ABSTRACT
Profound changes have taken place in human disease spectrum, constitution spectrum, and drug use behavior, and the safety of traditional Chinese medicine(TCM) faces new trends and problems. In particular, serious adverse reactions/events such as liver injury and kidney injury caused by non-toxic TCM have been frequently reported, overturning people's understanding of TCM safety, and even shaking the public's confidence in the development of TCM. In the new era of globalization, correctly understanding the situation and problems of TCM safety and addressing the dilemmas in safety evaluation and risk prevention of TCM are the key missions to be undertaken by TCM practitioners. This paper suggests that the situation and problems of TCM safety should be viewed objectively and dialectically, and the use standard of TCM should be advanced with the times. Furthermore, this paper puts forward the new conception and methodology of TCM safety(including one innovative understanding, two types of evaluation modes, tri-elements injury hypothesis; four-quadrant risk decision processes, and five-grade safety evidence body) for the first time, hoping to provide new theories, new strategies, new methods and successful examples for solving the safety problems of TCM.
Subject(s)
Humans , Medicine, Chinese Traditional/adverse effects , Internationality , Drugs, Chinese Herbal/adverse effectsABSTRACT
With the increase in the medical level, the improvement of adverse drug reaction(ADR) monitoring systems, and the enhancement of public awareness of safe medication, drug safety incidents have been frequently reported. Drug-induced liver injury(DILI), especially liver injury attributed to herbal and dietary supplements(HDS), has globally attracted high attention, bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision. Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS) in 2020. In this consensus, liver injury attributed to HDS was included in a special chapter for the first time. The hot topics, including the definition of HDS-induced liver injury, epidemiological history, potential risk factors, collection of related risk signals, causality assessment, risk prevention, control and management were discussed from a global perspective. Based on the previous works, some experts from China were invited by CIOMS to undertake the compilation of this chapter. Meanwhile, a new causality assessment in DILI based on the integrated evidence chain(iEC) method was widely recognized by experts in China and abroad, and was recommended by this consensus. This paper briefly introduced the main contents, background, and characteristics of the Consensus on drug-induced liver injury. Significantly, a brief interpretation was illustrated to analyze the special highlights of Chapter 8, "Liver injury attributed to HDS", so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.
Subject(s)
Humans , Consensus , Chemical and Drug Induced Liver Injury/etiology , Risk Factors , Dietary Supplements/adverse effectsABSTRACT
OBJECTIVE@#To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus (BGZP) related with hepatobiliary adverse drug reactions (ADR), in order to reinforce pharmacovigilance.@*METHODS@#A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016. Serious and general ADRs were analyzed and assessed.@*RESULTS@#There were 355 cases of hepatobiliary ADR related to BGZP. Both the amount of cases and the proportion of serious ADR showed an increasing growth by years (P<0.05). It was found that 10.43% of 355 cases may be involved with irrational drug use, including overdose, repeated medication, and combination of multiple drugs. There were 190 cases which used BGZP (non-combination), and they were mainly for common in diseases caused by abnormal immune activation (accounting for 40.53% of the total cases). Especially at the age group with the most cases with age of 41-50 years, the cases associated with immunological diseases of female were obviously more than that of male (P<0.05). The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days, and the median latency was 27.5 days, along with the range of cumulative dose (0.45-520.02 g) as well as the daily dose (0.09-2.64 g/d) after the conversion.@*CONCLUSIONS@#Cases of hepatobiliary ADR related to BGZP showed significant individual differences, and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR. It may be similar with idiosyncratic drug-induced liver injury, and recommended that BGZP should be used with more caution under monitoring liver function, especially in female patients with immunological diseases.
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Adverse Drug Reaction Reporting Systems , Chemical and Drug Induced Liver Injury/etiology , Drug-Related Side Effects and Adverse Reactions , Pharmacovigilance , Retrospective StudiesABSTRACT
The authors systemically evaluated and analyzed the safety of Areca catechu from domestic and foreign literatures about the herbal origin, toxicity recorded in ancient/current documents, safety case reports of clinical A. catechu, experimental studies on toxicity in recent years, and differences of safety risk between edible and medicinal A. catechu. Subsequently, they proposed a preliminary summary about the clinical characteristics and potential risk factors of safety related cases of A. catechu and its preparations. According to the authors, although clinical adverse events of A. catechu were fewer and controllable, clinicians shall stillstrictly standardize its application, and rationally combine it with other herbs, while strengthening fundamental and clinical studies related to safety, so as to give better guidance to safety application of A. catechu in clinic.
