中药联合标准三联疗法提高幽门螺杆菌根除率的临床疗效评价研究
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摘要
[目的]
对中医药治疗幽门螺杆菌(Helicobactor pylori, Hp)临床研究文献的理论、方法及研究设计等进行总结概述,分析目前优势及不足,为临床、科研提供参考；对中医药联合标准三联疗法治疗Hp的随机对照试验(Random control trial, RCT)进行系统评价,了解目前治疗现状；对辨证应用中药汤剂、中药散剂联合标准三联疗法提高Hp根除率进行多中心随机对照研究,评价其有效性和安全性；最后贯穿理论与临床研究进行讨论及展望。
[方法]
系统评价：确定严格的文献纳入、排除标准,充分检索中药联合标准治疗方案治疗Hp相关文献,并进行评价筛选,纳入最终符合的文献进行Meta分析,评价其有效性及安全性；
临床研究：采用多中心随机对照临床试验设计,对符合纳入标准、不符合排除标准的慢性胃炎伴Hp感染患者按入组顺序申请中心随机号码,并给予相应治疗,A组为对照组,给予西药标准三联疗法：奥美拉唑20mg、阿莫西林1.0、克拉霉素0.5,每日2次(Bid),持续10天,B、C、D组为试验组,分别给予同对照组西药10天+中药散剂2周,Bid、同对照组西药10天+中药汤剂4周,Bid、同对照组西药10天+中药汤剂2周,Bid,停用西药后1个月为疗后访视点,复查Hp、安全性检查项目,填写症状量表、SF-36量表、PRO量表,对观测指标进行统计分析。
[结果]
系统评价：最终纳入Meta分析的文献7篇,全部纳入的病例总数为1115例,试验组669例,对照组446例。完成治疗1058例,退出研究57例,其中拒绝复查失访45例,未按医嘱服药6例,因不良反应中止6例。各研究均报告了受试者的一般情况,包括性别、年龄等,具有基线可比性。Hp根除率方面,中药同期联合西药组根除Hp和单独西药组之间有统计学差异(P=0.005,RR=1.12,95%Cl [1.03,1.21]),中药同期联合西药组根除率高于单独西药组,；消化性溃疡组间比较,试验组优于对照组,具有统计学差异(P=0.02, RR=1.13,95%Cl [1.02,1.25]);慢性胃炎试验组和对照组比较无统计学差异(P=0.39,RR=1.22,95%Cl [0.78,1.91]);疗程7天中西医结合组和单纯西药组之间有统计学差异(P=0.05, RR=1.09,95%Cl [1.00,1.18]);疗程14天中西医结合组和单纯西药组之间有统计学差异(P=0.01, RR=1.35,95%Cl [1.08,1.70]);中成药联合西药vs西药的根除率组间无统计学差异(P=0.25, RR=1.07,95%Cl [0.95,1.22]),而汤药联合西药vs西药的根除率组间比较,试验组优于对照组,有统计学差异(P=0.0009, RR=1.17,95%Cl [1.07,1.29])。中药同期联合西药组和单独西药组的不良反应发生率无统计学差异(P=0.14,0R=0.47,95%Cl [0.17,1.27])。亚组分析,汤药联合西药组和单纯西药组之间不良反应发生率组间有统计学差异(P=0.004, OR=0.27,95%Cl [0.11,0.66])。中药同期联合西药组和单独西药组的溃疡愈合率无统计学差异(P=0.46, RR=1.16,95%Cl [0.79,1.70])。
临床研究：共入选符合标准的研究对象768例,其中61例因无任何治疗后疗效记录不纳入FAS分析,FAS分析707例；有21例因依从性低不纳入PPS分析,PPS分析686例；SS集分析714例。所有受试者性别、年龄、既往病史与合并疾病、合并用药情况在四组中分布均衡,P>0.05,没有统计学差异。受试者基线症状积分及生活质量量表各维度评分、PRO量表各维度评分四组间均没有统计学差异,P>0.05,具有可比性。Hp根除率(FAS)方面：A组为67.6%,B组为76.0%,C组为78.9%,D组为81.1%；Hp根除率(PPS)：A组为67.6%,B组为76.6%,C组为78.1%,D组为80.4%。FAS分析结果：四组的Hp根除率比较,P=0.0489<0.05,四组不完全相同；PPS分析结果：四组的Hp根除率比较,P=0.0750>0.05,无统计学差异。对FAS进行两两比较,按照校正水准修正值α=0.0083,得到A组和C组之间(P=0.0081<0.0083)、A组和D组之间(P=0.0065<0.0083),根除率有统计学差异,C、D组的Hp根除率比A组高。受试者治疗前后症状积分情况,组内治疗前后比较,P<0.05,差异显著,治疗后症状改善明显。B、C、D三组症状积分改善值高于A组,但组间比较,P>0.05,并无统计学差异,说明各组治疗前后症状改善情况一致。受试者治疗前后生活质量8个维度评分组内比较,P<0.05,各组治疗后均有改善,生活质量均有提高。但组间比较,仅有身体疼痛维度评分四组不完全相同,P<0.05,差异具有统计学意义。对身体疼痛维度做两两比较,只A组和D组维度评分比较,P<0.05,有统计学差异,D组对身体疼痛的改善明显比A组好。