Objective To evaluate the clinical effectiveness of laparoscopic cholecystectomy and laparoscopic common bile duct exploration （LC＋LCBDE） and endoscopic retrograde cholangiopancreatography/endoscopic sphincterectomy with LC（ERCP/EST＋LC） in treatment for cholecystolithiasis with choledocholithiasis. Methods From January 2008 to July 2011， 127 patients suffered from cholecystolithiasis with choledocholithiasis underwent either LC＋LCBDE（85 cases， LC＋LCBDE group） or ERCP/EST＋LC（42 cases， ERCP/EST＋LC group） were collected retrospectively. The clearance rate of calculus， hospital stay， hospitalization expenses， and the rate of postoperative complications were compared between two groups. Results Eighty-five patients were performed successfully in the LC＋LCBDE group， out of which 54 patients had primary closure of common bile duct （LC＋LCBDE primary closure group）， whereas in 28 patients common bile ducts were closed over T tube （LC＋LCBDE＋T tube group）. Forty-two patients were performed successfully in the ERCP/EST＋LC group. There were no differences in the clearance rate of calculus〔100%（82/82） versus 97.37%（37/38）， P=0.317〕 and postoperative complications rate 〔（4.71% （4/85） versus 4.76%（2/42）， P=1.000〕 between the LC＋LCBDE group and ERCP/EST＋LC group. The median （quartile） hospital stay in the LC＋LCBDE group was shorter than that in the ERCP/EST＋LC group 〔12 （6） d versus 17（9） d， P＜0.001〕. In the LC＋LCBDE primary closure group， both median （quartile）?hospital stay and median（quartile） hospitalization expenses were less than those of ERCP/EST＋LC〔hospital stay：11（5） d versus 17（9） d， P＜0.001；hospitalization expenses：27 054（8 452） yuan versus 31 595（11 743） yuan， P=0.005〕 . Conclusions In the management of patients suffered from cholecystolithiasis with choledocholithiasis， both LC＋LCBDE and ERCP/EST＋LC are safe and effective. LC＋LCBDE， especially primary closure after LCBDE， is associated with significantly less costs as compared with ERCP/EST＋LC. Moreover， patients can be cured by LC＋LCBDE through one-stage treatment with the protection of the papilla function and no limits to the amount or size of the choledocholithiasis. The LC＋LCBDE is a preferable choice for the appropriate cases of cholecystolithiasis with choledocholithiasis.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.
背景 随机对照临床试验的报告质量欠佳。当今，提高研究透明度至关重要，不充分的报告影响了对试验结果的可靠性和有效性的评估。临床试验报告的统一标准（Consolidated Standards of Reporting Trials，CONSORT）2010 声明是为提升随机对照临床试验的报告质量而制定的，但其最初关注的是两组平行对照试验。多臂试验常采用多个平行组设计方案，将试验者以相同概率随机分配至其中一个治疗组，比较多种干预措施的效应，但以三组或者更多的组别为常见。多臂试验的报告质量差异很大，使得对结果的判断和解释变得困难。尽管 CONSORT 2010 声明的大部分内容同样适用于多臂试验，但其中一些要素需要修改，并且在某些情况下还有额外的问题需要澄清。 目的 推出 CONSORT 2010 声明的多臂试验报告扩展版，以便于此类试验的报告。 设计 2014 年 CONSORT 工作组会议后，成立了一个包括所有作者的指南撰写工作组。工作组在 2014 年至 2018 年间，每两个月进行会面或电话会议，并通过电子邮件进行交流，讨论并制定了修订清单及其相关文本。草稿随后发给了包含 36 人的 CONSORT 工作组及另外 5 名在临床试验领域的知名专家，以供他们审阅。14 人提供了详细的反馈意见，工作组经过详细考虑，形成了扩展版的最终修订版。 结果 CONSORT 声明多臂试验扩展版，扩展了 CONSORT 2010 清单中的 10 个条目，并提供了良好的报告示例及对每个扩展条目重要性的详尽解释。核心要点是对多臂试验的明确定义，并要求清楚地报告涉及所有治疗组的目的和研究假设。应明确主要治疗方案的比较，并且作者应完整、透明地报告由各组得出的计划内和非计划内的比较。如果对多重性进行了统计校正，则应描述所使用的理由和方法。 结论和相关影响 CONSORT 2010 声明扩展版为多臂平行随机对照临床试验报告提供了具体指导，并有助于在此类试验报告中提供更高的透明度和准确性。