ABSTRACT
<p><b>OBJECTIVE</b>To compare the clinical effects of arthroscopic debridement versus open debridement on controlling and treatment of infection after total knee replacement.</p><p><b>METHODS</b>From October 2009 to September 2016 in three hospitals, 11 patients with 11 joints which were infected after total knee replacement were randomly divided into two groups:5 cases in arthroscopy group and 6 cases in routine group. Patients in arthroscopy group were treated with arthroscopic debridement to remove the necrotic tissues, then closed-type irrigation with sensitive antibiotics by using two sebific ducts were performed continuously for 2 or 3 weeks until the flushing fluid became clear for 3 or 5 days;other 6 patients in routine group were treated with open surgical debridement and the following procedures in keeping with those in the arthroscopy group. Operation time, blood loss and incision length were recorded during the operation, and pain scores were recorded on the 1st, 3rd and 7th day after the operation. The curative effects were evaluated according to the Hospital for Special Surgery score system.</p><p><b>RESULTS</b>The local and general symptoms of the 11 patients disappeared, and the test outcomes of biochemistry, blood and synovial fluid were normal. All patients were followed up, and the duration ranged from 6 to 18 months. Infection recurrences were observed in 1 case of arthroscopy group and 2 cases of routine group 3 months later after operation, and all these patients who underwent the second time operation with arthroscopic debridement were cured. According to the Hospital for Special Surgery score system, 3 cases obtained excellent result, 2 good, no poor and bad cases in arthroscopy group;3 cases obtained excellent result, 1 good, 1 poor and 1 bad in routine group.</p><p><b>CONCLUSIONS</b>If the sensitive antibiotics can be found for the infected joints without obvious destruction of bone and no prosthesis loosening, it has a better therapeutic effect by using arthroscopic debridement combined with continuous drainage and irrigation. The method has a better curative effect with smaller trauma.</p>
ABSTRACT
Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.
ABSTRACT
Decoction is one of the most commonly used dosage forms of traditional Chinese medicine. The stability of chemical constituents in decoction is closely related to the clinical efficacy and safety. There were few reports about the influence of metal ions in the stability of chemical constituents in traditional Chinese medicine. However, there is no evidence that metal ions in decoction water need to be controlled. In this study, 2,3,5,4'-tetrahydroxy stilbene-2-O-β-D-glucoside (THSG), one of the main constituents in Polygoni Multiflori Radix was studied. Ordinary tap water, deionized water, and water containing different metal ions were used to investigate and compare the influence on THSG . The results showed that after storage in a dark place at the room temperature for 10 days, the degradation of THSG was 7% in deionized water, while undetectable in tap water. The content of THSG could be decreased by different kinds of metal ions, and the effect was concentration- dependent. Moreover, Fe3+ and Fe2+ showed the greatest influence at the same concentration; and our study has shown that THSG decreased more than 98% in Fe3+ and Fe2+ solutions at 500 ppm concentration. In the same time we found out p-hydroxybenzaldehyde (molecular weight: 122.036 7) and 2,3,5-trihydroxybenzaldehyde-2- O-glycoside (molecular weight: 316.079 4) were the main degradation products of THSG in tap water and water containing Cu2+, Ca2+, Zn2+, Mg2+ and Al3+. The product of THSG dimer with a water molecule was found in water containing Fe3+ and Fe2+. The above results showed that the metal ions in water could significantly influence the stability of THSG in water, indicating that the clinical efficacy and safety of decoction would be affected if the metal ions in water were not under control. It's suggested that deionized water should be used in the preparation of decoction containing Polygoni Multiflori Radix in the clinic to avoid degradation of THSG. Meanwhile, decoction prepared by tap water should be taken by patients in a short time. Our investigation provides important information and reference about the influence of metal ions on the stability of decoctions in other traditional Chinese medicine that have unstable groups such as hydroxyls and unsaturated bonds, etc.