受试者PRO量表各维度评分在四个组组内治疗前后比较,P<0.05,改善有统计学意义。四个组组间比较,仅有反流、消化不良维度的改善情况,P<0.05,四个组不完全相同；对其进行两两比较,反流维度的改善情况,只有A组与D组比较,P<0.05,D组改善较A组改善明显。消化不良维度,A组与C组、D组比较,P<0.05,C、D组对消化不良的改善都比A组明显。治疗前后查血常规、尿常规、大便常规、肝肾功及心电图,发现有临床意义的指标变化记录为不良事件,如肝损害等,未发现其它有临床意义的指标变化。治疗过程中发生与试验药物可能相关的不良事件23例,其中A组11例(6%),B组7例(4%),C组2例(1.1%),D组3例(1.7%),未发生严重不良事件。多组间比较,P<0.05,四组不良反应发生率不全相同；再进行两两比较,得到只有A组和C组、D组之间比较,P<0.0083,不良反应发生率的差异有统计学意义,C组、D组的不良反应发生率都低于A组。
[结论]
系统评价：中药同期联合西药组的Hp根除率高于单独西药组。亚组分析结论：消化性溃疡和功能性消化不良的根除率组间有统计学差异,慢性胃炎的根除率组间无统计学差异；无论疗程为7天还是14天,中西医结合组根除率均优于单独西药组；中成药联合西药组和单纯西药间根除率无统计学差异,汤药联合西药组和单独西药组间根除率有统计学差异；中药同期联合西药组的不良反应发生率和单独西药组没有统计学差异,汤药联合西药组的不良反应发生率低于单独西药组间。
临床研究：辨证应用中药汤剂联合标准三联疗法能够提高Hp根除率,对患者生活质量及PRO改善明显,降低不良反应发生率,临床应用安全有效。
Objective To summarize theory, methods and design of clinical trials literature on TCM for the treatment of Hp and analyze dominant and insufficient position.A systematic review about eradication rate of Hp by TCM combined with standard triple therapy. To evaluate the efficacy and safety of TCM decoction and powder combined with standard triple therapy on improving eradication rate of Hp according to a multiple center RCT. At last, to discuss and expect the theory and clinical trials.
Methods Systematic review:Defining scrupulous inclusion and exclusion criteria of literature, Searching fully literature on TCM combined with standard triple therapy treating Hp, then evaluating and preparation by screening, finally Meta-analyzing all the inclusion literature, to evaluating efficacy and safety. Clinical trial:A multi-center randomized control clinical trial design was adopted in the trial. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences. Group A was control group, was given standard triple therapy-omeprazole20mg, amoxicillin1.0g, clarithromycin0.5g, twice a day, lOdays. Group B,C,D were all experiment group, were given respectively TCM powder-twice a day,2weeks combined with standard triple therapy, TCM decoction-twice a day,4weeks combined with standard triple therapy, TCM decoction-twice a day,2weeks combined with standard triple therapy. Patients were examined Hp and some other observation quota at the point that1month after stopping west medicine.
