, abdominal distention, stomach or abdominal enlargement", the two groups were not statistically different. The two groups were not. There was a statistical difference between the two groups at the same time, but there was no statistical difference in the score of the gastroparesis symptoms in the two groups. Therefore, after treatment, the changes in the flow rate of the nasal gastric tube after treatment were "nausea, vomiting, vomiting, stomach swell, no appetite, abdominal distention, gastric or abdominal enlargement" in 7 symptoms control and after treatment. As for the improvement of gastroparesis symptom score, it is not considered that the external application of gastroparesis is superior to the placebo.4. external application, which can cause the allergic reaction of the skin. The skin allergic reaction (1 cases of moderate dry blister pruritus, 1 cases of mild skin pruritus) in the treatment of PGS patients is 5.66%, compared with the placebo group. The significant difference (P=0.244) was found. Compared with placebo, the risk of worsening of blood routine, biochemical examination (liver function, renal function, ion), routine urine, routine + occult blood, electrocardiogram, gastroscope, enteroscopy, gastroenteroscopy, gastroenterography, abdominal erect, CT examination, and other indicators of worsening risk for PGS were not found in the treatment of patients with "gastroparesis external compress" in the treatment of patients. The clinical efficiency of PGS after the treatment of digestive system tumor is higher than that of placebo. The time required for the treatment is less than that of the placebo. "The external application of gastroparesis" can benefit the PGS patients who are "cold syndrome" after the digestive system tumor operation.
【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R735
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本文编号：2161369
[Abstract]:[background] Postsurgicalgastroparesis Syndrome (PGS) after digestive system tumor operation refers to a functional disorder characterized by the non mechanical obstruction of the gastric flow after the operation of the digestive system, and also a kind of gastric motility deficiency. The incidence of the disease has a rising trend, and the incidence of gastroparesis is reported to be 0.6%-7% at home. It is reported that the incidence of 5%-10%. digestive system tumor in China is increasing year by year, and the progress of medical technology has also made the early digestive system tumor patients get a longer survival period. The symptoms of discomfort and the long postoperative complications reduce the quality of life of the patients and the recovery of life confidence after the operation of the patients. The effect of modern medical treatment of PGS is limited. There are many domestic reports on traditional Chinese medicine for the treatment of PGS. The effective rate of the treatment is more than 80%, and the effective rate of the treatment of the disease is more than 80%. The Chinese medicine and the western medicine treatment of the disease have obvious difference. The Chinese Medicine Library and the Pubmed literature database have been found, although the Chinese medicine is used to treat PGS in Chinese There are many reports, its shortcomings are that many research conclusions lack the support of high level evidence-based medicine, only a retrospective case study or a simple case control study, and Pubmed is still retrieving any research report on the treatment of PGS by external use of traditional Chinese medicine. Therefore, a clinical trial with a higher level of evidence-based medical evidence is designed. The clinical effect of traditional Chinese medicine in the treatment of PGS will help to improve the status of the treatment of PGS and give full play to the advantages of traditional Chinese medicine. A prospective, multicenter, randomized, double blind, placebo-controlled, parallel controlled RCT clinical project was designed for the treatment of PGS after the operation of digestive system tumor, in order to increase the level of evidence-based medical evidence for PGS after the treatment of tumor surgery in traditional Chinese medicine, and then benefit more patients at home and abroad. [Objective]1. to explore the treatment of digestive system with the external compress of gastroparesis The clinical effect of PGS after tumor operation; 2. evaluate the PGS safety after the treatment of digestive system tumor after the treatment of digestive system tumor. [research method] this subject applies prospective, multicenter, double-blind, placebo parallel control clinical research design, and the whole research process accepts the Beijing Qi Huang arranged by the Beijing municipal science and Technology Commission of the subject management department. The center for drug clinical research conducted the third party real-time monitoring. After several plans, the final research plan was determined, the preparatory work was completed before the recruitment of the patients. At the same time, the international clinical trial registration was carried out through the ethical review of the four research centers, the four sub centers were trained, the drug purchase was arranged