ABSTRACT
Decoction is one of the most commonly used dosage forms of traditional Chinese medicine. The stability of chemical constituents in decoction is closely related to the clinical efficacy and safety. There were few reports about the influence of metal ions in the stability of chemical constituents in traditional Chinese medicine. However, there is no evidence that metal ions in decoction water need to be controlled. In this study, 2,3,5,4'-tetrahydroxy stilbene-2-O-β-D-glucoside (THSG), one of the main constituents in Polygoni Multiflori Radix was studied. Ordinary tap water, deionized water, and water containing different metal ions were used to investigate and compare the influence on THSG. The results showed that after storage in a dark place at the room temperature for 10 days, the degradation of THSG was 7% in deionized water, while undetectable in tap water. The content of THSG could be decreased by different kinds of metal ions, and the effect was concentration-dependent. Moreover, Fe3+ and Fe2+ showed the greatest influence at the same concentration; and our study has shown that THSG decreased more than 98% in Fe and Fe2+ solutions at 500 ppm concentration. In the same time we found out p-hydroxybenzaldehyde (molecular weight: 122.036 7) and 2,3,5-trihydroxybenzaldehyde-2-O-glycoside (molecular weight: 316.079 4) were the main degradation products of THSG in tap water and water containing Cu2+, Ca2+, Zn2+, Mg2+ and Al3+. The product of THSG dimer with a water molecule was found in water containing Fe3+ and Fe2+. The above results showed that the metal ions in water could significantly influence the stability of THSG in water, indicating that the clinical efficacy and safety of decoction would be affected if the metal ions in water were not under control. It's suggested that deionized water should be used in the preparation of decoction containing Polygoni Multiflori Radix in the clinic to avoid degradation of THSG. Meanwhile, decoction prepared by tap water should be taken by patients in a short time. Our investigation provides important information and reference about the influence of metal ions on the stability of decoctions in other traditional Chinese medicine that have unstable groups such as hydroxyls and unsaturated bonds, etc.
Subject(s)
Drugs, Chinese Herbal , Chemistry , Glucosides , Chemistry , Ions , Chemistry , Metals , Chemistry , Plant Roots , Chemistry , Polygonaceae , Chemistry , Stilbenes , ChemistryABSTRACT
In recent years, the rapid growth of reports on fleece-flower root-caused liver damages has drawn wide attention of both at home and abroad, however, there were rare literature on toxicology of fleece-flower root in ancient Chinese medicine. But why there are so many reports on toxicology of fleece-flower root now compared with the ancient literature? As a typical tonic medicine, the clinical utility of fleece-flower root was largely limited by its standardization and reliability of processing methods in ancient Chinese medicine. The ancient processing methods of fleece-flower root emphasized nine times of steaming and nine times of drying, while the modern processes have been simplified into one time of steaming. Whether the differences between ancient and modern processing methods are the potential cause of the increased events of fleece-flower root-caused liver damages. We will make deep analysis and provide new clues and perspectives for the research on its toxicity. This article, therefore, would discuss the affecting factors and key problems in toxicity attenuation of fleece-flower root on the basis of sorting out the processing methods of fleece-flower root in ancient medical books and modern standards, in order to provide the reference for establishing specification for toxicity attenuation of fleece-flower root.
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The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.
Subject(s)
Humans , China , Epidemiology , Drug Evaluation , Drug-Related Side Effects and Adverse Reactions , Epidemiology , Drugs, Chinese Herbal , Therapeutic Uses , Product Surveillance, PostmarketingABSTRACT
<p><b>OBJECTIVE</b>To analyze hepatotoxicity of Polygonum multiflorum and clinical character- istics of drug-induced liver injury (DILI) caused by Polygonum multiflorum and its preparations.</p><p><b>METHODS</b>A retrospective study was performed in 158 patients treated at 302 Military Hospital between January 2009 and January 2014. All of them had used Polygonum multiflorum and its preparations before the onset of DILI, and their clinical characteristics and prognoses were analyzed.</p><p><b>RESULTS</b>Of the 158 DILI patients who used Polygonum multiflorum or its preparations, 92 (58.2%) combined with Western medicine or Chinese herbal preparations without Polygonum multiflorum; 66 patients (41.8%) used Polygonum mult florum and its preparations alone. In 66 DILI patients induced by Polygonum multiflorum or its preparations alone, 51 cases (77.3%) were induced by Polygonum multiflorum compounds and 22.7% by single Po- lygonum multiflorum; 4 cases (6.1%) were caused by crude Polygonum multiflorum and 62 (93.9%) by processed Polygonum multiflorum and its preparations. Clinical injury patterns were hepatocellular 92.4% (61 cases), cholestatic 1.5% (1 case), and mixed 6.1% (4 cases). Pathological examination was per- formed by liver biopsy in 32 cases (48.15%), manifested as hepatocellular degeneration and necrosis, fibroplasia, Kupffer cells with pigment granule, and a large number of eosinophil infiltration, were ob- served. Four patients were developed into liver failure, 4 into cirrhosis, and 1 died.</p><p><b>CONCLUSION</b>Polygo- num multiflorum and its preparations could induce DILI, but clinical diagnosis of Polygonum multiflorum induced hepatotoxicity should be cautious.</p>
Subject(s)
Humans , Asian People , Chemical and Drug Induced Liver Injury , Diagnosis , Cholestasis , Drugs, Chinese Herbal , Fallopia multiflora , Liver Cirrhosis , Liver Failure , Plant Preparations , Polygonum , Retrospective StudiesABSTRACT
Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.