Results Systematic review:Finally inclusion literatures for meta-analyzing were7. There were1115subjects in all, among which669were experiment group,446were control group, and57were withdrawed-45were failed visit,6were taken medicine by doctor,6were break off for adverse reaction. Every study reported ordinary circumstance-gender, age and so on of patients, and baseline was comparable. Eradication rate:TCM combined with west medicine and single west medicine had the statistically significant difference (P=0.005, RR=1.12,95%Cl [1.03,1.21]). For PU, the differences were statistically significant between the experimental and control group (P=0.02, RR=1.13,95%Cl [1.02,1.25]). For CG, the differences were not statistically significant between the experimental and control group (P=0.39, RR=1.22,95%Cl [0.78,1.91]). For period of treatment-7days, the differences were not statistically significant between the experimental and control group (P=0.05, RR=1.09,95%Cl [1.00,1.18]). For course of treatment-14days, the differences were not statistically significant between the experimental and control group (P=0.01, RR=1.35,95%Cl [1.08,1.70]). For Chinese patent drug, the differences were not statistically significant between the experimental and control group (P=0.25, RR=1.07,95%Cl [0.95,1.22]). For Chinese decoction medicine, the differences were statistically significant between the experimental and control group (P=0.0009, RR=1.17,95%C1[1.07,1.29]). Adverse reaction:the differences were not statistically significant between the experimental and control group (P=0.14,OR=0.47,95%Cl [0.17,1.27]). For Chinese decoction medicine, the differences were statistically significant between the experimental and control group (P=0.004, OR=0.27,95%Cl [0.11,0.66]). Coalescence rate:the differences were not statistically significant between the experimental and control group (P=0.46, RR=1.16,95%Cl [0.79,1.70]). Clinical trial:768were included, and707were screened for FAS,686were screened for PPS,714were screened for SS. All patients'gender, age, medical history, combined disease, combined medicine, symptom scores, scores of SF-36and scores of PRO didn't have statistically significant difference at baseline (P>0.05). In FAS, eradication rate of Hp:Group A were67.6%, Group B were76.0%, Group C were78.9%, Group D were81.1%, and there were statistically significant difference in4groups (P=0.0489<0.05), but only Group A and Group C (P=0.0081<0.0083), Group A and Group D (P=0.0065<0.0083) had statistically significant difference in2groups. In PPS, eradication rate of Hp:Group A were67.6%, Group B were76.6%, Group C were78.1%, Group D were80.4%. For FAS, the socres of symptom:the scores after treatment had statistically significant difference from before in every group (P<0.05).But there were not statistically significant difference in4groups (P>0.05). For FAS, the socres of SF-36:the scores after treatment had statistically significant difference from before in every group (P<0.05).Only in body pain, there were statistically significant difference in4groups (P<0.05), and only between Group A and Group D there were statistically significant difference (P<0.05). For FAS, the socres of PRO:the scores after treatment had statistically significant difference from before in every group (P<0.05). Only in regurgitation and dyspepsia, there were statistically significant difference in4groups (P<0.05), and for regurgitation, only between Group A and Group D there were statistically significant difference (P<0.05), for dyspepsia, between Group A and Group C, between Group A and Group D there were both statistically significant difference (P<0.05). There were not any quota change of laboratory test between before and after treatment.23adverse reaction probably relevant with trial medicine happened in the treatment.11events happened in Group A (6%),7events happened in Group B (4%),2events happened in Group C (1.1%),3events happened in Group D (1.7%). There was not any serious adverse reaction happened. There were statistically significant difference in4groups (P<0.05), and only between Group A and Group C, between Group A and Group D there were both statistically significant difference (P<0.0083).
Conclusions systematic review:Hp eradication rate:TCM combined with west medicine group was better than single west medicine group, for PU and FD, there were both statistically significant difference between two groups, but for CG, there were not. Eradication rate had nothing to do with course of treatment, and there were both statistically significant difference between two groups in7days and14days. For Chinese patent drugs, there were not statistically significant difference between two groups, but for Chinese decoction medicine, there were. Among7trials,4trials reported the happening of adverse reaction.there were not statistically significant difference between two groups, but adverse reaction happening rate of Chinese decoction medicine combined with west medicine was less, the difference was statistically significant.
Clinical trial:Treatment based on syndrome differentiation combined with standard triple therapy group was better than standard triple therapy group in Hp eradication rate, improvement of quality of life and PRO and adverse reaction happening rate.