in a unified way, and the preparation room was based on evidence-based evidence. Drugs (including test drugs and placebo drugs) were prepared by the medical center in advance. Then PGS patients after tumor surgery were recruited according to the criteria of entry group, and pre group screening was completed, including gastrointestinal endoscopy, digestive tract angiography, thoracic and abdominal CT or abdominal orthostatic tablets, blood routine, liver and kidney function, urine routine, routine + Occult examination, electrocardiogram examination. According to the order of the patients, each center had been dispensed with a blind drug, the recovery time of gastric motility, the score of gastroparesis, gastric drainage and vomiting were recorded, and the adverse reactions were recorded. After the treatment was completed, the group was examined (the same as that in the group), and the patient's desire was unpaid in accordance with the patient's desire. After 2 weeks of "gastroparesis external compress" to continue the treatment, all case data were recorded by the evidence based medicine center of Beijing University of Chinese Medicine, in the subject and evidence-based medical center, the third Fang Qi Huang Research Center, three party inspectors under the presence of blindness, completed the statistics and analysis. Finally, the "gastroparesis external compress" treatment. The clinical efficacy of PGS after the treatment of tumor and the evaluation of safety. [results]1. subjects from starting, implementing, completing to final blindness are all completed under strict quality control, conforming to the expected quality control standards of the subject. The whole project carried out and completed the quality control items: ethical declaration, discussion and approval, evidence-based medicine The center should be blind according to the requirements of the blind law, the drug purchase, the whole quality control, the preparation process of the drug preparation room based on the research project, the registration of clinical trials on the international website, the training of all the four centers in the inner center, the recruitment of patients in the foreign channels, and the monthly quality supervision of the third party supervision units. The data management of evidence-based medicine and two standardized blindness were carried out after the number of cases reached the standard. The objective and accuracy of the detailed standard quality control process ensured the objective and accuracy of the data..2. this subject was recruited in 120 cases after the operation of the tumor for 24 months, of which 2 cases were terminated in advance because of adverse events and 1 cases were violated. The back test scheme withdrew from the test. 12 subjects were automatically withdrawn. A total of 105 patients completed the study for 14 days. The baseline analysis showed the age of the drug group and the placebo group in the patient's age, the history of drug allergy, the retention of the nasogastric tube after operation, the history of Chinese medicine treatment, the classification of gastroparesis, the classification of gastroparesis symptoms, the type of tumor, the site of tumor metastasis, and the name of the operation. There were no statistical differences between the two groups. The two groups were comparable in demographic characteristics. The group examination included two groups of patients in the blood routine, urine routine, routine + occult blood, liver function, renal function, ion level and electrocardiogram, including whether the nasogastric tube was indwelling with the group of gastroparesis when the group was entered. There was no significant difference in symptom score between the two groups (P0.05). Therefore, two groups of PGS patients were comparable in the baseline of the entry, which accorded with the randomized design of.3. according to the clinical effective criteria set according to the subject. 41 of the 60 patients in the FAS concentration test group were clinically effective and effective at 68.33%; 25 of the 60 placebo group were clinically effective and had an effective rate of 4. 1.67%, FAS concentration of two groups of patients in the effective rate of statistical difference, the effectiveness of the test group is higher than the placebo group (P=0.003).PPS set is all consistent with the test plan, compliance is good, in the test period did not take the prohibition drug, the smooth completion of the follow-up process prescribed by the research program, the same time the CRF table completed the contents of the cases, the test drug group is 45 For example, the consolation unit was 43 cases, of which 35 cases were effective in the experimental group, 10 cases were invalid, the effective rate was 77.78%, the consolation unit was 19 cases, 24 cases were invalid, the effective rate was 44.19%, the effective rate of the PPS concentration two groups was statistically different, the effective rate of the experimental group was higher than that of the placebo group (P=0.001). After deducting the central effect, the analysis found "the external application side of gastroparesis". The therapeutic effect of PGS was statistically different from placebo (P=0.002).4. secondary outcome indicators including two groups of effective time, changes in nasal gastric tube flow, changes in the main symptoms of gastroparesis, and the change of gastroparesis symptom score. The study found that two groups of difference.FAS set (P=0.017) were compared with the analysis of effective time use survival analysis (P=0.017). In the PPS set (P=0.006), two groups of patients were statistically different in the time required for effective treatment. The time required for effective treatment in the experimental group was less than that in the placebo group. (2) the variation in the flow of nasal gastric tube at first days, third days, fifth days, seventh days and fourteenth days, and there was no statistical difference between the FAS set and the PPS concentration group in the gastric tube flow rate. (3) the change degree of the main symptoms of gastroparesis before and after the main symptoms of FAS and PPS, there were statistical differences between the two groups of the main symptoms of gastroparesis (not the normal meal, the postprandial satiety feeling), and the other symptoms were not statistically different. (4) the score of gastroparesis symptom score, FAS set and PPS concentration in different time scores of gastroparesis symptom score Statistical differences, there was no statistical difference between the two groups in the score of gastroparesis, and 3 cases of adverse reactions were found in the.5. test group, and the incidence of adverse reactions was 5.66% in 53 cases (7 without shedding); the placebo group did not find the patients with ADR treatment. The incidence of ADR in the experimental group and the consolation of the placebo group. There was no statistical difference between the two groups (P=0.244). There was no significant difference in the incidence of abnormal values in the two groups (P0.05). [conclusion]1., based on sufficient demonstration before the test, completed this prospective, multicenter, randomized, double blindness. The clinical trials of consolation parallel control were strictly designed, the implementation process was rigorous, the third party supervision was strict, and the evidence based on the evidence-based medicine was provided. The conclusion of the true and reliable.2. main outcome indicators found that the external application of Chinese medicine under the guidance of the cold and heat theory could improve the clinical efficiency of the PGS patients after the digestive system tumor operation, and the external application of gastroparesis. The clinical efficiency of PGS with placebo was significantly different. The effective.3. secondary outcome index analysis showed that the time required for the treatment of gastroparesis external application was less than that of placebo, and the difference was statistically significant. There was no statistical difference between the two groups in the first days, the fifth days, the seventh days, and fourteenth days of the nasal gastric tube flow. Differences in the two groups were statistically different in the main symptoms of gastroparesis (not normal food intake, postprandial satiety feeling). The external application of gastroparesis was superior to placebo, while in "nausea, vomiting, vomiting, stomach distention, no appetite, abdominal distention, stomach or abdominal enlargement", the two groups were not statistically different. The two groups were not. There was a statistical difference between the two groups at the same time, but there was no statistical difference in the score of the gastroparesis symptoms in the two groups. Therefore, after treatment, the changes in the flow rate of the nasal gastric tube after treatment were "nausea, vomiting, vomiting, stomach swell, no appetite, abdominal distention, gastric or abdominal enlargement" in 7 symptoms control and after treatment. As for the improvement of gastroparesis symptom score, it is not considered that the external application of gastroparesis is superior to the placebo.4. external application, which can cause the allergic reaction of the skin. The skin allergic reaction (1 cases of moderate dry blister pruritus, 1 cases of mild skin pruritus) in the treatment of PGS patients is 5.66%, compared with the placebo group. The significant difference (P=0.244) was found. Compared with placebo, the risk of worsening of blood routine, biochemical examination (liver function, renal function, ion), routine urine, routine + occult blood, electrocardiogram, gastroscope, enteroscopy, gastroenteroscopy, gastroenterography, abdominal erect, CT examination, and other indicators of worsening risk for PGS were not found in the treatment of patients with "gastroparesis external compress" in the treatment of patients. The clinical efficiency of PGS after the treatment of digestive system tumor is higher than that of placebo. The time required for the treatment is less than that of the placebo. "The external application of gastroparesis" can benefit the PGS patients who are "cold syndrome" after the digestive system tumor operation.
【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R735
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本文编号：2161369
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