Subject(s)
Humans , China , Drugs, Chinese Herbal , History , History, Ancient , Medicine in Literature , Medicine, Chinese Traditional , History , Polygonum , Risk AssessmentABSTRACT
The liver injury induced by Polygonum multiflorum Thunb. (PM) was investigated based on idiosyncratic hepatotoxicity model co-treated with lipopolysaccharide (LPS) at a non-hepatotoxic dose. Sprague-Dawley (SD) rats were intragastrically administered with three doses (18.9, 37.8, 75.6 g crude drug per kg body weight) of 50% alcohol extracts of PM alone or co-treated with non-toxic dose of LPS (2.8 mg·kg(-1)) via tail vein injection. The plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities were assayed and the isolated livers were evaluated for histopathological changes. The dose-toxicity relationships of single treatment of PM or co-treatment of LPS were investigated comparatively to elucidate the idiosyncratic hepatotoxicity of PM. The results showed that no significant alterations of plasma ALT and AST activities were observed in the groups of solo-administration of LPS (2.8 mg·kg(-1), i.v.) or different dosage (18.9, 37.8 and 75.6 g·kg(-1), i.g.) of PM, compared to normal control group (P > 0.05); while significant elevations were observed in the co-administration groups of PM and LPS. Treatment with LPS alone caused slight infiltration of inflammatory cells in portal area but no evident hepatocytes injury. Co-treatment with LPS and PM (75.6 g·kg(-1), i.g.) caused hepatocyte focal necrosis, loss of central vein intima and a large number of inflammatory cell infiltration in portal areas. When further reduce the dosage of PM, significant increases of plasma ALT and AST activities (P < 0.05) were still observed in co-administration groups of LPS and PM (1.08 or 2.16 g·kg(-1)), but not in LPS or PM solo-administration groups. Nevertheless, the co-treatment of low dosage of PM (0.54 g·kg(-1)) with LPS did not induce any alteration of plasma ALT and AST. In conclusion, intragastric administration with 75.6 g·kg(-1) of PM did not induce liver injury in normal rats model; while the 2 folds of clinical equivalent dose of PM (1.08 g·kg(-1)) could result in liver injury in the LPS-based idiosyncratic hepatotoxicity model, which could be used to evaluate the idiosyncratic hepatotoxicity of PM.
Subject(s)
Animals , Rats , Alanine Transaminase , Blood , Aspartate Aminotransferases , Blood , Chemical and Drug Induced Liver Injury , Pathology , Hepatocytes , Pathology , Lipopolysaccharides , Polygonum , Toxicity , Rats, Sprague-DawleyABSTRACT
<p><b>OBJECTIVE</b>To investigate clinical effects of minimally invasive fixation and bone grafting througn medial side for the treatment of Schatzker III tibial plateau fracture.</p><p><b>METHODS</b>From April 2009 to August 2011, 18 patients with Schatzker III tibial plateau fracture were treated with minimally invasive fixation and bone grafting through medial side. There were 15 males and 3 females ranging in age from 64 to 73 years, with an average of (69.75 ± 1.22) years. Sixteen patients were caused by falling down, 2 cases were caused by traffic accident. Operative time and length of incision were be recorded. Clinical and radiological follow-up was performed after operation. Hospital for Special Surgery (HSS) score and Kellgren-Lawrence score were used to evaluate clinical effects.</p><p><b>RESULTS</b>The mean operative time was (45.32 ± 1.58) min, and the mean length of incision was (5.21 ± 0.65) cm. Postoperative X-ray showed excellent reduction. Eighteen patients were followed up for 10 to 13 months with an average of (11.5 ± 1.35) months. The mean HSS score was 86.51 ± 2.71, 12 cases got excellent results,4 good and 2 fair. Three patients were developed mild osteoarthritis according to the Kellgren-Lawrence system.</p><p><b>CONCLUSION</b>Minimally invasive fixation and bone grafting through medial side, not only could reduce surgical invasive, but also guarantee early function activities. It has advantages of keeping well after reduction. So it has the favorable future in clinic.</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Bone Transplantation , Fracture Fixation, Internal , Methods , Minimally Invasive Surgical Procedures , Methods , Retrospective Studies , Tibial Fractures , General SurgeryABSTRACT
The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Subject(s)
Animals , Humans , Aristolochia , Chemistry , Aristolochic Acids , Therapeutic Uses , Toxicity , Drug Therapy , Drug-Related Side Effects and Adverse Reactions , Epidemiology , Drugs, Chinese Herbal , Therapeutic Uses , ToxicityABSTRACT