对中医药治疗幽门螺杆菌(Helicobactor pylori, Hp)临床研究文献的理论、方法及研究设计等进行总结概述,分析目前优势及不足,为临床、科研提供参考；对中医药联合标准三联疗法治疗Hp的随机对照试验(Random control trial, RCT)进行系统评价,了解目前治疗现状；对辨证应用中药汤剂、中药散剂联合标准三联疗法提高Hp根除率进行多中心随机对照研究,评价其有效性和安全性；最后贯穿理论与临床研究进行讨论及展望。
[方法]
系统评价：确定严格的文献纳入、排除标准,充分检索中药联合标准治疗方案治疗Hp相关文献,并进行评价筛选,纳入最终符合的文献进行Meta分析,评价其有效性及安全性；
临床研究：采用多中心随机对照临床试验设计,对符合纳入标准、不符合排除标准的慢性胃炎伴Hp感染患者按入组顺序申请中心随机号码,并给予相应治疗,A组为对照组,给予西药标准三联疗法：奥美拉唑20mg、阿莫西林1.0、克拉霉素0.5,每日2次(Bid),持续10天,B、C、D组为试验组,分别给予同对照组西药10天+中药散剂2周,Bid、同对照组西药10天+中药汤剂4周,Bid、同对照组西药10天+中药汤剂2周,Bid,停用西药后1个月为疗后访视点,复查Hp、安全性检查项目,填写症状量表、SF-36量表、PRO量表,对观测指标进行统计分析。
[结果]
系统评价：最终纳入Meta分析的文献7篇,全部纳入的病例总数为1115例,试验组669例,对照组446例。完成治疗1058例,退出研究57例,其中拒绝复查失访45例,未按医嘱服药6例,因不良反应中止6例。各研究均报告了受试者的一般情况,包括性别、年龄等,具有基线可比性。Hp根除率方面,中药同期联合西药组根除Hp和单独西药组之间有统计学差异(P=0.005,RR=1.12,95%Cl [1.03,1.21]),中药同期联合西药组根除率高于单独西药组,；消化性溃疡组间比较,试验组优于对照组,具有统计学差异(P=0.02, RR=1.13,95%Cl [1.02,1.25]);慢性胃炎试验组和对照组比较无统计学差异(P=0.39,RR=1.22,95%Cl [0.78,1.91]);疗程7天中西医结合组和单纯西药组之间有统计学差异(P=0.05, RR=1.09,95%Cl [1.00,1.18]);疗程14天中西医结合组和单纯西药组之间有统计学差异(P=0.01, RR=1.35,95%Cl [1.08,1.70]);中成药联合西药vs西药的根除率组间无统计学差异(P=0.25, RR=1.07,95%Cl [0.95,1.22]),而汤药联合西药vs西药的根除率组间比较,试验组优于对照组,有统计学差异(P=0.0009, RR=1.17,95%Cl [1.07,1.29])。中药同期联合西药组和单独西药组的不良反应发生率无统计学差异(P=0.14,0R=0.47,95%Cl [0.17,1.27])。亚组分析,汤药联合西药组和单纯西药组之间不良反应发生率组间有统计学差异(P=0.004, OR=0.27,95%Cl [0.11,0.66])。中药同期联合西药组和单独西药组的溃疡愈合率无统计学差异(P=0.46, RR=1.16,95%Cl [0.79,1.70])。
临床研究：共入选符合标准的研究对象768例,其中61例因无任何治疗后疗效记录不纳入FAS分析,FAS分析707例；有21例因依从性低不纳入PPS分析,PPS分析686例；SS集分析714例。所有受试者性别、年龄、既往病史与合并疾病、合并用药情况在四组中分布均衡,P>0.05,没有统计学差异。受试者基线症状积分及生活质量量表各维度评分、PRO量表各维度评分四组间均没有统计学差异,P>0.05,具有可比性。Hp根除率(FAS)方面：A组为67.6%,B组为76.0%,C组为78.9%,D组为81.1%；Hp根除率(PPS)：A组为67.6%,B组为76.6%,C组为78.1%,D组为80.4%。FAS分析结果：四组的Hp根除率比较,P=0.0489<0.05,四组不完全相同；PPS分析结果：四组的Hp根除率比较,P=0.0750>0.05,无统计学差异。对FAS进行两两比较,按照校正水准修正值α=0.0083,得到A组和C组之间(P=0.0081<0.0083)、A组和D组之间(P=0.0065<0.0083),根除率有统计学差异,C、D组的Hp根除率比A组高。受试者治疗前后症状积分情况,组内治疗前后比较,P<0.05,差异显著,治疗后症状改善明显。B、C、D三组症状积分改善值高于A组,但组间比较,P>0.05,并无统计学差异,说明各组治疗前后症状改善情况一致。受试者治疗前后生活质量8个维度评分组内比较,P<0.05,各组治疗后均有改善,生活质量均有提高。但组间比较,仅有身体疼痛维度评分四组不完全相同,P<0.05,差异具有统计学意义。对身体疼痛维度做两两比较,只A组和D组维度评分比较,P<0.05,有统计学差异,D组对身体疼痛的改善明显比A组好。受试者PRO量表各维度评分在四个组组内治疗前后比较,P<0.05,改善有统计学意义。四个组组间比较,仅有反流、消化不良维度的改善情况,P<0.05,四个组不完全相同；对其进行两两比较,反流维度的改善情况,只有A组与D组比较,P<0.05,D组改善较A组改善明显。消化不良维度,A组与C组、D组比较,P<0.05,C、D组对消化不良的改善都比A组明显。治疗前后查血常规、尿常规、大便常规、肝肾功及心电图,发现有临床意义的指标变化记录为不良事件,如肝损害等,未发现其它有临床意义的指标变化。治疗过程中发生与试验药物可能相关的不良事件23例,其中A组11例(6%),B组7例(4%),C组2例(1.1%),D组3例(1.7%),未发生严重不良事件。多组间比较,P<0.05,四组不良反应发生率不全相同；再进行两两比较,得到只有A组和C组、D组之间比较,P<0.0083,不良反应发生率的差异有统计学意义,C组、D组的不良反应发生率都低于A组。
[结论]
系统评价：中药同期联合西药组的Hp根除率高于单独西药组。亚组分析结论：消化性溃疡和功能性消化不良的根除率组间有统计学差异,慢性胃炎的根除率组间无统计学差异；无论疗程为7天还是14天,中西医结合组根除率均优于单独西药组；中成药联合西药组和单纯西药间根除率无统计学差异,汤药联合西药组和单独西药组间根除率有统计学差异；中药同期联合西药组的不良反应发生率和单独西药组没有统计学差异,汤药联合西药组的不良反应发生率低于单独西药组间。
临床研究：辨证应用中药汤剂联合标准三联疗法能够提高Hp根除率,对患者生活质量及PRO改善明显,降低不良反应发生率,临床应用安全有效。
Objective To summarize theory, methods and design of clinical trials literature on TCM for the treatment of Hp and analyze dominant and insufficient position.A systematic review about eradication rate of Hp by TCM combined with standard triple therapy. To evaluate the efficacy and safety of TCM decoction and powder combined with standard triple therapy on improving eradication rate of Hp according to a multiple center RCT. At last, to discuss and expect the theory and clinical trials.
Methods Systematic review:Defining scrupulous inclusion and exclusion criteria of literature, Searching fully literature on TCM combined with standard triple therapy treating Hp, then evaluating and preparation by screening, finally Meta-analyzing all the inclusion literature, to evaluating efficacy and safety. Clinical trial:A multi-center randomized control clinical trial design was adopted in the trial. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences. Group A was control group, was given standard triple therapy-omeprazole20mg, amoxicillin1.0g, clarithromycin0.5g, twice a day, lOdays. Group B,C,D were all experiment group, were given respectively TCM powder-twice a day,2weeks combined with standard triple therapy, TCM decoction-twice a day,4weeks combined with standard triple therapy, TCM decoction-twice a day,2weeks combined with standard triple therapy. Patients were examined Hp and some other observation quota at the point that1month after stopping west medicine.