Recently traditional Chinese medicine (TCM)-induced liver injury has been an unresolved critical issue which impacts TCM clinical safety. The premise and key step to reduce or avoid drug-induced liver injury (DILI) is to identify the drug source of liver injury in early stage. Then the timely withdrawal of drug and treatment can be done. However, the current diagnosis of DILI is primarily governed by exclusive method relying on administering history supplied by patients and experience judgment from doctors, which lacks objective and reliable diagnostic indices. It is obvious that diagnosis of TCM-induced liver injury is especially difficult due to the complicated composition of TCM medication, as well the frequent combination of Chinese and Western drugs in clinic. In this paper, we proposed construction of research pattern and method for objective identification of TCM-related DILI based on translational toxicology, which utilizes clinical specimen to find specific biomarkers and characteristic blood-entering constituents, as well the clinical biochemistry and liver biopsy. With integration of diagnosis marker database, bibliographic database, medical record database and clinical specimen database, an integrative diagnosis database for TCM-related DILI can be established, which would make a transformation of clinical identification pattern for TCM-induced liver injury from subjective and exclusive to objective and index-supporting mode. This would be helpful to improve rational uses of TCM and promote sustainable development of TCM industry.
Subject(s)
Animals , Humans , Rats , Biomarkers, Pharmacological , Metabolism , Biopsy , Methods , Chemical and Drug Induced Liver Injury , Diagnosis , Metabolism , Pathology , Early Diagnosis , Liver , Pathology , Medicine, Chinese TraditionalABSTRACT
Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.
Subject(s)
Humans , Drug Evaluation , Methods , Drugs, Chinese Herbal , Medicine, Chinese TraditionalABSTRACT
<p><b>OBJECTIVE</b>To compare clinical efficacy for the treatment of proximal humeurs fractures in elderly patients between the minimally invasive plate osteosynthesis (MIPO) with less invasive stabilization system (LISS) and the open reduction and internal fixation (ORIF) with locking compression plate (LCP).</p><p><b>METHODS</b>From June 2008 to June 2011, 40 elderly patients suffering from proximal humeurs fractures were divided into two groups: 20 cases in minimally invasive group and 20 cases in routine group. Mini-incision approach from the lateral shoulder (minimally invasive group) and LISS can be chosen. It was short for MIPO. The antero-medial incision was used in routine group, LCP can be chosen in the method of ORIF. The operation time, the blood loss, the incision length, soreness at 1st, 3rd and 7th days after operation were recorded. The postoperative Neer score, the healing time of bone were recorded. The curative effects were compared according to Neer score system.</p><p><b>RESULTS</b>The mean operation times were (133.60 +/- 8.90) min and (132.70 +/- 8.41) min in minimally invasive group and routine group (P > 0.05). The blood losses were (155.20 +/- 19.07) ml and (324.05 +/- 48.32) ml (P < 0.05). The incision lengths were (8.15 +/- 1.89) cm and (13.05 +/- 1.95) cm (P < 0.05). The pain scores on the 1st,3rd and 7th days after operation were (6.20 +/- 2.39) and (8.33 +/- 3.01) (P < 0.05), (3.83 +/- 2.09) and (5.31 +/- 2.22) (P < 0.05), (1.22 +/- 0.89) and (3.13 +/- 1.75) (P < 0.05). The postoperative Neer scores were 93.16 +/- 2.55 and 80.31+/- 2.22 (P < 0.05) and the healing times of bone were (6.60 +/- 2.33) months and (8.93 +/- 3.41) months (P < 0.05). There were statistially differences in the blood losses, incision lengths, postoperative pain scores, postoperative Neer scores and the healing times of bone between two groups (P < 0.05). The operation time between the two groups had no statistically different (P > 0.05). According to Neer score system, 13 patients obtained an excellent results, 2 good, 5 fair in minimally invasive group; 6 patients obtained an excellent results, 5 good, 9 fair in routine group.</p><p><b>CONCLUSION</b>To compare with the routine group of ORIF, MIPO with LISS has the advantages of small incision, easier operation, less blood loss and improved postoperative shoulder joint function recovery for treatment of proximal humeurs fracture in elderly patients. It is another better method of internal fixation.</p>