Results Systematic review:Finally inclusion literatures for meta-analyzing were7. There were1115subjects in all, among which669were experiment group,446were control group, and57were withdrawed-45were failed visit,6were taken medicine by doctor,6were break off for adverse reaction. Every study reported ordinary circumstance-gender, age and so on of patients, and baseline was comparable. Eradication rate:TCM combined with west medicine and single west medicine had the statistically significant difference (P=0.005, RR=1.12,95%Cl [1.03,1.21]). For PU, the differences were statistically significant between the experimental and control group (P=0.02, RR=1.13,95%Cl [1.02,1.25]). For CG, the differences were not statistically significant between the experimental and control group (P=0.39, RR=1.22,95%Cl [0.78,1.91]). For period of treatment-7days, the differences were not statistically significant between the experimental and control group (P=0.05, RR=1.09,95%Cl [1.00,1.18]). For course of treatment-14days, the differences were not statistically significant between the experimental and control group (P=0.01, RR=1.35,95%Cl [1.08,1.70]). For Chinese patent drug, the differences were not statistically significant between the experimental and control group (P=0.25, RR=1.07,95%Cl [0.95,1.22]). For Chinese decoction medicine, the differences were statistically significant between the experimental and control group (P=0.0009, RR=1.17,95%C1[1.07,1.29]). Adverse reaction:the differences were not statistically significant between the experimental and control group (P=0.14,OR=0.47,95%Cl [0.17,1.27]). For Chinese decoction medicine, the differences were statistically significant between the experimental and control group (P=0.004, OR=0.27,95%Cl [0.11,0.66]). Coalescence rate:the differences were not statistically significant between the experimental and control group (P=0.46, RR=1.16,95%Cl [0.79,1.70]). Clinical trial:768were included, and707were screened for FAS,686were screened for PPS,714were screened for SS. All patients'gender, age, medical history, combined disease, combined medicine, symptom scores, scores of SF-36and scores of PRO didn't have statistically significant difference at baseline (P>0.05). In FAS, eradication rate of Hp:Group A were67.6%, Group B were76.0%, Group C were78.9%, Group D were81.1%, and there were statistically significant difference in4groups (P=0.0489<0.05), but only Group A and Group C (P=0.0081<0.0083), Group A and Group D (P=0.0065<0.0083) had statistically significant difference in2groups. In PPS, eradication rate of Hp:Group A were67.6%, Group B were76.6%, Group C were78.1%, Group D were80.4%. For FAS, the socres of symptom:the scores after treatment had statistically significant difference from before in every group (P<0.05).But there were not statistically significant difference in4groups (P>0.05). For FAS, the socres of SF-36:the scores after treatment had statistically significant difference from before in every group (P<0.05).Only in body pain, there were statistically significant difference in4groups (P<0.05), and only between Group A and Group D there were statistically significant difference (P<0.05). For FAS, the socres of PRO:the scores after treatment had statistically significant difference from before in every group (P<0.05). Only in regurgitation and dyspepsia, there were statistically significant difference in4groups (P<0.05), and for regurgitation, only between Group A and Group D there were statistically significant difference (P<0.05), for dyspepsia, between Group A and Group C, between Group A and Group D there were both statistically significant difference (P<0.05). There were not any quota change of laboratory test between before and after treatment.23adverse reaction probably relevant with trial medicine happened in the treatment.11events happened in Group A (6%),7events happened in Group B (4%),2events happened in Group C (1.1%),3events happened in Group D (1.7%). There was not any serious adverse reaction happened. There were statistically significant difference in4groups (P<0.05), and only between Group A and Group C, between Group A and Group D there were both statistically significant difference (P<0.0083).
Conclusions systematic review:Hp eradication rate:TCM combined with west medicine group was better than single west medicine group, for PU and FD, there were both statistically significant difference between two groups, but for CG, there were not. Eradication rate had nothing to do with course of treatment, and there were both statistically significant difference between two groups in7days and14days. For Chinese patent drugs, there were not statistically significant difference between two groups, but for Chinese decoction medicine, there were. Among7trials,4trials reported the happening of adverse reaction.there were not statistically significant difference between two groups, but adverse reaction happening rate of Chinese decoction medicine combined with west medicine was less, the difference was statistically significant.
Clinical trial:Treatment based on syndrome differentiation combined with standard triple therapy group was better than standard triple therapy group in Hp eradication rate, improvement of quality of life and PRO and adverse reaction happening rate.
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